Alemtuzumab is the most recently approved disease-modifying therapy for multiple sclerosis (MS). Alemtuzumab is a humanized monoclonal antibody against anti-CD52. Patricia K. Coyle, MD, describes alemtuzumab as a true induction strategy, requiring daily infusion for 5 days in the first cycle of treatment, and then after one year, daily infusions for 3 days in the second cycle of treatment. No additional therapy is required following the second cycle unless there is breakthrough activity. Coyle states that typically patients receive, at a minimum, 5 years of benefit from these 2 cycles of treatment. Fred Lublin, MD, comments that it is generally approved for use in individuals who have failed 2or more MS treatment regimens.
Coyle describes the challenges alemtuzumab faced before receiving FDA approval. Though pivotal phase 3 trials clearly demonstrated its efficacy in relapsing MS, the FDA turned down alemtuzumab twice based on concerns related to trial designs—the trials were not double-blinded. The company eventually addressed the concerns of the FDA, the application was resubmitted, and approval was granted in November 2014.
Lublin explains that alemtuzumab has a strict risk evaluation and mitigation strategy (REMS) due to some extreme health risks and side effects, including risk of infections, risk of tumors, and the upregulation of other autoimmune diseases, especially autoimmune thyroid disease, autoimmune kidney disease, and autoimmune hematologic diseases. The REMS also requires that patients be monitored monthly, therefore, patients must agree upfront to adhere to this visit schedule.