The evolving demographics of patients recruited to phase iii randomised controlled trials of biologic/ targeted synthetic disease-modifying anti-rheumatic drugs in psoriatic arthritis.

Aim: To describe the evolving demographics of patients recruited to phase 3 randomised controlled trials (RCTs) of biologic/targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) in Psoriatic Arthritis (PsA). Method(s): A scoping review was conducted to identify placebo-controlled phase 3 RCTs of b/tsDMARDs in PsA published up to January 2022. Inclusion criteria for all studies were reviewed. Demographic data were extracted from the active treatment arms by two authors (WZ, AA) including: age, sex, race, disease duration, swollen joint count (SJC), tender joint count (TJC), and Health Assessment Questionnaire - Disability Index (HAQ-DI). The date of study initiation and countries in which the studies were conducted were extracted from clinicaltrials.gov. Descriptive statistics were used to evaluate the data. Result(s): Thirty-eight eligible RCTs were identified; four were excluded due to a lack of published initiation date. Thirteen (38.2%) were b/tsDMARD-naive cohorts. The mean age of patients did not change over time, however, the proportion of females increased. Females represented 29-43.7% of participants in studies which began recruitment in 2000/01 and 47.7-55.4% in studies recruiting from 2018/19. The mean (range) of countries involved increased from 2 (1-5) in 2000/01 to 26 (14-39) in 2018/19, but 94.0-97.3% of patients in studies from the 2018/19 period were white. The highest percentage of non-white participants in the treatment arm of an RCT was 19.8%. There was minimal evolution in the mean SJC/TJC/HAQ-DI over two decades. Other variables extracted were excluded from analysis due to significant variation in reporting. Conclusion(s): The recruitment of female PsA patients to placebo-controlled phase 3 PsA RCTs has increased over time. Despite the increase in the number of countries in which RCTs are conducted, non-white patients remain sub-optimally represented in treatment data. TJC/SJC/HAQ-DI stability over decades may reflect the inclus