Abstract
Abstract Background Risankizumab (Risa) is a humanized monoclonal antibody designed to target interleukin 23A (IL-23A). In UK approved in 2023 for moderate to severe Crohn’s disease (CD). There is limited data on its use in PIBD patients. The aim of the study was to assess efficacy and safety of Risa in pIBD after treatment failure on previous biologic agents. Methods All children initiated on Risa between March and November 2023 were identified in our database in a retrospective review, including patients’ characteristics, treatment response and safety. All patients received 3 intravenous doses at 4 weekly intervals then went on to subcut doses. Clinical activity at initiation was assessed by the 4 point ‘Improve Care Now’ Physician Global Assessment (PGA) based on severity of symptoms (1=asymptomatic; 2=mild; 3=moderate, and 4=severe). Primary outcome was clinical reduction of PGA between week 12-16. Clinical remission was defined as a PGA of 1.Data on faecal calprotectin (FC), radiologic and endoscopic response between week 12-16 were collected. Adverse events were recorded to date Results 13 patients were identified (11 male) 6 had perianal Crohn’s. 11/13 have had follow up for at least 12 weeks. 2 were excluded for not meeting follow up at the time of the study. Age range from 13 years to 17 years old, median age 16 years. Prior to commencing Risa, 81% (9/11) had moderate to severe disease activity on PGA. Although the remaining 2 patients had mild or asymptomatic PGA for the GI tract, switched for metastatic penile Crohn’s disease and severe joint issues. At re-assessment between week 12 and 16 weeks, 92% (10/11) had a PGA of 1 indicating clinical remission. 1/11 patient had a PGA of 4. Faecal calprotectin available in 63.6% (7/11) showed a dramatic drop in 86% (6/7). Radiological assessment either MRI or SBUS at week 12 or 16 was performed in 37% (4/11) with 2 showing improvement of small bowel disease when compared to radiology assessment prior to Risa, 1 showed no response and 1 showed worsening of disease. 1 patient who had Risa for joint issues showed improvement in inflammatory joint symptoms and the other for penile CD awaits assessment. Endoscopy assessment performed in 1/11 showing persistent disease resulting in a laparotomy and resection of proximal ileal segment and anastomosis. No serious adverse events were reported Conclusion Risankizumab induces sustained clinical response in this heterogenous, refractory group of pIBD patients with no significant side effects reported. However, mucosal healing reflected by FC, radiologic and endoscopic findings remains challenging. Further longer term follow up studies and the use as a 1st or 2nd line bilogic treatment on effectiveness and safety of Risankizumab in pIBD patients are required
Published Version
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