Humira and concomitant standard antirheumatic therapy for the treatment of RA: results of STAR

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J Rheumatol. 2003 Dec; 30(12): 2563-71.

Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal

antibody, and concomitant standard antirheumatic therapy for the

treatment of rheumatoid arthritis: results of STAR (Safety Trial of

Adalimumab in Rheumatoid Arthritis).

Furst DE, Schiff MH, Fleischmann RM, Strand V, Birbara CA, Compagnone D,

Fischkoff SA, Chartash EK.

Division of Rheumatology, Department of Medicine, University of

California-Los Angeles, 32-59 Rehabilitation Center, 1000 Veteran

Avenue, Box 951670, Los Angeles, CA 90095-1670, USA.

defurst@...

OBJECTIVE: This study, known as STAR (Safety Trial of Adalimumab in

Rheumatoid Arthritis), evaluated the safety and efficacy of adalimumab

(Humira), a fully human monoclonal tumor necrosis factor-alpha (TNF-a)

antibody, when given with standard antirheumatic therapy in patients

with active rheumatoid arthritis (RA) not adequately responding to such

therapies. Standard antirheumatic therapy included traditional disease

modifying antirheumatic drugs (DMARD), low dose corticosteroids,

nonsteroidal antiinflammatory drugs (NSAID), and/or analgesics. METHODS:

In this 24-week, double-blind, placebo-controlled study, 636 patients

with RA were randomly assigned to receive adalimumab 40 mg

subcutaneously (sc) every other week (n = 318) or placebo (n = 318)

while continuing standard antirheumatic therapy. The frequencies of

adverse events, serious adverse events, severe or life-threatening

adverse events, adverse events leading to withdrawal, infection, or

serious infection were the primary endpoints. Secondary endpoints were

determined by American College of Rheumatology (ACR) response criteria.

RESULTS: During the study, the majority of patients received concomitant

traditional DMARD (83.5%) and/or corticosteroids, NSAID, and/or

analgesics (97.3%). Overall, 56.0% of patients continued treatment with

one, 23.6% with 2, and 3.9% with > or = 3 traditional DMARD. At 24

weeks, there were no statistically significant differences between the

adalimumab and placebo groups in their respective rates of adverse

events (86.5% vs 82.7%), serious adverse events (5.3% vs 6.9%), severe

or life-threatening adverse events (11.9% vs 15.4%), or those leading to

withdrawal (2.8% vs 2.2%). There were also no statistically significant

differences in the rates of infections (52.2% vs 49.4%) or serious

infections (1.3% vs 1.9%) between the groups. The incidence and types of

adverse events did not vary between adalimumab- and placebo-treated

patients by the number of concomitant traditional DMARD (0, 1, or 2).

Adalimumab-treated patients compared with placebo-treated patients

achieved statistically superior ACR20 (52.8% vs 34.9%), ACR50 (28.9% vs

11.3%), and ACR70 (14.8% vs 3.5%) response rates at Week 24 (p < or =

0.001).

CONCLUSION: This study demonstrated that addition of adalimumab 40 mg

given sc every other week to concomitant standard antirheumatic therapy

is well tolerated and provides significant improvements in signs and

symptoms of RA. The data indicate that adalimumab is a safe and

effective therapeutic option in patients with active RA who have an

inadequate response to standard antirheumatic therapy, including one or

more traditional DMARD, corticosteroids, NSAID, and analgesics.

PMID: 14719195

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