Phase III boost for Pfizer’s oral arthritis drug
pharmafile | April 18, 2011 | News story | Research and Development, Sales and Marketing | Pfizer, rheumatoid arthritis, tofacitinib
Pfizer’s rheumatoid arthritis treatment tofacitinib has induced clinical remission of the disease according to one-year data from a phase III study.
Tofacitinib – formerly known as tasocitinib – met all its primary endpoints at a 10mg BID dose, but did miss one at the lower 5mg dose in the ORAL Scan study.
The 10mg BID dose – meaning it is taken twice daily – showed statistically significant changes versus placebo in reducing signs and symptoms of rheumatoid arthritis (RA), as measured by ACR20 response rates at six months.
It also reached disease activity score – DAS28-4(ESR) – of less than 2.6 at six months, indicating a clinical remission of the disease in accordance with the Australian Rheumatology Association scoring criteria.
The drug also reduced progression to structural damage, as measured by change from baseline in modified Total Sharp Score (mTSS), and there were improvements in physical function, as measured by mean change in HAQ DI at three months.
For the 5mg BID dose, the study demonstrated statistically significant improvements versus placebo in ACR20 response rates at six months, but the difference from placebo in mTSS did not reach statistical significance in the same time period.
ORAL Scan is an ongoing two-year study in patients with moderate-to-severe active rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX). With full results expected in 2012.
A full analysis of the ORAL Scan efficacy and safety data will be submitted to a future scientific meeting and the results add to three-month data released by Pfizer in November last year.
Tofacitinib is an oral JAK inhibitors that impacts the signaling of proteins that affects autoimmune diseases such as rheumatoid arthritis.
Pfizer is also studying oral forms of the drug in psoriasis, inflammatory bowel disease (Crohn’s disease and ulcerative colitis) and renal transplant, and topical tofacitinib in both psoriasis and dry eye disease.
If successful in RA it will be competing with a number of established treatments, including Abbott’s Humira, J&J’s Remicade and Pfizer’s own Enbrel, which saw 2010 sales of $6 billion, $4.6 billion and $3.5 billion respectively.
All three are injectable forms of treatments, but whereas tofacitinib is taken as a pill twice daily, Humira can be injected every other week and patients taking Enbrel must inject themselves twice a week. J&J’s RA drug Remicade requires administration in hospital every eight weeks.
Ben Adams
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