Introduction GO-COLITIS is a multicentre, open-label, single-arm, phase 4 study (NCT02092285; 2013-004583-56) that measured efficacy of subcutaneous golimumab (GLM) in anti-tumour necrosis factor-naïve UK patients with moderate to severe ulcerative colitis (UC) despite conventional treatment. Results of the patient-reported outcomes (PROs) of the partial Mayo score from the 6 week induction phase are presented here.
Method Adults with UC ≥3 months, moderate to severe disease (partial Mayo score 4–9 or Mayo score 6–12) at baseline (BL), Mayo rectal bleeding subscore ≥1, and Mayo endoscopy subscore ≥2 (if full Mayo was used) were included. Patients received GLM on day 0 (200 mg) and day 14 (100 mg) during the 6 week induction phase, followed by GLM 50 mg or 100 mg every 4 weeks during the 48 week maintenance phase as per the Summary of Product Characteristics, with 12 week follow-up. Measurements taken at BL and week 6 included the PRO components of the Mayo score.
Results Overall, 205 patients were enrolled (mean [range] age, 39.3 [18–79] years; male, n=123 [60%]) and received one (n=2) or two doses (n=203) of induction GLM. This resulted in pronounced improvements from BL to week 6 in the stool frequency (mean change, –1.1; SD, 1.0), rectal bleeding (mean change, –1.1; SD, 0.9), and physician global assessment (mean change, –1.1; SD, 0.9) subscores of the Mayo score (all p<0.0001). Improvements in stool frequency and rectal bleeding subscores included increased proportions of patients with normal scores and decreased proportions with severe scores at week 6 versus BL (table 1).
Conclusion Patients with moderate to severe UC experienced significant improvements from BL to week 6 in the PROs of the partial Mayo score. These changes parallel the significant improvements found in the physician global assessment and patient-reported quality of life (EQ-5D/IBDQ) at week 6 versus BL.1 Rectal bleeding and stool frequency PROs of the Mayo score could thus be a simple and noninvasive way for patients with UC to monitor their response to treatment in daily clinical practice.
. P Irving, et al. ECCO2016; Poster P310.
Disclosure of Interest S Sebastian Conflict with: Abbvie, Ferring, Warner Chilcott, Conflict with: Abbvie, Takeda, Warner Chilcott, Conflict with: Falk Pharma, Ferring, MSD, Takeda, Vifor, Warner Chilcott, C Probert Conflict with: Abbvie, MSD, Napp, Takeda, Conflict with: Abbvie, Falk, Ferring, MSD, Shire, Takeda, Conflict with: Abbvie, Falk, MSD, Shire, Takeda, D Gaya Conflict with: Abbvie, Dr Falk Pharma, Ferring, MSD, Shire, Takeda, Vifor, Conflict with: Abbvie, Dr Falk Pharma, Ferring, MSD, Shire, Takeda, Vifor, P Hamlin Conflict with: MSD, Abbvie, Warner Chilcott, Ferring, Tillotts, Takeda, Conflict with: MSD, Abbvie, Tillotts, Falk Pharma, P Irving Conflict with: MSD, Takeda, Conflict with: Abbvie, Warner Chilcott, Ferring, Falk Pharma, Takeda, MSD, Johnson and Johnson, Shire, Conflict with: Abbvie, Warner Chilcott, Takeda, MSD, Vifor Pharma, Pharmacosmos, Topivert, Genentech, Hospira, G Gillespie Conflict with: MSD UK, Conflict with: Merck and Co., Inc., H Tate Conflict with: GSK, Conflict with: MSD UK, C Wheeler Conflict with: Shield Therapeutics, Tesaro, Clovis Oncology, Novelion, Conflict with: MSD, Daiichi Sankyo, Takeda, GSK, AstraZeneca, Aegerion, Sanofi, Amryt Pharma, Shionogi
- ulcerative colitis
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.