Pharmacovigilance in juvenile idiopathic arthritis patients treated with
biologic or synthetic drugs: combined data of more than 15,000 patients
from Pharmachild and national registries
BackgroundThe availability of methotrexate and the introduction of
multiple biological agents have revolutionized the treatment of juvenile
idiopathic arthritis (JIA). Several international and national drug
registries have been implemented to accurately monitor the long-term
safety/efficacy of these agents. This report aims to present the
combined data coming from Pharmachild/PRINTO registry and the national
registries from Germany (BiKeR) and Sweden.MethodsDescriptive statistics
was used for demographic, clinical data, drug exposure, adverse events
(AEs) and events of special interest (ESIs). For the Swedish register,
AE data were not available.ResultsData from a total of 15,284 patients
were reported: 8274 (54%) from the Pharmachild registry and 3990 (26%)
and 3020 (20%) from the German and the Swedish registries,
respectively. Pharmachild children showed a younger age (median of
5.4versus 7.6 years) at JIA onset and shorter disease duration at last
available visit (5.3 versus 6.1-6.8) when compared with the other
registries. The most frequent JIA category was the rheumatoid
factor-negative polyarthritis (range of 24.6-29.9%). Methotrexate
(61-84%) and etanercept (24%-61.8%) were the most frequently used
synthetic and biologic disease-modifying anti-rheumatic drugs (DMARDs),
respectively. There was a wide variability in glucocorticoid use
(16.7-42.1%). Serious AEs were present in 572 (6.9%) patients in
Pharmachild versus 297 (7.4%) in BiKeR. Infection and infestations were
the most frequent AEs (29.4-30.1%) followed by gastrointestinal
disorders (11.5-19.6%). The most frequent ESIs were infections
(75.3-89%).ConclusionsThis article is the first attempt to present a
very large sample of data on JIA patients from different national and
international registries and represents the first proposal for data
merging as the most powerful tool for future analysis of safety and
effectiveness of immunosuppressive therapies in JIA.Registry
registrationThe Pharmachild registry is registered at ClinicalTrials.gov
(NCT01399281) and at the European Network of Centres for
Pharmacoepidemiology and Pharmacovigilance (ENCePP)
(http://www.encepp.eu/encepp/viewResource.htm?id=19362). The BiKeR
registry is registered at ENCePP
(http://www.encepp.eu/encepp/viewResource.htm?id=20591)