Humira (adalimumab), the latest biologic therapy and first fully human monoclonal antibody for the treatment of rheumatoid arthritis (RA), was prescribed to more than 40000 patients suffering from the potentially crippling joint disease during its first year on the market. Approved by the US Food and Drug Administration (FDA) on December 31 2002, Humira is the most successful product launch in the Abbott's 115-year history.
"The success of Humira in its first year confirms it is a treatment meeting an important need for patients and physicians," said Tim Walbert, divisional vice president and general manager, Abbott Immunology. "It is a reflection of Abbott's larger commitment to providing patients with the most innovative treatments science has to offer."
At the time of its regulatory submission, Humira was the most studied biologic therapy for RA, with 23 clinical trials involving more than 2400 patients. Humira was FDA approved, just nine months after the company's regulatory submissions in the United States and Europe.
"The benefits of Humira for my patients have been remarkable," said Charles Birbara, MD, medical director of the Clinical Pharmacology Study Group at the University of Massachusetts City Campus, Worcester, Massachusetts. "Before starting Humira, some patients couldn't dress themselves or hold their children or grandchildren. Humira has given them their lives back, with some patients responding as early as one week after their first dose."
Humira offers convenient administration that is unmatched by available biologic medications. It is packaged in a pre-filled syringe specially designed for easy use at home by people with RA. The design, which has been tested with RA patients and received the Arthritis Foundation's Ease-of-Use Commendation seal, features unique plastic wings that are easy to hold and allows patients to self-administer their medication without having to mix or measure it. Humira offers patients convenient dosing (typically every other week), with 75 per cent fewer injections than another commonly prescribed self-injected RA treatment.
RA is a chronic autoimmune disease that affects more than five million people worldwide, with women accounting for three out of four cases. RA causes pain, swelling and stiffness in the joints of hands, feet and wrists, and often leads to the destruction of joints. Unlike osteoarthritis, the "wear and tear" joint condition and most common form of arthritis, RA is an autoimmune disease where joints are inflamed, often resulting in eventual destruction of the joint's interior and erosion of the surrounding bone. The long-term prognosis for RA patients can be poor, and many patients face disability and premature death. Quality of life is seriously affected as RA progresses. Many people with RA experience fatigue, which can be extreme and limit normal activity. Sufferers also endure pain that can interfere with daily function, missed workdays, and feelings of helplessness and depression.