Betaseron bulletin.

About side effects...

The "Phase III" clinical trial showed that side effects from Betaseron include "flu-like" reactions (meaning fever, malaise, and achy muscles) for several months, skin reactions at the injection site, and depression. As with any drug, different people have different experiences. Anyone taking Betaseron and experiencing side effects should be in close contact with the prescribing physician.

Physicians may send reports about side effects to Berlex Laboratories, the company that distributes this drug. Berlex, in turn, informs the FDA on an ongoing basis of any unusual problems or issues. The FDA continues to monitor drugs long after approvals have been granted; it informs physicians if there are any changes in how a medication should be used.

Thus, the use of Betaseron in the world outside of clinical trials is being carefully watched.

A formal "Phase IV" clinical trial to rigorously investigate side effects and safety in a larger group of patients than was studied in the Phase III trial will also take place, beginning in the next couple of months, according to Berlex. Right now, scientists are working on the design (or protocol) for the study, which will be funded by Berlex and conducted at large MS clinical centers nationwide. Phase IV studies are monitored by the FDA.

Will MS worsen without Betaseron?

Betaseron clinical studies showed no effect on disease "worsening" in relapsing/remitting disease. They did show that the drug can reduce frequency and severity of acute MS attacks and reduce accumulation of new brain lesions as seen in MRI scans.

With or without Betaseron treatment, MS is a highly variable and unpredictable disease. For some people, it may remain stable and not worsen for long periods of time.

The decision to take Betaseron must be made on an individual basis in consultation with a physician who is familiar with MS.

What happens if a person stops taking Betaseron?

In the clinical trials, no one who discontinued therapy experienced withdrawal effects or suddenly worsened. It appears to be safe to stop. However, based on the trials, Betaseron seems most likely to be beneficial if it isn't interrupted.

Betaseron for other forms of MS

The clinical trials were restricted to people with relapsing/remitting MS. Trials in relapsing/progressive MS, which might yield some information about Betaseron and changes in disability over time (MS worsening), are also in the process of being designed. According to Berlex, they are scheduled to start in the latter part of 1994.

A second beta interferon therapy

Another slightly different beta interferon agent is currently nearing the end of its Phase Ill clinical trial in people with relapsing/remitting MS. This drug, called Bioferon, was developed by Biogen Laboratories. It is injected intramuscularly once a week. Data from the Bioferon trials will be analyzed during 1994; if results are positive, Biogen Laboratories will ask the FDA for a review--a process that usually takes a year. If Bioferon is ultimately cleared for use, it, too, can be expected to be expensive.

How and why does beta interferon work?

Both Berlex and Biogen are studying the mechanism of action as are other investigators, including NMSS grantees Dr. Lawrence Jacobs of the State University of New York, Buffalo, and Dr. Richard Rudick at the Cleveland Clinic Foundation. Scientific understanding of what this naturally occurring molecule actually does to produce benefit in MS might lead to even more effective treatments.

Meanwhile, another approach...

A completely different drug called Copolymer I, which may reduce the number and severity of MS attacks, is also being studied in Phase III clinical trials. Investigators hope to have some definitive answers about the effectiveness of Copolymer I within a year. Again, positive findings, if any, would be investigated by the FDA, a process that usually takes a year or more.