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15. Serious infections and associated risk factors in patients receiving infliximab and immunotherapies for children with inflammatory bowel disease: DEVELOP registry data

R. Baldassano1, R. Colletti2, S. Cucchiara3, M. Dubinsky4, J. Escher5, W. Faubion6, J. Fell7, B. Gold8, A. Griffiths9, J. Hyams10, S. Koletzko11, S. Kugathasan12, J. Markowitz13, F.M. Ruemmele14, G. Veereman15, P. Callegari16, M. Molenda16, K.L. Tang17, R. Wright16, H. Winter18, 1Children's Hospital of Philadelphia, United States, 2University of Vermont, United States, 3University of Rome, Italy, 4Cedars-Sinai Medical Center, United States, 5Erasmus MC-Sophia Children's Hospital, Netherlands, 6Mayo Clinic, United States, 7Chelsea and Westminster Hospital, United Kingdom, 8Children's Center for Digestive Healthcare Pediatric Gastroenterology, United States, 9Hospital for Sick Children, Canada, 10Connecticut Children's Medical Center, United States, 11Ludwig Maximilians University, Germany, 12Emory University School of Medicine, United States, 13Cohen Children's Medical Center of New York, United States, 14Hôpital Necker-Enfants Malades, France, 15KCE-Belgian Health Care Knowledge Centre, Belgium, 16Janssen Services, LLC, United States, 17Janssen Biotech, Inc, United States, 18MassGeneral Hospital for Children, United States


DEVELOP is a prospective observational registry designed to study long-term safety of infliximab (IFX) and other therapies in childhood-onset IBD (Crohn's disease [CD], ulcerative colitis [UC] and indeterminate colitis [IC]). To identify serious infections (SI) and associated risk factors in pediatric IBD pts from DEVELOP.


Data were obtained from 86 centers in North America and Europe from 2007 to 2012. We performed a Cox proportional hazard regression model on time to first SI to evaluate associations of SI and pts receiving anti-TNFα agents and immunomodulators (IM). We categorized SI events and evaluated pts who experienced SI within 91 days of IFX, other anti-TNFα exposure, or within 31 days of IM exposure.


4343 pts (7883 pt-yrs [PY]) were enrolled as of 6/30/12, 2586 were exposed to anti-TNF biologics, including 2503 who received IFX (4347 PY). 1757 pts received only non-biologic therapies (3369 PY). Factors associated with significant risk (p < 0.05) of SI were (adjusted hazard ratio, 95% CI): younger age at baseline (0.92, 0.86–0.97), hospitalizations in the year prior to enrollment (1.81, 1.27–2.59), time-dependent IFX use (2.00, 1.38–2.91), time-dependent IM use (1.58, 1.07–2.34), and time-dependent PGA score (1.23, 1.06–1.44) (time-dependent variables reflected response status at each 6-month visit for a pt). Pts with anti-TNF exposure in the last 91 days showed a significant increased risk of SI in the categories of number of SI (5.82 vs. 2.89 events per 100 pt yr for exposed vs. nonexposed), especially on the subcategories of superficial infections, & abdominal abscess; & a trend of an increased risk of significant viral infections. IFX exposed pts showed a trend of an increase risk of number of SI (4.88 vs. 3.65 events per 100 pt yr for exposed vs. nonexposed), & a significant increase risk on superficial infections. There were no differences in all categories for IM exposure within 31 days of SI.


Time-dependent IFX use and hospitalizations in the year prior to enrollment conferred an approximate 2-fold increased risk for SI. Clinically significant risks for SI are associated with younger age, time-dependent IM use and time-dependent higher PGA score. IFX and anti-TNF exposed pts have an increased risk in general of SI and of superficial infections within 91 days of exposure. Anti-TNF exposure appeared to increase the risk of abdominal abscess and significant viral infections. No difference in SI for IM exposure within 31 days was observed.