New Pill Might Relieve Severe Rheumatoid Arthritis

WEDNESDAY, Aug. 8 (HealthDay News) -- A new oral medication may be available soon for people with rheumatoid arthritis who have not gained relief from other medicines.

As rheumatoid arthritis progresses, people often struggle with everyday tasks and find walking difficult. To help combat those issues, patients with severe forms of the disease often need drugs that must be injected, typically twice a month.

The new drug, tofacitinib, was approved by an advisory panel of the U.S. Food and Drug Administration in May and could be green-lighted by the FDA this month. However, the drug carries the risk of serious side effects, as do injectable treatments. The risks include blood and lymphatic system disorders, infections, and cancer.

"This is an advance, but it's not a cure-all," said Dr. Roy Fleischmann, study author and clinical professor of medicine at the University of Texas Southwestern Medical Center, in Dallas. "We have not cured rheumatoid arthritis."

Rheumatoid arthritis, which differs from age-related osteoarthritis, is a debilitating autoimmune disorder, meaning the body attacks its own tissues. It is characterized by inflammation of the lining, or synovium, of the joints.

The new drug, called a JAK inhibitor, blocks signals that activate inflammatory immune responses involved in the disease.

The FDA is not required to follow its panel's recommendations, but it usually does. Further evidence supporting the benefits of the drug comes in two studies published Aug. 9 in the New England Journal of Medicine.

Fleishmann explained that while people with the disease have benefitted from the discovery of "biologic" drugs such as Humira (adalimumab), Enbrel (etanercept) and Remicade (infliximab), many patients don't find relief from these medications. Biologic products are large proteins that are available only by injection or intravenous administration. The hope, he said, is that JAK inhibitors will help improve the lives of those not getting enough relief from other medications.

Both studies were phase 3 clinical trials, used to test the effectiveness and safety of potential drug therapies in large groups of people.

In Fleischmann's research, about 700 patients who had been taking methotrexate -- a commonly used drug for rheumatoid arthritis -- with inadequate relief were randomly assigned to take either 5 milligrams (mg) or 10 mg of tofacitinib twice daily, 40 mg of Humira every two weeks, or an inactive placebo.

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New Pill Might Relieve Severe Rheumatoid Arthritis