- 作者：Beatriz Pé ; rez-Zafrilla ; Miguel Á ; ngel Descalzo ; Loreto Carmona ; the BIOBADASER study group*
- 关键词：Infliximab ; Etanercept ; Adalimumab ; Toxicity ; Adverse efects ; Registry ; Rheumatic diseases
- 刊名：Reumatolog¨ªa Cl¨ªnica (English Edition)
- 出版年：2008
- 出版时间：2008
- 年：2008
- 卷：4
- 期：3
- 页码：90-95
- 全文大小：98 K
Objective
To estimate the frequency of administration related reactions (ARR), the risk window from the starting date, and finally if there are any differences between infliximab, etanercept, and adalimumab.Patients and method
BIOBADASER is an adverse event registry established in 2001 for active long-term follow-up of safety of biological therapies in rheumatic patients. Data from patients, diagnosis, treatment, and adverse events are recorded.
Results
Four-hundred ninety-six relevant ARR were registered, 19.6 % (496/2531) of all the adverse events communicated and 6.3 % (496/2531) of all the patients registered. The incidence rate per 1000 patients-year with infliximab is 28 cases (95 % CI, 25-31), with etanercept 0.2 (95 % CI, 0.1-0.4), and with adalimumab 0.2 (95 % CI, 0.07-0.7). Treatment was interrupted in more than 50 % of all the ARR and 5 % of all patients were hospitalized. More than 20 % ARR happened after 15 months of treatment; in addition 2 appeared after 5 years of treatment. In delayed reactions the symptoms that most frequently were recorded were rash, fever, malaise, and myalgia.
Conclusions
ARR can appear in any moment of the treatment; they are among the most frequent causes of treatment interruption. Although with less frequency, ARR are also associated with etanercept and adalimumab with symptoms that cannot be identified as such.