Table 2

Primary and key secondary efficacy outcomes during the placebo-controlled period*

FIL200
(n=475)
FIL100
(n=480)
ADA
(n=325)
PBO
(n=475)
Primary outcome
 ACR20, week 12
  n/N364/475335/480229/325237/475
  % (95% CI)76.6 (72.7 to 80.5)69.8 (65.6 to 74.0)70.5 (65.3 to 75.6)49.9 (45.3 to 54.5)
  Difference vs PBO (95% CI)†26.7 (20.6 to 32.8)19.9 (13.6 to 26.2)20.6 (13.6 to 27.5)
  P value vs placebo<0.001<0.001<0.001‡
Key secondary outcomes with hierarchical testing
 HAQ-DI change from baseline to week 12
  N457459311435
  Mean±SD−0.69±0.61−0.56±0.56−0.61±0.56−0.42±0.54
  Difference vs PBO (95% CI)†−0.29 (−0.36 to −0.22)−0.17 (−0.24 to −0.10)−0.20 (−0.28 to −0.13)
  P value vs PBO<0.001<0.001<0.001‡
 DAS28(CRP) <2.6, week 12
  n/N162/475114/48077/32544/475
  % (95% CI)34.1 (29.7 to 38.5)23.8 (19.8 to 27.7)23.7 (18.9 to 28.5)9.3 (6.6 to 12.0)
  Difference vs PBO (95% CI)†24.8 (19.6 to 30.0)14.5 (9.7 to 19.3)14.4 (8.9 to 20.0)
  P value vs PBO<0.001<0.001<0.001‡
 mTSS change from baseline to week 24
  N405404271351
  Mean±SD0.13±0.90.17±0.910.16±0.950.37±1.42
  Difference vs PBO (95% CI)†−0.27 (−0.43 to −0.12)−0.25 (−0.40 to −0.10)−0.22 (−0.39 to −0.05)
  P value vs PBO<0.0010.0010.012‡
 Non-inferiority DAS28(CRP) ≤3.2, week 12
  n/N236/475186/480141/325111/475
  % (95% CI)49.7 (45.1 to 54.3)38.8 (34.3 to 43.2)43.4 (37.8 to 48.9)23.4 (19.5 to 27.3)
  P value vs ADA<0.0010.054
Key secondary outcomes without multiplicity adjustment
 SF-36 PCS change from baseline to week 12
  N459463310440
  Mean±SD9.2±8.18.5±7.78.4±7.95.8±7.1
  Difference vs PBO (95% CI)†3.7 (2.8 to 4.6)3.1 (2.2 to 4.0)2.6 (1.6 to 3.6)
  Exploratory p value vs PBO<0.001<0.001<0.001
 FACIT-F change from baseline to week 12
  N452455304432
  Mean±SD9.2±9.89.1±10.28.8±9.26.8±9.9
  Difference vs PBO (95% CI)†2.8 (1.7 to 3.9)2.6 (1.5 to 3.7)2.1 (0.9 to 3.3)
  Exploratory p value vs PBO<0.001<0.001<0.001
 Superiority DAS28(CRP) ≤3.2, week 12
  Difference vs ADA (95% CI)†6.3 (−1.0 to 13.6)−4.6 (−11.8 to 2.6)
  Exploratory p value vs ADA0.0690.18
 Non-inferiority DAS28(CRP) <2.6, week 12
  Exploratory p value vs ADA<0.0010.002
 Superiority DAS28(CRP) <2.6, week 12
  Difference vs ADA (95% CI)†10.4 (3.9 to 17.0)0.1 (−6.2 to 6.3)
  Exploratory p value vs ADA0.0010.99
  • *Hierarchical testing according to prespecified, US Food and Drug Administration-reviewed, statistical analysis plan. Patients who had missing values were defined as non-responders, and NRI was employed for both primary and key secondary analyses.

  • †Difference in response rates vs placebo or ADA for categorical outcomes; least-squares mean difference vs placebo or ADA for continuous outcomes.

  • ‡Exploratory p value without multiplicity adjustment.

  • ACR20, American College of Rheumatology criteria 20% decrease from baseline; ADA, adalimumab; 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; mTSS, van der Heijde modified total Sharp score; NRI, non-responder imputation; PBO, placebo; SF-36 PCS, Short Form 36 Physical Component Summary.