Combination therapy for suboptimal responders is also common but not supported by strong evidence. Combination therapy has had “disappointing” results in randomized clinical trials, he said, and may increase the incidence of side effects, compared with monotherapy.
Dr. Rudick noted that his treatment of choice in patients with disease activity while on disease-modifying drug therapy is natalizumab. Symptomatic therapy and rehabilitation should not be forgotten for patients during the process of monitoring and managing patients with disease-modifying drugs.
“I think we need realistic expectations,” he said. “There are no drugs labeled for progressive MS, because there is no established efficacy in this category of patient.” He added that caution should be exercised when considering off-label use of drugs that are in phase II studies.
Dr. Rudick concluded that randomized controlled trials of alternative monotherapies or combination therapies are needed for patients with breakthrough disease, as are methods to stratify patients for treatment selection and biomarkers to predict individual response to therapy.
—Wayne Kuznar