Biogen, Inc. (NASDAQ/BGEN) announced that 76 percent of 21 patients with psoriasis achieved “clear” or “almost clear” results based on preliminary data from an open-label study combining alefacept and narrow band ultraviolet B light (NB UVB). The results were presented today at the Psoriasis: From Gene to Clinic International Congress in London, England.
The lead investigator in the study, Dr. Jean-Paul Ortonne, Chairman of the Department of Dermatology at the University Hospital of Nice-Sophia Antipolis, Nice, France, said, “In real-world settings, physicians may combine biologics with other therapies. We are pleased to see that in this preliminary study, alefacept plus narrow band UVB provided encouraging results.”
All 21 patients in the arms of the study receiving combination therapy achieved a 75 percent reduction in baseline PASI (Psoriasis Area and Severity Index), a standard measure of psoriasis severity. The open-label study randomized 30 men and women with chronic plaque psoriasis into three treatment groups: alefacept alone, alefacept plus 6 weeks of NB UVB and alefacept plus 12 weeks of NB UVB. Two weeks after the last dose of alefacept, patients´ psoriasis was evaluated using PASI and PGA (Physician Global Assessment) measurement scales. The objectives of the study were to determine the safety and tolerability of combination therapy, the efficacy of combination therapy and the total amount of light therapy needed to achieve a 50 percent PASI improvement.
The current FDA-recommended efficacy endpoint for psoriasis medications is PASI 75 reduction, which means that patients must achieve at least a 75 percent reduction in their disease area and severity. All of the patients treated with alefacept plus NB UVB achieved a 75 percent reduction in their PASI score over the course of the study. After three weeks of combination therapy consisting of alefacept plus NB UVB, 71 percent (15 of 21 patients) experienced 50 percent reduction in PASI and, after four weeks, 57 percent (12 of 21 patients) experienced 75 percent reduction in PASI score.
The most common adverse events in the study were rash in the alefacept plus NB UVB groups (6 of 21 patients) and pruritis in the alefacept monotherapy group (4 of 9 patients). With the exception of accidental injury in two patients, no other adverse events were experienced by more than one patient. Similar decreases in CD4 counts were reported in all three study groups.
In this study there were no infections reported among the 19 patients receiving alefacept alone or with six weeks of NB UVB. In 11 patients receiving alefacept plus 12 weeks of NB UVB, four infections were reported, with one case each of periodontal abscess, acne and bronchitis and one case of general infection (e.g., the common cold). There were no opportunistic infections reported in the 30 patients.
In regards to NB UVB dosing, six weeks was as effective as 12 weeks of treatment, with the majority of patients in both groups achieving “clear” or “almost clear” results.
In the study, alefacept was administered in 12 weekly 15 mg intramuscular injections and NB UVB light treatment was provided in an upright Waldman 7001 K irradiation cabinet.
Psoriasis is an autoimmune disease characterized by rapid skin growth. In psoriasis, skin cells grow ten times faster than the normal rate and the excess cells pile up on the surface of the skin, forming red, raised scaly plaques that are often itchy and painful. The disease affects about 4.5 million U.S. adults and 80 million people worldwide. Approximately one-third suffer from moderate-to-severe disease with psoriasis covering more than three percent of their body.
Psoriasis in not contagious, but many people with the disease hide their skin because of shame and embarrassment. A survey conducted by the National Psoriasis Foundation found that one-third of people with moderate-to-severe disease say their psoriasis is a very large problem in their life, with 40 percent reporting that it affects their clothing choices and 26 percent reporting that they alter or stop their normal daily activities because of their disease.
Biogen, Inc., winner of the U.S. National Medal of Technology, is a biotechnology company principally engaged in discovering and developing drugs for human healthcare through genetic engineering. Headquartered in Cambridge, MA, the Company´s revenues are generated from U.S. and European sales of AVONEX® (Interferon beta-1a) for treatment of relapsing forms of multiple sclerosis, and from the worldwide sales by licensees of a number of products, including alpha interferon and hepatitis B vaccines and diagnostic products. Biogen´s research and development activities are focused on novel products to treat inflammatory and autoimmune disease, neurological diseases, cancer, fibrosis and congestive heart failure. The Company maintains active clinical research programs in protein therapeutics, small molecules, genomics and gene therapy. For copies of press releases and additional information about the Company, please consult Biogen´s homepage on the World Wide Web at http://www.biogen.com.
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