Abbott announced that the company has simultaneously submitted a supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) seeking approval to market Humira (adalimumab) for psoriatic arthritis, an autoimmune disorder that combines symptoms of psoriasis, such as dry, scaly skin with arthritis symptoms, including joint pain and inflammation.
The filings are based on 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 the ADEPT trial were recently reported at the American College of Rheumatology congress in San Antonio, Texas, in October.
"Humira has been an effective treatment for people with rheumatoid arthritis and our research shows great promise for treating psoriatic arthritis and other inflammatory autoimmune conditions," said Alejandro Aruffo, Ph.D., president, Abbott Bioresearch Center and Immunoscience Development Center, Abbott. "This is encouraging news for the millions of people afflicted with such diseases worldwide. Abbott will continue to research the potential of Humira and other compounds as part of our commitment to use scientific innovation to address major unmet medical needs."
Humira is currently approved by the FDA and the EMEA for the treatment of moderate to severe rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.
"This news is encouraging for psoriatic arthritis patients and for the dermatologists and rheumatologists who have limited therapeutic options for treating this difficult disease," said Philip Mease, M.D., lead study investigator, Swedish Medical Center and University of Washington School of Medicine, Seattle. "The Humira data shows patients experienced significant relief from joint symptoms along with marked improvement in skin symptoms. Among those with significant psoriasis, about seven out of 10 patients achieved clear or almost clear skin."
The placebo-controlled, double-blind study assessed the efficacy and tolerability of Humira in 313 adults with 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.
The study found that patients' psoriatic arthritis skin symptoms showed a significant response to Humira. Of the 69 patients with greater than three percent of body surface involvement who were treated with Humira, 42 percent achieved a PASI 90 response at 24 weeks, which reflects at least a 90 per cent improvement in psoriasis symptoms assessed by the Psoriasis Area and Severity Index (PASI). Nearly one-third of patients achieved a PASI 90 by week 12, which was maintained through the study.
Patients' arthritic symptoms exhibited a rapid response to Humira, with nearly 60 per cent of patients achieving ACR20 at week 12, one of the study's primary endpoints, and sustaining 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 the 24-week follow-up, nearly one-fourth of these patients achieved ACR70, which means patients had a 70 per cent improvement in arthritis signs and symptoms.
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 per cent of patients) were upper respiratory infection, nasopharyngitis, injection site reaction, headache and hypertension. The safety profile of Humira in the psoriatic arthritis population was similar to that observed with Humira in the rheumatoid arthritis population.
Humira is the only fully human monoclonal antibody approved by the FDA and the EMEA for reducing the signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis (RA) who have had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs). Humira can be used alone or in combination with methotrexate or other DMARDs. Humira offers convenient every-other-week dosing by subcutaneous injection (shot beneath the skin) via a specially designed pre-filled syringe.
Humira is the first fully human monoclonal antibody approved in Europe for RA, and the first tumour necrosis factor-alpha (TNF-a) antagonist approved with an indication for use with methotrexate or as monotherapy. To date, Humira has been approved in 54 countries and prescribed to more than 83,000 patients suffering from rheumatoid arthritis worldwide.
Clinical trials are currently underway evaluating the potential of HUMIRA in other autoimmune diseases, including juvenile rheumatoid arthritis (JRA), psoriasis, Crohn's disease and ankylosing spondylitis.