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* = Presenting author

P436. Malignancies in children receiving infliximab and other inflammatory bowel disease therapies: an inflammatory bowel disease multicenter, prospective, long-term registry of pediatric patients (DEVELOP) registry data

R. Colletti1, S. Cucchiara2, M. Dubinsky3, J. Escher4, W. Faubion5, J. Fell6, B. Gold7, A. Griffiths8, J. Hyams9, S. Koletzko10, S. Kugathasan11, H. Winter12, R. Baldassano13, J. Markowitz14, F.M. Ruemmele15, P. Callegari16, M. Molenda16, L. Tang16, R. Wright16, G. Veereman17, 1University of Vermont, United States, 2University of Rome, Italy, 3Cedars-Sinai Medical Center, United States, 4Erasmus MC-Sophia Children's Hospital, Netherlands, 5Mayo Clinic, United States, 6Chelsea and Westminster Hospital, United Kingdom, 7Children's Center for Digestive Healthcare Pediatric Gastroenterology, United States, 8Hospital for Sick Children, Canada, 9Connecticut Children's Medical Center, United States, 10Ludwig Maximilians University, Germany, 11Emory University School of Medicine, United States, 12MassGeneral Hospital for Children, United States, 13Children's Hospital of Philadelphia, United States, 14Cohen Children's Medical Center of New York, United States, 15Hôpital Necker-Enfants Malades, France, 16Janssen Services, LLC, United States, 17KCE-Belgian Health Care Knowledge Centre, Belgium

Background

The occurrence of malignancies in pediatric patients with inflammatory bowel disease (IBD) treated with immunomodulators (IM) and/or anti-TNF α agents is a concern. To evaluate malignancies in pediatric IBD patients from the DEVELOP registry.

Methods

DEVELOP is an international observational registry, to document the natural history of pediatric IBD along with the safety of current and emerging therapies in use. Malignancy event rates from DEVELOP were compared with the expected event rates using the SEER database, adjusted for age, gender, and race. Standardized incidence ratios (SIRs) were estimated by dividing the number of patients with malignancies observed with expected number of patients with malignances for age-adjusted United States based on SEER.

Results

4343 pts (7883 pt-yrs [PY]) enrolled as of 6/30/12; 2586 were exposed to anti-TNF biologics, 2503 received IFX (4347PY), and 1757 received non-biologic therapies (3369 PY). 4 patients were exposed to IFX prior to a malignant event of which 2 were exposed to IFX prior to development of basal cell carcinoma and malignant melanoma, and 2 were exposed to both IFX and adalimumab prior to the development of acute monocytic leukemia and adenocarcinoma of the parotid gland. 3 patients exposed to non-biologic treatments developed malignancy: haematophagic histiocytosis, Hodgkin's disease, and malignant lymphohistiocytosis. The incidence of malignancies was similar among all 3 exposure cohorts each with an event rate of 0.09 per 100 PY. All patients had prior exposure to IM (1 azathioprine [AZA], 6 6-mercaptopurine [6-MP], and 2 methotrexate [MTX]). Comparisons between DEVELOP and SEER data yielded a SIR of 4.96 (95% CI 1.35, 12.69) for IFX exposed patients, 4.77 (95% CI 1.30, 12.20) for anti-TNF exposed patients and 5.09 (95% CI: 1.05, 14.86) for non-biologic therapies. Among those who were also exposed to immunomodulators, an increase SIR was observed: IFX (n = 1973) (SIR 5.98; 95% CI (1.63, 15.31), anti-TNF (n = 2042) (SIR 5.73; 95% CI: 1.56, 14.67) non-biologics (n = 1171) (SIR 7.12; 95% CI: 1.47, 20.79). Among patients who were not exposed to immunomodulators (n = 1130), no malignant events were reported.

Conclusion

Compared to children with IBD treated with other therapies, IFX did not significantly increase the risk of malignancies. Patients who were exposed to immunomodulators had a higher incidence of malignancy and higher SIR rates than those not exposed to immunomodulators.