ReviewDrug safety2021
Upadacitinib in Rheumatoid Arthritis: A Benefit-Risk Assessment Across a Phase III Program.
Review in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 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
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.
- Safety of Upadacitinib in Immune-Mediated Inflammatory Diseases: Systematic Literature Review of Indirect and Direct Treatment Comparisons of Randomized Controlled Trials.Advances in therapy · 2024Pooled it
- Trial
- Tofacitinib for the Treatment of Ulcerative Colitis: An Integrated Summary of up to 7.8 Years of Safety Data from the Global Clinical Programme.Journal of Crohn's & colitis · 2023Trial
- Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib.Inflammatory bowel diseases · 2023Trial
- Achievement and Maintenance of Remission with Upadacitinib in Patients with Moderate-to-Severe Rheumatoid Arthritis in Italy: 1-Year Data from UPHOLD, a Prospective Real-World Observational Study.Rheumatology and therapy · 2026Article
- Achievement and Maintenance of Disease Targets with Upadacitinib in Rheumatoid Arthritis: 2-Year Outcomes from the UPHOLD Real-World Study.Rheumatology and therapy · 2026Article
- Upadacitinib in rheumatoid arthritis: progress and challenges.Frontiers in pharmacology · 2026Review
- Rheumatoid Arthritis Management: Emerging Drug Therapies and Innovations.Current drug targets · 2026Review
- Arrhythmias in Rheumatoid Arthritis: A Call for a Multidisciplinary Team.Life (Basel, Switzerland) · 2025Review
- Achievement of treatment targets and maintenance of response with upadacitinib in patients with moderate-to-severe rheumatoid arthritis in real-world practice: 1-year outcomes from the UPHOLD observational study.Arthritis research & therapy · 2025Observational
- Therapeutic Advances in Psoriasis: From Biologics to Emerging Oral Small Molecules.Antibodies (Basel, Switzerland) · 2024Review
- Prior herpes zoster occurrence and high-dose corticosteroids increase herpes zoster risk in rheumatoid arthritis patients receiving janus kinase inhibitors in a retrospective and observational study.Clinical rheumatology · 2024Observational
- Saudi consensus guidance for the management of inflammatory bowel disease during pregnancy.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2023Article
- Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials.Rheumatology and therapy · 2022Article
- Neutrophils in the Pathogenesis of Rheumatic Diseases.Rheumatology and immunology research · 2022Review
- Janus kinase-targeting therapies in rheumatology: a mechanisms-based approach.Nature reviews. Rheumatology · 2022Review
- Lessons From the Success and Failure of Targeted Drugs for Rheumatoid Arthritis: Perspectives for Effective Basic and Translational Research.Immune network · 2022Review
- Recent progress in treatments of rheumatoid arthritis: an overview of developments in biologics and small molecules, and remaining unmet needs.Rheumatology (Oxford, England) · 2021Review
- Treatment of Cardiovascular Disease in Rheumatoid Arthritis: A Complex Challenge with Increased Atherosclerotic Risk.Pharmaceuticals (Basel, Switzerland) · 2021Review
- JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.The Journal of allergy and clinical immunology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 8 institutions in 5 countries.
Funding
Abstract
Treating to a target of clinical remission or low disease activity is an important principle for managing rheumatoid arthritis (RA). Despite the availability of biologic disease-modifying antirheumatic drugs (bDMARDs), a substantial proportion of patients with RA do not achieve these treatment targets. Upadacitinib is a once-daily, oral Janus kinase (JAK) inhibitor with increased selectivity for JAK1 over JAK2, JAK3, and tyrosine kinase 2. The SELECT phase III upadacitinib clinical program comprised five pivotal trials of approximately 4400 patients with RA, including inadequate responders (IR) to conventional synthetic (cs)DMARDs or bDMARDs. This review aims to provide insights into the benefit-risk profile of upadacitinib in patients with RA. Upadacitinib 15 mg once daily, in combination with csDMARDs or as monotherapy, achieved all primary and ranked secondary endpoints in the five pivotal trials across csDMARD-naïve, csDMARD-IR, and bDMARD-IR populations. Upadacitinib 15 mg also demonstrated significantly higher rates of remission and low disease activity in all five pivotal trials, compared with placebo, methotrexate, or adalimumab. Labeled warnings of JAK inhibitors include serious infections, herpes zoster, malignancies, major cardiovascular events, and venous thromboembolic events. Short- and long-term integrated analyses showed that upadacitinib 15 mg was associated with increased risk of herpes zoster and creatine phosphokinase elevations compared with methotrexate and adalimumab but otherwise had comparable safety with these active comparators. This review suggests that upadacitinib 15 mg had a favorable benefit-risk profile. The safety of upadacitinib will continue to be monitored in long-term extensions and post-marketing studies.
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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.