Preliminary Data From Two Clinical Trials Demonstrate Abbott Laboratories' HUMIRA(R) (Adalimumab) Improved Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis
Monday June 14, 8:02 am ET
BERLIN, June 14 /PRNewswire-FirstCall/ -- Preliminary data from two studies showing encouraging results in treating psoriatic arthritis and ankylosing spondylitis with HUMIRA® (adalimumab) 40 mg every other week were presented today at the European League Against Rheumatism (EULAR) annual congress in Berlin. Patients with psoriatic arthritis responded to HUMIRA treatment as early as two weeks after the initial dose showing significant improvement in both the signs and symptoms of the joint disease and skin manifestations with continued improvements at 12 weeks. Analysis of a separate 12-week study shows that HUMIRA significantly improves spinal symptoms in patients with active ankylosing spondylitis after only one dose.
"The findings of these two studies are significant because they validate our research to assess HUMIRA's potential to treat other autoimmune diseases in addition to rheumatoid arthritis," said James B. Lefkowith, M.D., divisional vice president, development, Abbott Immunology.
HUMIRA Provided Joint and Skin Improvement in Psoriatic Arthritis
Fifteen patients with active psoriatic arthritis were treated with HUMIRA 40 mg every other week, in this open-label trial, and observed over a 12-week period to evaluate the potential therapeutic effects of the treatment. After two weeks, significant improvements were seen in the signs and symptoms of the joint disease and skin manifestations associated with disease. Further improvements in the skin and joint disease were evident at 12 weeks.
Forty-two percent of patients treated with HUMIRA experienced an ACR 20 response after only one dose. ACR (American College of Rheumatology) 20, 50 and 70 criteria represent percent improvement in tender and swollen joint counts and other relevant clinical measures. Also after two weeks, 77 percent of patients experienced at least 25 percent improvement in health-related quality of life as measured by the Health Assessment Questionnaire (HAQ) disability index, which is designed to capture patients' assessment of activities of daily living such as grooming, dressing and walking. Health- related quality of life questionnaires are used to measure the impact of chronic illness on a patient's life.
Further improvement was seen at 12 weeks in both the arthritic symptoms and in health-related quality of life. Sixty-six percent of patients achieved an ACR 20 response and approximately 30 percent attained ACR 50. The HAQ disability index also showed further improvement at week 12 compared to week two.
Substantial improvements also were evident in the skin disease of these patients. Target lesion scores, an evaluation of the severity of a single psoriasis lesion, improved by nearly 30 percent after one dose. After 12 weeks, the target lesion score improved by more than 70 percent.
"The initial results and analysis of this study show that HUMIRA provided significant benefit to many patients with psoriatic arthritis shortly after the first dose," said Christopher T. Ritchlin, M.D., associate professor and lead investigator, University of Rochester, Rochester, New York. "While more research is necessary, these early findings are promising and support HUMIRA's potential as a treatment for psoriatic arthritis." |
