Pediatric Gastroenterology, Hepatology & Nutrition

The Korean Society of Pediatric Gastroenterology, Hepatology and Nutrition (대한소아소화기영양학회)
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Long-Term Efficacy and Safety of Golimumab for Ulcerative Colitis in a Pediatric Inflammatory Bowel Disease Center in Japan

  • Tokita, Kazuhide (Center for Pediatric Inflammatory Bowel Disease, Division of Gastroenterology, National Center for Child Health and Development) ;
  • Shimizu, Hirotaka (Center for Pediatric Inflammatory Bowel Disease, Division of Gastroenterology, National Center for Child Health and Development) ;
  • Takeuchi, Ichiro (Center for Pediatric Inflammatory Bowel Disease, Division of Gastroenterology, National Center for Child Health and Development) ;
  • Shimizu, Toshiaki (Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine) ;
  • Arai, Katsuhiro (Center for Pediatric Inflammatory Bowel Disease, Division of Gastroenterology, National Center for Child Health and Development)
  • Received : 2022.02.14
  • Accepted : 2022.08.09
  • Published : 2022.11.15
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Abstract

Purpose: Golimumab (GLM) is an anti-tumor necrosis factor (TNF)-α antibody preparation known to be less immunogenic than infliximab (IFX) or adalimumab. Few reports on GLM in pediatric patients with ulcerative colitis (UC) are available. This study aimed to review the long-term durability and safety of GLM in a pediatric center. Methods: The medical records of 17 pediatric patients (eight boys and nine girls) who received GLM at the National Center for Child Health and Development were retrospectively reviewed. Results: The median age at GLM initiation was 13.9 (interquartile range 12.0-16.3) years. Fourteen patients had pancolitis, and 11 had severe disease (pediatric ulcerative colitis activity index ≥65). Ten patients were biologic-naive, and 50% achieved corticosteroid-free remission at week 54. Two patients discontinued prior anti-TNF-α agents because of adverse events during remission. Both showed responses to GLM without unfavorable events through week 54. However, the efficacy of GLM in patients who showed primary nonresponse or loss of response to IFX was limited. Four of the five patients showed non-response at week 54. Patients with severe disease had significantly lower corticosteroid-free remission rate at week 54 than those without severe disease. No severe adverse events were observed during the study period. Conclusion: GLM appears to be safe and useful for pediatric patients with UC. Patients with mild to moderate disease who responded to but had some adverse events with prior biologics may be good candidates for GLM. Its safety and low immunogenicity profile serve as favorable options for selected children with UC.

Keywords

Acknowledgement

This work was supported by a Grant-in-Aid for the National Center for Child Health and Development (2019A-3) and Research Grants for Research on Intractable Disease (20FC1042) from the Ministry of Health, Labour and Welfare, Japan.

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