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ORIGINAL PAPER
“Long-term assessment of safety and efficacy of biological treatment in juvenile idiopathic arthritis” – the register of Polish patients
 
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Online publication date: 2011-03-16
 
 
Reumatologia 2011;49(1):10-15
 
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ABSTRACT
Patients undergoing the biological therapy require particularly intensive care. During numerous, systematically repeated monitoring visits, the patients’ documentation is enriched with a huge amount of data regarding their disease and treatment. Analysis of these data can help obtain a multi-dimensional evaluation of the effectiveness and safety profile of the therapy. This became an inspiration for the Polish scientific electronic register of children treated with biological therapies: “Long-term assessment of safety and efficacy of biological treatment in juvenile idiopathic arthritis” – the register of Polish patients. The registry started operating in April 2009. A year later it contained data of 218 patients suffering from juvenile idiopathic arthritis treated with biological agents: etanercept was used in 210 patients and adalimumab in 8 patients. The main aims of the registry are: 1) long-term assessment of the safety profile of the applied treatment by recording and analyzing the adverse events; 2) long-term assessment of the effectiveness profile of the given treatment on the basis of the activity of the disease and patient’s quality of life. The registry contains data coming from the patients’ medical history concerning the beginning and the course of JIA, previous treatment with the assessment of its effectiveness and tolerance, the activity of the disease, the occurrence of autoimmunization diseases in the family and the analysis of the quality of life before starting biological therapy. On the basis of the data collected during regular appointments, the doctor fills in an electronic questionnaire of 35 questions concerning the somatic development and present course of treatment. The activity of the disease profile is being evaluated (according to Gianinni), the improvement profile ACR Ped is being calculated. In addition, the effectiveness profile of the treatment is being assessed by the doctor, the patient and his or her parents. Also, absences from school and the number of hospitalizations are taken into account. The safety profile is being established by noting down the adverse events. This paper presents the main assumptions of the registry, its structure and trends in the analysis of the data and a list of study centres participating in the register (Table I and II).
 
REFERENCES (13)
1.
Cassidy JT, Petty RE. Juvenile idiopathic arthritis. In: Textbook of pediatric rheumatology, Cassidy JT, Petty RE (eds.), 5th ed. WB Saunders, Philadelphia 2005; 291-303.  .
 
2.
Petty RE. Prognosis in children with rheumatic diseases: justification for consideration of new therapies. Rheumatology (Oxford) 1999; 38: 739-742.  .
 
3.
Lovell DJ, Giannini EH, Reiff A, et al. Pediatric Rheumatology Collaborative Study Group. Etanercept in children with poly­articular juvenile rheumatoid arthritis. N Engl J Med 2000; 342: 763-769.  .
 
4.
Lovell DJ, Reiff A, Jones OY, et al. Long-term safety and efficacy of etanercept in children with polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum 2006; 54: 1987-1994.  .
 
5.
Lovell DJ, Reiff A, Ilowite NT, et al. Pediatric Rheumatology Collaborative Study Group. Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis. Arthritis Rheum 2008; 58: 1496-1504.  .
 
6.
Horneff G, Schmeling H, Biedermann T, et al. Paediatric Rheumatology Collaborative Group. The German etanercept registry for treatment of juvenile idiopathic arthritis. Ann Rheum Dis 2004; 63: 1638-1644.  .
 
7.
Horneff G, De Bock F, Foeldvari I, et al. German and Austrian Paediatric Rheumatology Collaborative Study Group. Safety and efficacy of combination of etanercept and methotrexate compared to treatment with etanercept only in patients with juvenile idiopathic arthritis (JIA): preliminary data from the German JIA Registry. Ann Rheum Dis 2009; 68: 519-525.  .
 
8.
Prince FH, Twilt M, Ten Cate R, et al. Ann Long-term follow-up on effectiveness and safety of etanercept in juvenile idiopathic arthritis: the Dutch national register. Rheum Dis 2009; 68: 635-641.  .
 
9.
Quartier P, Taupin P, Bourdeaut F, et al. Efficacy of etanercept for the treatment of juvenile idiopathic arthritis according to the onset type. Arthritis Rheum 2003; 48: 1093-1101. .
 
10.
Russo RA, Katsicas MM. Clinical remission in patients with systemic juvenile idiopathic arthritis treated with anti-tumor necrosis factor agents. J Rheumatol 2009; 36: 1078-1082. .
 
11.
Program terapeutyczny. „Leczenie reumatoidalnego zapalenia stawów i młodzieńczego idiopatycznego zapalenia stawów o przebiegu agresywnym”. Załącznik nr 6, Zarządzenie nr 30/2010/DGL Prezesa NFZ z dnia 30.06.2010. .
 
12.
Klareskog L, van der Heijde D, de Jager JP, et al. TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) study investigators. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet 2004; 363: 675-681. .
 
13.
Giannini EH, Ruperto N, Ravelli A, et al. Preliminary definition of improvement in juvenile arthritis. Arthritis Rheum 1997; 40: 1202-1209.
 
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