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Abatacept

patients with at least one bDMARD prescriptions

patient treated with DMARD

François MONTASTRUC, PhD MD

François MD MONTASTRUC, PhD

Isabelle OLIVIER, PhD

There are very few data on the safety of Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs), especially abatacept which compared to Tumor Necrosis Factor α (TNFα) inhibitors has distinct mechanism of action. Abatacept is a recombinant fusion protein of human Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) and the Fc region of human immunoglobulin gamma-1 (IgG1). This CTLA4-fusion protein blocks the signal of T cell activation by binding to CD80 and CD86.

Recently, the investigator's study found in a US cohort of 64,000 patients with Rheumatoid Arthritis (RA) a potential signal for a higher risk of cancer overall and particularly non-melanoma skin cancer with abatacept compared to other bDMARDs (article in press). These results were in accordance with another prospective cohort study of the public health care system in Sweden, showing an increased risk of NMSC in abatacept users compared with TNFα inhibitors. As these results warrant replication, the present study will assess whether abatacept is associated with an increased risk of reporting overall cancer and specific cancer, including breast, lung, lymphoma, cervical, melanoma and NMSC, compared to other bDMARDs.

A case non-case study using Vigibase®, the World Health Organization Global Individual Case Safety Reports (ICSRs) database which includes more than 18 million reports forwarded to the WHO Uppsala Monitoring Center by national pharmacovigilance systems from over 130 countries around the world since 1967. Information on the adverse effects reported include patient demographics and medical relevant history, drugs recorded according to the WHO Drug dictionary and adverse drug reactions coded with Medical Dictionary for Regulatory Activities (MedDRA) terms will be perform.

Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase

Estimate statistically the risk of reporting cancer overall and specific cancers (including breast, lung, lymphoma, cervical, melanoma and NMSC) compared with all other adverse drug reactions (ADR) for abatacept compared to all ADRs for other bDMARDs performing a disproportionality analysis

Estimate statistically the risk of specific cancers (including breast, lung, lymphoma, cervical, melanoma and NMSC) compared with all other adverse drug reactions (ADR) for abatacept compared to all ADRs for other bDMARDs performing a disproportionality analysis

University Hospital, Toulouse

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase	NCT03980639	Rheumatoid Arth...	patient treated...	18 Years -	University Hospital, Toulouse
Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase	NCT03980639	Rheumatoid Arth...	patient treated...	18 Years -	University Hospital, Toulouse
Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase	NCT03980639	Rheumatoid Arth...	patient treated...	18 Years -	University Hospital, Toulouse

Spots Global Cancer Trial Database for patient treated with dmard