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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) DELIVERED CLINICAL BENEFITS AND IMPROVED QUALITY OF LIFE IN A UK REAL WORLD SETTING1

Updated on 25/02/2019

IMMUNOLOGY

Results from GO-COLITIS, a phase 4 open-label study of 207 patients in the UK with moderate to severe UC, show that SIMPONI maintained clinical responsea and remissionb and improved quality of life through week 54.1

After just two induction doses, more than two-thirds of patients demonstrated clinical response and nearly 40% had clinical remission.1

GO-COLITIS response data

SIMPONI MAINTAINED CLINICAL RESPONSEa AND REMISSIONb THROUGH WEEK 541

Sustained clinical responsea through week 54 was achieved by 36.4% (n=51/140) of induction respondersc and 24.9% (n=51/205) of all patients.1

Clinical remissionb through to week 54 was achieved by 25.7% (n=36/140) of induction respondersc and 17.6% (n=36/205) of all patients1

aSustained clinical response was defined as a clinical response at both weeks 30 and 54. Clinical response was defined as a decrease in the partial Mayo score of ≥2 points and ≥30% from baseline, plus either a decrease in the rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of 0 or 1.1

bClinical remission was defined as partial Mayo score of ≤2 and no individual subscore of >1.1

Study design

GO-COLITIS study design

Week 0 - Partial Mayo Score; Health related quality of life; Routine lab assessments; adverse event recording
Week 6 - Partial Mayo Score; Health related quality of life; Routine lab assessments; adverse event recording
Week 30 - Partial Mayo Score; Routine lab assessments; adverse event recording
Week 54- Partial Mayo Score; Health related quality of life; Routine lab assessments; adverse event recording
Week 66 - Partial Mayo Score; adverse event recording

Primary endpoint was proportion of patients maintaining a clinical response at week 54
Secondary endpoints included clinical response at week 6, response and remission rates at week 54, proportion of patients with normal QoL, change in HRQoL from baseline at week 6 and 54 and safety.

SIMPONI IMPROVED QUALITY OF LIFE THROUGH WEEK 54, AS SHOWN BY THREE DIFFERENT MEASURES1

Mean change from baseline to week 54 in induction respondersc who completed 54 week treatment1

At week 54, the median IBDQ total score was 192.0, indicating that over 50% of patients who completed the study had normal quality of life.1

Safety: The safety analysis included all enrolled patients who received at least one injection of SIMPONI. Treatment-emergent AEs and serious AEs were reported in 174 (84.9%) and 49 (23.9%) patients, respectively. Thirty-one of 49 serious AEs were recorded as gastrointestinal disorders, 28 of which were recorded as UC. Serious AEs led to treatment discontinuation in 18 patients (8.8%).1

Study design: GO-COLITIS was an open-label, single-arm, Phase 4 study of 207 adult patients (≥18 years of age) with moderate to severe UC for ≥3 months (defined as a partial Mayo score of 4-9) who were anti-TNF-naïve and had a baseline rectal bleeding subscore of ≥1. During the 6-week induction phase, patients received SIMPONI 200 mg on day 0 and SIMPONI 100 mg on day 14. Those responding to induction, assessed by partial Mayo score change from baseline at week 6, were eligible to receive a maintenance dose of SIMPONI 50 mg or SIMPONI 100 mg (dependent on body weight as per the SmPC) every 4 weeks ±5 days, for a total of 54 weeks, with a 12-week follow-up at the investigator’s discretion. The primary endpoint was the proportion of patients maintaining a clinical response through week 54, as assessed by partial Mayo score measured at weeks 6, 30, and 54. Secondary endpoints included clinical response at week 6, response and remission rates at week 54, the proportion of patients with normal QoL (defined as IBDQ score >170), change in health-related QoL from baseline at weeks 6 and 54, and safety.1

cDuring the 6-week induction phase, patients received SIMPONI 200 mg on day 0 and SIMPONI 100 mg on day 14. Those responding to induction, assessed by partial Mayo score change from baseline at week 6, were eligible to receive a maintenance dose of SIMPONI 50 mg or 100 mg (dependent on body weight) every 4 weeks ±5 days, for a total of 54 weeks of treatment.1

Abbreviations
AE, adverse event
EQ-5D, EuroQol Group 5 Dimensions Health Questionnaire
EQ-VAS, EuroQol-Visual Analog Scale
IBDQ, Inflammatory Bowel Disease Questionnaire
QoL, quality of life
SmPC, Summary of Product Characteristics
TNF, tumor necrosis factor
UC, ulcerative colitis

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References

  1. Probert CSJ, Sebastian S, Gaya DR, et al; for GO-COLITIS Study Group. Golimumab induction and maintenance for moderate to severe ulcerative colitis: results from GO-COLITIS (golimumab: a Phase 4, UK, open label, single arm study on its utilization and impact in ulcerative colitis). BMJ Open Gastro. 2018;5:e000212. doi:10.1136/bmjgast-2018-000212.

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-00093 | Date of Preparation: February 2019