Researchers have combined national and international pharmacovigilance registry data pertaining to the use of biologic agents in patients with juvenile idiopathic arthritis (JIA) as a proposal for sharing data for future analysis of safety and effectiveness, according to results reported in Arthritis Research & Therapy.
Researchers merged long-term data from 3 large databases, which included the Pharmachild international registry and national patient registries from Sweden and Germany. These data included clinical, demographic, adverse event, and drug exposure information from 15,284 patients with JIA treated with immunosuppressive therapies. The authors also developed a computerized system to share clinical and scientific data related to disease treatment.
After retrospective analysis, the researchers found that patients from the Pharmachild registry were younger age at onset of JIA compared with those from the Swedish and German registries (median age, 5.4 vs 7.6 years). Patients in the Pharmachild registry also had a shorter disease duration (5.3 vs 6.1-6.8 years) compared with those in other registries. In addition, the most frequently reported disease type was rheumatoid factor-negative polyarthritis.
With respect to drug therapy, the disease-modifying antirheumatic drugs methotrexate and etanercept were the most commonly used agents, respectively.
The primary limitation of the analysis was the lack of efficacy results, which can only be obtained from prospective studies.
“Sharing of data from national and international registries [is] the most powerful tool for future analysis of safety and effectiveness, with the aim to address important questions on current daily practice in pediatric rheumatology,” the researchers wrote.
Swart J, Giancane G, Horneff G, et al. 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. Arthritis Res Ther. 2018;20(1):285.