A non-inferiority comparative study failed to demonstrate that treatment with rituximab is non-inferior to ocrelizumab in relapsing-remitting MS (RRMS). Rituximab was associated with a higher relapse risk than ocrelizumab.
B-cell therapies are highly effective treatments for RRMS. Ocrelizumab is a humanised, monoclonal antibody targeted against CD20+ B cells, which reduces the frequency of relapses by 46% and disability worsening by 40% compared with interferon-β 1a. Rituximab is a chimeric, monoclonal, anti-CD20 agent that serves as an off-label alternative to ocrelizumab.
A study evaluated the clinical non-inferiority of rituximab with ocrelizumab in RRMS. It was designed as a longitudinal, observational, cohort study that used 2 large MS registries: MSBase and the Danish MS registry (DMSR). Patients had to be pre-treated with either rituximab or ocrelizumab for at least 6 months. Patients with comparable baseline characteristics were matched 1-to-6 by propensity score on age, sex, MS duration, Expanded Disability Status Scale (EDSS), prior relapse rate, prior therapy, disease activity, MRI lesion burden, and country. The primary study outcome measure was the annualised-relapse rate (ARR). The pre-specified, non-inferiority margin was 1.2 rate ratio. Secondary outcome measures were the cumulative hazard of relapse, 6-months confirmed disability accumulation, and 6-months confirmed disability improvement. Dr Izanne Roos (University of Melbourne, Australia) presented the results.
Included were 1,613 patients; 898 from MSBase and 715 from the Danish registry. Of these, 1,354 received treatment with ocrelizumab and 259 with rituximab. Over a mean follow-up of 1.5 years, the ARR ratio was higher in rituximab-treated patients, with a rate ratio of 1.8 (95% CI 1.4–2.4). ARR was 0.20 for rituximab versus 0.09 for ocrelizumab (P<0.01). The cumulative hazard of relapse was higher in the rituximab group (HR 2.8; 95% CI 1.46–2.96; P<0.001) but the cumulative hazard of disability accumulation was not different (HR 1.51; 95% CI 0.86–2.64; P<0.15). Follow-up was insufficient to draw definitive conclusions on disability outcomes. Results were confirmed in sensitivity analyses with an intention-to-treat design.
The comparative effectiveness of rituximab and ocrelizumab should be further evaluated in randomised, clinical, non-inferiority trials.
- Roos I, et al. A non-inferiority study of rituximab versus ocrelizumab in relapsing-remitting multiple sclerosis. Abstract O180, ECTRIMS 2022, 26–28 October, Amsterdam, Netherlands.
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Table of Contents: ECTRIMS 2022
Letter from the Editor
ECTRIMS 2022 Highlights Podcast
Diagnosis and Prediction of Disease Course
A case for including optic nerve lesions in the McDonald criteria
Cerebrospinal fluid kappa-free light chains for MS diagnosis
Early, non-disabling relapses increase disability accumulation
Physical impairment is present before perceived MS onset
Chronic active MS lesions respond poorly to anti-CD20 antibodies
Treatment: Trials & Strategies
Dimethyl fumarate reduces the risk of a first clinical event in RIS
How and when to make a timely switch to high-efficacy DMT
Comparing real-world effectiveness of DMTs
Study fails to show non-inferiority of rituximab to ocrelizumab
Autologous haematopoietic stem cell transplantation versus DMTs
Stem cell transplantation not superior to natalizumab in progressive MS
Efficacy of DMTs fades away in secondary progressive MS
Smartphone tapping can help detect progressive MS
Early treatment with DMT effective in paediatric-onset MS
Fingolimod in paediatric MS: results of up to 6 years
Switching treatment after initial platform injectable DMT: real-world data
Pregnancy and infant outcomes in women receiving ocrelizumab
New safety data of anti-CD20 mAbs around pregnancy
MS activity and pregnancy outcomes after long-term use of natalizumab
Ravulizumab significantly reduced relapses in AQP4+ NMOSD
NMOSD patients are cognitively impaired regardless of serostatus
Evidence-based consensus on pregnancy in NMOSD
COVID-19 and MS: lessons learned thus far
Ocrelizumab and fingolimod increase the risk of COVID-19 and of worse outcomes
Humoral and cellular immune responses after SARS-CoV-2 vaccination
Re-myelination strategies in MS still pose many unanswered questions
MS associated with a broader Epstein-Barr virus specific T-cell receptor repertoire
Cognitive rehab and mindfulness reduce cognitive complaints in MS
Top score poster: Meta-analysis on the effect of DMTs
Challenges in diagnosing and treating progressive MS
T2 lesions independently predict early conversion to SPMS