Abstract Details

Title Matching-adjusted Indirect Comparisons of Diroximel Fumarate, Ocrelizumab, and Interferon Beta-1a

Topic Multiple Sclerosis

Presentation(s) P11 - Poster Session 11 (8:00 AM-9:00 AM)

Poster/Presentation
Number 1-005

Objective To report matching-adjusted indirect comparisons (MAIC) of efficacy for diroximel fumarate (DRF) vs ocrelizumab (OCR) and DRF vs interferon beta-1a (IFN), disease-modifying therapies for relapsing multiple sclerosis.

Background No randomized trials have compared the efficacy of DRF vs OCR or DRF vs IFN.

Design/Methods We obtained individual patient data from EVOLVE-MS-1 (NCT02634307), a 96-week, phase 3 study of DRF (462mg bid; n=1057), and group-level data from OPERA I/II (NCT01247324 and NCT01412333), two 96-week, randomized phase 3 studies of OCR (600mg every 24 weeks; n=827) and IFN (44μg tiw; n=829). EVOLVE-MS-1 data were restricted to meet OPERA I/II inclusion/exclusion criteria and weighted separately to match baseline characteristics in the OPERA I/II treatment arms. Annualized relapse rates (ARR), confirmed disability progression (CDP), and radiological outcomes were compared.

Results Baseline characteristics were balanced after restriction and weighting for DRF vs OCR and DRF vs IFN. At 96 weeks, ARR were similar for DRF vs OCR (0.18 [95%CI: 0.14–0.24] vs 0.16 [0.15, 0.17]) but favoured DRF over IFN (0.19 [95%CI: 0.15–0.24] vs 0.29 [0.24–0.33]; p<0.001). At 96 weeks, 12-week and 24-week CDP were similar for DRF and OCR (12-week: 6.4% [95%CI: 3.8–8.7] vs 9.1% [7.1–11.1]; 24-week: 4.8% [2.6–6.9] vs 6.9% [5.2–8.7]); both CDP outcomes favoured DRF vs IFN (12-week: 6.5% [3.8–8.7] vs 13.6% [11.3–15.9; p<0.0001]; 24-week: 4.9% [2.6–6.9] vs 10.5% [8.4– 12.7; p<0.0001]). The proportion of patients with gadolinium-enhancing lesions was higher for DRF vs OCR (16.4% vs 9.1%; p<0.0001) but lower for DRF vs IFN (15.7% vs 33.2%; p<0.0001). The proportion of patients with new/newly enlarging (N/NE) T2 lesions was higher for DRF vs OCR (59.5% vs 38.7%; p<0.0001) but similar for DRF vs IFN (58.4% vs 61.7%).

Conclusions The MAIC indicated no significant differences in clinical outcomes for DRF vs OCR; radiological outcomes favoured OCR. All outcomes favoured DRF vs IFN, apart from N/NE T2 lesions.

Authors/Disclosures
Carrie M. Hersh, DO, MSc, FAAN (Cleveland Clinic Lou Ruvo Center for Brain Health) PRESENTER	Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech_GN41791. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol-Myers Squibb . Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon Therapeutics. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Genzyme. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. The institution of Dr. Hersh has received research support from Biogen. The institution of Dr. Hersh has received research support from Novartis. The institution of Dr. Hersh has received research support from Genentech_GN41791. The institution of Dr. Hersh has received research support from PCORI. The institution of Dr. Hersh has received research support from Bristol Myers Squibb.
Yolanda Aladro	Yolanda Aladro has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck, Almirall, Sanofi, Novartis, Bristoll. The institution of Yolanda Aladro has received research support from Roche, Almirall, Merck.
James B. Lewin, PharmD	Dr. Lewin has received personal compensation for serving as an employee of Biogen. Dr. Lewin has stock in Biogen.
Changyu Shen, PhD	Dr. Shen has received personal compensation for serving as an employee of Biogen. Dr. Shen has stock in Biogen.
Ivan Bozin (Biogen International GmbH)	Dr. Bozin has received personal compensation for serving as an employee of Biogen. Dr. Bozin has received personal compensation for serving as an employee of Arvelle Therapeutics. Dr. Bozin has stock in Biogen.
Zhaonan Sun, PhD	Dr. Sun has received personal compensation for serving as an employee of Biogen. Dr. Sun has stock in Biogen.

��ɫ��

��ɫ��