Etanercept treatment in juvenile idiopathic arthritis: The Polish registry

Abstract

SummaryBackgroundTo evaluate the long-term safety and efficacy of etanercept treatment in Polish patients with juvenile idiopathic arthritis (JIA).Material/MethodsThe study involved patients, fulfilling the JIA criteria of the International League of Associations of Rheumatology (ILAR), who were started on etanercept therapy after methotrexate and other synthetic disease-modifying antirheumatic drugs (DMARDs) had proven ineffective. Patient data were collected in an electronic registry. Disease improvement was assessed based on Giannini’s criteria.ResultsThe statistical analysis involved 188 patients. Significant improvement was observed in all clinical and laboratory parameters after the first month of therapy and was maintained in the following months. ACR Pediatric 30, 50, 70, 90, and 100 improvement was observed in 81.4%, 65.9%, 27.5%, 16.2%, and 15%, respectively, of patients after 3 months and in 94.7%, 88.4%, 62.1%, 34.7%, and 26.3%, respectively, after 24 months of treatment. Throughout the 72-month safety observation period, 1162 adverse events were reported; the exposure-adjusted AE rate was 2.96 per patient per year.ConclusionsIn patients with various subtypes of JIA resistant to conventional DMARD treatment, etanercept resulted in significant and long-lasting improvements in disease activity. Combination treatment with etanercept and a DMARD was well tolerated.

Safety of biologic therapies for the treatment of juvenile idiopathic arthritis

“…Rates of AEs were similar among the three treatment groups (18. Data from the Polish registry about 188 JIA patients showed 1161 AEs during a 72-month safety observation period with an exposure-adjusted AE rate of 295/100 patient-years [27]. There were 16 cases of severe respiratory tract infections reported (4/100 patient-years).…”

“…The most frequent were upper respiratory tract infections, pharyngitis and headache. Infusion reactions occurred in 32% of patients with a higher incidence in patients who tested positive for ADA to infliximab (58%; 15/26) than in those who were negative ( [22] NL [20] P [27] BIKER STRIVE [31] BIKER § BIKER US [22] STRIVE [31] Patients <(exposed to biologic) 4/61 (6.6%). In summary, in this 4-year trial, infliximab turned out as a safe and effective with a high dropout rate [8].…”

Opportunistic infections and biologic therapies in immune-mediated inflammatory diseases: consensus recommendations for infection reporting during clinical trials and postmarketing surveillance

“…Pictured in figure are studies reporting incidence of herpes zoster 11 41 49 52 – 54 56 – 59 62. Incidence (patient-years) in biologic treated patients (incidence reflects combined outcome for anti-TNF therapy unless otherwise indicated): Beukelman 2013 510/100 000; Galloway 2013 1600/100 000; Winthrop 2013 1090/100 000; Dreiher 2012 1930/100 000 for infliximab (not pictured 1390/100 000 for etanercept); Failla 2012 520/100 000 (anti-TNF, rituximab, ustekinumab); Zuber 2011 800/100 000 for etanercept; McDonald 2008 1060/100 000; Strangfeld 2009 1010/100 000.…”

Continuity of monitoring the rheumatic diseases course in patients after 18 years of age – the point of view of internist

“…Na ich podstawie można śledzić postęp choroby, jej aktywność i skuteczność leczenia [30][31][32]. Członkowie stowarzyszeń mają możliwość wspólnego przeżywania choroby, mogą brać udział w grupowej kinezyterapii, wspólnych wyjazdach na leczenie sanatoryjne, a równocześnie nawiązywać kontakty towarzyskie z osobami znajdującymi się w tej samej sytuacji życiowej.…”