05) * Placebo: 41 percent ACR50
* 8 mg: 40 percent (p<0.
ACR20 or ACR50
does not provide optimal improvement in outcomes.
At the end of 6 months, 71% of the patients in the combination group demonstrated ACR20 and 39% ACR50
responses, compared with 27% (ACR20) and 3% (ACR50
) in the MTX-only group.
In the MTX-inadequate responder population, ACR20 responses up to 82 percent and ACR50
responses up to 50 percent
and ACR70 scores refer to a 50% and 70% improvement respectively.
At 12 and 24 weeks, the ACR50
response rates were significantly higher in the adalimumab arm than in the placebo arm, and a significant difference in ACR 70 responses was also evident," they said, adding that ACR responses developed rapidly, "with statistically significant between-group differences in the ACR20 and ACR50
responses observed at week 2"; 27% vs.
Secondary endpoints, including ACR20 and ACR50
responses, DAS-defined remission (DAS28-4(ESR) <2.
Other measures included ACR50
and ACR70, which represent 50 percent and 70 percent reductions in disease activity.
, 70, and 90, considered to be more stringent measures of efficacy, as well as DAS-28-CRP, also were assessed over 24 months and found to be similar between the two arms.
A higher level of ACR20 and ACR50
responses was seen in patients randomized to MTX plus cyclosporine than to MTX monotherapy.
Compared with methotrexate + placebo, patients on methotrexate + infliximab had far fewer MRI sites of erosion, far lower MRI global synovitis scores, and significantly greater ACR50
and ACR70 response at 52 weeks.
Statistical significance was also achieved on other key secondary endpoints including ACR50
and 70, DAS28 low disease activity and DAS28 remission.