FDA Approvals: Humira and Angeliq

Yael Waknine

October 06, 2005

Oct. 6, 2005 — The U.S. Food and Drug Administration (FDA) has approved adalimumab subcutaneous injection for the treatment of psoriatic arthritis and as first-line therapy for severe, active, and progressive rheumatoid arthritis in methotrexate-naive adults; drospirenone plus estradiol 0.5- and 1.0-mg tablets has been approved for the treatment of moderate to severe vasomotor symptoms and vulvar/vaginal atrophy associated with menopause.


Adalimumab (Humira) Approved for Psoriatic Arthritis and Early RA

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 and 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.


Drospirenone plus Estradiol (Angeliq) for Postmenopausal Symptoms

On Sept. 28, the FDA approved drospirenone plus estradiol 0.5- and 1.0-mg tablets (Angeliq, made by Berlex Inc., a subsidiary of Schering AG) for the treatment of moderate to severe vasomotor symptoms and vulvar/vaginal atrophy associated with menopause in women with an intact uterus.

In contrast with other hormone therapies, the product includes drospirenone (a spironolactone analog) to provide anti-aldosterone activity that counters excess water and sodium retention caused by estrogen.

The approval was based on the results of clinical trials in 1,759 women, showing the drug to be safe and effective in providing endometrial protection. Its effects on vasomotor symptoms (eg, hot flashes, night sweats) and vulvar and vaginal atrophy were generally observed within four weeks of treatment.

The most commonly observed adverse events were mild and transitory in nature, including vaginal bleeding, breast pain, and headaches.

Because drospirenone may increase potassium levels, it should not be used in women with liver, kidney, or adrenal disease. Patients receiving concurrent therapy that can affect electrolytes, such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or nonsteroidal anti-inflammatory drugs, should have serum potassium levels regularly monitored during the first treatment cycle.

Reviewed by Gary D. Vogin, MD

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