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This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

SIMPONI® (golimumab) Early Dose Optimisation for Ulcerative Colitis

For adult moderate to severe active UC patients <80 kg, with an inadequate response at week 6

Prescribing Information

Length: 02:56

Watch a short animation on how early dose optimisation in adult UC patients treated with SIMPONI can help them achieve Continuous Clinical Response*1

*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

PURSUIT INDUCTION study design

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

  • Phase 2: dose-finding2
  • Phase 3: evaluate the safety and efficacy of the selected SIMPONI induction regimens2

Efficacy results shown are from the phase 3 portion of the study2

Efficacy results shown are from the phase 3 portion of the study^2

*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

References:

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

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