201. Five-year Safety Data From ENCORE, a European Observational Safety Registry for Adults With Crohn's Disease Treated With Infliximab [Remicade (R)] or Conventional Therapy
- Author
-
Daniel W. Hommes, Cosimo Prantera, Judith A. Boice, Jean-Frederic Colombel, Zhiping Huang, Freddy Cornillie, Geert R. D'Haens, Subrata Ghosh, Walter Reinisch, Susan Huyck, Stefan Lindgren, Julián Panés, Gastroenterology and Hepatology, and AGEM - Amsterdam Gastroenterology Endocrinology Metabolism
- Subjects
Male ,Time Factors ,Anti-Inflammatory Agents ,0302 clinical medicine ,Crohn Disease ,Risk Factors ,Prednisone ,Azathioprine ,Prospective Studies ,Registries ,Infusions, Intravenous ,Mesalamine ,Prospective cohort study ,Aged, 80 and over ,Gastrointestinal agent ,Drug Substitution ,Mercaptopurine ,Hazard ratio ,Gastroenterology ,General Medicine ,Middle Aged ,Anti-Bacterial Agents ,030220 oncology & carcinogenesis ,Drug Therapy, Combination ,Female ,030211 gastroenterology & hepatology ,Immunosuppressive Agents ,medicine.drug ,Adult ,Narcotics ,medicine.medical_specialty ,Adolescent ,Infections ,Young Adult ,03 medical and health sciences ,Gastrointestinal Agents ,Internal medicine ,medicine ,Humans ,Mortality ,Adverse effect ,Aged ,business.industry ,Hematologic Diseases ,Infliximab ,Lymphoproliferative Disorders ,Confidence interval ,Surgery ,Sulfasalazine ,Methotrexate ,Relative risk ,business ,Demyelinating Diseases - 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.
- Published
- 2017