Mallinckrodt plc announces data publication on the treatment effectiveness of acthar® gel for resolution of multiple sclerosis relapse in a u.s. health plan population

Mallinckrodt plc 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 changes, and some people with ms experience relapses while on standard disease-modifying therapies. 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. key findings: 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%) had <2 relapse episodes and 26.0% of patients experienced two or more relapse episodes per year. 36.9% 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%), acthar gel (2.2%), and pmp (1.5%); 90% 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%), compared with ivig (43.9%) and pmp (50.7%). methods: 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 ?rst visit for relapse or a new relapse if greater than 30 days from the first visit for relapse.
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