Preliminary data from two studies showing encouraging results in treating psoriatic arthritis and ankylosing spondylitis with HUMIRA(reg) (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.”
ABOUT PSORIATIC ARTHRITIS
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. Psoriatic arthritis may stem from an autoimmune disorder in which a human protein, tumor necrosis factor-alpha (TNF-???), accumulates in the joints and initiates an inflammatory response that causes swelling and pain.
If left untreated, psoriatic arthritis can be a progressively disabling disease. Epidemiological studies indicate that psoriatic arthritis affects as many as 30 percent of people who have psoriasis, a non-contagious, chronic skin disease characterized by red plaques covered with white scales. Common symptoms of psoriatic arthritis include varying degrees of psoriasis activity along with stiffness, pain, swelling and tenderness of the joints that can lead to a reduced range of motion and potential severe joint destruction.
HUMIRA IMPROVED SYMPTOMS OF ACTIVE ANKYLOSING SPONDYLITIS
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.
HUMIRA was well tolerated by patients in the study and no serious infections occurred during the study.
ABOUT ANKYLOSING SPONDYLITIS
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. As one of the many forms of inflammatory arthritis known as spondyloarthropathies, AS is a chronic disease that primarily affects the spine but can also affect other joints and ligaments, resulting in severe joint and back stiffness and deformity over time.
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.
Spondyloarthropathies are arthritic in nature, but unlike many other rheumatic conditions, they affect young adults and commonly begin before the age of 35.
HUMIRA is the first human monoclonal antibody available in Europe for RA, and the first tumor necrosis factor alpha (TNF-B) antagonist approved in Europe with an indication for use with methotrexate or as monotherapy. HUMIRA resembles antibodies normally found in the body. It works by blocking TNF-B, a protein that plays a central role in the inflammatory responses of autoimmune diseases such as RA.
Available in many countries, HUMIRA is indicated for the treatment of moderate to severe, active RA in adult patients when the response to disease modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate.
To ensure maximum efficacy, HUMIRA is given in combination with methotrexate. In Europe, HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. The European Medicines Evaluation Agency (EMEA) issued a positive opinion in April to authorize a label extension for HUMIRA for use in the treatment of adult RA patients for reducing the rate of progression of joint damage and to improve physical function. Such authorizations generally occur approximately 90 days after the issuance of the EMEA opinion.
Abbott received a positive opinion from the EMEA in May 2003 for the treatment of adult RA and was granted European Union approval to market HUMIRA in September 2003. HUMIRA received approval from the U.S. Food and Drug Administration on December 31, 2002. To date, HUMIRA has been approved in 41 countries and launched in 26.
The recommended dose of HUMIRA is 40 mg every other week by subcutaneous injection (a shot beneath the skin). Abbott offers HUMIRA in specially designed pre-filled syringes so patients do not have to mix and measure the medicine or leave their homes for treatment. The pre-filled syringe features handles and a plunger head designed for use by patients whose hands have been affected by their RA.
At the present time, HUMIRA has not received regulatory approval for the treatment of psoriatic arthritis or AS. Clinical trials are currently underway in autoimmune diseases.
IMPORTANT SAFETY INFORMATION
Common adverse events (>1/100 and 1/10 patients.
Patients must be monitored closely for infections, including tuberculosis (TB), before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. HUMIRA should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.
TNF-antagonists, including HUMIRA, have been associated in rare cases with exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. Prescribers should exercise caution in considering the use of HUMIRA in patients with pre-existing or recent-onset central nervous system demyelinating disorders.
HUMIRA should be used with caution in patients with mild heart failure, and is contraindicated in patients with moderate or severe heart failure. HUMIRA must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries.
More information about Abbott Immunology is available at abbottimmunology/.
View drug information on Humira.