Delayed Signs of Early Disability Progression After 8.5 Years of Ocrelizumab Treatment in Patients With Relapsing Multiple Sclerosis (S46.003)

Field: Medicine (Health Sciences)

Objective:

To assess the efficacy of earlier initiation of ocrelizumab on reaching key disability milestones, after 8.5 years of follow-up in the double-blind period (DBP) and open-label extension (OLE) of the pooled OPERA I/II (NCT01247324/NCT01412333) studies in patients with relapsing multiple sclerosis.

Background:

Early intervention using high-efficacy therapies to prevent disease progression is an increasingly adopted therapeutic strategy in multiple sclerosis, as reaching disability milestones is associated with increased patient and societal burden.

Design/Methods:

Patients completing the DBP either continued ocrelizumab (OCR-OCR) or switched from interferon β-1a to ocrelizumab (IFN-OCR) when entering the OLE period. Time-to-onset of 24-week confirmed disability progression to Expanded Disability Status Scale (EDSS) scores reflecting onset of impairment perceived by the patient (EDSS ≥2.0 from baseline EDSS ≤1.0), walking impairment (EDSS ≥4.0 from baseline EDSS ≤3.0) and requiring a walking aid (EDSS ≥6.0 from baseline EDSS ≤5.5) since DBP baseline were analyzed.

Results:

Over 8.5 years of the DBP and OLE, the risk of reaching key disability milestones was significantly lower in those who initiated ocrelizumab earlier (OCR-OCR) vs delayed treatment (IFN-OCR) (Hazard Ratio [95% confidence interval]): onset of disability (EDSS ≥2.0: n=9/61 vs n=20/82; 0.42 [0.19–0.94]; p=0.0303); walking impairment (EDSS ≥4.0: n=49/538 vs n=62/544; 0.69 [0.47–1.00]; p=0.0486); requiring a walking aid (EDSS ≥6.0: n=61/822 vs n=79/823; 0.67 [0.48–0.94]; p=0.0207). Over 8.5 years, 85.2%, 90.9% and 92.6% of OCR-OCR patients had not progressed to EDSS ≥2.0, EDSS ≥4.0 and EDSS ≥6.0 from the respective baseline.

Conclusions:

After 8.5 years of follow-up, earlier treatment with ocrelizumab was associated with reduced numbers of patients reaching early disability milestones. Early institution of high-efficacy therapy can preserve function that is not regained when the same treatment is initiated later. Disclosure: Martin Weber, MD has nothing to disclose. The institution of Dr. Kappos has received research support from Bayer. The institution of Dr. Kappos has received research support from Biogen. The institution of Dr. Kappos has received research support from Genentech. The institution of Dr. Kappos has received research support from Genzyme. The institution of Dr. Kappos has received research support from Janssen. The institution of Dr. Kappos has received research support from Merck Serono. The institution of Dr. Kappos has received research support from Minoryx. The institution of Dr. Kappos has received research support from Novartis. The institution of Dr. Kappos has received research support from Roche. The institution of Dr. Kappos has received research support from Sanofi. The institution of Dr. Kappos has received research support from Santhera. The institution of Dr. Kappos has received research support from Swiss MS Society, Swiss National Research Foundation, European Union, Roche Research Foundation, Innosuisse. The institution of Dr. Kappos has received research support from Shionogi. The institution of Dr. Kappos has received research support from Japan Tobacco. The institution of Dr. Kappos has received research support from Auriga Vision AG. The institution of Dr. Kappos has received research support from EMD Serono. The institution of Dr. Kappos has received research support from Glaxo Smith Kline. The institution of Dr. Kappos has received research support from Wellmera AG. The institution of Dr. Kappos has received research support from Eli Lilly (Suisse) SA. The institution of Dr. Kappos has received research support from Bristol Myers Squibb. The institution of Dr. Kappos has received research support from Celltrion Inc. Dr. Kappos has received intellectual property interests from a discovery or technology relating to health care. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NGM Bio. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Accure. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alector. Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Annexon. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Neurona. Dr. Hauser has a non-compensated relationship as a Clinical Trial/Primary Investigator with Roche that is relevant to AAN interests or activities. Dr. Hauser has a non-compensated relationship as a Clinical Trial/Primary Investigator with Novartis that is relevant to AAN interests or activities. Dr. Schneble has received personal compensation for serving as an employee of F. Hoffmann-La Roche Ltd.. Dr. Schneble has received stock or an ownership interest from F. Hoffmann-La Roche, Ltd.. Qing Wang has nothing to disclose. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck KGaA. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Japanese Tobacco. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Oxford Health Policy Forum. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Peervoice. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Bristows .