title: Mycophenolate mofetil is a valid option in patients with inflammatory bowel disease resistant to TNF-α inhibitors and conventional immunosuppressants.
abstract: BACKGROUND
  Few studies investigated the role of mycophenolate mofetil in inflammatory bowel disease, and none of them had specifically focused on patients with previous multiple intolerances and/or nonresponses to conventional immunosuppressants and biologics.
  
  
  OBJECTIVE
  To evaluate clinical benefit and tolerability profile of mycophenolate mofetil in patients with inflammatory bowel disease and limited treatment options.
  
  
  METHODS
  All consecutive patients with previous multiple intolerances and/or nonresponses to immunosuppressants and biologics who started an off-label treatment with mycophenolate mofetil from January 2014 to February 2016 were entered in a prospectively maintained database.
  
  
  RESULTS
  Twenty-four patients were included. Four weeks after initiation of mycophenolate mofetil therapy, a steroid-free remission was achieved in 4 patients (16.7%), while a clinical response in 13 (54.1%). At the end of follow-up, 12 patients (50.0%) remained on mycophenolate mofetil. Six achieved and maintained steroid-free remission throughout the study period (25.0%), and a further 6 patients (25.0%) achieved a clinical response with complete discontinuation of steroids. Twelve patients (50.0%) were considered as treatment failure, and five of them underwent surgery.
  
  
  CONCLUSIONS
  This is the first experience reporting a clinical benefit and tolerability of mycophenolate mofetil in patients with inflammatory bowel disease and multiple previous failures to other immunosuppressants and/or biologics.
authors.affiliation: Di.Bi.M.I.S., Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, University of Palermo, Italy. Electronic address: fsmacaluso@gmail.com.
authors.forename: Fabio Salvatore
authors.initials: FS
authors.lastname: Macaluso
authors.affiliation: Gastroenterology and Endoscopy Unit, "Villa Sofia-Cervello" Hospital, Palermo, Italy.
authors.forename: Marcello
authors.initials: M
authors.lastname: Maida
authors.affiliation: Di.Bi.M.I.S., Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, University of Palermo, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Renna
authors.affiliation: Di.Bi.M.I.S., Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, University of Palermo, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Orlando
authors.affiliation: Di.Bi.M.I.S., Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, University of Palermo, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Affronti
authors.affiliation: Di.Bi.M.I.S., Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, University of Palermo, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Sapienza
authors.affiliation: Di.Bi.M.I.S., Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, University of Palermo, Italy.
authors.forename: Mariangela
authors.initials: M
authors.lastname: Dimarco
authors.affiliation: Di.Bi.M.I.S., Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, University of Palermo, Italy.
authors.forename: Rosalba
authors.initials: R
authors.lastname: Orlando
authors.affiliation: Di.Bi.M.I.S., Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, University of Palermo, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Rizzuto
authors.affiliation: Di.Bi.M.I.S., Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, University of Palermo, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Cottone
authors.affiliation: Di.Bi.M.I.S., Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, University of Palermo, Italy.
authors.forename: Ambrogio
authors.initials: A
authors.lastname: Orlando
mesh_terms: D000328:Adult; D000368:Aged; D001688:Biological Products / Q000627:therapeutic use; D004351:Drug Resistance; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000627:therapeutic use*; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D055815:Young Adult
chemical_list: D001688:Biological Products; D004791:Enzyme Inhibitors; D007166:Immunosuppressive Agents; D014409:Tumor Necrosis Factor-alpha; D009173:Mycophenolic Acid
keywords: Biologics; Crohn’s disease; Immunosuppressants; Ulcerative colitis