Additional efficacy outcomes at week 24
| FIL 200 mg+MTX n=416 | FIL 100 mg+MTX n=207 | FIL 200 mg n=210 | MTX n=416 | |
| DAS28(CRP) change from baseline | ||||
| N | 374 | 190 | 183 | 368 |
| Mean±SD | −3.2±1.3 | −2.9±1.3 | −3.0±1.2 | −2.5±1.3 |
| LSM difference versus MTX (95% CI) | −0.8 (−0.9 to –0.6) | −0.5 (−0.7 to –0.3) | −0.5 (−0.7 to –0.3) | |
| Exploratory P versus MTX | <0.001 | <0.001 | <0.001 | |
| CDAI change from baseline | ||||
| N | 372 | 187 | 184 | 364 |
| Mean±SD | −31.3±13.2 | −30.0±13.3 | −31.3±12.6 | −28.2±13.4 |
| LSM difference versus MTX (95% CI) | −4.1 (−5.3 to –2.9) | −2.8 (−4.3 to –1.3) | −2.9 (−4.4 to –1.4) | |
| Exploratory P versus MTX | <0.001 | <0.001 | <0.001 | |
| SDAI change from baseline | ||||
| N | 372 | 187 | 183 | 362 |
| Mean±SD | −32.7±13.8 | −31.1±14.1 | −32.7±13.1 | −29.0±14.1 |
| LSM difference versus MTX (95% CI) | −4.6 (−5.9 to –3.4) | −3.1 (−4.6 to –1.6) | −3.4 (−4.9 to –1.9) | |
| Exploratory P versus MTX | <0.001 | <0.001 | <0.001 | |
| SJC66 change from baseline | ||||
| N | 374 | 190 | 186 | 370 |
| Mean±SD | −14±8.9 | −14±8.8 | −15±9.5 | −13±8.8 |
| LSM difference versus MTX (95% CI) | −2 (−2 to –1) | −2 (−2 to –1) | −2 (−3 to –1) | |
| Exploratory P versus MTX | <0.001 | <0.001 | <0.001 | |
| TJC68 change from baseline | ||||
| N | 374 | 190 | 186 | 370 |
| Mean±SD | −20±12.5 | −20±13.0 | −22±12.4 | −19±12.9 |
| LSM difference versus MTX (95% CI) | −2 (−3 to –1) | −2 (−3 to –1) | −3 (−4 to –1) | |
| Exploratory P versus MTX | <0.001 | 0.005 | <0.001 | |
| Patient global assessment change from baseline | ||||
| N | 374 | 190 | 184 | 370 |
| Mean±SD | −42±26.8 | −36±27.4 | −38±26.6 | −34±27.4 |
| LSM difference versus MTX (95% CI) | −9 (−13 to –6) | −3 (−7 to 1) | −4 (−8 to 0) | |
| Exploratory P versus MTX | <0.001 | 0.11 | 0.066 | |
| Physician global assessment change from baseline | ||||
| N | 372 | 187 | 185 | 364 |
| Mean±SD | −51±21.1 | −51±22.2 | −49±19.5 | −46±21.4 |
| LSM difference versus MTX (95% CI) | −5 (−8 to –3) | −4 (−7 to –1) | −3 (−6 to 0) | |
| Exploratory P versus MTX | <0.001 | 0.007 | 0.046 | |
| Patient pain change from baseline | ||||
| N | 372 | 190 | 185 | 370 |
| Mean±SD | −41±28.0 | −37±27.8 | −39±26.1 | −34±27.6 |
| LSM difference versus MTX (95% CI) | −9 (−12 to –5) | −3 (−7 to 1) | −4 (−8 to 0) | |
| Exploratory P versus MTX | <0.001 | 0.13 | 0.047 | |
| hsCRP change from baseline | ||||
| N | 374 | 190 | 186 | 368 |
| Mean±SD | −13.4±27.1 | −10.9±24.5 | −12.7±24.5 | −7.5±23.5 |
| LSM difference versus MTX (95% CI) | −5.3 (−7.2 to –3.3) | −3.3 (−5.7 to –0.9) | −4.6 (−7.0 to –2.2) | |
| Exploratory P versus MTX | <0.001 | 0.007 | <0.001 | |
CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS28(CRP), Disease Activity Score in 28 joints with CRP; FIL, filgotinib; hsCRP, high-sensitivity CRP; LSM, least-squares mean; MTX, methotrexate; SDAI, Simplified Disease Activity Index; SJC66, swollen joint count based on 66 joints; TJC68, tender joint count based on 68 joints.