Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed

被引:482
作者
van de Putte, BA
Atkins, C
Malaise, M
Sany, J
Russell, AS
van Riel, PLCM
Settas, L
Biljsma, JW
Todesco, S
Dougados, M
Nash, P
Emery, P
Walter, N
Kaul, M
Fischkoff, S
Kupper, H
机构
[1] Univ Nijmegen, Nijmegen, Netherlands
[2] Serv Rhumatol, Liege, Belgium
[3] Hop Lapeyronie, Montpellier, France
[4] Univ Alberta Hosp, Edmonton, AB T6G 2B7, Canada
[5] AHEPA Hosp, Thessaloniki, Greece
[6] UMC Utrecht, Utrecht, Netherlands
[7] Univ Padua, Cattedra Reumatol, Padua, Italy
[8] Univ Padua, Div Reumatol, Padua, Italy
[9] Hop Cochin, Serv Rhumatol, F-75674 Paris, France
[10] Sixth Ave Specialist Ctr, Maroochydore, Australia
[11] Univ Leeds, Leeds, W Yorkshire, England
[12] Abbott GmbH & Co KG, Ludwigshafen, Germany
[13] Abbott Labs, Parsippany, NJ USA
关键词
D O I
10.1136/ard.2003.013052
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective: To evaluate the efficacy and safety of monotherapy with adalimumab in patients with RA for whom previous DMARD treatment has failed. Methods: In a 26 week, double blind, placebo controlled, phase III trial, 544 patients with RA were randomised to monotherapy with adalimumab 20 mg every other week, 20 mg weekly, 40 mg every other week, 40 mg weekly, or placebo. The primary efficacy end point was greater than or equal to 20% improvement in the ACR core criteria (ACR20 response). Secondary efficacy end points included ACR50, ACR70, EULAR responses, and the Disability Index of the Health Assessment Questionnaire (HAQ DI). Results: After 26 weeks, patients treated with adalimumab 20 mg every other week, 20 mg weekly, 40 mg every other week, and 40 mg weekly had significantly better response rates than those treated with placebo: ACR20 (35.8%, 39.3%, 46.0%, 53.4%, respectively v 19.1%; pless than or equal to 0.01); ACR50 (18.9%, 20.5%, 22.1%, 35.0% v 8.2%; pless than or equal to 0.05); ACR70 (8.5%, 9.8%, 12.4%, 18.4% v 1.8%; pless than or equal to 0.05). Moderate EULAR response rates were significantly greater with adalimumab than with placebo (41.5%, 48.2%, 55.8%, 63.1% v 26.4%; pless than or equal to 0.05). Patients treated with adalimumab achieved better improvements in mean HAQ DI than those receiving placebo (-0.29, -0.39, -0.38, -0.49 v -0.07; pless than or equal to 0.01). No significant differences were found between adalimumab and placebo treated patients for serious adverse events, serious infections, or malignancies. Injection site reaction occurred in 10.6% and 0.9% of adalimumab and placebo treated patients, respectively (pless than or equal to 0.05). Conclusion: Among patients with RA for whom previous DMARD treatment had failed, adalimumab monotherapy achieved significant, rapid, and sustained improvements in disease activity and improved physical function and was safe and well tolerated.
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页码:508 / 516
页数:9
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