Researchers in Germany reviewed the use of alemtuzumab, a monoclonal antibody used to treat relapsing remitting multiple sclerosis, over the last two years and identified important first steps in patient selection, preparation, infusion courses, and monitoring.
Researchers in Germany recently reviewed the use of alemtuzumab, a monoclonal antibody used to treat relapsing remitting multiple sclerosis (RRMS), over the last two years and identified important first steps in patient selection, preparation, infusion courses, and monitoring. Lina Hassoun, MD, of the MS Center Dresden, Center of Clinical Neuroscience, Department of Neurology, University Hospital Carl Gustav Carus at Dresden University of Technology, and colleagues conducted the review and it was published in the journal Multiple Sclerosis and Demyelinating Disorders on August 2, 2016.
Alemtuzumab, approved in Europe for treating RRMS since September 2013, “is the first depleting monoclonal antibody which was licensed for the treatment of RRMS,” according to the authors. They identify several key questions which need answers: Which patients will most likely benefit from this treatment? Where does Alemtuzumab fit into the standard MS treatment scenario? How should patients be switched from current treatments to Alemtuzumab? What should follow Alemtuzumab treatments? How should infusions be managed? What side effects are likely? How should the treatments be monitored?
The review aims “to summarize our experience with Alemtuzumab in clinical practice of the last two years following a structured approach,” the reviewers say.
Alemtuzumab therapy is two courses, with a 12 month break between, and the reviewers say “this approach guarantees a long-term stabilization of the disease activity,” and allows the necessary close monitoring. Alemtuzumab therapy should not be considered for patients who do not show disease activity or for those who are stable on a current therapy. Rather, they recommend it for “MS patients with high disease activity” and say that it should be used early, “in the presence of significant clinical and MRI inflammatory activity without significant disability.”
Patients who have not been treated for MS before, those who are experiencing acute relapse or those switching directly from Interferon-beta or Glatiramer Acetate may immediately start Alemtuzumab. Other treatments require some waiting periods, or specific results from various blood tests. The reviewers caution, “it should be kept in mind that these recommendations are general,” adding that individual cases could require deviation.
Because there are well-documented side-effects and contraindications, the authors recommend a detailed patient history and physical examination before treatment begins, with particular attention to infections. Additionally, there should be an MRI of the neuroaxis to establish a baseline before treatment, and antibody measurements should be done for patients who have not had chicken pox or a vaccination against chicken pox.
The introductory infusion takes place over five days, then 12 months later, the maintenance infusion is done over three days. Following treatment, patients should be closely monitored for the development of autoimmune diseases, infections, thyroid disease, and nephropathies.
The authors conclude, “Alemtuzumab is a highly efficacious disease-modifying therapy which offers a new treatment principle for the treatment of relapsing-remitting MS.” They recommend closely monitoring patients for four years following the treatment and say that additional clinical experience will provide long-term data that is currently lacking.