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Rheumatology Advance Access originally published online on May 29, 2009
Rheumatology 2009 48(8):916-919; doi:10.1093/rheumatology/kep122
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© The Author 2009. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Safety and efficacy of once weekly etanercept 0.8 mg/kg in a multicentre 12 week trial in active polyarticular course juvenile idiopathic arthritis

Gerd Horneff1, Annette Ebert1, Sigrid Fitter1, Kirsten Minden2, Ivan Foeldvari3, Jasmin Kümmerle-Deschner4, Angelika Thon5, Herrmann J. Girschick6, Frank Weller7 and Hans I. Huppertz7

1Department of Paediatrics, Asklepios Clinic Sankt Augustin, Sankt Augustin, 2Universitätskinderklinik Charité, Otto Heubner Centrum, Berlin, 3Hamburger Zentrum für Kinder und Jugendrheumatologie am Klinikum Eilbek, Kinderheilkunde I, Hamburg, 4Universitätsklinik für Kinderheilkunde und Jugendmedizin, Tübingen, 5Medizinische Hochschule Hannover, Abteilung Kinderheilkunde I, Hannover, 6Universitätsklinikum, Kinderklinik und Poliklinik – Pädiatrische Rheumatologie/Osteologie, Würzburg and 7Klinikum Bremen-Mitte, Professor Hess-Kinderklinik, Bremen, Germany.

Correspondence to: Gerd Horneff, Asklepios Clinic Sankt Augustin, Department of Pediatrics, Arnold-Jannssen Str. 29, 53757 Sankt Augustin, Germany. E-mail: g.horneff{at}asklepios.com


  Abstract

Objectives. Etanercept, a recombinant TNF receptor fusion protein, has been approved for the treatment of resistant polyarticular course juvenile idiopathic arthritis at a dosage of 0.4 mg/kg twice weekly in children older than 4 years. In adult patients, efficacy and safety of etanercept 25 mg twice weekly was comparable with 50 mg once weekly. Therefore, safety and efficacy of etanercept once weekly 0.8 mg/kg up to 50 mg s.c. was evaluated in a 3 month open label trial.

Methods. Twenty patients 4 to 17 years old received 0.8 mg of etanercept per kilogram of body weight subcutaneously once weekly for 3 months in an open multicentre trial. Active polyarticular disease was defined by the presence of five or more active joints with swelling, alternatively with pain or tenderness combined with limitation of motion. Safety assessments were based on adverse events (AEs) reports. Efficacy was assessed using the PedACR30/50/70 criteria.

Results. At the start of treatment the patients showed high disease activity. A rapid reduction of all disease activity parameters was observed. A PedACR30/50/70 response was reached by 75%/35%/10% of patients after 4 weeks, 90%/75%/35% after 8 weeks and 95%/75%/75% after 12 weeks of treatment. There were 37 AEs, none of them serious, with injection site reactions and minor infections being the most frequent. There was no drop out. Long-term follow-up of the patients will be carried out in the German JIA Registry.

Conclusion. Treatment with etanercept once weekly using a double dosage leads to a significant improvement of disease activity in patients with active polyarticular course juvenile idiopathic arthritis and is well tolerated.

KEY WORDS: Etanercept, Once-weekly application, Juvenile idiopathic arthritis

Submitted 7 November 2008; revised version accepted 16 April 2009.
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