RESEARCH ARTICLE


Storage Conditions of Immunobiologicals and their Influence on the Efficacy and Safety in the Treatment of Autoimmune Rheumatic Diseases



Tássia Moraes de Assis Damasceno1, *, Vander Fernandes1, Cristhiane Almeida Leite da Silva1, Ageo Mario Candido da Silva1, Luciana Carolina Ishikawa Cezar Santos1, Veronica Palmiro da Silva e Lima1
1 University of Cuiabá (UNIC), Cuiabá, MT, Brazil


© 2020 de Assis Damasce et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: (https://creativecommons.org/licenses/by/4.0/legalcode). This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

* Address correspondence to this author at the University of Cuiabá (UNIC), Cuiabá, MT, Brazil; Tel: 65998002209; E-mail: dra.tassia.damasceno@gmail.com


Abstract

Objective:

The study aimed to evaluate the influence of storage temperature on immunobiological efficacy and safety in autoimmune rheumatic disease treatment.

Methods:

This observational study included adult patients with autoimmune rheumatic diseases who used immunobiologicals stored at home and were followed up at the rheumatology outpatient clinic of the General University Hospital of Cuiabá, Mato Grosso, Brazil, in 2017/2018. Patients were evaluated regarding disease activity and occurrence of adverse events, and a household survey of the temperature of the storage environment of these drugs was conducted.

Results:

Sixty patients with a mean age of 50.4 years were evaluated. Of these, 39 patients (65%) stored their biological drugs outside the recommended temperature range. Storage of the immunobiological at the incorrect temperature was 76% higher among patients with moderate/high rheumatic disease activity (p=0.003).

Conclusion:

Most patients stored their immunobiologicals outside the temperature range recommended in the package insert, and there was an association between incorrect storage temperature and moderate/high autoimmune rheumatic disease activity.

Keywords: Biological therapy, Ambient temperature, Rheumatic diseases, Antirheumatic agents, Immunobiologicals, Biological drugs.