Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial

Feagan, Brian G.; Danese, Silvio; Loftus, Edward V.; Vermeire, Séverine; Schreiber, Stefan; Ritter, Timothy E.; Fogel, Ronald; Mehta, Rajiv; Nijhawan, Sandeep; Kempiński, Radosław; Filip, Rafał; Hospodarskyy, Ihor; Seidler, Ursula; Seibold, Frank; Beales, Ian; Kim, Hyo Jong; McNally, John; Yun, Chohee; Zhao, Sally; Liu, Xiaopeng; Hsueh, Chia‐Hsiang; Tasset, Chantal; Besuyen, R.; Watanabe, Mamoru; Sandborn, William J.; Rogler, Gerhard; Hibi, Toshifumi; Peyrin–Biroulet, Laurent

doi:10.1016/s0140-6736(21)00666-8

Cited by 249 publications

(269 citation statements)

References 23 publications

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“…Its half-life of 6 h for the parent compound and 23 h for the active metabolite allows once-daily dosing [ 7 ]. In 2021, Feagan et al assessed a phase 2b/3, double-blind, randomized, placebo-controlled trial including two induction studies and one maintenance study, conducted in 341 study centers in 40 countries for filgotinib treatment of ulcerative colitis [ 20 ]. Patients were randomly assigned to receive filgotinib 100 mg, filgotinib 200 mg, or placebo, and the patients entered the maintenance study.…”

Section: Other Jak Inhibitorsmentioning

confidence: 99%

The Era of Janus Kinase Inhibitors for Inflammatory Bowel Disease Treatment

Kim

2021

IJMS

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For a significant proportion of patients with inflammatory bowel disease (IBD), primary non-response and secondary loss of response to treatment remain significant issues. Anti-tumor necrosis factor therapies have been licensed for use in IBD. Other disease-related pathways have been targeted as well, including the interleukin 12/23 axis and lymphocyte tracking. However, the need for parenteral administration and the associated costs of dispensing and monitoring all biologics remain a burden on healthcare systems and patients. Janus kinase inhibitors are small-molecule drugs that can be administered orally and are relatively inexpensive, thus offering an additional option for treating IBD. They have been shown to be effective in patients with ulcerative colitis (UC), but they are less effective in those with Crohn’s disease (CD). Nonetheless, given the immune-system-based mechanism of these drugs, their safety profile remains a cause for concern. This article provides an overview of Janus kinase (JAK) inhibitors and new trends in the treatment of IBD.

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Section: Other Jak Inhibitorsmentioning

confidence: 99%

The Era of Janus Kinase Inhibitors for Inflammatory Bowel Disease Treatment

Kim

2021

IJMS

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“…Weiterhin befinden sich neue JAK-Inhibitoren im Zulassungsverfahren. Hier konnte Filgotinib, das wie Upadacitinib ein selektiver JAK1-Inhibitor ist, bereits eine Wirksamkeit bezüglich des Erreichens einer klinischen Remission in Woche 58 bei Patienten mit CU zeigen (37,2 % bei 200 mg Filgotinib/Tag vs. 11,2 % unter Placebo; [ 53 ]). Upadacitinib war wirksamer als Placebo im Erreichen einer klinischen Remission in Woche 8 (8,5–19,6 % je nach Dosis vs. 0 %; [ 54 ]).…”

Section: Therapiesteuerung Und Neue Ansätzeunclassified

Was ist gesichert in der Therapie chronisch-entzündlicher Darmerkrankungen

2021

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“…In actual clinical situations, the Baron index [6,23] and Matts classification [24] are used. Actually, MES has been used more in recent, large-scale clinical studies [9][10][11].…”

Section: Meaning Of Mesmentioning

confidence: 99%

“…Among them, the Mayo endoscopic subscore (MES) presented by Schroeder et al in 1987 [8] is a major endoscopic score system for evaluating the status of mucosal inflammation and disease activity. It remains the most commonly used endoscopic evaluation scale [9][10][11]. As an index of endoscopic activity based only on endoscopic mucosal findings, the MES system is used frequently.…”

Section: Introductionmentioning

confidence: 99%

Analysis of Endoscopic Evaluation Reliability for Ulcerative Colitis in Histological Remission

et al. 2021

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The Mayo endoscopic subscore (MES) is a major endoscopic scoring system used to assign a status of mucosal inflammation and disease activity to patients with ulcerative colitis (UC). Using interobserver reliability (IOR), this study clarified the difficulties for endoscopic observers imposed by MES parameters used for the endoscopic evaluation of UC in histological remission. First, 42 endoscopists of four observer groups examined each MES parameter, which were evaluated from endoscopically obtained images of 100 cases as Grade 0 or 1 of the Nancy histological index of histopathological inflammation. Then, IOR was assessed using multiple κ statistics for each finding of MES. The results showed that IOR among all the observers was slight or fair for all the parameters, indicating a low IOR. The experts of the UC practice group had “moderate” or higher IOR for seven of the nine parameters, whereas “slight” or “fair” results were found for all parameters by the trainee group. The IOR for each MES parameter was calculated separately for the observer groups. All the groups showed “slight” or “fair” for “Erythema” and “Decreased vascular pattern”. Large differences between the endoscopists were found in the IOR for the MES parameters in UC in histological remission. Even among UC practice experts, the IOR was low for “Erythema” and “Decreased vascular pattern”.

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Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial

Cited by 249 publications

References 23 publications

The Era of Janus Kinase Inhibitors for Inflammatory Bowel Disease Treatment

The Era of Janus Kinase Inhibitors for Inflammatory Bowel Disease Treatment

Was ist gesichert in der Therapie chronisch-entzündlicher Darmerkrankungen

Analysis of Endoscopic Evaluation Reliability for Ulcerative Colitis in Histological Remission

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