ACR response criteria (ACR20/50/70)
Immunology· appears in 400+ cited findings in this library
What it is and how the reviews use it
ACR response criteria (ACR20/50/70) are a set of endpoints used in clinical trials, particularly for conditions like rheumatoid arthritis and juvenile idiopathic arthritis. These criteria measure the improvement in a patient's condition based on a combination of clinical and laboratory parameters. The numbers 20, 50, and 70 refer to the percentage of improvement observed, with ACR20 indicating at least a 20% improvement, ACR50 at least a 50% improvement, and ACR70 at least a 70% improvement. These endpoints are frequently used to assess the efficacy of treatments in regulatory review documents.
In the provided regulatory review documents, ACR response criteria are commonly reported as response rates, indicating the percentage of patients achieving a certain level of improvement. For instance, the Otezla FDA Review reported an ACR70 response rate of 1%, while the Skyrizi FDA Review noted an ACR20 response rate (%) of 33.5%. The Bimzelx EMA EPAR variation assessment report showed an ACR50 responder rate of 7.1%. These metrics serve as key indicators of treatment effectiveness in various clinical trials.
Real examples — cited to the source page
| AMGEN INC — Otezla | ACR70 response rate | 1 | Otezla FDA Review, p.18 |
| ABBVIE INC — Skyrizi | ACR20 response rate (%) | 33.5 | Skyrizi FDA Review, p.75 |
| UCB S A — Bimzelx | ACR50 responder rate | 7.1 | Bimzelx EMA EPAR variation assessment report, p.78 |
| Eli Lilly and Company — Olumiant | Assumed ACR20 response rate for placebo | 35 | Olumiant FDA Review, p.194 |
| JANSSEN BIOTECH — Simponi Aria | ACR 50 response | 35 | Simponi Aria FDA Review, p.26 |
| NOVARTIS PHARMS CORP — Cosentyx | JIA ACR 50 response | 79 | Cosentyx FDA Review, p.38 |
| Bristol-Myers Squibb Company — Sotyktu | ACR50 response rate | 24.7 | Sotyktu EMA EPAR variation assessment r, p.67 |
| GENENTECH — Actemra | JIA ACR 70 Responders | 71 | Actemra FDA Review, p.53 |
Different drugs were studied in different trials — these values are not head-to-head comparisons.
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Figures are as stated in the cited source documents. Educational reference only — not medical or investment advice.