PURPOSE: To investigate the efficacy and safety of planned postoperative adalimumab (ADA) therapy for Japanese patients with Crohn's disease (CD). METHODS: The subjects of this study were 26 patients who underwent bowel resection for CD. All patients received subcutaneous injections of ADA 160/80 mg at the time of surgery and 2 weeks later, followed by 40 mg every 2 weeks thereafter. The primary endpoint of this study was the incidence of endoscopic recurrence, defined by Rutgeerts endoscopic recurrence scale ≥ i2, 1 year after surgery. RESULTS: After the median follow-up period of 41.3 months, the median number of treatments with ADA was 56 and the median time-to-treatment failure was 25.6 months. Endoscopic recurrence was observed in 34.6% of the patients 1 year after surgery. Univariate analyses showed that preoperative ADA therapy was significantly associated with endoscopic recurrence. Clinical recurrence developed in 16.7% of the patients within 1 year after surgery. Secondary surgery for recurrence was not required. Although adverse events (≥ grade 3) were experienced by 15.4% of patients, none was withdrawn from this study. CONCLUSION: Planned postoperative ADA therapy reduced the incidence of endoscopic and clinical recurrence after bowel resection in Japanese patients with CD. TRIAL REGISTRATION: This trial is registered with the University Hospital Medical Information Network (UMIN000007514).
PURPOSE: To investigate the efficacy and safety of planned postoperative adalimumab (ADA) therapy for Japanese patients with Crohn's disease (CD). METHODS: The subjects of this study were 26 patients who underwent bowel resection for CD. All patients received subcutaneous injections of ADA 160/80 mg at the time of surgery and 2 weeks later, followed by 40 mg every 2 weeks thereafter. The primary endpoint of this study was the incidence of endoscopic recurrence, defined by Rutgeerts endoscopic recurrence scale ≥ i2, 1 year after surgery. RESULTS: After the median follow-up period of 41.3 months, the median number of treatments with ADA was 56 and the median time-to-treatment failure was 25.6 months. Endoscopic recurrence was observed in 34.6% of the patients 1 year after surgery. Univariate analyses showed that preoperative ADA therapy was significantly associated with endoscopic recurrence. Clinical recurrence developed in 16.7% of the patients within 1 year after surgery. Secondary surgery for recurrence was not required. Although adverse events (≥ grade 3) were experienced by 15.4% of patients, none was withdrawn from this study. CONCLUSION: Planned postoperative ADA therapy reduced the incidence of endoscopic and clinical recurrence after bowel resection in Japanese patients with CD. TRIAL REGISTRATION: This trial is registered with the University Hospital Medical Information Network (UMIN000007514).
Authors: R Caprilli; M Cottone; F Tonelli; G Sturniolo; F Castiglione; V Annese; C Papi; A Viscido; C Cammà; G Corrao; G Latella Journal: Aliment Pharmacol Ther Date: 2003-02-15 Impact factor: 8.171
Authors: Stephen B Hanauer; Brian G Feagan; Gary R Lichtenstein; Lloyd F Mayer; S Schreiber; Jean Frederic Colombel; Daniel Rachmilewitz; Douglas C Wolf; Allan Olson; Weihang Bao; Paul Rutgeerts Journal: Lancet Date: 2002-05-04 Impact factor: 79.321
Authors: Stephen B Hanauer; Burton I Korelitz; Paul Rutgeerts; Mark A Peppercorn; Ronald A Thisted; Russell D Cohen; Daniel H Present Journal: Gastroenterology Date: 2004-09 Impact factor: 22.682
Authors: Johannan F Brandse; Charlotte P Peters; Krisztina B Gecse; Emma J Eshuis; Jeroen M Jansen; Hans A Tuynman; Mark Löwenberg; Cyriel Y Ponsioen; Gijs R van den Brink; Geert R DʼHaens Journal: Inflamm Bowel Dis Date: 2014-02 Impact factor: 5.325