Bookmark this site!
MS TREATMENTS: REBIF

 
Post new topic   Reply to topic    msspeaks Forum Index -> MS - RESEARCH, ARTICLES, ABSTRACTS, DISCUSSION
View previous topic :: View next topic  
Author Message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Sat Jul 15, 2006 6:30 pm    Post subject: MS TREATMENTS: REBIF Reply with quote

Here's a place to discuss Rebif if you're on it or thinking about starting it or if you were on it in the past.
Back to top
View user's profile Send private message
Guest






PostPosted: Fri Jul 21, 2006 1:24 pm    Post subject: Re: MS TREATMENTS: REBIF Reply with quote Edit/Delete this post

I have something I'd like to say about Rebif. Due to liver problems I had to discontinue Rebif but it wasn't all that bad. I've read so many stories about the side effects of interferons that I was scared to death to try it.

The shot itself is almost painless. A small needle. I don't think that I felt particularly more tired while on it until my liver started to show signs of trouble.

It did cause depression though I didn't notice it. It took my doctor and my husand to point it out to me.

I tend toward depression anyway. MS related. I take Cymbalta for it.

This post isn't a glowing report but, as I said, it wasn't as bad as the nightmare I painted in my mind.

Anyone on this one?

Joy
Back to top
stillstANNding



Joined: 26 Jul 2006
Posts: 23
Location: Left

PostPosted: Wed Jul 26, 2006 5:53 pm    Post subject: Reply with quote

Joy,

It works for me. No new lesions in 2 years.

The depression caution is important. I also became depressed on Rebif and have decreased to the 22mcg injections.

No new lesions on this dose after 1 year.

Regards,
ANN
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Wed Jul 26, 2006 6:23 pm    Post subject: Reply with quote

Did lowering the dosage help with the depression?
Back to top
View user's profile Send private message
Guest






PostPosted: Wed Jul 26, 2006 10:09 pm    Post subject: Reply with quote Edit/Delete this post

stillstANNding wrote:
Joy,

It works for me. No new lesions in 2 years.

The depression caution is important. I also became depressed on Rebif and have decreased to the 22mcg injections.

No new lesions on this dose after 1 year.

Regards,
ANN


YAY, ANN! No new lesions!!

agate, I never got over 22 mg Rebif at my doctor's recommendation. I'm just so sensitive to meds. My depression was minor, I think. At 44 mg? I don't know.
Back to top
stillstANNding



Joined: 26 Jul 2006
Posts: 23
Location: Left

PostPosted: Thu Jul 27, 2006 10:35 am    Post subject: Reply with quote

Agate, yes, the depression floated away and I am happy w the 22mcg dose. It is still more than twice the amount of beta interferon 1-A than in Avonex. 66mcg versus 30mcg for A. And I did have new lesions on the A.

Joy, thanks for the congratulations. I just stick the needles in and try to pay attention to the results:).

ANN
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Wed Oct 11, 2006 5:46 pm    Post subject: (Abstract) Long-term Rebif therapy in RRMS patients Reply with quote

[Moved into the Rebif topic]

Posted: 27 Sep 2006 07:26 pm Post subject: (Abstract) Long-term Rebif therapy in RRMS patients


From PubMed, 9/27/06:

Quote:

Neurology. 2006 Sep 26;67(6):944-53.

Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS

Kappos L, Traboulsee A, Constantinescu C, Eralinna JP, Forrestal F, Jongen P, Pollard J, Sandberg-Wollheim M, Sindic C, Stubinski B, Uitdehaag B, Li D.
University of Basel, Basel, Switzerland. lkappos@uhbs.ch

OBJECTIVE: To conduct systematic long-term follow-up (LTFU) of patients in the Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) study to provide up to 8 years of safety, clinical and MRI outcomes on subcutaneous (s.c.) interferon (IFN) beta-1a in relapsing-remitting multiple sclerosis (RRMS).

METHODS: The original cohort of 560 patients was randomized to IFNbeta-1a, 44 or 22 microg three times weekly (TIW) or to placebo; after 2 years, patients on placebo were rerandomized to active treatment and the blinded study continued for a further 4 years. The LTFU visit was scheduled 7 to 8 years after baseline.

RESULTS: LTFU was attended by 68.2% of the original PRISMS study cohort (382/560 patients). 72.0% (275/382) were still receiving IFNbeta-1a s.c. TIW. Patients originally randomized to IFNbeta-1a 44 microg s.c. TIW showed lower Expanded Disability Status Scale progression, relapse rate and T2 burden of disease up to 8 years compared with those in the late treatment group. Brain parenchymal volume did not show differences by treatment group.

Overall, 19.7% of patients progressed to secondary progressive MS between baseline and LTFU (75/381). No new safety concerns were identified and treatment was generally well tolerated.

CONCLUSIONS: Despite the limitations inherent in any long-term study (for example, potential differences between returning and nonreturning patients), these results indicate that patients with relapsing-remitting multiple sclerosis can experience sustained benefit over many years from early interferon beta-1a subcutaneous therapy three times weekly compared with patients whose treatment is delayed. This effect was more apparent in the patients receiving the higher dose.




The same article is summarized on Medscape Today, 10/11/06:

Quote:
Early Treatment of Multiple Sclerosis Yields Long-Term Benefits



By Will Boggs, MD

NEW YORK (Reuters Health) Oct 04 - Early and ongoing treatment with interferon beta-1a can provide lasting benefits to patients with relapsing-remitting multiple sclerosis (MS), according to a report in the second September issue of Neurology.

"Long-term treatment with this agent is feasible and tolerated by most patients with some evidence of sustained benefit regarding clinical disease progression and MRI related outcomes," Dr. Ludwig Kappos from University Hospital Basel, Switzerland told Reuters Health.

Dr. Kappos and colleagues report follow-up data for up to 8 years after entry of patients into the Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) study.

The annualized relapse rate was significantly lower among patients in both originally treated groups (44 mcg and 22 mcg interferon beta-1a, three times weekly) than among patients treated later, the researchers note, and patients were more likely to remain in remission if they were originally randomized to the high-dose treatment group.

Patients randomized originally to 44 mcg interferon (but not to 22 mcg interferon) had a lower median percentage increase in MRI-measured burden of disease during long-term follow-up, the report indicates.

Treatment with interferon was generally well tolerated, the investigators say, with no new safety concerns.

"This trial represents another enormous expenditure of effort to determine whether we are helping our relapsing-remitting MS patients with existing therapies," writes Dr. John H. Noseworthy from the Mayo Clinic College of Medicine, Rochester, Minnesota in a related editorial.

"I respect this effort," Dr. Noseworthy concludes, "but am cautious about the authors' conclusions that 'patients with relapsing-remitting MS can experience sustained benefit over many years from early interferon beta-1a subcutaneously three times weekly therapy.' Perhaps this is true (I hope it is), but the evidence is not yet fully convincing to me."

Dr. Kappos responded: "Dr. Noseworthy is correct in that this study did only provide indicative evidence for efficacy as it did not have an untreated control group from year 3 onwards and because at the end of the day we do not know what the impact of those patients who did not complete the follow-up would have been."

Nonetheless, he concluded, "Justification of early treatment with IFN-beta or glatiramer is not only based on this observation but also on data from early treatment studies and from new insights in the neuropathology of early and late phases of MS."

Neurology
2006;67:944-953,930-931



Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Mon Oct 30, 2006 8:20 pm    Post subject: Injection site reactions Reply with quote

Quote:
Posted: 02 Oct 2006 05:57 pm Post subject: (Abstract) Injection site reactions (Rebif)

From the 22nd congress of ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis), Madrid, 9/29/06:

Quote:
Quote:
Immunomodulation - Part II

Friday, September 29, 2006, 15:30 - 17:00

Product enhancements decrease the incidence of injection site reactions and pain resulting in improved adherence to therapy in patients with multiple sclerosis

J. Scanzillo, R. Bennett, P. Biancucci, V. Divan, S. Sherman, A. AL-Sabbagh (Rockland, New York, USA)

Background: Injection site reactions (ISRs) are a common cause of treatment discontinuation in patients with multiple sclerosis (MS). Support organizations such as the MS LifeLines program (http://www.mslifelines.com) may help patients to manage ISRs more effectively by providing support, education, and training on injection technique; however, simplification of the injection process through use of autoinjectors and finer gauge needles may also help to decrease ISRs.

Objective: Evaluate the impact of product enhancements such as a new autoinjector (Rebiject II) and finer needles upon adherence to therapy for patients receiving subcutaneous (sc) Interferon-beta-1a (IFNB-1a) 44 mcg tiw.

Methods: Data were gathered by the MS LifeLines program between August 2003 and November 2004 (before product enhancements) and again between December 2004 and March 2006 (after product enhancements).

Patients were contacted by nurse educators at regular intervals and asked a series of questions to determine whether they were adherent to therapy or had discontinued, and, if they had discontinued, why they had done so.

Reasons for discontinuation were recorded and divided into 3 categories: ISRs, pain and/or burning at the injection site, or other reasons. Interim data from this ongoing analysis are presented.

Results: Between August 2003 and November 2004, 11,783 total patients received subcutaneous (sc) IFNB-1a 44 mcg tiw. Of the 2079 patients who discontinued therapy (17.6%), 1714 (82.4%) cited reasons other than ISRs or injection pain and burning. Of the remaining discontinuations, 190 (9.1%) were due to ISRs and 175 (8.4%) were due to pain and/or burning at the injection site.
Between December 2004 and March 2006, when Rebiject II and finer gauge needles were incorporated, 12,968 total patients received sc IFNB-1a 44 mcg tiw. Of the 1780 (13.7%) who discontinued therapy, 1648 (92.6%) cited reasons other than ISRs or pain or burning. Of the remaining discontinuations, 99 (5.6%) were due to ISRs and 33 (1.9%) were due to pain and/or burning at the injection site.

Conclusions: These results demonstrate that product enhancements such as Rebiject II autoinjector and finer gauge needles have dramatically decreased discontinuation of therapy due to overall ISRs and injection pain or burning in patients administering (sc) IFNB-1a 44 mcg tiw. The decreased discontinuation to therapy may potentially improve long-term outcomes.

Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Thu Nov 23, 2006 6:57 pm    Post subject: (Abstract) Different Rebif formulations.... Reply with quote

From PubMed, 11/23/06:

Quote:
J Pharm Biomed Anal. 2006 Nov 20;

Assessment of the immunogenicity of different interferon beta-1a formulations using ex vivo T-cell assays

Jaber A, Baker M.
Laboratoires Serono SA, Zone Industrielle, CH-1267 Coinsins, Switzerland.

Recombinant homologues of human proteins have the potential to induce an immunogenic response when used therapeutically. Each of the three interferon (IFN) beta therapies currently approved for multiple sclerosis can induce the development of neutralising antibodies, the full effects of which on IFN beta therapy remain unclear.

To investigate the immunogenicity of the currently licensed formulation of subcutaneous IFN beta-1a, 22 or 44mug three times weekly (Rebif((R))), two new formulations of IFN beta-1a (Rebif((R)) New Formulation [RNF]1 and RNF2) have been developed. In this study, the immunogenicity of the current formulation was investigated against RNF1, RNF2 and an IFN beta standard using ex vivo T-cells.

Dendritic cells, isolated from peripheral blood monocytes donated by 26 healthy volunteers, were matured in vitro and incubated with the test antigens for 6h. Autologous CD4(+) T-cells from the same donors were added and further incubated before cytokine release was assessed by ELISpot assay and proliferation by [(3)H]thymidine pulse. Secretion of T-cell-derived interleukin-2 was 79%, 66% and 105% in incubations with RNF1, RNF2 and the current formulation, respectively (normalised to secretion with the IFN standard; p<0.05, RNF2 versus the current formulation). Secretion of IFN gamma was highly variable between donors, with no significant difference observed between formulations. Normalised values for T-cell proliferation were 56%, 44% and 88% with RNF1, RNF2 and the current formulation, respectively (p<0.05, RNF2 versus the current formulation).

The immunogenic potential of RNF2 is significantly lower than that of the current formulation when tested ex vivo. This result is now being confirmed through ongoing clinical trials.

Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Sat Feb 10, 2007 8:15 pm    Post subject: (Article) New Rebif formulation delayed Reply with quote

From Bloomberg.com, February 10, 2007:

Quote:
FDA Questions on Merck's New Rebif Delay Approval (Update2)

By Angela Cullen

Feb. 6 (Bloomberg) -- Merck KGaA faces a delay in introducing a new formulation of Rebif, the world's second- biggest multiple sclerosis medicine, after U.S. regulators asked for more information.

``We've received questions from the FDA that require our response,'' said Benedicte Bogh, a spokeswoman at the company's Merck Serono unit in Geneva, in a telephone interview today. ``We continue to work very closely with the FDA to address these requests.''

Merck needs Rebif to beef up sales from branded pharmaceuticals, which are growing slower than at competitors, as the German company rebuilds the unit to focus on cancer, diabetes and central nervous diseases. Merck Serono plans to use the new formulation to increase its share of the $5 billion global market and surpass its larger rival, Biogen Idec Inc.'s Avonex for MS.

The company applied for approval of the treatment, which has fewer side effects than the current version, last April. The Food and Drug Administration, which usually gives its decision within 10 months, was due to rule on the application by Feb. 4. Bogh declined to comment on how long the regulator may take to complete its review.

The new version, which isn't made from human or animal-based materials although it is produced in mammalian cells, reduces reactions at the injection site and results in fewer antibodies forming compared with older versions of the medicine.



``The new formulation is intended to replace the current formulation,'' Bogh said. ``It will support our objective to reach global market leadership for Rebif.''

Elan Corp. and Biogen Idec's Tysabri is the latest treatment to enter the multiple sclerosis market as companies jostle to defend their share. Berlin-based Bayer Schering Pharma AG is widening the use of its Betaseron, the oldest multiple sclerosis therapy, to include patients with early stages of the disease to fend off the rising competition.

Darmstadt, Germany-based Merck offered 16.6 billion francs ($13 billion) for Serono SA last September to become Europe's largest biotechnology company.

The German family-controlled drugmaker is raising around 2 billion euros ($2.6 billion) to help fund the acquisition by selling new shares in a capital increase scheduled to end today. Shareholders can buy four new shares for every 29 held at a price of 78 euros each.

Deutsche Bank AG, which managed the share sale, took temporary possession of the 13.2 million shares in the capital increase today before passing them on to investors who purchased stock in the sale.

Merck shares gained 1.11 euros, or 1.2 percent, to 91.74 euros at the close of trading in Frankfurt.

To contact the reporter on this story: Angela Cullen in Frankfurt at acullen8@bloomberg.net





This statement startled me a little bit:

Quote:
Berlin-based Bayer Schering Pharma AG is widening the use of its Betaseron, the oldest multiple sclerosis therapy, to include patients with early stages of the disease to fend off the rising competition.



It sounds almost as if "fending off the rising competition" is the main reason for including patients with early stages of MS. Can these drug companies be trusted to keep the interests of the patients first and foremost on their agenda?
Back to top
View user's profile Send private message
Matt



Joined: 21 May 2006
Posts: 961

PostPosted: Sun Feb 11, 2007 12:21 am    Post subject: Re: (Article) New Rebif formulation delayed Reply with quote

agate wrote:

Quote:
Berlin-based Bayer Schering Pharma AG is widening the use of its Betaseron, the oldest multiple sclerosis therapy, to include patients with early stages of the disease to fend off the rising competition.



It sounds almost as if "fending off the rising competition" is the main reason for including patients with early stages of MS. Can these drug companies be trusted to keep the interests of the patients first and foremost on their agenda?


There's no question that that is what it's all about.

But, from the perspective of someone living in a country where you can only get a drug if there is a clinical trial supporting it's use, the competition seems necessary for some people to get the drugs that might help them.
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Sun Feb 11, 2007 12:37 am    Post subject: Reply with quote

I agree that competition is usually a healthy driving force for an economy. I just cringed at the thought that people in the earlier stages of MS might be urged to take Rebif mainly because a pharmaceutical company wanted to show a bigger profit margin. Perhaps the patients' best interests will be too easily overlooked in such an extremely competitive atmosphere....
Back to top
View user's profile Send private message
Matt



Joined: 21 May 2006
Posts: 961

PostPosted: Sun Feb 11, 2007 1:59 pm    Post subject: Reply with quote

agate wrote:
I agree that competition is usually a healthy driving force for an economy. I just cringed at the thought that people in the earlier stages of MS might be urged to take Rebif mainly because a pharmaceutical company wanted to show a bigger profit margin. Perhaps the patients' best interests will be too easily overlooked in such an extremely competitive atmosphere....


This is always how things work with pharmaceutical compnies, as well as with companies that advocate alternative treatments. It's always suprizing when I run into someone who doesn't expect pharmaceutical companies or advocates of alternative treatments to be primarily concerned about profits, and profits alone.
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Sun Feb 11, 2007 2:23 pm    Post subject: Reply with quote

Guess I shouldn't be at all surprised. Maybe the surprising part is that it's being stated on a Website that's open to anyone. I'd have expected a bit more hypocrisy.
Back to top
View user's profile Send private message
Matt



Joined: 21 May 2006
Posts: 961

PostPosted: Sun Feb 11, 2007 2:39 pm    Post subject: Reply with quote

Yeah. After a while you get used to companies trying out slogans like "Biogen, the company devoted to safety". Please /I don't know if that was an actual SLOGAN/. There are some really dumb people out there and they know it! We start to expect it after a while.
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Fri Feb 16, 2007 3:26 pm    Post subject: Rebif in patients w/clinically isolated syndromes... Reply with quote

From PubMed, February 16, 2007:

Quote:
Clin Neurol Neurosurg. 2007 Feb 12

The effect of interferon-beta(1a) on relapses and progression of disability in patients with clinically isolated syndromes (CIS) suggestive of multiple sclerosis

Motamed MR, Najimi N, Fereshtehnejad SM.
Department of Neurology, Faculty of Medicine, Iran University of Medical Sciences and Health Services, Hemmat Highway, Tehran, Iran.

OBJECTIVES: In 85% of young adults with multiple sclerosis (MS), onset is a subacute clinically isolated syndrome (CIS) of the optic nerves, brain stem or spinal cord.

The advent of disease-modifying treatments for MS has increased attention to early stages of the disease. Therefore, the aim of this study was to evaluate the effect of interferon on relapses and progression of disability in patients with a CIS.

PATIENTS AND METHODS: This randomized, clinical trial was conducted in 25 patients who presented with a CIS indicative of MS. They were evaluated in two groups: 11 patients who were receiving interferon-beta(1a) (Rebif, Serono) subcutaneous injections three times a week (group A), and 14 patients who were not receiving disease-modifying treatment (group B). The progression of disability was determined using the Kurtzke Expanded Disability Status Scale (EDSS) and the numbers of new relapses were recorded during 21 months of follow-up.

RESULTS: The mean numbers of new relapses and changes in EDSS at the end of study period were 0.68 (standard deviation [S.D.]=0.80) and -1.09 (S.D.=0.49), and 1.79 (S.D.=1.05) and -0.64 (S.D.=0.49) in groups A and B, respectively. Statistical analysis showed that disease-modifying treatment with interferon-beta(1a) may reduce relapses (P=0.007) and prevent progressive disability (P=0.034).

CONCLUSION: Interferon-beta(1a) significantly delayed progression to disability and incidence of new relapses.

PMID: 17300863
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Sun Mar 11, 2007 6:35 pm    Post subject: (Abstract) Lipitor in combo w/Rebif in MS Reply with quote

Scheduled for the upcoming AAN conference in May:

Quote:
A Double-Blind, Placebo-Controlled Trial of Atorvastatin in Combination with Subcutaneous Interferon Beta 1a in Persons with Multiple Sclerosis

Gary Birnbaum, Irfan Altafullah, Golden Valley, MN, Anthony Reder, Chicago, IL

OBJECTIVE: To determine if treatment with atorvastatin [Lipitor], in combination with subcutaneous interferon beta 1a, was safe, and had a salutary effect on the course of MS.

BACKGROUND: Preliminary data suggest statins may modify MS disease activity. We hypothesized that treatment with a beta interferon and a statin could be tolerated and would result in increased therapeutic benefits.

DESIGN/METHODS: Subjects with clinically definite, stable MS, ages 18-56, on subcutaneous interferon beta 1a for at least 6 months, with no drug toxicity, were randomized into 3 groups, and treated for six months with either placebo, atorvastatin, 40 mg per day, or atorvastatin, 80 mg per day, with follow-up 3 months after stopping oral drug. Subjects had monthly blood and urine tests, blinded neurologic exams and brain MRIs at Months 0, 3, 6, and 9. MS relapses were treated as needed. Primary outcome measures were safety parameters with secondary outcomes of new or worsening MRI lesions and/or clinical relapses. Data were analyzed with Chi-square and Student t-test analyses.

RESULTS:
29 subjects were enrolled. Data could be analyzed for 24 subjects, 18 females and 6 males, ages 28 to 56. EDSS ranged from 1 to 5.5. Two subjects on high dose atorvastatin withdrew due to myalgias and elevated liver enzymes. New and enhancing MRI lesions and/or relapses were noted in 9 of 13 subjects on atorvastatin, either 40 mg or 80 mg per day, and in 1 of 9 subjects on placebo (p=0.004 for differences between the two groups). New lesions occurred as early as 12 weeks following atorvastatin and continued up to 12 weeks after stopping the drug.

CONCLUSIONS/RELEVANCE: Combination treatment of MS with subcutaneous interferon beta 1a and atorvastatin, while well tolerated, resulted in increased MRI and clinical disease activity. Possible mechanisms will be discussed.

Supported by: An unrestricted, independent, investigator-initiated grant from Serono/Pfizer.

Wednesday, May 2, 2007 4:45 PM
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Sun Apr 22, 2007 10:35 am    Post subject: (Abstract) Health-related quality of life in SPMS Reply with quote

From PubMed, April 19, 2007:

Quote:
Mult Scler. 2007 May;13(3):386-92


Health-related quality of life in secondary progressive multiple sclerosis

Beiske AG, Naess H, Aarseth JH, Andersen O, Elovaara I, Farkkila M, Hansen HJ, Mellgren SI, Sandberg-Wollheim M, Sorensen PS, Myhr KM.
Department of Neurology, University Hospital of Akershus, Lorenskog, Norway.

Common disability scales in multiple sclerosis (MS) are often weighted towards physical disability. Non-motor symptoms such as depression, fatigue and pain substantially influence well-being in MS.

Health-related quality of life (HRQoL) measures the broader impact of MS and might indicate less obvious disease burdens. We analysed HRQoL, using the Nottingham Health Profile Part I (NHP-I), among 345 secondary progressive MS (SPMS) patients participating in a randomized trial of interferon-beta1a (IFN-beta1a), 22 mug subcutaneously weekly, or matching placebo.

The results did not reveal any beneficial effect of IFN-beta1a in any outcome measure. NHP-I sub- and sum scores were compared for 217 population controls and correlated with demographic and clinical disease variables. SPMS patients had lower NHP-I sum and all subscores than the controls. Patients experiencing disease progression reported worse NHP-I sum scores. Increased fatigue, Expanded Disability Status Scale (EDSS) and Arm Index scores were independently associated with reduction in several NHP-I subscores.

SPMS patients had significantly lower HRQoL than controls and physical disability (EDSS and Arm Index), disease progression and fatigue strongly influenced this.

PMID: 17439908
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Sun Apr 22, 2007 10:44 am    Post subject: (Abstract) Reducing size of enhancing lesions in MS? Reply with quote

From PubMed, April 19, 2007:

Quote:
Mult Scler. 2007 May;13(3):343-7

An exploratory study of interferon beta dose effect on reducing size of enhancing lesions in multiple sclerosis

Di Rezze S, Gupta S, Durastanti V, Millefiorini E, Pozzilli C, Bagnato F.
Department of Neurological Sciences, La Sapienza University, Rome, Italy.

Sixty-two patients with multiple sclerosis (MS) were imaged monthly over a six-month (ie, seven monthly magnetic resonance images [MRI]) natural history period (NHP). Thereafter, patients were randomized to receive 11 or 33 mug of subcutaneously injected interferon beta 1a (IFNp-1 a) with imaging monthly for nine months and at months 12, 18 and 24 of therapy phase (TP).

In the present exploratory post hoc analysis, the authors evaluated IFNbeta-1a dose effect on reducing the size of contrast-enhancing lesions (CELs). MRIs performed at months 0, 3 and 6 of NHP and at months 3, 6, 9, 18 and 24 of TP were analysed.

While a significant reduction in mean number of CELs was observed in both treatment groups of patients, the mean total volume and size of CELs was reduced only in patients undergoing therapy with 33 mug of IFNbeta-1a. The latter suggests a significant dose effect exerted by IFNbeta-1a in the evolution of CELs' dimensions during therapy.

PMID: 17439903
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Thu May 24, 2007 4:46 pm    Post subject: Rebif New Formulation (RNF) Reply with quote

From Doctor's Guide:

Quote:
New Formulation Interferon Beta-1a Demonstrates Improved Safety for Multiple-Sclerosis Patients

Presented at AAN
http://www.pslgroup.com/dg/27A1A2.htm

Doctor's Guide
May 8, 2007


By Maria Bishop



BOSTON, MA -- May 8, 2007 -- One-year results of a phase 3b trial of the new formulation interferon beta-1a (Rebif New Formulation; RNF) demonstrate an improved safety and immunogenicity profile at a high dose and high frequency in patients with relapsing multiple sclerosis (MS), according to research presented here at the American Academy of Neurology (AAN) 59th Annual Meeting.

Treatment with interferon beta in MS patients can be associated with the development of neutralizing antibodies (NAbs), which have been shown to reduce the therapeutic effect of interferon at high titers, said lead investigator James P. Simsarian, MD, director, Multiple Sclerosis Program, Neurology Center of Fairfax, Ltd., Fairfax, Virginia, and neurologist, Inova Fairfax Hospital, Falls Church, Virginia.

The new human serum albumin-free formulation of Rebif was created to minimize the incidence of NAbs and to optimize the potential benefits of treatment with interferon.

A 96-week multicenter, single-arm, open-label study of RNF enrolled 260 adults with an Expanded Disability Status Scale score < 6.0 and a diagnosis of relapsing MS according to the McDonald criteria. Patients in the study self-injected RNF 44 mcg/0.5 mL subcutaneously, 3 times weekly.

Blood samples were examined at weeks 12, 24, and 48, and the proportion of RNF-treated Nab-positive patients was compared with historical Rebif data from similar patients treated with 44 mcg Rebif, 3 times weekly in the Evidence of Interferon Dose-response: European North American Comparative Efficacy (EVIDENCE) study.

At 48 weeks, 227 (87.3%) of patients were still on treatment. Patients treated with RNF were nearly 6 times less likely to become Nab-positive (titer >/= 20 NU/mL) at both 24 weeks and 48 weeks compared with patients in the EVIDENCE study.

Incidence of prespecified adverse events was markedly lower for injection-site reaction in RNF (30%) versus historical data (84%), which represented a threefold reduction. Similar reductions were noted for cytopenia (10% vs 12%), depression and suicidal ideation (6% vs 20%), hepatic disorders (13% vs 17%), skin rashes (5% vs 12%), thyroid disorders (2% vs 5%), and hypersensitivity reactions (5% vs 3%).

According to the authors, these changes constitute notable improvements to the typical safety profile of injectable Rebif.

As expected with an HSA-free formulation, incidence of flu-like symptoms was higher with RNF (71% vs 48%), although most events were mild/moderate in severity.

This study was sponsored by Merck Serono International SA.


[Presentation titles: Safety and Immunogenicity of Rebif New Formulation (RNF) a New Subcutaneous Formulation of Interferon beta-1a 44 mcg Three Times Weekly: 1-Year Results of a Phase IIIb Study in Patients With Relapsing Multiple Sclerosis. Abstract P06.077. Safety and Immunogenicity of Rebif New Formulation (RNF) a New Subcutaneous Formulation of Interferon beta-1a 44 mcg Three Times Weekly: 1-Year Results of a Phase IIIb Study in Patients With Relapsing Multiple Sclerosis. Abstract P06.077]


This news story was printed from Doctor's Guide to the Internet
located at http://www.docguide.com
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Fri Jun 01, 2007 5:17 pm    Post subject: (Abstract) Long-term cost-effectiveness of Rebif in RRMS... Reply with quote

From PubMed, May 31,2007:

Quote:
Clin Drug Investig. 2003;23(9):571-81

Long-Term Cost Effectiveness of Interferon-beta-1a in the Treatment of Relapsing-Remitting Multiple Sclerosis : An Econometric Model

Lepen C, Coyle P, Vollmer T, Blumhardt L, Lilliu H, Beresniak A.
Université Paris-Dauphine, Paris, France.

OBJECTIVE: To evaluate the cost effectiveness of subcutaneous interferon-beta-1a (IFNbeta-1a) 44mug three times weekly in relapsing-remitting multiple sclerosis (RRMS) using an econometric model.

METHODS: Data on RRMS patients treated with IFNbeta-1a 22 or 44mug subcutaneously three times weekly or placebo for up to 4 years were obtained from the Prevention of Relapses and disability by Interferon-beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) study. The area under the Expanded Disability Status Scale (EDSS) score-time curve was used as a measure of disability and the effectiveness of therapy was expressed as EDSS-months of disability prevented.

Costs were calculated for the UK and France, and results were projected to 10 and 20 years using a time series regression model.

RESULTS: Over 10 years, treatment with IFNbeta-1a 44mug subcutaneously three times weekly prevented 121 EDSS-months of additional disability at a cost of Euros (euro)732 each (year of costing 2000). Over 20 years, 321 EDSS-months were saved at a cost of euro359 per month (year of costing 2000).

CONCLUSION: This analysis indicated that IFNbeta-1a 44mug subcutaneously three times weekly is cost effective in RRMS and that treatment becomes increasingly cost effective over time.

PMID: 17535070
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Tue Jun 26, 2007 12:49 pm    Post subject: (Abstract) Rebif in SPMS: 3-year followup study... Reply with quote

From PubMed, June 26, 2007:

Quote:
Acta Neurol Scand. 2007 Jul;116(1):43-8

Once-weekly 22mug subcutaneous IFN-beta-1a in secondary progressive MS: a 3-year follow-up study on brain MRI measurements and serum MMP-9 levels

Wu X, Kuusisto H, Dastidar P, Huhtala H, Nikkari ST, Ukkonen M, Höyhtyä M, Elovaara I.
Neuroimmunology Unit, Medical School, University of Tampere, Tampere, Finland.

Objective - To study the effect of weekly injected subcutaneous interferon (IFN)-beta-1a 22 mug on the extent of brain lesions on magnetic resonance imaging (MRI) and the level of serum matrix metalloproteinase (MMP)-9 in patients with secondary progressive multiple sclerosis (SPMS).

Subjects and methods - All the 28 Finnish patients participating in the Nordic multicentre trial on the clinical efficacy of weekly IFN-beta-1a (Rebif) 22 mug in SPMS were studied neurologically and by volumetric MRI during a 3-year follow-up. The levels of MMP-9 in serum were measured over the 3-year study.

Results - There was no obvious effect on the number of contrast medium-enhancing lesions, the volume of T1 or T2 lesions or level of serum MMP-9, nor was any effect detected on the relapse rate and the Expanded Disability Status Scale (EDSS). Brain atrophy progression was not affected by the treatment.

Conclusion
- The lack of effect on MRI, clinical outcomes or the levels of MMP-9 indicates that subcutaneous administration of low-dose low-frequency IFN-beta-1a is insufficient in controlling either the inflammatory constitutes or the neurodegenerative changes of advanced SPMS.

PMID: 17587254
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Fri Sep 07, 2007 6:55 pm    Post subject: (Abstract) Immunogenicity comparison of IFN beta-1a... Reply with quote

From PubMed, September 7, 2007:

Quote:
New Microbiol. 2007 Jul;30(3):241-6

Immunogenicity comparison of interferon beta-1a preparations using the BALB/c mouse model: assessment of a new formulation for use in multiple sclerosis

Bellomi F, Muto A, Palmieri G, Focaccetti C, Dianzani C, Mattei M, Jaber A, Antonelli G.
Department of Experimental Medicine, Virology Section, La Sapienza University, Rome, Italy.

The in vivo immunogenicity of a new interferon (IFN) beta-1a product (Rebif New Formulation; RNF) was compared with that of two approved recombinant human IFN beta-1a products (Rebif and Avonex). Immunogenic potential was assessed based on time to development of neutralizing antibodies (NAbs) and NAb titer.

Female BALB/c mice (six in each group) received RNF, Rebif or Avonex (1.0 microg/mL subcutaneously three times weekly), and serum samples collected on Days 7, 21, and 35 (Study 1), or 28, 42, 49, and 60 (Study 2) were assayed for NAbs. In Study 1, no mice had NAbs at Day 7, but by Day 21 one mouse in the RNF group had NAbs, compared with three and four mice in the Rebif and Avonex groups, respectively. Results were similar in Study 2. All control mice were NAb negative; all actively treated mice had NAbs by day 35 or 42. Throughout Study 1, NAb titers were lowest in the RNF group and highest in the Avonex group, and at day 35, NAb titers were significantly lower in the RNF group than the Rebif group (p = 0.037).

Results indicate that, on a gram-for-gram basis, RNF appears less immunogenic than Rebif or Avonex.

PMID: 17802901
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Thu Oct 18, 2007 6:59 pm    Post subject: (Abstract) Treatment adherence in RRMS patients on Rebif Reply with quote

From the ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis) conference in Prague, October 11-14, 2007:

Quote:
Evaluation of the factors that influence treatment adherence in patients with relapsing-remitting multiple sclerosis treated with subcutaneous interferon beta 1a: preliminary results of the EFISEP study regarding treatment adherence

T. Moreau, J.M. Visy, S. Wiertlewski (Dijon, Reims, Nantes, F)

Background:

The EFISEP study is a prospective study aimed at investigating factors effectively influencing treatment compliance to subcutaneous (sc) interferon (IFN) beta-1a in patients with relapsing–remitting multiple sclerosis (RRMS). The study was carried out in France in 2005 at 150 centres.

Methods:

Selected patients with RRMS were divided into two groups: long-term treatment (LTT; ongoing sc IFN beta-1a: >18 months’ treatment); newly treated (NT; ongoing sc IFN beta-1a, >1 month but <3 months’ treatment).

Treatment adherence was assessed at 3–6 months (M6) and 12 months (M12) by neurologists. Patients were also asked to fill in a weekly notebook on injection achievement. Descriptive analysis of the first 106 patients (44 NT, 62 LTT) who completed the study is presented.

Results:

At inclusion, mean disease duration was 3 years for NT patients (mean age: 37 years; female: 82%) and 9 years for LTT patients (mean age: 42 years; female: 61%). A total of 48% of NT patients and 29% of LTT patients were followed through a nurses programme. A total of 52% of NT patients (following titration for 61% of these patients) and 18% of LTT patients received IFN beta-1a, 22 mcg sc three times weekly (tiw). Remaining patients received IFN beta-1a, 44 mcg sc tiw, following titration for 90.5% of NT patients. At inclusion, 45% of NT patients and 19% of LTT patients presented with flu-like syndrome, and 34% of NT patients and 39% of LTT patients mentioned injection-site reactions. A total of 75% of NT patients and 85% of LTT patients self-administered their medication. Mean Expanded Disability Status Scale scores were 1.80 for NT patients and 2.42 for LTT patients. By M12, 79% of NT patients and 83% of LTT patients had filled in their compliance notebooks correctly. At M6, treatment compliance was good: 80% of NT patients and 89% of LTT patients performed more than 95% of their injections. By M12, compliance had decreased: 60% of NT patients and 72% of LTT patients performed more than 95% of their injections.

Conclusions:

These preliminary results from a real-life clinical setting show that questionnaires on treatment adherence are well accepted and used by patients and, in neurologists’ opinion, can also improve treatment adherence. However, neurologists have to keep in mind that the effectiveness of such tools tends to decrease over time.
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Thu Oct 18, 2007 7:04 pm    Post subject: (Abstract) Rebif New Formulation for MS.... Reply with quote

Another abstract from the ECTRIMS conference:



Quote:
Development of Rebif® New Formulation for MS treatment: consolidated results from preclinical and phase I studies

R. Driebergen, A. Jaber, M. Antonelli, G. Giovannoni, H. Schellekens, J. Simsarian (Geneva, CH; London, UK; Utrecht, NL; Fairfax, USA)

Background:

Although the use of recombinant interferon beta has revolutionized the treatment of MS, innovative technologies provide an opportunity for formulation improvements. Rebif® New Formulation (RNF) has been developed, excluding human- or animal-derived components, to improve injection tolerability and reduce immunogenicity.

Methods:

Two formulations were identified from a pool of candidates for testing using a development model involving integrated assessment of physico-chemical stability, injection-site tolerability, pharmacokinetic (PK) profile and immunogenic potential.

Immunogenicity
The immunogenicity of two formulations (RNF1 and RNF2) was assessed in preclinical studies: an ex vivo assessment of RNF1, RNF2 and Rebif® (R) effects on human T cells, and a study in mice (12 per group) to assess the relative immunogenicity of RNF2, R and Avonex® (A) using identical dosing.

Tolerability
A double-blind, randomized, placebo-controlled, Phase I study (25394) was also carried out in healthy volunteers (12 per group) to assess the safety, tolerability and PK/pharmacodynamic (PD) properties, of single subcutaneous doses of RNF1, RNF2, R and saline.

Results:

Immunogenicity
The ex vivo study demonstrated that RNF2 had a low immunogenic potential compared with RNF1 and R, as shown by lower T cell proliferation (48% vs 60% and 91%) and lower secretion of interleukin-2 (66% vs 79% and 108%). The in vivo study in mice indicated that, on a gram-for-gram basis, with the same route and frequency of administration, RNF2 was less immunogenic than A or R: time to development of neutralizing antibodies was longest and titres were generally lower in the RNF2 group.

Tolerability The Phase I study showed that RNF2 injection tolerability was better than R: fewer adverse events were reported by those receiving RNF2 than RNF1 or R (21 vs 31 and 33 events); combined visual analogue scale pain scores for all subjects were also lower in the RNF1 and RNF2 groups than in the R or placebo groups at time of dose (4 and 12 vs 114 and 22 mm). The PK/PD characteristics of RNF2 were similar to those of R.

Conclusions:


This preclinical and Phase I development programme has enabled selection of a new formulation, RNF2, which appears to have improved local tolerability and lower immunogenicity than the current formulation. To validate the selection of this formulation, RNF, several clinical trials are now assessing its safety, immunogenicity and efficacy.
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Wed Feb 06, 2008 10:02 am    Post subject: (Article) Saliva-soluble HLA to mark response to Rebif... Reply with quote

An article in Medscape, February 6, 2008, called "Saliva-Soluble HLA as a Potential Marker of Response to Interferon Beta-1a in Multiple Sclerosis: A Preliminary Study," by Aliriza Minagar et al., can be read here.
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Wed Jun 04, 2008 6:54 pm    Post subject: (Abstract) MS patients treated w/Rebif by Rebiject for 1 yr. Reply with quote

From PubMed, June 4, 2008:

Quote:
Clin Neuropharmacol. 2008 May/June;31(3):167-172.

Safety and Tolerability in Relapsing-Remitting Multiple Sclerosis Patients Treated With High-Dose Subcutaneous Interferon-Beta by Rebiject Autoinjection Over a 1-Year Period: The CoSa Study

Lugaresi A, Durastanti V, Gasperini C, Lai M, Pozzilli C, Orefice G, Sotgiu S, Pucci E, Ardito B, Millefiorini E; the CoSa Study Group.
*Department of Oncology and Neuroscience, University "G. d'Annunzio," Chieti; the †Department of Neurological Sciences, University of Rome "La Sapienza"; the ‡Department of Neurology, San Camillo Hospital, Rome; the §Multiple Sclerosis Centre, Binaghi Hospital, Department of Cardiovascular and Neurological Sciences, University of Cagliari, Cagliari; the &spar;Department of Neurological Sciences, University of Roma "La Sapienza," Azienda Ospedaliera S. Andrea, Rome; the ¶Department of Neurological Sciences, University "Federico II", Naples; the #Institute of Clinical Neurology, University of Sassari, Sassari; the **U.O. Neurologia, Macerata Hospital, Macerata; and the ††Department of Neurology, Hospital Miulli, Acquaviva delle Fonti, BA, Italy.

OBJECTIVES:

Approved multiple sclerosis (MS) treatments include subcutaneous and intramuscular interferon beta (IFN-beta). Patient satisfaction during long-term IFN-beta treatment is crucial. This study investigated the satisfaction of patients with relapsing-remitting MS treated with IFN-beta-1a (Rebif) by the autoinjection system, Rebiject.

MATERIALS AND METHODS:

This prospective observational study recruited subjects with relapsing-remitting MS (n = 76) from 19 neurological centers in Italy who were eligible for subcutaneous IFN-beta-1a treatment either as a first immunomodulatory therapy or as a switch from other treatments.

Patients received IFN-beta-1a 44 mug 3 times weekly via the Rebiject system. A questionnaire on the use of Rebiject and the most common adverse effects related to IFN-beta-1a administration was completed monthly under the supervision of trained nurses.

RESULTS:

Satisfaction with treatment was reported by 80.2% of patients who received at least 1 dose. Advantages reported for the Rebiject system included its convenience (53% of all patients), ease of use (25%), reduced trauma and pain (11% and 6%, respectively), and reduced local skin reactions (5%). No significant changes from baseline were observed regarding the frequency or severity of local reactions.

CONCLUSIONS:

During the 1-year observation of this small cohort, most patients considered the Rebiject system to be convenient, with a third of the patients feeling that the system was easier to use than conventional procedures. Rebiject was also associated with less pain and trauma in some patients. Use of Rebiject may facilitate IFN-beta-1a administration and may lead to an increase in compliance and adherence, thus increasing the effectiveness of treatment.

PMID: 18520983
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Fri Jun 06, 2008 4:59 pm    Post subject: (Abstract) Rebif-Lipitor combo may increase disease activity Reply with quote

From PubMed, June 8, 2008:

Quote:
Neurology. 2008 Jun 4

Combining beta interferon and atorvastatin may increase disease activity in multiple sclerosis

Birnbaum G, Cree B, Altafullah I, Zinser M, Reder AT.
From the MS Treatment and Research Center (G.B., I.A.), Minneapolis Clinic of Neurology, MN; Department of Neurology (B.C.), University of California San Francisco; and Department of Neurology (A.T.R.), Pritzker School of Medicine, University of Chicago, IL.

OBJECTIVE:

To explore whether high dose atorvastatin can be administered safely to persons with relapsing remitting multiple sclerosis (MS) taking thrice weekly, 44 mcg dose subcutaneous interferon beta-1a.

METHODS:

Persons with clinically stable, relapsing remitting MS, on standard high-dose subcutaneous interferon beta-1a, were randomized in a double blinded fashion to receive either placebo or atorvastatin at dosages of 40 mg or 80 mg per day for 6 months. Blinded neurologic examinations and brain MRI readings were obtained at months 0, 3, 6, and 9. Laboratory blood testing was performed monthly. Main outcome measures were the determination of drug toxicity using blood tests and ECG and determination of MS-related disease activity, either clinical relapses, or new or contrast enhancing lesions on MRI.

RESULTS:

Twenty-six subjects received at least one dose of study drug. Ten of 17 subjects on either 80 mg or 40 mg of atorvastatin per day had either new or enhancing T2 lesions on MRI or clinical relapses. One of the nine subjects on placebo had a relapse with active lesions on MRI. The subjects receiving atorvastatin were at greater risk for either clinical or MRI disease activity compared to placebo (p = 0.019). Significant changes in blood tests were noted only for lower cholesterol levels in subjects receiving atorvastatin.

CONCLUSION:

The combination of 40 or 80 mg atorvastatin with thrice weekly, 44 mcg interferon beta-1a in persons with multiple sclerosis resulted in increased MRI and clinical disease activity. Caution is suggested in administering this combination.

PMID: 18525027


http://tinyurl.com/57nuzh
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Sat Oct 11, 2008 5:38 pm    Post subject: (Abstract) Novel needle for subq Rebif injection... Reply with quote

From PubMed, October 11, 2008:

Quote:
BMC Neurol. 2008 Oct 10;8(1):38.

A novel needle for subcutaneous injection of interferon beta-1a: Effect on pain in volunteers and satisfaction in patients with multiple sclerosis

Jaber A, Bozzato GB, Vedrine L, Prais WA, Berube J, Laurent PE.


BACKGROUND:

To reduce injection pain and improve satisfaction, a thinner (29-gauge [29G]), sharper (5-bevel) needle than the 27G/3-bevel needle used previously to inject interferon (IFN) beta-1a, 44 or 22 mcg subcutaneously (sc) three times weekly (tiw), was developed for use in multiple sclerosis (MS).

METHODS:

Two clinical trials in healthy volunteers and five surveys of patients with MS were conducted to assess whether the 29G/5-bevel needle with a Thermo Plastic Elastomer (TPE) needle shield (a sleeve that houses the tip of the needle in a secure location) is an improvement over the 27G/3-bevel needle with a rubber shield for injection of IFN beta-1a, 44 or 22 mcg sc tiw.

Parameters assessed were: pain and ease of insertion (healthy volunteer and nurse responses on subjective pain measurement scales); and patient satisfaction (surveys of patients with MS).

RESULTS:

In healthy volunteers, the 29G/5-bevel needle with TPE shield was associated with the least perceived pain on the Visual Analog Scale (VAS) and Verbal VAS (VB-VAS); mean VAS pain scores decreased by 40% and skin penetration improved by 69% compared with the 27G/3-bevel needle with standard rubber shield (p < 0.01). Pooled results from surveys of patients with MS indicated that 63% of patients thought that injections were less painful with the 29G/5-bevel needle than the 27G/3-bevel needle. Results from individual surveys indicated that the 29G/5-bevel needle was an improvement over the 27G/3-bevel needle for ease of insertion, injection-site reactions, bruising, burning and stinging.

CONCLUSIONS:

Together these studies indicate that the 29G/5-bevel needle with the TPE shield is an improvement over the 27G/3-bevel needle with standard rubber shield in terms of pain, ease of insertion and patient satisfaction. These improvements are expected to result in improved compliance in patients with MS treated with IFN beta-1a, 44 or 22 mcg sc tiw.

PMID: 18845005
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Fri Mar 05, 2010 11:34 pm    Post subject: (Abstract) Rapid benefits of new formulation... Reply with quote

From PubMed, March 5, 2010:

Quote:
Mult Scler. 2010 Mar 3.

Rapid benefits of a new formulation of subcutaneous interferon beta-1a in relapsing-remitting multiple sclerosis.

De Stefano N, Curtin F, Stubinski B, Blevins G, Drulovic J, Issard D, Shotekov P, Gasperini C.

Department of Neurological and Behavioral Sciences, University of Siena, Siena, Italy.

This study evaluated the efficacy of a new formulation of subcutaneous (sc) interferon (IFN)-beta1a in relapsing-remitting multiple sclerosis (RRMS). Patients (n = 180) were randomized (2 : 1) to IFN-beta-1a or placebo for 16 weeks; all patients then received IFN-beta-1a for 24 weeks. Monthly brain MRI was performed.

At week 16, the mean number of combined unique active (CUA) lesions was lower with IFN-beta-1a than with placebo (p < 0.001; 69% fewer lesions). The mean cumulative number of CUA lesions was already lower with IFN-beta-1a by week 4 (post hoc analysis; p = 0.015). The new formulation of sc IFN-beta-1a has rapid beneficial effects on MRI outcomes in RRMS.

PMID: 20200197


The abstract can be seen here.
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Thu May 06, 2010 5:25 pm    Post subject: (Abstract) Electronic self-injection device study Reply with quote

From PubMed, May 4, 2010:

Quote:
BMC Neurol. 2010 Apr 30;10(1):28.

Patient-rated suitability of a novel electronic device for self-injection of subcutaneous interferon beta-1a in relapsing multiple sclerosis: an international, single-arm, multicentre, Phase IIIb study

Devonshire V, Arbizu T, Borre B, Lang M, Lugaresi A, Singer B, Verdun di Cantogno E, Cornelisse P.

BACKGROUND:

Multiple sclerosis (MS) currently requires long-term treatment with disease-modifying drugs, administered parenterally up to once daily. The need for regular self-injection can be a barrier to treatment for many patients. Autoinjectors can help patients overcome problems or concerns with self-injection and could, therefore, improve treatment adherence.

This study was performed to assess the suitability of a new electronic device for the subcutaneous (sc) administration of interferon (IFN) beta-1a, 44 mcg three times weekly, for relapsing MS.

METHODS:

In this Phase IIIb, multicentre, single-arm study, patients with relapsing MS who had been consistently self-injecting sc IFN beta-1a using an autoinjector for at least 6 weeks were taught to use the new device and self-administered treatment for 12 weeks thereafter. Patient-rated suitability of the device was assessed at the end of Week 12 using the Patient User Trial Questionnaire. Patient satisfaction with, and evaluation of, the injection process was assessed using the MS Treatment Concern Questionnaire. Trainers evaluated the device using the Trainer User Trial Questionnaire.

RESULTS:

At Week 12, 71.6% (73/102) of patients considered the device 'very suitable' or 'suitable' for self-injection; 92.2% (94/102) reported some degree of suitability and only 7.8% (8/102) found the device 'not at all suitable'. At Weeks 4, 8 and 12, most patients reported that injection preparation and clean-up, performing injections and ease of device use in the previous 4 weeks compared favourably with, or was equivalent to, their previous experience of self-injection. Injection-related pain, injection reactions and 'flu-like' symptoms remained stable over the 12 weeks. Each device feature was rated 'very useful' or 'useful' by at least 80% of patients. All trainers and 95.2% (99/104) of patients found device functions 'very easy' or 'easy' to use. Overall convenience was considered the most important benefit of the device.

CONCLUSIONS:

Most patients considered the new electronic injection device suitable for the sc injection of IFN beta-1a. They found the device easy to use with useful features, and reported benefits such as overall convenience. The device may, therefore, increase treatment adherence in patients with MS, particularly those with injection-related issues.

Trial registration: NCT00735007.

PMID: 20433746


The abstract can be seen here.
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Wed Sep 22, 2010 8:11 am    Post subject: (Abstr.) Disease-modifying therapies in RRMS Reply with quote

Opinions differ about which of the ABCR drugs is the most effective. It's hard to tell from this abstract where the authors are getting their opinion from when they declare Rebif to be the most effective. Maybe they have a solid basis for this announcement--and maybe they don't.

From PubMed, September 22, 2010:

Quote:


Neuropsychiatr Dis Treat. 2010 Sep 7;6:365-373.

Disease-modifying therapies in relapsing-remitting multiple sclerosis

González-Andrade F, Alcaraz-Alvarez JL.

Department of Medicine, Metropolitan Hospital, Quito, Ecuador;


QUESTION: What is the best current disease-modifying therapy for relapsing-remitting multiple sclerosis?

RESULTS: The evidence shows that the most effective disease-modifying therapy for delaying short- to medium-term disability progression, prevention of relapses, reducing the area and activity of lesions on magnetic resonance imaging, with the least side effects, is high-dose, high-frequency subcutaneous interferon-β1a 44 μg three times per week.

IMPLEMENTATION:

The pitfalls in treatment of MS can be avoided by remembering the following points: The most effective therapy to prevent or delay the appearance of permanent neurological disability with the fewest side effects should be chosen, and treatment should not be delayed.

Adherence to treatment should be monitored closely, and needs comprehensive patient information and education to establish long-term adherence, which is a critical determinant of long-term outcome.The correct approach to the disease includes disease management, symptom management, and patient management.

A combination of tools is necessary to ease the various symptoms, which fall into three broad categories, i.e. rehabilitation, pharmacological, and procedural.It is important to understand that no treatment modality should be used alone, unless it is in itself sufficient to remedy the particular symptom/problem.

PMID: 20856600
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Tue May 31, 2011 6:01 pm    Post subject: Vitamin D3 as add-on therapy in RRMS patients on Rebif Reply with quote

A new study involving vitamin D3 supplementation in patients on Rebif has been described in PubMed, May 31, 2011:

Quote:
J Neurol Sci. 2011 May 25.

Efficacy of vitamin D(3) as add-on therapy in patients with relapsing-remitting multiple sclerosis receiving subcutaneous interferon beta-1a: A Phase II, multicenter, double-blind, randomized, placebo-controlled trial

Smolders J, Hupperts R, Barkhof F, Grimaldi LM, Holmoy T, Killestein J, Rieckmann P, Schluep M, Vieth R, Hostalek U, Ghazi-Visser L, Beelke M; on behalf of the SOLAR study group.
SourceMaastricht University Medical Centre, Maastricht, The Netherlands.

Recent studies have demonstrated the immunomodulatory properties of vitamin D, and vitamin D deficiency may be a risk factor for the development of MS. The risk of developing MS has, in fact, been associated with rising latitudes, past exposure to sun and serum vitamin D status. Serum 25-hydroxyvitamin D [25(OH)D] levels have also been associated with relapses and disability progression.

The identification of risk factors, such as vitamin D deficiency, in MS may provide an opportunity to improve current treatment strategies, through combination therapy with established MS treatments. Accordingly, vitamin D may play a role in MS therapy. Small clinical studies of vitamin D supplementation in patients with MS have reported positive immunomodulatory effects, reduced relapse rates and a reduction in the number of gadolinium-enhancing lesions. However, large randomized clinical trials of vitamin D supplementation in patients with MS are lacking.

SOLAR (Supplementation of VigantOL(®) oil versus placebo as Add-on in patients with relapsing-remitting multiple sclerosis receiving Rebif(®) treatment) is a 96-week, three-arm, multicenter, double-blind, randomized, placebo-controlled, Phase II trial (NCT01285401). SOLAR will evaluate the efficacy of vitamin D(3) as add-on therapy to subcutaneous interferon beta-1a in patients with RRMS.

Recruitment began in February 2011 and is aimed to take place over 1 calendar year due to the potential influence of seasonal differences in 25(OH)D levels.


PMID:21620416


The abstract can be seen here.
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Sat Jun 11, 2011 10:37 pm    Post subject: Differences in immunomodulatory effects of Rebif & Avone Reply with quote

From PubMed, June 11, 2011:
Abstract

Quote:
J Neurol Sci. 2011 Jun 7.

Quantitative differences in the immunomodulatory effects of Rebif and Avonex in IFN-β 1a treated multiple sclerosis patients

Christophi GP, Christophi JA, Gruber RC, Mihai C, Mejico LJ, Massa PT, Jubelt B.

Source

Department of Microbiology & Immunology, SUNY Upstate Medical University, Syracuse NY, USA; Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.

Interferon-β (IFN-β) is a current effective treatment for multiple sclerosis (MS) and exerts its therapeutic effects by down-modulating the systemic immune response and cytokine signaling.

In clinical practice there are several formulations of interferon including a low dose of IFN-β 1a formulation of 30μg IM once weekly (Avonex) and a high dose formulation of 44μg SC three times weekly (Rebif). Recent studies suggest that Rebif is more efficacious compared to Avonex in preventing relapses and decreasing MRI activity in relapsing remitting MS (RRMS) patients.

This study examines whether there are quantitative gene expression changes in interferon-treated RRMS patients that can explain the difference in efficacy and side effects between Rebif and Avonex. Herein, RRMS patients were treated for three months with IFN-β 1a and the levels of plasma cytokines and gene expression in peripheral blood mononuclear cells were examined.

Thirty-two normal subjects were compared to thirty-two RRMS patients, of which ten were treated with Rebif and ten with Avonex. Rebif and Avonex both significantly and equally suppressed plasma TNF-α and IL-6 levels. Rebif suppressed IL-13 significantly more than Avonex. Rebif also significantly suppressed the levels of the chemokines CCL17 and RANTES, the protease ADAM8, and COX-2 at a higher degree compared to Avonex. The STAT1-inducible genes IP-10 and caspase 1 were significantly increased with Rebif compared to Avonex.

In conclusion, the higher dosed, more frequently administered IFN-β 1a Rebif when compared to IFN-β 1a Avonex has more potent immunomodulatory effects. These quantitative results might relate to efficacy and side-effect profile of the two IFN-β 1a formulations and provide prospective practical clinical tools to monitor treatment and adjust dosage.


PMID:21658727


The abstract can be seen here.
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Thu Jul 07, 2011 7:48 am    Post subject: (Abstr.) New electronic subq injection device Reply with quote

This device may be a big improvement over the present injection techniques. It also makes it possible for the doctor to see if you've been doing your shots, apparently.

From PubMed, July 7, 2011:

Quote:
Expert Rev Med Devices. 2011 Jul 6.

A new electronic device for subcutaneous injection of IFN β-1a

Exell S, Verdun E, Driebergen R.

Merck Serono S.A. - Geneva*, 9 chemin des Mines, 1202 Geneva, Switzerland.

Disease-modifying drugs (DMDs) can provide important benefits for patients with multiple sclerosis (MS), but nonadherence to treatment is associated with an increased risk of relapse. All first-line DMDs used in MS require regular injection, but injection-related problems are common barriers to treatment adherence.

Autoinjectors that allow automatic injection at the press of a button have increased the ease and convenience of injection, compared with manual injection. A new electronic autoinjector has recently been introduced for the administration of subcutaneous IFN β-1a. This device is the first electronic autoinjector for use with any MS therapy, and includes several innovative features that may be advantageous to patients.

One of these features is an accurate electronic dosing log, which can be viewed by the patient and the healthcare provider. This article discusses this new electronic device in the context of other autoinjectors currently used to self-inject first-line DMDs in MS.

PMID:21728909


The abstract can be seen here.
Back to top
View user's profile Send private message
agate
Site Admin


Joined: 17 May 2006
Posts: 5694
Location: Oregon

PostPosted: Fri Jan 27, 2012 7:10 pm    Post subject: Rebif for early symptoms of MS, UK Reply with quote

From Medical News Today, January 26, 2012:

Quote:
Rebif® For Early Symptoms Of Multiple Sclerosis, UK

Rebif® (interferon beta-1a), a disease-modifying medication used to treat relapsing forms of multiple Sclerosis (MS), is now available in the UK to treat individuals with clinically isolated syndrome (CIS), a potential early indicator of MS, announced Merck Serono, a division of Merck KGaA, Darmstadt, Germany. The announcement comes after the recent positive opinion adopted by the Committee of Medicinal Products (CHMP), the scientific committee of the European Medicines Agency (EMA).

Rebif 44 micrograms is approved for use three times per week following an demyelinating event, in individuals at greater risk of developing MS.

Further evidence was supported by data from the REFLEX study, a phase III, randomized, double-blind, placebo-controlled, multi-centre human trial of Rebif 44 microgram in individuals at greater risk of developing MS.

Professor David Bates, Royal Victoria Infirmary Newcastle, explained:


"It is established that Disease Modifying Therapy (DMT) for people with multiple sclerosis is most effective when given early in the disease. The licensing of Rebif, an established DMT, for those with first symptoms of MS is another step forward in controlling the illness and give doctors an additional early treatment for their patients."


Rebif® has already shown to reduce the prevalence of MS relapses, reduce MRI lesion activity, as well as stall disease progression.

Rebif® is listed as one of the treatments funded through the NHS scheme in a recent Department of Health letter that restates the Multiple Sclerosis Risk Sharing Scheme. According to the letter, at present, there is no ban for beta-interferons like Rebif prescriptions and NHS Trust funding for patients falling outside the ABN guidelines who are considered to be in clinical need of the drug.

...

Written by Grace Rattue

References:
Merck Serono



The entire article can be seen here.
Back to top
View user's profile Send private message
Display posts from previous:   
Post new topic   Reply to topic    msspeaks Forum Index -> MS - RESEARCH, ARTICLES, ABSTRACTS, DISCUSSION All times are GMT - 7 Hours
Page 1 of 1

 
Jump to:  
You can post new topics in this forum
You can reply to topics in this forum
You can edit your posts in this forum
You can delete your posts in this forum
You cannot vote in polls in this forum
Create your own free forum now!
Terms of Service Purchase Ad Removal Forum Archive Report Abuse