Background Rheumatoid arthritis (RA) is characterized by chronic autoimmune diseases of progressive synovitis and joint destruction, which can eventually lead to joint deformation and disability. A number of clinical studies showed the effectiveness of tumor necrosis factor antagonist combined with methotrexate in the treatment of RA. Yisaipu used in this study is produced by CPGC Company (Shanghai, China), which was approved to treat RA by Chinese Food and Drug Administration, in 2005, which is biosimilar of etanercept (a soluble recombinant human receptor antibody fusion protein, an immunoglobulin molecule which connects two TNF receptors (p75) to the human IgG1 FC division). Etanercept had been confirmed the effectiveness in rheumatoid arthritis already in many clinical trial.5–8 However, there is rare randomized control study published regarding Yisaipu in international journals. We conducted an open-label, randomized controlled study for 24 weeks to evaluate the efficacy and safety of Yisaipu in combination with DMARDs in comparison with low or medium dose of glucocorticoid in patients with moderate to severe RA.
Objectives to evaluate the efficacy and safety of Yisaipu in combination with DMARDs in comparison with low or medium dose of glucocorticoid in patients with moderate to severe RA.
Methods Eighty four patients with moderate to severe rheumatoid arthritis were randomly assigned into 4 groups: group 1: methotrexate plus Yisaipu; group 2: methotrexate plus medium-dose prednisone (30mg/d, reduced to 15 mg/d after 2 weeks); group 3: methotrexate plus low-dose prednisone (prednisone 7.5mg/d); group 4: methotrexate alone. Each group was treated with MTX (12.5mg once weekly, the next day with folic acid 10mg) and hydroxychloroquine sulfate (200 mg twice a day) concomitantly. The primary endpoint was ACR20 response rate at week 24. Secondary efficacy endpoints were ACR20, ACR50, ACR70, DAS-28, Health Assessment Questionnaire (HAQ) and EULAR remission rate at week 4, 12 and 24.
Results At week 24, a higher proportion of patients in the group 1and group 2 than the other two groups met the ACR20 response criteria (85.7% in group 1 and 71.4% in group 2 vs. group 3 and group 4, P<0.05). The reductions of HAQ at week 24 showed significant improvement in group 1 and group 2 compared to group 3 and 4 (-2.96 and -2.69 respectively, P<0.05). Reduction of DAS-28 in group 1 and group 2 were significantly higher than the other two groups (P<0.05). The percentage of EULAR remission rate of group 1 and group 2 is significantly higher than group 3 and group 4 at week 24 (47.6% in group 1, 33.3% in group 2, 23.8% in group 3 and 14.3% in group 4, P<0.05). There were no significant differences of adverse event among four groups.
Conclusions Yisaipu plus MTX or GCs plus MTX in Chinese patients with moderate to severe RA is safe and effective in our study. More studies are needed to compare the long-term safety and cost-effectiveness between Yisaipu and GCs in treatment with RA.
Disclosure of Interest None declared