Modified-release phosphatidylcholine (LT-02) for ulcerative colitis

• Verfasst von: Dignaß, Axel Uwe [VerfasserIn]
• Verfasst von: Stremmel, Wolfgang [VerfasserIn]
• Verfasst von: Horyński, Marek [VerfasserIn]
• Verfasst von: Poyda, Oleksandr [VerfasserIn]
• Verfasst von: Armerding, Peter [VerfasserIn]
• Verfasst von: Fellermann, Klaus [VerfasserIn]
• Verfasst von: Langhorst, Jost [VerfasserIn]
• Verfasst von: Kuehbacher, Tanja [VerfasserIn]
• Verfasst von: Uebel, Peter [VerfasserIn]
• Verfasst von: Stein, Jürgen [VerfasserIn]
• Verfasst von: Novacek, Gottfried [VerfasserIn]
• Verfasst von: Avalueva, Elena [VerfasserIn]
• Verfasst von: Olijnyk, Oleksandr Ljeontijovyč [VerfasserIn]
• Verfasst von: Hasselblatt, Peter [VerfasserIn]
• Verfasst von: Dorofeyev, Andrey [VerfasserIn]
• Verfasst von: Heinemann, Heidrun [VerfasserIn]
• Verfasst von: Mueller, Ralph [VerfasserIn]
• Verfasst von: Greinwald, Roland [VerfasserIn]
• Verfasst von: Reinisch, Walter [VerfasserIn]
• Titel: Modified-release phosphatidylcholine (LT-02) for ulcerative colitis
• Titelzusatz: two double-blind, randomized, placebo-controlled trials
• Verf.angabe: Axel Dignass, Wolfgang Stremmel, Marek Horyński, Oleksandr Poyda, Peter Armerding, Klaus Fellermann, Jost Langhorst, Tanja Kuehbacher, Peter Uebel, Juergen Stein, Gottfried Novacek, Elena Avalueva, Oleksandr Oliinyk, Peter Hasselblatt, Andrey Dorofeyev, Heidrun Heinemann, Ralph Mueller, Roland Greinwald and Walter Reinisch
• E-Jahr: 2024
• Jahr: April 2024
• Umfang: 11 S.
• Fussnoten: Gesehen am 02.12.2024
• Titel Quelle: Enthalten in: Clinical gastroenterology and hepatology
• Ort Quelle: New York, NY : Elsevier Science, 2003
• Jahr Quelle: 2024
• Band/Heft Quelle: 22(2024), 4, Seite 810-820
• ISSN Quelle: 1542-7714
• DOI: doi:10.1016/j.cgh.2023.09.031
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Mesalamine
• Sach-SW: Mucus
• Sach-SW: Phosphatidylcholine
• Sach-SW: Ulcerative Colitis
• K10plus-PPN: 1910625361

Abstract

Background & Aims - The aim of this study was to evaluate the efficacy of LT-02, a novel modified-release phosphatidylcholine (PC) formulation, for induction and maintenance of remission in patients with mild to moderate ulcerative colitis (UC) and inadequate response to mesalamine. - Methods - LT-02 was evaluated in a multicenter double-blind, randomized, placebo-controlled study comprising a 12-week induction trial (PCG-2), followed by a 48-week maintenance trial (PCG-4). In PCG-2, patients were randomized 1:1:1 to treatment with 0.8 g LT-02 4 times daily (QID), 1.6 g LT-02 twice daily (BID), or placebo, respectively. All patients continued to take a standard dose of oral mesalamine (≥2.4 g/day). The primary end point in PCG-2 was deep remission. Patients achieving remission at week 12 were randomly assigned 2:1:1 to 1.6 g LT-02 BID, placebo, or 500 mg mesalamine (3 times daily), respectively, in PCG-4; the primary end point was remission at 48 weeks. - Results - PCG-2 was terminated early for futility after a prespecified interim analysis; 466 patients (of 762 planned) were randomized. There was no statistically significant difference in deep remission at week 12 (placebo, 13.5%; LT-02 BID, 14.2%; LT-02 QID, 9.7%). In PCG-4, 150 patients (of approximately 400 planned) were randomized. There was no statistically significant difference in remission rates at week 48 (LT-02 BID, 49.3%; mesalamine, 50.0%; placebo, 43.2%). LT-02 was safe. - Conclusions - Despite prior evidence of beneficial effects of PC in phase 2 trials, our induction study with LT-02 in patients with mild to moderate UC was terminated prematurely for futility. Signals of efficacy in maintenance therapy require confirmation in an adequately powered maintenance trial. LT-02 was safe and well-tolerated. ClinicalTrials.gov: NCT02280629, NCT02142725.