Ulcerative Colitis — Autoimmune Paradoxical Reactions in IBD Longitudinal Cohort
Citation(s)
Afzali A, Wheat CL, Hu JK, Olerud JE, Lee SD The association of psoriasiform rash with anti-tumor necrosis factor (anti-TNF) therapy in inflammatory bowel disease: a single academic center case series. J Crohns Colitis. 2014 Jun;8(6):480-8. doi: 10.1016/j.crohns.2013.10.013. Epub 2013 Nov 21.
Baumgart DC, Grittner U, Steingräber A, Azzaro M, Philipp S Frequency, phenotype, outcome, and therapeutic impact of skin reactions following initiation of adalimumab therapy: experience from a consecutive cohort of inflammatory bowel disease patients. Inflamm Bowel Dis. 2011 Dec;17(12):2512-20. doi: 10.1002/ibd.21643. Epub 2011 Feb 23.
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. Review.
Cullen G, Kroshinsky D, Cheifetz AS, Korzenik JR Psoriasis associated with anti-tumour necrosis factor therapy in inflammatory bowel disease: a new series and a review of 120 cases from the literature. Aliment Pharmacol Ther. 2011 Dec;34(11-12):1318-27. doi: 10.1111/j.1365-2036.2011.04866.x. Epub 2011 Sep 29. Review.
Denadai R, Teixeira FV, Steinwurz F, Romiti R, Saad-Hossne R Induction or exacerbation of psoriatic lesions during anti-TNF-a therapy for inflammatory bowel disease: a systematic literature review based on 222 cases. J Crohns Colitis. 2013 Aug;7(7):517-24. doi: 10.1016/j.crohns.2012.08.007. Epub 2012 Sep 7. Review.
Fiorino G, Danese S, Pariente B, Allez M Paradoxical immune-mediated inflammation in inflammatory bowel disease patients receiving anti-TNF-a agents. Autoimmun Rev. 2014 Jan;13(1):15-9. doi: 10.1016/j.autrev.2013.06.005. Epub 2013 Jun 15. Review.
Niess JH, Danese S Anti-TNF and skin inflammation in IBD: a new paradox in gastroenterology? Gut. 2014 Apr;63(4):533-5. doi: 10.1136/gutjnl-2013-304683. Epub 2013 Apr 9.
Singh S, Kumar N, Loftus EV Jr, Kane SV Neurologic complications in patients with inflammatory bowel disease: increasing relevance in the era of biologics. Inflamm Bowel Dis. 2013 Mar-Apr;19(4):864-72. doi: 10.1002/ibd.23011. Review.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
