at the end of the open label phase), the duration of morning stiffness was reduced from baseline by about 50%, and 37% of patients achieved improvement according to the ACR20
The study met its two primary endpoints, which were the proportion of people who achieved an ACR20
response at week 12 and the change from baseline in DAS28 at week 12.
The one year AMPLE data met its primary endpoint as measured by non-inferiority of ACR20
To qualify for an ACR20
, some criteria should be satisfied.
In conclusion, the efficacy of tofacitinib in all reported trials to date is significant when compared to a placebo group with ACR20
, 50, and 70 responses after treatment intervals of 12 to 24 weeks and promise of improvements has been seen in other areas measuring disease activity, such as HAQ and DAS scores as well as radiographic progression.
Planned 12-month analyses show that tofacitinib met all primary efficacy endpoints at the 10 mg BID dose, significantly reducing signs and symptoms of RA, as measured by ACR20
response rates at six months; reducing progression of structural damage, as measured by mean change from baseline in modified Total Sharp Score (mTSS) at six months; improving physical function, as measured by mean change in HAQ-DI at three months; and reducing disease activity, as measured by rates of DAS28-4(ESR) <2.
61 percent of patients who received ACTEMRA 8mg/kg plus DMARD(s) achieved ACR20
at Week 24, compared with 25 percent of patients treated with DMARDs plus placebo
In phase 2 clinical trials, the ACR20
response criteria should be preferred, since the number of patients needed according to this parameter is lower than the one needed according to the indices referring to the status.
response rates of 46 percent, 76 percent, 81 percent and 82 percent were observed for people who received 25 mg, 50 mg, 100 mg and 150 mg of VX-509, respectively, compared to 41 percent in the placebo arm.
Between 50% to 54% of secukinumab patients achieved ACR20
in both FUTURE 1 (p<0.
, ACR50 and ACR70 was achieved in 61%, 38% and 21%, respectively, of Actemra plus DMARDs patients versus 25%, 9% and 3%, respectively, in the placebo plus DMARDs arm.
The ORAL Scan study met all primary endpoints at the 10 mg BID dose, showing statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20
response rates at six months; in reducing the progression of structural damage, as measured by change from baseline in modified Total Sharp Score (mTSS) at six months; in improving physical function, as measured by mean change in HAQ DI at three months; and in reaching DAS28-4(ESR) <2.