BACKGROUND: Natalizumab is an efficacious agent for the induction and maintenance of remission in patients with Crohn's disease (CD) who have failed anti-tumor necrosis factor (TNF) agents. We aimed to assess the efficacy and safety of natalizumab outside of clinical trial at a US tertiary center. METHODS: Retrospective case review of patients with CD receiving natalizumab. RESULTS: Forty-nine patients with CD (28 women; median age, 33 years) receiving natalizumab from April 2008 to November 2011 were identified. Median duration of disease was 180 months (range, 36-576 months); 40 patients had ileocolonic disease, 1 had ileal disease, and 8 had colonic disease. Twenty-one patients had penetrating disease, and 28 had a history of CD-related surgical treatment. Forty-seven patients previously failed treatment with at least 1 anti-TNF agent. Median duration of natalizumab treatment was 7 months (interquartile range, 3-21.5 months). Twenty-four patients (49%) were continuing natalizumab at the time of this review, and 25 discontinued treatment because of the lack of response, side effects, or positive JC virus antibody. Seventeen patients (35%) successfully continued treatment with natalizumab for longer than 12 months, and nonpenetrating disease phenotype was identified as a predictor of longer response (compared with penetrating phenotype; P = 0.013). Nine patients (18.4%) experienced adverse effects, 5 of which were serious, but no case of progressive multifocal leukoencephalopathy occurred. CONCLUSIONS: This is the largest series of natalizumab-treated patients with CD. Our results show that natalizumab is an efficacious and safe treatment agent for patients refractory to anti-TNF agents and that nonpenetrating disease phenotype has more durable response over time.
BACKGROUND:Natalizumab is an efficacious agent for the induction and maintenance of remission in patients with Crohn's disease (CD) who have failed anti-tumor necrosis factor (TNF) agents. We aimed to assess the efficacy and safety of natalizumab outside of clinical trial at a US tertiary center. METHODS: Retrospective case review of patients with CD receiving natalizumab. RESULTS: Forty-nine patients with CD (28 women; median age, 33 years) receiving natalizumab from April 2008 to November 2011 were identified. Median duration of disease was 180 months (range, 36-576 months); 40 patients had ileocolonic disease, 1 had ileal disease, and 8 had colonic disease. Twenty-one patients had penetrating disease, and 28 had a history of CD-related surgical treatment. Forty-seven patients previously failed treatment with at least 1 anti-TNF agent. Median duration of natalizumab treatment was 7 months (interquartile range, 3-21.5 months). Twenty-four patients (49%) were continuing natalizumab at the time of this review, and 25 discontinued treatment because of the lack of response, side effects, or positive JC virus antibody. Seventeen patients (35%) successfully continued treatment with natalizumab for longer than 12 months, and nonpenetrating disease phenotype was identified as a predictor of longer response (compared with penetrating phenotype; P = 0.013). Nine patients (18.4%) experienced adverse effects, 5 of which were serious, but no case of progressive multifocal leukoencephalopathy occurred. CONCLUSIONS: This is the largest series of natalizumab-treated patients with CD. Our results show that natalizumab is an efficacious and safe treatment agent for patients refractory to anti-TNF agents and that nonpenetrating disease phenotype has more durable response over time.
Authors: Paul Rutgeerts; Brian G Feagan; Gary R Lichtenstein; Lloyd F Mayer; Stefan Schreiber; Jean Frederic Colombel; Daniel Rachmilewitz; Douglas C Wolf; Allan Olson; Weihang Bao; Stephen B Hanauer Journal: Gastroenterology Date: 2004-02 Impact factor: 22.682
Authors: Jean-Frédéric Colombel; William J Sandborn; Paul Rutgeerts; Robert Enns; Stephen B Hanauer; Remo Panaccione; Stefan Schreiber; Dan Byczkowski; Ju Li; Jeffrey D Kent; Paul F Pollack Journal: Gastroenterology Date: 2006-11-29 Impact factor: 22.682
Authors: William J Sandborn; Jean Frédéric Colombel; Roberts Enns; Brian G Feagan; Stephen B Hanauer; Ian C Lawrance; Remo Panaccione; Martin Sanders; Stefan Schreiber; Stephan Targan; Sander van Deventer; Ronald Goldblum; Darrin Despain; Gary S Hogge; Paul Rutgeerts Journal: N Engl J Med Date: 2005-11-03 Impact factor: 91.245
Authors: Subrata Ghosh; Eran Goldin; Fiona H Gordon; Helmut A Malchow; Jørgen Rask-Madsen; Paul Rutgeerts; Petr Vyhnálek; Zdena Zádorová; Tanya Palmer; Stephen Donoghue Journal: N Engl J Med Date: 2003-01-02 Impact factor: 91.245
Authors: Stephen B Hanauer; William J Sandborn; Paul Rutgeerts; Richard N Fedorak; Milan Lukas; Donald MacIntosh; Remo Panaccione; Douglas Wolf; Paul Pollack Journal: Gastroenterology Date: 2006-02 Impact factor: 22.682
Authors: Charles W Randall; John A Vizuete; Nicholas Martinez; John J Alvarez; Karthik V Garapati; Mazyar Malakouti; Carlo M Taboada Journal: Therap Adv Gastroenterol Date: 2015-05 Impact factor: 4.409
Authors: Emanuelle Bellaguarda; Kian Keyashian; Joel Pekow; David T Rubin; Russell D Cohen; Atsushi Sakuraba Journal: Clin Gastroenterol Hepatol Date: 2015-05-19 Impact factor: 11.382
Authors: Emily E Vivio; Navya Kanuri; Joanna J Gilbertsen; Kelly Monroe; Neelendu Dey; Chien-Huan Chen; Alexandra M Gutierrez; Matthew A Ciorba Journal: J Crohns Colitis Date: 2015-12-17 Impact factor: 9.071
Authors: Philipp Schreiner; Markus F Neurath; Siew C Ng; Emad M El-Omar; Ala I Sharara; Taku Kobayashi; Tadakazu Hisamatsu; Toshifumi Hibi; Gerhard Rogler Journal: Inflamm Intest Dis Date: 2019-07-09