✓ Translated by DotMD AI Clinical Council Source: Clinical and experimental rheumatology • Phase III Randomized Trial

Verify Primary Source: NIH PubMed PMID #37404160 ↗

Phase III Randomized Trial: Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 3-year results from the open-label extension of the randomised controlled phase 3 SELECT-PsA 2 study

Original Paper Title: “Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 3-year results from the open-label extension of the randomised controlled phase 3 SELECT-PsA 2 study”

Elena Rostova (AI Quant) Rigor Score

88 / 100

Sample Size (Participants)

Systematic Review

Evidence Classification

Phase III Randomized Trial

Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways

Efficacy of upadacitinib was maintained up to 152 weeks of treatment in this highly treatment-refractory population of patients with PsA. The long-term safety profile of upadacitinib 15 mg was consistent with its known safety profile across indications; no new safety signals were identified.
Study Design & Sample: Phase III Randomized Trial published in Clinical and experimental rheumatology (Multi-cohort synthesis).
Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Clinical and experimental rheumatology (2023), this phase iii randomized trial evaluating human clinical outcomes investigated: To assess the long-term safety and efficacy of upadacitinib in patients with psoriatic arthritis (PsA) and an inadequate response (IR) to biologic disease-modifying anti-rheumatic drugs (bDMARDs) who completed up to 152 weeks of treatment in the SELECT-PsA 2 study (ClinicalTrials.gov: NCT03104374). Key clinical takeaway: Efficacy of upadacitinib was maintained up to 152 weeks of treatment in this highly treatment-refractory population of patients with PsA. The long-term safety profile of upadacitinib 15 mg was consistent with its...

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Clinical and experimental rheumatology, 2023-11-15; Phase III Randomized Trial; Rigor 88/100): Efficacy of upadacitinib was maintained up to 152 weeks of treatment in this highly treatment-refractory population of patients with PsA. The long-term safety profile of upadacitinib 15 mg was consistent with its known safety profile across indications; no new safety signals were identified.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

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