OBJECTIVES: Ulcerative colitis (UC) is an autoimmune chronic inflammatory bowel disease. Tumor necrosis factor-α-antagonist monoclonal antibodies are first-line biologicals used in adult patients with moderate-to-severe UC. However, infliximab is the only approved biological therapy for children with UC. With this understanding, golimumab might be another option for pediatric moderate-to-severe UC. This study aims to evaluate the efficacy and safety of golimumab in pediatric UC patients.

METHODS: Medline and Embase via the OVID platform were searched through June 2022 for studies assessing the efficacy and safety of golimumab in pediatric UC patients. No restriction on the year of publication was applied. Two reviewers independently searched for articles and extracted data, resolving differences through consensus.

RESULTS: Of 163 identified studies, one single-arm trial was included with three associated publications. The trial was conducted for 126 weeks. At week 6, Hyams et al. 2022 reported Mayo clinical response in 60%, Mayo clinical remission in 43%, pediatric ulcerative colitis activity index (PUCAI) clinical remission in 34%, and mucosal healing in 54% of patients, respectively. Of the 60% of patients who achieved Mayo clinical response, PUCAI remission was observed in 45%, 55%, and 50% of patients at weeks 30, 54, and 126, respectively. Through week 14, 20 patients entered long-term extension (LTE) and 50% (10/20) of patients were in remission at week 110. Adverse events were reported in 94.3% (33/35) of patients through week 14 and 95% (19/20) of patients through week 126 (LTE). Frequently reported AEs were UC exacerbation (50%), and headache (35%). Deaths were not reported from weeks 14 through 126.

CONCLUSIONS: Golimumab demonstrated continued clinical benefit in pediatric UC patients with an acceptable safety profile. Further studies in larger populations are needed to ascertain the therapeutic benefit of golimumab in pediatric UC.