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PURSUIT Maintenance Study

Updated on 11/02/2019

IMMUNOLOGY

At 54 weeks, SIMPONI® achieved continuous clinical response in significantly more patients (Simponi® induction responders) versus placebo maintenance.1

PURSUIT Maintenance study – continuous clinical response

*Middlerowaphobia Under Control

*the phobia described above is fictional

Simponi: Achieving continuous clinical response (CCR)

PURSUIT Maintenance included SIMPONI induction responders from PURSUIT Induction.1,2

PURSUIT Maintenance results

Adapted from Sandborn et al. 2014

Clinical response was defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, accompanied by a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1. Patients were assessed for UC disease activity by partial Mayo score every 4 weeks (loss of response was confirmed by endoscopy) and full Mayo scores at weeks 30 and 54. Therefore, a patient who maintaind response was in a state of CCR at each evaluation through week 54.1

Study design

The phase 3 PURSUIT Maintenance study was a 54-week, multicentre, placebo-controlled double-blind, randomised withdrawal study that included the patients who previously completed the PURSUIT Induction studies.1,2 PURSUIT Maintenance study design

*These patients had an established diagnosis of moderate-to-severe active UC and were refractory/intolerant to at least one prespecified conventional therapy or were corticosteroid-dependent. SIMPONI induction responders (n=464) were re-randomised 1:1:1 to receive subcutaneous placebo, SIMPONI 50 mg, or SIMPONI 100 mg every 4 weeks through week 54. Induction-therapy responders who subsequently lost clinical response could have their treatment modified. Refer to the Summary of Product Characteristics or the Prescribing Information for weight-based dosing.

Sandborn WJ et al. Gastroenterology 2014; 146: 96–109.

Important safety information

QUICK: 51% of patients achieved clinician response at week 62
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;146:96–109.
  2. Sandborn WJ, et al. Gastroenterology 2014;146:85–95
  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-00056 | Date of Preparation: February 2019