Thomas R Einarson1, Basil G Bereza1, Xin Ying Lee2, Filippo Lelli3. 1. a Leslie Dan Faculty of Pharmacy , University of Toronto , Toronto , ON , Canada. 2. b Janssen-Cliag A/S , Birkerød , Denmark. 3. c Janssen-Cilag SpA , Cologno Monzese , Italy.
Abstract
BACKGROUND: Biologics used to treat Crohn's disease (CD) may lose their effect over time, requiring dose escalation. Little information is available on this topic. AIM: To summarize rates of dose escalation, duration, de-escalation in observational studies of CD in adults treated with adalimumab, infliximab, and vedolizumab in Europe. METHODS: Two independent investigators searched Medline and Embase for observational studies published in 1998-2015 and proceedings from four major scientific meetings. Rates were summarized descriptively. RESULTS: In total, 58 articles from 12 European countries were analyzed (49 full articles, nine abstracts), providing 65 reports with 7,850 patients; 35 reported on 3,830 patients with adalimumab (ADA), and 30 on 4,020 patients with infliximab (IFX). Overall, 29.9% ± 3.5% of patients required dose escalation; 32.8% ± 6.2% with ADA and 25.2% ± 2.4% with IFX (p = .35 between drugs). Rates increased according to line of treatment: 19% for first line, 37% second, and 41% third. The median time to loss of response was 12 months, and the weighted average was 15.1 ± 5.9 months. Median time to escalation was 6.7 months; 6.7 months for ADA and 7.5 for IFX (p = .86). Short-term response rates to escalation were 63% for ADA and 45% for IFX (p = .08). There were no papers available for vedolizumab. CONCLUSIONS: A substantial proportion of patients receiving ADA or IFX for Crohn's disease require dose escalation after a short period of time.
BACKGROUND: Biologics used to treat Crohn's disease (CD) may lose their effect over time, requiring dose escalation. Little information is available on this topic. AIM: To summarize rates of dose escalation, duration, de-escalation in observational studies of CD in adults treated with adalimumab, infliximab, and vedolizumab in Europe. METHODS: Two independent investigators searched Medline and Embase for observational studies published in 1998-2015 and proceedings from four major scientific meetings. Rates were summarized descriptively. RESULTS: In total, 58 articles from 12 European countries were analyzed (49 full articles, nine abstracts), providing 65 reports with 7,850 patients; 35 reported on 3,830 patients with adalimumab (ADA), and 30 on 4,020 patients with infliximab (IFX). Overall, 29.9% ± 3.5% of patients required dose escalation; 32.8% ± 6.2% with ADA and 25.2% ± 2.4% with IFX (p = .35 between drugs). Rates increased according to line of treatment: 19% for first line, 37% second, and 41% third. The median time to loss of response was 12 months, and the weighted average was 15.1 ± 5.9 months. Median time to escalation was 6.7 months; 6.7 months for ADA and 7.5 for IFX (p = .86). Short-term response rates to escalation were 63% for ADA and 45% for IFX (p = .08). There were no papers available for vedolizumab. CONCLUSIONS: A substantial proportion of patients receiving ADA or IFX for Crohn's disease require dose escalation after a short period of time.
Authors: Vito Annese; Rahul Nathwani; Maryam Alkhatry; Ahmad Al-Rifai; Sameer Al Awadhi; Filippos Georgopoulos; Ahmad N Jazzar; Ahmed M Khassouan; Zaher Koutoubi; Mazen S Taha; Jimmy K Limdi Journal: Therap Adv Gastroenterol Date: 2021-12-22 Impact factor: 4.409
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Authors: Wannee Kantasiripitak; An Outtier; Sebastian G Wicha; Alexander Kensert; Zhigang Wang; João Sabino; Séverine Vermeire; Debby Thomas; Marc Ferrante; Erwin Dreesen Journal: CPT Pharmacometrics Syst Pharmacol Date: 2022-06-15