NEW YORK (AP) – Pfizer Inc. confirmed that one patient who was taking its drug candidate tofacitinib, a pill designed to treat rheumatoid arthritis, died during a recent clinical trial and said the death was connected to the drug.
The world’s largest drugmaker said the patient died of respiratory failure. Three other patients who were treated with tofacitinib during the study died as well, but the other three deaths were not determined to be drug-related. Two of those deaths occurred several weeks after the patients stopped taking tofacitinib.
Pfizer has said more than 1,000 patients have taken tofacitinib during clinical trials, and it said late Thursday that overall death rate for patients in those studies is similar to what has been observed in other biologic treatments for rheumatoid arthritis.
The late-stage trial was called ORAL Sync, and Pfizer said in March that tofacitinib met its main goals in the 792-patient study. The patients received either 5 or 10 milligrams of the drug twice per day. Some patients received a placebo. Pfizer said it will present full results from the ORAL Sync trial on May 27 at a conference of the European League Against Rheumatism. The trials involved patients with moderate to severe active rheumatoid arthritis who have not been helped by an older class of drugs including methotrexate.
In April Pfizer said the drug met its goals in a separate late-stage trial.
Pfizer said the other deaths included a patient who died of acute heart failure, one death caused by brain injury following trauma, and one case of worsening rheumatoid arthritis. The brain injury death occurred 22 days after the patient stopped taking tofacitinib, and the patient who died of worsening rheumatoid arthritis had stopped taking tofacitinib six weeks earlier.
Tofacitinib, formerly called tasocitinib, is being tested as a treatment for moderate to severe rheumatoid arthritis, a chronic autoimmune disease that causes inflammation, usually of the hands and feet. The most common side effects of treatment with the drug have included bronchitis, headache, infections, and gastrointestinal symptoms like nausea, vomiting, and diarrhea. More serious side effects in a mid-stage trial included lower levels of a type of white blood cell called neutrophils, higher cholesterol levels, and increased creatinine levels.
Source: The Associated Press