Pfizer announced Thursday top-line data from two late-stage trials that demonstrated that the tofacitinib met all primary endpoints in patients with moderate-to-severe active rheumatoid arthritis (RA). The drugmaker noted that full results from the trials, which represent the last two of five Phase III studies of the oral JAK inhibitor, will be presented at an upcoming medical meeting.
The ORAL Standard trial randomised 717 patients with moderate-to-severe active RA who had an inadequate response to methotrexate to receive one of two doses of tofacitinib, adalimumab or placebo for 12 months. The ORAL step study, meanwhile, randomised 399 patients with the same disease profile but who had an inadequate response to at least one TNF inhibitor to receive one of two doses of tofacitinib or placebo added to methotrexate for six months.
The researchers noted that in the two trials, both doses of tofacitinib demonstrated significant changes versus placebo in signs and symptoms of RA, as well as in improving physical function. Pfizer spokeswoman Victoria Davis indicated that death rates across all five late-stage trials are "within the range of rates reported for biologic therapies for rheumatoid arthritis," and no new safety signals were observed in the latest trials.
Pfizer declined to say when the company would submit its regulatory filings for the drug. If approved, analysts suggest that the compound could garner peak annual sales of around $2 billion.
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