Rheumatoid Arthritis Drug Meets Key Study Goals
A rheumatoid arthritis drug met key treatment goals in two late-stage studies, drug developer Pfizer Inc. said Thursday.
The drug candidate tofacitinib, formerly called tasocitinib, met its key goals of reducing signs and symptoms of the condition, reports the AP.
Separate studies on patients were conducted over a 12-month and six-month period.
Rheumatoid arthritis is a chronic inflammatory disease typically affecting joints.
Over 717 patients with moderate-to-severe rheumatoid arthritis, who had an inadequate response to the drug methotrexate, were involved in the company's Oral Standard study over a 12-month period.
Meanwhile, the Oral Step study involved 399 patients over a six-month period with moderate-to-severe rheumatoid arthritis who did not have an adequate response to TNF inhibitor drugs, the AP reports.
Pfizer said no new safety signals emerged in the Oral Standard and Oral Step studies. A more detailed analysis of the data will be submitted to a future scientific meeting.
The positive study results follow Pfizer's confirmation on April 21 that that one patient who was taking tofacitinib died during a recent clinical trial called Oral Sync.
The company said the death was connected to the drug.The patient died of respiratory failure, according to the AP.
Three other patients who were treated with tofacitinib during the study also died, but those deaths were not determined to be drug-related.