Inflammatory Bowel Diseases

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Inflammatory Bowel Diseases:
doi: 10.1097/01.MIB.0000435438.84365.f7
Original Clinical Articles

Pharmacokinetics of Infliximab in Children with Moderate-to-Severe Ulcerative Colitis: Results from a Randomized, Multicenter, Open-label, Phase 3 Study

Adedokun, Omoniyi J. MS, RPh*; Xu, Zhenhua PhD*; Padgett, Lakshmi PhD; Blank, Marion PhD; Johanns, Jewel PhD§; Griffiths, Anne MD; Ford, Joyce MS; Zhou, Honghui PhD*; Guzzo, Cynthia MD; Davis, Hugh M. PhD; Hyams, Jeffrey MD**

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Background: To assess infliximab pharmacokinetics in pediatric ulcerative colitis (UC).

Methods: This phase 3, randomized, open-label multicenter study enrolled 60 children (6–17 yr) with moderate-to-severely active UC (Mayo score, 6–12; endoscopic subscore, ≥2), despite conventional therapy. Patients received infliximab 5-mg/kg induction infusions at weeks 0, 2, and 6. Week 8 clinical responders (n = 45) were randomized to infliximab 5 mg/kg given every 8 weeks (q8w) through week 46 or every 12 weeks (q12w) through week 42. Patients losing response during maintenance infliximab were eligible to increase the dose (5→10 mg/kg) and/or shorten the dosing interval (q12w→q8w). Blood samples were collected for infliximab concentration and pharmacokinetic determinations.

Results: Infliximab pharmacokinetics were not influenced by age (6–11 yr versus 12–17 yr), baseline immunomodulator use, or the extent of UC. At week 8, higher serum infliximab concentrations (≥41.1 μg/mL) were associated with greater proportions of patients achieving efficacy endpoints (clinical response, 92.9%; mucosal healing, 92.9%; and clinical remission, 64.3%) versus those with lower serum concentrations (<18.1 μg/mL; 53.9%, 53.9%, and 30.8%, respectively). At week 30, higher median trough serum infliximab concentrations were observed with infliximab 5 mg/kg q8w (1.9 μg/mL) versus q12w (0.8 μg/mL) and with infliximab 10 mg/kg (2.9 μg/mL) versus 5 mg/kg (1.1 μg/mL) among patients who are regimen adjusted.

Conclusions: Infliximab pharmacokinetics/exposure–response relationship in patients with UC aged 6 to 17 years were generally comparable with those observed in reference adult UC populations, supporting using infliximab 5 mg/kg at weeks 0, 2, and 6 followed by maintenance dosing with 5 mg/kg q8w in these patients. A positive relationship was noted between serum infliximab level and clinical effect following induction therapy similar to adults.

© Crohn's & Colitis Foundation of America, Inc.

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