Journal Article

AB0489 REAL-LIFE EFFICACY OF RISANKIZUMAB IN PSORIATIC ARTHRITIS

Chimenti, M. S., Selmi, C., Mauro, D., Ciccia, F., Costanzo, A., Pantano, I., Megna, M., Argenziano, G., Idolazzi, L., Gisondi, P., Giunta, A.

2024

Overview

Background:Risankizumab is the most recently approved drug used for the treatment of Psoriatic arthritis (PsA). Risankizumab is a humanized IgG1 monoclonal antibody that specifically inhibits interleukin 23 (IL-23) by binding to its p19 subunit.Objectives:The KEEPsAKE 1 and 2 trials have demonstrated the efficacy and safety of Risankizumab in naïve and TNF-experienced patients with PsA. Here we report the real-life efficacy and safety of Risankizumab in an Italian cohort of PsA patients.Methods:In this observational retrospective trial, we reported clinical data of PsA patients who satisfied CASPAR criteria admitted to the combined dermatologist-rheumatologist outpatient clinics of 5 Italian centers. Each patient underwent a complete clinical exam evaluating cutaneous and joint disease with activity index. We used DAPSA and VAS pain to assess the clinical activity of joint disease and BSA, PASI and VAS pruritus as dermatological indexes. All patients were treated with Risankizumab according to common clinical practice. The primary endpoint was the achievement of low disease activity or remission according to DAPSA after 6 months of therapy with good efficacy also on the skin component.Results:In this work, we enrolled 44 PsA patients (28 males and 16 females) who satisfied CASPAR criteria. The mean age was 56.2 years and most of the patients were overweight (mean BMI 29.1). Most of them had a long disease duration (mean duration 11.4 years) so it is not surprising that 73% of patients were already bDMARDs experienced (of them 61% TNF non-responders). At baseline, all patients reported moderate disease activity (mean DAPSA 19.7) with extensive skin psoriasis (mean Body surface area 21.3% and mean PASI 16.3). After 6 months of treatment with Risankizumab, 62% of patients obtained a good DAPSA response (p<0.0001). Figure 1 Of them 19% reached remission and 43% reached low disease activity. Moreover, good clinical responses were observed also for BSA and PASI with a reduction respectively of 75% and 87%. After 12 months of treatment, 82% of patients were in low disease activity or remission with a mean DAPSA of 7.4 (p<0.0001). Figure 2Conclusion:This is the first paper that evaluated the efficacy of Risankizumab in PsA patients in a real-life setting. Patients enrolled in clinical trials do not represent patients who are evaluated in a clinical setting and who have multiple comorbidities that influence therapeutic choice and pharmacological response. Particularly, our PsA patients had a long disease duration and most of them were bDMARDs experienced. Risankizumab was demonstrated to be efficacious both in naïve and in multi-failure patients. The primary and secondary endpoints were reached: 62% of patients had a good clinical response at 6 months and 82% of patients were in LDA/remission at 12 months of treatment. Numerous clinical trials and real-life data showed the effectiveness of Risankizumab on psoriasis, confirming the pivotal role of blocking IL-23 on the skin. The effectiveness on skin psoriasis was also confirmed in our work: after 6 months of treatment, a reduction in PASI of approximately 90% was recorded (mean PASI 2). During the entire follow-up period, no patient reported a reaction at the injection site, infectious episodes, or any adverse event worthy of medical discussion. In conclusion, risankizumab is a good option also for PsA patients who are multi-drug resistant. Further studies are necessary to confirm our results and to confirm the efficacy of risankizumab in “complex” patients in real life.REFERENCES:[1] Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Kristensen LE, Keiserman M, Papp K, McCasland L, White D, Lu W, Wang Z, Soliman AM, Eldred A, Barcomb L, Behrens F. Ann Rheum Dis. 2022 Feb;81(2):225-231.[2] Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study.Östör A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Lu W, Wang Z, Soliman AM, Eldred A, Padilla B, Kivitz A.Rheumatology (Oxford). 2023 Jun 1;62(6):2122-2129.Acknowledgements:NIL.Disclosure of Interests:None declared.

• Publisher: BMJ Publishing Group Ltd and European League Against Rheumatism,Elsevier B.V,Elsevier Limited
• Subject: biological DMARD / Clinical trials / Comorbidity / Drug resistance / Immunoglobulin G / Interleukin 23 / Joint diseases / Monoclonal antibodies / Multidrug resistance / Patients / Pruritus / Psoriasis / Psoriatic arthritis / Real-world evidence / Remission / Remission (Medicine) / Rheumatology / Safety / Scientific Abstracts / Skin