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

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.