Subcutaneous Golimumab in Pediatric Ulcerative Colitis

Jeffrey S. Hyams*, Daphne Chan, Omoniyi J. Adedokun, Lakshmi Padgett, Dan Turner, Anne Griffiths, Genevieve Veereman, Melvin B. Heyman, Joel R. Rosh, Ghassan Wahbeh, Richard Strauss

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

33 Scopus citations

Abstract

Background: Current treatments for pediatric ulcerative colitis (UC) are limited.We evaluated the pharmacokinetics and clinical benefits of subcutaneous golimumab, an anti-tumor necrosis factor agent, in moderately-to-severely active pediatric patients with UC refractory to conventional therapy. Methods: We report a multicenter, open-label study of golimumab with a pharmacokinetics phase (week 0 14). Patients had moderately-to-severely active UC and were naive to anti-tumor necrosis factor treatment. At weeks 0 and 2, patients received golimumab induction dosed by weight (,45 kg [90/45 mg/m2]; $45 kg [200/100 mg]). Week 6 clinical responders continued golimumab q4w. Serum golimumab concentrations, clinical outcomes (Mayo score, PUCAI score), and adverse events are reported. Results: Thirty-five patients (71.4% pancolitis) aged 6 to 17 years had baseline median (interquartile range), age, weight, and disease duration of 15.0 (11.0 16.0) years, 50.6 (35.2 59.0) kg, and 1.2 (0.6 3.1) years, respectively. Baseline Mayo and PUCAI scores were 8.0 (6.0 9.0) and 45 (35.0 65.0), respectively. Median (interquartile range) serum golimumab concentrations were comparable to a historical reference adult UC population at weeks 2 (5.72 [3.80 9.17] mg/mL), 4 (7.61 [3.22 9.51] mg/mL), and 6 (2.64 [0.92 3.83] mg/mL). Serum golimumab concentrations were generally lower in the ,45 kg than $45 kg weight subgroup. At week 6, 60%, 34%, and 54%, of patients achieved Mayo clinical response, PUCAI clinical remission, and mucosal healing (Mayo subscore 0/1). No clinically important safety concerns were reported. Conclusions: This open-label study demonstrates that pediatric and adult golimumab pharmacokinetics are similar. Clinical benefit and safety shows promise in biologically naive pediatric patients with UC.

Original languageAmerican English
Pages (from-to)2227-2237
Number of pages11
JournalInflammatory Bowel Diseases
Volume23
Issue number12
DOIs
StatePublished - 2017

Bibliographical note

Publisher Copyright:
Copyright 2017 Crohn s & Colitis Foundation.

Keywords

  • anti-TNFα
  • children
  • clinical remission
  • clinical response
  • golimumab concentrations
  • inflammatory bowel disease
  • mucosal healing

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