LAS VEGAS — Despite established guidance on dosing amounts and maintenance intervals, few pediatric patients with inflammatory bowel disease receive brand-name Remicade in those doses or at those time intervals, an expert said at the Crohn’s & Colitis Congress.
“In the international DEVELOP pediatric IBD, standard dosing of originator infliximab is the exception rather than the rule. The median maintenance doses used in Crohn’s disease, ulcerative colitis and IBD-U are all higher than the labeled dose of 5 mg/kg,” Anne Griffiths, MD, of The Hospital for Sick Children, University of Toronto, said during her presentation. “In UC and IBD-U, the median maintenance interval is also shorter than the labeled interval of every 8 weeks.”
Griffiths presented data from the international, multicenter, prospective, observational registry of the long-term safety and clinical status of 6,070 pediatric patients with IBD (Crohn’s n = 4,122; UC n = 1,643; IBD-U n = 305). Patients were enrolled from 2007 to 2017 and median age at enrollment was 13 years. Data through June 30, 2018 were analyzed and included 33,586.4 patient years (PY) of follow-up. Originator infliximab (Remicade, Janssen) follow-up comprised 14,537 PY.
Approximately half of the registry (47.5%) received originator infliximab prior to enrollment, a percentage reflected throughout the IBD diagnoses, Griffiths said. After baseline visit, another 20% of patients received originator infliximab, with a total of 67.7% exposed at some point. The median number of infusions with originator infliximab was 17 with a mean duration of 38.9 months, she added.
Looking at all of these patients, Griffiths and colleagues found that patients received a mean dosing of 7 mg/kg rather than the suggested 5 mg/kg. In looking at median maintenance dosing frequency, patients with CD were at 8 weeks but patients with UC were at 7 weeks and patients with IBD-U only 6 weeks.
During the follow-up period, 27.3% of patients discontinued originator infliximab, with the median interval between first dose and discontinuation of 20.9 months. Discontinuation was attributed to loss of efficacy in 47% of patients, followed by adverse events, administration reactions and patient choice.
Griffiths acknowledged there are restrictions with the study.
“There may be inconsistencies with how originator infliximab is administered, such as giving a full vial instead of a half vial, and because some sites may see patients with more advance disease progression, higher doses may be needed, reflecting a bias of the registry design,” she said. – by Katrina Altersitz
Griffiths A. Abstract 1. Presented at: Crohn’s & Colitis Congress; Feb. 7-9, 2019; Las Vegas.
Disclosures: Griffiths reports acting as a consultant for AbbVie, Janssen, Merck, Pfizer, Gilead, Lilly, Roche and Shire; and serving on advisory committees for AbbVie and Janssen.