Background Large real-world-evidence studies are required to confirm the durability of response, effectiveness, and safety of ustekinumab in Crohn’s disease (CD) patients in real-world clinical practice. Methods A retrospective, multicentre study was conducted in Spain in patients with active CD who had received ≥1 intravenous dose of ustekinumab for ≥6 months. Primary outcome was ustekinumab retention rate; secondary outcomes were to identify predictive factors for drug retention, short-term remission (week 16), loss of response and predictive factors for short-term efficacy and loss of response, and ustekinumab safety. Results A total of 463 patients were included. Mean baseline Harvey-Bradshaw Index was 8.4. A total of 447 (96.5%) patients had received prior biologic therapy, 141 (30.5%) of whom had received ≥3 agents. In addition, 35.2% received concomitant immunosuppressants, and 47.1% had ≥1 abdominal surgery. At week 16, 56% had remission, 70% had response, and 26.1% required dose escalation or intensification; of these, 24.8% did not subsequently reduce dose. After a median follow-up of 15 months, 356 (77%) patients continued treatment. The incidence rate of ustekinumab discontinuation was 18% per patient-year of follow-up. Previous intestinal surgery and concomitant steroid treatment were associated with higher risk of ustekinumab discontinuation, while a maintenance schedule every 12 weeks had a lower risk; neither concomitant immunosuppressants nor the number of previous biologics were associated with ustekinumab discontinuation risk. Fifty adverse events were reported in 39 (8.4%) patients; 4 of them were severe (2 infections, 1 malignancy, and 1 fever). Conclusions Ustekinumab is effective and safe as short- and long-term treatment in a refractory cohort of CD patients in real-world clinical practice.

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Objective: rectal diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that is used to prevent pancreatitis in high-risk patients during endoscopic retrograde cholangiopancreatography (ERCP). The European Society of Gastrointestinal Endoscopy (ESGE) recommends the use of prophylaxis with indomethacin or diclofenac in all patients undergoing ERCP, including those at low or intermediate risk of pancreatitis. A study to investigate the efficacy of this recommendation was performed.Methods: this was a mixed cohort study. A total of 1,512 ERCP procedures performed in our institution from January 2009 to July 2016 were included in the study. Until June 2012, 718 patients did not receive diclofenac. Subsequently, 794 patients without contraindications received 100 mg of rectal diclofenac at the onset of the procedure.Risk factors for post-ERCP pancreatitis (PEAP) and PEAP cases defined using consensus criteria were recorded.Results: a total of 47 PEAP events (3.1%) were reported, 3.4% in the diclofenac group and 2.8% in the non-diclofenac group (p = 0.554); 26.1% of patients had risk factors for PEAP. In the diclofenac group, PEAP developed in 4.4%, 0.5% and 2.6% of subjects with intact papillae, prior sphincterotomy and extended sphincterotomy, respectively. The results were similar for the non-diclofenac group: 4% with intact papillae, 0.9% with prior sphincterotomy, and 2.5% with extended sphincterotomy, respectively. PEAP severity was similar in both groups.Conclusions: rectal diclofenac before ERCP did not prevent the development of post-ERCP acute pancreatitis in non-selected consecutive patients.

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