Adalimumab (Humira) Approved for Psoriatic Arthritis and Early RA

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Adalimumab (Humira) Approved for Psoriatic Arthritis and Early RA

http://www.medscape.com/viewarticle/514181?src=nldne

On Oct. 3, the FDA approved a new indication and expanded the rheumatoid

arthritis (RA) indication for adalimumab subcutaneous injection (Humira,

made by Abbott Laboratories, Inc.), allowing its use in the treatment of

psoriatic arthritis, and as first-line treatment for severe, active, and

progressive RA in methotrexate (MTX)-naive adults.

Approval of the psoriatic arthritis indication was based on the results of

two clinical studies, including the phase 3 placebo-controlled Adalimumab

Effectiveness in Psoriatic Arthritis Trial (ADEPT) in 313 patients.

Data from the ADEPT trial showed that nearly 60% of adalimumab-treated

patients achieved a 20% improvement in arthritis signs and symptoms

(American College of Rheumatology [ACR] 20) at week 12. The response was

sustained through week 24, at which point nearly 25% of patients

demonstrated a 70% improvement in ACR score (ACR 70).

Adalimumab-treated patients also demonstrated significantly less bone

erosion and joint-space narrowing at week 24 compared with placebo (increase

in modified Total Sharp Score [mTSS] > 0.5 units: 9% vs 28.9%). Inhibition

of disease progression was maintained through week 48 in patients continuing

treatment during an open-label extension period.

In addition, 42% of adalimumab-treated patients with more than 3% body

surface involvement at baseline demonstrated a 90% improvement in Psoriasis

Area and Severity Index score at 24 weeks compared with none of those

receiving placebo.

Approval of adalimumab as first-line therapy for RA was based on results

from the PREMIER/early RA trial, showing that treatment with adalimumab plus

MTX successfully inhibited radiographic progression in patients with

recently diagnosed RA of fewer than three years' duration.

In the trial, addition of adalimumab to MTX therapy yielded significant

decreases in mTSS from baseline and nearly doubled remission rates at one an

d two years compared with use of MTX alone (mean, 1.3 vs 5.7 and 1.9 vs

10.4, respectively; Disease Activity Score < 2.6: 43% vs 21% and 49% vs 25%,

respectively).

Moreover, approximately twice as many patients receiving combination therapy

demonstrated no radiographic progression at two years compared with placebo

(mTSS change from baseline < .05 units, 61% vs 34%).

Data also showed that 62% of patients receiving adalimumab achieved ACR 50

at one year compared with 46% of those treated with MTX alone.

The indications were approved by the European Commission (EC) in August

2005.

Adalimumab was previously approved by the EC and FDA for reducing signs and

symptoms of RA, inhibiting the progression of structural damage, and

improving physical function in adults with active, moderate to severe RA who

have had inadequate response to disease-modifying antirheumatic drugs,

including MTX.