Video
In this video segment, the expert panelists offer explanations for the reduced rate of multiple sclerosis (MS) relapses in today’s clinical trials.
“If you look at the attack rate(s) from the pivotal trials in an untreated era, they’re way higher than they are in the current era trials … even when you look at placebo arms,” Patricia K. Coyle, MD, notes. “What’s the explanation for that? Well, we’re in a treatment era now (where) some people have said we’re cherry-picking off the most active patients, putting them on treatment, and not waiting to have them go into a trial. We’re even treating at the first attack.”
According to Coyle, the MS patients who most likely to benefit from early treatment with disease-modifying therapies are those with relapsing attack forms, even though guidelines are lacking for initiating treatment in every relapsing-remitting MS patient as soon as possible.
As a result, Stephen Krieger, MD, says neurologists may be “overtreating some patients that might not have been destined to go on and have multiple attacks and multiple relapses;” however, he believes some overtreatment is “okay at this point in time, particularly for the agents that we have that we know are safe (and) have a long track record where we’re not exposing people to significant risks.”
Although moderator Peter Salgo, MD, warns that such overtreatment might be subjecting MS patients to side effects they would not otherwise have experienced, Andrew D. Goodman, MD, FAAN, explains the majority of patients do not have a mild or benign form of the disease, so “we do think it makes sense … to begin (treating) people at their earliest phase of the disease once we identify it as relapsing in nature.”
When Salgo points out the panel discussion “sounds like the discussions the cardiologists had 10 or 15 years ago about putting everybody on aspirin,” Krieger notes the regularity of new MS disease activity seen in placebo groups proves that “what we have here is real consistency in the clinical trials of patients with their first MS attack,” rather than a public health campaign for a medication.