Infliximab for inflammatory bowel disease in Denmark 1999-2005: clinical outcome and follow-up evaluation of malignancy and mortality

S. Caspersen; M. Elkjaer; L. Riis; N. Pedersen; C. Mortensen; Tine Jess; P. Sarto; T.S. Hansen; F. Bendtsen; F. Moesgaard; P. Munkholm; V. Wewer; Sarah Caspersen; Margarita Elkjaer; Lene Riis; Natalia Pedersen; Christian Mortensen; Tine Jess; Pernille Sarto; Tanja S Hansen; Vibeke Wewer; Flemming Bendtsen; Flemming Moesgaard; Pia Munkholm; NN NN

doi:10.1016/j.cgh.2008.05.010

Infliximab for inflammatory bowel disease in Denmark 1999-2005: clinical outcome and follow-up evaluation of malignancy and mortality

S. Caspersen, M. Elkjaer, L. Riis, N. Pedersen, C. Mortensen, Tine Jess, P. Sarto, T.S. Hansen, F. Bendtsen, F. Moesgaard, P. Munkholm, V. Wewer, Sarah Caspersen, Margarita Elkjaer, Lene Riis, Natalia Pedersen, Christian Mortensen, Tine Jess, Pernille Sarto, Tanja S HansenVibeke Wewer, Flemming Bendtsen, Flemming Moesgaard, Pia Munkholm, NN NN

Institut for Klinisk Medicin

131 Citationer (Scopus)

Abstract

BACKGROUND & AIMS: Data on safety and long-term follow-up evaluation of population-based cohorts of inflammatory bowel disease (IBD) patients treated with infliximab are sparse. The aim of this article is to describe the use of infliximab in a national Danish population-based IBD cohort during 1999-2005. METHODS: Medical records of all infliximab-treated IBD patients were scrutinized to abstract information on patient demographics, treatment efficacy, and adverse events. RESULTS: A total of 651 patients (619 with Crohn's disease, 15 with ulcerative colitis, and 17 with colonic IBD type unclassified) received infliximab during 1999-2005. A total of 3351 infusions were administered, with a median of 3 infusions per patient. A positive clinical response was observed in 82.7% (95% confidence interval, 79.9-85.5) of patients. Infusion reactions were observed after 146 of 3351 infusions (4.4%). Significantly fewer infusion reactions were seen in patients also receiving azathioprine or methotrexate (63 of 2079; 3.0%), compared with patients not receiving azathioprine or methotrexate (83 of 1272; 6.5%) (P < .0001). Severe adverse events were observed after 112 of 3351 infusions (3.3%) in a total of 95 patients (14.6%). Four patients developed cancer versus 5.9 expected (standardized incidence ratio, 0.7; 95 confidence interval, 0.2-1.7) and 13 patients died versus 6.9 expected (standardized mortality ratio, 1.9; 95% confidence interval, 1.0-3.2). Two deaths caused by infections were possibly related to infliximab. CONCLUSIONS: Infliximab seemed effective in IBD and generally was well tolerated. However, rare but severe adverse events occurred, and patients receiving infliximab therefore should be selected carefully and monitored closely. No lymphomas and no increased risk of cancer were observed
Udgivelsesdato: 2008/11

Originalsprog	Engelsk
Tidsskrift	Clinical Gastroenterology and Hepatology
Vol/bind	6
Udgave nummer	11
Sider (fra-til)	1212-7; quiz 1176
ISSN	1542-3565
DOI	https://doi.org/10.1016/j.cgh.2008.05.010 https://doi.org/10.1016/j.cgh.2008.05.010
Status	Udgivet - 2008

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Caspersen, S., Elkjaer, M., Riis, L., Pedersen, N., Mortensen, C., Jess, T., Sarto, P., Hansen, T. S., Bendtsen, F., Moesgaard, F., Munkholm, P., Wewer, V., Caspersen, S., Elkjaer, M., Riis, L., Pedersen, N., Mortensen, C., Jess, T., Sarto, P., ... NN, NN. (2008). Infliximab for inflammatory bowel disease in Denmark 1999-2005: clinical outcome and follow-up evaluation of malignancy and mortality. Clinical Gastroenterology and Hepatology, 6(11), 1212-7; quiz 1176. https://doi.org/10.1016/j.cgh.2008.05.010, https://doi.org/10.1016/j.cgh.2008.05.010

Caspersen, S, Elkjaer, M, Riis, L, Pedersen, N, Mortensen, C, Jess, T, Sarto, P, Hansen, TS, Bendtsen, F, Moesgaard, F, Munkholm, P, Wewer, V, Caspersen, S, Elkjaer, M, Riis, L, Pedersen, N, Mortensen, C, Jess, T, Sarto, P, Hansen, TS, Wewer, V, Bendtsen, F, Moesgaard, F, Munkholm, P & NN, NN 2008, 'Infliximab for inflammatory bowel disease in Denmark 1999-2005: clinical outcome and follow-up evaluation of malignancy and mortality', Clinical Gastroenterology and Hepatology, bind 6, nr. 11, s. 1212-7; quiz 1176. https://doi.org/10.1016/j.cgh.2008.05.010, https://doi.org/10.1016/j.cgh.2008.05.010

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title = "Infliximab for inflammatory bowel disease in Denmark 1999-2005: clinical outcome and follow-up evaluation of malignancy and mortality",

abstract = "BACKGROUND & AIMS: Data on safety and long-term follow-up evaluation of population-based cohorts of inflammatory bowel disease (IBD) patients treated with infliximab are sparse. The aim of this article is to describe the use of infliximab in a national Danish population-based IBD cohort during 1999-2005. METHODS: Medical records of all infliximab-treated IBD patients were scrutinized to abstract information on patient demographics, treatment efficacy, and adverse events. RESULTS: A total of 651 patients (619 with Crohn's disease, 15 with ulcerative colitis, and 17 with colonic IBD type unclassified) received infliximab during 1999-2005. A total of 3351 infusions were administered, with a median of 3 infusions per patient. A positive clinical response was observed in 82.7% (95% confidence interval, 79.9-85.5) of patients. Infusion reactions were observed after 146 of 3351 infusions (4.4%). Significantly fewer infusion reactions were seen in patients also receiving azathioprine or methotrexate (63 of 2079; 3.0%), compared with patients not receiving azathioprine or methotrexate (83 of 1272; 6.5%) (P < .0001). Severe adverse events were observed after 112 of 3351 infusions (3.3%) in a total of 95 patients (14.6%). Four patients developed cancer versus 5.9 expected (standardized incidence ratio, 0.7; 95 confidence interval, 0.2-1.7) and 13 patients died versus 6.9 expected (standardized mortality ratio, 1.9; 95% confidence interval, 1.0-3.2). Two deaths caused by infections were possibly related to infliximab. CONCLUSIONS: Infliximab seemed effective in IBD and generally was well tolerated. However, rare but severe adverse events occurred, and patients receiving infliximab therefore should be selected carefully and monitored closely. No lymphomas and no increased risk of cancer were observed.",

author = "S. Caspersen and M. Elkjaer and L. Riis and N. Pedersen and C. Mortensen and Tine Jess and P. Sarto and T.S. Hansen and F. Bendtsen and F. Moesgaard and P. Munkholm and V. Wewer and Sarah Caspersen and Margarita Elkjaer and Lene Riis and Natalia Pedersen and Christian Mortensen and Tine Jess and Pernille Sarto and Hansen, {Tanja S} and Vibeke Wewer and Flemming Bendtsen and Flemming Moesgaard and Pia Munkholm and NN NN",

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year = "2008",

doi = "10.1016/j.cgh.2008.05.010",

language = "English",

volume = "6",

pages = "1212--7; quiz 1176",

journal = "Clinical Gastroenterology and Hepatology",

issn = "1542-3565",

publisher = "W.B.Saunders Co.",

number = "11",

}

TY - JOUR

T1 - Infliximab for inflammatory bowel disease in Denmark 1999-2005: clinical outcome and follow-up evaluation of malignancy and mortality

AU - Caspersen, S.

AU - Elkjaer, M.

AU - Riis, L.

AU - Pedersen, N.

AU - Mortensen, C.

AU - Jess, Tine

AU - Sarto, P.

AU - Hansen, T.S.

AU - Bendtsen, F.

AU - Moesgaard, F.

AU - Munkholm, P.

AU - Wewer, V.

AU - Caspersen, Sarah

AU - Elkjaer, Margarita

AU - Riis, Lene

AU - Pedersen, Natalia

AU - Mortensen, Christian

AU - Jess, Tine

AU - Sarto, Pernille

AU - Hansen, Tanja S

AU - Wewer, Vibeke

AU - Bendtsen, Flemming

AU - Moesgaard, Flemming

AU - Munkholm, Pia

AU - NN, NN

N1 - DA - 20081110IS - 1542-7714 (Electronic)LA - engPT - Journal ArticlePT - Research Support, Non-U.S. Gov'tRN - 0 (Antibodies, Monoclonal)RN - 0 (infliximab)RN - 446-86-6 (Azathioprine)RN - 59-05-2 (Methotrexate)SB - IM

PY - 2008

Y1 - 2008

N2 - BACKGROUND & AIMS: Data on safety and long-term follow-up evaluation of population-based cohorts of inflammatory bowel disease (IBD) patients treated with infliximab are sparse. The aim of this article is to describe the use of infliximab in a national Danish population-based IBD cohort during 1999-2005. METHODS: Medical records of all infliximab-treated IBD patients were scrutinized to abstract information on patient demographics, treatment efficacy, and adverse events. RESULTS: A total of 651 patients (619 with Crohn's disease, 15 with ulcerative colitis, and 17 with colonic IBD type unclassified) received infliximab during 1999-2005. A total of 3351 infusions were administered, with a median of 3 infusions per patient. A positive clinical response was observed in 82.7% (95% confidence interval, 79.9-85.5) of patients. Infusion reactions were observed after 146 of 3351 infusions (4.4%). Significantly fewer infusion reactions were seen in patients also receiving azathioprine or methotrexate (63 of 2079; 3.0%), compared with patients not receiving azathioprine or methotrexate (83 of 1272; 6.5%) (P < .0001). Severe adverse events were observed after 112 of 3351 infusions (3.3%) in a total of 95 patients (14.6%). Four patients developed cancer versus 5.9 expected (standardized incidence ratio, 0.7; 95 confidence interval, 0.2-1.7) and 13 patients died versus 6.9 expected (standardized mortality ratio, 1.9; 95% confidence interval, 1.0-3.2). Two deaths caused by infections were possibly related to infliximab. CONCLUSIONS: Infliximab seemed effective in IBD and generally was well tolerated. However, rare but severe adverse events occurred, and patients receiving infliximab therefore should be selected carefully and monitored closely. No lymphomas and no increased risk of cancer were observed.

AB - BACKGROUND & AIMS: Data on safety and long-term follow-up evaluation of population-based cohorts of inflammatory bowel disease (IBD) patients treated with infliximab are sparse. The aim of this article is to describe the use of infliximab in a national Danish population-based IBD cohort during 1999-2005. METHODS: Medical records of all infliximab-treated IBD patients were scrutinized to abstract information on patient demographics, treatment efficacy, and adverse events. RESULTS: A total of 651 patients (619 with Crohn's disease, 15 with ulcerative colitis, and 17 with colonic IBD type unclassified) received infliximab during 1999-2005. A total of 3351 infusions were administered, with a median of 3 infusions per patient. A positive clinical response was observed in 82.7% (95% confidence interval, 79.9-85.5) of patients. Infusion reactions were observed after 146 of 3351 infusions (4.4%). Significantly fewer infusion reactions were seen in patients also receiving azathioprine or methotrexate (63 of 2079; 3.0%), compared with patients not receiving azathioprine or methotrexate (83 of 1272; 6.5%) (P < .0001). Severe adverse events were observed after 112 of 3351 infusions (3.3%) in a total of 95 patients (14.6%). Four patients developed cancer versus 5.9 expected (standardized incidence ratio, 0.7; 95 confidence interval, 0.2-1.7) and 13 patients died versus 6.9 expected (standardized mortality ratio, 1.9; 95% confidence interval, 1.0-3.2). Two deaths caused by infections were possibly related to infliximab. CONCLUSIONS: Infliximab seemed effective in IBD and generally was well tolerated. However, rare but severe adverse events occurred, and patients receiving infliximab therefore should be selected carefully and monitored closely. No lymphomas and no increased risk of cancer were observed.

U2 - 10.1016/j.cgh.2008.05.010

DO - 10.1016/j.cgh.2008.05.010

M3 - Journal article

SN - 1542-3565

VL - 6

SP - 1212-7; quiz 1176

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

IS - 11

ER -

Infliximab for inflammatory bowel disease in Denmark 1999-2005: clinical outcome and follow-up evaluation of malignancy and mortality

Abstract

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