Effectiveness of adalimumab for ambulatory ulcerative colitis patients after failure of infliximab treatment: a first "real-life" experience in primary gastroenterology centers in Italy

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Effectiveness of adalimumab for ambulatory ulcerative colitis patients after failure of infliximab treatment: a first "real-life" experience in primary gastroenterology centers in Italy (EN)

Picchio, Marcello
Pelecca, Giorgio
Elisei, Walter
Zampaletta, Costantino
Giorgetti, Gian Marco
Tursi, Antonio
Faggiani, Roberto
Brandimarte, Giovanni
Penna, Antonio
Forti, Giacomo

Background Adalimumab (ADA) is the key treatment for ulcerative colitis (UC) unresponsive or intolerant to standard treatments. Our aim was to assess the efficacy and safety of ADA in treating ambulatory UC patients in primary gastroenterology centers.Methods Fifteen patients (6 male, median age 29.9 years, range 22.8-39.9 years) were enrolled. All were previously treated with infliximab (IFX). Clinical activity and endoscopic severity were scored according to the Crohn's disease activity index (CDAI) score and Mayo subscore for endoscopy, respectively. Patients were clinically assessed at weeks 4, 8, and thereafter at weeks 16, 24, 32, 40, 48, and 54. Colonoscopy was performed before starting treatment, at weeks 24 and 54. The co-primary endpoints were clinical remission at 24 and 54 weeks. The secondary endpoints included: 1) sustained clinical remission; 2) steroid-sparing effect; 3) mucosal healing; 4) need for colectomy. Induction dose of ADA was 160 mg at week 0, and then 80 mg at week 2, while ADA maintenance treatment was 40 mg every two weeks.Results Clinical remission was obtained in 11 (73.3%) and 15 (100%) patients at weeks 24 and 54 respectively. Ten patients (66.7%) were able to discontinue steroids and were under corticosteroidfree remission at week 54. No patients underwent to colectomy. Eight patients (53.33%) at week 24 and 9 patients (60%) at week 54 achieved complete mucosal healing (Mayo endoscopic score 0). Side effects were reported in 2 of 15 patients (13.3%); none of those patients stopped treatment.Conclusion ADA seems to be effective and safe in UC outpatients affected by UC, and previously treated with IFX.Keywords Adalimumab, clinical practice, clinical remission, mucosal healing, ulcerative colitisAnn Gastroenterol 2014; 27 (4): 369-373 (EN)

info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion

Ελληνική Γαστροεντερολογική Εταιρία (EL)
Hellenic Gastroenterologiki Company (EN)

2014-10-01


Hellenic Society of Gastroenterology (EN)

1792-7463
1108-7471
Annals of Gastroenterology; Volume 27, No 4 (2014); 369 (EN)



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