Contributions
Abstract: EP1690
Type: Poster Sessions
Abstract Category: Therapy - Symptomatic treatment
Background: Despite recent advances in multiple sclerosis (MS) treatments, patients continue to experience relapses. Effective treatment of MS relapses is highly important to minimise acute disability and potential residual deficits.
Objectives: To characterise patients receiving repository corticotropin injection (RCI) for treatment of acute MS relapse and describe treatment patterns, MS relapse recovery, and safety outcomes. The primary outcome measure was change in MS Impact Scale (MSIS-29v1) score from baseline (BL) through Month 2.
Methods: Patients whose MS relapse was treated with RCI were clinically evaluated and assessed with the MSIS-29v1, Expanded Disability Status Scale (EDSS), and Clinical Global Impression of Improvement scales. Health outcome assessments were also conducted.
Results: As of March 24, 2018, 120 patients had entered the study from multiple sites; presented results are from 98 patients in the intent-to-treat population. Mean age was 47.5 years; 88.8% of patients were female, and 86.7% were Caucasian. At BL, mean MSIS-29v1 physical subscale score (scaled to 100) was 56.3, and mean EDSS score was 4.0. The average time since diagnosis of MS was 10.6 years; 53.1% of patients had experienced a relapse within the last 2 years, and 61.2% had a history of insufficient treatment response, intolerance, or intravenous access problems associated with high‑dose corticosteroids. Disease‑modifying therapies (DMTs) most often used concomitantly with RCI were dimethyl fumarate (21.4%), natalizumab (16.3%), teriflunomide (12.2%), ocrelizumab (9.2%), glatiramer acetate (8.2%), fingolimod (7.1%), and interferon beta-1a (6.1%). Mean MSIS-29 physical subscale scores significantly improved from BL by 6.8 at Month 2 and by 11.0 at Month 6. There were 86 adverse events (AEs); 15 were serious AEs (SAEs), and 1 patient had an SAE (atrial fibrillation and dyspnoea) deemed related to RCI treatment by the investigator, resulting in study discontinuation and early termination.
Conclusions: This ongoing study is assessing current practices relating to RCI and its impact on clinical outcome assessments after acute MS relapse. BL data suggest that patients receiving RCI tend to be older, have longer MS duration, and use more contemporary DMTs than patients in prior relapse recovery studies. Despite this, interim results suggest clinically meaningful improvements in MSIS-29v1 scores and support the efficacy and tolerability of RCI as a treatment for MS relapse.
Disclosure: Editorial support was provided by MedLogix Communications, LLC, Itasca, Illinois, under the direction of the authors and was funded by Mallinckrodt ARD Inc. Bryan R Due, PhD, is an employee of Mallinckrodt ARD Inc. Patrice M Becker, MD, is a former employee of Mallinckrodt ARD Inc. and she owns company stocks. Patricia K Coyle, MD, has received consultancy fees from Accordant; Acorda; Bayer; Biogen; Celgene; EMD Serono; Genentech/Roche; Novartis; Sanofi Genzyme; and Teva. Dr. Coyle has received research grants from Actelion; Alkermes; Genentech/Roche; MedDay; National Institute of Neurological Disorders and Stroke (NINDS); and Novartis.
Abstract: EP1690
Type: Poster Sessions
Abstract Category: Therapy - Symptomatic treatment
Background: Despite recent advances in multiple sclerosis (MS) treatments, patients continue to experience relapses. Effective treatment of MS relapses is highly important to minimise acute disability and potential residual deficits.
Objectives: To characterise patients receiving repository corticotropin injection (RCI) for treatment of acute MS relapse and describe treatment patterns, MS relapse recovery, and safety outcomes. The primary outcome measure was change in MS Impact Scale (MSIS-29v1) score from baseline (BL) through Month 2.
Methods: Patients whose MS relapse was treated with RCI were clinically evaluated and assessed with the MSIS-29v1, Expanded Disability Status Scale (EDSS), and Clinical Global Impression of Improvement scales. Health outcome assessments were also conducted.
Results: As of March 24, 2018, 120 patients had entered the study from multiple sites; presented results are from 98 patients in the intent-to-treat population. Mean age was 47.5 years; 88.8% of patients were female, and 86.7% were Caucasian. At BL, mean MSIS-29v1 physical subscale score (scaled to 100) was 56.3, and mean EDSS score was 4.0. The average time since diagnosis of MS was 10.6 years; 53.1% of patients had experienced a relapse within the last 2 years, and 61.2% had a history of insufficient treatment response, intolerance, or intravenous access problems associated with high‑dose corticosteroids. Disease‑modifying therapies (DMTs) most often used concomitantly with RCI were dimethyl fumarate (21.4%), natalizumab (16.3%), teriflunomide (12.2%), ocrelizumab (9.2%), glatiramer acetate (8.2%), fingolimod (7.1%), and interferon beta-1a (6.1%). Mean MSIS-29 physical subscale scores significantly improved from BL by 6.8 at Month 2 and by 11.0 at Month 6. There were 86 adverse events (AEs); 15 were serious AEs (SAEs), and 1 patient had an SAE (atrial fibrillation and dyspnoea) deemed related to RCI treatment by the investigator, resulting in study discontinuation and early termination.
Conclusions: This ongoing study is assessing current practices relating to RCI and its impact on clinical outcome assessments after acute MS relapse. BL data suggest that patients receiving RCI tend to be older, have longer MS duration, and use more contemporary DMTs than patients in prior relapse recovery studies. Despite this, interim results suggest clinically meaningful improvements in MSIS-29v1 scores and support the efficacy and tolerability of RCI as a treatment for MS relapse.
Disclosure: Editorial support was provided by MedLogix Communications, LLC, Itasca, Illinois, under the direction of the authors and was funded by Mallinckrodt ARD Inc. Bryan R Due, PhD, is an employee of Mallinckrodt ARD Inc. Patrice M Becker, MD, is a former employee of Mallinckrodt ARD Inc. and she owns company stocks. Patricia K Coyle, MD, has received consultancy fees from Accordant; Acorda; Bayer; Biogen; Celgene; EMD Serono; Genentech/Roche; Novartis; Sanofi Genzyme; and Teva. Dr. Coyle has received research grants from Actelion; Alkermes; Genentech/Roche; MedDay; National Institute of Neurological Disorders and Stroke (NINDS); and Novartis.