Tofacitinib versus methotrexate as the first-line disease-modifying antirheumatic drugs in the treatment of rheumatoid arthritis: An open-label randomized controlled trial.

OBJECTIVE: To compare tofacitinib and methotrexate (MTX) as first-line disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis (RA). METHODS: This 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. RESULTS: LDA 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. CONCLUSIONS: As 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.

Adverse Events Following COVISHIELD Vaccination Among Adult Population in Bangladesh.

The study aimed to determine how frequently the adverse events of the COVISHIELD vaccine occur among the Bangladeshi population. This cross-sectional study was conducted at Sheikh Russel Gastroliver Institute and Hospital, Mohakhali, Dhaka, Bangladesh, in May 2021. The inclusion criteria were the adult populations who received the 2nd dose of the COVISHELD vaccine and had passed 28 days following the completion of the 2nd dose. Three hundred and five persons fulfilling the inclusion criteria were asked over the telephone-based on a predesigned questionnaire. The rates of adverse events were 54.1% and 41.3% after the 1st and 2nd dose of vaccine, respectively, and the difference was statistically significant (p < 0.001). Pain at the injection site was the most common adverse event (32.5% following the 1st dose and 27.9% following the 2nd dose). All of the symptoms were mild and lasted for about 2 days. Age and comorbidities were significantly associated with the adverse events (p < 0.001). Neither doses had any vaccine-related life-threatening adverse event nor had any symptoms related to vaccine-related blood clotting. Nineteen persons (6.2%) had been diagnosed with COVID-19 after the 1st dose of vaccination, and three (1%) persons had been diagnosed with COVID-19 after the 2nd dose of vaccination. As no significant life-threatening adverse event was observed, this study might help reduce the hesitancy for vaccination among the population and thus help reduce transmission of this highly contagious virus.