Background The situation with a treatment of juvenile idiopathic arthritis (JIA) is complicated in Ukraine. Mainly due to financial reason biological therapy is hardly accessible for Ukrainian patients. Nevertheless, some patients with JIA receive biologics within governmental programme. Clinical data of these patients were scattered and not systematized until 2014. The Task Force of Ukrainian Association of rheumatologists, by analogy to other European registries, has developed a registry of JIA patients receiving biologics. Ukrainian register of JIA patients is an observational, prospective, non-interventional clinical study.
Objectives The main aim of Ukrainian register of JIA patients is an assessment of long-term safety, efficacy and cost of biological treatment of JIA. in the routine clinical practice.
Methods 33 clinical sites from different regions of Ukraine are participating. Inclusion criteria: i) diagnosis of JIA: ii)age ≤2 years old, iii)planned start of biological therapy due to JIA; iv)negative screening for tuberculosis; v)provided informed consent. Patients have undergone standard clinical assessment every 3 months. Disease activity is measured using JADAS27 in all age groups. ANA, HLAB27, RF and anti-CCP detection are highly recommended. Uveitis and other comorbid conditions should also be fixed.
Results 339 patients were enrolled into the study during 3 years. 64% of patients are girls. Mean age–10.98±4.41 years, with mean disease duration –5.81±3.48 years. The duration of the period between diagnosis and biologics start was 54.31±40.28 months. Comorbid conditions were found in 41.03% patients. In 14.65% of the patients uveitis was diagnosed. Most common JIA subtypes in patients receiving biologics are pJIA with negative RF (45%), sJIA (20%), enthesitis-associated JIA (11%) and persistent oligoarthritis (11%). 67.3% of enrolled patients received adalimumab (ADA); 27.9%>tocilizumab (TOZ) and 4.8%>etanercept, respectively. During observational period biologics was discontinued in 19.8% of patients due to different reasons: adverse events were observed in 6.7% (ADA) and 16.7% (TOZ), insufficient efficiency of 23.3% (ADA) and 33.3% (TOZ), remission - 6.7% (ADA); drug absence - 63.3% (ADA) and 50% (TOZ), respectively. Comparative analysis of ADA and TOZ efficacy was performed in the 144 patients with pJIA with negative RF. Administration either ADA or TOZ resulted in statistically significant reducing of disease activity according to JADAS27. In ADA group after 3 months of administration JADAS27 decreased from 16.3±10.3 to 10.0±7.8 (p<0.00001). In TOZ group after 3 months of administration JADAS27 reduced from 22.2±12.2 to 13.1±9.1 (p=0.0012). The functional disability of the patients also statistically significant decrease in both treatment group starting from 3 months of administration: 1.1±0.8 to 0.7±0.7 (p=0.0081) in ADA and 1.6±1.0 to 1.0±0.7 in TOZ, respectively.
Conclusions Ukrainian national registry of JIA patients provides real-life long-term data concerning safety, efficacy, outcomes and comparative analysis of biologics in Ukrainian population of JIA patients. Data collection continues and the data received expected to be a background for clinical decision-making in future.
Disclosure of Interest None declared