The effect of rituximab on patient reported outcomes in the preclinical phase of rheumatoid arthritis: 2 year data from the PRAIRI study
Authors' conclusion
One single dose of RTX plus MP administered to RA-risk individuals does not have a meaningful and measurable positive effect on PROs after 2 years of follow-up and/or perceived disease severity at the time of arthritis development.
Study context
- Population
- Seropositive individuals at risk of developing RA (RA-risk) in the preclinical phase
- Participants
- 78 individuals
- Comparison
- Single dose of rituximab (RTX) 1000 mg vs placebo (PBO), both with methylprednisolone (MP) 100 mg and anti-histamines
- Primary endpoint
- Patient-reported outcomes (PROs): VAS pain, health assessment questionnaire disability index (HAQ-DI), EQ-5D, SF-36 physical and mental component scores
- Follow-up
- 24 months
Methodological detailsdouble-blind, placebo-controlled
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
PRO scores, RTX vs PBO
Mean difference
0.07
HAQ score; SEM 0.16
Mean difference
−0.02
EQ-5D; SEM 0.05
Mean difference
11.11
Visual analogue scale (VAS) pain; SEM 7.40
Further findings
Perceived arthritis severity at time of clinically manifest arthritis
- No significant effect of treatment
Original publication
The effect of rituximab on patient reported outcomes in the preclinical phase of rheumatoid arthritis: 2 year data from the PRAIRI study. RMD Open. Published 18 October 2024. doi:10.
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