Catalytic Health

6 Special Supplement, May 2023 by an SES-CD ulcerated surface subscore of 0 in participants with ulcerations at baseline) (30.5% [43/141] vs. 10.5% [17/162], p<0.0001). Safety To date, ADVANCE, MOTIVATE, and FORTIFY represent the largest CD-specific Phase 3 dataset. The safety of risankizumab was consistent with that observed in plaque psoriasis and psoriatic arthritis. Treatment is generally very well tolerated, and rates of adverse events (AEs) were similar in patients who received risankizumab 360 mg (448 events per 100 person-years exposure) vs patients receiving placebo (545 events per 100 person-years exposure in FORTIFY). There were no differences in severe or serious AEs, or AEs leading to treatment discontinuation between participants receiving risankizumab vs placebo, either during induction or maintenance. Treatment discontinuation of risankizumab was rare: In FORTIFY, 144/157 in the 180 mg and 124/141 in the 360 mg risankizumab groups completed the trial to week 52. Infections are an important potential AE for CD patients undergoing immunosuppression. Most infections occurring in the Phase 3 risankizumab program were mild; serious or opportunistic infections were rare and occurred similarly in the placebo group vs the risankizumab group. No cases of herpes zoster or active tuberculosis were observed in patients receiving risankizumab 360 mg in the FORTIFY trial. These findings highlight the favourable safety profile of risankizumab, which is consistent with integrated safety data from the psoriasis literature. 23 To date, across indications, 26 clinical trials over 7 years have been performed evaluating risankizumab, with more than 107,000 patients treated worldwide since 2019, and approximately 13,500 patient-years of exposure. Conclusion In summary, risankizumab is a potent novel therapy that has been added to the therapeutic armamentarium for moderate-to-severely active CD in Canada. It is the first IL-23p19 specific monoclonal antibody, with a mechanism of action distinct from IL-12/23p40 blockade. The efficacy and safety of risankizumab have been demonstrated in the largest Phase 3 CD program to date, which was the first to enroll patients based on both clinical symptoms and endoscopically confirmed inflammation at baseline, and then subsequently measure both clinical and endoscopic outcomes relevant to clinical care. Risankizumab demonstrated efficacy across both biologic treatment naïve and failure populations, with rapid induction of symptomatic and endoscopic response followed by maintenance of clinical remission and achievement of endoscopic remission and ulcer-free mucosal healing. Combined with a highly favourable safety profile, risankizumab is likely to become a dominant therapy for first- and second- line treatment of moderate-to-severely active CD. Correspondence: Christopher Ma Email: christopher.ma@ucalgary.ca Financial Disclosures: CM has received consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma Inc., BioJAMP, Bristol Myers Squibb, Celltrion, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Pendopharm, Pfizer, Prometheus Biosciences Inc., Roche, Sanofi, Takeda, Tillotts Pharma; speaker's fees from AbbVie, Amgen, AVIR Pharma Inc, Alimentiv, Bristol Myers Squibb, Ferring, Fresenius Kabi, Janssen, Organon, Pendopharm, Pfizer, Takeda; royalties from Springer Publishing; research support from Ferring, Pfizer.

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