The Italian Society of Gastroenterology (SIGE) and the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) Clinical Practice Guidelines: The use of tumor necrosis factor-alpha antagonist therapy in inflammatory bowel disease.
Biological therapies are an important step in the management of Inflammatory Bowel Diseases. In consideration of high cost and safety issues there is the need to have clear recommendations for their use. Despite the American Gastroenterological Association and the European Crohn's and Colitis Organisation have published exhaustive Inflammatory Bowel Disease guidelines, national guidelines may be necessary as cultural values, economical and legal issues may differ between countries. For these reasons the Italian Society of Gastroenterology and the Italian Group for the study of Inflammatory Bowel Disease have decided to elaborate the Italian guidelines on the use of biologics in Inflammatory Bowel Disease. The following items have been chosen: definitions of active, inactive, steroid dependent and resistant disease; measures of activity; anti-tumor necrosis factor alpha therapy use in active steroid dependent and refractory luminal Crohn's Disease, in fistulising Crohn's Disease, in steroid dependent and resistant active Ulcerative Colitis; risk of cancer; risk of infections during anti-tumor necrosis factor alpha therapy; special situations. These guidelines are based on evidence from relevant medical literature and clinical experience of a national working group.
Orlando
Ambrogio
A
Department of Medicine, Pneumology and Nutrition Clinic, "V. Cervello" Hospital, Ospedali Riuniti "Villa Sofia-Cervello" University of Palermo, Italy. ambrogiorlando@tiscali.it
Armuzzi
Alessandro
A
Papi
Claudio
C
Annese
Vito
V
Ardizzone
Sandro
S
Biancone
Livia
L
Bortoli
Aurora
A
Castiglione
Fabiana
F
D'Incà
Renata
R
Gionchetti
Paolo
P
Kohn
Anna
A
Poggioli
Gilberto
G
Rizzello
Fernando
F
Vecchi
Maurizio
M
Cottone
Mario
M
D000068879:Adalimumab; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001327:Autoimmune Diseases / Q000209:etiology; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use; D000069285:Infliximab; D007412:Intestinal Fistula / Q000175:diagnosis / Q000188:drug therapy / Q000601:surgery; D007558:Italy; D009369:Neoplasms / Q000209:etiology; D009894:Opportunistic Infections / Q000209:etiology; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy; D012074:Remission Induction / Q000379:methods; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab