New Oral RA Drug Works in Unique Way
Study: Tofacitinib Improves Symptoms in Patients Who Have Not Responded to Other Drugs
Tofacitinib Study Details continued...
At the 12-month mark, nearly 37% of those in the higher-dose drug group had a 50% improvement. And 16% of those on the higher dose had a 70% improvement. In contrast, only 3% of those on placebo got the 70% improvement.
The drug's effects were seen after two weeks of therapy, according to the researchers.
In the drug's study, side effects included infections, but most were mild, Kremer says. As for the four deaths, Kremer says, "After reviewing all the source documents on this case, it appears to me that one of the four deaths could have been related to the drug." In a separate analysis, the researchers looked at 610 patients and found both doses had "clinically significant efficacy and acceptable safety."
Victoria Davis, a Pfizer spokeswoman, says the company plans to file for FDA approval for the drug by the end of 2011.
New RA Drug: Perspective
The drug data look good, says Yusuf Yazici, MD, assistant professor of medicine and a rheumatologist at New York University's Langone Medical Center. He reviewed the study findings for WebMD but was not involved in the study. "It looks like it works."
''The results are similar to what we saw with other [RA drugs],'' says Yazici.
Whether the new oral RA drug, if approved, will become more popular than other RA drugs is not known, Yazici says. It may simply become one more option for RA patients, giving more of a choice, he says.
Kremer reports research and grant support from Pfizer and serving as a company consultant. Yazici reports serving as a consultant for Pfizer, Merck, and other companies.