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Infliximab and newly diagnosed neoplasia in Crohn’s disease: a multicentre matched pair study
  1. L Biancone1,
  2. A Orlando2,
  3. A Kohn3,
  4. E Colombo4,
  5. R Sostegni5,
  6. E Angelucci6,
  7. F Rizzello7,
  8. F Castiglione8,
  9. L Benazzato9,
  10. C Papi10,
  11. G Meucci11,
  12. G Riegler12,
  13. C Petruzziello1,
  14. F Mocciaro2,
  15. A Geremia1,
  16. E Calabrese1,
  17. M Cottone2,
  18. F Pallone1
  1. 1GI Unit, Centre of Excellence for the Study of Complex and Multifactorial Diseases, “Tor Vergata” University, Roma, Italy
  2. 2“V Cervello” Hospital, Palermo, Italy
  3. 3GI Unit, “S Camillo” Hospital, Roma, Italy
  4. 4GI Unit, “L Sacco” Hospital, Milano, Italy
  5. 5GI Unit, “Mauriziano Hospital”, Torino, Italy
  6. 6GI Unit, University “La Sapienza”, Roma, Italy
  7. 7Policlinico “S Orsola”, Bologna, Italy
  8. 8GI Unit, “Federico II” University, Napoli, Italy
  9. 9GI Unit, University Padova, Padova, Italy
  10. 10GI Unit, “San Filippo Neri” Hospital, Roma, Italy
  11. 11Department of Gastroenterology, “Valduce” Hospital, Como, Italy
  12. 12Centre of Inflammatory Bowel Disease, 2nd University, Napoli, Italy
  1. Correspondence to:
    Dr L Biancone
    Cattedra di Gastroenterologia, Dipartimento di Medicina Interna, Università di “Tor Vergata”, Via Montpellier, 1 Rome 00131, Italy; biancone{at}


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

  • 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
  • Crohn’s disease
  • anti-tumour necrosis factor α antibody
  • Infliximab
  • neoplasia
  • multicentre matched pair study

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  • Published online first 24 August 2005

  • Conflict of interest: None declared.

  • Results from this study were featured in an oral presentation at the Digestive Diseases Week, Chicago, 2005.

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