PURSUIT-SC and PURSUIT-MUC · Induction and maintenance
Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis
Sandborn WJ, et al.
Gastroenterology 2014 · PMID 23735746 (PubMed, opens in a new tab) · doi 10.1053/j.gastro.2013.05.048 (full paper, opens in a new tab)
| Endpoint | 200/100 mg | 400/200 mg | 100 mg every 4 weeks | 50 mg every 4 weeks | Placebo | Difference |
|---|---|---|---|---|---|---|
| Clinical response, Induction · week 6 · two doses 2 weeks apart (primary endpoint) | 51.0% | 54.9% | not in this comparison | not in this comparison | 30.3% | P≤0.0001 for both doses vs placebo |
| Clinical response maintained, Maintenance · through week 54 (primary endpoint) | not in this comparison | not in this comparison | 49.7% | 47.0% | 31.2% | P<0.001 (100 mg) and P=0.010 (50 mg) vs placebo |
| Clinical remission, Maintenance · at both weeks 30 and 54 | not in this comparison | not in this comparison | 27.8% | 23.2% | 15.6% | P=0.004 for 100 mg vs placebo |
Both maintenance doses kept response, but the remission benefit was shown only with 100 mg every 4 weeks.
Source: Sandborn 2014, abstracts of the induction (PMID 23735746, phase 3 part) and maintenance (PMID 23770005) papers. The abstracts give percentages only, not counts. In maintenance, placebo means withdrawal after response to golimumab.
Structured abstract
BackgroundLittle was known about golimumab, a fully human anti-TNF antibody given subcutaneously, as induction or maintenance therapy for UC.
MethodsIntegrated phase 2 dose-finding and phase 3 double-blind induction trial (PURSUIT-SC), then a phase 3 double-blind randomised-withdrawal maintenance trial (PURSUIT-M). 1,064 patients. Primary endpoint: Induction: clinical response at week 6 (phase 3). Maintenance: clinical response maintained through week 54.
ResultsPrimary result. Induction: 51.0% (200/100 mg) and 54.9% (400/200 mg) vs 30.3% with placebo (both P≤0.0001). Maintenance: 47.0% (50 mg) and 49.7% (100 mg) vs 31.2% with placebo (P=0.010 and P<0.001).
Take-homeSubcutaneous golimumab induces and maintains response in anti-TNF-naive UC; the remission and mucosal-healing benefit in maintenance was seen with 100 mg every 4 weeks.
| Patients | 1,064 |
|---|---|
| Population | TNF-antagonist-naive adults with moderate to severe UC (Mayo 6–12, endoscopic subscore ≥2) despite conventional therapy; 774 in the phase 3 induction part; 464 induction responders randomised in maintenance |
| Comparison | Golimumab SC 200 mg then 100 mg, or 400 mg then 200 mg (2 weeks apart), vs placebo; responders re-randomised to golimumab 50 mg or 100 mg every 4 weeks vs placebo |
| Drugs | golimumab |
| Classes | Anti-TNF |
| Published | Sandborn WJ, et al. Gastroenterology 2014;146:85–95 (induction) and 2014;146:96–109 (maintenance). |
Key points
- Induction clinical remission, mucosal healing and IBDQ improvement were all greater with both golimumab doses than placebo (P≤0.0014 for all comparisons).
- Maintenance, 100 mg every 4 weeks: clinical remission at both weeks 30 and 54 in 27.8% vs 15.6% with placebo (P=0.004), and mucosal healing at both timepoints in 42.4% vs 26.6% (P=0.002). The 50 mg arm: 23.2% and 41.7%.
- Maintenance serious adverse events: 7.7% (placebo), 8.4% (50 mg) and 14.3% (100 mg); serious infections 1.9%, 3.2% and 3.2%.
- Among golimumab-treated maintenance patients, 3 died (sepsis, tuberculosis, cardiac failure, all on 100 mg) and 4 developed active tuberculosis.
Limitations
- Anti-TNF-naive patients only.
- Primary endpoints were clinical response, not remission.
- Randomised-withdrawal maintenance enrols only induction responders, which inflates maintenance rates relative to treat-through designs.
Commentary
This page covers two companion papers. The maintenance trial is Sandborn WJ, et al. “Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis.” Gastroenterology 2014;146:96–109 (PMID 23770005).
Context. Golimumab is the third anti-TNF approved for UC and is given subcutaneously every 4 weeks. Like ULTRA 2 (PMID 22062358) for adalimumab, PURSUIT showed real but moderate placebo-adjusted gains. The tuberculosis cases are a reminder that latent TB screening before any anti-TNF is mandatory.
Journal club
Design
Integrated phase 2 dose-finding and phase 3 double-blind induction trial (PURSUIT-SC), then a phase 3 double-blind randomised-withdrawal maintenance trial (PURSUIT-M). 1,064 patients.
Primary result. Induction: 51.0% (200/100 mg) and 54.9% (400/200 mg) vs 30.3% with placebo (both P≤0.0001). Maintenance: 47.0% (50 mg) and 49.7% (100 mg) vs 31.2% with placebo (P=0.010 and P<0.001).
Validity and applicability
- Anti-TNF-naive patients only.
- Primary endpoints were clinical response, not remission.
- Randomised-withdrawal maintenance enrols only induction responders, which inflates maintenance rates relative to treat-through designs.
Where it sits now
Subcutaneous golimumab induces and maintains response in anti-TNF-naive UC; the remission and mucosal-healing benefit in maintenance was seen with 100 mg every 4 weeks.
- ASTRO (2026): Guselkumab can be started with subcutaneous 400 mg injections instead of IV infusions, with clear benefit over placebo by week 12.
- RELIEVE UCCD (UC) (2026): Duvakitug, an anti-TL1A antibody, showed a dose-related remission signal in UC in phase 2b; phase 3 trials will decide its place.
- QUASAR (2025): Guselkumab induces and maintains remission in UC, and the follow-up ASTRO trial showed induction can be given subcutaneously.
- TUSCANY-2 (2025): Afimkibart missed its phase 2b primary endpoint (total Mayo remission), although remission by the modified Mayo score favoured it; anti-TL1A therapy still needs phase 3 proof.
Questions for discussion
- The primary endpoints were clinical response, not remission. How does that change how you compare golimumab with newer drugs?
- Only the 100 mg dose clearly improved maintenance remission. Which dose would you use, and for which patients?
- Randomised-withdrawal maintenance enrols only induction responders. How would you explain the expected one-year benefit to a patient starting golimumab today?