In this study, four deaths were reported in the tofacitinib arms, three of which were determined by the investigators not to be study drug related. The cases reported that were determined not to be study drug related involve one case of brain injury following trauma 22 days after discontinuation of study drug; one case of worsening of RA 42 days after discontinuation of study drug; and one case of acute heart failure. In addition, one case of respiratory failure was reported by the investigator as study drug related.
Because the initial randomization design of the study includes only one-fifth of the patients on placebo (2:2:1 randomization, n = 792), and because the placebo patients are converted to active arms beginning as early as 3 months into the study, the majority of adverse events would be expected to occur in patients on active treatment.
The mortality rate from all causes across the tofacitinib RA development program, including the ORAL Sync study, is within the range of rates reported for biologic therapies for RA.
Full results of ORAL Sync will be presented in a late-breaker oral session at EULAR on May 27, 2011, at 4:20 p.m. GMT in London.
About ORAL Sync
ORAL Sync evaluated the efficacy and safety of tofacitinib doses 5 mg and 10 mg given twice daily compared to placebo in patients with moderately to severely active RA who had a previous inadequate response to a DMARD and who continued to receive background traditional DMARD therapy throughout the study.
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