Original article—alimentary tractInduction and Maintenance Therapy With Infliximab for Children With Moderate to Severe Ulcerative Colitis
Section snippets
Eligibility
Eligible patients were 6–17 years old, inclusive, with moderately to severely active UC (defined as having a baseline [ie, week 0] Mayo score12 of 6–12 points, including an endoscopy subscore ≥2). A UC diagnosis, confirmed by biopsy, must have been established ≥2 weeks before screening. Patients must have failed to respond to adequate treatment with or have experienced medical complications or adverse effects from 5-aminosalicylic acid (5-ASA); compounds, immunomodulators (6-mercaptopurine
Patient Disposition, Baseline Characteristics, and Prior Concomitant Medication Use
Twenty-three investigative sites participated in the United States and Canada (52 of 60 patients, 86.7%) and Belgium and the Netherlands (8 of 60 patients, 13.3%).
All patients were receiving baseline UC medications (Table 1). Among enrolled patients, 53.3% (32 of 60 patients) were female, 81.7% (49 of 60 patients) were white, median age was 14.5 years, median C-reactive protein level was 0.3 mg/dL, median disease duration was 1.4 years, and 76.7% (46 of 60 patients) had extensive disease. The
Discussion
Our study achieved the primary efficacy end point of clinical response at week 8. Infliximab induced clinical response in 73.3% of patients. The criterion for a positive study was met because the lower limit of the 95% CI for the proportion of patients in clinical response was 62.1%, which is greater than the protocol-specified limit of 40%.
Efficacy was also demonstrated by multiple other measures and end points. Infliximab induced Mayo and PUCAI clinical remission in at least one-third of
Acknowledgements
Editorial and writing support was provided by James P. Barrett, an employee of the Medical Affairs Publications Group, Janssen Biotech, Inc. Members of the T72 Study Group are listed in the Appendix.
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Conflicts of interest The authors disclose the following: Jeffrey Hyams, Harland S. Winter, Subra Kugathasan, Stanley Cohen, James Markowitz, Johanna Escher, Gigi Veereman-Wauters, Wallace Crandall, Robert Baldassano, and Anne Griffiths received research funding in conjunction with the conduct of this study. Jeffrey Hyams, James Markowitz, and Anne Griffiths received research funding in conjunction with other studies sponsored by Janssen Research & Development, LLC. Jeffry Hyams, Harland S. Winter, Subra Kugathasan, James Markowitz, Wallace Crandall, Robert Baldassano, and Anne Griffiths served as Consultants to Janssen Research & Development, LLC. Marion Blank, Lakshmi Damaraju, Jewel Johanns, and Cynthia Guzzo are employees of Janssen Research & Development, LLC. Subra Kugathasan, James Markowitz, and Wallace Crandall received honoraria from Janssen Research & Development, LLC. Stanley Cohen received other research grants from and chaired conferences sponsored by Janssen Research & Development, LLC.
Funding Janssen Research & Development, LLC, provided support for this study.