FDA Approves Golimumab for Treatment of Pediatric Ulcerative Colitis

The Food and Drug Administration (FDA) approved golimumab (Simponi; Johnson & Johnson) for the treatment of children with moderately to severely active ulcerative colitis (UC) who weigh at least 15 kg. With this action, golimumab can now be used as a treatment in both children and adults with this condition.¹

UC is a form of inflammatory bowel disease in which the colon is chronically inflamed because the immune system inappropriately attacks and damages healthy cells in the lining of the colon. Patients can experience a range of unpredictable symptoms, such as loose and more frequent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue. Over 1 million people in the US live with UC, according to a news release from the manufacturer, and about 20% of these are pediatric patients.¹

Golimumab is an anti-tumor necrosis factor (TNF) biologic medicine that targets and blocks the protein TNF-alpha. The approval is supported by data from the PURSUIT program, which includes 2 multicenter, open-label studies—the phase 3 PURSUIT 2 (NCT03596645)² and phase 1 PURSUIT Pediatric PK (NCT01900574)³ studies—evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab in pediatric patients with UC.¹

PURSUIT 2 evaluated the use of golimumab in patients aged 2 years and older with moderately to severely active UC. The primary end point was clinical remission at week 6, which was achieved by about 32% of patients treated with golimumab. Secondary end points were clinical response at week 6 (achieved by 58%) and endoscopic improvement at week 6 (achieved by 40%). Of note, among those who were in clinical remission at week 6, 57% maintained clinical remission symptoms at the 54-week point. Safety results were also consistent with clinical trials evaluating golimumab in adults.^1,2

Results from PURSUIT Pediatric PK, which were published in Crohn’s & Colitis 360, demonstrated that among the 35 enrolled children, 21 patients (60%) responded at week 6, and 20 entered the long-term extension (median age: 14.5 years; median weight: 46.1 kg). Eleven of 20 patients (55%) completed 2 years of treatment. There were no anaphylactic or serum sickness-like reactions, opportunistic infections, malignancies, tuberculosis, or deaths that occurred. Significantly, the safety profile of golimumab from weeks 14 through 126 and that observed through week 14 were generally consistent. At week 110, 10 patients (50%) were in remission, and among all enrolled patients, 10 (28.6%) achieved remission at week 110.⁴

This is the first pediatric approval for golimumab, according to the manufacturer. It is also approved in adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. It comes in a prefilled syringe that can be self-administered after patients or their caregivers receive proper training from a health care professional. It is recommended that pediatric patients weighing at least 40 kg receive 200 mg at week 0, followed by 100 mg at weeks 2, 6, and every 4 weeks thereafter; and pediatric patients weighing at least 15 kg but less than 40 kg receive 100 mg at week 0, followed by 50 mg at weeks 2, 6, and every 4 weeks thereafter.¹

“UC is a complex, lifelong condition that is often challenging to manage effectively, particularly for pediatric patients, where relatively few approved options are available,” Chris Gasink, MD, vice president, medical affairs, gastroenterology & autoantibody, Johnson & Johnson Innovative Medicine, said in a news release. “The approval of [golimumab] represents a meaningful milestone, offering a therapy with well-established efficacy and safety along with subcutaneous dosing, for younger patients where treatment options have historically been limited.”¹

REFERENCES

1. Johnson & Johnson. U.S. FDA approves SIMPONI® (golimumab) for the treatment of pediatric ulcerative colitis. News release. October 7, 2025. Accessed October 8, 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-simponi-golimumab-for-the-treatment-of-pediatric-ulcerative-colitis

2. A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (PURSUIT 2). ClinicalTrials.gov identifier: NCT03596645. Updated September 15, 2025. Accessed October 8, 2025. https://clinicaltrials.gov/study/NCT03596645

3. A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis. ClinicalTrials.gov identifier: NCT01900574. Updated May 11, 2023. Accessed October 8, 2025. https://clinicaltrials.gov/study/NCT01900574

4. Hyams JS, O'Brien CD, Padgett L, et al. Maintenance Golimumab Treatment in Pediatric UC Patients With Moderately to Severely Active UC: PURSUIT PEDS PK Long-Term Study Results. Crohns Colitis 360. 2020;2(4):otaa063. Published 2020 Aug 4. doi:10.1093/crocol/otaa063