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03-08-2006, 08:35 AM
Adalimumab (Humira) Efficacious Against Psoriatic Arthritis Skin Disease in Variety of Psoriasis Patients: Presented at AAD
By Bruce Sylvester SAN FRANCISCO, CA -- March 7, 2006 -- Adalimumab (Humira) is effective against psoriatic arthritis skin disease in patients with various levels of severity at the start of treatment, researchers reported here in a poster discussion session at the 64[th Annual Meeting of the American Academy of Dermatology (AAD).
Dafna Gladman, MD, Professor of Medicine, University of Toronto, Toronto, Canada, and colleagues conducted a study to determine whether there is any relationship between the degree of psoriasis at initiation of adalimumab treatment and the degree of patient response.
Their study was a sub-analysis of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), a multi-center, international, randomized, phase 3 study of patients who had failed non-steroidal anti-inflammatory drug therapy.
Study subjects all had with active psoriatic arthritis, defined as three or more swollen and three or more tender joints.
Subjects in ADEPT were stratified by methotrexate use and whether they had less than or more than 3% body surface area involvement. Subjects received adalimumab 40 mg or placebo every other week for 24 weeks.
Subjects who finished Week 24 were eligible to continue in an open-label extension.
Efficacy measures included: American College of Rheumatology (ACR) response criteria with a co-primary endpoint of ACR20 (20% response) at week 12; Psoriasis Area and Severity Index (PASI) in patients with 3% or more body surface area involvement; and Physician's Global Assessment (PGA) of psoriasis.
This post-hoc sub-analysis examined data according to severity of psoriasis at baseline in 151 patients treated with adalimumab and 162 patients in the placebo group.
Results show that ACR 20/50/70 responses at week 24 were 57, 39, and 23 subjects in the adalimumab group compared with 15, 6, 1 subjects in the placebo group.
Investigators evaluated PASI responses for 138 of 313 enrolled patients. Baseline data for this subset showed baseline PASI scores of 7.4 for adalimumab and 8.3 for placebo.
The researchers reported that PASI 50/75/90 responses at week 24 were 75, 59, and 42 subjects in the adalimumab group versus 12, 1, 0 subjects in the placebo group.
Of the 69 adalimumab subjects evaluated at baseline for PASI response, 53 had mild to moderate psoriasis, and 16 had moderate to severe psoriasis. Mean baseline PASI scores for patients with mild psoriasis versus patients with moderate to severe disease were 4.8 versus 16.1, respectively.
After 24 weeks, the percentage of subjects achieving PASI 50/75/90 responses were similar between the two groups: 74/62/43 for those with low PASI scores at baseline and 81/50/38 for those with high PASI scores. The percentages of patients with cleared or almost cleared psoriatic arthritis at 24 weeks were 75% for those with less than 3% body surface involvement and 38% for those with more than 3% body surface involvement.
Mean change in Dermatology Life Quality Index at 24 weeks for patients with PASI scores <10 was -4.7 and for patients with PASI >/=10 it was -10.6.
The authors concluded that, in this subanalysis, clinically significant improvements were observable for subjects with moderate to severe psoriasis at baseline as well as those who had entered the trial with mild to moderate disease.
"The responses were almost equal between those who had mild psoriasis and those with moderate to severe disease. It is effective treatment for both groups," said Dr. Gladman.
Adalimumab is a fully human anti-TNF monoclonal antibody, and it is approved for the treatment of rheumatoid arthritis and psoriatic arthritis.
The study was supported by Abbott Laboratories.
[Presentation title: Adalimumab Is Efficacious in Treating Skin Disease in Psoriatic Arthritis: Subanalysis of Moderate Versus Severe Psoriasis in the ADEPT Trial. Abstract P40]
By Bruce Sylvester SAN FRANCISCO, CA -- March 7, 2006 -- Adalimumab (Humira) is effective against psoriatic arthritis skin disease in patients with various levels of severity at the start of treatment, researchers reported here in a poster discussion session at the 64[th Annual Meeting of the American Academy of Dermatology (AAD).
Dafna Gladman, MD, Professor of Medicine, University of Toronto, Toronto, Canada, and colleagues conducted a study to determine whether there is any relationship between the degree of psoriasis at initiation of adalimumab treatment and the degree of patient response.
Their study was a sub-analysis of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), a multi-center, international, randomized, phase 3 study of patients who had failed non-steroidal anti-inflammatory drug therapy.
Study subjects all had with active psoriatic arthritis, defined as three or more swollen and three or more tender joints.
Subjects in ADEPT were stratified by methotrexate use and whether they had less than or more than 3% body surface area involvement. Subjects received adalimumab 40 mg or placebo every other week for 24 weeks.
Subjects who finished Week 24 were eligible to continue in an open-label extension.
Efficacy measures included: American College of Rheumatology (ACR) response criteria with a co-primary endpoint of ACR20 (20% response) at week 12; Psoriasis Area and Severity Index (PASI) in patients with 3% or more body surface area involvement; and Physician's Global Assessment (PGA) of psoriasis.
This post-hoc sub-analysis examined data according to severity of psoriasis at baseline in 151 patients treated with adalimumab and 162 patients in the placebo group.
Results show that ACR 20/50/70 responses at week 24 were 57, 39, and 23 subjects in the adalimumab group compared with 15, 6, 1 subjects in the placebo group.
Investigators evaluated PASI responses for 138 of 313 enrolled patients. Baseline data for this subset showed baseline PASI scores of 7.4 for adalimumab and 8.3 for placebo.
The researchers reported that PASI 50/75/90 responses at week 24 were 75, 59, and 42 subjects in the adalimumab group versus 12, 1, 0 subjects in the placebo group.
Of the 69 adalimumab subjects evaluated at baseline for PASI response, 53 had mild to moderate psoriasis, and 16 had moderate to severe psoriasis. Mean baseline PASI scores for patients with mild psoriasis versus patients with moderate to severe disease were 4.8 versus 16.1, respectively.
After 24 weeks, the percentage of subjects achieving PASI 50/75/90 responses were similar between the two groups: 74/62/43 for those with low PASI scores at baseline and 81/50/38 for those with high PASI scores. The percentages of patients with cleared or almost cleared psoriatic arthritis at 24 weeks were 75% for those with less than 3% body surface involvement and 38% for those with more than 3% body surface involvement.
Mean change in Dermatology Life Quality Index at 24 weeks for patients with PASI scores <10 was -4.7 and for patients with PASI >/=10 it was -10.6.
The authors concluded that, in this subanalysis, clinically significant improvements were observable for subjects with moderate to severe psoriasis at baseline as well as those who had entered the trial with mild to moderate disease.
"The responses were almost equal between those who had mild psoriasis and those with moderate to severe disease. It is effective treatment for both groups," said Dr. Gladman.
Adalimumab is a fully human anti-TNF monoclonal antibody, and it is approved for the treatment of rheumatoid arthritis and psoriatic arthritis.
The study was supported by Abbott Laboratories.
[Presentation title: Adalimumab Is Efficacious in Treating Skin Disease in Psoriatic Arthritis: Subanalysis of Moderate Versus Severe Psoriasis in the ADEPT Trial. Abstract P40]