Easing trepidation about biologics

Sep 01, 2004, 4:00am

Efficacy, safety encourage use for psoriasis

Albany, N.Y. - Just a year ago, a great deal of trepidation and concern revolved around the use of biologics for the treatment of psoriasis and psoriatic arthritis, but this apprehension has now been eased as dermatologists re-educate themselves about the benefits offered by these drugs, according to David E. Cohen, M.D., M.P.H.

Speaking at the Annual Dermatology Teaching Day, Dr. Cohen addressed the efficacy and safety of what are being touted as "new" biologic drugs used for the treatment of psoriasis and psoriatic arthritis - a line of treatment he feels should be integrated into the primary protocols against these particular conditions due to the promise it holds.

"These biologics add to the current armamentarium of psoriasis treatment, particularly for moderate to severe psoriasis, or psoriasis that affects body parts that impact on the ability to participate in routine daily living and work," says Dr. Cohen, assistant professor, department of dermatology, NYU School of Medicine, New York. "Biologics certainly offer advantages over existing medications because many times their safety profile is better than such drugs as cyclosporine and methotrexate, and (they) are more convenient than ultraviolet light."

Biologics that are approved or are in late-stage development for treating moderate to severe psoriasis and psoriatic arthritis include alefacept (Amevive, Biogen), etanercept (Enbrel, Amgen/Wyeth), adalimumab (Humira, Abbott), efalizumab (Raptiva, Genentech) and infliximab (Remicade, Centocor). The U.S. Food and Drug Administration approved Enbrel for the treatment of moderate to severe plaque psoriasis on April 30.

Dr. Cohen says recommended therapy protocol of Enbrel for psoriasis is 50 mg (two injections) twice a week for three months. After three months, it is recommended to lower the dosage to 25 mg, (one injection) twice a week.

"If a patient is in the minority of not responding well to Enbrel, then I would consider adding Soriatane (Connetics) or UV light, then cyclosporine or methotrexate," says Dr. Cohen. "I feel comfortable adding on to Enbrel to improve its efficacy when necessary."

Looking aheadAlthough Enbrel's results are attracting a dermatologic following in the fight against psoriasis and psoriatic arthritis, other biologics also are gaining attention. Both Humira and Remicade, typically used to treat arthritis, are showing promise, but the final verdict on their safety is still pending, Dr. Cohen says.

"Research regarding Humira and Remicade for psoriasis looks fairly good; we just don't have the formal phase 3 data or the safety data yet," says Dr. Cohen. "As with any new class of drugs, it's important to have long-term safety monitoring. These are the things that are going to be helpful to the dermatologist down the line."

While apprehensions about biologics may be subsiding, some doctors tend to undertreat psoriasis and psoriatic arthritis, contends Dr. Cohen.

"The use of biologics doesn't have to turn their treatment paradigms upside down," he says. "Often, the use of these drugs is easier than traditional treatments, and their safety and efficacy prove their usefulness."