Published on July 31, 2012 at 11:00 AM
Pfizer Inc. (NYSE:PFE) announced today top-line results from ORAL Start
(A3921069), a Phase 3 study of the investigational agent tofacitinib, a
novel, oral Janus kinase (JAK) inhibitor for the treatment of adults
with moderate-to-severe active rheumatoid arthritis (RA).
ORAL Start, an ongoing two-year study in methotrexate (MTX)-naïve
patients with moderate-to-severe active RA, randomized to receive
tofacitinib 5 or 10 mg twice-daily (BID) as monotherapy or MTX, met its
primary endpoints at both the 5 and 10 mg BID doses. Tofacitinib was
found to be superior to MTX with statistically significant changes shown
in inhibiting structural damage, as measured by change from baseline in
modified Total Sharp Score (mTSS), and in reducing signs and symptoms of
RA, as measured by ACR70 response rates. Both primary endpoints assessed
tofacitinib versus MTX at six months. The data reported are from a
planned analysis at one year.
No new safety signals emerged in the ORAL Start study, and the safety
profile of tofacitinib remained consistent with that seen previously in
the clinical development program. Safety findings observed in the
overall tofacitinib RA program include serious and other important
infections, including tuberculosis and herpes zoster; malignancies,
including lymphoma; decreased neutrophil counts and neutropenia; and
A detailed analysis of the ORAL Start findings will be submitted to a
future scientific meeting.
Pfizer also noted today during its second quarter earnings call that the
U.S. Food and Drug Administration (FDA) has recently requested
additional analysis of the existing data in the tofacitinib New Drug
Application (NDA). Pfizer is planning to provide FDA with this
information in early August and, given this timing, it anticipates that
FDA may require additional time beyond the August 21 Prescription Drug
User Fee Act (PDUFA) date to review the information.
Source: Pfizer Inc.