Abstract
This review summarizes the immunological consequences of biological therapies used in juvenile idiopathic arthritis (JIA). For every frequently used biological agent the characteristics are clearly specified (molecular target, isotype, registered indication for JIA, route of administration, half-life, contraindication, very common side effects, expected time of response and average cost in the first year). The emphasis of this review is on the immunological side effects that have been encountered for every separate agent in JIA populations. For each agent these adverse events have been calculated as incidence per 100 patient-years for the following categories: serious infections, tuberculosis, malignancies, response to vaccination, new-onset autoimmune diseases and development of anti-drug antibodies. There are large differences in side effects between various agents and there is a clear need for an international and standardized collection of post-marketing surveillance data of biologicals in the vulnerable group of JIA patients. Such an international pharmacovigilance database, called Pharmachild, has now been started.
Highlights
Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children, with an incidence in Europe of about 16 to 150 per 100,000 per year, and an important cause of short-term and long-term disability [1]
The tuberculin skin test (TST), measuring the Th1 cell-type response to purified protein derivative, is significantly lower in bacillus CalmetteGuerin (BCG)-vaccinated children with JIA compared to healthy children [44]. These results show that the purified protein derivative response that has been used for years in screening for TB will not be accurately informative in cases of JIA; these would require the application of more sensitive tests [44]
The immunogenicity of vaccines is good in JIA patients
Summary
Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children, with an incidence in Europe of about 16 to 150 per 100,000 per year, and an important cause of short-term and long-term disability [1]. A larger study examined the immunogenicity and safety of two doses of 7-valent conjugate pneumococcal vaccine in JIA patients with median age 12.9 years treated with anti-TNF agents plus DMARDs and age-matched children treated only with DMARDs [65]. During a prospective study with 2-year follow-up of newly developed autoantibodies after the start of infliximab, only 1 of 12 JIA patients developed anti-smooth muscle antibodies at a low titer (1:80), which lasted 12 months but did not involve any relevant clinical entity [71]. Anakinra Just one study mentions development of anti-IL-1ra antibodies in 86 polyarticular course JIA patients (only 17% with SJIA) using anakinra during 3 months followed by a 4-month placebo-controlled phase and afterwards a 12-month open-label extension phase [73]. The ENCePP Seal has been awarded to the Pharmachild register
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