Abbott's HUMIRA(R) (Adalimumab) Receives Positive Opinion for Treatment of Psoriatic Arthritis from the European Medicines Agency
Monday June 27, 9:46 am ET
Psoriatic Arthritis is First New Indication Beyond Rheumatoid Arthritis
ABBOTT PARK, Ill., June 27 /PRNewswire-FirstCall/ -- Abbott today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued a positive opinion recommending approval of HUMIRA® (adalimumab) for the treatment of psoriatic arthritis, a chronic disease that combines the symptoms of arthritis, including joint pain and inflammation, with those of psoriasis, such as dry, scaly skin.
The positive opinion for HUMIRA as a treatment for psoriatic arthritis is based upon two placebo-controlled studies, including data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), a Phase III clinical trial showing patients on HUMIRA achieved significant improvement in both arthritic and psoriatic signs and symptoms. Results from ADEPT were reported at the annual congress of the European League Against Rheumatism (EULAR) in Vienna, Austria in June.
"Psoriatic arthritis can be a devastating disease that severely impacts a patient's total quality of life by attacking their skin and joints," said Alejandro Aruffo, Ph.D., vice president, Global Pharmaceutical Research and Development, and president, Abbott Bioresearch Center, Abbott. "HUMIRA's ability to treat the combination of symptoms and its convenience in administration, via self-injection, will provide doctors and patients with a new weapon in the battle against this terrible disease."
The positive opinion follows Abbott's simultaneous submission in December 2004 of a Marketing Authorization Application (MAA) to the EMEA and a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to market HUMIRA for the treatment of psoriatic arthritis.
HUMIRA is currently approved by the EMEA for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate. HUMIRA is currently being evaluated in clinical trials for other autoimmune diseases. The European Commission is expected to issue an authorization decision regarding the marketing of HUMIRA in European Union countries in approximately 90 days.
About ADEPT
ADEPT, a placebo-controlled, double-blind study, assessed the efficacy and tolerability of HUMIRA in 313 adults with moderate to severely active psoriatic arthritis (defined as three or more swollen joints and three or more tender joints) who had an inadequate response to therapy with nonsteroidal anti-inflammatory drugs (NSAIDs). Patients received placebo or 40 mg of HUMIRA administered subcutaneously every other week, the same dose as the RA indication.
Patients' arthritic symptoms exhibited a response to HUMIRA, with nearly 60 percent of patients achieving ACR 20 at week 12, one of the study's primary endpoints, and sustained the response through week 24. American College of Rheumatology (ACR) scores measure the percentage of improvement in tender and swollen joint count and other clinical measures. At week 24, nearly one- fourth of the patients achieved ACR 70, which means patients had at least 70 percent improvement in select arthritis signs and symptoms.
The study's second primary endpoint examined the change in modified Total Sharp Score (mTSS), a measurement used to assess changes in bone erosion and joint-space narrowing, at week 24. Patients treated with HUMIRA had significantly less change in mTSS than patients treated with placebo at week 24. Approximately three times as many patients receiving placebo had an increase in their scores (increase in mTSS >0.5 units) than patients treated with HUMIRA (28.9 percent vs. 9 percent, respectively) at week 24. Data from the open-label extension showed that the inhibition of disease progression at week 24 achieved in patients taking HUMIRA was maintained through week 48.
In addition, among the 69 patients in the trial who had greater than three percent body surface involvement who were treated with HUMIRA, 42 percent achieved a PASI 90 response at 24 weeks, which reflects at least 90 percent improvement in psoriasis symptoms assessed by the Psoriasis Area and Severity Index (PASI). Nearly one-third of these patients achieved a PASI 90 by week 12, which was maintained through the study. At week 24, none of the patients on placebo reached PASI 90.
Data presented recently at EULAR showed that quality of life improved considerably for patients treated with HUMIRA during a 24-week period, using multiple assessment tools. In a standard eight-category questionnaire, the Short Form-36 Health Status Survey (SF-36), patients treated with HUMIRA at week 24 showed clinically significant improvement versus placebo in seven of eight categories (physical and social functioning, role-physical, bodily pain, general medical health, role-emotional and vitality). For six of these seven categories with clinical significance, the changes were statistically significant compared with placebo. Because clinically significant improvements in SF-36 categories have not yet been defined for psoriatic arthritis, the rheumatoid arthritis (RA) defined differences were considered the best substitute.
The rates of adverse events and serious adverse events in the study were comparable between HUMIRA and placebo. Among patients taking HUMIRA, the most common adverse events (those affecting at least five percent of patients) were upper respiratory infection, nasopharyngitis, injection site reaction, headache and hypertension.
About Psoriatic Arthritis
Psoriatic arthritis combines symptoms of psoriasis, such as dry, scaly skin and patches of red, raised skin known as plaques, with arthritis symptoms including joint pain and inflammation. 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.
Left untreated, psoriatic arthritis can be a progressively disabling disease. The arthritic manifestations often include debilitating disease of the hands and feet, as seen in rheumatoid arthritis, as well as painful inflammation of the tendon insertions and arthritis of the spine. Psoriatic arthritis is most often found in patients who suffer from psoriasis, a chronic skin disease that affects nearly three percent of the world's population. It is estimated that up to 30 percent of people with psoriasis also develop psoriatic arthritis.
Like RA, psoriatic arthritis is an autoimmune disorder in which a human protein, tumor necrosis factor-alpha (TNF-a), has been suggested to play a role in disease development. HUMIRA, which is a fully human monoclonal antibody that resembles antibodies normally found in the body, works by specifically blocking TNF-a.
Important Safety Information
Common adverse events (>1/100 and less than or equal to 1/10) at least possibly causally related to HUMIRA include headache, dizziness, respiratory tract and urinary tract infection, nausea, diarrhea, sore throat, herpes simplex, abdominal pain, rash, pruritis and anemia. Injection site pain was reported by >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.
Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully. In clinical studies with another TNF antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events including worsening CHF and new onset CHF have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA.... |
