Effect of Health Care Providers' Focused Discussion and Proactive Education About Relapse Management on Patient Reporting of Multiple Sclerosis Relapse.

BACKGROUND: Treatments for multiple sclerosis (MS) relapse include intravenous corticosteroids and repository corticotropin injection. Despite available treatment, in the Multiple Sclerosis in America 2017 survey, only 47% of patients reported always/often contacting their MS health care provider (HCP) during relapse. In this study, the Multiple Sclerosis in America 2017 survey participants who received intravenous corticosteroids or repository corticotropin injection for treatment of past relapses completed a follow-up survey to understand how patients characterize relapse severity and to explore predictors of patients contacting their HCP during a relapse. METHODS: Patients were 18 years and older, diagnosed as having MS by an HCP, and currently using disease-modifying therapy. Patients completed an online survey assessing relapse characteristics and interactions with the HCP treating the patient's MS. Regression analysis identified predictors of patients contacting their HCP during relapse. RESULTS: Mean age of the 126 respondents was 49.2 years, 81.0% were female, and most (80.2%) had one or more relapses in the past 2 years. Patients estimated that 38.3% of their relapses were mild; 45.1%, moderate; and 16.6%, severe. Number and frequency of symptoms increased with relapse severity. Less than half (46.0%) reported they were extremely likely to contact their HCP during a relapse. The best predictors of being likely to contact the HCP during relapse were the HCP having previously discussed the importance of immediately communicating a relapse and patients' willingness to accept the HCP's recommendation for relapse treatment. CONCLUSIONS: Findings highlight the importance of HCPs' advance discussions with patients with MS regarding relapse management to increase the likelihood patients will contact their HCP during relapse.

Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis.

PURPOSE: Repository corticotropin injection (RCI) is indicated for a number of autoimmune-mediated diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and dermatomyositis (DM)/polymyositis (PM). To better understand the practice patterns and outcomes of RCI in patients with RA, SLE, or DM/PM, we conducted a retrospective medical record analysis. PATIENTS AND METHODS: Participating providers selected deidentified medical records of patients meeting the inclusion criteria (age ≥18 years; physician-reported diagnosis of RA, SLE, or DM/PM; initiation of treatment with RCI between 1/1/2011 and 2/15/2016; ≥3 in-office visits with same site/provider). Collected data spanned 12 months before and after the first prescription date for RCI. Analyses included patient demographics and clinical history, RCI treatment patterns, and physician's impression of change. RESULTS: Data from 54 patients with RA, 30 patients with SLE, and 8 patients with DM/PM were analyzed. The most frequently reported reasons for initiating RCI were lack of efficacy with prior treatment, acute exacerbation of disease, and use as add-on to ongoing therapy. The most common initial RCI dosing, 80 U twice weekly, was used for 84% of patients with RA, 75% with SLE, and 86% with DM/PM. The mean duration of treatment was 4.8, 6.5, and 6.8 months for RA, SLE, and DM/PM, respectively. Among the 57 patients with data on physician's impression of change with RCI, 78.1% of patients with RA, 94.7% with SLE, and 66.7% with DM/PM had a rating of "improved," and the mean time to best impression of change was 3.4, 4.3, and 3.4 months for RA, SLE, and DM/PM, respectively. CONCLUSION: This study reports the real-world patient profile, use patterns, and outcomes of patients who used RCI for the treatment of RA, SLE, and DM/PM. These data can inform appropriate use and clinical expectations when using RCI.

Efficacy, safety, and quality-of-life of treatments for acute relapses of multiple sclerosis: results from a literature review of randomized controlled trials.

BACKGROUND: Intravenous methylprednisolone (IVMP), repository corticotropin injection (RCI), plasmapheresis (PMP), and intravenous immunoglobulin (IVIG) are used in the treatment of acute multiple sclerosis (MS) relapse. A systematic literature review (SLR) of randomized controlled trials (RCTs) was conducted to examine the highest quality evidence available for these therapies. METHODS: English-language articles were searched in MEDLINE, Embase, and Cochrane Library through May 2016 per Preferred Reporting Items for Systematic Reviews and Meta-Analyses standards. MS conferences, SLRs, and bibliographies of included studies were also searched. Eligible studies included adults treated with ≥1 aforementioned therapy. RESULTS: Twenty-three RCTs were identified: 22 on efficacy, 11 on safety, and 3 on QOL (ie 18 IVMP, 2 RCI, 2 PMP, and 2 IVIG). IVMP and RCI improved relapse-related disability; however, IVIG and PMP showed inconsistent efficacy. QOL data were only ascertained for IVMP. CONCLUSIONS: RCTs indicate IVMP and RCI are efficacious and well tolerated treatments for MS relapse. Overall, many RCTs were dated, with sample sizes of fewer than 30 patients and no definitions for relapse nor clinically significant change. Contemporary evidence generation for all relapse treatments of interest, across efficacy, safety, and QOL outcomes, is still needed.

Medication Utilization Patterns 90 Days Before Initiation of Treatment with Repository Corticotropin Injection in Patients with Infantile Spasms.

INTRODUCTION: Infantile spasms (IS) is a rare and devastating form of early childhood epilepsy. Two drugs are approved in the United States for treatment of IS, H.P. Acthar® Gel (repository corticotropin injection, RCI) and Sabril® (vigabatrin). Given real-world variation in treatment of patients with IS, this study characterized treatment patterns with IS medications and determined all-cause health care resource utilization (HCRU) during the 90 days before initiating therapy with RCI in patients with IS. MATERIALS AND METHODS: Truven Health MarketScan® Research Databases were used to identify commercially insured US patients <2 years of age at RCI initiation with an IS diagnosis, per label use, from 1/1/07 to 12/31/15; presence of an electroencephalogram following diagnosis was required to assure diagnosis. Diagnosis codes and dispensed IS treatments of interest (drug classes including corticosteroids, vigabatrin, and other antiepileptic drugs [AEDs] excluding vigabatrin) before RCI initiation were evaluated. RESULTS: The 5 most common diagnoses other than IS observed in the study cohort (n=422) were "other convulsions," "acute upper respiratory infection," "esophageal reflux," "epilepsy, unspecified," and "abnormal involuntary muscle movements." Among the study cohort, 51.7% received RCI first; 38.9% received 1 drug class and 9.5% received >1 drug class before RCI initiation. Other AEDs were dispensed most often, either alone (31.3%) or with other drug classes (9.3%). Mean HCRU included 11.8 all-cause outpatient visits and 4.5 medications dispensed. Patients who received RCI or corticosteroids as their initial IS treatment had the lowest and second-lowest HCRU. CONCLUSION: In the 90 days before initiating RCI, patients with IS received multiple diagnoses and treatments, characterized by frequent HCRU. Use of RCI first (no prior IS medications) and AEDs first were associated with the lowest and highest HCRU, respectively, across all categories (all-cause outpatient visits, emergency department visits, hospital admissions, prescription medications).