Long-term Outcome of Risankizumab in Crohn's Disease: a Real-world GETAID Study.

BACKGROUND & AIMS: The aim of this study was to assess the long-term effectiveness and safety of risankizumab maintenance treatment in a large real-world cohort of patients with Crohn's Disease (CD). METHODS: From May 2021 to August 2023, all consecutive patients with CD treated with risankizumab in 25 GETAID centers have been retrospectively included. The primary endpoint was steroid-free clinical remission (Harvey Bradshaw Index [HBI] <5) at 52 weeks. RESULTS: Of the 174 patients included, 99%, 93%, and 96% had been previously exposed to anti-TNF, vedolizumab, and ustekinumab, respectively. All patients had received ≥3 biologics, and 108 (62%) had previous intestinal resection. Median follow-up was 13.7 months (interquartile range, 10.0-18.1 months). The rates of steroid-free clinical remission and clinical remission at week 26 were 47% (72/152) and 52% (79/152), and 46% (58/125), and 48% (60/125) at week 52, respectively. Risankizumab persistence rates were 94%, 89%, and 79% at weeks 12, 26, and 52, respectively. At the end of follow-up, 45 (45/174; 26%) patients had discontinued risankizumab (loss of response, 42%; primary failure, 37%; intolerance, 13%). Thirty-six patients (36/174; 20.9%) were hospitalized, and 22 (22/174; 12.6%) required intestinal resection. Fifty-one patients (29%) had an adverse event, including 26 (15%) serious adverse events (CD flare, n = 17). One death (myocardial infarction) and one cancer (papillary thyroid carcinoma) were observed. CONCLUSION: This is the first real-life study to report long-term outcomes in patients with refractory CD treated with risankizumab. One-half of the patients achieved steroid-free clinical remission after 1 year, and the safety profile was consistent with the literature.

Changes Over Time in the Lémann Index and the Inflammatory Bowel Disease Disability Index in a Prospective Cohort of Patients With Crohn's Disease.

BACKGROUND: Crohn's disease (CD) is a progressive, destructive, and disabling disorder. Our study aimed to assess changes over time in the Lémann index (LI) and the Inflammatory Bowel Disease Disability Index (IBD-DI) in a cohort of CD patients. METHODS: This was a single-center prospective cohort study of 130 consecutive CD patients with a follow-up of at least 4 years. The LI 1 and the IBD-DI 1 questionnaires were assessed in 2016 and again between September 2020 and October 2021 (LI 2 and IBD-DI 2). RESULTS: Of the 130 patients with assessment of both LI 1 and IBD-DI 1, 61 had calculation of the LI 2 and 98 patients answered the IBD-DI 2 questionnaire, with a median time between the 2 evaluations of 4.2 years. The LI increased for 16 (26%), decreased for 26 (43%), and remained unchanged for 19 (31%) patients. The median LI did not change over time (9.6 vs 9.3; P = .14). Clinical disease activity was significantly associated with bowel damage progression. A high initial LI (>7.9) was not associated with CD progression (surgery, drug dose escalation, or change of biologic). The IBD-DI decreased for 59 (60.2%), increased for 37 (37.8%), and remained unchanged for 2 (2%) patients. The median IBD-DI decreased significantly over time (23.2 vs 21.4; P = .006). There was no correlation between the 2 indexes. CONCLUSIONS: This is the first prospective cohort study assessing changes over time in both the LI and the IBD-DI in CD patients. After 4 years, the LI appeared to be stable and the IBD-DI decreased, with no correlation between the 2 indexes.

After a long period of follow-up (4 years) of patients with Crohn's disease, bowel damages (assessed by the Lémann index) appeared stable and disability (assessed by the Inflammatory Bowel Disease Disability Index) decreased, without there being any correlation between the 2 indexes over time.

Real-world comparison of the effectiveness between ustekinumab and vedolizumab in patients with ulcerative colitis exposed to at least one anti-TNF agent.

BACKGROUND: Both vedolizumab and ustekinumab can be considered for the treatment of ulcerative colitis (UC) but head-to-head trials are lacking. AIM: We aimed to compare the effectiveness of vedolizumab and ustekinumab after anti-TNF failure in UC patients. PATIENTS AND METHODS: In this multicenter study, we included consecutive adult patients with UC, with partial Mayo score >2 and prior anti-TNF exposure, treated with vedolizumab or ustekinumab between January 2019 and August 2022. Comparisons were performed using propensity score analyses (inverse probability of treatment weighting). RESULTS: Among a total of 293 patients included, 151 and 142 received vedolizumab and ustekinumab, respectively. After propensity-score analysis, steroid-free clinical remission (SFCR) (Mayo score partial ≤ 2) was achieved at week 16 in 38.0% and 40.3%, of patients treated with vedolizumab and ustekinumab, respectively (aOR = 1.11 [0.39-3.13], p = 0.85). Rate of SFCR in patients exposed to one line, 2 lines and 3 lines of biologics/small molecules among patients treated with vedolizumab and ustekinumab were respectively 53.3% vs 62.1% (p=0.52), 44.4% vs 33.8% (p=0.52) and 2.6% vs 19.1% (p=0.027). Endoscopic remission (SFCR and endoscopic Mayo score ≤1) and histological remission (SFCR, endoscopic remission and Nancy histological index ≤1) at W16 were achieved in respectively, 5.3% vs 17.5% (aOR = 3.77 [1.25-11.36], p=0.018) and 2.1% vs 11.1% (aOR = 5.85 [1.47-23.30], p=0.012) in vedolizumab and ustekinumab groups. No difference regarding the risk of drug discontinuation between the two groups (aHR = 1.03 [0.51-2.08], p = 0.92) were observed. While no factor was identified for vedolizumab, primary failure to at least one biologic/small molecule (OR=0.31, 95%CI [0.11-0.82], p=0.018) was significantly associated with decreased rate of SFCR among patients treated with ustekinumab. CONCLUSION: While no difference in terms of short-term clinical remission was observed, ustekinumab appears to be more effective than vedolizumab to induce endoscopic and histological remission at week 16 after failure of anti-TNFs in UC.