Date: Monday, November 14, 2016
Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy II: Safety and Cost Effectiveness
Session Type: ACR Concurrent Abstract Session
Session Time: 2:30PM-4:00PM
Background/Purpose: Patients with a history of cancer were excluded from pivotal clinical trials evaluating biologics. Therefore, only registries can inform us on the incidence of cancers in such patients treated with a biologic.
Methods: Registries of the French Society of Rheumatology AIR and ORA included 1986 and 1024 patients to study tolerance and efficacy of rituximab (RTX) and abatacept (ABA) in common practice, respectively. Cancers and serious infections were validated by analysis of the charts of patients.
Results: Treatment with rituximab 270 patients had a history of cancer and 1656 patients did not have a history of cancer before RTX (60 missing data). The 1656 patients without a history of cancer had a mean follow-up of 5.4 years (8942 patient-years) and 83 cancers occurred (0.9 cancers/100 patient-years). Among the 270 patients with a history of cancer, mean follow-up was 5.2 years (1404 patient-years) and 48 incident cancers (3.4 cancers/100 patient-years), including 19 new cancers (1.3 cancers/100 patient-years) and 29 relapses of past cancers (2.1 cancers/100 patient-years). Cancers occurred after a median period of 32.2 (18.5 ; 53.9) months and 37.7 (21.7 ; 57.8) months after RTX initiation in patients with and without a history of cancer, respectively. Cancers occurred after a median number of 2 (1 ; 4) and 2 (1 ; 4) cycles, in patients with and without a history of cancer, respectively. Treatment with abatacept 55 patients had a history of cancer and 961 patients did not have a history of cancer before abatacept (8 missing data). The 961 patients had a mean follow-up of 4.8 years (4613 patient-years) and 61 cancers occurred (1.3 cancers/100 patient-years). The 55 patients with a history of cancer had a mean follow-up of 4.6 years (253 patient-years). Five incident cancers occurred (2.0 cancers/100 patient-years) including 3 new cancers (1.2 cancers/100 patient-years) and 2 relapses of past cancers (0.8 cancers/100 patient-years). Cancers occurred after a median period of 8.0 (6.4 ; 24.3) months and 34.8 (19.4 ; 46.1) months after ABA initiation in patients with and without a history of cancer, respectively.
Conclusion: The incidence of cancers in patients with a history of cancer treated with abatacept and rituximab, approximately two to three-fold that of patients without a history of cancer, is in the range of what is expected in these patients at higher risk of cancer.
To cite this abstract in AMA style:Gottenberg JE, Ravaud P, Bardin T, Cantagrel A, Combe B, Dougados M, FLIPO RM, Vittecoq O, Schaeverbeke T, Pane I, Sibilia J, Mariette X. Incidence of Cancer in Patients with Rheumatoid Arthritis and a History of Cancer Treated with Rituximab or Abatacept [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/incidence-of-cancer-in-patients-with-rheumatoid-arthritis-and-a-history-of-cancer-treated-with-rituximab-or-abatacept/. Accessed June 1, 2023.
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