Matching-adjusted indirect comparisons of diroximel fumarate, ocrelizumab and interferon beta-1a for relapsing multiple sclerosis

<b>Aim:</b> This study compares the efficacy of diroximel fumarate (DRF) with ocrelizumab (OCR) and interferon beta-1a (IFNβ-1a) for treating relapsing multiple sclerosis (MS) through matching-adjusted indirect comparisons (MAICs). <b>Materials & methods:</b> We used individual patient data from the EVOLVE-MS-1 (NCT02634307) study, the phase III trial of DRF (n = 1057), and group-level data from the OPERA I/II studies (NCT01247324 and NCT01412333), the 96-week, randomized, double-blind, phase III trials of OCR (n = 827) and IFNβ-1a (n = 829). EVOLVE-MS-1 data were adjusted to match the inclusion/exclusion criteria and baseline characteristics of OPERA I/II participants. Comparisons were made for annualized relapse rates (ARRs), confirmed disability progression (CDP) and radiological outcomes. <b>Results:</b> Baseline characteristics were balanced post-adjustment. ARR comparisons at 96 weeks showed no significant difference for DRF versus OCR (0.18 vs 0.16, p = 0.347) but favored DRF over IFNβ-1a (0.19 vs 0.29, p = 0.002). At 96 weeks, there were no significant differences in rates of 12-week or 24-week CDP between DRF and OCR (12 week: 6.4 vs 9.1%, p = 0.074; 24 week: 4.8 vs 6.9%, p = 0.14); both CDP outcomes favored DRF over IFNβ-1a (12 week: 6.5 vs 13.6%, p < 0.0001; 24 week: 4.9 vs 10.5%, p < 0.0001). The proportion of patients with gadolinium-enhancing lesions was higher for DRF versus OCR (16.4 vs 9.1%, p < 0.0001) but lower for DRF versus IFNβ-1a (15.7 vs 33.2%, p < 0.0001). The proportion of patients with new/newly enlarging T2 lesions was higher for DRF versus OCR (59.5 vs 38.7%, p < 0.0001), but there was no significant difference for DRF versus IFNβ-1a (58.4 vs 61.7%). <b>Conclusion:</b> While there were no significant differences in clinical outcomes (ARR, 12-week CDP and 24-week CDP) observed for DRF versus OCR, radiological outcomes indicated favorability for OCR. All outcomes favored DRF over IFNβ-1a, except from new/newly enlarging T2 lesions, which showed no significant difference.

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Journal
Journal of Comparative Effectiveness Research
Published
2025-09-12
DOI
https://doi.org/10.57264/cer-2025-0061
Primary Topic
Multiple Sclerosis Research Studies
Type
article
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article

Matching-adjusted indirect comparisons of diroximel fumarate, ocrelizumab and interferon beta-1a for relapsing multiple sclerosis

Yolanda Aladro, Ivan Božin, Changyu Shen, Carrie M. Hersh et al.
Journal of Comparative Effectiveness Research
Multiple Sclerosis Research Studies
article

Matching-adjusted indirect comparisons of diroximel fumarate, ocrelizumab and interferon beta-1a for relapsing multiple sclerosis

Yolanda Aladro, Ivan Božin, Changyu Shen, Carrie M. Hersh, James B. Lewin, Zhaonan Sun
article en

Abstract

<b>Aim:</b> This study compares the efficacy of diroximel fumarate (DRF) with ocrelizumab (OCR) and interferon beta-1a (IFNβ-1a) for treating relapsing multiple sclerosis (MS) through matching-adjusted indirect comparisons (MAICs). <b>Materials & methods:</b> We used individual patient data from the EVOLVE-MS-1 (NCT02634307) study, the phase III trial of DRF (n = 1057), and group-level data from the OPERA I/II studies (NCT01247324 and NCT01412333), the 96-week, randomized, double-blind, phase III trials of OCR (n = 827) and IFNβ-1a (n = 829). EVOLVE-MS-1 data were adjusted to match the inclusion/exclusion criteria and baseline characteristics of OPERA I/II participants. Comparisons were made for annualized relapse rates (ARRs), confirmed disability progression (CDP) and radiological outcomes. <b>Results:</b> Baseline characteristics were balanced post-adjustment. ARR comparisons at 96 weeks showed no significant difference for DRF versus OCR (0.18 vs 0.16, p = 0.347) but favored DRF over IFNβ-1a (0.19 vs 0.29, p = 0.002). At 96 weeks, there were no significant differences in rates of 12-week or 24-week CDP between DRF and OCR (12 week: 6.4 vs 9.1%, p = 0.074; 24 week: 4.8 vs 6.9%, p = 0.14); both CDP outcomes favored DRF over IFNβ-1a (12 week: 6.5 vs 13.6%, p < 0.0001; 24 week: 4.9 vs 10.5%, p < 0.0001). The proportion of patients with gadolinium-enhancing lesions was higher for DRF versus OCR (16.4 vs 9.1%, p < 0.0001) but lower for DRF versus IFNβ-1a (15.7 vs 33.2%, p < 0.0001). The proportion of patients with new/newly enlarging T2 lesions was higher for DRF versus OCR (59.5 vs 38.7%, p < 0.0001), but there was no significant difference for DRF versus IFNβ-1a (58.4 vs 61.7%). <b>Conclusion:</b> While there were no significant differences in clinical outcomes (ARR, 12-week CDP and 24-week CDP) observed for DRF versus OCR, radiological outcomes indicated favorability for OCR. All outcomes favored DRF over IFNβ-1a, except from new/newly enlarging T2 lesions, which showed no significant difference.

Journal of Comparative Effectiveness ResearchVol. 14(10)
Biogen (United States) (US), Cleveland Clinic (US), Lou Ruvo Brain Institute (US), Hospital Universitario de Getafe (ES), Biogen (Switzerland) (CH)
Openalex Percentile: Top 65%
Multiple Sclerosis Research Studies
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