RESEARCH - Lymphoma in patients treated with anti-TNF inhibitors: RATIO

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Ann Rheum Dis 2010;69:400-408 doi:10.1136/ard.2009.117762

Clinical and epidemiological research

Extended report

Lymphoma in patients treated with anti-TNF: results of the 3-year

prospective French RATIO registry

X Mariette1, F Tubach2, H Bagheri3, M Bardet4, J M Berthelot5, P

Gaudin6, D Heresbach7, A 8, T Schaeverbeke9, D Salmon10, M

Lemann11, O Hermine12, M Raphael13, P Ravaud2

+ Author Affiliations

1Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Bicêtre,

Service de rhumatologie, Université Paris-Sud 11, INSERM U802, Le

Kremlin-Bicêtre, France

2Université Paris 7 Denis Diderot, UFR de médecine; INSERM, U738;

AP-HP, Hôpital Bichat, Département d’Epidémiologie, Biostatistique et

Recherche Clinique, Paris, France

3Service de Pharmacologie Clinique, Centre Midi-Pyrénées de

Pharmacovigilance, de Pharmacoépidémiologie et d’Informations sur le

Médicament, Unité de Pharmacoépidémiologie, EA 3696, Université de

Toulouse, Faculté de Médecine, Toulouse, France

4Hôpital de la Source, Service de médecine interne et rhumatologie,

Orléans, France

5Hôtel Dieu, Service de rhumatologie, Nantes, France

6Centre Hospitalo-Universitaire, Service de rhumatologie, Grenoble, France

7Hôpital Pontchaillou, Service des maladies digestives, Rennes, France

8Hôpital de Saint Brieuc, Service de rhumatologie, Saint Brieuc, France

9Hôpital Pellegrin, Service de rhumatologie, Université Bordeaux II,

Bordeaux, France

10AP-HP, Hôpital Cochin, Service de médecine interne, Université Paris

V, Paris, France

11AP-HP, Hôpital Saint Louis, Service de gastro-entérologie,

Université Paris 7, Paris, France

12AP-HP, Hôpital Necker, Service d’hématologie, CNRS UMR 8143,

Université Paris V, Paris, France

13AP-HP, Hôpital Bicêtre, Laboratoire d’hématologie, Université

Paris-Sud 11, Le Kremlin-Bicêtre, France

Abstract

Objective: To describe cases of lymphoma associated with anti-TNF

therapy, identify risk factors, estimate the incidence and compare the

risks for different anti-TNF agents.

Methods: A national prospective registry was designed (Research Axed

on Tolerance of bIOtherapies; RATIO) to collect all cases of lymphoma

in French patients receiving anti-TNF therapy from 2004 to 2006,

whatever the indication. A case–control analysis was conducted

including two controls treated with anti-TNF per case and an incidence

study of lymphoma with the French population was used as the

reference.

Results: 38 cases of lymphoma, 31 non-Hodgkin’s lymphoma (NHL) (26 B

cell and five T cell), five Hodgkin’s lymphoma (HL) and two

Hodgkin’s-like lymphoma were collected. Epstein–Barr virus was

detected in both of two Hodgkin’s-like lymphoma, three of five HL and

one NHL. Patients receiving adalimumab or infliximab had a higher risk

than those treated with etanercept: standardised incidence ratio (SIR)

4.1 (2.3–7.1) and 3.6 (2.3–5.6) versus 0.9 (0.4–1.8). The exposure to

adalimumab or infliximab versus etanercept was an independent risk

factor for lymphoma in the case–control study: odds ratio 4.7

(1.3–17.7) and 4.1 (1.4–12.5), respectively. The sex and age-adjusted

incidence rate of lymphoma was 42.1 per 100 000 patient-years. The SIR

was 2.4 (95% CI 1.7 to 3.2).

Conclusion: The two to threefold increased risk of lymphoma in

patients receiving anti-TNF therapy is similar to that expected for

such patients with severe inflammatory diseases. Some lymphomas

associated with immunosuppression may occur, and the risk of lymphoma

is higher with monoclonal-antibody therapy than with soluble-receptor

therapy.

http://ard.bmj.com/content/69/2/387.abstract?etoc

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