"Adalimumab Reduces Functional Loss Associated With Psoriatic Arthritis: Presented at EADV"
By Jill Stein
RHODES, GREECE -- October 10, 2006 -- Treatment with the fully human, antitumour necrosis factor (anti-TNF) adalimumab is associated with a complete resolution of arthritis- or dermatologic-related functional loss in about a third of patients, according to results announced at the 15[th Congress of the European Academy of Dermatology and Venereology (EADV).
Dafna Gladman, MD, professor, division of medicine, University of Toronto, Toronto, Canada, reported findings on October 6th in 313 patients randomised to 24 weeks of treatment with adalimumab 40 mg or placebo given subcutaneously every other week.
"Psoriatic arthritis is associated with significant disability and functional loss related to both skin and joint components of the disease, and 11% to 15% of affected patients develop long-term disability," Dr. Gladman pointed out.
Participants were 18 years of age or older and had a diagnosis of psoriatic arthritis with moderately to severely active disease defined by the presence of at least 3 swollen and 3 tender/painful joints. All of them had had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs.
Subjects also had active cutaneous lesions of chronic plaque psoriasis or a documented history of chronic plaque psoriasis.
Prior to randomisation patients were stratified according to use of methotrexate and extent of psoriasis (< 3% or greater than or equal to 3% body surface area, BSA).
The disability index of the Health Assessment Questionnaire (HAQ, range, 0-3) and the Dermatology Life Quality Index (DLQI, range, 0-30, in patients with BSA > 3%) were used to measure changes in functional limitations. Lower scores for both measures denote less impairment.
Patients' baseline characteristics were similar between the 2 treatment groups and consistent with moderate to severely active psoriatic arthritis. Mean baseline HAQ and DLQI scores were also similar in the treatment groups.
About half of each group had a BSA of 3% or greater.
At weeks 12 and 24, significantly more patients in the adalimumab treatment group had no functional loss (HAQ DI = 0) compared with placebo-treated patients (34% and 14% for the 2 groups at 12 weeks, respectively, [P < .0001] and 34% and 13% for the 2 groups at 24 weeks, respectively, [P < .0001]).
In terms of dermatologic-related functional loss, 37% of adalimumab patients versus 5% of placebo patients demonstrated a DLQI of 0 at week 12 (P < .0001), and 45% versus 5%, respectively, at week 24 (P < .0001).
"The results show that from 30% to 40% of moderately to severely active psoriatic arthritis patients had a complete resolution of arthritis or dermatologic-related functional loss when treated with adalimumab every other week compared with only 5% with placebo," Dr. Gladman said. "Adalimumab 40 mg every other week reversed the debilitating disease effects of psoriatic arthritis on physical function early in therapy and provided sustained benefit with continued treatment."
Psoriatic arthritis is associated with significant disability and functional loss related to both skin and joint components of the disease. Between 11% and 15% of affected patients develop long-term disability.
The study, conducted at 50 sites in North America and Europe, was sponsored by Abbott Laboratories.
[Presentation title: Complete Resolution of Arthritis- and Dermatologic-Related Functional Loss With Adalimumab in Patients With Psoriatic Arthritis. Abstract P035.101]
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