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- Title
(RTH03) Efficacy and Safety Outcomes from a Prospective Observational Registry of Repository Corticotropin Injection for Relapse of Multiple Sclerosis.
- Authors
Kaplan, Jeffrey; Miller, Tamara; Baker, Matthew; Due, Bryan; Enxu Zhao
- Abstract
Background: Effective relapse treatment is critical for minimizing disability in patients with multiple sclerosis (MS). Repository corticotropin injection (RCI) is approved by the US Food and Drug Administration for the treatment of MS exacerbations. Objectives: This multicenter, prospective, observational registry study aimed to characterize treatment response, recovery, and safety outcomes of RCI in the treatment of acute MS relapse. Methods: The following data were obtained upon initiation of RCI therapy (baseline) and again at various time points after. Clinical outcomes were assessed using the MS Impact Scale (MSIS-29v1), Expanded Disability Status Scale (EDSS), and Clinical Global Impression of Improvement (CGI-I) scale. Patient-reported outcomes were collected via the Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS) and Health Resource Utilization (HRU) questionnaire. Mean changes from baseline were evaluated at 2 and 6 months via 2-sided paired t tests. Serious and nonserious adverse events (SAEs/AEs) were reported throughout the study. Results: After treatment with RCI (N = 125), mean MSIS-29v1 physical subscale scores (primary end point) decreased from baseline (55.69) at 2 months (-7.99, P = .0002) and 6 months (-9.64, P < .0001). Post hoc analyses showed larger improvements in patients who received >5 doses of RCI (n = 23) vs ≤5 doses (n = 71) at 2 months (-10.74, P = .0180 vs -6.48, P = .0177) and 6 months (-14.62, P = .0415 vs -7.90, P = .0011). Mean EDSS scores decreased from baseline (3.92) at 2 months (-0.37, P < .0001) and 6 months (-0.45, P < .0001), with greater improvement in patients who received >5 doses vs ≤5 doses at 2 months (-0.50, P = .0068 vs -0.24, P = .0059) and 6 months (-0.64, P = .0430 vs -0.36, P = .0111). CGI-I scores improved in 63.38% of patients (P < .0001) at 2 months and 61.40% of patients (P < .0001) at 6 months postbaseline. Eighty-three AEs were reported by 35 patients (28%), and 16 SAEs were reported by 11 patients (8.8%). The most common AEs/SAEs were MS relapse (4% AE, 4% SAE) and urinary tract infection (3.2% AE, 1.6% SAE). WPAI:MS and HRU responses showed improvements from baseline for most end points at 2 and 6 months. Conclusions: Improvements in clinical MS scales and patient-reported measures of MS impact, along with the low incidence of AEs/SAEs, support the efficacy and safety of RCI as a treatment option for MS relapse. Treatment response showed greater improvements with >5 doses.
- Subjects
ADRENOCORTICOTROPIC hormone; CONFERENCES &; conventions; INJECTIONS; MULTIPLE sclerosis; DISEASE relapse; TREATMENT effectiveness
- Publication
International Journal of MS Care, 2020, Vol 22, Issue S2, p77
- ISSN
1537-2073
- Publication type
Article