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PURSUIT Induction Study

Updated on 11/02/2019

IMMUNOLOGY

51% of patients achieved clinical response at week 6 with SIMPONI1

PURSUIT Induction study - clinical response at week 6

*Middlerowaphobia Under Control

*the phobia described above is fictional

Percentage of patients achieving clinical response at week 6 was significantly greater for SIMPONI 200/100 mg vs placebo1 (p<0.0001, primary endpoint)

Clinical responses in PURSUIT Induction

Adapted from Sandborn WJ et al

Percentage of patients achieving clinical remission at week 6 was significantly greater for SIMPONI 200/100 mg vs placebo (p<0.0001, secondary endpoint)1

Clinical remission in PURSUIT Induction

Adapted from Sandborn WJ et al

Percentage of patients achieving mucosal healing at week 6 was significantly greater for SIMPONI 200/100 mg vs placebo (p<0.0014, secondary endpoint)1

Mucosal healing in PURSUIT Induction

Study design

6-week multicentre, randomised, double-blind, placebo-controlled trial in two parts:

  • Phase 2: dose-finding1
  • Phase 3: evaluate the safety and efficacy of the selected SIMPONI induction regimens1

Efficacy results shown are from the phase 3 portion of the study1

PURSUIT Induction study design

*In the phase 3 portion of the study, 774 patients with an established diagnosis of moderate-to-severe active UC who were refractory/intolerant to at least one prespecified conventional therapy or were corticosteroid-dependent were randomised 1:1:1 to receive subcutaneous injections of placebo, SIMPONI 200/100 mg, or SIMPONI 400/200 mg at weeks 0/2.

*Golimumab 400/200 mg* is not a licensed induction dose of SIMPONI

Adapted from Sandborn WJ et al. Gastroenterology 2014; 146: 85-95

Important safety information - adapted from Sandborn WJ et al

CONTROL: SIMPONI maintains clinical response in patients with moderate to severe UC2
Adapted from Sandborn WJ et al View Study
CONTINUOUS: In the PURSUIT long-term extension study (LTE) SIMPONI maintained efficacy over 216 weeks3
Adapted from Reinisch W et al View Study
CONVENIENT: SIMPONI’s 4-weekly dosing4 offering convenient dosing for patients View Dosing

Related content

 

References

  1. Sandborn WJ, et al. Gastroenterology 2014;146:85–95.
  2. Sandborn WJ, et al. Gastroenterology 2014; 146: 96-109.
  3. Reinisch W et al. J Crohn's and Colitis 2018;12:1053-1066.
  4. SIMPONI Summary of Product Characteristics.

Supporting documentation

SIMPONI 50 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet for Pre-filled Syringe | Patient Information Leaflet for Pre-filled Pen

SIMPONI 100 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet for Pre-filled Pen

GB-GOL-00055 | Date of Preparation: February 2019