Vasculitis & polymyalgia rheumatica
Rituximab versus azathioprine for maintenance of remission for patients with ANCA-associated vasculitis and relapsing disease: an international randomised controlled trial
Primary result · Time to disease relapseResult — go to the resultHazard ratio 0.41 95% CI 0.27–0.61Authors' conclusion
Following induction of remission with rituximab, fixed-interval, repeat-dose rituximab was superior to azathioprine for preventing disease relapse in patients with AAV with a prior history of relapse.
Study context
- Population
- Patients with relapsing antibody-associated vasculitis (AAV) in whom remission was reinduced with rituximab and GC, 29 centres in seven countries, April 2013–November 201685 per arm randomised
- Participants
- 188 patients
- Comparison
- Repeat-dose rituximab vs daily oral azathioprine for maintenance after rituximab reinduction
- Rituximabn = 85
- Azathioprinen = 85reference
- Primary endpoint
- Time to disease relapse (either major or minor relapse)
Methodological detailsinternational, open-label, superiority, Minimum follow-up 36 months
- International
- Open-label
- Superiority
- Minimum follow-up 36 months
Primary result
Time to disease relapse
Hazard ratio
0.41
95% CI 0.27–0.61
P < 0.001
Rituximabvs Azathioprine
HR 0.41 (95% CI 0.27–0.61); P < 0.001
As reported in the abstract
Safety
At least one serious adverse event during the treatment period
Hypogammaglobulinaemia or infection
- No differences in rates between groups
Original publication
Rituximab versus azathioprine for maintenance of remission for patients with ANCA-associated vasculitis and relapsing disease: an international randomised controlled trial. Ann Rheum Dis. Published 23 March 2023. doi:10.
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