Safety, effectiveness, and pharmacokinetics of adalimumab in children with polyarticular juvenile idiopathic arthritis aged 2 to 4 years

Clinical Rheumatology

Volumn 33, Issue 10, 2014, Pages 1433-1441

  Kingsbury, Daniel J ^a   Bader Meunier, Brigitte ^b   Patel, Gina ^c   Arora, Vipin ^c   Kalabic, Jasmina ^c   Kupper, Hartmut ^c  

^a Randall Children's Hospital   (United States)

^b HÔPITAL NECKER ENFANTS MALADES   (France)

^c ABBVIE INC   (United States)

Author keywords

Adalimumab; Polyarticular juvenile idiopathic arthritis; Safety

Indexed keywords

ADALIMUMAB; ANTIRHEUMATIC AGENT; BIOLOGICAL MARKER; C REACTIVE PROTEIN; METHOTREXATE; MONOCLONAL ANTIBODY;

ARTHRITIS, JUVENILE; BLOOD; CLINICAL TRIAL; DOSE RESPONSE; DRUG COMBINATION; EUROPE; FEMALE; HUMAN; INTERNATIONAL COOPERATION; MALE; METABOLISM; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PRESCHOOL CHILD; TREATMENT OUTCOME; UNITED STATES;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, JUVENILE; BIOLOGICAL MARKERS; C-REACTIVE PROTEIN; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; EUROPE; FEMALE; HUMANS; INTERNATIONAL COOPERATION; MALE; METHOTREXATE; TREATMENT OUTCOME; UNITED STATES;

EID: 84893206114     PISSN: 07703198     EISSN: 14349949     Source Type: Journal    
DOI: 10.1007/s10067-014-2498-1     Document Type: Article

References (22)

1. Ravelli A, Martini A (2007) Juvenile idiopathic arthritis. Lancet 369:767–778
2. Cassidy JT, Petty RE (2001) Textbook of pediatric rheumatology, 4th edn. WB Saunders Company, Philadelphia
3. Petty RE, Southwood TR, Manners P, Baum J, Glass DN, Goldenberg J et al (2004) International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol 31:390–392
4. Humira [Prescribing Information, Japan]. Abbott Japan Co., Ltd. Mita, Minato-Ku, Tokyo. (Accessed 07 February 2013, at http://www.info.pmda.go.jp/go/pack/3999426G1024_1_15/)
5. Humira [Prescribing Information]. AbbVie Inc. 2012. (Accessed 07 February 2013, at http://www.rxabbvie.com/pdf/humira.pdf)
6. Humira [Summary of product characteristics]. Abbott Biotechnology Deutschland GmbH. (Accessed 12 November 2013, at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf)
7. Lovell DJ, Ruperto N, Goodman S, Reiff A, Jung L, Jarosova K et al (2008) Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med 359:810–820
8. Lovell DJ, Ruperto N, Reiff A, Jung LK, Higgins G, Kóne-Paut I et al (2011) Long-term efficacy and safety of adalimumab for up to 6 years in patients with juvenile idiopathic arthritis. Arthritis Rheum 63(Suppl 10):265
9. Imagawa T, Takei S, Umebayashi H, Yamaguchi K, Itoh Y, Kawai T et al (2012) Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan. Clin Rheumatol 31:1713–1721
10. Bracaglia C, Buonuomo PS, Tozzi AE, Pardeo M, Nicolai R, Campana A et al (2012) Safety and efficacy of etanercept in a cohort of patients with juvenile idiopathic arthritis under 4 years of age. J Rheumatol 39:1287–1290
11. Tzaribachev N, Kuemmerle-Deschner J, Eichner M, Horneff G (2008) Safety and efficacy of etanercept in children with juvenile idiopathic arthritis below the age of 4 years. Rheumatol Int 28:1031–1034
12. Richez C, Blanco P, Gin H, Schaeverbeke T (2006) Development of type 1 diabetes mellitus in a patient with rheumatoid arthritis receiving anti-tumor necrosis factor alpha. Clin Exp Rheumatol 24:607
13. Boulton JG, Bourne JT (2007) Unstable diabetes in a patient receiving anti-TNF-alpha for rheumatoid arthritis. Rheumatology (Oxford) 46:178–179
14. Tack CJ, Kleijwegt FS, Van Riel PL, Roep BO (2009) Development of type 1 diabetes in a patient treated with anti-TNF-alpha therapy for active rheumatoid arthritis. Diabetologia 52:1442–1444
15. Pohjankoski H, Kautianinen H, Korppi M, Savolainen A (2012) Simultaneous juvenile idiopathic arthritis and diabetes mellitus type 1—a Finnish nationwide study. J Rheumatol 39(2):377–381
16. Prahalad S, O’brien E, Fraser AM, Kerber RA, Mineau GP, Pratt D, Donaldson D, Barnshad MJ, Bohnsack J (2004) Familial aggregation of juvenile idiopathic arthritis. Arthritis Rheum 50(12):4022–4027
17. Schiff MH, Burmester GR, Kent JD, Pangan AL, Kupper H, Fitzpatrick SB et al (2006) Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. Ann Rheum Dis 65:889–894
18. Mushtaq T, Ahmed SF (2002) The impact of corticosteroids on growth and bone health. Arch Dis Child 87(2):93–96
19. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R et al (2006) The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum 54:26–37
20. Kavanaugh A, Fleischmann RM, Emery P, Kupper H, Redden L, Guérette B, et al (2012) Clinical, functional and radiographic consequences of achieving stable low disease activity and remission with adalimumab plus methotrexate or methotrexate alone in early rheumatoid arthritis: 26-week results from the randomised, controlled OPTIMA study. Ann Rheum Dis Published Online First: 19 May. doi:10.1136/annrheumdis-2011-201247
21. Kobayashi S, Harigai M, Mozaffarian N, Pangan AL, Sharma S, Brown LS et al (2012) A multicenter, open-label, efficacy, pharmacokinetic, and safety study of adalimumab in Japanese patients with ankylosing spondylitis. Mod Rheumatol 22:589–597
22. van der Bijl AE, Breedveld FC, Antoni CE, Kalden JR, Kary S, Burmester GR et al (2008) An open-label pilot study of the effectiveness of adalimumab in patients with rheumatoid arthritis and previous infliximab treatment: relationship to reasons for failure and anti-infliximab antibody status. Clin Rheumatol 27:1021–1028