Rheumatoid arthritis clinical trial by Pfizer records one fatality

Rheumatoid Arthritis Drug Trial Claims One Life

Rheumatoid arthritis drug tofacitinib had caused the death of one participant in a clinical trial conducted by Pfizer, Inc., the drug maker had confirmed.

There were actually four deaths recorded during the trial, but Pfizer said only the one who died of respiratory failure can be linked to the experimental drug. Of the three others, one died of heart failure, one died of brain injury and one from complications of advanced rheumatoid arthritis.

About 1,000 patients participated in the trial and the overall fatality rate was comparable to other trials conducted to treat the condition, the pharmaceutical company said.

Pfizer has been testing the drug to treat moderate to severe cases of rheumatoid arthritis, an autoimmune disorder that attacks joints but also vital body tissues and organs.

In the ORAL Sync drug trial, patients were given either 5 or 10 milligrams of tofacitinib twice daily. Others were given a placebo. All the participants suffered from moderate to severe cases of rheumatoid arthritis and were not responsive to treatment using older medications like methotrexate.

Common side effects reported by participants of the clinical trial were headache, nausea, vomiting, diarrhea, bronchitis and infections. Serious side effects reported were low white blood cell count and elevated blood cholesterol levels.

Pfizer will present its findings on May 27 at a meeting of the European League Against Rheumatism.

The New York-based pharmaceutical firm said that they have met the trial's primary goals. Industry observers have downplayed the death and expects Pfizer to eventually get regulatory approval for their new rheumatoid arthritis drug.

Posted by George Daniels on Saturday April 23 2011, 6:07 AM EST. Ref: AP. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0