ACR 20 Response

ACR 20 Response

A measure—based on American College of Rheumatology criteria—of at least a 20% improvement in the number of tender and swollen joints, and a 20% improvement in at least 3 of the following: the patient’s global assessment of disease status; the patient’s assessment of pain; the patient’s assessment of function—measured using the Stanford Health Assessment Questionnaire; the physician’s global assessment of disease status; serum C-reactive protein levels.
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These data follow initial results that showed 58 percent of patients treated with TREMFYA achieved an ACR 20 response at week 24, the primary endpoint of the study, compared with 18.
These data follow initial results that showed 58% of patients treated with Tremfya achieved an ACR 20 response at week 24, the primary endpoint of the study, compared with 18.
Nearly half (47%) of first-time switchers met the primary outcome measure--an ACR 20 response at 3 months--compared with only 22% of second-time switchers, the investigators said (J Rheumatol.
Otezla treatment with or without concomitant Dmards, compared with placebo with or without concomitant Dmards, resulted in greater improvement in the signs and symptoms of psoriatic arthritis, as demonstrated by the proportion of patients with an ACR 20 response at week 16.
In a phase 2 placebo-controlled study exploring the effect of several doses of IV abatacept in 170 patients with PsA, ACR 20 response was achieved by 48% of those receiving the RA-labeled dose of 10 mg/kg at 6 months.
Overall, 67% of patients in the R788 twice-daily, 100-mg dose group registered an ACR 20 response at 6 months; in the once-daily, 150-mg group, the response rate was 57%.
The primary efficacy endpoint of this study is to determine the percent of patients with ACR 20 response at the end of 12 weeks.
An ACR 20 response is defined as a reduction of at least 20% in the number of tender and swollen joints plus an improvement of at least 20% in at least three of the following five criteria: patient's assessment of pain, patient's assessment of disease activity, physician's assessment of disease activity, patient's assessment of physical function, and serum C-reactive protein concentration.
The primary endpoint will be the rate of ACR 20 response at week 26.
Of 28 patients treated with this interleukin 1 receptor antagonist after failing a TNF blocker, only 8% achieved an ACR 20 response, and no patients achieved an ACR 50 or ACR 70 response, she said.
The primary endpoint of ACQUIRE was to determine non-inferiority of ORENCIA SC plus methotrexate (MTX) to ORENCIA IV plus MTX by difference in ACR 20 response at 6 months.
The approval was based on results from two randomized, double-blind, placebo-controlled studies (Studies PSA-I and PSA-II) in which a higher proportion of patients achieved an ACR 20 response, the primary endpoint, after treatment with ORENCIA 10 mg/kg intravenous (IV) or 125 mg subcutaneous injection (SC) compared to placebo at Week 24: 47.