Saturday, April 23, 2011

Pfizer Says Patient Died in Oral RA Drug Study

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Pfizer Inc. declared that one patient who was having its medicine candidate tofacitinib, a pill designed to cure rheumatoid arthritis, passed away in a latest clinical trial and said the death was associated to the drug.

The world’s biggest drugmaker says that the patient died because of respiratory failure. Three further patients who were in treatment with tofacitinib in the study passed away as well, but those deaths were not considered to be drug-associated. Two from those deaths happened several weeks following the patients ceased taking tofacitinib. Tofacitinib, formerly called tasocitinib, is being tried as a cure for slight to severe rheumatoid arthritis, a chronic autoimmune illness that causes inflammation, commonly of the hands and feet.

Almost more than 1,000 patients have been taking tofacitinib in clinical trials, and Pfizer said late on Thursday that on the whole death toll for patients in those studies is alike to what has been experienced in further biologic treatments for rheumatoid arthritis.

The late-stage trial was termed as ORAL Sync. Pfizer says that in March that tofacitinib achieved its key goals in the 792-patient study. The patients got either 5 or 10 milligrams of the drug two times per day. Several patients obtained a placebo. The trials includes patients with slight to severe rheumatoid arthritis who have not been assisted by an previous class of drugs counting methotrexate. Pfizer will present full outcomes from the ORAL Sync trial on May 27 at a conference of the European League Against Rheumatism.

Prior this month Pfizer said the drug achieved its goals in a another late-stage trial.

Pfizer says that the other deaths involves a patient who passed away because of acute heart failure, one death by brain injury following trauma, and one case of deterioration of rheumatoid arthritis. The brain injury incident happened 22 days following the patient ceased taking tofacitinib.

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