Psoriasis research at center of AAD conference
Biologics studies show improvement for moderate to severe psoriasis
Research on psoriasis and its treatments continues to gather steam. The American Academy of Dermatology's (AAD) 62nd Annual Meeting in Washington, D.C., had several presentations, including a psoriasis symposium led by the National Psoriasis Foundation, that focused exclusively on breaking research in psoriasis treatments.
The following are highlights of the research presented at the February 2004 conference on biologics that are in the pre-approval stages for psoriasis.
Humira study shows promise for psoriasis
New phase II data showed that patients with moderate to severe plaque psoriasis who received Humira for 12 weeks achieved significant results. Humira, an anti-tumor necrosis factor biologic treatment, is given by subcutaneous injection (under the skin).
In clinical trials, patients were given either placebo or an initial 80 mg the first week, and then were split into two groups, one receiving 40 mg weekly and the other 40 mg every other week. By week 12, of those taking the drug weekly, 80 percent achieved 75 percent improvement in psoriasis severity score and 76 percent were "clear" or "almost clear." More than half the patients taking 40 mg every other week achieved 75 percent improvement in their psoriasis score and nearly half were "clear" or "almost clear."
The most common side effects were injection site reactions, upper respiratory infection, injection site pain, headache, rash and sinusitis.
Commented Dr. Jeffrey Weinberg, "people are very excited about the potential efficacy and safety of this drug for psoriasis," after preliminary results were announced at the AAD. Humira, manufactured by Abbott Laboratories, is approved for rheumatoid arthritis.
"Loading dose" of Enbrel found to be effective
Psoriasis patients may be able to speed their clearing time at a higher dose and then maintain it at a lower dose, according to research presented on Enbrel. The biologic medication is approved for treatment of psoriatic arthritis, and adult and juvenile rheumatoid arthritis.
In the phase III trial for psoriasis treatment, 583 patients with moderate to severe psoriasis received placebo, 25 mg twice weekly or 50 mg twice weekly for 12 weeks. Patients then continued treatment for an additional 12 weeks, but those who were given 50 mg initially were "stepped down" to 25 mg twice weekly.
During the first twelve weeks, 34 percent of those given 25 mg throughout the study achieved 75 percent improvement in their score. Of those given the 50 mg loading dose, 49 percent achieved 75 percent improvement in their psoriasis score, and 77 percent maintained this response with the lower dose through week 24. In a session on biologic drugs for psoriasis, Mark Ling, M.D., Ph.D., medical director of Medaphase, Inc., said "This study suggests that we may be able to achieve the higher response rate of the 50 mg dose, then drop to the lower 25 mg dose for maintenance, while maintaining the improved response of the higher dose."
Side effects were similar to those reported in other Enbrel clinical trials, with injection site reactions being the most common. Enbrel is manufactured by Amgen Wyeth.
Remicade study shows quality of life improvement
A phase II trial of 249 patients found that Remicade significantly improved their quality of life. In this phase II trial of 249 patients, patients were divided into three groups: those who received 5 mg/kg, 3 mg/kg or placebo. Quality of life was evaluated for 30 weeks using the Dermatology Life Quality Index (DLQI). The index rates symptoms and feelings, daily activities, leisure, work and school, personal relationships, and annoyance with psoriasis treatment.
The median change in DLQI was 84 percent for patients on the 3 mg/kg and 91 percent for those given 5 mg/kg. At week 10, 40 percent of patients given 5 mg/kg scored 0. In a presentation about biologics used in psoriasis, Ken Gordon, M.D., from Loyola University Medical Center in Chicago, interpreted this finding to mean that patients report that disease had no effect after treatment. "People who use topicals or phototherapy rarely report these results compared to biologics," he said.
Remicade, manufactured by Centocor, is approved for Crohn's disease and rheumatoid arthritis, and is in ongoing clinical trials for the treatment of psoriasis and psoriatic arthritis.
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