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P439 Effectiveness of Ustekinumab on Crohn's disease associated spondyloartropathy: real-world data from the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD)

Macaluso, F.(1);Fries, W.(2);Viola, A.(2);Costantino, G.(2);Muscianisi, M.(2);Cappello, M.(3);Guida, L.(3);Giuffrida, E.(3);Magnano, A.(4);Pluchino, D.(4);Ferracane, C.(4);Magrì, G.(5);Di Mitri, R.(6);Mocciaro, F.(6);Privitera, A.C.(7);Camilleri, S.(8);Garufi, S.(8);Renna, S.(1);Casà, A.(1);Scrivo, B.(1);Ventimiglia, M.(1);Orlando, A.(1);

(1)"Villa Sofia-Cervello" Hospital, IBD Unit, Palermo, Italy;(2)A.O.U. Policlinico "G. Martino”, IBD Unit, Messina, Italy;(3)A.O.U. Policlinico “G. Giaccone”, Gastroenterology and Hepatology Unit, Palermo, Italy;(4)A.O.U. Policlinico “Vittorio Emanuele”, Gastroenterology Unit, Catania, Italy;(5)A.O. “Santa Marta e S. Venera”, Gastroenterology Unit, Acireale, Italy;(6)A.R.N.A.S. “Civico Di Cristina Benfratelli”, Gastroenterology and Endoscopy Unit, Palermoo, Italy;(7)A.O. “Cannizzaro”, IBD Unit, Catania, Italy;(8)A.O.O.R. “S. Elia- M. Raimondi”, Gastroenterology Unit, Caltanissetta, Italy Sicilian Network for Inflammatory Bowel Disease (SN-IBD).

Background

The efficacy of Ustekinumab (UST) on Crohn’s disease (CD) associated spondyloarthropathy (SpA) was evaluated neither in randomized controlled trials nor in real-world studies. Web-based data from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD) were extracted to perform a multicentre, real-world assessment of the effectiveness of UST on CD-associated SpA

Methods

All consecutive CD patients with active SpA at the initiation of the treatment with UST from January 2019 (the date on which the drug became available for clinical practice in Sicily) to August 2019 were extracted from the SN-IBD cohort. The study outcomes were evaluated at 8 and 24 weeks. The primary outcome was the articular response, defined as the disappearance of objective signs of arthritis (swelling and/or articular stiffness) and resolution of pain. As ancillary end-points, the clinical response (reduction of Harvey-Bradshaw Index ≥ 3 compared with baseline with a concomitant reduction of at least ≥ 50% of steroid dosage compared with baseline) and the steroid-free remission (Harvey-Bradshaw Index < 5 without steroids use) were assessed.

Results

Out of 131 total patients treated with UST, 30 consecutive patients (22.9%) had active SpA at baseline (axial SpA: 3/30; peripheral SpA: 18/30; axial plus peripheral SpA: 9/30). After 8 weeks, 10 patients (33.3%) reported an articular response [0/3 patients with axial SpA, 7/18 patients (38.9%) with peripheral SpA, and 3/9 patients (33.3%) with axial and peripheral SpA]. After 24 weeks, 13 patients (43.3%) had an articular response [0/3 patients with axial SpA, 10/18 patients (55.5%) with peripheral SpA, and 3/9 patients (33.3%) with axial and peripheral SpA]. None of these 13 responders was taking systemic steroids at 24 weeks. The concomitant presence of a clinical response on intestinal symptoms was associated with the articular response at 24 weeks at univariable analysis (OR 5.14, CI 1.09-32.70, p=0.038).

Conclusion

UST obtained a response on articular symptoms in nearly half of the patients with CD and active SpA at baseline after 24 weeks. The rate of response was higher in case of peripheral arthropathy. The articular response was associated with the clinical response on intestinal symptoms.

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