Concomitant iguratimod therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate: a randomized, double-blind, placebo-controlled trial
Modern Rheumatology, 07/31/2012
Ishiguro N et al. – The study results suggest that iguratimod in combination with methotrexate (MTX) was efficacious and had a manageable safety profile.Methods
- In this multicenter, double-blind, controlled trial, a total of 253 patients were randomized at 2:1 ratio to either the iguratimod group or the placebo group.
- Iguratimod was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for the subsequent 20 weeks (25 mg twice daily).
- MTX at dosage of 6 or 8 mg/week was administered to patients in both groups.
- The rate of 20 % improvement in American College of Rheumatology criteria (ACR20) at week 24 was 69.5 % in the iguratimod group compared with 30.7 % in the placebo group (P < 0.001).
- Significant improvements in the ACR50, ACR70, Health Assessment Questionnaire Disability Index, Disease Activity Score 28 <3.2, and rheumatoid factor were also observed.
- The most commonly reported adverse events (AEs) were blood iron decrease, nasopharyngitis, and lymphocyte decrease.
- These AEs were mild or moderate in severity.
- No deaths occurred.