EFFICACY OF ETANERCEPT COMPARED WITH METHOTREXATE IN RHEUMATOID ARTHRITIS: A TWO-YEAR OBSERVATIONAL COHORT STUDY AT A TERTIARY RHEUMATOLOGY CENTRE IN ALBANIA

Background: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterised by persistent symmetrical synovitis that, if inadequately treated, leads to progressive joint destruction and disability. Tumour necrosis factor (TNF)-α inhibitors such as etanercept are recommended after failure of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Real-world data from South-Eastern Europe are scarce. We compared the effectiveness and tolerability of etanercept with those of methotrexate (MTX) in routine clinical practice Methods: Observational cohort study with a retrospective component, conducted at the Rheumatology Service of the University Hospital Center “Mother Teresa”, Tirana, from March 2021 to March 2023. Eighty-one adults with RA were included: 52 treated with etanercept and 29 treated with MTX. Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and the 28-joint Disease Activity Score (DAS28) were recorded at baseline, mid-treatment and end of follow-up. Within-group and between-group differences were assessed with the Wilcoxon signed-rank and Mann–Whitney U tests; associations were explored with correlation and linear regression analysis. Results: Mean age was 49.2 ± 12.5 years (etanercept) and 46.5 ± 11.1 years (MTX); 69% of patients in both groups were women. Mean disease duration in the etanercept group was 8.1 ± 3.6 years. In the etanercept group, mean ESR fell from 32.6 to 10.8 mm/h, CRP from 15.2 to 3.1 mg/L and DAS28 from 6.12 to 3.22 (all p < 0.01). In the MTX group the corresponding reductions were smaller (ESR 30.7 → 18.0 mm/h; CRP 13.7 → 8.2 mg/L; DAS28 6.07 → 3.94). End-of-study ESR, CRP and DAS28 were significantly lower with etanercept than with MTX (p = 0.001 for each). No patient on etanercept remained in high disease activity at the end of follow-up, compared with 31.1% on MTX. Longer etanercept exposure was associated with lower final DAS28 (B = −0.129 per month; p = 0.002). No serious adverse events were recorded. Conclusions: In this real-world cohort, etanercept achieved greater reductions in inflammatory markers and disease activity than MTX and was well tolerated. DAS28 proved a practical tool for monitoring response to anti-TNF therapy.