Matthew J. Baker, MD: Dr Kaplan, you are the lead author on a poster that was recently presented at ACTRIMS [The Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2020] in West Palm Beach, Florida. It’s a prospective, observational study of the repository corticotropin injection for MS [multiple sclerosis] at relapses. Can you tell us more about that?
Jeffrey M. Kaplan, MD: Yes, absolutely. Basically, this is a real-world multicenter trial in which Acthar, which, as I described previously, is used to treat relapses. It was shown that there was a clinical improvement in both patient-reported outcomes and EDSS [Expanded Disability Status Scale] measurements. The primary endpoints included change from baseline in the MS impact scale, the physical subcortical scale, and then also EDSS and the global impression of improvement.
There were about 125 patients. This was a little bit older of a population studied than the average population. The mean was about 47 years of age. Eighty-eight percent were female. Eighty-four percent were Caucasian. The average time of diagnosis of MS was about 10.2 years. In the study, 58.4% of patients had experienced relapse within the last 2 years, and 60% of these patients had an insufficient treatment relapse or limited intravenous access associated with high-dose corticosteroids.
After treatment with Acthar, they noticed there was a significant decrease from baseline—by 8 points at 2 months and by 9.64 points at 6 months—which was very statistically significant. That’s the best way to put that. And their mean EDSS scores decreased from baseline—by 0.37 at 2 months and by 0.45 at 6 months, both of which were statistically significant to a P value of 0.0001. The global clinical impression scores indicate an improvement in 63.4% of patients at 2 months and 61.4% of the patients at 6 months.
And the results from this prospective observational study of Acthar in patients with treatment-refractory MS show clinical improvement in this MSIS-29 version 1 subscale scores as well as significant improvements in the clinician-rated scores, EDSS, and the CGI-1. We had patient-reported outcomes. We examined the CGI with them. And what this did is it supported the efficacy and the tolerability of Acthar as a treatment for multiple sclerosis relapses.
Matthew J. Baker, MD: Yeah, I thought that was a fascinating poster. What kind of jumped out at me is that you made the decision in a real-world setting to treat a typical MS patient who was experiencing a relapse and they were enrolled in the trial. And you were looking at patient-reported outcome, which I think is the most meaningful endpoint in the real-world setting. In my practice, I give 5 days of IV [intravenous] Solu-Medrol [methylprednisolone]. And so, we just have this 5 days, 5 days stuck in our head; or 3 to 5 days. And so, my typical Acthar, or ACTH [adrenocorticotropic hormone] repository protocol, is also 5 days. And when you looked at those patients who had more than 5 doses, that was fascinating. Can you highlight that a little bit?
Jeffrey M. Kaplan, MD: The FDA approval for Acthar is actually 2 to 3 weeks of the 80-unit therapy. And so, I normally use 10 days, and sometimes more. I have found that to be more successful than 5 days. In this study, what we found was there was a trend where there were clearly improved clinical outcomes when we gave greater than 5 days of treatment. But I just want to make sure that I’m being completely honest here, it was a small sample size.