References
- Danese S, Furfaro F, Vetrano S. Targeting S1P in Inflammatory bowel disease: new avenues for modulating intestinal leukocyte migration. J Crohns Colitis. 2018 Aug 22;12(suppl_2):S678–S686.
- Kaplan GG, Ng SC. Understanding and preventing the global increase of inflammatory bowel disease. Gastroenterology. 2017 Feb;152(2):313–321 e2.
- Molodecky NA, Soon IS, Rabi DM, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46–54 e42; quiz e30.
- Ng SC, Tang W, Ching JY, et al. Incidence and phenotype of inflammatory bowel disease based on results from the Asia-pacific Crohn’s and colitis epidemiology study. Gastroenterology. 2013 Jul;145(1):158–165 e2.
- Harbord M, Eliakim R, Bettenworth D, et al. Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 2: current management. J Crohns Colitis. 2017 Jul 1;11(7):769–784.
- Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019 Mar;114(3):384–413.
- Peyrin-Biroulet L, Loftus EV Jr., Colombel JF, et al. The natural history of adult Crohn’s disease in population-based cohorts. Am J Gastroenterol. 2010 Feb;105(2):289–297.
- Ungaro R, Mehandru S, Allen PB, et al. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756–1770.
- van der Valk ME, Mangen MJ, Leenders M, et al. Healthcare costs of inflammatory bowel disease have shifted from hospitalisation and surgery towards anti-TNFalpha therapy: results from the COIN study. Gut. 2014 Jan;63(1):72–79.
- Peyrin-Biroulet L, Christopher R, Behan D, et al. Modulation of sphingosine-1-phosphate in inflammatory bowel disease. Autoimmun Rev. 2017 May;16(5):495–503.
- Nixon GF. Sphingolipids in inflammation: pathological implications and potential therapeutic targets. Br J Pharmacol. 2009 Oct;158(4):982–993.
- Karuppuchamy T, Behrens EH, Gonzalez-Cabrera P, et al. Sphingosine-1-phosphate receptor-1 (S1P1) is expressed by lymphocytes, dendritic cells, and endothelium and modulated during inflammatory bowel disease. Mucosal Immunol. 2017 Jan;10(1):162–171.
- Kitatani K, Iwabuchi K, Snider A, et al. Sphingolipids in inflammation: from bench to bedside. Mediators Inflamm. 2016;2016:7602526.
- Biswas S, Bryant RV, Travis S. Interfering with leukocyte trafficking in Crohn’s disease. Best Pract Res Clin Gastroenterol. 2019 Feb–Apr;38-39:101617.
- Chaudhry BZ, Cohen JA, Conway DS. Sphingosine 1-phosphate receptor modulators for the treatment of multiple sclerosis. Neurotherapeutics. 2017 Oct;14(4):859–873.
- Theiss AL. Sphingosine-1-phosphate: driver of NFkappaB and STAT3 persistent activation in chronic intestinal inflammation and colitis-associated cancer. JAKSTAT. 2013 Jul 1;2(3):e24150.
- Mizushima T, Ito T, Kishi D, et al. Therapeutic effects of a new lymphocyte homing reagent FTY720 in interleukin-10 gene-deficient mice with colitis. Inflamm Bowel Dis. 2004 May;10(3):182–192.
- Kovarik JM, Schmouder R, Barilla D, et al. Single-dose FTY720 pharmacokinetics, food effect, and pharmacological responses in healthy subjects. Br J Clin Pharmacol. 2004 May;57(5):586–591.
- Faulkner M. Risk of progressive multifocal leukoencephalopathy in patients with multiple sclerosis. Expert Opin Drug Saf. 2015;14(11):1737–1748.
- Agency. MaHpR. Fingolimod (Gilenya): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections. [ cited 2019 Sep 28]. Available from: https://www.gov.uk/drug-safety-update/fingolimod-gilenya-risks-of-progressive-multifocal-leukoencephalopathy-basal-cell-carcinoma-and-opportunistic-infections
- Camm J, Hla T, Bakshi R, et al. Cardiac and vascular effects of fingolimod: mechanistic basis and clinical implications. Am Heart J. 2014 Nov;168(5):632–644.
- Meissner A, Limmroth V. Update on the cardiovascular profile of fingolimod in the therapy of relapsing-remitting multiple sclerosis (MS). Mult Scler Relat Disord. 2016 Jul;8:19–26.
- Chew WS, Wang W, Herr DR. To fingolimod and beyond: the rich pipeline of drug candidates that target S1P signaling. Pharmacol Res. 2016 Nov;113(Pt A):521–532.
- Schreiber S, Morgan M, Christopher R, et al. Etrasimod (APD334), a potent, selective, oral S1P receptor modulator with autoimmune disease-modifying activity that exhibits favourable PK/PD properties in healthy volunteers. Advances in inflammatory bowel diseases (AIBD); December 8–10, 2016 Orlando, FL, USA. p. P–180.
- Peyrin-Biroulet L, Gatlin J, Soloman M, et al. Receptor profile and efficacy of etrasimod (APD334), an oral, next-generation sphingosine-1-phosphate receptor modulator in development for ulcerative colitis. United European gastroenterology week (UEGW); 15–19 October, 2016; Vienna, Austria. p. LB20.
- ClinicalTrialsGov. Safety and efficacy of etrasimod (APD334) in patients with ulcerative colitis. NCT02447302. [ cited 2019 Sep 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT02447302
- Peyrin-Biroulet L GJ, Chiorean MV, et al. Histologic remission and mucosal healing in a randomized, placebo-controlled, phase 2 study of etrasimod in patients with moderately to severely active ulcerative Colitis. Gastroenterology. 2019;156(6):S–217.
- ClinicalTrialsGov. Etrasimod versus placebo as induction therapy in moderately to severely active ulcerative colitis (ELEVATE UC 12). NCT03996369 [ cited 2019 Sep 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT03996369
- ClinicalTrialsGov. Etrasimod versus placebo for the treatment of moderately to severely active ulcerative colitis (ELEVATE UC 52). NCT03945188. [ cited 2019 September 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT03945188
- ClinicalTrialsGov. An extension study for treatment of moderately to severely active ulcerative colitis (ELEVATE UC OLE). NCT03950232. [ cited 2019 Sep 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT03950232
- Cohen JA, Arnold DL, Comi G, et al. Safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Apr;15(4):373–381.
- Scott FL, Clemons B, Brooks J, et al. Ozanimod (RPC1063) is a potent sphingosine-1-phosphate receptor-1 (S1P1) and receptor-5 (S1P5) agonist with autoimmune disease-modifying activity. Br J Pharmacol. 2016 Jun;173(11):1778–1792.
- Sandborn WJ, Feagan BG, Wolf DC, et al. Ozanimod induction and maintenance treatment for ulcerative colitis. N Engl J Med. 2016 May 5;374(18):1754–1762.
- Feagan BG, Sandborn WJ, D’Haens G, et al. P687 Clinical remission demonstrated with oral ozanimod in the overall population and across multiple subgroups of patients with moderately to severely active ulcerative colitis in the TOUCHSTONE trial. J Crohns Colitis. 2019;13:S464.
- Cohen JA, Comi G, Selmaj KW, et al. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019 Nov;18(11):1021–1033.
- To evaluate efficacy and long-term safety of ozanimod in Japanese subjects with moderately to severely active ulcerative colitis [ cited 2019 Sep 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT03915769?term=ozanimod&cond=Ulcerative+Colitis&draw=2&rank=4
- Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis. [ cited 2019 Sep 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT02435992?term=ozanimod&cond=Ulcerative+Colitis&draw=2&rank=2
- Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis. [ cited 2019 Sep 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT02531126?term=ozanimod&cond=Ulcerative+Colitis&draw=2&rank=1
- ClinicalTrialsGov. Efficacy and safety trial of RPC1063 for Moderate to Severe Crohn’s Disease. NCT02531113. [ cited 2019 September 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT02531113
- Feagan BG, D'Haens G, Usiskin K, et al. P661 Early histological improvement demonstrated with oral ozanimod in patients with moderately to severely active Crohn’s disease in the STEPSTONE trial. J Crohns Colitis. 2019;13:S450.
- ClinicalTrialsGov. Induction study #1 of oral ozanimod as induction therapy for moderately to severely active Crohn’s Disease. NCT03440372. [ cited 2019 Sep 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT03440372
- ClinicalTrialsGov. Induction study #2 of oral ozanimod as induction therapy for moderately to severely active Crohn’s Disease. NCT03440385. [ cited 2019 Sep 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT03440385
- ClinicalTrialsGov. A placebo-controlled study of oral ozanimod as maintenance therapy for moderately to severely active Crohn’s Disease. NCT03464097. [ cited 2019 Sep 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT03464097
- ClinicalTrialsGov. An extension study of oral ozanimod for moderately to severely active Crohn’s Disease. NCT03467958. [ cited 2019 Sep 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT03467958
- ClinicalTrialsGov. Safety and efficacy of MT-1303 in subjects with moderate to severe active Crohn’s disease. NCT02378688. [ cited 2019 Sep 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT02378688
- ClinicalTrialsGov. Extension Study of MT-1303 in Subjects With Crohn’s Disease. NCT02389790. [ cited 2019 Sep 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT02389790
- Geert R. D’Haens SD, Toshifumi H, Watanabe M, et al. 1005 – A controlled trial of amiselimod, a selective S1p receptor modulator in Crohn’s Disease. Gastroenterology. 2019;156(6):S–217.
- Salix Enters Into Exclusive License Agreement With Mitsubishi Tanabe Pharma To Develop And Commercialize Late Stage Investigational S1P Modulator For The Treatment Of Inflammatory Bowel Disease. 2019. [cited 2019 Dec 17]. Available from: https://www.prnewswire.com/news-releases/salix-enters-into-exclusive-license-agreement-with-mitsubishi-tanabe-pharma-to-develop-and-commercialize-late-stage-investigational-s1p-modulator-for-the-treatment-of-inflammatory-bowel-disease-300838229.html
- Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462–2476.