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SIMPONI® (golimumab) The concept of Continuous Clinical Response and clinical outcomes associated with this1

Prescribing Information

Length: 03:08

A short animation on the concept of continuous clinical response along with the clinical benefits associated with it in ulcerative colitis.

Continuous Clinical Response was defined as maintenance of clinical response through week 54, measured by ulcerative colitis disease activity assessments through partial Mayo score evaluations every 4 weeks (loss of response was confirmed by endoscopy) and additional Mayo score assessments at weeks 30 and 54 to substantiate that patients had maintained clinical response at each visit. Therefore, a patient who maintained clinical response was in a state of continuous response throughout the 54 weeks of the study.2

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.2,3

PURSUIT Maintenance study design image

*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 (n=156), SIMPONI 50 mg (n=154) or SIMPONI 100 mg (n=154) 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.

References:

  1. SIMPONI Summary of Product Characteristics.
  2. Sandborn WJ, et al. Gastroenterology 2014;146:96–109.
  3. Sandborn WJ, et al. Gastroenterology 2014;146:85–95.

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