(Article) MS treatment adherence

 
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PostPosted: Wed Jun 21, 2006 5:40 pm    Post subject: (Article) MS treatment adherence Reply with quote

From Medscape Neurology:

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MS Treatment Adherence: A Canadian Expert Viewpoint

Virender Bhan, MBBS, FRCPC, and Trudy Campbell, BSCN, MN



Medscape Neurology & Neurosurgery. 2006;8(1) ©2006 Medscape
Posted 06/09/2006

Editor's Note:

Multiple sclerosis (MS) is a chronic and progressive inflammatory disorder of the central nervous system, and available treatments continue to present many challenges for physicians and patients. The Dalhousie MS Clinic in Halifax, Nova Scotia, Canada, has reported high adherence rates for their patients taking disease-modifying drugs (DMDs). Medical Editor Penelope Gray-Allan, on behalf of Medscape, discussed DMD treatment adherence and the factors that have helped to make this clinic so successful with Virender Bhan, MBBS, FRCPC, Director of the Dalhousie MS Clinic, and Trudy Campbell, NP, RN, Clinic Manager of the Dalhousie MS Clinic, Dalhousie University, Halifax, Nova Scotia.

Medscape: Getting patients to adhere to DMD treatment can be challenging. What do you see as the key factors with regard to this issue?

Dr. Bhan: The most important factor is education. It's vital for physicians to emphasize to their patients how important complete or near-complete adherence is to optimize the benefits to be derived from DMDs. Patients often think that these drugs will completely prevent relapses and halt the progression of disease. This is not true, and therefore, we have to give them realistic expectations.

Ms. Campbell: Frequently we see patients who experience a temporary worsening of their MS symptoms when they begin injectable therapies, particularly with the interferons. If they are not told this information up front, they may fear that they are having a relapse, that their disease is worsening, or that the medication is making them worse instead of better. It is important to clarify treatment expectations before treatment initiation and as needed in subsequent follow-up appointments.

Ongoing support of the patient is also key, by providing resources in different media (ie, printed materials, telephone support, multimedia presentations, and public lectures). Patients can be given a sense of empowerment, which can directly influence adherence when they know about their disease and its management.

Dr. Bhan: Another factor is injection-site frequency. For some, less frequent injections may mean greater adherence to the drug.

Ms. Campbell: For others the reverse is true. Some patients believe that infrequent therapy is harder to implement because it is harder to make it a part of their daily routine.

Medscape: At the 2005 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference, Dr. Rieckmann[1] discussed the use of DMDs and the importance of balancing expectations and adherence to treatment. What were the key points?

Dr. Bhan: Dr. Rieckmann emphasized that what ultimately matters is the drug's effectiveness, how information is communicated to the patient, and how much support patients receive. He also noted that there is better adherence if patients understand why they are taking these drugs, are forewarned about possible side effects, and are informed about what the drugs will do in the long run for their disease. Patients adhere to therapy and tolerate side effects better when they receive proper treatment and support for their side effects.

Medscape: Can you please tell us about the program you use in your own clinic?

Ms. Campbell: In 1998, the provincial government in Nova Scotia developed a funding program giving the MS unit in Halifax, and its satellite clinic in Cape Breton, the sole ability to prescribe and monitor injectable MS medications. In order to receive full or partial drug coverage from the provincial government, MS patients must be seen on an annual basis in either of these MS clinics. Of note, in Nova Scotia the vast majority of patients require government financial assistance.

At the outset of the program, an education curriculum was developed for patients and their family members. After the initial discussion with the physician, they would return to the clinic for a 2-hour education session with an MS nurse. Information about MS, its symptoms, and its treatments, including DMDs, is presented. Patients are provided with printed materials and other multimedia to take home to review. The MS nurse follows up with the patient by phone. Although many people elect to use these therapies, some do not. So we also discuss up and coming alternatives that are at various stages of testing.

Until 2002, these sessions were done in groups of approximately 10 patients. After that, the nursing complement in the clinic was increased so that one-on-one education sessions became possible, allowing patients to connect with that nurse and feel more supported.

Initially, because the available treatments are given by injection, education for self-injection was done individually with a special therapies nurse in the clinic. However, more recently home teaching has become available and patient response to that has been favorable.

Once patients begin therapy, the MS clinic nurse follows up with them by telephone within 24-48 hours, on a monthly basis for the first 6 months, and every 6 months thereafter. The nurse reviews any symptoms and side effects, providing interventions for management and, in the case of interferons, reviews their blood work, including liver enzymes and white blood cell counts, which are monitored regularly while the patient is on therapy. At regular intervals, as a part of the special therapies program, we periodically assess quality of life with questionnaires.

Medscape: What factors do you believe contribute to the success of this program?

Dr. Bhan: A great deal of education, support, and making the patient a part of the decision-making process.

Medscape
: What criteria do you use to decide when it is necessary to change to a different treatment?

Dr. Bhan: This is always a difficult topic, that is, how to define DMD failure. Patients having significant relapses or signs of disability progression are clearly failing and as such need to be switched to a different agent. In situations when I'm not sure, I will order a gadolinium-enhanced contrast MRI scan. If there are many new lesions, especially gadolinium-enhancing lesions, in addition to the "soft signs" of clinical failure, I may switch these patients.

Another test to consider, if it is available, is the neutralizing antibodies assay. These antibodies are produced by the body in response to interferons and can inhibit their biological activity and may in some situations neutralize their therapeutic effects. If the antibodies are present in high titers and they persist, and especially if the person is showing signs of soft failure, I would switch them to another agent.

Ms. Campbell: Over time, patients on these injectable therapies can develop problematic injection sites, thus limiting areas for injections that then necessitate the need to change to a different therapy. Proper technique and site rotation are of key importance for long-term injection therapy.

Medscape: How do adherence rates change over time?

Dr. Bhan: Most adherence problems occur in the first 6 months. However, there is a second time frame when adherence rates decline, after the first few years of treatment when the drugs are starting to fail, or when using needle therapy for such a long time becomes cumbersome for some.

Medscape: At the 2005 ECTRIMS meeting, you and your colleagues presented a longitudinal population-based comparison of the effectiveness of DMDs in MS.[2] What were the key results from this study?

Dr. Bhan: We had a very large therapy-naive population with data going back to 1979. In 1998, when DMDs became available, most eligible patients were screened and placed on therapy. The same data collection was continued. Analysis of the data in 2004 allowed us to investigate the effectiveness of these drugs in a population-based sample. We looked at the time it took for our patients to reach an EDSS (Expanded Disability Status Scale) of 6, that is, when a cane is needed. Before 1998, it took 14.5 years; after 1998, this time period increased to 18.4 years, suggesting that these drugs do delay disability progression in a "real-world" setting.

We also looked at the disability progression paths for patients on each individual drug. We found that all 4 drugs were effective at delaying disability progression. We had a group of 56 patients who were eligible for treatment, but refused it. After 1998 their disease continued to advance, although the progression of patients on therapy was delayed.

Medscape: Treatment administration can be a problem for some patients. What progress is being made toward producing agents that can make administration easier?

Dr. Bhan: One new oral drug that is being reviewed in clinical trials is FTY720 (fingolimod). Phase 2 study results showed > 50% reduction in relapse rate.[3] It was tolerated reasonably well, and because it is an oral drug, it bypasses all of the problems with the injectable therapies. If the phase 3 trials duplicate the phase 2 results, we may have an excellent, well-tolerated oral therapy for MS patients. Some time ago, oral glatiramer acetate (Copaxone) was thought to be an option, but early trial results were disappointing. However, now investigators are looking into whether the dose used was too low.

Another agent that is easy to administer is natalizumab (Tysabri). This drug has excellent efficacy and is given as a monthly IV [intravenous] infusion, which patients find very convenient. Unfortunately, all dispensing of the drug for MS patients was stopped because of 2 cases of progressive multifocal leukoencephalopathy (PML). A third case of PML, this one fatal, was later identified in a patient with Crohn's disease. Since then, a careful follow-up of all MS patients who received the drug has revealed no further cases of PML. Currently, we're awaiting FDA [US Food and Drug Administration] decision as to how and when the drug will come back into the market.

Ms. Campbell: With daily injectables, several improvements have been made to ease administration. The introduction of autoinjector devices allows greater ease of injection and help to reduce reactions at the injection site. In addition, there has been a move toward providing prefilled syringes to patients. Hopefully within the next few months, all of the agents will be available in prefilled applications in Canada. Certainly, making administration easier improves adherence.

Dr. Bhan: Drugs are also being refined. One interferon beta-1a product, Avonex, has a newer formulation that is less immunogenic. In addition, a less immunogenic formulation of interferon beta-1a, Rebif, is currently being investigated. These refinements should make the drugs better overall in terms of tolerability and immunogenicity.

Medscape: What practical suggestions can you recommend to other centers/communities to improve their adherence rates?

Dr. Bhan: Simple: Hire an MS nurse who can provide the proper education, communication, and support that are so important for patient adherence.

Ms. Campbell: Initiate a program of supportive care and follow-up for patients. This support during the diagnosis and treatment initiation process is important, as is providing ongoing care and regular follow-up. Although it is important to focus efforts on disease treatment, it is also important to provide optimal symptom management and timely assessment of new symptoms and relapses. Ideally, a multidisciplinary team approach can provide the support that patients need.

References

1. Rieckmann P, Wurzburg D. Adherence: DMDs -- balancing expectations and adherence to treatment. Program and abstracts of the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis; September 28-October 1, 2005; Thessaloniki, Greece. Abstract 60.

2. Veugelers P, Bhan V, Fisk JD, et al. Effectiveness of disease-modifying agents in multiple sclerosis: a longitudinal population-based comparison. Program and abstracts of the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis; September 28-October 1, 2005; Thessaloniki, Greece. Abstract 36.

3. O'Connor P, Antel J, Comi G, et al. Oral FTY720 in relapsing MS: results of the dose-blinded, active drug extension phase of a phase 2 study. Program and abstracts of the American Academy of Neurology 58th Annual Meeting; April 1-8, 2006; San Diego, California. Abstract S12.003.


Funding Information

Supported by an independent educational grant from Serono Canada, Inc.



Virender Bhan, MBBS, FRCPC, Director, Dalhousie MS Clinic, Centre for Clinical Research, Halifax, Nova Scotia, Canada

Trudy Campbell, BSCN, MN, Adjunct Professor, School of Nursing, Dalhousie University, Halifax, Nova Scotia, Canada; Nurse Practitioner, MS Research Unit, QEII Health Sciences Centre, Capital Health, Halifax, Nova Scotia, Canada


Disclosure: Penelope Gray-Allan has disclosed no relevant financial relationships.

Disclosure: Virender Bhan, MBBS, FRCPC, has disclosed that he has served as an advisor or consultant to Serono, Biogen, Teva, and Berlex.

Disclosure: Trudy Campbell, BSCN, MN, has disclosed that she has received grants for educational activities from Teva Neuroscience, Serono Canada, Biogen Idec, and Berlex Canada.


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