Real-world trajectories in psoriatic arthritis under risankizumab therapy
Saviana Gandolfo, Ilenia Pantano, Daniele Mauro, Anna Balato, Maurizio Caminiti, Eleonora Celletti, Maria Sole Chimenti, Antonio Ciancio, Luca Idolazzi, Matteo Megna, Giuseppa Pagano Mariano, Maura Raimondi, Flavia Riccio, Enrico Tirri, Alessandro Giunta, Paolo Gisondi, Giuseppe Argenziano, Antonio Costanzo, Carlo Selmi, Francesco CicciaBackground
Risankizumab, a selective IL-23p19 inhibitor, has demonstrated efficacy in randomized clinical trials, but real-world data remain limited.
Objectives
To evaluate the real-world effectiveness and safety of risankizumab in PsA, and to identify baseline predictors of treatment response.
Design
This multicentre, retrospective, longitudinal, real-world study included 112 PsA patients fulfilling the CASPAR criteria enrolled across seven Italian combined dermato-rheumatology centers.
Methods
DAPSA and other longitudinal variables were assessed at baseline, 3, 6, and 12 months. Patients were stratified as D2T (risankizumab as ≥3 rd -line biologic therapy) or nD2T, and as responders (DAPSA≤14) or non-responders at 6 months. Univariable and multivariable logistic regression analyses were performed to identify baseline predictors of DAPSA response.
Results
Risankizumab induced rapid and sustained improvement across PsA domains. A significant DAPSA reduction was observed (p<0.001), with 62.5% and 69% of evaluable patients achieving DAPSA response at 6 and 12 months, respectively. D2T patients exhibited higher baseline disease activity and burden but achieved comparable disease control by month 12. In multivariable analysis, higher baseline VAS pain was independently associated with lower odds of DAPSA response at 6 months (OR 0.74; 95% CI 0.55–0.96). Treatment persistence at 12 months was 82.1%. Adverse events were infrequent (4.5%), and only one led to treatment discontinuation.
Conclusion
Risankizumab demonstrated real-world effectiveness and tolerability across heterogeneous PsA trajectories, including multi-failure patients. Higher baseline pain was independently associated with lower odds of achieving DAPSA remission/low disease activity, highlighting the importance of pain assessment in treatment stratification and supporting further studies on inflammatory and non-inflammatory determinants of response.