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Abstract Details

Long-term Reduction of Confirmed Disability Progression and Time to Walking Aid After 6 Years of Ocrelizumab Treatment in Patients with Relapsing Multiple Sclerosis
Multiple Sclerosis
S5 - Multiple Sclerosis: Clinical Trials and Disease-modifying Therapy (2:48 PM-3:00 PM)
010

To assess the efficacy of switching to or maintaining ocrelizumab (OCR) on disease activity and progression after 4 years of open-label extension (OLE) of the Phase III OPERA I (NCT01247324) and OPERA II (NCT01412333) trials in patients with relapsing multiple sclerosis (RMS).

The efficacy and safety of OCR in RMS were demonstrated in the 96-week controlled double-blind period (DBP) of OPERA I and OPERA II.

Patients completing the DBP either continued OCR (OCR-OCR) or switched from interferon (IFN) β-1a to OCR (IFN-OCR) when entering the OLE period. Adjusted annualized relapse rate, time to onset of 24-week confirmed disability progression (CDP24) and risk of requiring a walking aid (Expanded Disability Status Scale score ≥6.0) from the DBP baseline were analyzed.

Overall, 82.3% of patients who entered the OLE period completed OLE Year 4. Adjusted annualized relapse rate decreased year-on-year from the pre-switch year to OLE Year 4 in IFN-OCR switchers (pre-switch, 0.2; OLE Year 4, 0.04) and was maintained at low levels in OCR-OCR continuers (pre-switch, 0.13; OLE Year 4, 0.05). The rates of CDP24 were lower in OCR-OCR continuers vs IFN-OCR switchers in the pre-switch year (7.7% vs 12.0%) and at OLE Year 1 (10.1% vs 15.6%), Year 2 (13.9% vs 18.1%), Year 3 (16.2% vs 21.3%) and Year 4 (19.2% vs 23.7%); p<0.05 all comparisons. Over the DBP and OLE periods, the risk of requiring a walking aid was 44% lower (p=0.004) in OCR-OCR continuers vs IFN-OCR switchers. Safety profiles in the DBP and OLE were generally consistent.
After 6 years of follow-up, the rates of patients with CDP24 and the risk of requiring a walking aid remained lower in earlier initiators of ocrelizumab therapy (OCR-OCR) vs those receiving IFN initially (IFN-OCR), demonstrating the maintained benefits of earlier treatment with ocrelizumab.
Authors/Disclosures
Gavin Giovannoni, MD (QMUL)
PRESENTER 		Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 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 Roche-Genentech. 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 Sandoz. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Astoria Biologica. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas. 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.
Ludwig Kappos, MD, FÂ鶹´«Ã½Ó³»­ (RC2NB, University Hospital Basel) Dr. Kappos has nothing to disclose.
Jerome De Seze Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma.
Stephen L. Hauser, MD (UCSF Weill Institute for Neurosciences) 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 $500-$4,999 for serving as a Consultant for BD. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pheno Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nurix Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gilead. 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 $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hinge Therapeutics. 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 Â鶹´«Ã½Ó³»­ interests or activities. Dr. Hauser has a non-compensated relationship as a Clinical Trial/Primary Investigator with Novartis that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
No disclosure on file
Harold Koendgen, MD Dr. Koendgen has received personal compensation for serving as an employee of F. Hoffmann-La Roche Ltd. Dr. Koendgen has received stock or an ownership interest from F. Hoffmann-La Roche Ltd .
No disclosure on file
Marianna Manfrini No disclosure on file
Qing Wang Qing Wang has nothing to disclose.
Jerry S. Wolinsky, MD, FÂ鶹´«Ã½Ó³»­ (McGovern Medical School, UTHealth) Dr. Wolinsky has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avotres. Dr. Wolinsky has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Brainstorm Cell Therapeutics. Dr. Wolinsky has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cleveland Clinic Foundation. Dr. Wolinsky has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Wolinsky has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inmagene. Dr. Wolinsky has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis/Sandoz. Dr. Wolinsky has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Wolinsky has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. Dr. Wolinsky has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for University of Alabama Birmingham. Dr. Wolinsky has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Wolinsky has received intellectual property interests from a discovery or technology relating to health care. Dr. Wolinsky has received intellectual property interests from a discovery or technology relating to health care.