Abstract Background Risankizumab, a selective IL-23 inhibitor, is approved for moderate to severe Crohn’s disease (CD). Real-world data in biologic-experienced patients remain limited. We evaluated its effectiveness, safety, and persistence in routine clinical practice. Methods We performed a retrospective, single-center study including CD patients with available baseline assessment. Clinical activity (Harvey-Bradshaw Index, HBI), CRP, corticosteroid use, adverse events, surgery, and treatment discontinuation were collected at baseline (week 0), week 12, and when available at week 24. Clinical remission was defined as HBI ≤4 without corticosteroids. Clinical response was defined as a reduction of ≥ 3 HBI points in patients who did not achieve remission. Subgroup analyses evaluated prior surgery and previous exposure to ustekinumab, anti-TNF agents, and vedolizumab. Comparisons were performed using Fisher’s exact test. Results Seventy-eight patients were included (median age 36 years, 51.3% female, 41.0% smokers). Disease location was ileal in 24.4%, colonic in 14.1%, and ileocolonic in 61.5%. Prior surgery for Crohn’s disease had been performed in 70.5% of cases. All patients were biologic-experienced (96.2% anti-TNF, 46.2% vedolizumab, 74.4% ustekinumab). At baseline, 39.7% had mild, 30.8% moderate, and 5.1% severe clinical activity. Median CRP at baseline was 1.19 mg/dL, and 32.1% used corticosteroids. At week 12, steroid-free clinical remission was achieved by 30.8% (24 of 78), with clinical response in an additional 24.4% (19 of 78). Median CRP improved to 0.44 mg/dL, and steroid use decreased to 2.6%. At week 24, 27 patients had available clinical data; among them, 48.1% (13 of 27) achieved steroid-free remission and 25.9% (7 of 27) achieved clinical response. No significant differences in week 12 steroid-free remission were observed according to prior surgery (29.1% vs 34.8%, p = 0.79), ustekinumab exposure (34.5% vs 20%, p = 0.27), anti-TNF exposure (30.7% vs 33.3 %, p = 1.00), or vedolizumab exposure (27.8% vs 33.3%, p = 0.63). By week 24, 12.8% (10 of 78) discontinued risankizumab: 6.4% due to loss of response, 3.8% due to adverse events, 1.3% due to surgery, and 1.3% for other reasons. No serious adverse events were observed. Treatment persistence at week 24 was 87.2%. Conclusion In this real-world cohort of biologic-experienced CD patients, risankizumab showed meaningful short-term effectiveness, biochemical improvement, substantial steroid-sparing effects, high treatment persistence, and a favorable safety profile. Effectiveness was comparable across prior surgical status and previous exposure to ustekinumab, anti-TNF agents, and vedolizumab. Conflict of interest: Dr. Dussias, Nikolas: Consultant fee from Cadigroup and Janssen Melotti, Laura: No conflict of interest Dragone, Pasquale: No conflict of interest Salice, Marco: None Privitera Hrustemovic, Hana: No conflict of interest Vanigli, Nicholas: No conflict of interest Gionchetti, Paolo: Personal Fees: Ferring, Celgene, Janssen, Takeda, Chiesi, Abbvie, Pfizer, MSD, Amgen, BMS, Gilead, Arena Eli-Lilly Alfa-Sigma Rizzello, Fernando: No conflict of interest
Dussias et al. (Thu,) studied this question.