Trial reportAnnals of the rheumatic diseases2022
Infections in patients with rheumatoid arthritis receiving tofacitinib versus tumour necrosis factor inhibitors: results from the open-label, randomised controlled ORAL Surveillance trial.
Trial report in Annals of the rheumatic diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02092467 (PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR), which is not on this map. Cited by 39 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 3b/4 randomized safety endpoint study of 2 doses of tofacitinib in comparison to a tumor necrosis factor (tnf) inhibitor in subjects with rheumatoid arthritis
Who cites it
39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 64 citations in OpenAlex.
- Large-scale meta-analysis of infection risk with JAK-STAT inhibitors in 29,000 patients.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Pooled it
- Infection risks associated with b/tsDMARDs in rheumatoid arthritis: a systematic review and network meta-analysis.European journal of clinical pharmacology · 2026Pooled it
- Trial
- Risk of major adverse cardiovascular events with tofacitinib versus tumour necrosis factor inhibitors in patients with rheumatoid arthritis with or without a history of atherosclerotic cardiovascular disease: a post hoc analysis from ORAL Surveillance.Annals of the rheumatic diseases · 2023Trial
- Therapeutics in Axial Spondyloarthritis: A Review of What Works - SPARTAN 2026 Annual Meeting Proceedings.Current rheumatology reports · 2026Review
- Tofacitinib safety in inflammatory bowel disease: a disproportionality analysis of the FDA adverse event reporting system.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- From Convenience to Clinical Efficacy: Selective TYK2 Inhibition in Psoriasis and the Evolving Role of Next-Generation Oral Targeted Therapies.Pharmaceutics · 2026Review
- Long-Term Real-World Evaluation of Abrocitinib in Moderate-to-Severe Atopic Dermatitis Across a Diverse Patient Population in a Multi-site Hospital System.American journal of clinical dermatology · 2026Observational
- Risk Factors for Major Adverse Cardiovascular Events, Malignancies, and Serious Infections With Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of a 3-Year J-Post-Marketing Surveillance.International journal of rheumatic diseases · 2026Article
- From concept to practice: real-world safety of JAK inhibitors in rheumatoid arthritis treatment.Frontiers in medicine · 2026Review
- Glucocorticoid reduction with baricitinib in rheumatoid arthritis refractory to prior therapies: a 24-week real-world analysis.Frontiers in medicine · 2026Article
- Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease.Advances in therapy · 2025Article
- Changes in NK Cells and Exhausted Th Cell Phenotype in RA Patients Treated with Janus Kinase Inhibitors: Implications for Adverse Effects.International journal of molecular sciences · 2025Article
- The Dual-Edged Sword: Risks and Benefits of JAK Inhibitors in Infections.Pathogens (Basel, Switzerland) · 2025Review
- JAK-STAT pathway, type I/II cytokines, and new potential therapeutic strategy for autoimmune bullous diseases: update on pemphigus vulgaris and bullous pemphigoid.Frontiers in immunology · 2025Review
- Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis.Advances in rheumatology (London, England) · 2024Article
- Tofacitinib Safety and Effectiveness in Canadian Patients with Rheumatoid Arthritis by Cardiovascular Risk Enrichment: Subanalysis of the CANTORAL Study.Rheumatology and therapy · 2024Article
- Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib.Arthritis research & therapy · 2024Article
- Biologics Versus JAK Inhibitors. Part II: Risk of Infections. A Narrative Review.Dermatology and therapy · 2024Review
- JAK Inhibitors in Rheumatoid Arthritis: Immunomodulatory Properties and Clinical Efficacy.International journal of molecular sciences · 2024Review
Corrections and comments
- Erratum issued
Authors and funding
11 authors at 8 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo characterise infections in patients with rheumatoid arthritis (RA) in ORAL Surveillance.
methodsIn 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.
resultsIRs/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.
conclusionsInfections were higher with tofacitinib versus TNFi. Findings may inform future treatment decisions. TRIAL REGISTRATION NUMBER: NCT02092467.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.