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The following is a summary of “Patient profiles in randomised controlled trials versus a real-world study, in psoriatic arthritis: scoping review and meta-analysis.” published in the November 2024 issue of Rheumatology by Alle et al.
They noted that patients with PsA in RCTs may not match those in real-world settings.
Researchers conducted a retrospective study comparing patient with PsA characteristics in RCTs of biologic disease-modifying antirheumatic drugs (bDMARDs) with those in a real-world study.
They reviewed phase III RCTs of bDMARDs in PsA (2015–2020) and analyzed data from the PsABio study (NCT02627768) of patients with PsA starting bDMARDs (2015–2018). Data collected at baseline included swollen and tender joint counts (SJC/TJC), skin involvement (body surface area -BSA-), C-reactive protein (CRP), physician global assessment (PhGA) and patient-reported outcomes (HAQ, pain), with a random-effects meta-analysis calculating pooled means and proportions.
The results showed that 5,654 patients from 10 RCTs were compared to 930 PsABio patients. SJC/TJC were higher in RCTs (11.8/21.5 vs. 5.7/11.9), and enthesitis and BSA≥3% were more frequent in RCTs (64.7% vs. 48.2%, 62.2% vs. 54.0%). PhGA was also higher in RCTs (59.7mm vs 54.1mm), while patient-reported outcomes were similar. CRP was higher in PsABio (1.4mg/dl vs 1.1mg/dl).
Investigators found that patients with PsA in RCTs had more active disease and higher burden, while patients with real-world PsABio had lower joint counts and skin disease but similar disease burden.
Source: jrheum.org/content/early/2024/11/06/jrheum.2024-0653