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Ann Rheum Dis. 2007 May; 66(5): 704–705.
PMCID: PMC1954640

Effectiveness of a once weekly double dose of etanercept in patients with juvenile idiopathic arthritis: a clinical study

Etanercept is effective in juvenile idiopathic arthritis (JIA).1,2,3 Currently it is administered subcutaneously at a dose of 0.4 mg/kg (maximum of 25 mg) twice a week. Clinical trials in adults show that administration of a double dose once a week is effective enough to induce and retain remission.4,5 A pharmacokinetic model developed by Yim et al6 indicates that the same dosing regimen could be used in children. Wallace7 mentions the once weekly double dose in patients with JIA, but this is not supported by clinical trials. Therefore we evaluated the efficacy of etanercept administered subcutaneously once a week at a dose of 0.8 mg/kg (maximum of 50 mg) to retain and induce remission in patients with JIA.

Eleven patients with JIA, in remission, who had already been treated with etanercept twice a week at the usual dose were switched to the double dose of 0.8 mg/kg subcutaneously once a week. Two patients with JIA in whom etanercept at a dose of 0.8 mg/kg subcutaneously once a week was initiated were observed from the start of the treatment, to see if remission could be induced.

Table 11 shows the patient and disease characteristics. The outcome measures used to assess disease activity consisted of the following set of seven response variables: global assessment of disease activity by the physician and of pain and well‐being by the patient all by visual analogue scale, Children Health Assessment Questionnaire, number of active joints, number of limited joints, and erythrocyte sedimentation rate. Patients were evaluated at the start of the study and after three months.

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Table 1 Patients characteristics, disease characteristics and disease activity variables; at start of study/after 3 months

Table 1A summarises the data for patients for whom the administration of etanercept was switched to a double dose once a week. The equality between the response variables at the start of the study and after 3 months indicates remission according to the criteria of Wallace et al.8 None of the patients had a flare during the 3‐month course of the study according to the definition of Brunner et al.9

Table 1B summarises the data for patients for whom etanercept was initiated at a double dose once a week. It is notable that there was a major improvement in all the response variables, except for the number of limited joints, which stayed the same. Lovell et al1 modified this variable in their study because it is not a quick response variable and therefore not a good marker for short‐term studies. The improvement in both patients met the definition of Giannini et al.10

There were no serious adverse events.

A limitation of this study is the open‐label design, but a double‐blind comparison of the two regimens would require a number of patients with JIA that is almost impossible to recruit.

In conclusion, our clinical study supports what has been reported in theory in the literature, namely that the once weekly double dose of etanercept is just as effective at retaining remission in patients with JIA. Considering the good outcome in the two patients in whom etanercept was initiated at the once weekly double dose, it can also induce remission of JIA.

Footnotes

Competing interests: None declared.

References

1. Lovell D J, Giannini E H, Reiff A, Cawkwell G D, Silverman E D, Nocton J J. et al Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group. N Engl J Med 2000. 342763–769.769 [PubMed]
2. Lovell D J, Reiff A, Jones O Y, Schneider R, Nocton J, Stein L D. et al Long‐term safety and efficacy of etanercept in children with polyarticular‐course juvenile rheumatoid arthritis. Arthritis Rheum 2006. 541987–1994.1994 [PubMed]
3. Horneff G, Schmeling H, Biedermann T, Foeldvari I, Ganser G, Girschick H J. et al The German etanercept registry for treatment of juvenile idiopathic arthritis. Ann Rheum Dis 2004. 631638–1644.1644 [PMC free article] [PubMed]
4. Keystone E C, Schiff M H, Kremer J M, Kafka S, Lovy M, DeVries T. et al Once‐weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis: results of a multicenter, randomized, double‐blind, placebo‐controlled trial. Arthritis Rheum 2004. 50353–363.363 [PubMed]
5. van der Heijde D, Da Silva J C, Dougados M, Geher P, van der Horst‐Bruinsma I, Juanola X. et al Etanercept 50 mg once weekly is as effective as 25 mg twice weekly in patients with ankylosing spondylitis. Ann Rheum Dis 2006. 651572–1577.1577 [PMC free article] [PubMed]
6. Yim D S, Zhou H, Buckwalter M, Nestorov I, Peck C C, Lee H. Population pharmacokinetic analysis and simulation of the time‐concentration profile of etanercept in pediatric patients with juvenile rheumatoid arthritis. J Clin Pharmacol 2005. 45246–256.256 [PubMed]
7. Wallace C A. Current management of juvenile idiopathic arthritis. Best Pract Res Clin Rheumatol 2006. 20279–300.300 [PubMed]
8. Wallace C A, Huang B, Bandeira M, Ravelli A, Giannini E H. Patterns of clinical remission in select categories of juvenile idiopathic arthritis. Arthritis Rheum 2005. 523554–3562.3562 [PubMed]
9. Brunner H I, Lovell D J, Finck B K, Giannini E H. Preliminary definition of disease flare in juvenile rheumatoid arthritis. J Rheumatol 2002. 291058–1064.1064 [PubMed]
10. Giannini E H, Ruperto N, Ravelli A, Lovell D J, Felson D T, Martini A. Preliminary definition of improvement in juvenile arthritis. Arthritis Rheum 1997. 401202–1209.1209 [PubMed]

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