Rectal bleeding and stool frequency may offer a non-invasive way of measuring response to treatment
Hoddesdon, UK, 18th October, 2016 – MSD (Merck & Co., Inc., Kenilworth, New Jersey, USA),
today announced new findings that indicate patient-reported outcomes (PROs), such as rectal bleeding and stool frequency, 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 which were reported at the 11th Congress of the European Crohn’s and Colitis Organisation (ECCO) showed that 68.8% of patients experienced clinical response with golimumab and 38.5% demonstrated clinical remission at week six.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 ≤1.3 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 15 (7%) 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 clearly demonstrate that the improvement in patient-reported outcomes with golimumab at 6 weeks closely mirror the improvements in physician global assessment and quality of life measures,” added Dr Sebastian. “These findings suggest that in real-world practice, one can potentially avoid the need for early sigmoidoscopy to assess response.”
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Notes to Editors:
GO-COLITIS is a phase 4, multicentre, open-label, single-arm trial in the United Kingdom, evaluating the efficacy of golimumab (GLM) in inducing and maintaining clinical response in anti-TNF naïve patients (≥18yr) with moderate to severe ulcerative colitis (UC).3 The induction phase lasted six weeks. The maintenance phase is ongoing.
Inclusion criteria for the study consisted of patients naïve to anti-TNF therapies with UC ≥3 months and with moderate to severe disease (partial Mayo score 4–9 or Mayo score 6–12) at baseline, Mayo rectal bleeding subscore ≥1, and Mayo endoscopy subscore ≥2 (if full Mayo was used).3
Overall, 205 patients received GLM in the study (mean [range] age, 39.3 [18–79] years; male, n=123 [60%]). The mean baseline (SD) partial Mayo score was 6.4 (1.4). All patients received one or two doses of induction GLM.3
About ulcerative colitis5
Ulcerative colitis is a chronic inflammatory bowel disease affecting approximately 146,000 people in the UK. Ulcerative colitis is often diagnosed in young adults between the ages of 15 and 25, but can affect children and older adults as well. It is a condition that causes inflammation and ulceration of the inner lining of the rectum and colon (the large bowel). In UC, tiny ulcers develop on the surface of the lining and these may bleed and produce pus. Symptoms typically include diarrhoea, fatigue, weight loss, abdominal pain and anemia.
About SIMPONI® (golimumab)6
SIMPONI (golimumab) is a human monoclonal antibody that targets and neutralises tumour necrosis factor (TNF)-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. Licensed indications for golimumab include: moderate to severe, active rheumatoid arthritis in adults, in combination with methotrexate, when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including methotrexate has been inadequate; severe, active and progressive rheumatoid arthritis, in combination with methotrexate, in adults not previously treated with methotrexate; active and progressive psoriatic arthritis in adult patients, alone or in combination with methotrexate, when the response to previous DMARD therapy has been inadequate; moderate to severe, active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies; severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy; for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs); and for polyarticular juvenile idiopathic arthritis in combination with methotrexate in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with methotrexate. Golimumab is a subcutaneous biologic therapy and is available either through the SmartJect autoinjector/prefilled pen or a prefilled syringe as a SC administered injection.
SIMPONI® is a Registered Trademark owned by Johnson & Johnson and licensed to Merck and Co., Inc. (known as MSD outside the US), Kenilworth, New Jersey, USA.
Please refer to the Summary of Product Characteristics for full information on ‘Simponi’ including contraindications, precautions, special warnings and side effects. Available from: www.medicines.org.uk/EMC/medicine/23766/SPC/Simponi+50+mg+solution+for+injection.
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1. Sebastian S, Probert C, Gaya DR, et al. GO-COLITIS 6-week induction: patient-reported outcomes of partial Mayo Score results. Poster P0850, presented at UEGW 2016.
2. Irving P, Probert C, Gaya DR, 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. Probert C, Gaya DR, Hamlin PJ, et al. Efficacy and safety of golimumab induction
for moderate-to-severe ulcerative colitis in the United Kingdom: results from the GO-COLITIS study. Poster DOP049, presented at ECCO 2016.
4. Gray JR, Leung E, Scales J, et al. Treatment of ulcerative colitis from the patient’s perspective: A survey of preferences and satisfaction with therapy.Aliment Pharmacol Ther 2009;29:1114–1120.
5. Crohn’s and Colitis UK. What is Ulcerative Colitis. Available at: www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/ulcerative-colitis. Last accessed September 2016
6. SIMPONI. Summary of product characteristics. Available at: https://www.medicines.org.uk/emc/medicine/23766. Last accessed September 2016.