Weighing Risks and Rewards with Alemtuzumab in Patients with Multiple Sclerosis

Alemtuzumab has been shown in clinical trials to be more effective than treatment with interferon beta-1a for patients with relapsing-remitting multiple sclerosis. However, the drug's side effect profile requires careful treatment monitoring and follow up.

Samuel F. Hunter, MD, PhD, president of the Advanced Neurosciences Institute in Franklin, Tennessee, gave a presentation on outcomes in patients with relapsing multiple sclerosis (MS) treated with Lemtrada (alemtuzumab) at the 2015 Annual Meeting of the Consortium of Multiple Sclerosis Centers in Indianapolis, Indiana.

The Food and Drug Administration approved the drug in November 2014 after two large, phase III clinical trials that demonstrated its ability to reduce relapse rates over 2 years over standard subcutaneous dosing of Rebif (interferon beta-1a, EMD Serono Inc. and Pfizer). One of the studies also showed that Lemtrada may also reduce disease progression.

He said the first trial began 24 years ago, so primary care physicians may want to share this with their relapsing MS patients who are concerned about trying a “new” drug.

Hunter explained that Lemtrada is thought of as a “permanent” disease-modifying therapy. “It cleans the immune system up, both the B and T cells. Transiently, it removes a lot of these cells and lets the immune system reconstitute. No one knows how it can make MS better yet, but the immune system is different,” he said.

At the same time, there is a risk of autoimmunity, infusion reactions, and malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders in patients who receive treatment.

He said that Lemtrada was the first drug that was tested head-to-head with interferon beta-1a, which is the standard treatment. In the 2 trials that were done, it was very clear that Lemtrada was much more effective than interferon beta-1a. “The longer it goes, the better it looks because you’re changing the immune system with Lemtrada,” he said.

Hunter added that Lemtrada is good in the short term and even better in the long term for RRMS. “This is a big stick for treating relapsing MS. It has a little more risk than other treatments, but you get something for it that any internist could manage,” he said. It includes monthly laboratory testing for kidney problems at the manufacturer’s expense to watch for blood, thyroid, or kidney problems.

Hunter conducted a phase I nonrandomized open label study of 60 patients, using them as their own control. Most patients who switched to Lemtrada had been on the injectable drugs interferon beta-1a or Copaxone.

He said most patients stayed stable for up to 2 years after one treatment and then got even better with more treatments. “It’s clear that Lemtrada works for a while, then it wears off and then we retreat those patients,” he said.

“MRI is really boring after treatment because it stays calm,” Hunter added. “At the same time, some will also get worse. You just have to find the treatment responders.”