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P295 Prospective assessment of the adalimumab discontinuation during pregnancy in inflammatory bowel disease patients
Clinical: Therapy and observation Conclusions: Azathioprine often needs to be stopped due to adverse events. Well-controlled patients are less likely to relapse if the decision to stop is taken with their gastroenterologist and if they have been on the drug more than 5 years. P294 Distal colitis: Evolution and prognosis during 10 years F.Z. Ajana1 , A. Bousseaden1 *, W. Essamri1 , I. Benlbaghdadi1 , A. Essaid1 . 1 CHU Ibn Sina, hepatogastroenterology medical clinic “C”, Rabat, Morocco Background: The term ‘distal colitis’ applies to the form of ulcerative colitis involving the colon up to the mid portion of the descending colon. Most experts agree that disease extension should be determined according to endoscopic criteria. Whatever definition is given, it is important to note that the upper limit of inflammatory involvement can be reached by topical therapy. This study reviews the main therapeutic strategies, the evolution and the prognosis of this disease. Methods: A retrospective study of 300 cases with ulcerative colitis between 1983 and January 2009, including 170 cases with distal colitis. Topical and/or oral aminosalicylate therapy was initially instaured in all cases. Alternative treatments were instaured in patients refractory or intolerant to standard treatment. Results: 87 women and 83 men, aged between 16 72 years old, followed during 10 years 23 patients lost during follow-up. The diagnosis of distal colitis was retained in all cases, with 80 cases of rectosigmoiditis, 60 cases of rectal location and 30 cases of left-sided colitis. 70% of patients were treated by sulfasalazine. The rapid therapeutic effect of topical and/or oral aminosalicylate treatment was obtained in 75% cases, with maintenance of remission during the follow up in 92% cases. However 6 patients presented salicylate sensitivity. Distal colitis refractory to salicylates represented 21% cases and was treated by oral glucocorticoids. 10 patients developed a steroids resistance, 15 cases developed steroids dependance and 1 case developed surrenal failure. 22 cases were treated by Azathioprine. Anti-TNF was instaured in 2 cases with a good response in 1 case and failure in another case requiring a surgical treatment. In 2 cases hepatic cytotoxicity due to azathioprine was noted. A proximal extension of the lesions was noted in 30% cases, the mean follow-up was 10 years years, including 35 cases of rectal location extended to a left colitis and 7 cases of pancolitis. A coloproctectomy with ileo-anal anastomosis was realized in 5 cases with an acute colitis after failure of the medical treatment. No case of carcinoma was noted in our study. Conclusions: Distal colitis is generally a benign entity. However there are refractory forms to pharmacotherapy with persistence of symptoms affecting patient’s quality of life. Extension of the distal colitis up to the splenic flexure was described; the risk of carcinoma was rare. This entity requires a correct therapeutic approach and an appropriate follow-up. P295 Prospective assessment of the adalimumab discontinuation during pregnancy in inflammatory bowel disease patients Z. Zelinkova1 *, C. Van der Ent1 , C.J. Van der Woude1 . Erasmus MC, Rotterdam, Netherlands
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Background: Adalimumab (ADA) is considered to be safe for the use during pregnancy but placental transfer of ADA, presumably starting in the second trimester, has been reported. In order to limit the intra-uterine exposure to ADA, it is advised to stop the treatment during the third trimester but the data evaluating the safety of this approach for the mothers are scarce. Therefore, the aim of this study was to assess the effect
S127 of the discontinuation of ADA treatment during pregnancy on disease activity and potential complications of the resumption of the treatment. Methods: Pregnant inflammatory bowel disease (IBD) patients using ADA were prospectively followed during pregnancy and post partum until the resumption of the treatment. In patients with quiescent disease, the treatment was discontinued in the second trimester. Disease activity and complications of the treatment resumption were assessed by the treating physician. In addition, pregnancy outcomes were noted. Results: In total, thirteen pregnancies in 12 IBD patients (mean age 30 years, range 21 to 38) were prospectively followed. One patient had spontaneous miscarriage at gestational week 8; 12 pregnancies resulted in live births. The mean gestational age was 39 weeks (range 36 to 41) and the mean birth weight was 3260 grams (range 2000 to 4320), there were no congenital malformations. All patients discontinued the treatment during the second trimester, mean gestational week of discontinuation was 23 (range 21 to 27). The resumption of the treatment post partum went uneventful. Two patients (16%) experienced a relapse of the disease after discontinuation, at respective gestational weeks 30 and 36. One patient was successfully treated with systemic steroids, the second patient underwent an elective C-section at gestational week 37 and ADA was resumed immediately after delivery without complications. Both relapsing patients were the only patients with weekly use of 40 mg of ADA, the remaining patients were using 40 mg every other week. Conclusions: In the majority of IBD patients in remission with adalimumab, the treatment can be discontinued in the second trimester of the pregnancy without the risk of flare. However, this approach might not be suitable for patients on established treatment with escalated dose. P296 CATS1 study: Immunomonitoring and clinical results of Treg cell therapy for Crohn’s disease A. Foussat1 *, P. Desreumaux2 , M. Allez3 , L. Beaugerie4 , X. Hebuterne5 , Y. Bouhnik6 , M. Nachury7 , V. Brun8 , A. Duchange9 , N. Clerget-Chossat8 , M. Forte8 , J.-F. Colombel10 . 1 TXCELL, R&D, Valbonne Sophia Antipolis, France, 2 Lille University Hospital, IBD Research Center INSERM, D´ el´ egation A La Recherche, Lille, France, 3 Saint-Louis Hospital, Gastroenterology, Paris, France, 4 Saint-Antoine Hospital, Gastroenterology, Paris, France, 5 CHU Nice Hoptial L’ Archet Pole Digestif, Gastroenterology and Nutrition, Nice, France, 6 Beaujon Hospital, Department of Gastoenterology, Clichy, France, 7 CHU Jean Minjoz, Gastroenterology, Besancon, France, 8 TXCELL, Clinical, Valbonne Sophia Antipolis, France, 9 Effi-Stat, Valbonne Sophia Antipolis, France, 10 Centre Hospitalier Universitaire de Lille, Hˆ opital Claude Huriez, Lille, France Background: CATS1 study assessed the tolerability and efficacy of Ovasave, an antigen-specific T regulatory (Treg) therapy for patients with Crohn’s Disease (CD). Treg cells induce immunomodulating effects through cytokines secretion and cell-cell contact. Methods: CATS1 was an open label, 12-week multicenter, single injection, ascending dose, phase I/II study in 20 patients (4 dose groups of 10e6 cells: 8 pts; 10e7: 3 pts; 10e8: 3 pts; 10e9: 6pts) with CD and active inflammation. Ovasave was produced ex vivo from patients’ PBMC (peripheral blood mononuclear cells) exposed to ovalbumin followed by cell cloning, cell expansion and formulation for infusion. Patients were assessed for tolerability and efficacy (CDAI: responder: decrease 100; remission: <150; IBDQ and CRP). Patient’s peripheral blood was collected before and 1, 3, 8 and 12 weeks after Ovasave administration. Change in peripheral blood
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Background: Adalimumab (ADA) is considered to be safe for the use during pregnancy but placental transfer of ADA, presumably starting in the second trimester, has been reported. In order to limit the intra-uterine exposure to ADA, it is advised to stop the treatment during the third trimester but the data evaluating the safety of this approach for the mothers are scarce. Therefore, the aim of this study was to assess the effect
S127 of the discontinuation of ADA treatment during pregnancy on disease activity and potential complications of the resumption of the treatment. Methods: Pregnant inflammatory bowel disease (IBD) patients using ADA were prospectively followed during pregnancy and post partum until the resumption of the treatment. In patients with quiescent disease, the treatment was discontinued in the second trimester. Disease activity and complications of the treatment resumption were assessed by the treating physician. In addition, pregnancy outcomes were noted. Results: In total, thirteen pregnancies in 12 IBD patients (mean age 30 years, range 21 to 38) were prospectively followed. One patient had spontaneous miscarriage at gestational week 8; 12 pregnancies resulted in live births. The mean gestational age was 39 weeks (range 36 to 41) and the mean birth weight was 3260 grams (range 2000 to 4320), there were no congenital malformations. All patients discontinued the treatment during the second trimester, mean gestational week of discontinuation was 23 (range 21 to 27). The resumption of the treatment post partum went uneventful. Two patients (16%) experienced a relapse of the disease after discontinuation, at respective gestational weeks 30 and 36. One patient was successfully treated with systemic steroids, the second patient underwent an elective C-section at gestational week 37 and ADA was resumed immediately after delivery without complications. Both relapsing patients were the only patients with weekly use of 40 mg of ADA, the remaining patients were using 40 mg every other week. Conclusions: In the majority of IBD patients in remission with adalimumab, the treatment can be discontinued in the second trimester of the pregnancy without the risk of flare. However, this approach might not be suitable for patients on established treatment with escalated dose. P296 CATS1 study: Immunomonitoring and clinical results of Treg cell therapy for Crohn’s disease A. Foussat1 *, P. Desreumaux2 , M. Allez3 , L. Beaugerie4 , X. Hebuterne5 , Y. Bouhnik6 , M. Nachury7 , V. Brun8 , A. Duchange9 , N. Clerget-Chossat8 , M. Forte8 , J.-F. Colombel10 . 1 TXCELL, R&D, Valbonne Sophia Antipolis, France, 2 Lille University Hospital, IBD Research Center INSERM, D´ el´ egation A La Recherche, Lille, France, 3 Saint-Louis Hospital, Gastroenterology, Paris, France, 4 Saint-Antoine Hospital, Gastroenterology, Paris, France, 5 CHU Nice Hoptial L’ Archet Pole Digestif, Gastroenterology and Nutrition, Nice, France, 6 Beaujon Hospital, Department of Gastoenterology, Clichy, France, 7 CHU Jean Minjoz, Gastroenterology, Besancon, France, 8 TXCELL, Clinical, Valbonne Sophia Antipolis, France, 9 Effi-Stat, Valbonne Sophia Antipolis, France, 10 Centre Hospitalier Universitaire de Lille, Hˆ opital Claude Huriez, Lille, France Background: CATS1 study assessed the tolerability and efficacy of Ovasave, an antigen-specific T regulatory (Treg) therapy for patients with Crohn’s Disease (CD). Treg cells induce immunomodulating effects through cytokines secretion and cell-cell contact. Methods: CATS1 was an open label, 12-week multicenter, single injection, ascending dose, phase I/II study in 20 patients (4 dose groups of 10e6 cells: 8 pts; 10e7: 3 pts; 10e8: 3 pts; 10e9: 6pts) with CD and active inflammation. Ovasave was produced ex vivo from patients’ PBMC (peripheral blood mononuclear cells) exposed to ovalbumin followed by cell cloning, cell expansion and formulation for infusion. Patients were assessed for tolerability and efficacy (CDAI: responder: decrease 100; remission: <150; IBDQ and CRP). Patient’s peripheral blood was collected before and 1, 3, 8 and 12 weeks after Ovasave administration. Change in peripheral blood