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.
Patients in the placebo group who didn't see notable improvement in their joint pain were switched after three months to get either 5 mg or 10 mg of tofacitinib. Participants were rated on a commonly used index of disability and checked for clinical signs of disease activity. The 12-month study showed that tofacitinib was superior to placebo and similar to Humira in its effectiveness.
The second study involved about 610 patients who had had an inadequate response to methotrexate. Tofacitinib was found to be associated with reductions in symptoms of rheumatoid arthritis and improvement in physical functioning.
Experts not associated with the study think the new drug, if approved by the FDA, would be a positive treatment option.
"It looks like tofacitinib could be used as a first-line agent, before taking a patient to a biologic," said Dr. Ernest Brahn, professor of medicine and rheumatology training program director at University of California, Los Angeles School of Medicine.
However, he noted that the studies involved a relatively small number of patients and no long-term data.
Dr. David Fox, of the rheumatology division at University of Michigan, Ann Arbor, writes in an accompanying journal editorial that a better understanding of the drug's safety picture is needed to determine at what point patients might turn to tofacitinib.
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