Infliximab and newly diagnosed neoplasia in Crohn's disease: a multicentre matched pair study.
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.
Biancone
L
L
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
Orlando
A
A
Kohn
A
A
Colombo
E
E
Sostegni
R
R
Angelucci
E
E
Rizzello
F
F
Castiglione
F
F
Benazzato
L
L
Papi
C
C
Meucci
G
G
Riegler
G
G
Petruzziello
C
C
Mocciaro
F
F
Geremia
A
A
Calabrese
E
E
Cottone
M
M
Pallone
F
F
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
D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab