First results from the GO-COLITIS UK study

MSD has announced findings presented at the 11^th Congress of the European Crohn’s and Colitis Organisation (ECCO) from GO-COLITIS, a UK study evaluating the efficacy of golimumab (GLM) in inducing and maintaining clinical response in 205 anti-TNF naïve patients with moderate to severe UC.

The results showed that 68.8% of patients experienced a clinical response and 38.5% of patients experienced clinical remission in the six-week induction phase. It was concluded that patients with clinical response (68.8%) were eligible to continue to the maintenance phase.¹ Further findings from GO-COLITIS also show that at the end of the induction phase, patients reported significant improvements in generic quality of life (QoL) and disease-specific QoL, including bowel symptoms, emotional function, systemic symptoms, and social function.²

Adverse events (AEs) recorded were consistent with previous observations and no new safety signals were identified.1 AEs (any cause) occurred in 37 (18%) patients. Serious AEs occurred in 17 (8%) patients: UC flare/worsening (n=11), accidental overdose (n=2), anaphylaxis (n=1), constipation (n=1), rectal fissure (n=1), and respiratory tract infection (n=1). Eight patients (4%) discontinued due to serious AEs. There were no fatal AEs.¹

Lead study investigator, Professor Chris Probert, University of Liverpool, UK, comments: “We are delighted to be able to contribute real-world data to the growing clinical experience with golimumab. This response rate shows the potential efficacy of golimumab in the management of moderately to severely active ulcerative colitis.”

Clinical response and remission in golimumab induction
Clinical response occurred in 68.8% of patients (n=141).1 Clinical response was defined as a decrease in partial Mayo score* of ≥2 points and ≥30% from baseline, plus either a decrease in rectal bleeding subscore of ≥1 point, or an absolute rectal bleeding score of ≤1.¹

Clinical remission occurred in 38.5% of patients (n=79). Clinical remission was defined as a partial Mayo score of ≤2 and no individual Mayo subscore >1.¹

The mean (SD) change from baseline in partial Mayo score (n=198) was -3.2 (2.4).¹

*The Mayo score and the non-invasive partial Mayo score are scoring systems for the assessment of ulcerative colitis therapy.³

Patient-reported quality of life (QoL)
Consistent relief of symptoms is among the most important attributes considered by patients with UC when selecting a therapy.⁴ In GO-COLITIS, QoL was assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) and the EuroQoL Group 5 Dimensions Health Questionnaire (EQ-5D).² Patients completed both at baseline and at Week 6 of the induction phase. Statistically significant improvements from baseline were observed at Week 6 for the IBDQ total score (p<0.0001) as well as the individual IBDQ domains (bowel symptoms, systemic symptoms, and emotional and social function [p<0.0001]).² Significant improvements were also seen in the EQ-5D index score (p<0.0001) and health state visual analogue scale (VAS) (p<0.0001).²

In an observational study to identify cut-off values for patient-defined remission, an IBDQ increase of >20 points was identified as an objective and clinically meaningful endpoint.⁵ In GO-COLITIS, the degree of improvement in IBDQ total score was 45.2 points.²

“GO-COLITIS has shown us that golimumab may offer patients significant improvements in quality of life in the induction phase”, says Dr Mark Toms, Executive Director, Medical Affairs, MSD UK and Ireland. “We hope that this response in the UK is continued in the maintenance phase of the study.”

References

1. Probert C et al. Efficacy and safety of golimumab inductionfor moderate-to-severe ulcerative colitis in the United Kingdom: results from the GO-COLITIS study. Poster DOP049, presented at ECCO 2016.
2. Irving P et al. Patient-reported quality of life during golimumab induction for moderate-to-severe ulcerative colitis in the United Kingdom: results from the GO-COLITIS study. Poster P310, presented at ECCO 2016.
3. Lewis J et al. Use of the non-invasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis 2008;14(12):1660–6.
4. Gray JR et al. Treatment of ulcerative colitis from the patient’s perspective: A survey of preferences and satisfaction with therapy. Aliment Pharmacol Ther 2009;29:1114–20.
5. Higgins PDR et al. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut 2005;54:782–8.