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A late-stage study of Pfizer Inc.'s experimental drug for moderate-to-severe rheumatoid arthritis found it worked better than the standard treatment, Pfizer said Tuesday.
Pfizer released limited results of the study, called ORAL Start, of its tofacitinib. It's a new type of drug to fight the painful chronic inflammatory disorder, in which the immune system attacks the body's joints, particularly the hands and feet.
The ongoing two-year study, sponsored by Pfizer, compared two doses of tofacitinib with methotrexate in 958 adults not previously treated with methotrexate. Data from a planned interim analysis found that after six months of treatment, the half of study participants getting tofacitinib had fewer signs and symptoms of the disorder, as well as less structural damage, than those getting methotrexate.
The study has not revealed any additional safety problems with tofacitinib. Research to date shows it can cause tuberculosis, herpes and other serious infections; lymphoma and other cancers; decreased levels of infection-fighting white blood cells called neutrophils; and elevated levels of lipids, or molecules in the blood that include cholesterol, fats and waxes.
Pfizer plans to submit a detailed analysis of the findings to a future medical conference.
Tofacitinib is being reviewed by regulators in the U.S., Europe and Japan. If approved, it would be the first rheumatoid arthritis treatment in a new class of medicines called Janus kinase or JAK inhibitors. The pill works by targeting pathways inside cells that function as hubs in the network of cytokines — messengers between cells that regulate inflammatory responses.
Pfizer noted the results during a conference call to review its second-quarter results. The New York-based company also said it plans in early August to submit a new analysis of tofacitinib data that the U.S. Food and Drug Administration requested. That will almost certainly push back the agency's Aug. 21 target date for an approval decision.
FDA advisers in May voted 8-2 to recommend approval of the drug, but the agency later requested the data analysis.