Natalizumab in the treatment of Crohn’s disease patients

References

• Podolsky DK. Inflammatory bowel disease. N Engl J Med. 2002;347:417–429.
   PubMed Web of Science ®Google Scholar
• 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;142:46–54 e42; quiz e30.
   PubMed Web of Science ®Google Scholar
• Baumgart DC, Sandborn WJ. Crohn’s disease. Lancet. 2012;380:1590–1605.
   PubMed Web of Science ®Google Scholar
• Costa J, Magro F, Caldeira D, et al. Infliximab reduces hospitalizations and surgery interventions in patients with inflammatory bowel disease: a systematic review and meta-analysis. Inflamm Bowel Dis. 2013;19:2098–2110.
   PubMed Web of Science ®Google Scholar
• Loftus EV Jr., Johnson SJ, Wang ST, et al. Risk-benefit analysis of adalimumab versus traditional non-biologic therapies for patients with Crohn’s disease. Inflamm Bowel Dis. 2011;17:127–140.
   PubMed Web of Science ®Google Scholar
• Leung Y, Panaccione R. Anti-adhesion molecule strategies for Crohn disease. Bio Drugs. 2008;22:259–264.
   Google Scholar
• Bamias G, Cominelli F. Immunopathogenesis of inflammatory bowel disease: current concepts. Curr Opin Gastroenterol. 2007;23:365–369.
   PubMed Web of Science ®Google Scholar
• Zundler S, Neurath MF. Novel insights into the mechanisms of gut homing and antiadhesion therapies in inflammatory bowel diseases. Inflamm Bowel Dis. 2017;23:617–627.
   PubMed Web of Science ®Google Scholar
• McLean LP, Cross RK. Integrin antagonists as potential therapeutic options for the treatment of Crohn’s disease. Expert Opin Investig Drugs. 2016;25:263–273.
   PubMed Web of Science ®Google Scholar
• Arseneau KO, Cominelli F. Targeting leukocyte trafficking for the treatment of inflammatory bowel disease. Clin Pharmacol Ther. 2015;97:22–28.
   PubMed Web of Science ®Google Scholar
• Habtezion A, Nguyen LP, Hadeiba H, et al. Leukocyte trafficking to the small intestine and colon. Gastroenterology. 2016;150:340–354.
   PubMed Web of Science ®Google Scholar
• US Department of Health & Human Services. Drugs @ FDA - Label and approval history. FDA [online]. [Cited 2012 Feb 20]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf
   Google Scholar
• Sandborn WJ, Colombel JF, Enns R, et al. Natalizumab induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2005;353:1912–1925.
   PubMed Web of Science ®Google Scholar
• Targan SR, Feagan BG, Fedorak RN, et al. Natalizumab for the treatment of active Crohn’s disease: results of the ENCORE Trial. Gastroenterology. 2007;132:1672–1683.
   PubMed Web of Science ®Google Scholar
• Gordon FH, Lai CW, Hamilton MI, et al. A randomized placebo-controlled trial of a humanized monoclonal antibody to alpha4 integrin in active Crohn’s disease. Gastroenterology. 2001;121:268–274.
   PubMed Web of Science ®Google Scholar
• Ghosh S, Goldin E, Gordon FH, et al. Natalizumab for active Crohn’s disease. N Engl J Med. 2003;348:24–32.
   PubMed Web of Science ®Google Scholar
• Sands BE, Kozarek R, Spainhour J, et al. Safety and tolerability of concurrent natalizumab treatment for patients with Crohn’s disease not in remission while receiving infliximab. Inflamm Bowel Dis. 2007;13:2–11.
   PubMed Web of Science ®Google Scholar
• MacDonald JK, McDonald JW. Natalizumab for induction of remission in Crohn’s disease. Cochrane Database Syst Rev. 2007;24(1):CD006097.
   Google Scholar
• Chandar AK, Singh S, Murad MH, et al. Efficacy and safety of natalizumab and vedolizumab for the management of Crohn’s Disease: a systematic review and meta-analysis. Inflamm Bowel Dis. 2015;21:1695–1708.
   PubMed Web of Science ®Google Scholar
• Juillerat P, Wasan SK, Fowler SA, et al. Efficacy and safety of natalizumab in Crohn’s disease patients treated at 6 Boston academic hospitals. Inflamm Bowel Dis. 2013;19:2457–2463.
   PubMed Web of Science ®Google Scholar
• Sakuraba A, Keyashian K, Correia C, et al. Natalizumab in Crohn’s disease: results from a US tertiary inflammatory bowel disease center. Inflamm Bowel Dis. 2013;19:621–626.
   PubMed Web of Science ®Google Scholar
• Chen CH, Kularatna G, Stone CD, et al. Clinical experience of natalizumab in Crohn’s disease patients in a restricted distribution program. Ann Gastroenterol. 2013;26:189–190.
   PubMedGoogle Scholar
• Kane SV, Horst S, Sandborn WJ, et al. Natalizumab for moderate to severe Crohn’s disease in clinical practice: the mayo clinic rochester experience. Inflamm Bowel Dis. 2012;18:2203–2208.
   PubMed Web of Science ®Google Scholar
• Hyams JS, Wilson DC, Thomas A, et al. Natalizumab therapy for moderate to severe Crohn disease in adolescents. J Pediatr Gastroenterol Nutr. 2007;44:185–191.
   PubMed Web of Science ®Google Scholar
• Singh N, Deshpande R, Rabizadeh S, et al. Real world experience with natalizumab at a tertiary care pediatric IBD center. J Pediatr Gastroenterol Nutr. 2016;62:863–866.
   PubMed Web of Science ®Google Scholar
• Kleinschmidt-DeMasters BK, Tyler KL. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis. N Engl J Med. 2005;353:369–374.
   PubMed Web of Science ®Google Scholar
• Langer-Gould A, Atlas SW, Green AJ, et al. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N Engl J Med. 2005;353:375–381.
   PubMed Web of Science ®Google Scholar
• Van Assche G, Van Ranst M, Sciot R, et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn’s disease. N Engl J Med. 2005;353:362–368.
   PubMed Web of Science ®Google Scholar
• Bozic C, Subramanyam M, Richman S, et al. Anti-JC virus (JCV) antibody prevalence in the JCV Epidemiology in MS (JEMS) trial. Eur J Neurol. 2014;21:299–304.
   PubMed Web of Science ®Google Scholar
• Brew BJ, Davies NW, Cinque P, et al. Progressive multifocal leukoencephalopathy and other forms of JC virus disease. Nat Rev Neurol. 2010;6:667–679.
   PubMed Web of Science ®Google Scholar
• Bloomgren G, Richman S, Hotermans C, et al. Risk of natalizumab-associated progressive multifocal leukoencephalopathy. N Engl J Med. 2012;366:1870–1880.
   PubMed Web of Science ®Google Scholar
• Gandhi S, Jakimovski D, Ahmed R, et al. Use of natalizumab in multiple sclerosis: current perspectives. Expert Opin Biol Ther. 2016;16:1151–1162.
   PubMed Web of Science ®Google Scholar
• Kerwood F, Cristiano L, Bloomgren G, et al. Natalizumab use in patients with Crohnʼs disease (CD) and relapsing multiple sclerosis (MS): updated utilization and safety results. Inflamm Bowel Dis. 2012;18:S67.
   Web of Science ®Google Scholar
• Bellaguarda E, Keyashian K, Pekow J, et al. Prevalence of antibodies against JC virus in patients with refractory Crohn’s disease and effects of natalizumab therapy. Clin Gastroenterol Hepatol. 2015;13:1919–1925.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. European public assessment reports (natalizumab). European Medicines Agency [online], refusal CHMP assessment report for natalizumab elan pharma. [Cited 2008 Jan 25]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000624/WC500070715.pdf
   Google Scholar
• Arseneau KO, Cominelli F. Vercirnon for the treatment of Crohn’s disease. Expert Opin Investig Drugs. 2013;22:907–913.
   PubMed Web of Science ®Google Scholar
• Kachuck NJ. Registries, research, and regrets: is the FDA’s post-marketing REMS process not adequately protecting patients?. Ther Adv Neurol Disord. 2011;4:339–347.
   PubMedGoogle Scholar
• Avasarala J. The TOUCH program and natalizumab: fundamental flaw in patient protection. F1000Res. 2015;4:1450.
   PubMedGoogle Scholar