References
- Papers of special note have been highlighted as
- either of interest (•) or of considerable interest
- (••) to readers.
- Murch SH, Braegger CP, Walker-Smith JA, et al. Location of tumor necrosis factor alpha in chronic inflammatory bowel disease. Gut. 1993;34:1705–1709.
- Reinecker HC, Steffen M, Witthoeft T, et al. Enhanced secretion of tumour necrosis factor-alpha, IL-6, and IL-1 beta by isolated lamina propria mononuclear cells from patients with ulcerative colitis and Crohn’s disease. Clin Exp Immunol. 1993;94:174–181.
- van Deventer SJ. Tumor necrosis factor and Crohn’s disease. Gut. 1997;40:443–448.
- Derkx B, Taminiau J, Radema S. Tumour-necrosis-factor antibody treatment in Crohn’s disease. Lancet. 1993;342:173–174.
- van Dullemen HM, van Deventer SJ, Hommes DW, et al. Treatment of Crohn’s disease with anti-tumor necrosis factor chimeric monoclonal antibody (cA2). Gastroenterology. 1995;109:129–135.
- Stasi R, Amadori S, Newland AC, et al. Infliximab chimeric antitumor necrosis factor-a monoclonal antibody as potential treatment for myelodysplastic syndromes. Leuk Lymphoma. 2005;46:509–516.
- Targan SR, Hanauer SB, van Deventer SJ, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn’s disease: Crohn’s Disease cA2 Study Group. N Engl J Med. 1997;337:1029–1035.
- Schreiber S, Rutgeerts P, Fedorak RN, et al. A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn’s disease. Gastroenterology. 2005;129:807–818.
- Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn’s disease: the CLASSIC-I trial. Gastroenterology. 2006;130:323–333.
- Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007;146:829–838.
- Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet. 2002;359:1541–1549.
- Colombel JF, Sandborn WJ, Rutgeerts P, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trial. Gastroenterology. 2007;132:52–65.
- Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn’s disease. N Engl J Med. 2007;357:228–238.
- Schreiber S, Khalig-Kareemi M, Lawrence IC, et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med. 2007;357:239–250.
- Nesbitt A, Fossati G, Bergin M, et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis. 2007;13:1323–1332.
•• CZP lacks apoptotic and cytotoxic actions due to the absence of the Fc antibody region.
- Tracey D, Klareskog L, Sasso E, et al. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharma and Ther. 2008;117:244–279.
- Eissner G, Kirchner S, Lindner H, et al. Reverse signaling through transmembrane TNF confers resistance to lipopolysaccharide in human monocytes and macrophages. J Immunol. 2000;164:6193–6198.
- Nesbitt AM, Fossati G, Dt B. Comparison of certolizumab pegol, etanercept, adalimumab, and infliximab: effect on lipopolysaccharide-induced cytokine production by human peripheral blood monocytes. Am H Gastroenterol. 2006;101:S420–70.
- Kirchner S, Holler E, Haffner S, et al. Effect of different tumor necrosis factor TNF reactive agents on reverse signaling of membrane integrated TNF in monocytes. Cytokiune. 2004;28:67–74.
- Shen C, Assche GV, Colpaert S, et al. Adalimumab induces apoptosis of human monocytes: a comparative study with infliximab and etanercept. Aliment Pharmacol Ther. 2005;21:251–258.
- Katz LH, Kopylov U, Fudim E, et al. Expression of IL-2, IL-17 and TNF-alpha in patients with Crohn’s disease treated with anti-TNF antibodies. Clin Res Hepatol Gastroenterol. 2014;38:491–498.
- Mitoma H, Horiuchi T, Hatta N, et al. Infliximab induces potent anti-inflammatory response by outside-to-inside signal through transmembrane TNF-α. Gastroenterology. 2005;128:376–392.
- Ina K, Itoh J, Fukushima K, et al. Resistance of Crohn’s disease T cells to multiple apoptotic signals is associated with a Bcl-2/Bax mucosal imbalance. J Immunol. 1999;163:1081–1090.
- Cabal-Hierro L, Lazo PS. Signal transduction by tumor necrosis factor receptors. Cell Signal. 2012;24:1297–1305.
- Ten Hove T, van Montfrans C, Peppelenbosch MP, et al. Infliximab treatment induces apoptosis of lamina propria T lymphocytes in Crohn’s disease. Gut. 2002;50:206–211.
- Oikonomopoulos A, van Deen WK, Hommes DW. Anti-TNF antibodies in inflammatory bowel disease: do we finally know how it works? Curr Drug Targets. 2013;14:1421–1432.
•• A summary of anti-TNF-α mechanisms of action in IBD.
- van den Brande JM, Koehler TC, Zelinkova Z, et al. Prediction of antitumour necrosis factor clinical efficacy by real-time visualisation of apoptosis in patients with Crohn’s disease. Gut. 2007;56:509–517.
- Sipos O, Torok A, Kalic T, et al. Reverse signaling contributes to control of chronic inflammation by anti-TNF therapeutics. Antibodies. 2015;4:123–140.
- Waetzig GH, Rosenstiel P, Arlt A, et al. Soluble tumor necrosis factor (TNF) receptor-1 induces apoptosis via reverse TNF signaling and autorince transforming growth factor- β1. FASEB J. 2005;19:91–93.
- Sandborn WJ, Lee SD, Randall C, et al. Long-term safety and efficacy of certolizumab pegol in the treatment of Crohn’s disease: 7-year results from the PRECiSE 3 study. Aliment Pharmacol Ther. 2014;40:903–916.
- Arora T, Padaki R, Liu L. Differences in binding and effector functions between classes of TNF antagonists. Cytokine. 2009;45:124–131.
- Mitoma H, Horiuchi T, Tsukamoto H, et al. Mechanisms for cytotoxic effects of anti–tumor necrosis factor agents on transmembrane tumor necrosis factor α–expressing cells: Comparison among infliximab, etanercept, and adalimumab. Arthritis Rheum. 2008;58:1248–1257.
- Vande Casteele N, Gils A. Pharmacokinetics of ant-TNF monoclonal antibodies in inflammatory bowel disease: addaing value to current practice. J Clin Pharmacol. 2015;55:S39–50.
- Schellekens H. Factors influencing the immunogenicity of therapeutic proteins. Nephrol Dial Transplant. 2005;20:vi3–9.
- Fasanmade AA, Adedokun OJ, Blank M, et al. Pharmacokinetic properties of infliximab in children and adults with Crohn’s disease: a retrospective analysis of data from 2 phase III clinical trials. Clin Ther. 2011;33:946–964.
- Feuerstein JD, Cheifetz AS. Miscellaneous adverse events with biologic agents [excludes infection and malignancy]. Gastroenterol Clin North Am. 2014;43:543–563.
- Choquette D, Faraawi RY, Njoya M, et al. What are the implications of concomitant and pre-medication on infusion reactions to infliximab: results from “RemiTRAC Infusion”, a prospective real-world community registry. Arthritis Rheum. 2013;65(Suppl 10):452.
- Miehsler W, Novacek G, Wenzl H, et al. A decade of infliximab: the Austrian evidence based consensus on the safe use of infliximab in inflammatory bowel disease. J Crohns Colitis. 2010;4:221–256.
- Vermeire S, Van AG, Rutgeerts P. Serum sickness, encephalitis and other complications of anti-cytokine therapy. Best Pract Res Clin Gastroenterol. 2009;23:101–112.
- O’Meara S, Nanda KS, Moss AC. Antibodies to infliximab and risk of infusion reactions in patients with inflammatory bowel disease: a systematic review and meta-analysis. Inflamm Bowel Dis. 2014;20:1–6.
- Baert F, Norman M, Vermeire S, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn’s disease. N Engl J Med. 2003;348:601–608.
- Vande Casteele N, Breynaert C, Vermeire S, et al. Incidence of acute severe infusion reactions to infliximab depends on definition used rather than assay. Aliment Pharmacol Ther. 2011;34(401–3): 404–405.
- Farrell RJ, Alsahli M, Jeen YT, et al. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn’s disease: a randomised controlled trial. Gastroenterology. 2003;124:917–924.
- Cheifetz A, Smedley M, Martin S, et al. The incidence and management of infusion reactions to infliximab: a large center experience. Am J Gastroenterol. 2003;98:1315–1324.
- Colombel JF, Loftus EV Jr, Tremaine WJ, et al. The safety profile of infliximab in patients with Crohn’s disease: the Mayo clinic experience in 500 patients. Gastroenterology. 2004;126:19–31.
- Rahier JF, Magro F, Abreu C, et al. Second European evidence-based consensus on the prevention, diagnosis and management of opportunistic infections in inflammatory bowel disease. J Crohns Colitis. 2014;8:443–468.
- Toruner M, Loftus EV, Harmsen WS, et al. Risk factors for opportunistic infections in patients with inflammatory bowel disease. Gastroenterology. 2008;134:929–936.
- Dave M, Purohit T, Razonable R, et al. Opportunistic infections due to inflammatory bowel disease therapy. Inflamm Bowel Dis. 2014;20:196–212.
- Keane J, Gershon S, Wise RP, et al., et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med. 2001;345:1098–1104.
- Afif W, Loftus EV Jr. Safety profile of IBD therapeutics: infectious risks. Med Clin North Am. 2010;94:115–133.
- Askling J, Fored CM, Brandt L, et al Risk and case characteristics of tuberculosis in rheumatoid arthritis associated with tumor necrosis factor antagonists in Sweden. Arthritis Rheum. 2005;52:1986–1992.
- Wolfe F, Michaud K, Anderson J, et al Tuberculosis infection in patients with rheumatoid arthritis and the effect of infliximab therapy. Arthritis Rheum. 2004;50:372–379.
- Murdaca G, Spano F, Ctatore M, et al. Infection risk associated with anti-TNF-α agents: a review. Expert Opin Drug Saf. 2015;14:571–582.
• This review covers infection risks associated with anti-TNF-α use.
- The American Gastroenterological Association. Adult inflammatory bowel disease phyisican performance measures set. Last updated October 26, 2011. https://www.gastro.org/practice/quality-initiatives/IBD_Measures.pdf. Accessed August 20, 2015.
- Lichtenstein GR, Feagan BG, Cohen RD, et al. Serious infections and mortality in association with therapies for Crohn disease: TREAT registry. Clin Gastroenterol Hepatol. 2006;4:621–630.
- Peyrin-Biroulet L, Deltenre P, De Suray N, et al. Efficacy and safety of tumor necrosis factor antagonists in Crohn’s disease: meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol. 2008;6:644–653.
• Meta-analysis of safety an efficacy of anti-TNF-α treatment in CD.
- Lichtenstein GR, Feagan BG, Cohen RD, et al. Drug therapies and the risk of malignancy in Crohn’s disease: results from the TREAT™ Registry. Am J Gastroenterol. 2014;109:212–223.
- Osterman MT, Sandborn WJ, Colombel JF, et al. Increased risk of malignancy with adalimumab combination therapy, compared with monotherapy, for Crohn’s disease. Gastroenterology. 2014;146:941–949.
•• This paper provides evidence that anti-TNF-α therapy with concomitant immunomodulator treatment increases the risk of malignancy in CD patients.
- Lee J, Clarke K. Anti-TNF agents in patients with inflammatory bowel disease and malignant melanoma—challenges in management. Int J Colorectal Dis. 2015. [Epub ahead of print]
- Long MD, Martin CF, Pipkin CA, et al. Risk of melanoma and nonmelanoma skin cancer among patients with inflammatory bowel disease. Gastroenterology. 2012;143:390–399.
- Nardone B, Hammel JA, Raisch DW, et al. Melanoma associated with tumor necrosis factor-α inhibitors: a Research on Adverse Drug events and Reports (RADAR) project. Br J Dermatol. 2014;170:1170–1172.
- Raaschou P, Simard JF, Holmqvist M, et al. Rheumatoid arthritis, anti-tumour necrosis factor therapy, and risk of malignant melanoma: nationwide population based prospective cohort study from Sweden. BMJ. 2013;346:f1939. DOI:10.1136/bmj.f1939.
- West RL, Zelinkova Z, Wolbink GJ, et al. Immunogenicity negatively influences the outcome of adalimumab treatment in Crohn’s disease. Aliment Pharmacol Ther. 2008;28:1122–1126.
- Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn’s disease. Gastroenterology. 2009;137:1628–1640.
- Ben-Horin S, Kopylov U, Chowers Y. Optimizing anti-TNF treatments in inflammatory bowel disease. Autoimmun Rev. 2014;13:24–30.
- Rojas JR, Taylor RP, Cunningham MR, et al. Formation, distribution, and elimination of infliximab and anti-infliximab immune complexes in cynomolgus monkeys. J Pharmacol Exp Ther. 2005;313:578–585.
- Steenholdt C, Palarasah Y, Bendtzen K, et al. Pre-existing IgG antibodies corss-reacting with the Fab region of infliximab predict efficacy and safety of infliximab therapy in inflammatory bowel disease. Aliment Pharmacol Ther. 2013;37:1172–1183.
- Hwang WY, Foote J. Immunogenicity of engineered antibodies. Methods. 2005;36:3–10.
- Baert F, Kondraqunta V, Lockton S, et al. Antibodies to adalimumab are associated with future inflammation in Crohn’s patients receiving maintenance adalimumab therapy: a post hoc analysis of the Kamiris trial. Gut. 2015. doi:10.1136/gutjnl-2014-307882.
- Veronese FM, Mero A. The impact of PEGylation on biological therapies. BioDrugs. 2008;22:315–329.
- Rivkin A. Certolizumab pegol for the management of Crohn’s disease in adults. Clin Therp. 2009;31:1158–1176.
- Ben-Horin S, Mazor Y, Yanai H, et al. The decline of anti-drug antibodies titres after discontinuation of anti-TNFs: implications for predicting re-induction outcome in IBD. Aliment Pharmacol Ther. 2012;35:714–722.
- Vande Casteele N, Gils A, Singh S, et al. Antibody response to infliximab and its impact on pharmacokinetics can be transient 2013. Am J Gastroenterol. 2013;108:962–971.
- Krieckaert C, Bartelds GM, Lems WF, et al. The effect of immunomodulators on the immunogenicity of TNF-blocking therapeutic monoclonal antibodies: a review. Arthritis Res Ther. 2010;12:217.
- Vermeire S, Norman M, Van Assche G, et al. Effectiveness of concomitant immunosuppressive therapy in suppressing the formation of antibodies to infliximab in Crohn’s disease. Gut. 2007;56:1226–1231.
- Ben-Horin S, Chowers Y. Loss of response to anti-TNF treatments in Crohn’s disease. Aliment Pharmacol Ther. 2011;33:987–995.
- Suzuki Y, Matsui T, Ito H, et al. Circulating interleukin 6 and albumin, and infliximab levels are good predictors of recovering efficacy after dose escalation infliximab therapy in patients with loss of response to treatment for Crohn’s disease: a prospective trial. Inflamm Bowel Dis. 2015;21:2114–2122.
- Cornillie F, Hanauer SB, Diamond RH, et al. Postinduction serum infliximab trough level and decrease of C-reactive protein level are associated with durable sustained response to infliximab: a retrospective analysis of the ACCENT I trial. Gut. 2014;63:1721–1727.
- Hibi T, Sakuraba A, Watanabe M, et al. C-reactive protein is an indicator of serum infliximab level in predicting loss of response in patients with Crohn’s disease. J Gastroenterol. 2014;49:254–262.
- Gisbert JP, Marin AC, McNicholl AG, et al. Systematic review with meta-analysis: the efficacy of a second anti-TNF in patients with inflammatory bowel disease whose previous anti-TNF treatment has failed. Aliment Pharmacol Ther. 2015;41:613–623.
- Allez M, Vermeire S, Mozziconacci N, et al. The efficacy and safety of a third anti-TNF monoclonal antibody in Crohn’s disease after failure of two other anti-TNF antibodies. Aliment Pharmacol Ther. 2010;31:92–101.
- Gagniere C, Beaugerie L, Pariente B, et al. Benefit of infliximab reintroduction after successive failure of infliximab and adalimumab in Crohn’s disease. J Crohns Colitis. 2015;9:349–355.
- Hassid B, Mahadevan U. The use of biologic therapy in pregnancy: a gastroenterologist’s perspective. Curr Opin Rheumatol. 2014;26:347–353.
- Nielsen OH, Loftus EV Jr, Jess T. Safety of TNF-alpha inhibitors during IBD pregnancy: a systematic review. BMC Med. 2013;11:174.
- Schnitzler F, Fidder H, Ferrante M, et al. Outcome of pregnancy in women with inflammatory bowel disease treated with antitumor necrosis factor therapy. Inflamm Bowel Dis. 2011;17:1846–1854.
- Odes S, Greenberg D. A medicoeconomic review of early intervention with biologic agents in the treatment of inflammatory bowel diseases. Clinicoecon Outcomes Res. 2014;6:431–443.
- van der Valk ME, Mangen M-J-J, Leenders M, et al. Healthcare costs of inflammatory bowel disease have shifted from hospitalization and surgery towards anti-TNFα therapy: results from the COIN study. Gut. 2014;63:72–79.
• This study analyzes the current healthcare utilization and establishes anti-TNF-α therapy as the primary cost driver for the treatment of inflammatory bowel disease.
- Tang DH, Armstrong EP, Lee JK. Cost-utility analysis of biologic treatments for moderate-to-severe Crohn’s diseases. Pharmacotherapy. 2012;32:515–526.
- Malik NN. Controlling the cost of innovative cancer therapeutics. Nat Rev Clin Oncol. 2009;6:550–552.
- Information for healthcare professionals (biosimilars) US Food and Drug Administration. Silver Spring, MD: FDA, 2015. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241719.htm [Last accessed 12 August 2015].
- McKeage K. A review of CT-P13: an infliximab biosimilar. BioDrugs. 2014;28:313–321.
•• This review provides in depth knowledge about the infliximab biosimilar CT-P13.
- Remsima Assessment Report. EMA Committee for Medicinal Products for Human Use. London, UK: EMA, 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf [Last accessed 13 August 2015].
- Farkas K, Rutka M, Balint A, et al. Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis - experiences from a single center. Expert Opin Biol Ther. 2015;15:1257–1262.
- Jung YS, Park DI, Yh K, et al. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study. J Gastroenterol Hepatol. 2015. doi:10.1111/jgh.12997.
•• CT-P13 shows comparable clinical efficacy and safety compared to originator infliximab.
- 2014 annual report on form 10-K and 2015 proxy statement. AbbVie Inc. North Chicago, IL: AbbVie Inc., 2015. Available at: http://www.abbvieinvestor.com/phoenix.zhtml?c=251551&p=irol-reportsannual [Last accessed 12 August 2015].
- Jani RH, Gupta R, Bhatia G, et al. A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis. Int J Rheum Dis. 2015. doi:10.1111/1756-185X.12711.
- Roger SD, Mikhail A. Biosimilars: opportunity or cause for concern? J Pharm Sci. 2007;10:405–410.
- Shealy D, Cai A, Staquest K, et al. Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor α. MAbs. 2010;2:428–439.
- Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146:85–95.
- Ben-Bassat O, Iacono A, Irwin SP, et al. Tu1327a Golimumab for Treatment of Moderate to Severe Anti-TNF Refaractory Crohn’s Disease: Open Label Experience. Gastroenterology. 2012;142:S804.
•• A study demonstrating golimumab’s clinical efficacy in refractory CD patients.
- Harris MS, Hartman D, Spence S, et al. AVX-470, an Orally Delivered Anti-TNF Antibody for Treatment of Acute Ulcerative Colitis: results of a First-in Human Trial. Available at: www.avaxiabiologics-.com/docs/UEGW%202014%20Presentation%20v%203.1.pdf [Last accessed 12 August 2015].
• These preliminary findings of oral anti-TNF-α AVX-470 show positive results in UC patients.
- Bhol KC, Tracey DE, Lemos BR. AVX-470: A Novel Oral Anti-TNF Antibody with Therapeutic Potential in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2013;19:2273–2281.
- Vandepapeliere P, Malan F, Rogler G, et al. Safety, immunogenicity and clinical Phase I–II results of TNFα-kinoid immunotherapeutic in Crohn’s disease patients. Gastroenterology. 2011;140:S123.
•• This paper establishes TNF-K’s ability to induce anti-TNF-α antibodies that provide clinically significant response rates in CD patients.
- Michelsen KS, Wong KG, Ko B, et al. HMPL-004 (Andrographis paniculata extract) prevents development of murine colitis by inhibiting T-cell proliferation and TH1/TH17 responses. Inflamm Bowel Dis. 2013;19:151–164.
- Sandborn WJ, Targan SR, Byers VS, et al. Andrographis panciulata extract (HMPL-004) for active ulcerative colitis. Am J Gastroenterol. 2013;108:90–98.
• A randomized, double-blind, placebo controlled study demonstrating superior clinical response rates in UC to HMPL-004 nonbiologic anti-TNF-α versus placebo.
- Tang T, Targan SR, Li SZ, et al. Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis - a double-blind comparison with sustained release mesalazine. Aliment Pharmacol Ther. 2011;33:194–202.
- Shelton E, Allegretti JR, Stevens B, et al. Efficacy of Vedolizumab as Induction Therapy in Refractory IBD Patients: A Multicenter Cohort. Inflamm Bowel Dis. 2015. [ Epub ahead of print].
- Wei Y, Zhu W, Gong J, et al. Fecal Microbiota Transplantation Improves the Quality of Life in Patients with Inflammatory Bowel Disease. Gastroenterol Res Pract. 2015;2015:517597.
•• Fecal microbiota transplantation is a nondrug intervention that can provide clinically significant improvements for IBD patients.
- Suskind DL, Brittnacher MJ, Shaffer ML, et al. Fecal microbial transplant effect on clinical outcomes and fecal microbiome in active Crohn’s disease. Inflamm Bowel Dis. 2015;21:556–563.
- Hommes DW, Duijvestein M, Zelinkova Z, et al. Long-term follow-up of autologous hematopoietic stem cell transplantation for severe refractory Crohn’s disease. J Crohns Colitis. 2011;5:543–549.
- Labidi A, Serghini M, Ben Mustapha N, et al. Stem cell transplantation as rescue therapy for refractory Crohn’s disease: a sytematic review. Tunis Med. 2014;92:655–659.
- POSTPONED: March 17, 2015: Arthritis Advisory Committee Meeting Announcement.US Food and Drug Administration. Silver Spring, MD: FDA, 2015. Available at: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm433919.htm [Last accessed 13 August 2015].
- European Medicines Agency recommends approval of first two monoclonal antibody biosimilars: recommendation marks extension of biosimilar concept to new product-class. European Medicines Agency. London, UK: EMA, 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/06/WC500144941.pdf [Last accessed 13 August 2015].