Infections in patients with rheumatoid arthritis receiving tofacitinib versus tumour necrosis factor inhibitors: results from the open-label, randomised controlled ORAL Surveillance trial. Issue 11 (3rd August 2022)

• Record Type: Journal Article
• Authors: Balanescu, Andra-Rodica; Citera, Gustavo; Pascual-Ramos, Virginia; Bhatt, Deepak L; Connell, Carol A; Gold, David; Chen, All-Shine; Sawyerr, Gosford; Shapiro, Andrea B; Pope, Janet E; Schulze-Koops, Hendrik
• Is Part Of: Annals of the rheumatic diseases. Volume 81:Issue 11(2022)
• Page Start: 1491
• Page End: 1503
• Publication Date: 2022-08-03
• Subjects: antirheumatic agents -- arthritis, rheumatoid -- therapeutics -- tumor necrosis factor inhibitors; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/ard-2022-222405
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Objectives: To characterise infections in patients with rheumatoid arthritis (RA) in ORAL Surveillance. Methods: In this open-label, randomised controlled trial, patients with RA aged≥50 years with ≥1 additional cardiovascular risk factor received tofacitinib 5 or 10 mg two times per day or a tumour necrosis factor inhibitor (TNFi). Incidence rates (IRs; patients with first events/100 patient-years) and hazard ratios (HRs) were calculated for infections, overall and by age (50–<65 years; ≥65 years). Probabilities of infections were obtained (Kaplan-Meier estimates). Cox modelling identified infection risk factors. Results: IRs/HRs for all infections, serious infection events (SIEs) and non-serious infections (NSIs) were higher with tofacitinib (10>5 mg two times per day) versus TNFi. For SIEs, HR (95% CI) for tofacitinib 5 and 10 mg two times per day versus TNFi, respectively, were 1.17 (0.92 to 1.50) and 1.48 (1.17 to 1.87). Increased IRs/HRs for all infections and SIEs with tofacitinib 10 mg two times per day versus TNFi were more pronounced in patients aged≥65 vs 50–<65 years. SIE probability increased from month 18 and before month 6 with tofacitinib 5 and 10 mg two times per day versus TNFi, respectively. NSI probability increased before month 6 with both tofacitinib doses versus TNFi. Across treatments, the most predictive risk factors for SIEs were increasing age, baseline opioid use, history of chronic lung disease and time-dependent oral corticosteroid use, and, for NSIs, female sex, history of chronic lung disease/infections, past smoking and time-dependent Disease Activity Score in 28 joints, C-reactive protein. Conclusions: Infections were higher with tofacitinib versus TNFi. Findings may inform future treatment decisions. Trial registration number: NCT02092467 .