Multiple Sclerosis Drug Studies: REGARD and BEYOND
Multiple Sclerosis care is so rewarding because it is so multi-faceted - from the different types of presentation, different patients, different personalities, and different medication options. Fifteen years ago there were no FDA approved medications for MS. That has changed rapidly and so the pipeline for new medications grows every year. Recently, something fairly big has happened in the MS community in regards to medications which I will use this blog to address.
As most of you know, there are four injectable medications for MS - three of them are interferons and one of them is not (glatiramer acetate). Doctors and patients have been left to decide on their own how these different medications compare for individual patients, and so two big studies were developed to compare these medications head-to-head.
The first study is called REGARD and it was sponsored by Serono, the makers of Rebif (interferon beta 1a under the skin three times a week) to compare the use of Rebif and Copaxone (Glatiramer Acetate, a non-interferon, given under the skin daily). Serono thought if they did this study and showed that their drug was better than their competitor’s then more doctors and patients would choose their drug. This was a two year study of 764 people with RRMS (relapsing-remitting MS) randomized to either take Rebif three times a week or Copaxone daily. At the end of the study there was no statistical difference in the primary endpoint, which was the amount of time until the next relapse.
The second study is called BEYOND and it was sponsored by Bayer, the makers of Betaseron (interferon beta 1b under the skin every other day) to compare the use of regular dose Betaseron (250 mcg) to double dose Betaseron (500 mcg) to Copaxone. This was a two year study of 2,244 people with RRMS randomized to either take regular dose Betaseron, double dose Betaseron, or Copaxone. In this study there was also no statistical difference in the primary endpoint of risk for relapse.
So what does this mean? Does this change anything? Should you be concerned if you are on one of these medications and doing well?
The first important thing for you to know is that clinical trials or studies give us an idea of how a population on a certain intervention or medication reacts. It does not tell us anything about how the individual patient is going to do, or is doing. The results of a study should never make you doubt that you are doing well if you are indeed doing well. The most we hope to gain from doing research trials, or reading them, is to get an idea of how patients similar to the people in the study would do on a particular medication.
So what does that mean?
It means that we are exactly where we were before REGARD and BEYOND - there is no evidence based medicine to support the use of high-dose high -frequency interferons (Betaseron and Rebif) over glatiramer acetate (Copaxone) or vice versa. If there was compelling evidence either way, then almost all patients would be on one particular medication, and we all know that there are people on all sorts of medications. The best advice is to keep an open dialogue in your doctor-patient relationship and to ensure that you remain the center of the MS Team. By developing and enhancing your own Multiple Sclerosis Team Approach Rule (M*STAR), you can help advance your own health and happiness.
We are trying to develop individualized testing so that we can know who will respond to which therapy and so we can make more rational decisions in choosing therapy, but in the mean time we have to weigh the risks vs. benefits of every decision we make in treating MS.
I will continue to remain your window to the research side of MS, but I continue to encourage you to have an open dialogue in this community so that we can truly be the Multiple Sclerosis Patient Network (MSPN).
I look forward to reading your questions and comments, but please remember that I cannot make specific medical consultations - for all of those you need to speak to your own personal doctor, nurse practitioner or physician assistant. I will answer general questions that can help ensure that you are empowered through education when you speak to your healthcare provider.
Daniel Kantor, M.D. is a former Assistant Professor of Neurology and former Director of the Comprehensive Multiple Sclerosis Center at the University of Florida in Jacksonville, Florida. He wrote for HealthCentral as a health professional for Multiple Sclerosis.