A sizeable proportion of patients were also taking a disease-modifying antirheumatic drug at study entry.
The primary efficacy end point was ASAS20, defined as an improvement of at least 20% in response criteria, at week 12.
“The predicted dose of 5 mg twice daily had a response rate of 63%, which was almost 23% higher than the response rate in placebo controls,” Dr van der Heijde reported. The 10 mg twice-daily dose “had a high response rate as well.”
In fact, the ASAS20 response rate was 15.8% higher in the 2 mg group than in the placebo group, 22.9% higher in the 5 mg group, and 27.3% higher in the 10 mg group.
Table. Response Rates at 16 Weeks
|Criteria||Tofacitinib 2 mg Group||Tofacitinib 5 mg Group||Tofacitinib 10 mg Group||Placebo Group|