Early Results Suggest Alefacept Plus Light Therapy May Clear Psoriasis
CAMBRIDGE, Mass., Nov. 22 /PRNewswire-FirstCall/ --
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.
(Photo: newscom.com )
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.
About Psoriasis
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.
About Biogen
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(R) (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
biogen.com. |
