Trial reportRMD open2022
Waiting for JAK inhibitor safety data.
Trial report in RMD open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 4 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
38 citing papers in PubMed, 4 syntheses or guidelines pooled it, 85 citations in OpenAlex.
- Considerations for establishing occupational exposure limits for small molecule kinase inhibitors in drug development.Frontiers in toxicology · 2026Pooled it
- Efficacy and safety of upadacitinib in the treatment of moderate-to-severe atopic dermatitis: A systematic review.PloS one · 2024Pooled it
- Janus kinase inhibitors in atopic dermatitis: an umbrella review of meta-analyses.Frontiers in immunology · 2024Pooled it
- Different biologics for biological-naïve patients with psoriatic arthritis: a systematic review and network meta-analysis.Frontiers in pharmacology · 2024Pooled it
- A phase 2a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy and safety of NuGel, a novel topical GPCR19-mediated inflammasome inhibitor, in patients with mild to moderate atopic dermatitis: a proof-of-concept study withFrontiers in immunology · 2025Trial
- Trial
- Trial
- Review
- Tumor safety of biologic agents and targeted therapies in immune-mediated inflammatory arthritides.Frontiers in immunology · 2026Review
- Beyond a gatekeeper: the non-classical signaling role of STRA6 in driving endothelial senescence and atherosclerosis.Frontiers in immunology · 2026Review
- Practical considerations for managing patients being treated with topical roflumilast.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2026Review
- Safety evaluation of deucravacitinib: a real-world analysis based on the FDA adverse event reporting system database.International journal of clinical pharmacy · 2025Article
- Expanding the Scope of PROTACs: Opportunities and Challenges in Topical Delivery.Journal of medicinal chemistry · 2025Review
- Cardiovascular Safety of COVID-19 Treatments: A Disproportionality Analysis of Adverse Event Reports from the WHO VigiBase.Infectious diseases and therapy · 2025Article
- Neurological Adverse Events Associated with the Use of Janus Kinase Inhibitors: A Pharmacovigilance Study Based on Vigibase.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Investigating associations between JAK inhibition and venous thromboembolism by systematic mining of large-scale datasets.Inflammopharmacology · 2025Article
- Recent advances in AI-based toxicity prediction for drug discovery.Frontiers in chemistry · 2025Review
- Practical Recommendations on Laboratory Monitoring in Patients with Atopic Dermatitis on Oral JAK Inhibitors.Dermatology and therapy · 2024Article
- Safety Profile of Upadacitinib up to 5 Years in Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis: An Integrated Analysis of Clinical Trials.Rheumatology and therapy · 2024Article
- Changes in Characteristics of Patients Initiating and Discontinuing Advanced Therapies for Rheumatoid Arthritis Following the Release of Safety Data.Arthritis care & research · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The US Food and Drug Administration (FDA) has recently added a new 'black box warning' on all currently approved Janus kinase (JAK) inhibitors indicated for the treatment of arthritis and other inflammatory conditions based on results from the ORAL Surveillance study of tofacitinib versus tumour necrosis factor alpha inhibitors in rheumatoid arthritis. This is a warning difficult to ignore because the data, being from a randomised controlled trial, are of high fidelity and hard to reproach. It is especially problematic because safety data for all the other JAK inhibitors will be pending for several years. So how might we proceed, without being bound by our stasis? The lack of absolute certainty seems to require a pragmatic approach to the routine care use of JAK inhibitors. The patients who were at greatest risk were older and had other risk factors for the corresponding adverse events, in keeping with effect modification. This highlights the need to focus on risk stratification when tailoring therapy. In this viewpoint, we propose a simple illustration to guide clinical decision-making. First, identify general risk factors for venous thromboembolic event (VTE), major adverse cardiac event (MACE) and cancer (age>65 years and smoking) and whether there is a previous history of VTE, MACE or cancer. Then, evaluate risk based on the number of other risk factors for VTE and the number of other risk factors for MACE. Ultimately, 'treat-to-target' will in the end always be 'treat-to-agreement'. As we have done in the past, and will do in the future, the optimal treatment strategy will have to be tailored based on individual patient risk factors and preferences in a shared-decision process.
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.