AbstractIntroduction. The data on the safety profile of anti-tumor necrosis factor (anti-TNF) therapy in real-life patients cohorts with inflammatory bowel disease (IBD) still are lacking.
Aim. The aim of the study was to assess the adverse events (AE) of anti-TNF therapy in a single Polish IBD center.
Material and methods. Data on the safety of anti-TNF therapy among Crohn’s disease (CD) and ulcerative colitis (UC) patients treated in years 2009–2015 at the Department of Gastroenterology, Human Nutrition and Internal Diseases of Poznań University of Medical Sciences were analyzed.
Results. There were 41 AE/188 therapies reported (21.8%) – 39/176 (22.1%) in CD and 2/12 (16.6%) in UC patients. The most common AE were infections – 10.1%, followed by dermatological complications – 2.6%, and infusion allergic reactions – 2.1%. The majority of AE (27/41 – 66%) were treated successfully or resolved without a treatment. The frequency of AE among patients treated with different molecules was similar – 17/85 (20%) in the adalimumab group, 20/91 (21.9%) in the originator infliximab group, and 4/18 (22.2%) in the biosimilar infliximab group. Concomitant treatment seemed not to influence the AE risk.
Conclusions. Anti-TNF therapy, which is used among the most severely ill IBD patients, seems to be safe. However, further assessment is needed in real-life patients cohorts, especially to assess the long-term safety of anti-TNF treatment in IBD.
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- Amiot A, Peyri-Biroulet L. Current, new and future biological agents on the horizon for the treatment of inflammatory bowel diseases. Therap Adv Gastroenterol. 2015 Mar;8(2):66–82.
- Gomollon F. Biosimilars in inflammatory bowel disease: ready for prime time? Curr Opin Gastroenterol. 2015 Jul;31(4):290–295.
- Sousa P, Allez M. Complications of biologics in inflammatory bowel disease. Curr Opin Gastroenterol. 2015 Jul;31(4):296–302.
- Stallmach A, Hagel S, Bruns T. Adverse effects of biologics used for treating IBD. Best Practice & Research Clinical Gastroenterology. 2010 Apr;24(2):167-82.
- Szymańska E, Dądalski M, Oracz G, Kierkuś J. Safety profile of anti-TNF agents in Polish pediatric patients with Crohn’s disease. Austin J Gastroenterol. 2014 Aug;1(4):1016.
- Łodyga M, Eder P, Bartnik W, Gonciarz M, Kłopocka M, Linke K et al. Guidelines for the management of Crohn’s disease. Recommendations of the Working Group of the Polish National Consultant in gastroenterology and the Polish Society of Gastroenterology. Prz Gastroenterol 2012 Dec;7(6):317–338.
- Eder P, Łodyga M, Łykowska-Szuber L, Bartnik W, Durlik M, Gonciarz M et al. Guidelines for the management of ulcerative colitis. Recommendations of the Working Group of the Polish National Consultant in gastroenterology and the Polish Society of Gastroenterology. Prz Gastroenterol 2013 Jan;8(1):1–20.
- Colombel JF, Loftus EV, Tremaine WJ, Egan EJ, Harmsen WS, Schleck CD et al. The safety profile of infliximab in patients with Crohn’s disease: the Mayo Clinic experience in 500 patients. Gastroenterology. 2004 Jan;126(1): 19–31.
- Lees CW, Ali AI, Thompson AI, Ho GT, Forsythe RO, Marquez L et al. The safety profile of anti-tumour necrosis factor therapy in inflammatory bowel disease in clinical practice: analysis of 620 patient-years follow-up. Aliment Pharmacol Ther. 2009 Feb;29(3):286–297.
- Targownik LE, Bernstein CN. Infectious and malignant complications of TNF inhibitor therapy in IBD. Am J Gastroenterol. 2013 Dec;108(12):1835–1842.
- Gecse K, Khanna R, Stoker J, Jenkins JT, Gabe S, Hahnloser D et al. Fistulizing Crohn's disease: Diagnosis and management. United European Gastroenterol J. 2013 Jun;1(3):206–213.
- Freling E, Baumann C, Cuny JF, Bigard MA, Schmutz JL, Barbaud A et al. Cumulative incidence of, risk factors for, and outcome of dermatological complications of anti-TNF therapy in inflammatory bowel disease: a 14-year experience. Am J Gastroenterol. 2015 Aug;110(8):1186–1196.
- Mocci G, Marzo M, Papa A, Armuzzi A, Guidi L. Dermatological adverse reactions during anti-TNF treatments: focus on inflammatory bowel disease. J Crohns Colitis. 2013 Nov;7(10):769–779.
- Lee HH, Song IH, Friedrich M, Gauliard A, Detert J, Rowert J et al. Cutaneous side-effects in patients with rheumatic diseases during application of tumour necrosis factor-alpha antagonists. Br J Dermatol. 2007 Mar;156(3):486–491.
- Long MD, Martin CF, Pipkin CA, Herfarth HH, Sandler RS, Kappelman MD. Risk of melanoma and nonmelanoma skin cancer among patients with inflammatory bowel disease. Gastroenterology. 2012 Aug;143(2):390–399.
- 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):1318–1327.
- Denadai R, Teixera FV, Saad-Hossne R. The onset of psoriasis during the treatment of inflammatory bowel diseases with infliximab: should biological therapy be suspended? Arq Gastroenterol. 2012 Apr-Jun;49(2):172–176.
- Lakatos PL, Miheller P. Is there an increased risk of lymphoma and malignancies under anti-TNF therapy in IBD? Curr Drug targets. 2010 Feb;11(2):179–186.
- Kopylov U, Vutcovici M, Kezouh A, Seidman E, Bitton A, Afif W. Risk of lymphoma, colorectal and skin cancer in patients with IBD treated with immunomodulators and biologics: a Quebec claims database study. Inflamm Bowel Dis. 2015 Aug;21(8):1847–1853.