Abstract
Background Methotrexate (MTX) which has been used for 20 years in Juvenile Idiopathic Arthritis (JIA) has now become the first-choice, second-line agent for children with polyarticular course JIA. New biologic drugs are used for MTX-failing patients and have been assessed in controlled trials for effectiveness. Safety data of these drugs are slowly and selectively emerging as post-marketing data. For better efficiency of collecting these data a large pharmacovigilance registry (PharmaChild) is being constructed supported by the European Union. This will enable the pediatric rheumatologists to overlook the whole spectrum of moderate to serious adverse events of these newer drugs and hence to advise their patients better on the effectiveness as well as the relative safety of the newer agents. The patients treated with these newer drugs need to be compared to the patients treated with MTX. To get a better understanding of all adverse events already encountered in MTX-therapy in JIA-patients we performed a meta-analysis.
Highlights
Methotrexate (MTX) which has been used for 20 years in Juvenile Idiopathic Arthritis (JIA) has become the first-choice, second-line agent for children with polyarticular course JIA
The most common adverse events were found in the liver (8.08%, mainly elevated liver enzyme tests) and gastrointestinal events (7.23%, mainly nausea or vomiting), followed by unspecified- (6.25%), infectiologic- (2.61%), skin- (2.56%), mucosal- (1.36%), hematologic- (0.93%), neurologic- (0.90%), psychologic- (0.88%) events
More than two-thirds of patients do not have any adverse events when treated with MTX for 1 year
Summary
Methotrexate (MTX) which has been used for 20 years in Juvenile Idiopathic Arthritis (JIA) has become the first-choice, second-line agent for children with polyarticular course JIA. New biologic drugs are used for MTX-failing patients and have been assessed in controlled trials for effectiveness. Safety data of these drugs are slowly and selectively emerging as post-marketing data. For better efficiency of collecting these data a large pharmacovigilance registry (PharmaChild) is being constructed supported by the European Union. This will enable the pediatric rheumatologists to overlook the whole spectrum of moderate to serious adverse events of these newer drugs and to advise their patients better on the effectiveness as well as the relative safety of the newer agents. Aim To offer insight into the incidences of the adverse events (AEs) due to treatment of JIA with MTX
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