Patients with multiple sclerosis and the neurologists who treat them have eagerly monitored recent developments in the therapeutic realm. From the launch of the first alternative formulation of interferon to the acceleration of oral MS therapies and further refinement of warnings on one agent, the past few months have brought important changes.
While MS is certainly a challenging disease for patients, and many of them deal with significant morbidity, a good number of affected individuals are well-managed with the immunomodulatory therapies that have been available for many years now. Of course, these agents may have some drawbacks in particular instances. Among them are high costs associated with long-term therapy. The emergence on the market of the first challenge formulation of interferon beta-1b (Extavia, Novartis) may be a boon to patients who now have more alternatives in their treatment decisions; other alternative injectable formulations may follow.
Certain patients remain troubled by regular injections. Injections can be a significant though manageable challenge that can conflict with a patient's personal and professional life—for example, boarding a plane with a pack of syringes and medication vials is no treat with today's heightened security. By offering more convenience and comfort, oral disease-modifying therapies may be a welcome alternative for some MS patients...as long as they can match the safety of currently available therapies and meet or exceed their efficacy. The data are promising, as explored in this issue, but there's much to learn, particularly regarding safety. As the case of natalizumab (Tysabri, Biogen-Idec) shows, defining safety can be a challenge. In early February, FDA clarified the warning label on the agent to indicate that risks of PML increase with the number of natalizumab infusions received. Importantly, the agency concluded, “Based on the available information, FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks.” (For more, see the cover feature on p. 27.) As new agents come to market, the challenge for patients and physicians will be to weigh risks and benefits to make decisions that achieve the best outcomes.