ArticleInflammatory bowel diseases2026
Efficacy, Safety, and Pharmacokinetics of Golimumab in Children with Moderately-To-Severely Active Ulcerative Colitis: Results from the PURSUIT 2 Study.
Article in Inflammatory bowel diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03596645 (A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
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1 citing paper in PubMed.
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14 authors.
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Abstract
backgroundGolimumab is an anti-TNFα biologic agent that has been approved for adults with moderately-to-severely active ulcerative colitis (UC). We investigated the efficacy, safety, and pharmacokinetics (PK) of golimumab in biologic-naïve children with moderately-to-severely active UC.
methodsThe prospective, multicenter, open-label PURSUIT 2 study enrolled biologic-naïve children (2 to <18 years) with moderately-to-severely active UC (Mayo score 6-12; endoscopic subscore ≥2) despite conventional treatment. During the 6-week induction phase, patients received subcutaneous (SC) golimumab dosed by weight (<45 kg: 120/60 mg/m2; ≥45 kg: 200/100 mg) at weeks 0/2. Week 6 clinical responders (Mayo score decrease from baseline ≥30% and ≥3 points, with either a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0/1) continued golimumab dose q4w during the 48-week maintenance phase. The primary endpoint was clinical remission (Mayo score ≤2 points with no individual subscore >1) at week 6. Efficacy and PK data are presented alongside a reference adult UC population who received golimumab SC 200/100 mg at weeks 0/2 and 100 mg q4w thereafter.
resultsOf the 69 patients (mean age, 13.4 ± 3.3 years) enrolled, 31.9% (22/69) were in clinical remission at week 6, and of those, 54.5% (12/22) remained in clinical remission at week 54. At week 54, 31.7% (13/41) of week 6 clinical responders achieved clinical remission. Additionally, 33.3% achieved clinical remission by the Pediatric Ulcerative Colitis Activity Index (PUCAI), 56.5% clinical response by Mayo, 40.6% endoscopic improvement, and 7.2% endoscopic remission at week 6. Of those who were clinical responders at week 6, 34.1% achieved clinical remission by PUCAI, 31.7% corticosteroid-free clinical remission by Mayo, 36.6% endoscopic improvement, and 9.8% endoscopic remission at week 54. Serum golimumab concentrations through week 6 were comparable to the reference adult UC population. Through week 54, 40.6% reported serious adverse events and 13.0% serious infections. No new safety concerns were identified.
conclusionsOverall, the results of the PURSUIT 2 study support golimumab treatment for children with moderately-to-severely active UC. ClinicalTrials.gov ID: NCT03596645.
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