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Psoriatic Arthritis Drug Humira(reg) Submitted For US & European Approval

Main Category: Eczema / Psoriasis
Also Included In: Arthritis / Rheumatology | Regulatory Affairs / Drug Approvals
Article Date: 17 Dec 2004

Abbott Laboratories today announced it has simultaneously submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) seeking approval to market HUMIRA(reg) (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."

About the ADEPT Trial

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 percent 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 percent 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 percent 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 percent 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.

About Psoriatic Arthritis

Psoriatic arthritis is an autoimmune disorder that 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 which 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, tendonitis 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 rheumatoid arthritis, psoriatic arthritis is an autoimmune disorder in which a human protein, tumor necrosis factor-alpha (TNF-α), 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-α.

Important Safety Information

Cases of tuberculosis (TB) have been observed in patients receiving HUMIRA. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these infections occurred in patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections. The combination of HUMIRA and anakinra is not recommended.

TNF-blocking agents, including HUMIRA, have been associated in rare cases with demyelinating disease and severe allergic reactions. Infrequent reports of serious blood disorders and rare reports of lymphoma have been reported with TNF-blocking agents. Patients with rheumatoid arthritis, particularly those with highly active disease are at a higher risk for the development of lymphoma. The potential role of TNF-blocking therapy in the development of malignancies is not known.

The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (HUMIRA vs. placebo) were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.

About HUMIRA

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 tumor necrosis factor-alpha (TNF-α) 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.

Abbott's Commitment to Immunology

Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Massachusetts, United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases. More information about Abbott Immunology and HUMIRA, including full prescribing information, is available on the Web sites http://www.abbottimmunology.com and http://www.HUMIRA.com, or in the United States by calling Abbott Medical Information at (800) 633-9110.

About Abbott
Abbott 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.

Original article posted on Medical News Today.
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