THE PEDIATRIC ASTHMA PATIENT REGISTRY IN IMPLEMENTATION OF LONG TERM FOLLOW UP

Author(s)

Vishneva E, Namazova-Baranova L, Smirnov V, Alekseeva A, Levina J, Efendieva K, Voznesenskaya N, Dobrynina E, Selimzianova L, Promyslova E
Scientific Centre of Children Health, Moscow, Russia

OBJECTIVES: The randomized clinical trials (RCT), as gold standard for evidence-based medicine, have a number of shortcomings, and their results do not fully reflect actual clinical practice. In cases where RCTs are difficult to conduct because of ethical or other aspects, data bases of clinical cases - medical registries are used to determine the effectiveness and safety of any medical intervention in long-term observation. Due to heterogeneity of clinical symptoms in different groups of patients with bronchial asthma (BA), to assess the efficacy and safety of treatment of severe persistent uncontrolled asthma in the real clinical practice, the best practice is to use a long-term clinical monitoring. Aim - to create patient registry for children and adolescents with severe persistent uncontrolled BA. METHODS: By experts of center in the result of system work software was created. It was shell for management of database of clinical cases – patient registry of children with uncontrolled severe persistent BA, who received Omalizumab as addition to basis therapy. RESULTS: The database included information about 64 children (62.5% boys) from 6 to 17 y 11 mo (mean age 12.9 y) with severe persistent uncontrolled BA, who received / receive (31 patients, 70.9% boys) bioengineered treatment (duration of treatment from 1 till 70 mo). During the analyzed period of treatment safety of Omalizumab was confirmed: more than 5384 injections were conducted. Local adverse events were registered at frequency of 1/100 and were manifested as light redness, induration and light edema, were realized in 1-1.5 days after Omalizumab administration. Local allergic reactions such as rash were observed in two patients and were stopped by antihistamines CONCLUSIONS: The patient registry will help in solving problems as epidemiological, and in order to achieve optimal endpoints for monitoring and analysis of efficacy and safety of innovative high-tech medications and approaches which have been used previously for long time.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PRM60

Topic

Real World Data & Information Systems

Topic Subcategory

Reproducibility & Replicability

Disease

Pediatrics, Respiratory-Related Disorders

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