ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1313

Tolerance of Rituximab in Patients with a History of Cancer : Data From the Registry Air

Jacques-Eric Gottenberg1, Marie-Odile Duzanski2, Thomas Bardin3, Patrice Cacoub4, Alain G. Cantagrel5, Bernard Combe6, Maxime Dougados7, Rene-Marc Flipo8, Bertrand Godeau9, Loic Guillevin10, Eric Hachulla11, Xavier Le Loet12, Thierry Schaeverbeke13, Jean Sibilia14, Isabelle Pane15, Philippe Ravaud16, Gabriel Baron17 and Xavier Mariette18, 1Rheumatology, Strasbourg University Hospital, Strasbourg, France, 2Service Pharmacie - Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg, Strasbourg, France, 3Rheumatology, Hôpital Lariboisière, Paris, France, 4Internal Medicine, Assistance Publique-Hôpitaux de Paris, Hopital Pitié-Salpétrière, Paris, France, 5Dept of Rheumatology, Hopital Purpan, Toulouse CEDEX 9, France, 6Rheumatology, Hopital Lapeyronie, Montpellier, France, 7Rheumatology B Department, Paris-Descartes University, APHP, Cochin Hospital, Paris, France, 8Rheumatology, Hopital R Salengro CHRU, Lille, France, 9Internal Medicine, University of Paris, AP-HP, Hôpital Mondor Créteil, Creteil, France, 10Department of Internal Medicine, Referral Center for Rare Autoimmune and Systemic Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, France, Paris, France, 11Department of Internal Medicine, Claude Huriez University Hospital, Lille, France, 12Rheumatology Department, CHU de ROUEN, Rouen, France, 13Service de Rhumatologie, Groupe Hospitalier Pellegrin, Bordeaux, France, 14Rheumatology, CHU Hautepierre, Strasbourg, France, 15Hotel Dieu University Hospital Paris, Hotel Dieu University Hospital Paris, Paris, France, 16Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France, 17Hotel Dieu University Hospital Paris, Epidemiology, Paris, France, 18Rheumatology, Université Paris-Sud, Le Kremlin Bicetre, France

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords:

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy

Session Type: Abstract Submissions (ACR)

Background/Purpose:

Data regarding tolerance of biologics in patients with a history of cancer are very limited.

We therefore analyzed tolerance of rituximab (RTX) in patients with a history of cancer

included in the AIR (“Autoimmunity and Rituximab”) registry.

Methods: The French Society of Rheumatology has set up a nationwide prospective 7-year registry, AIR to investigate the long-term safety and efficacy in real life of RTX.

Results:

Among the 2000 patients enrolled, 272 patients (13.6%) treated with RTX had a history of cancer prior to RTX. 33% of them had a history of breast cancer with a median duration of  6 years, 15% of skin cancer (6% melanoma ), 14% of lymphoma, 7% a prostate cancer, 6% an uterus cancer, 5% a colorectal cancer, 3% a thyroid cancer and 17% another cancer (kidney, bladder, lung, blood malignancies,  brain). The main baseline characteristics of these patients (disease duration 15 years, record of serious or recurrent infections: 35.2%, proportion of patients treated without a concomitant synthetic DMARD:38.2%) were comparable to those of patients without a history of cancer, except an older age (63 vs 58 years), a higher proportion of patients without anti-TNF prior to RTX (55% vs 83%) and a lower disease activity (median DAS28: 5.2 vs 5.6). The median time between the diagnosis of cancer and the first infusion was 4 [0-46] years. 270 patients with a history of cancer had at least 1 follow-up visit respectively, with a median follow-up period of 2.8 years (756 patient/years) and 1709 patients without a history of cancer had a follow-up visit with a median follow-up of 2.8 years  (4785 patient/years).

–Cancers : Among the patients with a history of cancer, 20 patients had a recurrence of cancer or a second cancer (2.6 cancers /100 patient/years). 13 (5%, 1.7/100 patient/years) developed metastases or recurrence of their previous cancer (breast:3, colon: 1, liver; 2, lung:2, myeloma:1, skin:1, uterus:1, bladder:1, kidney: 1) and 7 (2.6%, 0.9 cancer/100 PY).)developed a new cancer (skin:3, bladder:2, colon: 1,  pancreas:1).. Among the patients without a history of cancer, 43 cancers (0.9 cancer/100 patient/years) (skin: 10, breast: 6, lung: 5, prostate: 4, others: 18) occurred after a median duration of 22 months after the 1st RTX infusion.

– Serious infections :25 and 214 patients with/without history of cancer had a serious infection (3.3 and 4.5 serious infections /100 patient/years, respectively).

– Deaths :15 and 64 patients with/without history of cancer died (1.9 and 1.3 deaths /100 patient/years, respectively).

Conclusion:

RTX is often used in common practice in patients with history of cancer, although data are limited except for lymphomas. After nearly 3 years of follow-up, overall safety of RTX seems comparable in patients with or without history of cancer. The risk of a new cancer is the same than in patients without any previous cancer. The risk of cancer recurrence is difficult to evaluate in the absence of a control group of RA patients with cancers of matched histology, severity and duration, non-treated with RTX. Collaboration between registries might help to address this issue.

Disclosure:

J. E. Gottenberg,
None;

M. O. Duzanski,
None;

T. Bardin,
None;

P. Cacoub,
None;

A. G. Cantagrel,
None;

B. Combe,
None;

M. Dougados,
None;

R. M. Flipo,
None;

B. Godeau,
None;

L. Guillevin,
None;

E. Hachulla,
None;

X. Le Loet,
None;

T. Schaeverbeke,
None;

J. Sibilia,
None;

I. Pane,
None;

P. Ravaud,
None;

G. Baron,
None;

X. Mariette,
None.

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