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.

AL amyloidosis presenting as inflammatory polyarthritis: a case report.

Amyloidosis is a condition characterised by extracellular tissue deposition of fibrils causing a wide range of clinical manifestations. This protein deposition can occur in any tissue, most commonly in the kidney, heart, skin, peripheral nervous system, and gastrointestinal tract. However, the deposition of amyloid fibrils in the synovium is seldom reported. Musculoskeletal manifestations are subtle, subclinical and rarely the patient presents with symptoms that resemble rheumatic diseases. Here, we describe a 55-year-old man with AL (amyloid light chain) amyloidosis who presented with inflammatory polyarthritis with significant morning stiffness, inflammatory low back pain, and painful thickened tongue. The patient had anaemia, macroglossia with lateral scalloping of the tongue, papules, and plaques in the periocular, perioral and perinasal area, bilateral carpal tunnel syndrome, localised soft tissue swelling over the joints, restricted movement in different joints with flexion contractures in some joints. Rheumatoid factor and ACPA were negative and the X-ray of the sacroiliac joints was normal. We confirmed amyloidosis by biopsy of an affected skin lesion. In the urine, no Bence Jones protein was found and bone marrow study and x-ray of the skull were normal. Plasma immuno-electrophoresis and serum free light chain (FLC) assay confirmed lambda light chain type monoclonal gammopathy. Take home message: Although AL amyloidosis is a rare condition, it should be considered while evaluating atypical symptoms in patients presenting with rheumatic complaints. A high index of suspicion is necessary for proper diagnosis as delay in diagnosis will yield a poorer treatment outcome.