Pfizer has announced results from the ORAL Scan Phase 3 study of tofacitinib, an oral JAK inhibitor being developed to treat rheumatoid arthritis. The ORAL Scan Phase 3 study is actually a two-year study of patients with moderate to severely active rheumatoid arthritis who had an inadequate response to methotrexate. Patients in the study were randomly assigned 5 or 10 mg tofacitinib twice a day or placebo added to background methotrexate.
The results being reported now are from the one-year interval of the two-year planned study. All primary endpoints of the study were met for the 10 mg dose of tofacitinib -- the drug showed statistically significant changes versus placebo in reducing signs and symptoms of rheumatoid arthritis, in reducing progression of structural damage, and in improving physical function at 6 months. With the 5 mg dose, there was also a statistically significant difference compared to placebo for reducing signs and symptoms -- but there was not a statistically significant reduction in the progression of stuctural damage at 6 months compared to placebo.
Four deaths were reported in a previous tofacitinib study, referred to as the ORAL Sync study -- but three of the four deaths were found not to be related to the study drug. One of the deaths involved brain injury following trauma that occurred 22 days after discontinuing the drug. Another death was related to worsening rheumatoid arthritis 42 days after discontinuing the drug. The third death was related to acute heart failure. There was one case of respiratory failure that was related to the study drug, tofacitinib. Pfizer has commented, on their website, that the mortality rate throughout the tofacitinib development program is consistent with the range reported for all biologic therapies for rheumatoid arthritis.
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