Background and Aims To evaluate the clinical outcomes in patients with IBD after switching from Remicade® to CT-P13 in comparison with patients who maintain Remicade®. Methods Patients under Remicade® who were in clinical remission with standard dosage at study entry were included. The ‘switch cohort’ [SC] comprised patients who made the switch from Remicade® to CT-P13, and the ‘non-switch’ cohort [NC] patients remained under Remicade®. Results A total of 476 patients were included: 199 [42%] in the SC and 277 [58%] in the NC. The median follow-up was 18 months in the SC and 23 months in the NC [p < 0.01]. Twenty-four out of 277 patients relapsed in the NC; the incidence of relapse was 5% per patient-year. The cumulative incidence of relapse was 2% at 6 months and 10% at 24 months in this group. Thirty-eight out of 199 patients relapsed in the SC; the incidence rate of relapse was 14% per patient-year. The cumulative incidence of relapse was 5% at 6 months and 28% at 24 months. In the multivariate analysis, the switch to CT-P13 was associated with a higher risk of relapse (HR = 3.5, 95% confidence interval [CI] = 2–6). Thirteen percent of patients had adverse events in the NC, compared with 6% in the SC [p < 0.05]. Conclusions Switching from Remicade® to CT-P13 might be associated with a higher risk of clinical relapse, although this fact was not supported in our study by an increase in objective markers of inflammation. The nocebo effect might have influenced this result. Switching from Remicade® to CT-P13 was safe.

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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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Project management, coordination, formal analysis, data preservation, first draft, revision and editing of the manuscript, methodology and research. Pilar Navajas Hernández: Data collection and preservation, revision and editing of the manuscript. María del Mar Martín Rodríguez: Data collection and preservation, revision and editing of the manuscript. Marta Lázaro Sáez: Data collection and preservation, formal analysis, first draft, revision and editing of the manuscript. Raúl Olmedo Martín: Data collection and preservation, revision and editing of the manuscript. Andrea Núñez Ortiz: Data collection and preservation, revision and editing of the manuscript. Federico Arguelles Arias: Data collection and preservation, revision and editing of the manuscript. María Carmen Fernández Cano: Data collection and preservation, revision and editing of the manuscript. Francisco Gallardo Sánchez: Data collection and preservation, revision and editing of the manuscript. Sandra Marín Pedrosa: Data collection and preservation, revision and editing of the manuscript.Javier González García: Data collection and preservation, revision and editing of the manuscript.Juan María Vázquez Morón: Project management, coordination, methodology, data collection and preservation, revision and editing of the manuscript. Conflicts of interest:A. Hernández has received payments as fees-for-service, participation in scientific meetings and funding for attendance from Abbvie, Ferring, Janssen, MSD, Pfizer, Sandoz and Takeda; M.M. Martín has received payments for advisory, participation in scientific meetings and attendance from MSD, Takeda, Janssen, Abbvie, Tillots Pharma, Chiesi and Ferring; M. Lázaro has received payments as fees-for-service, participation in scientific meetings and funding for attendance from Janssen, Pfizer and Takeda; R.Olmedo has received payments as fees-for-service and advisory from MSD, Abbvie, Takeda, Ferring, FAES Farma and Janssen; F. Arguelles has received payments for advisory, consultancy and research fundings from Janssen, MSD, Abbvie,