Repository Corticotropin Injection Shows Efficacy in Relapsing-Remitting MS

Repository corticotropin injection (RCI) is a safe and highly effective treatment option for patients with relapsing-remitting multiple sclerosis (RRMS) with an inadequate response to high-dose corticosteroids, according to study results presented at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), held October 25 to 28, 2021 in Orlando, Florida.

Up to 35% of acute relapses in patients with RRMS do not respond to high-dose corticosteroids. The US Food and Drug Administration (FDA) approved RCI, a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides, for the treatment of multiple sclerosis relapse.

The objective of the current study was to determine the efficacy and safety of RCI in patients with RRMS relapse and an inadequate response to high-dose corticosteroids.

The multicenter, randomized, double-blind, placebo-controlled OPTIONS trial included 35 patients (77.1% women) diagnosed with RRMS relapse. The participants received 3 to 5 days of intravenous or oral methylprednisolone at a daily dose of 1 gram, or oral prednisolone at a daily dose of 1250 milligram within 28 days of relapse onset.

At 14 days after steroid initiation, patients without a ≥1 point improvement in ≥1 function of the Functional Systems Score (FSS) were randomized to subcutaneous RCI 1 milliliter (80 U) or matching placebo daily for 14 days.

The Expanded Disability Status Scale (EDSS), Clinical Global Impression of Improvement scale, 29-item MS Impact Scale and adverse events, were evaluated up to 42 days after randomization.

Response to treatment, defined as EDSS score improvement of ≥ 1.0 point (if ≤ 5.5 at baseline) or ≥ 0.5 point (if >5.5 at baseline), was the primary efficacy outcome.

At day 42, response rates according to EDSS were 61.1% in the RCI group compared with 11.1% in the placebo group. Differences between groups were also noted on days 21 (38.9% vs. 23.5%, respectively) and 7 (38.9% vs. 11.8%, respectively).

Nearly 90% of patients receiving RCI, compared with approximately 70% of those receiving placebo, were very much or much improved by day 42 (88.9% vs. 70.6%, respectively), according to qualitative Clinical Global Impression of Improvement analysis. No difference was noted between the groups for 29-item MS Impact Scale.

Treatment-emergent adverse events were reported for 77.8% of patients receiving RCI and for 70.6% of those receiving placebo, with no serious adverse events or deaths in the RCI group.

“These results support RCI as a safe and highly effective treatment for MS relapse in patients with an inadequate response to high-dose corticosteroids,” concluded the researchers.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

Reference

Wynn D, Goldstick LP, Bauer W, et al. Results from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotrophin injection for relapsing-remitting multiple sclerosis. Presented at: CMSC 2021 Annual Meeting; October 25-28, 2021; Orlando, Florida. Abstract RTH02.