Primary and key secondary efficacy outcomes at week 24
| FIL | MTX | Difference versus MTX* | P value versus MTX | |
| Primary outcome | ||||
| ACR20, FIL200+MTX versus MTX | ||||
| n/N | 337/416 | 297/416 | ||
| % (95% CI) | 81.0 (77.1 to 84.9) | 71.4 (66.9 to 75.9) | 9.6 (3.6 to 15.6) | <0.001† |
| Key secondary outcomes, hierarchically tested | ||||
| ACR20, FIL100+MTX versus MTX | ||||
| n/N | 166/207 | 297/416 | ||
| % (95% CI) | 80.2 (74.5 to 85.9) | 71.4 (66.9 to 75.9) | 8.8 (1.5 to 16.1) | 0.017† |
| HAQ-DI change from baseline, FIL200+MTX versus MTX | ||||
| N | 372 | 370 | ||
| Mean±SD | −0.94±0.72 | −0.79±0.63 | −0.2 (−0.3, –0.1) | <0.001† |
| HAQ-DI change from baseline, FIL100+MTX versus MTX | ||||
| N | 190 | 370 | ||
| Mean±SD | −0.90±0.68 | −0.79±0.63 | −0.1 (−0.2, 0.0) | 0.008† |
| DAS28(CRP) <2.6, FIL200+MTX versus MTX | ||||
| n/N | 225/416 | 121/416 | ||
| % (95% CI) | 54.1 (49.2 to 59.0) | 29.1 (24.6 to 33.6) | 25.0 (18.3 to 31.7) | <0.001† |
| DAS28(CRP) <2.6, FIL100+MTX versus MTX | ||||
| n/N | 88/207 | 121/416 | ||
| % (95% CI) | 42.5 (35.5 to 49.5) | 29.1 (24.6 to 33.6) | 13.4 (5.0 to 21.8) | <0.001† |
| ACR20, FIL200 versus MTX | ||||
| n/N | 164/210 | 297/416 | ||
| % (95% CI) | 78.1 (72.3 to 83.9) | 71.4 (66.9 to 75.9) | 6.7 (−0.7 to 14.1) | 0.058† |
| Key secondary outcomes after break in statistical testing hierarchy | ||||
| HAQ-DI change from baseline, FIL200 versus MTX. | ||||
| N | 185 | 370 | ||
| Mean±SD | −0.89±0.63 | −0.79±0.63 | −0.1 (−0.2, 0.0) | 0.029 |
| DAS28(CRP) <2.6, week 24, FIL200 versus MTX | ||||
| n/N | 89/210 | 121/416 | ||
| % (95% CI) | 42.4 (35.5 to 49.3) | 29.1 (24.6 to 33.6) | 13.3 (5.0 to 21.6) | <0.001 |
| mTSS change from baseline, FIL200+MTX versus MTX | ||||
| N | 355 | 356 | ||
| LSM (95% CI) | 0.1 (−0.2 to 0.4) | 0.4 (0.1 to 0.7) | −0.3 (−0.6 to 0.0) | 0.068 |
| mTSS change from baseline, FIL100+MTX versus MTX | ||||
| N | 184 | 356 | ||
| LSM (95% CI) | 0.1 (−0.2 to 0.5) | 0.4 (0.1 to 0.7) | −0.3 (−0.7 to 0.1) | 0.14 |
| mTSS change from baseline, FIL200 versus MTX | ||||
| N | 173 | 356 | ||
| LSM (95% CI) | −0.1 (−0.5 to 0.2) | 0.4 (0.1 to 0.7) | −0.6 (−0.9, 0.2) | 0.006 |
| SF-36 PCS change from baseline, FIL200+MTX versus MTX | ||||
| N | 373 | 371 | ||
| Mean±SD | 12.3±8.9 | 9.7±8.6 | 2.9 (1.8, 4.0) | <0.001 |
| SF-36 PCS change from baseline, FIL100+MTX versus MTX | ||||
| N | 190 | 371 | ||
| Mean±SD | 11.1±9.0 | 9.7±8.6 | 1.6 (0.3, 2.9) | 0.019 |
| SF-36 PCS change from baseline, FIL200 versus MTX | ||||
| N | 185 | 371 | ||
| Mean±SD | 10.4±9.1 | 9.7±8.6 | 0.8 (−0.5, 2.2) | 0.23 |
| FACIT-F change from baseline, FIL200+MTX versus MTX | ||||
| N | 365 | 365 | ||
| Mean±SD | 10.6±11.5 | 10.1±11.2 | 1.3 (−0.1, 2.6) | 0.061 |
| FACIT-F change from baseline, FIL100+MTX versus MTX | ||||
| N | 189 | 365 | ||
| Mean±SD | 11.4±11.3 | 10.1±11.2 | 1.3 (−0.3, 2.9) | 0.11 |
| FACIT-F change from baseline, FIL200 versus MTX | ||||
| N | 181 | 365 | ||
| Mean±SD | 10.2±11.4 | 10.1±11.2 | 0.3 (−1.3, 1.9) | 0.70 |
*Difference versus MTX (95% CI) for dichotomous outcomes and LSM difference versus MTX (95% CI) for continuous outcomes.
†P value adjusted for multiplicity. All other p values are exploratory.
ACR20, 20% improvement in American College of Rheumatology criteria; DAS28(CRP), Disease Activity Score in 28 joints with C-reactive protein; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; FIL100, filgotinib 100 mg; FIL200, filgotinib 200 mg; HAQ-DI, Health Assessment Questionnaire-Disability Index; LSM, least-squares mean; mTSS, Modified total Sharp/van der Heijde score; MTX, methotrexate; SF-36 PCS, Short Form-36 Physical Component Summary.