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Efficacy and Safety of Opinercept Tumor Necrosis Factor Inhibitor Therapy for Drug-Refractory Rheumatoid Arthritis: A Randomized Clinical Trial
- Source :
- Arch Rheumatol
- Publication Year :
- 2020
- Publisher :
- Turkish League Against Rheumatism, 2020.
-
Abstract
- 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
- Subjects :
- 030203 arthritis & rheumatology
musculoskeletal diseases
medicine.medical_specialty
medicine.diagnostic_test
business.industry
Incidence (epidemiology)
medicine.disease
Placebo
Rheumatology
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
Refractory
law
Internal medicine
Rheumatoid arthritis
Erythrocyte sedimentation rate
medicine
Original Article
030212 general & internal medicine
business
Adverse effect
skin and connective tissue diseases
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Arch Rheumatol
- Accession number :
- edsair.doi.dedup.....0370e3e335a1656b036d2c5ae97370ac