Dai C, Liu WX, Jiang M, Sun MJ Mucosal healing did not predict sustained clinical remission in patients with IBD after discontinuation of one-year infliximab therapy. PLoS One. 2014 Oct 20;9(10):e110797. doi: 10.1371/journal.pone.0110797. eCollection 2014.
Gisbert JP, Marin AC, Chaparro M Systematic review: factors associated with relapse of inflammatory bowel disease after discontinuation of anti-TNF therapy. Aliment Pharmacol Ther. 2015 Aug;42(4):391-405. doi: 10.1111/apt.13276. Epub 2015 Jun 15.
Gisbert JP, Marin AC, Chaparro M The Risk of Relapse after Anti-TNF Discontinuation in Inflammatory Bowel Disease: Systematic Review and Meta-Analysis. Am J Gastroenterol. 2016 May;111(5):632-47. doi: 10.1038/ajg.2016.54. Epub 2016 Mar 22.
Gisbert JP, Panes J Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol. 2009 Mar;104(3):760-7. doi: 10.1038/ajg.2008.88. Epub 2009 Jan 27.
Lichtenstein GR, Yan S, Bala M, Blank M, Sands BE Infliximab maintenance treatment reduces hospitalizations, surgeries, and procedures in fistulizing Crohn's disease. Gastroenterology. 2005 Apr;128(4):862-9. doi: 10.1053/j.gastro.2005.01.048.
Louis E, Belaiche J, Reenaers C Anti-TNF and Crohn's disease: when should we stop? Curr Drug Targets. 2010 Feb;11(2):148-51. doi: 10.2174/138945010790309957.
Luppino I, Spagnuolo R, Marasco R, Cosco C, Ruggiero G, Cosco V, et al Withdrawal of infliximab (IFX) after achieving remission: outcome in a cohort of inflammatory bowel disease (IBD) patients. Dig Liver Dis. [Conference abstract: Abstracts of the 19th National Congress of Digestive Diseases]. 2013;45S:S100-S1.
Pariente B, Laharie D Review article: why, when and how to de-escalate therapy in inflammatory bowel diseases. Aliment Pharmacol Ther. 2014 Aug;40(4):338-53. doi: 10.1111/apt.12838. Epub 2014 Jun 23.
Sorrentino D, Nash P, Viladomiu M, Hontecillas R, Bassaganya-Riera J Stopping anti-TNF agents in patients with Crohn's disease in remission: is it a feasible long-term strategy? Inflamm Bowel Dis. 2014 Apr;20(4):757-66. doi: 10.1097/01.MIB.0000442680.47427.bf. No abstract available.
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.