Safety and Durability of Accelerated Infliximab Dosing Strategies in Pediatric IBD
A Single Center, Retrospective Study
Meghan Gibson MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorShova Subedi MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorDavid H. Barker PhD
Department of Child and Adolescent Psychiatry, Rhode Island Hospital, Providence, RI
Search for more papers by this authorSamuel Masur MD
Warren Alpert Medical School of Brown University, Providence, RI
Department of Pediatrics, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorMeaghan M. Mallette MPA
Lifespan Biostatistics Core, Rhode Island Hospital, Providence, RI
Search for more papers by this authorArchana Lingannan MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorAldo Alejandro Recinos Soto MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorDyadin Esharif MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorSarah H. Maxwell MD
Warren Alpert Medical School of Brown University, Providence, RI
Department of Pediatrics, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorMuhammad Safwan Riaz MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorMichael I. Herzlinger MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorLinda B. Shalon MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorCarolina S. Cerezo MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorVania L. Kasper MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorAlbert M. Ross MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorNeal S. Leleiko MD, PhD
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Columbia University Irving Medical Center, New York, NY
Search for more papers by this authorCorresponding Author
Jason M. Shapiro MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Address correspondence and reprint requests to Jason M. Shapiro, MD, Division of Pediatric Gastroenterology, Nutrition and Liver Diseases, Hasbro Children’s Hospital and Rhode Island Hospital, Warren Alpert Medical School of Brown University, 593 Eddy Street, Providence, RI 02903 (e-mail: [email protected]).Search for more papers by this authorMeghan Gibson MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorShova Subedi MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorDavid H. Barker PhD
Department of Child and Adolescent Psychiatry, Rhode Island Hospital, Providence, RI
Search for more papers by this authorSamuel Masur MD
Warren Alpert Medical School of Brown University, Providence, RI
Department of Pediatrics, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorMeaghan M. Mallette MPA
Lifespan Biostatistics Core, Rhode Island Hospital, Providence, RI
Search for more papers by this authorArchana Lingannan MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorAldo Alejandro Recinos Soto MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorDyadin Esharif MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorSarah H. Maxwell MD
Warren Alpert Medical School of Brown University, Providence, RI
Department of Pediatrics, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorMuhammad Safwan Riaz MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorMichael I. Herzlinger MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorLinda B. Shalon MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorCarolina S. Cerezo MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorVania L. Kasper MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorAlbert M. Ross MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Search for more papers by this authorNeal S. Leleiko MD, PhD
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Columbia University Irving Medical Center, New York, NY
Search for more papers by this authorCorresponding Author
Jason M. Shapiro MD
Warren Alpert Medical School of Brown University, Providence, RI
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Hasbro Children’s Hospital, Providence, RI
Address correspondence and reprint requests to Jason M. Shapiro, MD, Division of Pediatric Gastroenterology, Nutrition and Liver Diseases, Hasbro Children’s Hospital and Rhode Island Hospital, Warren Alpert Medical School of Brown University, 593 Eddy Street, Providence, RI 02903 (e-mail: [email protected]).Search for more papers by this authorThe authors report no conflicts of interest.
M.G. and S.S. contributed equally to the article.
Abstract
Objectives:
Infliximab (IFX) is commonly used to treat children with inflammatory bowel disease (IBD). We previously reported that patients with extensive disease started on IFX at a dose of 10 mg/kg had greater treatment durability at year one. The aim of this follow-up study is to assess the long-term safety and durability of this dosing strategy in pediatric IBD.
Methods:
We performed a retrospective single-center study of pediatric IBD patients started on IFX over a 10-year period.
Results:
Two hundred ninety-one patients were included (mean age = 12.61, 38% female) with a follow-up range of 0.1–9.7 years from IFX induction. One hundred fifty-five (53%) were started at a dose of 10 mg/kg. Only 35 patients (12%) discontinued IFX. The median duration of treatment was 2.9 years. Patients with ulcerative colitis (P ≤ 0.01) and patients with extensive disease (P = 0.01) had lower durability, despite a higher starting dose of IFX (P = 0.03). Adverse events (AEs) were observed to occur at a rate of 234 per 1000 patient-years. Patients with a higher serum IFX trough level (≥20 µg/mL) had a higher rate of AEs (P = 0.01). Use of combination therapy had no impact on risk of AEs (P = 0.78).
Conclusions:
We observed an excellent IFX treatment durability, with only 12% of patients discontinuing therapy over the observed timeframe. The overall rate of AEs was low, the majority being infusion reactions and dermatologic conditions. Higher IFX dose and serum trough level> 20 µg/mL were associated with higher risk of AEs, the majority being mild and not resulting in cessation of therapy.
Graphical Abstract
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