Objective: To define the optimal dose of nimesulide (NIM) for treating psoriatic arthritis.
Methods: Eighty patients entered a 4-week, double-dummy, randomised, controlled study. Each patient was allocated to one of the following treatment groups: NIM 100 mg/day, NIM 200 mg/day, NIM 400 mg/day, or placebo. Primary end points for arthritis assessment were the scores for tender and swollen joints, and the physician's and patient's global assessment of efficacy.
Results: 76/80 patients completed the study. NIM decreased the score for tender and swollen joints from baseline to the end swollen joints from baseline to the end of therapy (p < 0.05). Pain severity on a visual analogue scale (VAS) was reduced by NIM 200 mg (p = 0.03) or NIM 400 mg (p = 0.019) compared to placebo, as was morning stiffness (p = 0.038 and p = 0.008, respectively), but the trends with 100 mg were not statistically significant. The investigators and patients assessed the global efficacy of the NIM 200 and 400 mg/day groups as better than placebo or NIM 100 mg. Side effects were observed in 12 patients (15%) during treatment. They were mostly mild, only one patient withdrew from the study as a result, and the trend for a higher incidence with NIM was not statistically significant. The Psoriasis Area Severity Index (PASI) and the ESR did not show any significant changes. Patients in the placebo group took more paracetamol per day compared with those in the NIM groups (p = 0.007).
Conclusions: Nimesulide 200 and 400 mg/day are effective and safe in psoriatic arthritis.