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Rheumatoid arthritis drug success in trial

Pfizer's oral Janus kinase inhibitor tasocitinib has been shown to reduce the symptoms of rheumatoid arthritis and improve physical function

Tasocitinib, an oral Janus kinase (JAK) inhibitor being developed by Pfizer, has demonstrated in the phase III ORAL Solo (1045) trial that it can reduce the signs and symptoms, and improve physical function, when administered as a monotherapy to rheumatoid arthritis (RA) patients.

In the six-month, double-blind, placebo-controlled study, inflammation was reduced by at least 20 per cent after six months of treatment in 71 per cent of the 611 randomised patients. Patients in the trial were treated twice daily with placebo, tasocitinib 5mg or tasocitinib 10mg.

Of the trial's three primary endpoints, two (reduction of signs and symptoms of RA and improvement in physical function) were met. In the third, disease remission at three months compared with placebo, numerically higher values were achieved but statistical significance was not reached.

Prinicipal trial investigator Dr Roy Fleischmann, clinical professor of internal medicine at the University of Texas Southwestern Medical Center, Dallas, US, said: "We are encouraged by the statistically significant and clinically meaningful improvements we observed in a proportion of patients treated with tasocitinib monotherapy in ORAL Solo.

"Further research into additional treatment options for patients with moderately to severely active RA is important, and we look forward to seeing the results of the additional phase III ORAL trials of tasocitinib."

The trial results are to be presented on Wednesday November 10 at the ACR (American College of Rheumatology) Annual Meeting, which is being held until November 11 in Atlanta, Georgia.

The current approved treatment for RA is repeated injections of anti-TNF (tumour necrosis factor) medications (including Enbrel, a treatment Pfizer gained when it acquired Wyeth last year, but an estimated 20 to 40 per cent of RA patients do not respond to this treatment. Head-to-head trials of tasocitinib, which targets signalling pathways, and anti-TNF treatments, which target inflammatory protein molecules, are planned for next year.

Tasocitinib is also being investigated as a possible treatment for psoriasis, ulcerative colitis, Crohn's disease and organ transplant.

The clinical programme of tasocitinib in RA includes more than 4,000 patients. If approved, tasocitinib would represent the first tablet treatment for RA in a decade. Other oral RA treatments in development include fostimatinib (R788), a syk kinase inhibitor from Rigel and AstraZeneca; VX-509, a Janus kinase 3 (JAK3) inhibitor from Vertex Pharmaceuticals and a JAK inhibitor from Incyte.

8th November 2010

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