Clinical efficacy of the Toll-like receptor 9 agonist cobitolimod using patient-reported-outcomes defined clinical endpoints in patients with ulcerative colitis

Atreya R, Reinisch W, Peyrin-Biroulet L, Scaldaferri F, Admyre C, Knittel T, Kowalski J, Neurath M, Hawkey C (2018)

Publication Type: Journal article

Publication year: 2018

Journal

Digestive and Liver Disease WB Saunders

Book Volume: 50

Pages Range: 1019-1029

Journal Issue: 10

DOI: 10.1016/j.dld.2018.06.010

Abstract

BACKGROUND: The Toll-like-receptor 9 (TLR-9) agonist cobitolimod (DIMS0150, Kappaproct®) is a promising therapeutic option for ulcerative colitis (UC) patients. AIMS: The objectives of this post-hoc analysis using the COLLECT study data was to investigate the clinical effects of cobitolimod using patient-reported-outcomes (PRO) defined endpoints. METHODS: Dual topical administration of cobitolimod was studied in a randomised, multicentre clinical trial named COLLECT in moderate-to-severe UC patients. Symptomatic remission (SR) was studied in 104 patients based on their e-diary records and was defined as absence of blood in stool and a mean daily stool frequency (SF) < 4. RESULTS: SR was achieved at week 4 in 17.1% of cobitolimod vs. 5.9% of placebo treated patients (p = 0.13), at week 8 in 35.7% vs. 17.6% (p = 0.07), and at week 12 in 38.6% vs. 17.6% (p = 0.04) of the patients, respectively. SR rates with cobitolimod and placebo in anti-TNFα experienced patients were smaller but with a broadly similar relative effect-size to anti-TNFα naïve patients. Clinical efficacy was higher in patients with moderate compared to severe disease. CONCLUSIONS: Application of the Toll-like-receptor 9 (TLR-9) agonist cobitolimod is able to induce remission as assessed by PRO measures in UC patients with moderate-to-severe activity as well as in anti-TNFα experienced and naïve patients supporting the overall efficacy of the substance.

Authors with CRIS profile

Raja Atreya Professur für Translationale Immunforschung bei chronisch entzündlichen Darmerkrankungen (Heisenberg-Professur) Markus Neurath Lehrstuhl für Innere Medizin I

Involved external institutions

Medizinische Universität Wien AT Austria (AT) Université de Lorraine FR France (FR) Catholic University of the Sacred Heart / Università Cattolica del Sacro Cuore IT Italy (IT) InDex Pharmaceuticals SE Sweden (SE) Nottingham University Hospitals GB United Kingdom (GB)

How to cite

APA:

Atreya, R., Reinisch, W., Peyrin-Biroulet, L., Scaldaferri, F., Admyre, C., Knittel, T.,... Hawkey, C. (2018). Clinical efficacy of the Toll-like receptor 9 agonist cobitolimod using patient-reported-outcomes defined clinical endpoints in patients with ulcerative colitis. Digestive and Liver Disease, 50(10), 1019-1029. https://doi.org/10.1016/j.dld.2018.06.010

MLA:

Atreya, Raja, et al. "Clinical efficacy of the Toll-like receptor 9 agonist cobitolimod using patient-reported-outcomes defined clinical endpoints in patients with ulcerative colitis." Digestive and Liver Disease 50.10 (2018): 1019-1029.

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