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PURSUIT Maintenance Long Term Extension (LTE) Study

Updated on 26/02/2019

IMMUNOLOGY

Simponi® maintains efficacy over 4 years1

PURSUIT Maintenance LTE study – Simponi maintains efficacy over 4 years

*Middlerowaphobia Under Control

*the phobia described above is fictional

In the PURSUIT long-term extension study, SIMPONI maintained efficacy over 216 weeks.1

Results in the 134 patients who completed the study through to final efficacy evaluation at week 216.

PURSUIT LTE results

Adapted from Reinisch W, et al. 2018.

Disease activity was evaluated using the Physician's Global Assessment (PGA), a subscore of the Mayo score, at Week 56 and every 3 months through Week 216. Health-related quality of life was assessed with the Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 54 then every 6 months through Week 216 begininning at Week 80. Corticosteroid dose was evaluated at Week 56 and every 4 weeks through Week 228. Efficacy analyses were based on observed data from 195 patients who were randomised to golimumab at maintenance basleine and continued to receive golimumab in the LTE.

Study design

The PURSUIT-Maintenance long-term study is an extension of the Pursuit-Maintenance study. Of the 235 patients who had been randomised to receive either golimumab 50 mg or 100 mg in the PURSUIT-Maintenance study and had received treatment every 4 weeks through to week 52 and evaluations at week 56, 203 were entered into the PURSUIT-Maintenance long-term study, and were treated through to week 212, with a safety evaluation at week 228. Of these 203 patients, 134 completed the study through to the final efficacy evaluation at week 216 and 128 patients were assessed for the final safety evaluation at week 228. Efficacy endpoints were summarised as observed for golimumab-induction responders who were randomised to receive golimumab during PURSUIT-Maintenance and who continued treatment throughout the LTE. Efficacy analyses were based on observed data. Observation relating to safety were summarised for al treated patients. No new safety signals were observed. Overall, 63% of patients who received SIMPONI at the beginning of the LTE (week 56) remained on treatment through 4 years (last golimumab dose administration at week 212 with safety evaluation at week 228).

Important safety information

CONTROL: SIMPONI maintains clinical response in patients with moderate to severe UC2
Adapted from Sandborn WJ et al View Study
QUICK: 51% of patients achieved clinician response at week 63
Adapted from Sandborn WJ et al View Study
CONVENIENT: SIMPONI’s 4-weekly dosing4 offering convenient dosing for patients View Dosing

Related content

 

References

  1. Reinisch W, et al. J Crohn's Colitis 2018; 12(9): 1053-1066.
  2. Sandborn WJ, et al. Gastroenterology 2014; 146: 96-109.
  3. Sandborn WJ, et al. Gastroenterology 2014; 146: 85-95.
  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-00058 | Date of Preparation: February 2019