Safety Profile of Biologics at Pediatrics Rheumatology Clinic, at Children Hospital in Tripoli City, (2009-2019)

Abstract

The advent of biological drugs has revolutionized the management of various pediatric rheumatologic diseases,
primarily juvenile idiopathic arthritis (JIA). These drugs enable better disease control and prevent or retard damage
due to active disease in a substantial number of children. The study conducted to evaluate the risk of infection,
(mild and sever), anaphylaxis, malignancy and autoimmunity among pediatric rheumatology patients treated with
biologics. This was a case series retrospective study; carried out in Rheumatology unit Tripoli Children Hospital,
including all children receiving biologics. The six biologics studied were etanercept, adalimumab, anakinira,
infliximab, rituximab and tocilizumb. Medical records were reviewed demographic data; information related
therapy, infections, anaphylaxis, malignancy, autoimmune diseases, and reason of discontinuation were collected.
Data analyzed by using the Statistical Program for Social Sciences version 16.
All 92 patients treated with six different biologics between 2009 and 2019 were included, 53(58%) were females.
The majority of patients had JIA 66(71.7%). Most common side effect was mild to moderate infection in 49 patients
(33.3%) in all biologics,and no cases of TB or meningitis. The most common type of infection was mild upper
respiratory tract infections, pneumonia that does not require hospitalization. Injection site reaction only noted in
16 patients treated with anakinra .
New onset uveitis in two patients in Etanercept group, hypersensitivity reaction was recorded in 4(4.3%) patients.
Abnormal LFT in form of high transaminase or bilirubin registered noted in 17 patients most of them (75%) among
cases receiving Tocilizumab. Biologics discontinued in 47(51%) of the cases for different reasons, remission and
inefficacy were most common causes.
The safety profiles of the six available studied biologics, are highly acceptable and encouraging. However, more
long-time data is needed for sever adverse events