Abstract
Background: The British Association of Dermatologists Biologic Interventions Register (BADBIR) is a prospective, longitudinal, observational pharmacovigilance register of psoriasis patients, which aims to explore the long-term safety of biologic agents compared to conventional systemic agents. Patients are currently recruited from 152 dermatology centres in the UK and Republic of Ireland. Patients are flagged with the Health and Social Care Information Centre (HSCIC) for cancer reporting in England and Wales to maximise the capture of these events.
Objective: To investigate the overlap in reporting of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) to BADBIR and the HSCIC.
Methods: Data up to 1st December 2014 including 8413 patients receiving biological and/or systemic therapy from England and Wales were included in this analysis. SCCs and BCCs were pre-specified as an event of special interest in BADBIR. SCCs and BCCs with an event date prior to the start date of the BADBIR registration therapy were recorded as previous cancers; incident SCCs and BCCs were classified as serious adverse events (SAEs) that were identified during follow-up following registration. In situ SCCs (Bowen’s disease) were excluded.
Results: 142 SAEs (63 SCCs and 79 BCCs) for 86 patients were recorded with BADBIR and 32 SAEs (17 SCCs and 15 BCCs) for 29 patients recorded with the HSCIC. In total, 152 SAEs (69 SCCs and 83 BCCs) were recorded for 94 patients. 318 previous cancers (141 SCCs and 177 BCCs) for 150 patients were recorded with BADBIR, and 105 previous cancers (36 SCCs and 69 BCCs) for 94 patients recorded with the HSCIC. Overall, 342 previous cancers (150 SCCs and 194 BCCs) were recorded for 172 patients. 91 patients were recorded in both databases, but only 24 of 68 SAEs and 81 of 204 previous cancers were matched for these patients.
Conclusion: The findings suggest that the reporting of SCCs and BCCs is more complete in BADBIR than HSCIC. Each data source missed a substantial proportion and failure to use linked sources may lead to biased estimates of the incidence of SCCs and BCCs.
Objective: To investigate the overlap in reporting of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) to BADBIR and the HSCIC.
Methods: Data up to 1st December 2014 including 8413 patients receiving biological and/or systemic therapy from England and Wales were included in this analysis. SCCs and BCCs were pre-specified as an event of special interest in BADBIR. SCCs and BCCs with an event date prior to the start date of the BADBIR registration therapy were recorded as previous cancers; incident SCCs and BCCs were classified as serious adverse events (SAEs) that were identified during follow-up following registration. In situ SCCs (Bowen’s disease) were excluded.
Results: 142 SAEs (63 SCCs and 79 BCCs) for 86 patients were recorded with BADBIR and 32 SAEs (17 SCCs and 15 BCCs) for 29 patients recorded with the HSCIC. In total, 152 SAEs (69 SCCs and 83 BCCs) were recorded for 94 patients. 318 previous cancers (141 SCCs and 177 BCCs) for 150 patients were recorded with BADBIR, and 105 previous cancers (36 SCCs and 69 BCCs) for 94 patients recorded with the HSCIC. Overall, 342 previous cancers (150 SCCs and 194 BCCs) were recorded for 172 patients. 91 patients were recorded in both databases, but only 24 of 68 SAEs and 81 of 204 previous cancers were matched for these patients.
Conclusion: The findings suggest that the reporting of SCCs and BCCs is more complete in BADBIR than HSCIC. Each data source missed a substantial proportion and failure to use linked sources may lead to biased estimates of the incidence of SCCs and BCCs.
| Original language | English |
|---|---|
| Title of host publication | Pharmacoepidemiology and Drug Safety |
| Pages | 437-438 |
| Volume | 25 |
| Edition | Suppl 3 |
| Publication status | Published - 2016 |
| Event | 32nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management - The Convention Centre, Dublin, Ireland Duration: 25 Aug 2016 → 28 Aug 2016 https://www.pharmacoepi.org/meetings/32ICPE/ |
Conference
| Conference | 32nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management |
|---|---|
| Abbreviated title | ICPE |
| Country/Territory | Ireland |
| City | Dublin |
| Period | 25/08/16 → 28/08/16 |
| Internet address |
