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 at the European League Against Rheumatism (EULAR) annual congress in Berlin, a company release said.
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 improves spinal symptoms in patients with active ankylosing spondylitis after only one dose.
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.
About 42 per cent 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 per cent of patients experienced at least 25 per cent 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. 66 per cent of patients achieved an ACR 20 response and approximately 30 per cent 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 per cent after one dose. After 12 weeks, the target lesion score improved by more than 70 per cent.
"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, 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," he added.
Psoriatic arthritis is an inflammatory arthritis that is associated with the skin condition psoriasis. It causes inflammation and stiffness in and around the joints, including the knees, wrists, ankles, lower back and neck.
To examine the potential therapeutic effects of Humira in patients with non-steroidal anti-inflammatory drug (NSAID)-refractory ankylosing spondylitis (i.e. patients not readily responding to NSAID therapy), researchers studied 10 patients over a 12-week period that received Humira 40 mg every other week. In this open label study, all 10 patients suffered from spinal pain.
Humira treatment induced a positive response in patients after the first dose, with further improvement at the end of the initial 12-week therapy, as measured by Assessment of Ankylosing Spondylitis (ASAS) criteria. ASAS evaluates four primary categories: function, pain, patient's global assessment and inflammation. Scores of ASAS20, ASAS40 and ASAS70 indicate corresponding symptom improvement percentages in at least three of the evaluation categories with no worsening in the remaining category.
The majority of patients in the trial experienced improvement in their symptoms with 70 percent achieving a score of ASAS20, 50 percent reached ASAS40 and 20 percent attained ASAS70.
Also at week 12, 50 percent of the patients experienced 50 percent or greater improvement in scores according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), a patient-assessed composite index of disease activity measuring pain, stiffness and fatigue.
"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, divisional vice president, development, Abbott Immunology.
Humira was well tolerated by patients in the study and no serious infections occurred during the study.
Ankylosing spondylitis (AS), or arthritis of the spine, is thought to be an autoimmune disorder in which a human protein has been suggested to play a role in the disease development. It is estimated that between 350,000 and one million people in the United States are affected by AS or a related disease and nearly three million in the European community.
Humira is the first human monoclonal antibody available in Europe for RA, and the first tumor necrosis factor alpha (TNF-a) antagonist approved in Europe with an indication for use with methotrexate or as monotherapy, the company claims.