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SIMPONI® (golimumab)
Medical Information
SIMPONI - Use in Pediatric Patients with Ulcerative Colitis (PURSUIT 2 Study)
Last Updated: 08/11/2026
SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- PURSUIT 2 (NCT03596645) is a phase 3, randomized, open-label study to assess the efficacy and safety of SIMPONI in pediatric patients with moderately to severely active ulcerative colitis (UC).1
Efficacy and safety through week 54 are reported below.2 , 3
UNITED STATES PRESCRIBING INFORMATION
Recommended Dosage for Moderately to Severely Active UC in Adults and Pediatric Patients Weighing at least 15 kg
- The recommended dosage and administration by subcutaneous (SC) injection in adults and pediatric patients weighing at least 15 kg is shown in Table: Recommended SC Dosage for Adults and Pediatric Patients Weighing at least 15 kg with Moderately to Severely Active UC.
| Body weight at time of dosing | Week 0 | Week 2 | Week 6 and every 4 weeks thereafter |
|---|---|---|---|
| Adults and pediatric patients 40 kg and greatera | 200 mg | 100 mg | 100 mg |
| Pediatric patients at least 15 kg to less than 40 kga | 100 mg | 50 mg | 50 mg |
| aFor pediatric patients weighing 15 kg or greater, administer the appropriate dose using the prefilled syringe (50 mg/0.5 mL or 100 mg/mL). | |||
Adults and Pediatric Patients Weighing at least 15 Kg with UC
- In general, adverse reactions reported in adult patients with UC in Trials UC-1, UC-2, and UC-3 were similar to those reported in clinical trials of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS).4
- Adverse reactions reported in the clinical trial of pediatric patients weighing at least 15 kg with UC were also similar to those reported in clinical trials of adults with UC and the other indicated populations.4
- Additional adverse reactions reported in at least 10% of pediatric patients in the trial were headache (17%) and pyrexia (10%).4
Clinical Study - Pediatric UC
- The efficacy and safety of SIMPONI was evaluated in a multicenter, open‑label pediatric trial (NCT03596645) involving 69 patients, with moderately to severely active UC (defined as a Mayo score of 6 to 12 with an endoscopy subscore of ≥2) who had inadequate response, intolerance, or contraindications to corticosteroids, azathioprine or 6-mercaptopurine, and were tumor necrosis factor (TNF)‑blocker-naïve.4
- Among the 66 patients evaluated for efficacy, the mean age was 13.4 years (range, 4-17 years), the median body weight was 51 kg, and 53% were female.
- Patients weighing 15 to less than 45 kg received SIMPONI subcutaneously at 120 mg/m2 at dosages of 120 mg/m2 at week 0, 60 mg/m2 at week 2 and 60 mg/m2 every 4 weeks from week 6 onward.
- Patients weighing at least 45 kg received SIMPONI 200 mg at week 0, 100 mg at week 2 and 100 mg every 4 weeks from week 6 onward.
- The recommended body-weight tiered dosage for pediatric patients weighing 15 to less than 40 kg and 40 to less than 45 kg differs from the body surface area-based dosage administered in this study. There are no anticipated clinically relevant differences in efficacy between the recommended and studied pediatric dosages of SIMPONI.
- Efficacy was assessed using Mayo score at weeks 6 and 54.4
- Primary endpoint: clinical remission at week 6.
- Secondary endpoint: clinical response at week 6.
- For results from the primary and secondary endpoints, see Table: Proportion of Pediatric Patients Weighing at Least 15 kg with UC in Clinical Remission and Clinical Response at Week 6.
| Endpoint | SIMPONI n (%) (90% CI) N=66 |
|---|---|
| Clinical remission at week 6a | 21 (32%) (22%, 41%) |
| Clinical response at week 6b | 38 (58%) (48%-68%) |
| Abbreviations: CI, confidence interval. aClinical remission is defined as a Mayo score ≤2 points, with no individual subscore >1. bClinical response is defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with either a decrease from baseline in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1. | |
- Of the 38 pediatric patients with clinical response at week 6, 13 patients (34%) were in clinical remission and 15 patients (39%) had endoscopic improvement, defined as an endoscopy subscore of 0 or 1 based on local endoscopy, at week 54. Of the 21 patients in clinical remission at week 6, 12 patients (57%) maintained clinical remission at week 54.4
CLINICAL DATA - PURSUIT 2
PHASE 3 STUDY IN PEDIATRIC UC
Study Design
Inclusion Criteria2
- Patients 2 to <18 years of age
- Mayo score 6-12 (inclusive) (endoscopy subscore ≥2, assessed by local endoscopist)
- No prior use of anti‑TNFα biologics
- Patients were required to meet ≥1 of the following medication-related criteria:
- Current treatment with oral corticosteroids or immunomodulators (6-mercaptopurine, methotrexate, or azathioprine)
- Prior non-response, intolerance, or contraindication to oral or intravenous (IV) corticosteroids or immunomodulators
- Inability to taper corticosteroids without recurrence of UC symptoms
- Requirement for ≥3 corticosteroid courses within the past year.
Weight or BSA-Based Dosing Regimen
- Patients <45 kg2,3: SIMPONI SC 120 mg/m2 at week 0 and 60 mg/m2 at week 2
- Patients ≥45 kg2: SIMPONI SC 200 mg at week 0 and 100 mg at week 2
- During the 48-week maintenance phase (week 6 to week 54), patients in clinical response to SIMPONI at week 6 continued to receive SIMPONI SC 100 mg or 60 mg/m2 every 4 weeks (q4w) through week 50. Patients not in clinical response at week 6 could (at the discretion of the investigator) receive 2 additional doses of SIMPONI SC (i.e., at week 6 and week 10), and those who were partial Mayo responders at week 14 (defined as a decrease from the week 0 partial Mayo score of ≥3 points) continued to receive SIMPONI SC 100 mg or 60 mg/m2 q4w through week 50.2
Primary Endpoint
- Clinical remission (Mayo score ≤2, with no individual subscore >1) at week 62
Other Endpoints2
- Clinical remission (Pediatric Ulcerative Colitis Activity Index [PUCAI] <10) at week 6
- Clinical response (≥30% and ≥3-point reduction in Mayo score from baseline, with either a ≥1point decrease in rectal bleeding subscore or a subscore of 0 or 1) at week 6
- Endoscopic improvement (Mayo endoscopic subscore of 0 or 1) at week 6
- Endoscopic remission (Mayo endoscopy subscore of 0) at week 6
- Clinical remission at week 54 (Mayo)
- Clinical remission at week 54 (PUCAI)
- Endoscopic improvement at week 54
- Endoscopic remission at week 54
- Maintenance of clinical remission (Mayo) at week 54 among patients who were in clinical remission (Mayo) at week 6
- Corticosteroid-free clinical remission (Mayo) at week 54 in patients not receiving corticosteroids for ≥12 weeks before week 54
Results
Baseline Characteristics
- A total of 69 patients received SIMPONI.2 Baseline demographics and disease characteristics are summarized in Table: Baseline Demographics and Disease Characteristics.
| Characteristic | SIMPONI (N=69) |
|---|---|
| Age, years, mean (SD) | 13.4 (3.3) |
| Age category, years, n (%) | |
| 2 to <6 | 2 (2.9) |
| 6 to <12 | 13 (18.8) |
| 12 to <18 | 54 (78.3) |
| Female, n (%) | 37 (53.6) |
| Weight category, kg, n (%) | |
| <45 | 17 (24.6) |
| <30 | 8 (11.6) |
| ≥30 to <45 | 9 (13.0) |
| ≥45 | 52 (75.4) |
| UC duration, years, median (range) | 1.43 (0.2-7.8) |
| Extent of UCa, n (%) | |
| Left-sided | 32 (46.4) |
| Extensive | 37 (53.6) |
| Mayo score, median (range) | 7.0 (5-11) |
| Mayo score ≥3 to ≤5 (mild) | 2 (2.9)b |
| Mayo score ≥6 to ≤10 (moderate) | 63 (91.3) |
| Mayo score >10 (severe) | 4 (5.8) |
| PUCAI score, median (range) | 40.0 (0-85) |
| PUCAI score <10 (no disease) | 1 (1.4) |
| PUCAI score ≥10 to ≤34 (mild) | 20 (29.0) |
| PUCAI score >34 to <65 (moderate) | 37 (53.6) |
| PUCAI score ≥65 (severe) | 11 (15.9) |
| CRP, mg/L, median (range) | 1.59 (0.1-92.4)c |
| FCP, mg/kg, median (range) | 1590.0 (36-36,000)d |
| UC medication history at induction baseline,e | 67 (97.1) |
| Corticosteroid use | 36 (52.2) |
| 6-Mercaptopurine or azathioprine use | 33 (47.8) |
| Oral 5-aminosalicylate | 61 (88.4) |
| Abbreviations: CRP, C-reactive protein; FCP, fecal calprotectin; PUCAI, Pediatric Ulcerative Colitis Activity Index; SD, standard deviation; UC, ulcerative colitis. aBased on local endoscopy. bTwo patients were inadvertently enrolled with a Mayo score of 5 due to miscalculation and were therefore categorized with mild UC. Both patients had endoscopy subscores ≥2 (1 with a subscore of 2 and 1 with a subscore of 3) and were allowed to remain in the study. cN=68. dN=63. ePatients could appear in more than one category. | |
- For efficacy results through week 6 and 54, respectively, see Table: Clinical and Endoscopic Outcomes at Week 6, Table: Clinical and Endoscopic Outcomes at Week 54 Among Patients in Clinical Response at Week 6.2
| Outcome, % | SIMPONI (N=69) |
|---|---|
| Clinical remissiona,b | 31.9 |
| Clinical remissionc (PUCAI) | 33.3 |
| Clinical responseb,d | 56.5 |
| Endoscopic improvemente,f | 40.6 |
| Endoscopic remissionf,g | 7.2 |
| Abbreviations: PUCAI, Pediatric Ulcerative Colitis Activity Index; SC, subcutaneous. aClinical remission(per Mayo score) is defined as a Mayo score ≤2, with no individual subscore >1. bPatients who were missing all 4 Mayo subscores at week 6 were considered not to have achieved the endpoint. cClinical remission (per PUCAI) is defined as a PUCAI score <10. Patients who were missing >3 PUCAI subscores at week 6 were considered not to have achieved the endpoint. dClinical response is defined as a ≥30% and ≥3‑point decrease from baseline in Mayo score, with either a ≥1‑point decrease in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. eEndoscopic improvement is defined as a Mayo endoscopy subscore of 0 or 1. f g | |
Of the patients who were in clinical remission at week 6 (according to Mayo criteria), 12/22 (54.5%) remained in clinical remission at week 54.2
| Outcome (%) | SIMPONI (N=41) |
|---|---|
| Clinical remissiona,b (Mayo score) | 31.7 |
| Clinical remissionc (PUCAI) | 34.1 |
| Corticosteroid-free clinical remissionb,d | 31.7 |
| Endoscopic improvemente,f | 36.6 |
| Endoscopic remissionf,g | 9.8 |
| Abbreviations: PUCAI, Pediatric Ulcerative Colitis Activity Index; SC, subcutaneous. Note: Among the adult reference population (N=151) receiving SIMPONI, clinical remission (per Mayo score) was achieved in 33.8% of patients, clinical response in 49.7% of patients, symptomatic remission in 43.7% of patients, and endoscopic improvement in 46.4% of patients. Patients received SIMPONI SC 100 mg. aClinical remission (per Mayo score) is defined as a Mayo score ≤2, with no individual subscore >1. bPatients who were missing all 4 Mayo subscores at week 54 were considered not to have achieved the endpoint. cClinical remission (per PUCAI) is defined as a PUCAI score <10. Patients who were missing >3 PUCAI subscores at week 54 were considered not to have achieved the endpoint. dCorticosteroid-free clinical remission (Mayo) at week 54 among patients who were not receiving corticosteroids for ≥12 weeks before week 54. Patients who had a missing value in corticosteroid use had their last value carried forward. eEndoscopic improvement is defined as a Mayo endoscopy subscore of 0 or 1. fPatients with missing endoscopy score data at week 54 were considered not to have achieved the endpoint. gEndoscopic remission was defined as a Mayo endoscopy subscore of 0. | |
- For safety results through week 54 see Table: Treatment-Emergent AEs through Week 54.2
| Induction phase Week 0-6 (N=69) | Maintenance phase Week 6 (postdose) to week 54 (N=62)b | Week 0 through week 54 (N=69) | |
|---|---|---|---|
| Patients with ≥1, n (%) | |||
| AEs | 47 (68.1) | 58 (93.5) | 67 (97.1) |
| Serious AEs | 10 (14.5) | 21 (33.9) | 28 (40.6) |
| Deaths | 0 | 0 | 0 |
| AEs leading to discontinuation | 6 (8.7) | 9 (14.5) | 15 (21.7)c |
| Infections | 17 (24.6) | 38 (61.3) | 43 (62.3) |
| Serious Infections | 1 (1.4) | 9 (14.5) | 9 (13.0)d |
| Malignant neoplasms | 0 | 0 | 0 |
| Injection-site reactions | 2 (2.9) | 3 (4.8) | 4 (5.8) |
| Abbreviations: AE, adverse event; COVID-19, Coronavirus disease 2019; MedDRA, Medical Dictionary for Regulatory Activities; UC, ulcerative colitis. aPatients were only counted once for any given event, regardless of the number of times they experienced the event.AEs were coded using MedDRA version 26.1. bIncludes patients who received ≥1 dose (complete or partial) of SIMPONI during the maintenance phase. cThirteen patients discontinued due to UC, 1 due to cytomegalovirus colitis, and 1 due to a positive fungal test (Candida). dTwo cases each of cytomegalovirus colitis and pneumonia, and 1 case each of Clostridium difficile infection, COVID-19, pseudomembranous colitis, stump appendicitis, and a positive fungal test (Candida) were reported. One case of “UC worsening” was initially classified as an infection; however, the investigator later confirmed that no evidence of infection was found. | |||
Literature Search
A literature search of MEDLINE®
References
| 1 | Janssen Research & Development, LLC. A study to assess the efficacy and safety of golimumab in pediatric participants with moderately to severely active ulcerative colitis (PURSUIT 2). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 June 8]. Available from: https://clinicaltrials.gov/study/NCT03596645 NLM Identifier: NCT03596645. |
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