A Prospective Observational Registry of H.P. ActharŽ Gel for the Treatment of Multiple Sclerosis Relapse
Objectives: This study is collecting data to characterize the patient population who receive repository corticotropin injection (RCI) to treat acute MS relapse. It will describe treatment patterns, MS relapse recovery, and safety outcomes.
Methods: 260 patients are due to be enrolled at up to 60 study sites, over a period of 24 months. Patients who have experienced a relapse are clinically evaluated with the MS impact scale (MSIS-29), Expanded Disability Status Scale (EDSS), and Clinical Global Impression of Improvement scale (CGI-I) at baseline, two months, and six months following their clinical attack. Patients are also evaluated with Health Outcomes assessments, including the Health Resource Utilization (HRU) and Work Productivity and Activity Impairment (WPAI) questionnaires.
Results: As of 27/Oct/2016, demographic data had been collected on 36 patients. On average patients are approximately 50 years old, female (68.9%), and Caucasian (64.4%), with a baseline EDSS of 4.4 and MSIS-29 physical subscale score of 65.4 following the index relapse. At least 71.1% of patients are receiving a disease modifying therapy at the time of relapse. The median number of doses of RCI received are 5, with a median dose strength of 80 U. Three serious adverse events have been reported: MS relapse, urinary tract infection, and asthenia. These adverse events were judged to be unlikely related or not related to study medication, and all patients recovered. Thus far, adverse events reported in the study are consistent with the known adverse event profile for RCI.
Conclusions: The study is an ongoing study. Enrollment is expected to be concluded by the end of 2017. The study will contribute to understanding of the current use of RCI, and its impact on clinical and health outcome assessments following acute MS relapse.