Clinical trial NCT03980639: Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase
Official title: Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 594226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with one bDMARD

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* case reported in the World Health Organization (WHO) database of individual safety case report to 11/20/2018
* Patient treated with at least one bDMARD prescriptions
* adverse events reported were including the MedDRA terms

Exclusion Criteria:

* Chronology not compatible

Primary outcomes:
measure: Risk of reporting cancer overall specific cancers
timeFrame: Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
measure: Risk of reporting specific cancers
timeFrame: Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: François MONTASTRUC, PhD MD
role: STUDY_DIRECTOR
References:
citation: 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.