INFLAMMATORY BOWEL DISEASE

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

L Biancone¹, A Orlando², A Kohn³, E Colombo⁴, R Sostegni⁵, E Angelucci⁶, F Rizzello⁷, F Castiglione⁸, L Benazzato⁹, C Papi¹⁰, G Meucci¹¹, G Riegler¹², C Petruzziello¹, F Mocciaro², A Geremia¹, E Calabrese¹, M Cottone², F Pallone¹

¹ GI Unit, Centre of Excellence for the Study of Complex and Multifactorial Diseases, "Tor Vergata" University, Roma, Italy
² "V Cervello" Hospital, Palermo, Italy
³ GI Unit, "S Camillo" Hospital, Roma, Italy
⁴ GI Unit, "L Sacco" Hospital, Milano, Italy
⁵ GI Unit, "Mauriziano Hospital", Torino, Italy
⁶ GI Unit, University "La Sapienza", Roma, Italy
⁷ Policlinico "S Orsola", Bologna, Italy
⁸ GI Unit, "Federico II" University, Napoli, Italy
⁹ GI Unit, University Padova, Padova, Italy
¹⁰ GI Unit, "San Filippo Neri" Hospital, Roma, Italy
¹¹ Department of Gastroenterology, "Valduce" Hospital, Como, Italy
¹² Centre of Inflammatory Bowel Disease, 2nd University, Napoli, Italy

Correspondence to:
Dr L Biancone
Cattedra di Gastroenterologia, Dipartimento di Medicina Interna, Università di "Tor Vergata", Via Montpellier, 1 Rome 00131, Italy; biancone{at}med.uniroma2.it

Background and aims: The widespread use of anti-tumour necrosis factor 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).

Conclusion: 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.

Abbreviations: CD, Crohn’s disease; IBD, inflammatory bowel disease; AZA, azathioprine; 6-MP, 6-mercaptopurine; NHL, non-Hodgkin’s lymphoma; OR, odds ratio; RR, relative risk

Keywords: Crohn’s disease; anti-tumour necrosis factor antibody; Infliximab; neoplasia; multicentre matched pair study

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