Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO)

Abstract

A routine-based Danish database for biological therapies covers approximately 90% of patients and improves the reporting of adverse events.

Efficacy and tolerability of anti-tumour necrosis factor therapy in psoriatic arthritis patients: results from the South Swedish Arthritis Treatment Group register

“…However, our data on adverse events mainly rely on a systematic voluntary adverse event reporting system, which may underestimate the true level of adverse events 26. At the same time, it should be noted that routine database reporting of adverse events has been proven up to 20 times superior compared to unstructured spontaneous adverse event reporting 27. Finally, another important observation is that no unexpected types of SAE were reported.…”

Predictors of treatment response and drug continuation in 842 patients with ankylosing spondylitis treated with anti-tumour necrosis factor: results from 8 years' surveillance in the Danish nationwide DANBIO registry

“…More than 90% of the patients who are prescribed biological treatment are included in the database 27 28. By 15 November 2008, 5366 patients receiving biological treatment had been registered in DANBIO.…”

“…The mandatory reporting of biological treatment to the database makes coverage and completeness of data high 27 28. The registry currently includes up to 8 years of follow-up.…”

“…The registry currently includes up to 8 years of follow-up. Several papers have previously described DANBIO data in patients with rheumatoid arthritis,16 27–31 whereas data for patients with AS have not been published until now.…”

Do changes in prescription practice in patients with rheumatoid arthritis treated with biological agents affect treatment response and adherence to therapy? Results from the nationwide Danish DANBIO Registry

“…In 2002, coverage was 90% 3. In 2006 and 2007, all departments of rheumatology were asked to report how many of their patients were currently receiving biological agents.…”