Geert D'Haens1, Walter Reinisch2, Jean-Frederic Colombel3, Julian Panes4, Subrata Ghosh5, Cosimo Prantera6, Stefan Lindgren7, Daniel W Hommes8, Zhiping Huang9, Judith Boice9, Susan Huyck9, Freddy Cornillie10. 1. Department of Gastroenterology, Academic MedicalCenter, Amsterdam, The Netherlands. 2. Klinische Abt. Gastroenterologie & Hepatologie, Medical University, Vienna, Austria and McMaster University, Hamilton, ON, Canada. 3. Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. 4. Department of Gastroenterology, Hospital Clinic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain. 5. Department of Gastroenterology, University of Calgary, Calgary, AB, Canada. 6. Department of Gastroenterology, A.O. San Camillo Forlanini, Rome, Italy. 7. Department of Gastroenterology, Lund University, University Hospital Skane, Malmö, Sweden. 8. Centre for Inflammatory Bowel Diseases, Univerisity of California Los Angeles, Los Angeles, CA, USA. 9. Centre for Biostatistics, Merck Inc., Kenilworth, NJ, USA. 10. Global Medical Affairs, MSD International GmbH, Lucerne, Switzerland.
Abstract
BACKGROUND AND AIMS: The ENCORE registry aimed at comparing the long-term safety of Crohn's disease [CD] treatment with infliximab [Remicade®] and with conventional therapies in real-world clinical practice. METHODS: The 5-year, prospective, observational ENCORE registry followed patients with CD in nine European countries, who received treatment with infliximab, conventional therapies, or switched to infliximab from conventional therapy. Adverse events [AEs] in pre-specified categories and serious AEs were recorded at least every 6 months of the 5-year observation period. Frequency of events was evaluated, and multivariable analyses using follow-up time [Cox proportion hazards model] and exposure time [Poisson regression] were used to identify risk factors for time to AEs in pre-specified categories. RESULTS: Patients who received infliximab [N = 1541], conventional therapies [N = 1121], or switched to infliximab [N = 298] were followed for medians of 60.4, 55.6, and 42.5 months, respectively. Infliximab median exposure was 18.7 and 19.3 months in the infliximab and switched-to-infliximab groups, respectively. In time-to-event Cox proportion hazards [PH] analyses adjusting for confounders, infliximab [vs conventional therapy] was associated with serious infections (hazard ratio [HR] = 1.64, 95% confidence interval [CI]: 1.17, 2.31] and haematological conditions [HR = 2.91, CI: 1.51, 5.59], and not associated with lymphoproliferative disorders/malignancy [HR = 1.44, CI: 0.86, 2.42] or death [HR = 1.22, CI: 0.63, 2.36]. Prednisone use was associated with higher mortality [HR = 3.58, CI: 1.49, 8.61]. In exposure-adjusted Poisson regression analyses, infliximab was associated with lower mortality (risk ratio [[RR] 0.39, CI: 0.17, 0.88]). CONCLUSIONS: Data from 5-year safety follow-up of patients with CD in the ENCORE registry demonstrate that infliximab [Remicade®] exposure is associated with increased risk of serious infections and haematological conditions, whereas mortality may be decreased.
BACKGROUND AND AIMS: The ENCORE registry aimed at comparing the long-term safety of Crohn's disease [CD] treatment with infliximab [Remicade®] and with conventional therapies in real-world clinical practice. METHODS: The 5-year, prospective, observational ENCORE registry followed patients with CD in nine European countries, who received treatment with infliximab, conventional therapies, or switched to infliximab from conventional therapy. Adverse events [AEs] in pre-specified categories and serious AEs were recorded at least every 6 months of the 5-year observation period. Frequency of events was evaluated, and multivariable analyses using follow-up time [Cox proportion hazards model] and exposure time [Poisson regression] were used to identify risk factors for time to AEs in pre-specified categories. RESULTS: Patients who received infliximab [N = 1541], conventional therapies [N = 1121], or switched to infliximab [N = 298] were followed for medians of 60.4, 55.6, and 42.5 months, respectively. Infliximab median exposure was 18.7 and 19.3 months in the infliximab and switched-to-infliximab groups, respectively. In time-to-event Cox proportion hazards [PH] analyses adjusting for confounders, infliximab [vs conventional therapy] was associated with serious infections (hazard ratio [HR] = 1.64, 95% confidence interval [CI]: 1.17, 2.31] and haematological conditions [HR = 2.91, CI: 1.51, 5.59], and not associated with lymphoproliferative disorders/malignancy [HR = 1.44, CI: 0.86, 2.42] or death [HR = 1.22, CI: 0.63, 2.36]. Prednisone use was associated with higher mortality [HR = 3.58, CI: 1.49, 8.61]. In exposure-adjusted Poisson regression analyses, infliximab was associated with lower mortality (risk ratio [[RR] 0.39, CI: 0.17, 0.88]). CONCLUSIONS: Data from 5-year safety follow-up of patients with CD in the ENCORE registry demonstrate that infliximab [Remicade®] exposure is associated with increased risk of serious infections and haematological conditions, whereas mortality may be decreased.
Authors: Aditi Kumar; Alexander Cole; Jonathan Segal; Philip Smith; Jimmy K Limdi Journal: Therap Adv Gastroenterol Date: 2022-02-17 Impact factor: 4.409
Authors: Chelle L Wheat; Cynthia W Ko; Kindra Clark-Snustad; David Grembowski; Timothy A Thornton; Beth Devine Journal: BMC Gastroenterol Date: 2017-04-14 Impact factor: 3.067