Summary of response rates in the six key randomised controlled studies evaluating rituximab and methotrexate
| Study | Response measure | 6 Months | 12 Months | ||||
|---|---|---|---|---|---|---|---|
| Plc + MTX | RTX (2×500 mg) + MTX | RTX (2×1000 mg) + MTX | Plc + MTX | RTX (2×500 mg) + MTX | RTX (2×1000 mg) + MTX | ||
| MTX-naive | |||||||
| IMAGE25 (n=755) | ACR 20 | 64.3 | 76.7 | 80.0 | |||
| ACR 50 | 41.8 | 59.4 | 64.8 | ||||
| ACR 70 | 24.9 | 42.2 | 46.8 | ||||
| EULAR (mod+good) | 71.1 | 82.3 | 86.0 | ||||
| DAS28 Rem | 12.6 | 25.4 | 30.5 | ||||
| MTX-IR | |||||||
| Phase IIa1 (n=80) | ACR 20 | 38.0 | 73.0 | 20.0 | 65.0 | ||
| ACR 50 | 13.0 | 43.0 | 5.0 | 35.0 | |||
| ACR 70 | 5.0 | 23.0 | 0 | 15.0 | |||
| EULAR (mod+good) | |||||||
| DAS28 Rem | |||||||
| SERENE24 (n=512) | ACR 20 | 23.3 | 54.5 | 50.6 | 55.7 | 57.6 | |
| ACR 50 | 9.3 | 26.3 | 25.9 | 32.9 | 34.1 | ||
| ACR 70 | 5.2 | 9.0 | 10.0 | 12.6 | 13.5 | ||
| EULAR (mod+good) | 50.0 | 82.0 | 87.0 | 89.0 | 81.0 | ||
| DAS28 Rem | 4.0 | 16.0 | 16.0 | 15.0 | 19.0 | ||
| MIRROR72 (n=227; excludes dose escalation group) | ACR 20 | 64.0 | 72.0 | ||||
| ACR 50 | 39.0 | 48.0 | |||||
| ACR 70 | 20.0 | 23.0 | |||||
| EULAR (mod+good) | 73.0 | 89.0 | |||||
| DAS28 Rem | 9.0 | 19.0 | |||||
| MTX±TNF-IR | |||||||
| DANCER2 (n=465) | ACR 20 | 28.0 | 55.0 | 54.0 | |||
| ACR 50 | 13.0 | 33.0 | 34.0 | ||||
| ACR 70 | 5.0 | 13.0 | 20 | ||||
| EULAR (mod+good) | 37.0 | 73.0 | 67.0 | ||||
| DAS28 Rem | |||||||
| TNF-IR | |||||||
| REFLEX3 | ACR 20 | 18.0 | 51.0 | ||||
| ACR 50 | 5.0 | 27.0 | |||||
| ACR 70 | 1.0 | 12.0 | |||||
| EULAR (mod+good) | 20.0 | 50.0 | |||||
| DAS28 Rem | 0 | 9.0 | |||||
ACR, American College of Rheumatology; DAS28, disease activity score 28; EULAR, European League Against Rheumatism; IR, inadequate-responder; mod, moderate; MTX, methotrexate; Plc, placebo; Rem, remission; RTX, rituximab; TNF, tumour necrosis factor.