Research on Etanercept

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Etanercept for DMARD-failure RA patients

Paper: Etanercept therapy in rheumatoid arthritis: a randomized,

controlled trial

Authors: Moreland LW, Schiff MH, Baumgartner SW, et

al.

Ref: Ann Intern Med 1999;130:478-486.

Type: Clinical Study

Summary: Etanercept (recombinant human tumor

necrosis

factor receptor p75:Fc fusion protein)

represents a novel

approach to the management of patients with

severe, active

rheumatoid arthritis (RA) who have not

responded to prior

therapy with DMARDs. This study demonstrated

that

twice-weekly injections of the drug for 6

months resulted in

clinical improvement, and that the therapy was

generally well

tolerated.

This double-blind, placebo-controlled study

enrolled 234

patients with active RA who had not responded

to DMARDs

such as azathioprine, methotrexate, and

penicillamine.

Following a 1-month washout period, patients

were treated

with either placebo, 10 mg or 25 mg of

etanercept

subcutaneously twice weekly for 26 weeks. The

patients

were primarily women with a mean disease

duration of 12

years.

Etanercept significantly reduced disease

activity in a

dose-related manner. At 3 months, 62% of those

receiving

the 25-mg dose and 23% of those receiving

placebo achieved

a 20% American College of Rheumatology (ACR)

response

(p<0.001). After 6 months, 59% of those

receiving 25 mg of

etanercept, 51% receiving the 10-mg dose, and

11 % of

placebo-treated patients achieved this

response level

(p<0.001). When a 50% ACR response was

evaluated, the

response was achieved by 40% of 25 mg

etanercept-treated

patients, 24% of the 10-mg treated patients,

and 5% of

placebo-treated patients (p<0.01). The mean

number of

tender and swollen joints and quality of life

showed greater

improvements in the etanercept groups. Mild

injection site

reactions were the most common events, being

noted by

almost half of the patients treated with the

drug; most

required no intervention and resolved

spontaneously. No

significant laboratory abnormalities were

observed during the

study.

These findings indicate that etanercept is

effective and

generally well tolerated by patients who have

failed therapy

with DMARDs, especially when used at a dose of

25 mg

twice weekly.