Primary Endpoints Met In Phase 3 Trial of Tofacitinib

MARCH 07, 2011
In an update of clinical trial of the drug Tofacitinib, Pfizer Inc. announced that the primary endpoints in Phase 3 have been met.

“Tofacitinib is a novel, oral Janus kinase (JAK) inhibitor that is being investigated as a targeted immunomodulator and disease modifying therapy for RA,” said Drug Discovery and Development.  The drug, formerly known as tasocitinib, is a different kind of therapy for RA because it does not aim for extracellular targets such as pro-inflammatory cytokines, like most drugs do, but instead takes an approach which targets intercellular signaling pathways in the inflammatory cytokine network.

The ORAL Sync Phase 3 study of tofacitinib has been studying the effects of the drug as opposed to the effects of a placebo in moderate-to-severe rheumatoid arthritis (RA) patients. The study met it’s endpoints by showing statistically significant changes in the reduction of symptoms connected to RA over a six month period versus the placebo.

Also, the drug has shown improvement of physical functionality with no new safety signal detected.

The safety and efficiency of tofacitinib was measured by 5 mg and 10 mg doses given to participants in the study; this was juxtaposed to the doses of the placebo given to other patients, all of whom have the same degree of RA and same symptoms.

All patients had previously been unresponsive or inadequately responsive to disease modifying drugs (DMARD), but continued to receive DMARD therapy throughout the study.
According to the study update, over 4,000 RA patients have received treatment in the form of tofacitinib in clinical trials, which include six studies spread across 35 countries, with over 350 locations worldwide.

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