By Pat Anson, PNN Editor
Patients with moderate to severe rheumatoid arthritis (RA) may soon have a new treatment option.
Abbvie has announced positive results from a Phase 3 clinical study of its investigational drug upadacitinib and said it would file for FDA approval later this year.
Patients taking daily doses of upadacitinib for 14 weeks showed significant improvements in physical function, quality of life, pain and morning joint stiffness when compared with patients taking methotrexate, a standard first line treatment for RA.
Patients using upadacitinib reported reductions in pain and morning stiffness and better physical function as early as two weeks after starting treatment.
The results were announced at the annual meeting of the American College of Rheumatology (ACR) in Chicago.
"Upadacitinib as a monotherapy showed significant improvements in rheumatoid arthritis patients' ability to perform daily activities and overall health-related quality of life," said Marek Honczarenko, MD, vice president of global immunology development at AbbVie. "These results show that the improvements in clinical symptoms are accompanied by improvement in outcomes important to patients. These results reinforce upadacitinib's therapeutic potential across diverse rheumatoid arthritis patient populations and its use as a monotherapy treatment option."
Upadacitinib belongs to a class of medication known as JAK inhibitors, which block enzymes that cause inflammation. The drug is also being investigated as a treatment for psoriatic arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis and atopic dermatitis.
RA is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing swelling, inflammation and bone erosion. Because RA is incurable, treatments focus on suppressing the immune system to reduce inflammation and slow progression of the disease.
Many RA patients do not respond to or cannot tolerate methotrexate, a drug that was first used in chemotherapy because of its ability to stop the growth and spread of tumors. Because it also acts as an immune system inhibitor, low doses of methotrexate became a first line therapy for rheumatoid arthritis in the 1950’s.
Until the late 1990s, one in three RA patients were permanently disabled within five years of disease onset. There has been significant improvement in RA treatment for many patients who receive biologic disease modifying drugs such as Enbrel and Humira. The cost of biologic drugs can be as much as $25,000 a year and many patients can’t afford them or have insurers unwilling to pay for them.