Exploring Sex-related Mechanisms of Psoriatic Arthritis (PsA) response to advanced therapies (EXSEMP): Individual participant data (IPD) meta-analysis of randomized controlled trials of advanced therapies

Background: Psoriatic arthritis (PsA), a chronic inflammatory arthritis that affects 1 in 1000 adults, presents differently in males and females. Biologic treatment is a type of medical treatment that uses substances from living organisms to treat disease. Biologic treatments are effective yet costly medications for arthritis. However, female patients living with PsA are less likely to achieve remission with biologic treatments and are more likely to develop side effects. There is limited understanding of the reasons for these differences in response to treatment between males and females.

Objective: The objective of our study is to investigate whether certain types of biologic treatments are more effective and safer in females living with PsA. Additionally, we aim to study whether selected patient characteristics typically found in females, such as obesity, may explain the lower response to treatment in female patients.

Research Plan: We plan to perform a meta-analysis of data from randomized controlled clinical trials (RCTs) that evaluated biologic therapies in PsA. A meta-analysis combines the results of many studies on the same topic to see the overall picture. We have identified 40 trials that evaluated biologic therapies in PsA that we hope to include in our analysis. We will compare the effect of each biologic medication in male and female patients in each trial and then analyze these effects together in a meta-analysis to estimate the overall degree of sex difference in response to treatment. In addition, using statistical models across the different trials, we will evaluate how much of the response to treatment is influenced by factors associated with the sex of the patient, like body weight, level of inflammation, drug dose, and more. With this analysis, we hope to gain an understanding of the mechanisms explaining the expected poorer response in female patients.

Outcome: The results of our study could contribute to the development of sex-specific recommendations for prescribing biologic treatment in PsA, ultimately resulting in better patient care.