ArticleAdvances in therapy2025
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.
Article in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 15 registered trials, which are not on this map. Cited by 24 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.
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
A Phase 3, Randomized, Active-Controlled, Double-Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)
A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)
A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) - SELECT - PsA 1
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects With Axial Spondyloarthritis Followed by a Remission-Withdrawal Period
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Asian Pacific Association of Gastroenterology (APAGE) Clinical Practice Guidelines on the Use of Small Molecules and IL-23 p19 Inhibitors in Ulcerative Colitis and Crohn's Disease.Journal of gastroenterology and hepatology · 2026Guideline
- Benefit-risk profile of upadacitinib: exploratory post hoc analysis of phase 2b/3 studies in patients with moderately to severely active ulcerative colitis or Crohn's disease.Journal of Crohn's & colitis · 2026Trial
- Medical Therapies Beyond Infliximab for Perianal Fistulizing Crohn's Disease: Current Evidence and Future Perspectives.Journal of clinical medicine · 2026Review
- Upadacitinib Restrains the Pathogenic Fitness of CD4Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Letter to the Editor: Can upadacitinib dose escalation redefine treatment strategies in refractory inflammatory bowel disease?World journal of gastrointestinal pharmacology and therapeutics · 2026Article
- Upadacitinib for Severe Alopecia Areata in Adults and Adolescents: Two Phase 3 UP-AA Randomized Clinical Trials.JAMA dermatology · 2026Article
- Targeting the non-coding RNA-PANoptosis axis: a novel frontier in disease diagnosis and therapy.Apoptosis : an international journal on programmed cell death · 2026Review
- Risk of venous thromboembolism with upadacitinib in rheumatoid arthritis: a meta-analysis.Journal of thrombosis and thrombolysis · 2026Review
- Comparative safety of JAK inhibitors versus TNF inhibitors in psoriatic arthritis: a real-world propensity score-matched cohort study.Annals of medicine and surgery (2012) · 2026Article
- Comparative Effectiveness of Upadacitinib vs. Other JAK Inhibitors in Patients With Rheumatoid Arthritis in a Global Real-World Setting.Rheumatology and therapy · 2026Article
- Impact of Upadacitinib on Reducing Pain in Patients Across the Axial Spondyloarthritis Spectrum: A Post Hoc Analysis of the Phase 2/3 SELECT-AXIS Studies.Rheumatology and therapy · 2026Article
- Positioning of advanced therapies in patients with moderate-to-severe Crohn's disease.Singapore medical journal · 2026Review
- Psoriatic Arthritis: Therapeutic Advances and Novel Treatment Strategies-A Scoping Review.Life (Basel, Switzerland) · 2026Review
- Cardiovascular involvement in ankylosing spondylitis and axial spondyloarthritis: epidemiology, mechanisms, and clinical management.Frontiers in medicine · 2026Review
- Evolving Research Hotspots and Emerging Trends in Atopic Dermatitis and Inflammatory Bowel Disease: A Bibliometric Analysis.Clinical, cosmetic and investigational dermatology · 2026Article
- Update of the evidence- and consensus-based S3 guideline on atopic dermatitis: Systemic therapy with biologics or Janus kinase inhibitors and specific aspects of systemic therapy in pregnancy and lactation.Allergologie select · 2026Article
- JAK inhibitors and adverse cardiovascular events: Class effect or molecule-specific risk?Frontiers in pharmacology · 2026Review
- Real-World Use of Upadacitinib for Moderate-to-Severe Atopic Dermatitis in Saudi Arabia: A Single-Centre Retrospective Descriptive Analysis.Clinical, cosmetic and investigational dermatology · 2026Article
- From concept to practice: real-world safety of JAK inhibitors in rheumatoid arthritis treatment.Frontiers in medicine · 2026Review
- The Impact of Targeted Therapies on the Bone-Vascular Axis in Psoriasis: A Narrative Review.Clinical, cosmetic and investigational dermatology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionWe report the long-term safety of upadacitinib (oral, selective, and reversible Janus kinase inhibitor) in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), atopic dermatitis (AD), Crohn's disease (CD), and ulcerative colitis (UC).
methodsData were analyzed from 16 studies (data cutoff August 15, 2024). Each treatment group was pooled across studies within each indication. Active comparator arms included adalimumab (RA/PsA) and methotrexate (RA). Treatment-emergent adverse events (TEAEs) were reported as exposure-adjusted incidence rates per 100 patient-years (n/100 PY).
resultsThis analysis included 8632 (RA, n = 3209; PsA, n = 907; AS, n = 596; nr-axSpA, n = 286; AD, n = 2683; CD, n = 450; UC, n = 501) upadacitinib-treated patients over 27,164.2 patient-years (range 199.4-12,315.8 PY across indications). Rates (n/100 PY) of any TEAEs ranged from 112.0 (AS) to 401.1 (RA). Most frequently reported TEAEs included COVID-19, upper respiratory tract infection, nasopharyngitis, herpes zoster, urinary tract infection, and acne (primarily patients with AD). Serious TEAEs ranged from 4.5 (AD) to 11.0 (UC), and those leading to discontinuation ranged from 2.9 (AS) to 8.3 (UC). TEAEs leading to death ranged from 0 (nr-axSpA, UC) to 0.7 (RA). Among upadacitinib-treated patients across indications, rates of adverse events of special interest ranged from 1.3 to 4.6 (serious infection), 2.4-6.6 (herpes zoster), 0.2-0.9 (malignancy excluding nonmelanoma skin cancer [NMSC]), 0-1.4 (NMSC), 0-0.5 (major adverse cardiovascular event [MACE]), 0-0.9 (venous thromboembolism [VTE]), and 0-9.2 (elevated creatine kinase). In RA and PsA, herpes zoster, NMSC, and elevated creatine kinase rates were numerically higher with upadacitinib vs active comparators. Serious infection, herpes zoster, malignancy (excluding NMSC), NMSC, MACE, and VTE rates remained stable over time.
conclusionThis descriptive analysis indicates a long-term safety profile of upadacitinib consistent with previous reports, further supporting long-term treatment of chronic diseases with upadacitinib. Variations in TEAE rates across indications likely reflected differences in populations and underlying comorbidities.
trial registrationClinicalTrials.gov identifiers NCT02675426, NCT02706951, NCT02706847, NCT02629159, NCT02706873, NCT03086343, NCT03104374, NCT03104400, NCT03178487, NCT04169373, NCT03569293, NCT03568318, NCT03607422, NCT03345823, NCT02819635.
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What Socratic 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 Socratic graph.