2021 CMSC Annual Meeting

Evaluating the Impact of Administering Ocrelizumab Via a Home Infusion on Safety and Patient Reported Outcomes

Background: US payers are looking to reduce the cost of administering infusible drugs for multiple sclerosis (MS). Home-based infusion has not been evaluated and may allow safe treatment during the SARS-CoV-2 pandemic. Objectives: Evaluate ocrelizumab (OCR) administered as a 2-hour home infusion on the rate of infusion-related reactions (IRRs) and patient-reported outcomes (PROs). Methods: Enroll 100 MS patients from Rocky Mountains MS Center who: a) 18-55yrs, b) relapsing or primary progressive MS, c) completed first 600 mg dose of OCR, d) have neurologist approved therapy monitoring labs, e) reside in an area with rapid 911 access, f) complete PROs in English and without ?Grade 3 IRR in a prior infusion. Eligible patients receive one OCR infusion at home administered by a local infusion center. Primary outcome is IRRs with Common Terminology Criteria for Adverse Events (AE) (1=mild 5=death) collected at the infusion visit. Other AEs are collected from infusion-2 weeks via telehealth. Patients are asked to recall their last OCR infusion and current home infusion using validated PROs measuring general health, infusion experience, responsiveness of the infusion nurses, and confidence in receiving an infusion at home. Results: Currently 51/100 patients have received a home infusion. Mean age of 42.5 years, min-max [26.0, 55.9] respectively; 73% female; 89% white; 96% with relapsing MS; mean MS duration 8.8 years; 3.3 years on OCR. 15.69% of patients experienced any IRR (n=8/51) with the majority (n=6) being Grade 1. A total of 43/51 patients reported other AEs. Most common were fatigue, itching in the throat/mouth/skin, tingling, and headache/migraine during follow up. No SAEs were observed. PROs trending favorably post vs pre home infusion (1=strongly disagree, 5=strongly agree). Overall receiving OCR was a good experience (pre=4.22; post=4.43; p=0.13); nurses explaining things in a way I could understand (pre=3.78; post=3.94; p=0.01) confidence in nurses administering my infusion (pre=4.40; post=4.67; p=0.02); felt safe and respected during home infusion (pre=4.45; post=4.69; p=0.03); felt comfortable in my surroundings (pre=3.98; post=4.65; p<0.0001). Mental health (pre=3.65; post=3.84; p=0.05) and social satisfaction (pre=3.94; post=4.16; p=0.02) improved. Worries about safe and AEs decreased (1=strongly agree, 5=strongly disagree) (pre=3.75; post=4.16; p=0.008). Conclusions: Interim analysis for OCR home infusion safety and experience are encouraging.