Efficacy and Safety of Opinercept Tumor Necrosis Factor Inhibitor Therapy for Drug-Refractory Rheumatoid Arthritis: A Randomized Clinical Trial
Toong-Hua LIANG1, Chyou-Shen LEE2, Shinn-Shing LEE3, Chien-Sheng WU4, Kun-Hung CHEN5, Ping-Ning HSU6, Hsiao-Yi LIN7
1Department of Internal Medicine, Taipei City Hospital Renai Branch, Taipei, Taiwan
2Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
3Department of Internal Medicine, Cheng Hsin General Hospital, Taipei, Taiwan
4Department of Internal Medicine, Far Eastern Memorial Hospital, Taipei, Taiwan
5Division of Rheumatology and Immunology, Cathay General Hospital, Taipei, Taiwan
6National Taiwan University, Graduate Institute of Immunology, College of Medicine, Taipei, Taiwan
7Department of Medicine, Cheng Hsin General Hospital, Taipei, Taiwan
Keywords: Clinical trial, disease-modifying anti-rheumatic drugs, opinercept, rheumatoid arthritis
Objectives: This study aims to evaluate the efficacy and safety profile of opinercept for rheumatoid arthritis (RA) patients undergoing disease- modifying anti-rheumatic drugs (DMARDs) therapy.
Patients and methods: A total of 98 patients with active RA (17 males, 81 females; mean age 58.6±12.2 years; range, 24.3 to 85.3 years) were randomized into opinercept plus DMARDs (OD group) or placebo plus DMARDs (PD group), in a 24-week treatment period. Primary outcome was American College of Rheumatology score (ACR20) at week 24. Other exploratory endpoints included ACR50, ACR70 and disease activity score-28 (DAS28) at week 12 and 24, tender/swollen joint counts, pain, Health Assessment Questionnaire-Disability Index, erythrocyte sedimentation rate, and C-reactive protein level. Incidence of adverse events (AEs), vital signs and physical findings, and laboratory test results were also evaluated.
Results: Patients in OD group showed significantly higher achievement percentage of ACR20 at week 24 than the PD group (76.6% vs. 30.3%, p<0.001). The evaluation of DAS28 was significantly improved in OD patients compared to PD patients at weeks 12 and 24. Most of the occurred AEs were mild or moderate and considered unrelated to study treatments.
Conclusion: Opinercept concurrent with DMARDs was superior to DMARDs alone in slowing RA progression and ameliorating symptoms, with well- tolerated and acceptable safety profile.