Vienna, 18th October 2016 – Scientists today announced findings that indicated patient-reported outcomes (PROs) of the Mayo score could provide a simple and non-invasive tool for monitoring patients with ulcerative colitis (UC). These results were presented at the United European Gastroenterology week (UEG week) as part of GO-COLITIS, a UK study evaluating the efficacy of SIMPONI® (golimumab) in inducing and maintaining clinical response in anti-TNF-α-naïve patients with moderate to severe UC.1
Patients with UC who received golimumab experienced significant improvements from baseline to week 6 in PROs of the partial Mayo score.1 These changes paralleled the significant improvements found in the physician global assessment (PGA) and patient-reported quality of life (QoL).2 The PRO results included an increase in the proportion of patients reporting normal scores for stool frequency and rectal bleeding, accompanied by a decrease in the proportion of those reporting severe scores.1
“Patient-reported outcomes have an increasingly important role in evaluating treatments for inflammatory bowel diseases,” explained study author, Dr Shaji Sebastian, Hull & East Yorkshire NHS Trust, United Kingdom. “These provide simple, practical measures of response which are relevant to patients, particularly in early stages of treatment.”
GO-COLITIS is a multicentre, open-label, single-arm, Phase 4 UK study evaluating the efficacy of subcutaneous golimumab in anti-TNF-α-naïve patients with moderate to severe UC despite conventional treatment.1 Additional data from the GO-COLITIS study reported at the 11th Congress of the European Crohn’s and Colitis Organisation (ECCO) showed that 68.8% of patients experienced clinical response and 38.5% of patients experienced clinical remission in the 6-week induction phase of golimumab treatment.3 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. Clinical remission was defined as a partial Mayo score of ≤2 and no individual Mayo subscore >1.3
Adverse events (AEs) recorded were consistent with previous observations and no new safety signals were identified.3 AEs (any cause) occurred in 37 (18%) patients. Serious AEs occurred in 17 (8%) patients: UC flare/worsening (n=11), anaphylaxis of unknown origin (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.3
Patients also reported significant improvements in generic and disease-specific QoL, including bowel symptoms, emotional function, systemic symptoms, and social function.2 Consistent relief of symptoms is considered by patients with UC to be among the most important attributes when selecting a therapy.4
“The data from the GO-COLITIS study clearly demonstrate that the improvement in PROs with golimumab at 6 weeks closely mirror the improvements in PGA and QoL measures,” added Dr Sebastian. “These findings suggest that in real-world practice, one can potentially avoid the need for early sigmoidoscopy to assess response.”Editor's Details
Last updated on: 19/10/2016
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