Approximately 1% of those studied also had dangerously low platelet counts, putting them at high risk for bleeding complications, he said. Opportunistic infections, kidney failure, fetal complications, and even suicidal ideation were all reported adverse events that soured Dr. Wallin’s view of alemtuzumab as a front-runner for first-line therapy. "You give one dose, and the effects probably last at least a year, and some of these effects are seen beyond that."
Why be ‘squeamish’?
This long-lasting effect is precisely what Dr. Stüve said makes alemtuzumab an imperative treatment. "This is a therapy we don’t have to treat patients with indefinitely, or even long term. There is a detectable, dramatic benefit in patients who receive short-term therapy," he said. And because the CARE MS extension data indicated that 20% of patients who’d received alemtuzumab received sequential disease-modifying therapy (DMT) with no increase in adverse events, "it shows that alemtuzumab could potentially be used as a very effective induction therapy, up-front and for a limited amount of time, followed by a safe DMT, without added safety concerns. I think this is something many of us have really been waiting for to treat patients who declare themselves early on as having aggressive disease."
Although Dr. Stüve did cite his concerns about ITP, opportunistic infections associated with alemtuzumab, and the occurrence of various malignancies, particularly thyroid kinds, the extension trial data indicated that these adverse events tend to occur in the third year of treatment, which allows clinicians to possibly anticipate and monitor these conditions and subsequently treat them.
When Dr. Stüve was challenged by panel moderator Dr. Dennis Bourdette, director of the Multiple Sclerosis and Neuroimmunology Center at Oregon Health & Science University, Portland, he responded that when viewed within the entire current treatment landscape, the risks of alemtuzumab were worth the benefits. "The other player is natalizumab, which has a 1 in 250 chance of PML, and 20% of those patients die. So I don’t see why I should be squeamish about ITP," which he said was, like thyroid disease, treatable.
"We should not withhold these kinds of drugs from patients who really need them," he concluded.
The ‘1 percent’
Oregon Health & Science University
Dr. Dennis Bourdette
When asked in an interview whether Americans would benefit from seeking treatment with alemtuzumab out of the country, Dr. Bourdette rejected the idea.
"In my opinion, most patients with MS should not be treated with alemtuzumab, so I see very little need for anyone to go out of the country to receive it." And if they did, he warned, they would need extensive follow-up treatment for "autoimmune disease, particularly thyroid disease, platelet abnormalities, kidney dysfunction, and cancer."
"I personally consider this to be a very toxic drug that should be used with great caution and in a very small group of patients with very active and difficult-to-control disease, perhaps 1% to 2% of cases at most," he said.
Dr. Stüve said he had no relevant disclosures. Dr. Wallin declared that he has done research for Biogen Idec. Dr. Bourdette declared that he had no relevant disclosures.
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