Affiliation:
1. Department of Rheumatology Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
2. Department of Rheumatology Mymensingh Medical College Hospital Mymensingh Bangladesh
3. Department of Rheumatology Dhaka Medical College Hospital Dhaka Bangladesh
4. Department of Rheumatology Chittagong Medical College Hospital Chittagong Bangladesh
5. Department of Rheumatology Combined Military Hospital Dhaka Bangladesh
6. Green Life Center for Rheumatic Care and Research Dhaka Bangladesh
Abstract
AbstractObjectiveTo compare tofacitinib and methotrexate (MTX) as first‐line disease‐modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis (RA).MethodsThis open‐label, randomized controlled, parallel‐group, 3‐month trial randomly assigned 100 RA patients to tofacitinib 10 mg daily (49 patients) or MTX 25 mg subcutaneously weekly (51 patients). The primary end point was low disease activity (LDA) measured with Disease Activity Score‐28 with C‐reactive protein (DAS28‐CRP), and the secondary end point was LDA and remission measured by DAS28‐erythrocyte sedimentation rate (ESR), Clinical Disease Activity Index (CDAI), and Simplified Disease Activity Index (SDAI). Health Assessment Questionnaire Disability Index (HAQ‐DI) response and mean reduction of core set of outcomes from baseline at 12 weeks were also analyzed as secondary end points. In addition, acute‐phase reactants and composite measurements among groups were examined.ResultsLDA in DAS28‐CRP was achieved in 17 (34.7%) tofacitinib patients and 18 (35.3%) MTX patients (p = .95). Fourteen (28.6%) and 11 (21.6%) tofacitinib and MTX patients, respectively, achieved LDA by DAS28‐ESR (p = .42). Tofacitinib and MTX groups achieved LDA similarly in CDAI (36.7% against 37.3%; p = .96) and SDAI (38.8% vs. 39.2%; p = .96). There was no significant difference in achieving remission between the groups. At 12 weeks, tofacitinib reduced ESR and CRP (p < .05). Composite measures and functional status decreased within groups but not between groups (p > .05). Five (13.51%) tofacitinib patients developed hypertension. MTX caused gastrointestinal problems in 12 (30%) individuals. Two MTX (5%) and two tofacitinib (5.4%) patients had increased liver enzymes and renal impairment, respectively. Tofacitinib had 5.4% infection compared with 5% for MTX.ConclusionsAs tofacitinib may be more effective than MTX according to previous reports such as the ORAL Start study, high‐dose MTX (25 mg/week, subcutaneously) used in this study may be as efficacious as tofacitinib in patients with established RA who were DMARD naive or had not received a therapeutic dose of DMARDs. However, adverse effects differed between groups.Registered on: ClinicalTrials.gov; ID: NCT04464642.
Reference17 articles.
1. Systematic Review of Tofacitinib: A New Drug for the Management of Rheumatoid Arthritis
2. Improved health‐related quality of life with effective disease‐modifying anti‐rheumatic drugs: evidence from randomized controlled trials;Strand V;Am J Manag Care,2007
3. Risk factors for oral methotrexate failure in patients with inflammatory polyarthritis: results from a UK prospective cohort study
4. Patient, disease, and therapy‐related factors that influence discontinuation of disease‐modifying anti‐rheumatic drugs: a population‐based incidence cohort of patients with rheumatoid arthritis;Maradit‐Kremers H;J Rheumatol,2006
Cited by
2 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献