title: Infliximab and newly diagnosed neoplasia in Crohn's disease: a multicentre matched pair study.
abstract: OBJECTIVE
  The widespread use of anti-tumour necrosis factor alpha antibody (Infliximab) in Crohn's disease (CD) raises concerns about a possible cancer risk in the long term. In a matched pair study, we assessed whether Infliximab is associated with an increased risk of neoplasia.
  
  
  METHODS
  In a multicentre matched pair study, 404 CD patients treated with Infliximab (CD-IFX) were matched with 404 CD patients who had never received Infliximab (CD-C). Cases and controls were matched for sex, age (+/-5 years), site of CD, age at diagnosis (+/-5 years), immunosuppressant use, and follow up. New diagnoses of neoplasia from April 1999 to October 2004 were recorded.
  
  
  RESULTS
  Among the 404 CD-IFX, neoplasia was diagnosed in nine patients (2.22%) while among the 404 CD-C, seven patients developed neoplasia (1.73%) (odds ratio 1.33 (95% confidence interval 0.46-3.84); p=0.40). The survival curve adjusted for patient year of follow up showed no differences between CD-IFX and CD-C (p=0.90; log rank test). In the CD-IFX group, there was one cholangiocarcinoma, three breast cancers, one skin cancer, one leukaemia, one laryngeal cancer, and two anal carcinomas. Among the 7/404 (1.73%) CD-C, there were three intestinal adenocarcinomas (two caecum, one rectum), one basalioma, one spinalioma, one non-Hodgkin's lymphoma, and one breast cancer. Age at diagnosis of neoplasia did not differ between groups (CD-IFX v CD-C: median 50 (range 40-70 years) v 45 (27-72); p=0.50).
  
  
  CONCLUSIONS
  In our multicentre matched pair study, the frequency of a new diagnosis of neoplasia in CD patients treated with Infliximab was comparable with CD patients who had never received Infliximab.
authors.affiliation: GI Unit, Centre of Excellence for the Study of Complex and Multifactorial Diseases, Tor Vergata University, Roma 00131, and V Cervello Hospital, Palermo, Italy. biancone@med.uniroma2.it
authors.forename: L
authors.initials: L
authors.lastname: Biancone
authors.forename: A
authors.initials: A
authors.lastname: Orlando
authors.forename: A
authors.initials: A
authors.lastname: Kohn
authors.forename: E
authors.initials: E
authors.lastname: Colombo
authors.forename: R
authors.initials: R
authors.lastname: Sostegni
authors.forename: E
authors.initials: E
authors.lastname: Angelucci
authors.forename: F
authors.initials: F
authors.lastname: Rizzello
authors.forename: F
authors.initials: F
authors.lastname: Castiglione
authors.forename: L
authors.initials: L
authors.lastname: Benazzato
authors.forename: C
authors.initials: C
authors.lastname: Papi
authors.forename: G
authors.initials: G
authors.lastname: Meucci
authors.forename: G
authors.initials: G
authors.lastname: Riegler
authors.forename: C
authors.initials: C
authors.lastname: Petruzziello
authors.forename: F
authors.initials: F
authors.lastname: Mocciaro
authors.forename: A
authors.initials: A
authors.lastname: Geremia
authors.forename: E
authors.initials: E
authors.lastname: Calabrese
authors.forename: M
authors.initials: M
authors.lastname: Cottone
authors.forename: F
authors.initials: F
authors.lastname: Pallone
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D004812:Epidemiologic Methods; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000139:chemically induced*; D012907:Smoking / Q000009:adverse effects; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab