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

NCT03980639 | Unknown

• 1 other identifier: RC31/18/0440
• Study Type: observational
• Target: 594,226
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

abatacept

patients with abatacept prescription

Drug: patient treated with DMARD

others bDMARDs

patients with at least one bDMARD prescriptions

Drug: patient treated with DMARD

Interventions

patient treated with DMARD DRUG

Case report of cancer overall

abatacept; others bDMARDs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with one bDMARD

You may qualify if:

• 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

You may not qualify if:

• Chronology not compatible

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

UHToulouse

Toulouse, 31059, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 31880308 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Antirheumatic Agents

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• François MONTASTRUC, PhD MD

  University Hospital, Toulouse

  STUDY DIRECTOR

Central Study Contacts

François MONTASTRUC, PhD MD

CONTACT

5 61 14 59 60; francois.montastruc@univ-tlse3.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: June 10, 2019
• Study Start: November 20, 2018
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: June 10, 2019

Record last verified: 2019-06

Locations

FR (1)