Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Toulouse, Frankrike, 31059
- Rekrytering
- UHToulouse
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Kontakt:
- François MD MONTASTRUC, PhD
- Telefonnummer: +33 5 61 14 59 60
- E-post: francois.montastruc@univ-tlse3.fr
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Kontakt:
- Isabelle OLIVIER, PhD
- Telefonnummer: +33 561777051
- E-post: olivier.i@chu-toulouse.fr
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Retrospektiv
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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abatacept
patients with abatacept prescription
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Case report of cancer overall
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others bDMARDs
patients with at least one bDMARD prescriptions
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Case report of cancer overall
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Risk of reporting cancer overall specific cancers
Tidsram: Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
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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
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Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
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Risk of reporting specific cancers
Tidsram: Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
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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
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Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: François MONTASTRUC, PhD MD, University Hospital, Toulouse
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RC31/18/0440
Läkemedels- och apparatinformation, studiedokument
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Kliniska prövningar på patient treated with DMARD
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Marmara UniversityOkänd