ReviewRheumatology and therapy2021
Update on the Safety Profile of Tofacitinib in Rheumatoid Arthritis from Clinical Trials to Real-World Studies: A Narrative Review.
Review in Rheumatology and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.
- The incidence of opportunistic infections in patients with psoriatic arthritis treated with biologic and targeted synthetic agents: A systematic review and meta-analysis.Frontiers in pharmacology · 2022Pooled it
- Article
- Safety of Sarilumab in the treatment of rheumatoid arthritis: a real-world study based on the FAERS database.Frontiers in medicine · 2025Article
- Review
- Janus kinase inhibitors and tumour necrosis factor inhibitors show a favourable safety profile and similar persistence in rheumatoid arthritis, psoriatic arthritis and spondyloarthritis: real-world data from the BIOBADASER registry.Annals of the rheumatic diseases · 2024Article
- Seronegative cutaneous rheumatoid nodules with positive response to tofacitinib.JAAD case reports · 2024Article
- Comparative effectiveness of baricitinib and alternative biological DMARDs in a Swiss cohort study of patients with RA.BMJ open · 2024Observational
- The Saudi consensus recommendations for the management of psoriatic arthritis (2023).Clinical rheumatology · 2024Review
- Review
- Pharmacological strategies for mitigating anti-TNF biologic immunogenicity in rheumatoid arthritis patients.Current opinion in pharmacology · 2023Review
- JAK inhibitors and risk of major cardiovascular events or venous thromboembolism: a self-controlled case series study.European journal of clinical pharmacology · 2022Article
- Therapeutic potential of pyrrole and pyrrolidine analogs: an update.Molecular diversity · 2022Review
- [Recent research on tofacitinib in the treatment of pediatric rheumatic diseases].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2022Review
- Oral Tofacitinib and Systemic Corticosteroids, Alone or in Combination, in Patients With Moderate-to-Severe Alopecia Areata: A Retrospective Study.Frontiers in medicine · 2022Article
- Is Tofacitinib Effectiveness in Patients with Rheumatoid Arthritis Better After Conventional Than After Biological Therapy? - A Cohort Study in a Colombian Population.Biologics : targets & therapy · 2022Article
- Real-life experience of tofacitinib in patients with treatment-resistant rheumatoid arthritis: A 5-year follow-up: Monocentric experience.Northern clinics of Istanbul · 2022Article
- Alopecia Areata: an Update on Etiopathogenesis, Diagnosis, and Management.Clinical reviews in allergy & immunology · 2021Review
- JAK inhibitors for asthma.The Journal of allergy and clinical immunology · 2021Review
- Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study.Rheumatology and therapy · 2021Article
- Tofacitinib downregulates antiviral immune defence in keratinocytes and reduces T cell activation.Arthritis research & therapy · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Tofacitinib is approved for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who do not respond adequately or are intolerant to one or more disease-modifying anti-rheumatic drugs. The tofacitinib RA clinical development program included randomized controlled trials of 6-24-month duration and long-term extension studies with > 7061 patients and 22,875 patient-years of exposure. To date, there are no data from other randomized studies in patients with cardiovascular risk factors comparing the long-term safety of a JAK inhibitor versus an anti-TNF. Real-world studies are necessary to complete the body of evidence supporting the effectiveness and safety of a therapeutic agent. In the case of tofacitinib, real-world data derive from health insurance claims databases, registries (US Corrona Registry, Swiss Registry, and others), national pharmacovigilance programs, and hospital databases (case series). The present article provides complete and up-to-date information on the safety profile of tofacitinib in RA, from clinical trials to real-world studies. Tofacitinib has demonstrated a consistent safety profile during up to 9.5 years of experience in randomized controlled trials and long-term extension studies. Real-world evidence has not added new safety issues with respect to those found in the clinical program. In general, the safety profile of tofacitinib is consistent with that of biologic disease-modifying anti-rheumatic drugs, with an increased risk of herpes zoster that seems to be a class effect of Janus kinase inhibitors. The continuous follow-up of therapeutic agents to treat rheumatoid arthritis is needed to adequately establish the safety profile for new mechanisms of action and potential risks associated with their longer term use.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.