Adalimumab with or without methotrexate in juvenile rheumatoid arthritis

被引：423

作者：

Lovell, Daniel J. ^{[1
]}

Ruperto, Nicolino ^{[2
]}

Goodman, Steven ^{[3
]}

Reiff, Andreas ^{[4
]}

Jung, Lawrence ^{[5
,6
]}

Jarosova, Katerina ^{[7
]}

Nemcova, Dana ^{[8
,9
]}

Mouy, Richard ^{[10
]}

Sandborg, Christy ^{[11
]}

Bohnsack, John ^{[12
]}

Elewaut, Dirk ^{[13
]}

Foeldvari, Ivan ^{[14
]}

Gerloni, Valeria ^{[15
]}

Rovensky, Jozef ^{[16
]}

Minden, Kirsten ^{[17
]}

Vehe, Richard K. ^{[18
]}

Weiner, L. Wagner ^{[19
]}

Horneff, Gerd ^{[20
]}

Huppertz, Hans-Iko ^{[21
]}

Olson, Nancy Y. ^{[22
]}

Medich, John R. ^{[23
]}

Carcereri-De-Prati, Roberto ^{[24
]}

McIlraith, Melissa J. ^{[24
]}

Giannini, Edward H. ^{[1
]}

Martini, Alberto ^{[2
]}

机构：

[1] Childrens Hosp, Med Ctr, Div Rheumatol, Cincinnati, OH 45229 USA

[2] Pediat Rheumatol Int Trials Org, Ist Ricovero & Cura Carattere Sci G Gaslini, Genoa, Italy

[3] Arthrit Associates S Florida, Delray Beach, FL USA

[4] Childrens Hosp, Los Angeles, CA 90027 USA

[5] Creighton Univ, Med Ctr, Omaha, NE USA

[6] Childrens Hosp, Omaha, NE USA

[7] Revmatol Ustav, Prague, Czech Republic

[8] First Fac Med, Prague, Czech Republic

[9] Gen Fac Hosp, Prague, Czech Republic

[10] Hop Necker Enfants Malad, Paris, France

[11] Stanford Univ, Med Ctr, Stanford, CA 94305 USA

[12] Univ Utah, Hlth Sci Ctr, Salt Lake City, UT USA

[13] Ghent Univ Hosp, B-9000 Ghent, Belgium

[14] Hamburger Zentrum Kinder & Jugendrheumatol, Hamburg, Germany

[15] Ist Gaetano Pini, Milan, Italy

[16] Natl Inst Rheumat Dis, Piestany, Slovakia

[17] Charite, Berlin, Germany

[18] Univ Minnesota, Minneapolis, MN USA

[19] Univ Chicago, Larabida Hosp, Chicago, IL 60637 USA

[20] Zentrum Allgemeine Padiatrie & Neonatol, St Augustin, Germany

[21] Klinikum Bremen Mitte, Bremen, Germany

[22] Univ Kansas, Med Ctr, Kansas City, KS 66103 USA

[23] Abbott Labs, Parsippany, NJ USA

[24] Abbott Labs, Ludwigshafen, Germany

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2008年 / 359卷 / 08期

关键词：

D O I：

10.1056/NEJMoa0706290

中图分类号：

R5 [内科学];

学科分类号：

1002 [临床医学]; 100201 [内科学];

摘要：

Background: Tumor necrosis factor (TNF) has a pathogenic role in juvenile rheumatoid arthritis. We evaluated the efficacy and safety of adalimumab, a fully human monoclonal anti-TNF antibody, in children with polyarticular-course juvenile rheumatoid arthritis. Methods: Patients 4 to 17 years of age with active juvenile rheumatoid arthritis who had previously received treatment with nonsteroidal antiinflammatory drugs underwent stratification according to methotrexate use and received 24 mg of adalimumab per square meter of body-surface area (maximum dose, 40 mg) subcutaneously every other week for 16 weeks. We randomly assigned patients with an American College of Rheumatology Pediatric 30% (ACR Pedi 30) response at week 16 to receive adalimumab or placebo in a double-blind fashion every other week for up to 32 weeks. Results: Seventy-four percent of patients not receiving methotrexate (64 of 86) and 94% of those receiving methotrexate (80 of 85) had an ACR Pedi 30 response at week 16 and were eligible for double-blind treatment. Among patients not receiving methotrexate, disease flares (the primary outcome) occurred in 43% of those receiving adalimumab and 71% of those receiving placebo (P=0.03). Among patients receiving methotrexate, flares occurred in 37% of those receiving adalimumab and 65% of those receiving placebo (P=0.02). At 48 weeks, the percentages of patients treated with methotrexate who had ACR Pedi 30, 50, 70, or 90 responses were significantly greater for those receiving adalimumab than for those receiving placebo; the differences between patients not treated with methotrexate who received adalimumab and those who received placebo were not significant. Response rates were sustained after 104 weeks of treatment. Serious adverse events possibly related to adalimumab occurred in 14 patients. Conclusions: Adalimumab therapy seems to be an efficacious option for the treatment of children with juvenile rheumatoid arthritis. (ClinicalTrials.gov number, NCT00048542.). .

引用

页码：810 / 820

页数：11

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