PO:04:056 | Willingness of patients with psoriatic arthritis to participate in pharmacological and nutritional clinical trials: a cross-sectional study

Miriam Perino^1|2, Francesca Ingegnoli^1|2, Luca Ingrao^1|2, Debora Piredu^1|2, Antonio Varvaro^1|2, Camilla Riboldi^1|2, Gilberto Cincinelli², Francesca Desiati², Martina Biggioggero², Orazio De Lucia², Silvia Casari², Maria Manara², Ennio Giulio Favalli^1|2, Roberto Caporali^1|2 | ¹Università degli Studi di Milano, Dipartimento di Scienze Cliniche e di Comunità, Milano; ²ASST G. Pini-CTO, UOC di Clinica Reumatologica, Milano, Italy

Background. Psoriatic arthritis (PsA) is a chronic inflammatory disease that significantly affects patients’ quality of life. Clinical trials are fundamental tools for improving therapeutic strategies and disease management; high patient adherence is desirable to reduce selection bias and ensure the generalizability of the results. However, data regarding patients’ willingness to participate in pharmacological and nutritional interventional studies are currently limited. The aim of this study is to evaluate the willingness of patients with PsA to participate in pharmacological and nutritional clinical trials, and to identify clinical and demographic factors potentially associated with such willingness.

Materials and Methods. A cross-sectional, non-profit survey was conducted using a structured questionnaire administered consecutively to patients attending the rheumatology clinic between October 31, 2024 and January 7, 2025. For each participant, demographic data (sex, age, education level, body mass index [BMI]) and clinical data (disease duration, disease activity, current therapy, and comorbidities) were collected. Descriptive analysis was used to characterize the cohort. Results. A total of 225 patients with PsA were enrolled, with a mean age of 57.68 years (range: 28–85). The sample included 96 female participants (42.6%), with a mean BMI of 25.81. The median disease duration was 14 years; 94.2% of patients had disease activity ranging from remission to low activity. The main results are shown in Figure 1. Overall, 186 patients (82.7%) expressed willingness to participate in clinical studies; among these, 129 (57.3%) were willing to take part in both pharmacological and nutritional trials, while 45 patients (20%) reported willingness to participate exclusively in nutritional studies. Chi-square analysis did not reveal statistically significant associations between sex, BMI, education level, disease duration, and willingness to participate (p > 0.05 for all variables analyzed).

Conclusions. Patients with PsA showed a greater inclination to participate in dietary intervention studies compared to pharmacological ones. This attitude was not significantly associated with sex, education level, BMI, disease duration, or disease activity. However, further studies with larger samples are needed to confirm these preliminary findings and to better explore the determinants of participation willingness in different patient subgroups. These results highlight the importance of personalized recruitment strategies, tailored to patients’ therapeutic and behavioral interests, in order to optimize enrollment and promote heterogeneous representation within clinical trials.