Infliximab and newly diagnosed neoplasia in Crohn's disease: a multicentre matched-pair study

Livia Biancone ^1*, Ambrogio Orlando ², Anna Kohn ³, Elisabetta Colombo ⁴, Roberto Sostegni ⁵, Erika Angelucci ⁶, Fernando Rizzello ⁷, Fabiana Castiglione ⁸, Luigi Benezzato ⁹, Claudio Papi ¹⁰, Gianmichele Meucci ¹¹, Gabriele Riegler ¹², Filippo Mocciaro ², Alessandra Geremia ¹, Emma Calabrese ¹, Mario Cottone ² and Francesco Pallone ¹

¹ University "Tor Vergata", Roma, Italy
² "V. Cervello" Hospital, Palermo, Italy
³ "S. Camillo" Hospital, Roma, Italy
⁴ "L. Sacco" Hospital, Milano, Italy
⁵ "Mauriziano" Hospital, Torino, Italy
⁶ "La Sapienza" University, Rome, Italy
⁷ Policlinico "S. Orsola", Bologna, Italy
⁸ University "Federico II", Napoli, Italy
⁹ GI Unit, University Padova, Italy
¹⁰ "San Filippo Neri" Hospital, Rome, Italy
¹¹ "Valduce" Hospital, Como, Italy
¹² 2nd University, Naples, Italy

^* To whom correspondence should be addressed. E-mail: biancone{at}med.uniroma2.it.

Accepted 16 August 2005

Abstract

Background and aims: The widespread use of anti- tumour necrosis factor-á antibody (Infliximab) in Crohn's Disease (CD) rises concerns about 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 multicenter matched-pair study, 404 CD patients treated with Infliximab (CD-IFX) were matched with 404 CD never receiving Infliximab (CD-C). Cases and controls were matched for sex, age (±5 years), site of CD, age at diagnosis (±5 years), immunosuppressants 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 9 patients (2.22%), while among the 404 CD- C,7 patients developed neoplasia (1.73%)(p=0.40; OR=1.33; 95% CI=0.46-3.84). 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 were 1 cholangiocarcinoma, 3 breast cancers, 1 skin cancer, 1 laryngeal cancer and 2 anal carcinomas. Among the 7/404 (1.73%) CD-C, there were 3 intestinal adenocarcinomas (2 coecum, 1 rectum), 1 basalioma, 1 spinalioma, 1 NHL, 1 breast cancer. The age at diagnosis of neoplasia did not differ between groups (CD-IFX vs CD- C: median 50, range 40-70 yrs vs 45, range 27-72; p=0.50).

Conclusion: In our multicenter matched-pair study, the frequency of a new diagnosis of neoplasia in CD patients treated with Infliximab was comparable to CD patients never receiving Infliximab.

Keywords: anti-tumour necrosis factor-alpha antibody, Crohn's disease, Infliximab, multicenter matched-pair study, neoplasia

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