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.

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.

Selective inner muscle layer myotomy is associated with lower pain and same clinical efficacy that full-thickness myotomy in patients treated by POEM for achalasia: A multicenter retrospective comparative analysis of 158 patients.

INTRODUCTION: The aim of this study was to compare the impact of the depth of myotomy (selective inner layer myotomy (SIM) vs. full-thickness myotomy (FTM)) on the outcome of patients treated with POEM for achalasia. METHODS: This was a retrospective, observational, conducted in two tertiary centers between October 2018 and September 2022. Patients were divided into two groups: SIM and FTM. The primary endpoint was clinical efficacy at 6 months, while secondary endpoints were postoperative criteria (such as pain, length of hospital stay, complications) and occurrence of gastroesophageal reflux disease (GERD) (esophagitis at 6 months, heartburn, and pH-metry). RESULTS: 158 patients were included in the study (33 in the FTM group and 125 in the SIM group). The success rates at 6 and 12 months were similar in both groups, with 84 % and 70 % in the SIM group versus 90 % and 80 % in the FTM group, respectively (p = 0.57 and p = 0.74). However, more opioid analgesics were consumed in the FTM group compared to the SIM group (41% vs 21 %, p < 0.01). The length of hospitalization was longer in the FTM group than in the SIM group (2.17 ± 2.62 vs 2.94 ± 2.33, p < 0.001). The rate of esophagitis at 6 months was comparable (16 % in the SIM group vs 12 % in the FTM group, p = 0.73). There was no significant difference in terms of heartburn at 6 or 12 months between the SIM and FTM groups (18.5% vs 3.8 %, p = 0.07 and 27% vs 12.5 %, p = 0.35, respectively). CONCLUSION: There was no significant difference in terms of clinical efficacy and GERD occurrence between FTM and SIM. However, full-thickness myotomy was associated with more postoperative pain and a longer length of hospital stay. Therefore, selective internal myotomy should be preferred over full-thickness myotomy.

Patient preferences for adalimumab in inflammatory bowel disease: a nationwide study from the GETAID.

Background: Several adalimumab preparations are now available for patients with inflammatory bowel disease (IBD). Comparative satisfaction and tolerability are unknown. Objectives: This study investigated IBD patient satisfaction with approved adalimumab biosimilars and their originator. Design: In this cross-sectional study, we included 941 consecutive adalimumab-treated patients with IBD across 45 centres affiliated with the Groupe d'Etude Therapeutique des Affections Inflammatoires du tube Digestif who completed a satisfaction questionnaire comprising four items each rated by a 10-point scale. Methods: The differences in responses were performed using a one-way analysis of variance followed by Tukey's honest significant difference test. Results: The most commonly used drugs at inclusion were Humira® (436/941, 46.3%), Amgevita® (177/941, 18.8%) and Hulio® (105/941, 11.2%). The mean overall satisfaction rate with adalimumab was 8.5 (standard deviation 1.8). Overall satisfaction was significantly higher in patients treated with Humira (8.6 (1.5)), Hulio (8.6 (1.8)) or Amgevita (8.5 (1.4)) (p < 0.05). Satisfaction with the subcutaneous injection form was higher for patients treated with Yuflyma® (9.0 (1.4)), Humira (8.9 (1.3)) and Hulio (8.9 (1.7)) (p < 0.05). A total of 299 patients (31.8%) described injection site reactions. In all, 223 patients (23.7%) reported being previously treated with another adalimumab of which (32/223, 14.3%) discontinued treatment due to side effects. Conclusion: In this real-world setting, patients with IBD had a high level of satisfaction with adalimumab treatment, with some differences in terms of overall satisfaction and satisfaction with the injection device.