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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abatacept | patients with abatacept prescription |
| |
| others bDMARDs | patients with at least one bDMARD prescriptions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patient treated with DMARD | Drug | Case report of cancer overall |
|
| Measure | Description | Time Frame |
|---|---|---|
| Risk of reporting cancer overall specific cancers | 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 | Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018 |
| Risk of reporting specific cancers | 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 | Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with one bDMARD
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François MONTASTRUC, PhD MD | Contact | 5 61 14 59 60 | +33 | francois.montastruc@univ-tlse3.fr |
| Name | Affiliation | Role |
|---|---|---|
| François MONTASTRUC, PhD MD | University Hospital, Toulouse | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHToulouse | Recruiting | Toulouse | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31880308 | Derived | de Germay S, Bagheri H, Despas F, Rousseau V, Montastruc F. Abatacept in rheumatoid arthritis and the risk of cancer: a world observational post-marketing study. Rheumatology (Oxford). 2020 Sep 1;59(9):2360-2367. doi: 10.1093/rheumatology/kez604. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D018501 | Antirheumatic Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |