drugset / Trial / NCT03629379
Response to Ustekinumab for Anti-tnf Induced Psoriasiform Skin Lesions
Non-randomizedParallel-groupOpen-labelBasic science
Summary
Using transcriptomics and proteomics to gain insights in the development of psoriasiform skin lesions under anti-tumor necrosis factor (TNF) therapy, and predicting response to ustekinumab.
Timeline
- Start
- 2019-01-22
- Primary completion
- 2021-01-01
- Completion
- 2021-07-01
Publications
- Results Cleynen I, Van Moerkercke W, Billiet T, Vandecandelaere P, Vande Casteele N, Breynaert C, Ballet V, Ferrante M, Noman M, Assche GV, Rutgeerts P, van den Oord JJ, Gils A, Segaert S, Vermeire S. Characteristics of Skin Lesions Associated With Anti-Tumor Necrosis Factor Therapy in Patients With Inflammatory Bowel Disease: A Cohort Study. Ann Intern Med. 2016 Jan 5;164(1):10-22. doi: 10.7326/M15-0729. Epub 2015 Dec 8.
- Results Cleynen I, Vermeire S. Paradoxical inflammation induced by anti-TNF agents in patients with IBD. Nat Rev Gastroenterol Hepatol. 2012 Sep;9(9):496-503. doi: 10.1038/nrgastro.2012.125. Epub 2012 Jul 3.
- Results Tillack C, Ehmann LM, Friedrich M, Laubender RP, Papay P, Vogelsang H, Stallhofer J, Beigel F, Bedynek A, Wetzke M, Maier H, Koburger M, Wagner J, Glas J, Diegelmann J, Koglin S, Dombrowski Y, Schauber J, Wollenberg A, Brand S. Anti-TNF antibody-induced psoriasiform skin lesions in patients with inflammatory bowel disease are characterised by interferon-gamma-expressing Th1 cells and IL-17A/IL-22-expressing Th17 cells and respond to anti-IL-12/IL-23 antibody treatment. Gut. 2014 Apr;63(4):567-77. doi: 10.1136/gutjnl-2012-302853. Epub 2013 Mar 6.
- Results Grine L, Dejager L, Libert C, Vandenbroucke RE. An inflammatory triangle in psoriasis: TNF, type I IFNs and IL-17. Cytokine Growth Factor Rev. 2015 Feb;26(1):25-33. doi: 10.1016/j.cytogfr.2014.10.009. Epub 2014 Oct 31.
- Results Conrad C, Di Domizio J, Mylonas A, Belkhodja C, Demaria O, Navarini AA, Lapointe AK, French LE, Vernez M, Gilliet M. TNF blockade induces a dysregulated type I interferon response without autoimmunity in paradoxical psoriasis. Nat Commun. 2018 Jan 2;9(1):25. doi: 10.1038/s41467-017-02466-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ustekinumab | Monoclonal antibody | 90 mg | Intravenous |
| Comparator | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |