Matthew J. Baker, MD: So when there is a relapse and you’re treating, you’re trying to get patients to recover more quickly, you want to get a patient back to their baseline—those are our goals—and you exhausted the IV [intravenous] Solu-Medrol [methylprednisolone], how do you know what to do next? What data do we have? Is there any research that’s going on, specifically? I think there was a poster at ACTRIMS [The Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2020] that looked at those patients who had been treated with IV Solu-Medrol, and the traditional dose had failed them in the treatment of the relapse.
Jeffrey M. Kaplan, MD: Right, so that’s another trial that I’m involved with. This is a randomized, double-blind, placebo-controlled study [OPTIONS (NCT03126760)] of repository corticotropin injection, which is Acthar, for acute exacerbations in relapsing/remitting multiple sclerosis. This study is from University of Cincinnati and Mount Sinai Hospital, New York.
But basically, this is for individuals who had an incomplete recovery from IV methylprednisolone for 3 to 5 days, oral prednisone 1250 mg per day, or oral methylprednisolone 1000 mg per day, which, again, was also given for 3 to 5 days. If the patient did not have a greater or equal to 1-point improvement in greater than or equal to 1 functional system at 14 days, they are being randomized to either subcutaneous RCI [repository corticotropin injection], or Acthar, 80 units for a period of 14 days or a matching placebo for 14 days.
At first, I’ll be honest with you, I had some reservations about this study because of the placebo end of it. But the fact is most patients naturally wind up on the placebo end of it because most MS [multiple sclerosis] physicians, or most general neurologists, after a patient receives their typical treatment of IV methylprednisolone or high-dose oral steroids, if the patient doesn’t respond, they figure this is as good as it is going to get. What this study is showing us is, “No, why don’t we get the patient 14 additional days of treatment and see what occurs?”
Now, we do not have results from this trial yet. We are still placing patients in the trial and randomizing them. I’m eagerly awaiting the results of this trial because I’m hopeful that it will show that this is a very good alternative for patients who do not respond well to initial treatment.
Matthew J. Baker, MD: Do you think there is something about the patient’s biology that keeps them from improving on IV Solu-Medrol or causes them to need another alternative, maybe on the basis of those melanocortin receptors you mentioned, just hypothetically?
Jeffrey M. Kaplan, MD: Right. Basically, patients who are a little bit older don’t respond quite as well. I think patients who have highly active disease will not respond as well. The patients who really do extremely well with IV Solu-Medrol are usually my patients who have less active disease. And so, when these patients are placed on IV Solu-Medrol, they have a big response from it.
Not only do they sometimes get a good response clinically, but they actually feel well on the medication. They tell me they love their steroids because they get everything cleaned in their house that they haven’t gotten done in a long time. But for my patients who have highly active disease, who are my more difficult-to-treat patients and are my older patients, I have found they really struggle with adverse effects from the IV Solu-Medrol and do not get as good of a response.
Matthew J. Baker, MD: So your expectations out of this trial are that you want to see if there is efficacy there? And again, it’s a real-world setting, right? These are patients who are from our clinical practices.
Jeffrey M. Kaplan, MD: Exactly, and my expectation is it is going to show that there is a clinical difference in the end with this trial. I do think patients will improve, both from the patient-reported outcomes portion of it and the clinical examination portion of it by the physician.