Trial reportRMD open2025
Benefit-risk analysis of upadacitinib versus adalimumab in patients with rheumatoid arthritis and higher or lower risk of cardiovascular disease.
Trial report in RMD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 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
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Therapeutic approaches for difficult-to-treat rheumatoid arthritis: a systematic literature review of current evidence.RMD open · 2026Pooled it
- Trial
- 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
- Risk of venous thromboembolism with upadacitinib in rheumatoid arthritis: a meta-analysis.Journal of thrombosis and thrombolysis · 2026Review
- The Impact of PRAC EMA/AIFA Recommendations on the Prescriptions of JAKi and b-DMARDs: Preliminary Results of the Survey from 21 Rheumatological Italian Centers Affiliated with CReI.Journal of personalized medicine · 2026Article
- Post-marketing surveillance of upadacitinib: multilevel analysis of venous thromboembolism reporting in global data and rheumatoid arthritis.Frontiers in medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesEvaluate the risks and benefits of upadacitinib 15 mg vs adalimumab in rheumatoid arthritis (RA) patients with an inadequate response to methotrexate based on cardiovascular (CV) risk.
methodsIn SELECT-COMPARE, patients received upadacitinib 15 mg, placebo or adalimumab 40 mg every other week, with background methotrexate. This post hoc analysis assessed patients with lower (age <65 years; no CV risk factors) and higher CV risk (age ≥65 years and/or ≥1 CV risk factor). Safety and efficacy outcomes were compared between upadacitinib and adalimumab over the short term (~6 months) and long term (5 years) based on CV risk.
resultsThe study included 211 lower-risk patients (upadacitinib, n=129; adalimumab, n=82) and 767 higher-risk patients (upadacitinib, n=522; adalimumab, n=245). Rates of malignancy excluding nonmelanoma skin cancer (NMSC), major adverse cardiovascular event and venous thromboembolism were comparable between upadacitinib and adalimumab in both risk groups but numerically higher in the higher-risk group. Upadacitinib showed higher rates of herpes zoster versus adalimumab in both risk groups and numerically higher rates of serious infection and NMSC in the higher-risk group. Upadacitinib demonstrated consistently better efficacy outcomes, including 28-joint Disease Activity Score (C reactive protein) <2.6, Clinical Disease Activity Index remission and Boolean remission at 6 months, which were generally maintained through 5 years.
conclusionsRegardless of baseline CV risk, upadacitinib demonstrated comparable safety to adalimumab, except for higher rates of herpes zoster in both CV risk groups and NMSC and serious infections in the higher-risk group. Upadacitinib consistently showed better clinical and functional outcomes than adalimumab. The benefit-risk profile of upadacitinib in RA patients was favourable, independent of CV risk category, in both short and long term.
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