NEW YORK (AP) – Drug developer Pfizer Inc. said that its potential rheumatoid arthritis drug met key treatment goals in two late-stage studies.
The drug candidate tofacitinib, formerly called tasocitinib, met its key goals of reducing signs and symptoms of the condition in separate studies on patients over a 12-month and six-month period. Rheumatoid arthritis is a chronic inflammatory disease typically affecting joints.
The company’s Oral Standard study involved 717 patients over a 12-month period with moderate-to-severe rheumatoid arthritis who had an inadequate response to the drug methotrexate. 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.
Pfizer said no new safety signals emerged in the Oral Standard and Oral Step studies. A more detailed analysis off the data will be submitted to a future scientific meeting.
The positive study results come on the heels of 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. Three other patients who were treated with tofacitinib during the study also died, but those deaths were not determined to be drug-related.
In March, the company said the drug met its key goals in the 792-person Oral Sync study.
The most common side effects of treatment with tofacitinib 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.
Tofacitinib is a key developing drug for Pfizer and is also being studied as a potential treatment for psoriasis, inflammatory bowel disease, and renal transplant. A topical version of the drug is being studied as a psoriasis treatment and a dry eye disease treatment.
Date: April 28, 2011
Source: Associated Press