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Abstract Details

Ocrelizumab in Patients With Early-stage RRMS—Results from the Phase IIIb ENSEMBLE Trial and the Matched Real-world NTD MS Registry Cohort
Multiple Sclerosis
P9 - Poster Session 9 (8:00 AM-9:00 AM)
6-005
To contextualize ocrelizumab effectiveness in early-stage relapsing-remitting multiple sclerosis (RRMS) from the multicenter, open-label, single-arm, Phase IIIb ENSEMBLE trial (NCT03085810) with real-world, first-line disease-modifying therapies (DMTs), using the German NeuroTransData (NTD) MS registry

Early treatment with high-efficacy DMTs can provide long-term benefits on MS disease outcomes. Understanding of ocrelizumab effectiveness in early-stage MS is still limited.

Treatment-naive patients with early-stage RRMS from ENSEMBLE receiving ocrelizumab were matched to NTD intent-to-treat (ITT) patients initiating interferon β-1a/-1b, glatiramer acetate, dimethyl fumarate and teriflunomide as index therapies. We applied propensity-score methods targeting a 2:1 matching ratio, controlling for seven baseline covariates, including brain-imaging activity. No evidence of disease activity (NEDA-2; including no relapses or 24-week confirmed disease worsening [CDW]) up to 120 weeks was explored as an efficacy outcome.

Overall, 301 ENSEMBLE patients were matched to 198 NTD–ITT patients. Baseline covariates were similar and well-balanced post-matching (standardized mean difference <0.2). The number of patients achieving NEDA-2 at Week 120 was 238 (79.1%) and 122 (61.6%) in the matched ENSEMBLE and NTD–ITT cohorts, respectively. The odds ratio (OR; 95% CI) comparing ENSEMBLE versus NTD–ITT cohort for NEDA-2 were 2.30 (1.50–3.52), primarily driven by an effect on relapses whereas there was no significant effect on 24-week CDW. Treatment switches including to high-efficacy DMTs occurred across the treatment pathways in NTD–ITT cohort.

Ocrelizumab in early RRMS was associated with significantly lower risk of disease activity assessed by NEDA-2 compared with real-world treatment pathways including first-line DMTs. The study is limited by the short observation period while non-disabling relapses are frequent in early RRMS. The ITT approach accounted for the real-world treatment pathways and DMT switches; however, it may not fully account for the effect on disability worsening of escalation strategy to high-efficacy DMTs applied in NTD.
Authors/Disclosures
Hans-Peter Hartung, MD, FAAN (Heinrich Heine University Medical Faculty)
PRESENTER
Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS Celgene. Dr. Hartung has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Geneuro. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hartung 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. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Hartung 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. Hartung has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers Neurology.
Trygve Holmoy, MD (Aventis Pharma AS) Dr. Holmoy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Norwegian MS Society. Dr. Holmoy has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Holmoy has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Holmoy has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Holmoy has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Holmoy has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck.
Jens Wuerfel, MD (Hoffmann-LaRoche) Dr. Wuerfel has received personal compensation for serving as an employee of MIAC AG. The institution of Dr. Wuerfel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Actelion. The institution of Dr. Wuerfel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. The institution of Dr. Wuerfel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche.
Yanic Heer No disclosure on file
Stefan Braune (Gemeinschaftspraxis) Stefan Braune has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NeuroTransData. Stefan Braune has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Stefan Braune has received personal compensation in the range of $5,000-$9,999 for serving as an officer or member of the Board of Directors for NeuroTransData.
Arnfin Bergmann Dr. Bergmann has nothing to disclose.
Mel Zürcher (Rewoso AG) No disclosure on file
Sabrina Guye (F. Hoffmann-La Roche Ltd.) No disclosure on file
Thomas Kuenzel No disclosure on file
Suzanne Moore Suzanne Moore has received personal compensation for serving as an employee of Hoffmann-la-Roche. Suzanne Moore has stock in Hoffmann-la-Roche.
Timothy L. Vollmer, MD, FAAN The institution of Dr. Vollmer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen IDEC. The institution of Dr. Vollmer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech/Roche. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Siranax. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Meyers Squib. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viela Bios. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. The institution of Dr. Vollmer has received research support from Rocky Mountain MS Center. The institution of Dr. Vollmer has received research support from Biogen. The institution of Dr. Vollmer has received research support from Actelion. The institution of Dr. Vollmer has received research support from Genentech/Roche. The institution of Dr. Vollmer has received research support from Anokion. The institution of Dr. Vollmer has received research support from TG Therapeutics.