The following is a summary of “Sex-related differences in patient characteristics, and efficacy and safety of advanced therapies in randomised clinical trials in psoriatic arthritis: a systematic literature review and meta-analysis,” published in the December 2023 issue of Rheumatology by Eder et al.
Sex-related differences in clinical presentations and disease outcomes are evident in psoriatic arthritis; however, there is limited information on these differences in randomized controlled trials (RCTs). This study aimed to compare patient characteristics and assess the efficacy and safety of advanced therapies, including biological and targeted synthetic therapies, among male and female participants with psoriatic arthritis in RCTs.
For this systematic review and meta-analysis, we conducted searches in Medline, Embase, and Central databases and conference abstract archives from inception to June 10, 2022 to identify RCTs evaluating the efficacy of advanced therapies in psoriatic arthritis. Two reviewers extracted data on participant characteristics and rates of American College of Rheumatology (ACR) 20 and ACR50 response and minimal disease activity (MDA) by sex. Random-effects models were used to calculate pooled ACR20, ACR50, and MDA effects in male versus female patients by drug class.
We included 54 trials (11,514 [50.9%] of 22,621 participants were female, and 11,107 [49.1%] were male). Sex-disaggregated results were reported in a minority of studies (nine [17%] of 54 reported baseline characteristics by sex, 18 [33%] reported efficacy by sex, and two [4%] reported safety endpoints by sex). At baseline, male patients exhibited lower tender joint count, health assessment questionnaire scores, pain scores, patient global assessment, and physician global assessment than female patients. Male patients had higher baseline psoriasis area and severity index scores and C-reactive protein concentrations than female patients. ACR20 response by sex varied across drug classes, with higher rates in males than females with interleukin (IL)-17 inhibitors, IL-23 inhibitors, IL-12 and IL-23 inhibitors, and tumor necrosis factor (TNF) inhibitors, but no difference with JAK and TYK2 inhibitors. Similarly, ACR50 response rates were higher in male patients than female patients in all drug classes except for JAK and TYK2 inhibitors. Male patients were more likely to reach MDA with most drug classes, including IL-17 inhibitors, IL-23 inhibitors, TNF inhibitors, and JAK and TYK2 inhibitors. The risk of bias was low for most studies.
Biological sex influences the response of patients with psoriatic arthritis to advanced therapies, with variations across drug classes. Selective reporting may have influenced these results, emphasizing the need for future trials to report baseline characteristics and endpoint results by sex.
Source: sciencedirect.com/science/article/abs/pii/S2665991323002643