The safety of vedolizumab for ulcerative colitis and Crohn's disease
Jean-Frederic Colombel,Bruce E. Sands,Paul Rutgeerts,William J. Sandborn,Silvio Danese,Geert R. D'Haens,Remo Panaccione,Edward V. Loftus,Serap Sankoh,I. Fox,Asit Parikh,Catherine Milch,Brihad Abhyankar,Brian G. Feagan +13 more
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Vedolizumab has a favourable safety profile with low incidence rates of serious infections, infusion-related reactions and malignancies over an extended treatment period.Abstract:
Objective Vedolizumab is a gut-selective antibody to α 4 β 7 integrin for the treatment of ulcerative colitis (UC) and Crohn9s disease (CD). We report an integrated summary of the safety of vedolizumab. Design Safety data (May 2009–June 2013) from six trials of vedolizumab were integrated. Adverse events were evaluated in patients who received ≥1 dose of vedolizumab or placebo and were reported as exposure-adjusted incidence rates as the number of patients experiencing the event per 100 person-years (PYs) of exposure. Predictors of serious infection were assessed using a Cox proportional hazards model. Results In total, 2830 patients had 4811 PYs of vedolizumab exposure (median exposure range, 1–1977 days). No increased risk of any infection or serious infection was associated with vedolizumab exposure. Serious clostridial infections, sepsis and tuberculosis were reported infrequently (≤0.6% of patients). No cases of progressive multifocal leucoencephalopathy were observed. Independent risk factors for serious infection in UC were prior failure of a tumour necrosis factor α antagonist (HR, 1.99; 95% CIs 1.16 to 3.42; p=0.0122) and narcotic analgesic use (HR, 2.68; 95% CI 1.57 to 4.58; p=0.0003), and in CD were younger age (HR, 0.97; 95% CI 0.95 to 0.98; p Conclusions Vedolizumab has a favourable safety profile with low incidence rates of serious infections, infusion-related reactions and malignancies over an extended treatment period. Trial registration number NCT01177228, NCT00619489, NCT00783718, NCT00783692, NCT01224171, NCT00790933.read more
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British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults
Christopher A. Lamb,Christopher A. Lamb,Nicholas A. Kennedy,Tim Raine,P Hendy,P Hendy,Philip J Smith,Jimmy K. Limdi,Jimmy K. Limdi,Bu'Hussain Hayee,Bu'Hussain Hayee,Miranda Lomer,Miranda Lomer,Gareth Parkes,Gareth Parkes,Christian P. Selinger,Christian P. Selinger,Kevin Barrett,R Justin Davies,Cathy Bennett,Stuart Gittens,Malcolm G. Dunlop,Malcolm G. Dunlop,Omar Faiz,Aileen Fraser,Vikki Garrick,Paul D Johnston,Miles Parkes,Jeremy D. Sanderson,Jeremy D. Sanderson,Helen Terry,Daniel R. Gaya,Daniel R. Gaya,Tariq Iqbal,Tariq Iqbal,Stuart A. Taylor,Stuart A. Taylor,Melissa A. Smith,Melissa A. Smith,Matthew J Brookes,Richard Hansen,A Barney Hawthorne +41 more
TL;DR: Comprehensive up-to-date guidance is provided regarding indications for, initiation and monitoring of immunosuppressive therapies, nutrition interventions, pre-, peri- and postoperative management, as well as structure and function of the multidisciplinary team and integration between primary and secondary care.
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Evidence-based clinical practice guidelines for inflammatory bowel disease
Katsuyoshi Matsuoka,Taku Kobayashi,Fumiaki Ueno,Toshiyuki Matsui,Fumihito Hirai,Nagamu Inoue,Jun Kato,Kenji Kobayashi,Kiyonori Kobayashi,Kazutaka Koganei,Reiko Kunisaki,Satoshi Motoya,Masakazu Nagahori,Hiroshi Nakase,Fumio Omata,Masayuki Saruta,Toshiaki Watanabe,Toshiaki Tanaka,Takanori Kanai,Yoshinori Noguchi,Ken Ichi Takahashi,Kenji Watanabe,Toshifumi Hibi,Yasuo Suzuki,Mamoru Watanabe,Kentaro Sugano,Tooru Shimosegawa +26 more
TL;DR: This English version was produced and edited based on the existing updated guidelines for ulcerative colitis and Crohn’s disease in Japanese, developed with the basic concept of the Grading of Recommendations Assessment, Development, and Evaluation system.
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A comprehensive review and update on Crohn's disease
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Journal ArticleDOI
The Medical Management of Paediatric Crohn's Disease: an ECCO-ESPGHAN Guideline Update.
Patrick F. van Rheenen,Marina Aloi,Amit Assa,Jiri Bronsky,Johanna C. Escher,Ulrika L. Fagerberg,Marco Gasparetto,Konstantinos Gerasimidis,Anne M. Griffiths,Paul Henderson,Sibylle Koletzko,Sibylle Koletzko,Kaija-Leena Kolho,Arie Levine,Johan Van Limbergen,Francisco Javier Martin de Carpi,Víctor Manuel Navas-López,Salvatore Oliva,Lissy de Ridder,Richard K Russell,Dror S. Shouval,Dror S. Shouval,Antonino Spinelli,Dan Turner,David C. Wilson,Eytan Wine,Frank M. Ruemmele,Frank M. Ruemmele +27 more
TL;DR: An evidence-supported update of the ECCO-ESPGHAN guideline on the medical management of paediatric Crohn's disease is provided, establishing that it was key to identify patients at high risk of a complicated disease course at the earliest opportunity to reduce bowel damage.
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A comprehensive review and update on ulcerative colitis.
Mahesh Gajendran,Priyadarshini Loganathan,Guillermo Jimenez,Anthony P. Catinella,Nathaniel Ng,Chandraprakash Umapathy,Nathalie Ziade,Jana G. Hashash +7 more
TL;DR: Ulcerative colitis (UC) is a chronic idiopathic inflammatory bowel disorder of the colon that causes continuous mucosal inflammation extending from the rectum to the more proximal colon, with variable extents.
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