P0742A Postmarketing, Prospective, Noninterventional Study Evaluating the Real-World Clinical Effectiveness and Safety of Risankizumab in Patients With Crohn’s Disease: Interim Results From the APPRISE Study

Abstract Background Pivotal clinical trials have shown the efficacy of the anti-interleukin-23 p19 antibody risankizumab (RZB) for treatment of moderate-to-severe Crohn’s disease (CD) in adults. Here, efficacy and safety in a real-world setting were evaluated. Methods APPRISE (NCT05841537) is an ongoing prospective, single arm, noninterventional, postmarketing, observational study. Adults (aged ≥15 years y, if allowed per local label) with a confirmed diagnosis of CD initiated RZB at the investigator’s discretion in accordance with local marketing authorisation. The first 500 enrolled pts were included in this interim analysis. Study visits were prespecified, occurring monthly (± 7 days) for the first 3 mo, with an additional visit at 6 mo. The primary outcome of clinical remission per Harvey Bradshaw Index (HBI) at 12 months in patients with clinical response per HBI at mo 3 is not included here as it is not within the scope of this interim analysis. Secondary outcomes included clinical remission and corticosteroid (CS)-free clinical remission (HBI) (outcomes defined in Table 1 footnotes). A post hoc analysis of efficacy stratified by CS use, advanced therapy inadequate response (AT-IR), and ustekinumab (UST) failure at baseline (BL) was also performed. Data are as observed after handling of intercurrent events (Table 1 footnote). Results Of pts who received ≥1 dose of RZB (483 pts), 52% were male, 51% were AT-exposed, 17% used CS at BL, and 74 pts had UST failure at BL. Median (min, max) disease duration was 10.2 y (0.0, 54.0). Sustained clinical remission at 6 mo was achieved by 84.1% of pts who clinical remission at 3 mo (Table 1). CS-free clinical remission at 3 mo was achieved by 60.3% of pts. Sustained CS-free clinical remission at 6 mo was achieved by 82.5% of pts who achieved the outcome at 3 mo. A post hoc subgroup analysis found that, among pts who had failure of UST at BL, 95.5% achieved clinical remission at both 3 mo and 6 mo. At 3 mo, 36.7% of pts who used CS at BL achieved CS-free clinical remission (vs 65.4% of pts not using CS at BL); approximately 60% of pts achieved CS-free clinical remission at 3 mo regardless of BL AT-IR status or prior UST failure at BL. In 41.6% of pts, ≥ 1 treatment emergent adverse event (TEAE) was reported, 8.9% of pts reported serious TEAEs, and 2.9% discontinued RZB treatment (Table 2). A TEAE resulting in death, unrelated to RZB treatment, was reported in 1 pt after the 6-mo data cutoff. Conclusion In a real-world setting, most pts treated with RZB achieved and sustained clinical and steroid-free clinical remission, and the durability of effect was observed regardless of prior UST failure. RZB was well tolerated, and no new safety concerns were identified. Conflict of interest: Bossuyt, Peter: Grant support for research from AbbVie, EG Consulting fee from AbbVie, Bristol Meyers Squibb, CIRC, Galapagos, Janssen, Jeito capital, Lilly, Pentax, Pfizer, PSI-CRO, Roche, Takeda, Tetrameros Speakers fee from AbbVie, AMC ICP, Amgen, Bristol Myers Squibb, Celltrion, Dr Falk Benelux, EG, Galapagos, Globalport, Lilly, Medtalks, Materia Prima, Pentax, Springer Media Hisamatsu, Tadakazu: Grant support: Mitsubishi Tanabe Pharma Corporation, EA pharma Co. Ltd., AbbVie GK, JIMRO Co. Ltd., Zeria Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., Pfizer Inc., Mochida Pharmaceutical Co. Ltd., Boston Scientific Corporation, Kissei Pharmaceutical Co. Ltd. Consulting: Mitsubishi Tanabe Pharma Corporation, EA pharma Co. Ltd., AbbVie GK, Janssen Pharmaceutical K.K., Pfizer Inc., Eli Lilly, Gilead Sciences, Bristol Myers Squibb, Abivax, MSD, Chugai. Lecture fee: Mitsubishi Tanabe Pharma Corporation, AbbVie GK, EA pharma Co. Ltd., Kyorin Pharmaceutical Co. Ltd., JIMRO Co., Janssen Pharmaceutical K.K., Mochida Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co. Ltd., Pfizer Inc., Kissei Pharmaceutical Co. Ltd. Atreya, Raja: RA has served as a speaker, or consultant, or received research grants from AbbVie, Abivax, AlfaSigma, Arena Pharmaceuticals, Astra-Zeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion Healthcare, Dr Falk Pharma, Galapagos, Gilead, GlaxoSmithKline, InDex Pharmaceuticals, Johnson & Johnson, Lilly, Materia Prima, Merck Sharpe & Dohme, Pfizer, Roche Pharma, Takeda Pharma, Viatris. Tinoco da Silva Torres, Joana: Grant: Abbvie, Janssen Personal Fees: Pfizer, Janssen, Abbvie, Sandoz, Lilly, Sanofi, Takeda Non-financial Support: Janssen, Abbvie Aponte, Fernando: AbbVie employee and may own AbbVie stock or options. Mallick, Madhuja: Full-time employee of AbbVie and may own AbbVie stock or options. Chen, Shirley H.: AbbVie contractor and may own AbbVie stock or options. Kligys, Kristina: Full-time employee of AbbVie and may own AbbVie stock or options. Juillerat, Pascal: Speaker and advisor Fees: AbbVie, Amgen, Aspen Pharmacare, Bristol Myers Squibb, CLS Vifor Pharma, Eli Lilly, Ferring Pharmaceuticals, Gilead Sciences, Johnson & Johnson, Merck Sharp & Dohme, Pfizer, Pierre Fabre, Sandoz, Takeda, Tillotts Pharma AG, UCB Pharma.