Premium
Risk of requiring a walking aid after 6.5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis: Data from the OPERA I and OPERA II trials
Author(s) -
Giovani Gavin,
Kappos Ludwig,
Seze Jerome,
Hauser Stephen L.,
Overell James,
Koendgen Harold,
Manfrini Marianna,
Wang Qing,
Wolinsky Jerry S.
Publication year - 2022
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/ene.14823
Subject(s) - ocrelizumab , medicine , expanded disability status scale , multiple sclerosis , hazard ratio , confidence interval , opera , milestone , physical therapy , immunology , rituximab , art , literature , archaeology , lymphoma , history
Background and purpose Requiring a walking aid is a fundamental milestone in multiple sclerosis (MS), represented by an Expanded Disability Status Scale (EDSS) score ≥6.0. In the present study, we assess the effect of ocrelizumab (OCR) on time to EDSS score ≥6.0 in relapsing MS. Methods Time to EDSS score ≥6.0 confirmed for ≥24 and ≥48 weeks was assessed over the course of 6.5 years (336 weeks) in the double‐blind period (DBP) and open‐label extension (OLE) period of the OPERA I (NCT01247324) and OPERA II (NCT01412333) studies. Results Time to reach EDSS score ≥6.0 was significantly delayed in those initially randomized to OCR versus interferon. Over 6.5 years, the risk of requiring a walking aid confirmed for ≥24 weeks was 34% lower among those who initiated OCR earlier versus delayed treatment (average hazard ratio [HR] DBP + OLE 0.66, 95% confidence interval [CI] 0.45–0.95; p = 0.024); the risk of requiring a walking aid confirmed for ≥48 weeks was 46% lower (average HR DBP+OLE 0.54, 95% CI 0.35–0.83; p = 0.004). Conclusion The reduced risk of requiring a walking aid in earlier initiators of OCR demonstrates the long‐term implications of earlier highly effective treatment.