Lupus & antiphospholipid syndrome
Efficacy and safety of obinutuzumab β in patients with active systemic lupus erythematosus: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial
Primary result · Proportion of patients with an SLE Responder Index (SRI)-4 responseResult — go to the resultAdjusted risk difference 19 percentage points 95% CI 3–36Authors' conclusion
Obinutuzumab β plus standard therapy improved SRI-4 response at week 12 in Chinese patients with active SLE, with a generally manageable safety profile over 52 weeks. These phase 2 findings support further evaluation and longer-term safety follow-up.
Study context
- Population
- Patients aged 18–80 years fulfilling the 2019 European Alliance of Associations for Rheumatology-American College of Rheumatology classification criteria for systemic lupus erythematosus (SLE) with active disease (SLEDAI-2K score of 8 or more and positivity for antinuclear antibodies or anti-double stranded DNA antibodies), 30 tertiary hospitals in Chinarandomly assigned, included in both the full analysis set and safety analysis sets, 171 patients screened
- Participants
- 123 patients
- Comparison
- Obinutuzumab β vs placebo, with background standard therapy
- OBINUTUZUMAB βn = 61
- PLACEBOn = 62
- Primary endpoint
- Proportion of patients with an SLE Responder Index (SRI)-4 response
- Follow-up
- Week 12
Methodological detailsstratified by SLEDAI-2K score and 24-h urine protein level, 1:1 allocation
- Stratified by SLEDAI-2K score and 24-h urine protein level
- 1:1 allocation
Primary result
As reported in the abstract
Adjusted risk difference
19 percentage points
95% CI 3–36
P = 0.022
Events by treatment group
OBINUTUZUMAB βvs PLACEBO
adjusted risk difference 19 percentage points (95% CI 3–36); P = 0.022
Safety
Serious adverse events · 52 weeks
Fatal treatment-emergent adverse event
- One fatal treatment-emergent adverse event (sepsis) occurred in the placebo group
Original publication
Efficacy and safety of obinutuzumab β in patients with active systemic lupus erythematosus: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Rheumatol. Published 8 November 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →