A randomized placebo-controlled trial of MTX in PsA
Kingsley GH et al. – This trial of active PsA found no evidence for MTX improving synovitis and consequently raises questions about its classification as a disease–modifying drug in PsA.Methods
- A 6–month double–blind randomized placebo–controlled trial (RCT) compared MTX (15 mg/week) with placebo in active PsA.
- The primary outcome was PsA response criteria (PsARC).
- Other outcomes included ACR20, DAS–28 and their individual components.
- Missing data were imputed using multiple imputation methods.
- Treatments were compared using logistic regression analysis (adjusted for age, sex, disease duration and, where appropriate, individual baseline scores).
- Four hundred and sixty–two patients were screened and 221 recruited.
- One hundred and nine patients received MTX and 112 received placebo.
- Forty–four patients were lost to follow–up (21 MTX, 23 placebo).
- Twenty–six patients discontinued treatment (14 MTX, 12 placebo).
- Comparing MTX with placebo in all randomized patients at 6 months showed no significant effect on PsARC [odds ratio (OR) 1.77, 95% CI 0.97, 3.23], ACR20 (OR 2.00, 95% CI 0.65, 6.22) or DAS–28 (OR 1.70, 95% CI 0.90, 3.17).
- There were also no significant treatment effects on tender and swollen joint counts, ESR, CRP, HAQ and pain.
- The only benefits of MTX were reductions in patient and assessor global scores and skin scores at 6 months (P = 0.03, P < 0.001 and P = 0.02, respectively).
- There were no unexpected adverse events.