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MS TREATMENTS - AVONEX

 
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PostPosted: Sat Jul 15, 2006 6:24 pm    Post subject: MS TREATMENTS - AVONEX Reply with quote

Here's a place for people on Avonex or thinking about Avonex--or for people who have been on Avonex.
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PostPosted: Thu Jul 20, 2006 9:03 am    Post subject: Reply with quote

Well, I guess I'll start.

I picked Avonex because one big needle sounded better than several little ones each week. This was pre-Rebif, otherwise I may have considered that.

My neuro is very pro-interferon; he believes that Copax doesn't do as much as AB or R. So, my choices were really Avonex or Betaseron. Again, the big needle won out.

I've only relapsed once during active Avonex therapy. I've been on it about a four years combined (went off while pregnant and nursing for two months), and side effects, after beginning treatment (or resuming) subside substantially after just a few weeks. I've been fortunate in this sense, since some folks continue to have awful side effects throughout treatment.

I've noticed that I experence less side effects from the mix-it-yourself (LYO vial) type than the prefilled syringes. LYO is avaialble, but must be prescribed specifically.

Injectfully yours,

mello
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PostPosted: Wed Aug 09, 2006 11:50 pm    Post subject: Reply with quote

marshmello, that was the way I was thinking too when I opted for Avonex instead of B, C or R.

I was all for one shot a week instead of several, and the big needle didn't bother me at all.

Avonex turned out to be wrong for me, but it clearly isn't wrong for a lot of people. You seem to be one of those it's right for.
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PostPosted: Thu Aug 24, 2006 12:54 pm    Post subject: (Article) EMLA cream to reduce pain w/ Avonex shot Reply with quote

From PubMed:

Quote:



J Neurosci Nurs. 2006 Aug;38(4):222-6.

Efficacy of EMLA cream to reduce fear and pain associated with interferon beta-1a injection in patients with multiple sclerosis

Buhse M.
Stony Brook University School of Nursing, Stony Brook, NY, USA. Marijean.buhse@stonybrook.edu

Fear of pain from injections may affect adherence to needed drug therapy.

A single-blind, placebo-controlled crossover study was conducted to evaluate the efficacy of EMLA cream in reducing the fear and pain associated with intramuscular (IM) injection during administration of interferon beta-1a to patients with multiple sclerosis.

Patients rated fear of injection on a visual analog scale before the injection and rated injection pain following the injection.

With the application of EMLA cream, the mean pain-of-injection score was found to be significantly lower than the mean fear-of-injection score. The 18 patients who completed the study experienced a statistically significant decrease in both scores.

This study suggests that the use of EMLA cream may reduce the pain and fear associated with IM injections.





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PostPosted: Fri Oct 20, 2006 3:30 pm    Post subject: Prefilled Avonex now storable at room temp 7 days Reply with quote

Quote:
Press Release Source: Biogen Idec


AVONEX(R), The #1 Prescribed Multiple Sclerosis Therapy Worldwide, Improves Patient Convenience

Friday October 20, 9:58 am ET

Additional Supplemental Application for Room Temperature Storage with Prefilled Syringe Approved by FDA

CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVONEX® (Interferon beta-1a), the most prescribed multiple sclerosis (MS) therapy worldwide, may now be stored at room temperature (up to 77 degrees F or 25 degrees C) in its prefilled formulation for a period up to 7 days.

AVONEX remains the only once-a-week disease modifying therapy to both slow the progression of physical disability and reduce the frequency of clinical relapses for people with MS.

"Biogen Idec is committed to the discovery and development of new therapeutic options for people living with MS as well as continuous improvement of existing ones ." said Michael Panzara MD, MPH, VP, Chief Medical Officer, Neurology Strategic Business Unit.



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PostPosted: Sat Mar 03, 2007 7:45 pm    Post subject: (Abstract) Results of the Avonex combination trial Reply with quote

Scheduled for upcoming AAN conference in May 2007:

Quote:
Results of the Avonex Combination Trial (ACT)

Jeffrey Cohen, Solon, OH, Peter Calabresi, Baltimore, MD, Thorsten Eickenhorst, Keith Edwards, Bennington, VT, Warren Felton, Richmond, VA, Elizabeth Fisher, Robert Fox, Andrew Goodman, Rochester, NY, Claire Hara-Cleaver, George Hutton, Houston, TX, Peter Imrey, Brian Mandell, Cleveland, OH, Thomas Scott, Pittsburgh, PA, Hao Zhang, Cambridge, MA

OBJECTIVE: ACT was a multicenter investigator-run safety and efficacy trial of interferon beta-1a (IFN-1a, Avonex) combined with methotrexate (MTX), intravenous methylprednisolone (IVMP) or both for relapsing-remitting multiple sclerosis (RRMS) patients with active disease on IFN-1a monotherapy.

BACKGROUND: Current RRMS therapies are partially effective. Combination therapies are useful for other disorders. Preliminary data support safety and benefit of MTX or IVMP combined with IFN in MS.

DESIGN/METHODS: Eligibility criteria included RRMS, EDSS 0-5.0 and active disease (1 relapse or gadolinium enhancing MRI lesion) in the prior year on IFN-1a therapy. Subjects were randomized to adjunctive weekly placebo or MTX 20 mg PO, each with or without IVMP 1000 mg/d 3d every other month, and followed 12 months. ACT was governed by an investigator Steering Committee with input from independent Advisory and Data Safety Monitoring Committees, and managed by the Cleveland Clinic MS Academic Coordinating Center.

RESULTS: The four treatment groups (n=313 total) had similar baseline demographic, clinical and MRI characteristics. MTX-IVMP-IFN-1a combinations were safe and well-tolerated. Last-observation-carried-forward mean-imputed data showed favorable, though not statistically significant, trends in multiple clinical and MRI outcomes, with least evidence of disease activity usually in the three-drug combination. New or enlarged T2 lesions, the primary outcome, averaged 1.53/patient overall with upper-count category odds ratios (95% CI) in a main-effects proportional odds model MTX 0.90 (0.59-1.36) and IVMP 0.74 (0.48-1.13). Relapses averaged 0.40/patient-year overall with rate ratios in a main-effects negative binomial regression model MTX 0.77 (0.51-1.16) and IVMP 0.70 (0.46-1.05). Baseline to last observation T2 volume percent increase was reduced by IVMP (p=0.038) but not significantly by MTX.

CONCLUSIONS/RELEVANCE: Initial analyses of ACT showed trends favoring the combination therapy regimens. Further pre-planned analyses, including multiple imputation analyses, are in progress. ACT provides an innovative model for academic-industry collaborative MS research.

Supported by: Biogen Idec, Inc. supported this study. Pfizer, Inc. provided methylprednisolone.

Tuesday, May 1, 2007 4:45 PM

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PostPosted: Sat Apr 28, 2007 2:06 pm    Post subject: (Abstract) IFN-beta-1a slows brain atrophy in RRMS.... Reply with quote

From PubMed, April 28, 2007:

Quote:
Mult Scler. 2007 May;13(4):490-501.

Interferon beta-1a slows progression of brain atrophy in relapsing-remitting multiple sclerosis predominantly by reducing gray matter atrophy

Zivadinov R, Locatelli L, Cookfair D, Srinivasaraghavan B, Bertolotto A, Ukmar M, Bratina A, Maggiore C, Bosco A, Grop A, Catalan M, Zorzon M.
Department of Neurology, Buffalo Neuroimaging Analysis Center, The Jacobs Neurological Institute, University at Buffalo, State University of New York, Buffalo, NY, USA. rzivadinov@thejni.org.

BACKGROUND: Brain atrophy, as assessed by magnetic resonance imaging (MRI), has been correlated with disability in patients with multiple sclerosis (MS). Recent evidence indicates that both white matter (WM) and gray matter (GM) are subject to atrophy in patients with MS. Although neurological deficiencies in MS are primarily due to loss of WM, the clinical significance of GM atrophy has not been fully explored in MS.

METHODS: We have undertaken a three-year, open-label study, comparing 26 patients who elected to receive intramuscular interferon beta-1a (IFN beta-1a) therapy, with 28 patients who elected not to receive therapy. Both groups had quantitative cranial MRI scans at study entry and after three years, and standardized clinical assessments every six months. Brain parenchymal fraction (BPF), GM fraction (GMF), and WM fraction (WMF) percent changes were calculated, and T2- and T1-lesion volumes (LVs) assessed.

RESULTS
: After three years, mean percent (%) change in BPF favored the IFN beta-1a treatment group (IFN beta-1a -1.3% versus the control group -2.5%, P=0.009), as did the mean percent change in GMF (+0.2 versus -1.4%, P=0.014), and the mean percent change in T1-LV (-9.3 versus +91.6%, P=0.011). At the end of the study, there was a significant within-patient decrease in BPF for both groups (P=0.02 for the IFN beta-1a treatment group, and P<0.001 for the control group), a significant within-patient decrease in WMF for the IFN beta-1a treatment group (P=0.01), and a significant decrease in GMF for the control group (P=0.013) when compared with baseline.

CONCLUSION: Over a three-year period, treatment with IFN beta-1a significantly slowed the progression of whole-brain and GM atrophy, and of T1-hypointense LV accumulation, when compared with the control group.

PMID: 17463072


Note that this is an open-label study.
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PostPosted: Tue Jul 03, 2007 1:34 pm    Post subject: (Abstract) Treating early-onset MS w/Avonex Reply with quote

From PubMed, July 3, 2007:

Quote:
Neurol Sci. 2007 Jun;28(3):127-32

Treatment of early-onset multiple sclerosis with intramuscular interferon beta-1a: long-term results

Ghezzi A, Amato MP, Capobianco M, Gallo P, Marrosu MG, Martinelli V, Milanese C, Moiola L, Milani N, La Mantia L, Patti F, Pozzilli C, Trojano M, Comi G, Zaffaroni M; the Immunomodulatory Treatment of Early-onset MS (ITEMS) Group.
Centro Studi Sclerosi Multipla, Ospedale di Gallarate, Via Pastori 4, I-20013, Gallarate, Italy, angelo.ghezzi@aogallarate.it.

The objective was to evaluate the safety, tolerability and effectiveness of intramuscular (IM) interferon beta-1a (IFNbeta-1a; Avonex, Biogen) 30 mg once a week in patients with onset of symptoms of multiple sclerosis (MS) in childhood or adolescence.

Patients with a diagnosis of definite MS according to McDonald's criteria, relapsing course according to Lublin's criteria, onset of symptoms of MS before 16 years of age, and who had received IM IFNbeta-1a therapy before 16 years of age were eligible for the study if they had a pretreatment and treatment duration of at least 6 months.

Clinical and laboratory evaluations were performed every 3 months. A total of 52 patients were identified as receiving treatment with IM IFNbeta-1a 30 mg once a week before 16 years of age. Mean age at onset of symptoms of MS was 11.7+/-2.7 years, mean disease duration was 25.9+/-30.3 months, mean annualised relapse rate was 1.9+/-1.1 and mean Expanded Disability Status Scale (EDSS) score was 1.5+/-1.1. After a mean (+/-SD) treatment duration of 42.9+/-19.9 months, annualised relapse rate decreased to 0.4+/-0.5. Final EDSS score was 1.3+/-1.1.

Adverse events were recorded for 35 (67%) patients (flulike syndrome, 33%; headache, 29%; myalgia, 21%; fever, 11%; fatigue, 6%; nausea and vomiting, 6%; and skin reaction, 4%); most were transient. IM IFNbeta-1a was effective and well tolerated in these paediatric patients with MS.

PMID: 17603763
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PostPosted: Wed Sep 19, 2007 5:14 pm    Post subject: (Abstract) Relieving flulike sx in MS patients.... Reply with quote

From PubMed, September 19, 2007:

Quote:
Curr Med Res Opin. 2007 Jul;23(7):1667-72

Alleviating flu-like symptoms with dose titration and analgesics in MS patients on intramuscular interferon beta-1a therapy: a pilot study

Brandes DW, Bigley K, Hornstein W, Cohen H, Au W, Shubin R.
Northridge MS Center, Northridge, CA 91325, USA. dwbnorth@sbcglobal.net

OBJECTIVE
: To determine the effectiveness of dose titration and choice of analgesic in reducing flu-like side effects of intramuscular interferon beta-1a (i.m. IFNbeta-1a).

METHODS: Patients were randomly assigned to receive weekly i.m. IFNbeta-1a, with or without dose titration, plus acetaminophen or ibuprofen. After 27 patients had been randomized, the original formulation of i.m. IFNbeta-1a became unavailable and the remaining patients used a pre-packaged liquid formulation, necessitating a change in protocol from initially quarter-dose to half-dose titration. Patients scored presence and intensity of muscle aches, chills, and weakness, and measured body temperature; information was recorded in diaries.

RESULTS: Forty-seven patients were enrolled; 36 completed the study. Fifteen patients received full-dose therapy plus acetaminophen, eight patients received quarter-dose titration and acetaminophen, 10 patients received quarter-dose titration and ibuprofen, eight patients received half-dose titration and acetaminophen, and six patients received half-dose titration and ibuprofen. The mean number of acetaminophen doses taken was not statistically different from the mean number of ibuprofen doses taken per patient per week in any dose-titration group over measured time intervals (p > 0.05).

Symptom scores from acetaminophen and ibuprofen dose-titration groups were combined and compared with the no-titration group. The proportion of patients with a mean increase of > or = 2 from baseline in flu-like symptom score trended lower in the titrated group compared with the no-titration group at 4 hours and 12-15 hours post-injection; these differences reached statistical significance only during the first 2 weeks of treatment (p = 0.015, quarter-dose vs. no titration).

CONCLUSION: This study supports the findings of previous studies demonstrating no difference in the effectiveness of acetaminophen and ibuprofen in controlling flu-like symptoms associated with IFNbeta treatment in patients with relapsing-remitting MS.

Trends in this small pilot study suggest that the combination of initial dose titration and analgesic administration is useful for the reduction of flu-like symptoms with IFNbeta-1a therapy.

PMID: 17588298
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PostPosted: Sat Oct 20, 2007 11:49 am    Post subject: (Abstract) Effect of statins on Avonex for RRMS Reply with quote

From the ECTRIMS conference in Prague, October 11-14, 2007:

Quote:
Effects of statins on intramuscular interferon beta-1a for relapsing-remitting multiple sclerosis

R. Rudick, A. Pace, M. Panzara, S. Rani, J. Schrock, P. Calabresi, C. Confavreux, S. Galetta, F. Lublin, E.W. Radue, W. Stuart, B. Weinstock-Guttman, D. Wynn (Cleveland, Cambridge, Baltimore, USA; Lyon, F; Philadelphia, New York, USA; Basel, CH; Atlanta, Buffalo, Northbrook, USA)


Background:

Animal studies suggest statins may have a therapeutic effect in multiple sclerosis (MS). However, a study combining atorvastatin 40 or 80 mg/d with subcutaneous interferon beta-1a (IFNB-1a) suggested that atorvastatin inhibited clinical and MRI therapeutic effects of IFNB-1a (Birnbaum G, AAN 2007).

Objective:

To determine effects of statins on clinical and biological responses to intramuscular (IM) IFNB-1a in RRMS.

Methods:

Of 1171 RRMS patients in the SENTINEL trial, 582 were assigned to IFNB-1a 30 mcg once weekly and treated for up to 116 weeks. Annualised relapse rate (ARR), 12-week sustained disability progression, change in Expanded Disability Status Scale (EDSS) score, number of new or enlarging T2-hyperintense lesions, and number of gadolinium-enhancing (Gd+) lesions were analyzed by statin treatment status. In a separate cohort, IFN-stimulated gene expression was determined in RRMS patients initiating IM IFNB-1a, using a customized cDNA array comprised of 197 IFN response genes.

Results:

At baseline, patients who received combination therapy with IM IFNB-1a and statins (n=40; 35 patients took atorvastatin or simvastatin <=20 mg) were slightly older, but well matched for clinical characteristics vs those who received IM IFNB-1a and no statin (n=542). The adjusted ARR at 2 years was similar in both groups (0.663 for statin therapy vs 0.673 for no statin therapy; P=0.937). The cumulative probability of disability progression was similar in both groups (0.29 for statin therapy vs 0.31 for no statin therapy; P=0.693). At 2 years, the median number of Gd+ lesions was 0 in both groups (P=0.604). Over 2 years, statin patients had a median of 1 new or enlarging T2-hyperintense lesion vs a median of 2 lesions in those not receiving statins (P=0.802). In RRMS patients initiating IM IFNB-1a who were also taking statins, there was robust IFN response gene expression in response to IFNB-1a similar to patients not taking statins. Results from other clinical trials will also be presented.

Conclusion:

We found no evidence that statins antagonize the clinical or biological response to IM IFNB-1a. Clinical, MRI, and IFN-stimulated gene responses were similar in patients taking statins together with IM IFNB-1a compared with IM IFNB-1a alone. Adequately powered prospective studies would be required to determine if statins have additive benefits to IFNB.
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PostPosted: Thu Nov 08, 2007 6:46 pm    Post subject: (Abstract) Time of Avonex injection...& side effects Reply with quote

From PubMed, November 2007:

Quote:
Mult Scler. 2007 Nov;13(9):1138-1145

Time of interferon-{beta}-1a injection and duration of treatment affect clinical side effects and acute changes of plasma hormone and cytokine levels in multiple sclerosis patients

Kümpfel T, Schwan M, Pollmächer T, Yassouridis A, Uhr M, Trenkwalder C, Weber F.
Institute of Clinical Neuroimmunology, Klinikum Großhadern, Ludwig-Maximilians-Universität, Munich, Germany. tania.kuempfel@med.uni.

During initiation of interferon-beta (IFN-beta) therapy, many multiple sclerosis (MS) patients experience systemic side effects which may depend on the time point of IFN-beta injection. We investigated the time course of plasma hormone-, cytokine- and cytokine-receptor concentrations after the first injection of IFN-beta either at 8.00 a.m. (group A) or at 6.00 p.m. (group B) and quantified clinical side effects within the first 9 h in 16 medication free patients with relapsing-remitting MS.

This investigation was repeated after 6-month IFN-beta therapy.Plasma ACTH and cortisol concentrations followed their physiological rhythms, with lower levels in the evening compared to the morning, but rose earlier and stronger in group B after IFN-beta administration. IFN-beta injection in the evening led to a faster increase of plasma IL-6 concentrations and temperature during the first hours and correlated with more intense clinical side effects compared to group A. Plasma IL-10 concentrations increased more in group A compared to group B, but sTNF-RI and sTNF-RII concentrations rose 7 h after IFN-beta injection only in group B. Acute effects on plasma hormone and cytokine concentrations adapted after 6-month IFN-beta treatment, while diurnal variations were still present. Baseline sTNF-RII concentrations were elevated after 6-month IFN-beta therapy only in group A.

Our results show that the time point of IFN-beta injection has differential effects on acute changes of plasma hormone and cytokine concentrations and is related to systemic side effects. This may have implications for the tolerability and effectiveness of IFN-beta therapy.

PMID: 17967841


http://tinyurl.com/24pu9j
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PostPosted: Tue Jul 08, 2008 11:05 pm    Post subject: New patient assistance program Reply with quote

Quote:
July 2, 2008 - There is a new Copay Assistance Program for Avonex through MS Active Support (1-800-456-2255). The monthly copay is only $10 with no annual limit for patients who qualify. For more information, please visit http://www.avonex.com.
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PostPosted: Sat Jun 06, 2009 6:36 pm    Post subject: (Abstract) IM IFNbeta-1a in patients w/CIS... Reply with quote

From PubMed, June 2, 2009:

Quote:
Mult Scler. 2009 Jun;15(6):728-34.

Efficacy of intramuscular interferon beta-1a in patients with clinically isolated syndrome: analysis of subgroups based on new risk criteria

O'Connor P, Kinkel R, Kremenchutzky M.
St. Michael's Hospital, Toronto, ON, Canada oconnorp@smh.toronto.on.ca.

Approximately 85% of multiple sclerosis (MS) cases begin as clinically isolated syndromes (CIS).

Results from the Controlled High-Risk Subjects Avonex((R)) Multiple Sclerosis Prevention Study (CHAMPS) demonstrated that, in patients with CIS, treatment with intramuscular (IM) interferon beta-1a (IFNbeta-1a) 30 mug once weekly delayed conversion to clinically definite MS (CDMS) in the total population and in subgroups based on presenting syndromes and baseline magnetic resonance imaging (MRI) characteristics.

Changes to clinical and MRI risk classification of presenting symptoms in recent studies prompted reanalysis of CHAMPS data. Presenting syndromes were assessed using a derived algorithm that stratifies patients into mono- or multifocal categories based on functional system scores.

The ability of IM IFNbeta-1a to delay progression to CDMS in subgroups based on clinical presentation and MRI characteristics was assessed. Reanalysis of CHAMPS patients showed that 30% could be classified by clinical criteria as having multifocal disease at baseline.

IM IFNbeta-1a initiated at a first demyelinating attack delayed CDMS in monofocal patients (P = 0.0013), patients with or without gadolinium-enhancing lesions (P = 0.0007, P = 0.0405) and patients with at least nine T2 lesions at baseline (P = 0.0044). These data confirm that IM IFNbeta-1a delays conversion to CDMS in patients with CIS.

PMID: 19482863


The abstract can be seen here.
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PostPosted: Sun May 23, 2010 6:22 pm    Post subject: Avonex --a 15-year follow-up study Reply with quote

From Multiple Sclerosis, May 20, 2010:

Quote:
Intramuscular interferon beta-1a therapy in patients with relapsing-remitting multiple sclerosis: a 15-year follow-up study

RA Bermel
Department of Neurology, Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA, bermelr@ccf.org

B. Weinstock-Guttman

Department of Neurology, Baird Multiple Sclerosis Center, Buffalo, NY, USA

D. Bourdette

Oregon Health & Science University, Portland, OR, USA

P. Foulds

Biogen Idec, Inc., Wellesley, MA, USA

X. You

Biogen Idec, Inc., Wellesley, MA, USA

RA Rudick

Department of Neurology, Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA

Disease-modifying drugs are initiated early and continued for years in patients with multiple sclerosis. Long-term tolerability and impact are not known. The objective of this study was to evaluate long-term tolerability of intramuscular interferon beta-1a and effects on disability and quality of life. Patients were evaluated an average of 15 years after randomization into a placebo-controlled, double-blind trial of intramuscular interferon beta-1a for relapsing multiple sclerosis. Patient-reported Expanded Disability Status Scale, the Short Form-36, a visual analog scale of self-care independence, and a living situation questionnaire were administered. Status was ascertained in 79% (136/172) of eligible patients.

Analysis focused on 122 living patients. Despite open-label, non-standardized treatment after the 2-year clinical trial, 46% (n= 56) of the patients remained on intramuscular interferon beta-1a. Expanded Disability Status Scale scores were correlated highly with Short Form-36 subcategories and visual analog scale scores. Patients currently using intramuscular interferon beta-1a had a significantly lower mean Expanded Disability Status Scale score (p= 0.011), less progression to Expanded Disability Status Scale milestones, significantly better scores on the physical component of the Short Form-36 (p< 0.0001), and reported better general health and greater independence.

We conclude that patients continuing to use intramuscular interferon beta-1a had less disability and better quality of life compared with patients not currently using intramuscular interferon beta-1a 15 years after randomization into a clinical trial.


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PostPosted: Sun Jul 18, 2010 6:40 pm    Post subject: Abstract: Disability progression in RRMS clinical trial... Reply with quote

From Archives of Neurology, July 12, 2010:

Quote:


Disability Progression in a Clinical Trial of Relapsing-Remitting Multiple Sclerosis:
Eight-Year Follow-up


Richard A. Rudick, MD; Jar-Chi Lee, MS; Gary R. Cutter, PhD; Deborah M. Miller, PhD; Dennis Bourdette, MD; Bianca Weinstock-Guttman, MD; Robert Hyde, PhD; Hao Zhang, PhD; Xiaojun You, PhD



Objective

To investigate the value of Expanded Disability Status Scale (EDSS) worsening sustained for at least 6 months and other parameters as predictors for disability status.

Design

Retrospective analysis of the Multiple Sclerosis Collaborative Research Group study data.

Setting

The intramuscular interferon beta-1a pivotal trial was a double-blind, placebo-controlled phase 3 study.

Participants


Patients with relapsing-remitting multiple sclerosis who received at least 2 years of treatment and completed an EDSS evaluation 8 years postrandomization.

Intervention

Thirty micrograms of intramuscular interferon beta-1a or placebo once weekly during the 2-year clinical trial.

Main Outcome Measures


Positive predictive values for 6-month sustained progression during 2 years were calculated to determine the ability to predict disability status at 8 years. A multivariate logistic regression model was used to assess the relationship between predictors and EDSS milestones at follow-up.

Results

Forty-five patients had sustained 6-month EDSS progression during the clinical trial and 115 did not. Progression during the trial was the strongest predictor of reaching EDSS milestones at the follow-up visit, 8 years after randomization. Other independent predictors were treatment arm assignment and baseline EDSS score.

Conclusion

In this phase 3 clinical trial of intramuscular interferon beta-1a, compared with effects of treatment, baseline EDSS score, and number of relapses during the study, worsening of 1 point or more on EDSS from baseline lasting 6 months was the strongest predictor of clinically significant disability 8 years after randomization into the clinical trial.


Author Affiliations:

Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, Ohio (Drs Rudick and Miller; and Ms Lee); Department of Biostatistics, University of Alabama at Birmingham, Birmingham (Dr Cutter); Oregon Health & Science University, Portland (Dr Bourdette); William C. Baird Multiple Sclerosis Center, Buffalo, New York (Dr Weinstock-Guttman); and Biogen Idec Inc, Cambridge, Massachusetts (Drs Hyde, Zhang, and You).
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PostPosted: Tue Oct 05, 2010 8:17 am    Post subject: (Abstract) Widespread hives due to Avonex therapy for MS Reply with quote

Only two cases but the ABCR drugs are still new enough, in my opinion, for a watchful eye on adverse events that occur.

From PubMed, October 5, 2010:

Quote:
Neurol Sci. 2010 Oct 2. [Epub ahead of print]

Widespread urticaria due to intramuscular interferon beta-1a therapy for multiple sclerosis

Guijarro C, Benito-León J, Bermejo-Pareja F.

Department of Neurology, University Hospital "12 de Octubre", Madrid, Spain.

We describe two multiple sclerosis patients who displayed widespread urticaria due to intramuscular interferon beta-1a (INF-β-1a). Clinicians should be aware of this adverse event, since it may be severe and it may lead to the definitive interruption of treatment.

Widespread urticaria complicating intramuscular INF-β-1a therapy in multiple sclerosis should therefore be added to the list of dermatological lesions associated with interferon therapy.

PMID: 20890624


The abstract can be seen here.
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PostPosted: Thu Jun 02, 2011 10:02 am    Post subject: Avonex "pen" now available in Canada Reply with quote

Canadian patients with MS on Avonex can now get their medicine through an autoinjector device, the Avonex pen. The needle is 25 gauge 16mm.

You can read about it here.

National Post, June 1, 2011.
_________________
MS diagnosed 1980.

Avonex 2002-2005. Copaxone 2007-2010.


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PostPosted: Sat Jun 25, 2011 2:34 pm    Post subject: Positive data from dose titration study Reply with quote

From Medical News Today, June 6, 2011:

Quote:
Biogen Idec Reports Positive Data From AVONEX Dose Titration Study At 2011 Annual Meeting Of The Consortium Of Multiple Sclerosis Centers

Biogen Idec today announced the findings from a randomized, multicenter, dose-blinded clinical trial that evaluated the effect of AVONEX®(interferon beta-1a) dose titration, or gradual dose escalation, on flu-like symptoms associated with the therapy. The data demonstrated that dose titration with AVONEX over three weeks at the initiation of treatment resulted in a 76 percent reduction in flu-like symptom severity between pre-injection and the four-six-hour post-injection time point versus no titration (p<0.001).

The study also showed that titration over six weeks at the initiation of treatment led to a 50 percent reduction in flu-like symptom severity between the same pre- and post-injection time point versus no titration (p<0.001). These data were presented at the 2011 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting in Montreal.

"Some physicians have practiced titration in the past based on experience of improved tolerability at initiation of interferon treatment; however, there has been limited clinical evidence on the benefits of dose titration," said Elliot Frohman, M.D., Ph.D., Professor of Neurology and Neurotherapeutics and of Ophthalmology at UT Southwestern Medical Center in Dallas, and member of the AVONEX U.S. advisory board. "We now have robust data showing that people who initially received titrated doses of AVONEX experienced a reduction in severity and incidence of flu-like symptoms."

Flu-like symptoms (e.g., fever, chills, headache, muscle aches and pains, and fatigue) have been shown to occur with interferon treatment, and physicians currently may employ several different strategies to alleviate these symptoms. Biogen Idec conducted the AVONEX dose titration study to help characterize the impact of titration on severity and incidence of flu-like symptoms.

"AVONEX has been a leading prescribed treatment for multiple sclerosis for 15 years and continues to provide hope for patients suffering from this disease," said Aaron Deykin, M.D., Director of Late Stage Neurology Development at Biogen Idec. "Findings from the dose titration study add to the real-world efficacy and safety data we have acquired for AVONEX, and can potentially provide the medical community with additional knowledge they can use to augment their own clinical experience to guide their approach to the initiation of AVONEX treatment."

About the Study

An eight-week, randomized, multicenter, dose-blinded study (n=234) was conducted to evaluate the effect of dose titration on the severity and incidence of AVONEX-related flu-like symptoms, with a subsequent two-week follow-up. The primary endpoint of the study was the change in total flu-like symptoms severity score from pre-injection to the four-six-hour post-injection time point. Healthy volunteers were randomized to one of three treatment arms:

- Three-week titration, in which AVONEX was started at one-quarter of the full dose and increased in quarter-dose increments at weekly intervals over three weeks to full-dose (30 µg); then was administered at full-dose for the remaining five weeks.

- Six-week titration, in which AVONEX was started at one-quarter of the full dose and increased in quarter-dose increments at biweekly intervals over six weeks to full-dose (30 µg); then was administered at full-dose for the remaining two weeks.

- No titration, in which the full 30-µg dose was administered weekly for eight weeks.

All subjects received 650 mg of oral acetaminophen within one hour prior to each AVONEX injection, and then at four-six hours, eight-ten hours and 12-15 hours post-injection. A total flu-like symptoms score was calculated based on a 12-point scale, which was the summation of scores for four individual symptoms: fever, chills, muscle aches and pains, and fatigue. Secondary endpoints included change in total flu-like symptoms severity score from pre-injection to the 12-15-hour post-injection time point over the eight-week treatment period, and incidence (defined as the percentage of subjects with a ≥two-point increase in score between pre-injection and post-injection) of flu-like symptoms at the four-six- and 12-15-hour time points.

Results showed that over the treatment period, change in flu-like symptom severity between pre-injection and the four-six-hour post-injection time point was reduced by 76 percent with AVONEX titration over three weeks versus no titration, and by 50 percent with AVONEX titration over six weeks versus no titration. Over the same treatment period, change in flu-like symptom severity between pre-injection and the 12-15-hour post-injection time point was reduced by 37 percent with AVONEX titration over three weeks versus no titration and by 32 percent with AVONEX titration over six weeks versus no titration.

The study results also showed that dose titration reduced the incidence of post-injection flu-like symptoms. Participants in both titration arms had lower incidence of flu-like symptoms at the four-six-hour post-injection time point than subjects in the no-titration arm, with a numerically greater benefit observed with three-week titration (odds ratio [OR] 0.179; 95% confidence interval [CI] 0.075-0.429; P<0.001) than six-week titration (OR 0.414; 95% CI 0.194-0.884; P=0.023). Participants in both titration arms also had lower incidence of flu-like symptoms at the 12-15-hour post-injection time point than subjects in the no-titration arm, with a numerically greater benefit observed with three-week titration (OR 0.469; 95% CI 0.272-0.807; P=0.006) than six-week titration (OR 0.562; 95% CI 0.338-0.936; P=0.027).

The safety profiles for both titration regimens were similar to the safety profile for the no titration AVONEX regimen. Side effects observed in the study were consistent with those outlined in the existing AVONEX product labeling.

...

Source:
Biogen Idec


The article can be seen here.
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PostPosted: Mon Oct 10, 2011 10:21 pm    Post subject: (Abstr.) Immediate Avonex for CIS & long-term outcomes.. Reply with quote

From Archives of Neurology, October 10, 2011:

Quote:
Association Between Immediate Initiation of Intramuscular Interferon Beta-1a at the Time of a Clinically Isolated Syndrome and Long-term Outcomes

A 10-Year Follow-up of the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance

R. Philip Kinkel, MD; Mariya Dontchev, MPH; Craig Kollman, PhD; Thomai T. Skaramagas, BA; Paul W. O’Connor, MD; Jack H. Simon, MD, PhD; for the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance Investigators


Objective

To determine whether immediate initiation of treatment at the time of a clinically isolated syndrome in patients at high risk for clinically definite multiple sclerosis alters disease course over 10 years.

Design

Prospective follow-up study.

Setting

Twenty-four Controlled High-Risk Subjects Avonex Multiple Sclerosis Prevention Study (CHAMPS) sites in the United States and Canada.

Participants

A total of 81 patients originally randomly assigned to receive intramuscular interferon beta-1a (the immediate-treatment group) and 74 patients originally randomly assigned to receive placebo (the delayed-treatment group). All patients were from CHAMPS.

Intervention

For the immediate-treatment group, treatment was initiated within a month after the onset of a clinically isolated syndrome, and for the delayed-treatment group, treatment was initiated a median of 30 months (interquartile range, 24-35 months) after CHAMPS randomization.

Main Outcome Measures

Rate of developing clinically definite multiple sclerosis, annualized relapse rate, disease course classification, disability measures, and magnetic resonance imaging measures.

Results

The immediate-treatment group showed a lower 10-year rate of clinically definite multiple sclerosis (unadjusted hazard ratio, 0.64 [95% CI, 0.48-0.87]; P = .004) and a lower annualized relapse rate between years 5 and 10 (P = .03). There was no differential effect on disability, magnetic resonance imaging T2-weighted lesions, or the proportion of patients developing progressive disease at 10 years. Few patients reached the Expanded Disability Status Scale milestone scores of 4.0 or greater (9% of patients) or 6.0 or greater (6% of patients).

Conclusions

Immediate initiation of intramuscular interferon beta-1a at the time of a clinically isolated syndrome in high-risk patients reduces relapse rates over 10 years but does not improve disability outcomes compared with a control group that also initiated therapy relatively early in the disease course.

Trial Registration clinicaltrials.gov

Identifier: NCT00179478


Author Affiliations:

Multiple Sclerosis Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (Dr Kinkel); Jaeb Center for Health Research, Tampa, Florida (Ms Dontchev and Dr Kollman); Cleveland Clinic Foundation, Ohio (Ms Skaramagas); St Michael's Hospital, Toronto, Ontario, Canada (Dr O’Connor); and Portland Veterans Affairs Medical Center, Oregon (Dr Simon).
Group Information: The Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance investigators are listed above.






The abstract can be seen here.
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PostPosted: Thu Oct 13, 2011 9:27 am    Post subject: Avonex dose titration reduces flu-like sx... Reply with quote

This was a widespread notion when I started Avonex in 2001, but this is the first study about it that I've seen.

From PubMed, October 13, 2011:

Quote:
Curr Med Res Opin. 2011 Oct 11.

Dose titration of intramuscular interferon beta-1a reduces the severity and incidence of flu-like symptoms during treatment initiation

Matson MA, Zimmerman TR, Tuccillo D, Tang Y, Deykin A.

PRISM Research, Inc. , St. Paul, MN , USA.

Background/Objective:

Flu-like symptoms (FLS) are common side effects of interferon beta (IFNβ) therapy and can negatively affect the willingness of patients with multiple sclerosis to initiate therapy. Although dose titration is commonly used to reduce the severity and incidence of IFNβ-related FLS during treatment initiation, these benefits have not been confirmed in a well-controlled study.

The objective of this randomized, dose-blinded, parallel-group study was to assess the effect of dose titration on the severity and incidence of FLS during the initial 8 weeks of once-weekly intramuscular (IM) IFNβ-1a administration.

Methods:

Healthy volunteers were randomized 1:1:1 to one of three IM IFNβ-1a regimens: 3-week titration (weekly quarter-dose increments over 3 weeks to full dose [30 µg]); 6-week titration (biweekly quarter-dose increments over 6 weeks to full dose); or no titration (full dose over 8 weeks). At weekly clinic visits, the severity of each FLS was rated 1 hour pre-injection and 4-6 hours and 12-15 hours post-injection. Study endpoints included post-injection change in FLS severity and post-injection FLS incidence (percentage of subjects with a ≥2-point increase in total FLS severity score) at each time point.

Clinical trial registration:

clinicaltrials.gov identifier: NCT01119677.

Results:

Of 234 subjects enrolled, 194 (83%) completed the study. At 8 weeks, FLS severity was significantly reduced at both post-injection time points with 3-week titration (76% reduction at 4-6 hours; 37% reduction at 12-15 hours; p < 0.001) and 6-week titration (50% reduction at 4-6 hours; 32% reduction at 12-15 hours; p < 0.001) compared with no titration. The incidence of FLS was also significantly reduced at both time points with both titration regimens. Safety profiles for both titration regimens were consistent with the current IM IFNβ-1a label.

Study limitations included that there is currently no validated assessment tool for evaluating the severity of FLS, that the study enrolled healthy volunteers, that different proportions of females were randomized to the 3-week-titration group than to the 6-week and no-titration groups, and that evaluation of the potential impact of titration on symptoms occurring substantially later after injection was not part of the study protocol.

Conclusion:

Dose titration during initiation of IM IFNβ-1a reduces FLS severity and incidence in healthy volunteers compared with no titration.

PMID:21988668


The abstract can be seen here.
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PostPosted: Fri Oct 21, 2011 11:45 am    Post subject: (ECTRIMS video) Avonex self-injector demonstrated Reply with quote

Here is a link to a video showing how to use the new Avonex self-injecting device:

http://vimeo.com/30822577

It was taken at the ECTRIMS/ACTRIMS conference currently going on. The background noise is bothersome but you can see how the injector works.
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PostPosted: Thu Nov 03, 2011 10:23 am    Post subject: (Abstr.) Adverse events of Avonex... Reply with quote

From PubMed, November 3, 2011:

Quote:

PLoS One. 2011;6(10):e26568.

Adverse Events of Interferon Beta-1a: A Prospective Multi-Centre International ICH-GCP-Based CRO-Supported External Validation Study in Daily Practice

Jongen PJ, Sindic C, Sanders E, Hawkins S, Linssen W, van Munster E, Frequin S, Borm G; and the Functional composite and quality of Life in Avonex-treated Relapsing multiple sclerosis patients (FLAIR) Study Group.

Source
MS4 Research Institute, Nijmegen, The Netherlands.

BACKGROUND:

Due to methodological shortcomings the available post-registration data on the adverse events (AEs) occurring in interferon beta-1a (INFb-1a)-treated patients fail to adequately validate phase III data and only partially inform on safety in daily practice. We assessed AEs in relapsing remitting multiple sclerosis (RRMS) patients treated with intramuscular (IM) INFb-1a in daily practice using data quality assurance measures similar to those in phase III trials.

METHODS:

A prospective, International Conference on Harmonization (ICH) - Good Clinical Practice (GCP)-based, clinical research organization (CRO)-supported study in 36 practices in the Netherlands, Belgium, the United Kingdom and Luxembourg. During 24 months after start of IM INFb-1a treatment 275 RRMS patients were assessed for AEs' severity (mild, moderate, severe) and relationship to treatment (not, unlikely, likely, definite). Data were compared with those reported in the pivotal phase III trial.

FINDINGS:

75.3% of the patients experienced one or more AEs that were likely or definitely related to INFb-1a. Of all AEs 40.5% were likely or definitely treatment-related; 68.5% of these were mild, and 3% severe. 6.6% of the patients discontinued treatment because of an AE. Compared to the pivotal phase III trial, we found statistically significantly lower incidences for most of the common AEs: headache, muscle ache, fatigue, fever, chills, nausea. One patient died following two cerebral vascular events in study month 22, both AEs were assessed as not related to INFb-1a.

CONCLUSION:

Three out of four RRMS patients treated with IM INFb-1a in daily practice experience treatment-related AEs, most of these being mild. Our data externally validate the favorable phase III safety profile of IM INFb-1a and suggest that the real-life incidence of treatment-related AEs is less than reported in the pivotal phase III trial. Larger studies are needed to detect rare, potentially hazardous AEs of IM INFb-1a.

PMID:22046309


The abstract can be seen here.
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PostPosted: Mon Feb 13, 2012 7:14 pm    Post subject: Immediate initiation of Avonex for CIS--10-year study Reply with quote

From Archives of Neurology, February 13, 2012:

Quote:
Association Between Immediate Initiation of Intramuscular Interferon Beta-1a at the Time of a Clinically Isolated Syndrome and Long-term Outcomes

A 10-Year Follow-up of the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance

R. Philip Kinkel, MD; Mariya Dontchev, MPH; Craig Kollman, PhD; Thomai T. Skaramagas, BA; Paul W. O’Connor, MD; Jack H. Simon, MD, PhD; for the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance Investigators


Arch Neurol. 2012;69(2):183-190. doi:10.1001/archneurol.2011.1426

Objective

To determine whether immediate initiation of treatment at the time of a clinically isolated syndrome in patients at high risk for clinically definite multiple sclerosis alters disease course over 10 years.

Design

Prospective follow-up study.

Setting

Twenty-four Controlled High-Risk Subjects Avonex Multiple Sclerosis Prevention Study (CHAMPS) sites in the United States and Canada.

Participants

A total of 81 patients originally randomly assigned to receive intramuscular interferon beta-1a (the immediate-treatment group) and 74 patients originally randomly assigned to receive placebo (the delayed-treatment group). All patients were from CHAMPS.

Intervention

For the immediate-treatment group, treatment was initiated within a month after the onset of a clinically isolated syndrome, and for the delayed-treatment group, treatment was initiated a median of 30 months (interquartile range, 24-35 months) after CHAMPS randomization.

Main Outcome Measures

Rate of developing clinically definite multiple sclerosis, annualized relapse rate, disease course classification, disability measures, and magnetic resonance imaging measures.

Results

The immediate-treatment group showed a lower 10-year rate of clinically definite multiple sclerosis (unadjusted hazard ratio, 0.64 [95% CI, 0.48-0.87]; P = .004) and a lower annualized relapse rate between years 5 and 10 (P = .03). There was no differential effect on disability, magnetic resonance imaging T2-weighted lesions, or the proportion of patients developing progressive disease at 10 years. Few patients reached the Expanded Disability Status Scale milestone scores of 4.0 or greater (9% of patients) or 6.0 or greater (6% of patients).

Conclusions

Immediate initiation of intramuscular interferon beta-1a at the time of a clinically isolated syndrome in high-risk patients reduces relapse rates over 10 years but does not improve disability outcomes compared with a control group that also initiated therapy relatively early in the disease course.

Trial Registration clinicaltrials.gov Identifier: NCT00179478


Author Affiliations:

Multiple Sclerosis Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (Dr Kinkel); Jaeb Center for Health Research, Tampa, Florida (Ms Dontchev and Dr Kollman); Cleveland Clinic Foundation, Ohio (Ms Skaramagas); St Michael's Hospital, Toronto, Ontario, Canada (Dr O’Connor); and Portland Veterans Affairs Medical Center, Oregon (Dr Simon).




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PostPosted: Fri Mar 02, 2012 6:18 pm    Post subject: Avonex autoinjector pen OK'd Reply with quote

From MedPage Today, February 28, 2012:

Quote:
Autoinjector Pen for MS Drug OK'd

By John Gever, Senior Editor, MedPage Today


A pen-type intramuscular injector that allows multiple sclerosis patients to self-administer interferon-beta-1a (Avonex) has won FDA approval, the drug's manufacturer said.

Biogen Idec said the device is the first intramuscular autoinjector to be approved for MS. It uses a thinner and shorter needle (25 gauge, 5/8 inch length) than the prefilled syringes that have been the company's mainstay for administering the drug.

The firm said the new autoinjector has been tested in a phase IIIb trial, in which some 90% of patients were able to dose themselves correctly. A similar percentage said they preferred the device to the prefilled syringe.

Separately, prescribing information for Avonex has been updated to include an optional titration regimen at the start of therapy, the company announced.

The regimen calls for gradual dosage escalation over a four-week period, starting at 7.5 mcg and increasing in 7-mcg increments each week until the regular dose of 30 mcg is reached. A clinical trial in healthy volunteers indicated that severity of flu-like symptoms was reduced by 76% compared with starting treatment at 30 mcg/week.

During titration, patients must use the conventional prefilled syringes fitted with a special kit for delivering the reduced doses. Once the full dose is reached, patients may then switch to the autoinjector pen, Biogen Idec said.

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PostPosted: Wed Mar 21, 2012 7:52 am    Post subject: (Abst.) Earlyh predictors of non-response to IFN in MS Reply with quote

From PubMed, March 21, 2012:

Quote:
Acta Neurol Scand. 2012 Mar 16.

Early predictors of non-response to interferon in multiple sclerosis

Horakova D, Kalincik T, Dolezal O, Krasensky J, Vaneckova M, Seidl Z, Havrdova E.

Department of Neurology and Center of Clinical Neuroscience, 1st Faculty of Medicine and General University Hospital, Charles University, Prague, Czech Republic.

OBJECTIVE:

To identify early clinical and MRI predictors of non-response to interferon (IFN) treatment in multiple sclerosis (MS).

METHODS:

In 172 patients with relapsing-remitting MS treated with IFNβ, we evaluated prediction of future treatment non-response. Candidate predictors comprised disability and its sustained progression, relapse score (combining frequency and severity of relapses), brain volume change, brain parenchymal fraction, number of new T2 lesions, and T2 and T1 lesion volume within the initial year of treatment. Treatment non-response was evaluated as confirmed disability progression or overall average annual relapse score exceeding 1 over the following 5 years. Logistic regression model was adjusted for patient age, gender, disease duration and changes in treatment.

RESULTS:

Ninety patients (52%) reached the status of IFN non-responders in years 2-6. Patients with ≥1 new T2 lesion and relapse score ≥2 (odds ratio ≥5.7) or those with ≥3 new T2 lesions regardless of the relapse score (odds ratio = 3) were [at] a significantly higher risk of future treatment non-response.

CONCLUSIONS:

In patients with MS treated with IFNβ for 1 year, number of new T2 lesions and annualized relapse score predict individual risk of treatment non-response over the following 5 years.


PMID:22428845


The abstract can be seen here.
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PostPosted: Sun Mar 25, 2012 8:19 am    Post subject: US FDA warning to Biogen Idec about its claims for Avonex Reply with quote

Apparently the US FDA has issued a warning to Biogen Idec about making misleading claims about the risks and benefits of Avonex. The FDA letter, dated March 14, 2012, can be seen here.
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PostPosted: Tue Jun 26, 2012 2:52 pm    Post subject: (Abstr.) Tranfer of Avonex into human breast milk Reply with quote

From PubMed, June 26, 2012:

Quote:
Breastfeed Med. 2012 Apr;7(2):123-5.

Transfer of interferon β-1a into human breastmilk

Hale TW, Siddiqui AA, Baker TE.

Department of Pediatrics, Texas Tech University School of Medicine, 1400 Coulter, Amarillo, TX 79106, USA. Thomas.Hale@ttuhsc.edu

AIM:

This study determined the transfer of intramuscular interferon β-1a into human milk and provides an estimate of infant exposure to this antiviral in six women chronically receiving intramuscular interferon β-1a (Avonex(®), Biogen Idec, Research Triangle Park, NC).

METHODS:

Interferon β-1a was measured at various times at steady state in milk samples collected from women receiving interferon β-1a at 30 μg/week.

RESULTS:

Average milk concentrations were 46.7, 97.4, 66.4, 77.5, 103.1, 108.3, 124, and 87.9 pg/mL at 0, 1, 4, 8, 12, 24, 48, and 72 hours, respectively, after dosing. Using the highest value measured (179 pg/mL), the estimated relative infant dose would be 0.006% of the maternal dose.

CONCLUSIONS:

These data clearly suggest that interferon β-1a does not penetrate the milk compartment significantly and that levels in milk are far subclinical. No side effects were noted in any of the breastfed infants.

PMID:21988602
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PostPosted: Tue Feb 05, 2013 1:52 pm    Post subject: (Abst.) Predictors of long-term outcome... Reply with quote

From PubMed, February 5, 2013:

Quote:
Ann Neurol. 2013 Jan;73(1):95-103.

Predictors of long-term outcome in multiple sclerosis patients treated with interferon beta

Bermel RA, You X, Foulds P, Hyde R, Simon JH, Fisher E, Rudick RA.

Neurological Institute, Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH. bermelr@ccf.org.

OBJECTIVE:

To identify early predictors of long-term outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) treated with intramuscular (IM) interferon beta-1a (IFNβ-1a).

METHODS:

A multicenter, observational, 15-year follow-up study of patients who completed ≥2 years in the pivotal trial of IM IFNβ-1a for RRMS was conducted. One hundred thirty-six patients participated in the 15-year follow-up (69 originally randomized to IM IFNβ-1a and 67 to placebo). After the 2-year clinical trial, treatment was not regulated by study protocol. Disease activity during the 2-year trial was defined as: ≥2 gadolinium-enhancing lesions (cumulative) on year 1 and/or year 2 magnetic resonance imaging (MRI); ≥3 new T2 lesions on year 2 MRI compared to baseline; and ≥2 relapses over 2 years. Odds ratios were calculated for early disease activity predicting severe Expanded Disability Status Scale (EDSS) worsening (worst quartile of change, ≥4.5 EDSS points) during the 15-year interval.

RESULTS:

The proportion of patients experiencing early disease activity was lower in patients on IM IFNβ-1a than placebo for all disease activity markers (range, 23.5-29.0% vs 41.0-45.5%). In the IM IFNβ-1a group, persistent disease activity predicted severe EDSS worsening: gadolinium-enhancing lesions (odds ratio [OR], 8.96; p < 0.001); relapses (OR, 4.44; p = 0.010); and new T2 lesions (OR, 2.90; p = 0.080). In placebo patients, early disease activity was not as strongly associated with long-term outcomes (OR range, 1.53-2.62; p = 0.069-0.408).

INTERPRETATION:

isease activity despite treatment with IFNβ is associated with unfavorable long-term outcomes. Particular attention should be paid to gadolinium-enhancing lesions on IFNβ therapy, as their presence strongly correlates with severe disability 15 years later. The results provide rationale for monitoring IFNβ-treated patients with MRI, and for changing therapy in patients with active disease.


PMID:23378325
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