Abstract
This study evaluates upadacitinib (UPA) effectiveness and drug retention rate (DRR) in patients with rheumatoid arthritis (RA). Multicentre prospective observational study. Consecutive patients with RA receiving UPA were evaluated at 0, 3, 6, 12, 18, and 24 months of treatment. Key outcomes included UPA DRR and changes in clinical and serological measures over time. The study included 215 patients (72.6% female sex, mean age 60.1 ± 11.7 years). The DRR of UPA was 91.6% (95% CI 88.0-95.4%) at 6 months, 84.6% (95% CI 79.8-89.7%) at 12 months, 80.3% (95% CI 75.0-86.0%) at 18 months and 80% (95% CI 75.0-86.0%) at 24 months. UPA DRR was similar between monotherapy and methotrexate combination (p = 0.47), and across different treatment lines (p = 0.58). A statistically significant improvement from baseline was observed over 24 months considering erythrocyte sedimentation rate, C-reactive protein (CRP), Health Assessment Questionnaire (HAQ), Disease Activity Score (DAS)28-CRP, Physician's (Ph) and Patient's (Pt) Global Assessment (GA), Visual Analogue Scale (VAS) Pain, Simplified and Clinical Disease Activity Index (SDAI and CDAI) (p < 0.00 for all of them). Patients discontinuing UPA were more likely to be male (p = 0.02), with a longer disease duration (p = 0.03), higher baseline values of VAS Pain (p < 0.00), PtGA (p < 0.00), PhGA (p < 0.00), CDAI (p < 0.00), SDAI (p < 0.00) and corticosteroid dosage (p = 0.04). This study confirms UPA effectiveness in managing RA in the real-world practice, demonstrating sustained drug retention and improvements in clinical and laboratory measures over time. Also, UPA could be a valuable option for patients with multi-refractory RA and when monotherapy is preferred.