Efficacy and safety of recombinant human tumor necrosis factor-α receptor II IgG: Fc fusion protein for injection in Chinese patients with early rheumatoid arthritis and active spondyloarthritis

Abstract

Objective To evaluate the efficacy and safety of recombinant human tumor necrosis factor-α receptor Ⅱ IgG: Fc fusion protein for injection (rhTNFR: Fc) treatment in Chinese patients with early rheumatoid arthritis (ERA) and active spondyloarthritis. Methods This was a large-scale, multicenter, open-label, phase Ⅳ clinical observational study. The dosage of rhTNFR: Fc was 50 mg per week, combined or not combined with other drugs. The primary endpoint of efficacy included the proportion of patients with low disease activity [simplified disease activity index (SDAI) ≤11] at 3 month and 6 month. Secondary endpoint variables included clinical disease activity index (CDAI), disease activity score 28 based on C-reactive protein (DAS28-CRP) and health assessment questionnaire (HAQ). The primary endpoint of SpA was the ankylosing spondylitis disease activity score (ASDAS-CRP) at month 3. The secondary endpoints were the proportion of subjects achieving ASDAS<1.3 and ASDAS<2.1, Bath AS functional index (BASFI) and CRP. All subjects in the study were evaluated for safety. T test, χ2 test and rank sum test were used for satistical analysis. Results One thousand two hundred and seventy subjects with ERA were studied. The difference between the baseline and month 3 after treatment in SDAI, CDAI, DAS28-CRP were 26±16, 23±15, 1.86±1.01 respectively (P<0.01). The above parameters 6 months after treatment were similar to those at 3 months after treatment, which demonstrated the persistence of drug efficacy. Two thousand three hundred and twenty eight subjects of SpA were studied. The difference between the baseline and 3 months after treatment in ASDAS, BASFI was 2.6±1.7, 3.4±3.8 respectively (t=13 .54, t=42.36, P<0.01). The overall incidence of adverse events was 8.03%(289/3 598), including the common adverse events such as injection site reactions, skin rash and elevated liver enzyme levels. Adverse events were improved after proper treatment, without severe infections and tumor. These data confirmed that the overall safety of rhTNFR: Fc was good. Conclusion The study confirms that rhTNFR: Fc is effective for the treatment of ERA and SpA, and it is safe and well-tolerated. Key words: Arthritis, rheumatoid; Spondylitis, ankylosing; Recombinant human tumor necrosis factor-α receptor Ⅱ: IgG Fc fusion protein; Treatment outcome; Safety