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

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: patient treated with DMARD

• Registration Number: NCT03980639
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2018-11-20
• Study First Submitted: 2019-01-18
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-07
• Last Update Submitted: 2019-06-07
• Study First Posted: 2019-06-10
• Last Update Posted: 2019-06-10
• Primary Completion: 2019-06-28
• Study Completion: 2019-06-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 594226

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
abatacept	patient treated with DMARD	patients with abatacept prescription
others bDMARDs	patient treated with DMARD	patients with at least one bDMARD prescriptions

Primary Outcome Measures

Name	Time	Method
Risk of reporting cancer overall specific cancers	Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018	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
Risk of reporting specific cancers	Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018	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

Trial Locations

Locations (1)

UHToulouse; 🇫🇷 Toulouse, France