دورية أكاديمية

Effectiveness of golimumab in patients with ulcerative colitis: results of a real-life study in Switzerland.

التفاصيل البيبلوغرافية
العنوان: Effectiveness of golimumab in patients with ulcerative colitis: results of a real-life study in Switzerland.
المؤلفون: Perrig K; Department of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland., Krupka N; Department of Visceral Surgery and Medicine, Inselspital Bern University Hospital, University of Bern, Bern, Switzerland., Jordi SBU; Department of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, SwitzerlandDepartment of Visceral Surgery and Medicine, Inselspital Bern University Hospital, University of Bern, Bern, Switzerland., Rossel JB; Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland., Biedermann L; Department of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland., Greuter T; Department of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland., Schreiner P; Department of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland., Vavricka SR; Center of Gastroenterology and Hepatology, Zurich, Switzerland., Juillerat P; Department of Visceral Surgery and Medicine, Inselspital Bern University Hospital, University of Bern, Bern, Switzerland., Burri E; Department of Gastroenterology and Hepatology, University Medical Clinic, Kantonsspital Baselland, Liestal, Switzerland., Zimmermann D; Department of Gastroenterology, Kantonsspital Nidwalden, Stans, Switzerland., Maillard MH; Service of Gastroenterology and Hepatology, Lausanne University Hospital, Lausanne, Switzerland; Crohn and Colitis Center, Gastroentérologie Beaulieu SA, Lausanne, Switzerland., Sulz MC; Department of Gastroenterology, Kantonsspital Münsterlingen, Münsterlingen, Switzerland., Brand S; Department of Gastroenterology and Hepatology, Kantonsspital St. Gallen, St. Gallen, Switzerland., Rogler G; Department of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland., Misselwitz B; Department of Visceral Surgery and Medicine, Inselspital Bern University Hospital, University of Bern, Freiburgstr. 18, 3010 Bern, Switzerland.
المصدر: Therapeutic advances in gastroenterology [Therap Adv Gastroenterol] 2022 Feb 09; Vol. 15, pp. 17562848221074188. Date of Electronic Publication: 2022 Feb 09 (Print Publication: 2022).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Sage Publications Country of Publication: England NLM ID: 101478893 Publication Model: eCollection Cited Medium: Print ISSN: 1756-283X (Print) Linking ISSN: 1756283X NLM ISO Abbreviation: Therap Adv Gastroenterol Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: London : Sage Publications
مستخلص: Background: Tumor necrosis factor (TNF) inhibitors have improved treatment of ulcerative colitis (UC), but loss of response remains a frequent problem. The anti-TNF agent, golimumab, was approved in Switzerland for the treatment of UC in 2014. This study aims to summarize the experience of golimumab in a real-world setting in Switzerland.
Methods: We analyzed real-world data from 1769 UC patients from the Swiss Inflammatory Bowel Disease Cohort (SIBDC) study and performed a chart review of golimumab-treated patients. We extracted the partial Mayo score at t 0 (baseline), t 1 (2-16 weeks), t 2 (17-35 weeks), and t 3 (36-89 weeks). The primary endpoint was clinical response at t 1 , defined as marked improvement in partial Mayo score and objective parameters. Clinical remission was defined as resolution of symptoms and normalization of objective parameters.
Results: Our chart review included 103 UC patients with golimumab treatment (5.8% of all SIBDC UC patients); only 16 (15.5%) were anti-TNF naïve. Sixty-three patients remained on golimumab (61.2%) after 180 days, 51 (44.7%) after 365 days, and 34 (33%) after 630 days after the start of treatment. Upon golimumab treatment, the partial Mayo score decreased from 4 [interquartile range (IQR): 2-6] at t 0 to 2 (IQR: 0-4) at t 1 , 1 (IQR: 0-3.5) at t 2 , and 1 (IQR: 0-3) at t 3 ( p  < 0.001 for all comparisons with t 0 ). The primary endpoint, clinical response at t 1 , could be evaluated in 52 patients and was met in 15 individuals (28.8%). Clinical remission at t 1 was observed in 8 out of 52 patients (15.4%). Golimumab was generally well tolerated, one patient developed meningitis. The most frequent reasons to stop treatment were primary and secondary non-response.
Conclusion: Golimumab was used in 5.8% of Swiss UC patients, mainly in biologic-experienced individuals. Golimumab treatment was associated with a sustained reduction of symptoms and clinical response in approximately 30% of patients.[ClinicalTrials.gov identifier: NCT00488631].
Competing Interests: Conflict of interest statement: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: KP has nothing to disclose. NK has nothing to disclose. SBUJ has nothing to disclose. JBR has nothing to disclose. LB reports fees for consulting/advisory board from Abbvie, MSD, Vifor, Falk, Esocap, Calypso, Ferring, Pfizer, Shire, Takeda, Janssen, and Ewopharma. TG has consulting contracts with Sanofi-Regeneron and Falk Pharma GmbH, received travel grants from Falk Pharma GmbH and Vifor, and an unrestricted research grant from Novartis. PS has consulted to Pfizer, Takeda, Abbvie, and Janssen-Cilag and received travel support from Falk and UCB. SRV has received consulting fees, speakers honorary, and unrestricted research grants from Abbott, Alfasigma, Amgen, Arenapharm, Falk Pharma GmbH, Ferring Pharmaceuticals, Gilead, iQuone, Janssen, MSD, Permamed, Pfizer Inc, Sanofi-Aventis, Takeda, Tillotts, UCB, and Vifor. PJ has received a research grant from Vifor unrelated to this work. EB received consultant and/or speaker fees from Abbvie, Janssen, MSD, Norgine, Pfizer, Sandoz, Takeda, and Vifor. DZ has nothing to disclose. MHM has received consultant fees from Vifor, Abbvie, UCB, MSD, Lilly, Janssen, and Takeda. He also received grants from UCB, Abbvie, Vifor, MSD, Takeda. He received speaker fess from Vifor, Janssen, Abbvie, MSD, Pfizer, UCB, and Takeda. MCS has received consultant and/or speaker fees from Abbvie, Ferring, MSD, Janssen, Pfizer, Takeda, UCB. SB has consulted to Abbvie, Celgene, Ferring, Gilead, Janssen, MSD, Pfizer, Roche, UCB, and Takeda, Vifor; SB has received speaker’s honoraria from Abbvie, FALK, Ferring, MSD, Takeda, UCB, and Vifor; SB has received an educational grant from Takeda. GR has consulted to Abbvie, Augurix, BMS, Boehringer, Calypso, Celgene, FALK, Ferring, Fisher, Genentech, Gilead, Janssen, MSD, Novartis, Pfizer, Phadia, Roche, UCB, Takeda, Tillots, Vifor, Vital Solutions, and Zeller; GR has received speaker’s honoraria from Astra Zeneca, Abbvie, FALK, Janssen, MSD, Pfizer, Phadia, Takeda, Tillots, UCB, Vifor, and Zeller; GR has received educational grants and research grants from Abbvie, Ardeypharm, Augurix, Calypso, FALK, Flamentera, MSD, Novartis, Pfizer, Roche, Takeda, Tillots, UCB, and Zeller. BM has received a research grant from MSD for this work. BM has served at an advisory board for Gilead and Novigenix. He has received speaking fees from Vifor, MSD, and Takeda and traveling fees from Vifor, Novartis, Gilead, and Takeda.
(© The Author(s), 2022.)
References: Rev Esp Enferm Dig. 2016 Mar;108(3):129-32. (PMID: 26786341)
Aliment Pharmacol Ther. 2018 Jan;47(2):162-175. (PMID: 29205406)
Eur J Gastroenterol Hepatol. 2021 Jan;33(1):54-61. (PMID: 32804854)
Sci Rep. 2020 Oct 20;10(1):17774. (PMID: 33082359)
J Crohns Colitis. 2018 May 25;12(6):635-643. (PMID: 29370397)
BMJ Open Gastroenterol. 2018 Jul 7;5(1):e000212. (PMID: 30002864)
Digestion. 2020;101 Suppl 1:69-82. (PMID: 32570252)
PLoS One. 2016 Oct 24;11(10):e0165435. (PMID: 27776175)
Behav Res Methods. 2007 May;39(2):175-91. (PMID: 17695343)
Aliment Pharmacol Ther. 2020 Jul;52(2):292-302. (PMID: 32506695)
Gastroenterology. 2014 Jan;146(1):85-95; quiz e14-5. (PMID: 23735746)
Dig Dis Sci. 2020 Jun;65(6):1767-1776. (PMID: 31722059)
World J Gastroenterol. 2016 Dec 21;22(47):10432-10439. (PMID: 28058024)
Autoimmun Rev. 2014 Jan;13(1):24-30. (PMID: 23792214)
Expert Opin Biol Ther. 2016 Oct;16(10):1277-90. (PMID: 27329436)
Therap Adv Gastroenterol. 2016 Jul;9(4):513-26. (PMID: 27366220)
Pharmacol Res. 2015 Oct;100:220-7. (PMID: 26277232)
J Crohns Colitis. 2015 Oct;9(10):819-29. (PMID: 26116554)
Aliment Pharmacol Ther. 2021 Jan;53(1):138-149. (PMID: 33159475)
Gastroenterology. 2014 Jan;146(1):96-109.e1. (PMID: 23770005)
J Crohns Colitis. 2018 Jun 28;12(7):811-818. (PMID: 29617750)
Inflamm Bowel Dis. 2017 Aug;23(8):1394-1402. (PMID: 28671873)
Therap Adv Gastroenterol. 2016 Jul;9(4):548-59. (PMID: 27366223)
J Crohns Colitis. 2016 May;10(5):575-81. (PMID: 26738756)
Clin Gastroenterol Hepatol. 2022 Jan;20(1):126-135. (PMID: 33039584)
Aliment Pharmacol Ther. 2017 May;45(10):1291-1302. (PMID: 28326566)
J Can Assoc Gastroenterol. 2018 Sep;1(3):129-134. (PMID: 31294354)
Int J Epidemiol. 2009 Aug;38(4):922-31. (PMID: 18782896)
J Dig Dis. 2018 Aug;19(8):468-474. (PMID: 30039533)
Int J Epidemiol. 2019 Apr 1;48(2):385-386f. (PMID: 30689927)
Adv Ther. 2018 Nov;35(11):1763-1774. (PMID: 30357570)
Aliment Pharmacol Ther. 2018 Feb;47(4):454-465. (PMID: 29205421)
Expert Rev Gastroenterol Hepatol. 2015 May;9(5):693-700. (PMID: 25763862)
Clin Res Hepatol Gastroenterol. 2016 Nov;40(5):e61-e63. (PMID: 27297910)
Clin Gastroenterol Hepatol. 2012 Sep;10(9):1002-7; quiz e78. (PMID: 22343692)
فهرسة مساهمة: Keywords: TNF inhibitor; golimumab; inflammatory bowel disease; ulcerative colitis
سلسلة جزيئية: ClinicalTrials.gov NCT00488631
تواريخ الأحداث: Date Created: 20220214 Latest Revision: 20220501
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC8832575
DOI: 10.1177/17562848221074188
PMID: 35154389
قاعدة البيانات: MEDLINE
الوصف
تدمد:1756-283X
DOI:10.1177/17562848221074188