Humira as monotherapy in patients with RA for whom previous DMARD treatment has failed

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Ann Rheum Dis. 2004 May;63(5):508-16.

Efficacy and safety of adalimumab as monotherapy in patients with

rheumatoid arthritis for whom previous disease modifying antirheumatic

drug treatment has failed.

Van De Putte LB, Atkins C, Malaise M, Sany J, AS, Van Riel PL,

Settas L, Bijlsma JW, Todesco S, Dougados M, Nash P, Emery P, Walter N,

Kaul M, Fischkoff S, Kupper H.

University Medical Centre Nijmegen, Department of Rheumatology, PO Box

9101, 6500 HB Nijmegen, The Netherlands.

annrheumdis.edoff@...

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 >/=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%; p</=0.01);

ACR50 (18.9%, 20.5%, 22.1%, 35.0% v 8.2%; p</=0.05); ACR70 (8.5%, 9.8%,

12.4%, 18.4% v 1.8%; p</=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%; p</=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; p</=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 (p</=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.

PMID: 15082480

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