Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced the publication of "Treatment Effectiveness for Resolution of Multiple Sclerosis Relapse in a U.S. Health Plan Population" in an electronic publication posted in advance of print publication in the peer-reviewed journal Neurology and Therapy. Results from the analysis showed that multiple sclerosis (MS) relapse patients taking Acthar® Gel (repository corticotropin injection) had a higher relapse resolution rate than those taking intravenous immunoglobulin (IVIG) or plasmapheresis (PMP) treatment.
MS is a chronic, degenerative disease that can cause numerous impairments including fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes1, and some people with MS experience relapses while on standard disease-modifying therapies.2
Acthar Gel is U.S. Food and Drug Administration (FDA)-approved for the treatment of acute exacerbations of MS in adults. Controlled clinical trials have shown Acthar Gel to be effective in speeding the resolution of acute exacerbations of MS. However, there is no evidence that it affects the ultimate outcome or natural history of the disease.3 Please see Important Safety Information for Acthar Gel below.
"The management of MS relapse is an ongoing challenge, in particular for those patients who need additional treatment options after first-line agents such as corticosteroids," said George Wan, Ph.D., Vice President and Global Head of Health Economics and Outcomes Research at Mallinckrodt. "We are committed to working toward a better understanding of the potential clinical and health economic outcomes associated with Acthar Gel and other late-line treatments for MS relapse to help guide clinical practice and potentially improve outcomes for patients. In addition, we look forward to the results of Mallinckrodt's ongoing, randomized, double-blind, placebo-controlled OPTIONS study, which we anticipate will provide data on some of the more difficult-to-treat MS patients in the future."
"Treatment Effectiveness for Resolution of Multiple Sclerosis Relapse in a US Health Plan Population" evaluated the rate of MS relapse occurrence, frequency of use of MS relapse treatments including corticosteroids, and relapse treatment effectiveness (or relapse resolution rates) for corticosteroid treatment alternatives – Acthar Gel, IVIG, and PMP. No minimum health plan enrollment was required. The data were originally shared in a poster presentation at MSParis2017, the joint ECTRIMS-ACTRIMS meeting.4
- 9,574 patients with relapse episodes were identified with 25,162 relapse episodes [mean (SD) of 2.6 (4.0) relapse episodes per person]. The mean follow-up time per patient was 2.7± 2.1 years.
- The majority of patients (74.0 percent) had <2 relapse episodes and 26.0 percent of patients experienced two or more relapse episodes per year. 36.9 percent of patients had ≥1 unresolved relapse events during the study period which required additional relapse therapy beyond the initial relapse treatment received.
- The frequencies of relapse treatment alternatives used were as follows: IVIG (6.0 percent), Acthar Gel (2.2 percent), and PMP (1.5 percent).
- 90 percent of initial relapse events within the first relapse episodes were treated with corticosteroids
- Relapse resolution rates differed by treatment. Acthar Gel had the highest proportion of patients achieving relapse resolution (96.9 percent), compared with IVIG (43.9 percent) and PMP (50.7 percent).
- A retrospective analysis of patients 18-89 years experiencing MS relapse from January 1, 2008 to June 30, 2015 was conducted using administrative claims data from Humana Inc.
- MS relapse was estimated based on established claims-based methodology; and was defined as an inpatient admission or hospitalization with a principal diagnosis of MS or an outpatient visit or emergency department visit with a diagnosis of MS, followed by a medical or pharmacy claim for a relapse treatment of interest (oral corticosteroids, intravenous corticosteroids, Acthar Gel, PMP or IVIG) within 30 days.
- Treatment was deemed effective in resolving the relapse (relapse resolution) if no additional relapses followed within the episode; otherwise, the relapse was considered unresolved.
- A 30-day time frame was used as a marker to correlate MS relapse as either one unresolved relapse if within 30 days of the ﬁrst visit for relapse or a new relapse if greater than 30 days from the ﬁrst visit for relapse.
- Administrative claims data are collected for reimbursement purposes, and thereby may lack important clinical detail, such as disease severity. Claims are often used in MS relapse studies. Here, a number of definitions used in prior studies were implemented in order to mitigate this limitation.
- Relapses were identified based on treatment-seeking behavior using an established claims-based algorithm; treatment received/prescribed outside a healthcare visit was not addressed.
- Index relapse events were first observed, which may/not be the actual first events. However, relapse resolution was based on the occurrence of subsequent relapses, not prior relapses.
- Variation in treatment regimens would impact the rate of relapse resolution.
- Acthar Gel and PMP/IVIG have not been studied head-to-head in any randomized, controlled clinical trials.
- Not all improvements can be solely attributed to Acthar Gel.
- The study assessed response to Acthar Gel and did not capture safety