Pfizer Inc. (PFE: Quote) announced Monday that 14 abstracts for tofacitinib, an investigational oral Janus kinase or JAK inhibitor for the treatment of adults with moderate-to-severe active rheumatoid arthritis or RA, will be presented at the American College of Rheumatology or ACR / Association of Rheumatology Health Professionals or ARHP 2012 Annual Meeting, which is being held November 9-14 in Washington, D.C.
The company stated that Tofacitinib is currently under review for the treatment of moderate-to-severe active RA by several regulatory agencies around the world, including in the United States, Europe and Japan. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) date of November 21, 2012.
According to the company, ORAL Start (A3921069), an ongoing Phase 3, two-year study in methotrexate or MTX-naïve patients with moderate-to-severe active RA randomized to receive tofacitinib 5 or 10 mg twice-daily or BID as monotherapy or MTX, met its primary endpoints at both the 5 and 10 mg BID doses.
The company said that phase 3 Study ORAL Start Showed Tofacitinib Monotherapy Superior to Methotrexate in Inhibiting Structural Damage and Reducing Signs and Symptoms of RA in Methotrexate-Naïve Patients.
Results from a two-year analysis of ORAL Scan (A3921044), a completed Phase 3 study in patients with moderate-to-severe active RA who had an inadequate response to MTX, will also be presented. Patients were randomized to receive tofacitinib 5 or 10 mg BID or placebo, in each case with background MTX. The two-year analysis evaluated consistency of the efficacy and safety profile of tofacitinib 5 or 10 mg BID in patients who remained on active treatment through 24 months.
The company added that the two-year results showed that patients on tofacitinib maintained improvements in efficacy including reductions in signs and symptoms, inhibition of structural damage, and improvements in physical function through month 24.
Data from a pooled analysis of two long-term, open-label extension studies (NCT00413699, NCT00661661) involving patients with moderate-to-severe RA who had participated in randomized Phase 2 or 3 studies of tofacitinib dosed at 5 or 10 mg BID showed a consistent safety profile and sustained efficacy over 48 months. Safety and efficacy were similar for patients receiving tofacitinib as monotherapy or with background nonbiologic disease-modifying antirheumatic drugs or DMARDs, the company noted.
The company said that the overall safety profile of tofacitinib was consistent across all aforementioned trials. The most common serious adverse events were serious infections. The most commonly reported adverse events were upper respiratory tract infections, headache, nasopharyngitis and diarrhea.
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by RTT Staff Writer
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