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Clinical efficacy of the Toll-like receptor 9 agonist cobitolimod using patient-reported-outcomes defined clinical endpoints in patients with ulcerative colitis.
Dig Liver Dis 2018; 50(10):1019-1029DL

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+Show Affiliations

University of Erlangen-Nürnberg, Department of Medicine 1, Erlangen, Germany.Department of Internal Medicine III, Division Gastroenterology & Hepatology, Medical University of Vienna, Vienna, Austria.Inserm U954 and Department of Hepato-Gastroenterology, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France.Catholic University of Rome, Internal Medicine Department/Gastroenterology Division, Rome, Italy.InDex Pharmaceuticals, Stockholm, Sweden.InDex Pharmaceuticals, Stockholm, Sweden.InDex Pharmaceuticals, Stockholm, Sweden.University of Erlangen-Nürnberg, Department of Medicine 1, Erlangen, Germany.Nottingham Digestive Diseases Centre, Department of Gastroenterology, Nottingham University Hospitals, Nottingham, United Kingdom. Electronic address: cj.hawkey@nottingham.ac.uk.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

30120066

Citation

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 : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, vol. 50, no. 10, 2018, pp. 1019-1029.
Atreya R, Reinisch W, Peyrin-Biroulet L, et al. Clinical efficacy of the Toll-like receptor 9 agonist cobitolimod using patient-reported-outcomes defined clinical endpoints in patients with ulcerative colitis. Dig Liver Dis. 2018;50(10):1019-1029.
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 : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 50(10), pp. 1019-1029. doi:10.1016/j.dld.2018.06.010.
Atreya R, et al. Clinical Efficacy of the Toll-like Receptor 9 Agonist Cobitolimod Using Patient-reported-outcomes Defined Clinical Endpoints in Patients With Ulcerative Colitis. Dig Liver Dis. 2018;50(10):1019-1029. PubMed PMID: 30120066.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical efficacy of the Toll-like receptor 9 agonist cobitolimod using patient-reported-outcomes defined clinical endpoints in patients with ulcerative colitis. AU - Atreya,Raja, AU - Reinisch,Walter, AU - Peyrin-Biroulet,Laurent, AU - Scaldaferri,Franco, AU - Admyre,Charlotte, AU - Knittel,Thomas, AU - Kowalski,Jan, AU - Neurath,Markus Friedrich, AU - Hawkey,Christopher, Y1 - 2018/06/22/ PY - 2017/08/11/received PY - 2018/05/14/revised PY - 2018/06/13/accepted PY - 2018/8/19/pubmed PY - 2019/4/19/medline PY - 2018/8/19/entrez KW - TLR-9 KW - Therapy KW - Toll-like receptor-9 KW - Ulcerative colitis SP - 1019 EP - 1029 JF - Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver JO - Dig Liver Dis VL - 50 IS - 10 N2 - 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. SN - 1878-3562 UR - https://www.unboundmedicine.com/medline/citation/30120066/Clinical_efficacy_of_the_Toll_like_receptor_9_agonist_cobitolimod_using_patient_reported_outcomes_defined_clinical_endpoints_in_patients_with_ulcerative_colitis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1590-8658(18)30797-7 DB - PRIME DP - Unbound Medicine ER -