Efficacy assessments and disease activity assessments at weeks 12 and 24 (NRI (ITT population) and LOCF (ITT population))
| Filgotinib once-daily dose groups | Filgotinib twice-daily dose groups | ||||||
|---|---|---|---|---|---|---|---|
| Time point | Placebo (N=86) | 50 mg (N=82) | 100 mg (N=85) | 200 mg (N=86) | 2×25 mg (N=86) | 2×50 mg (N=85) | 2×100 mg (N=84) |
| ACR20† | |||||||
| Week 12, n (%) | 38 (44.2) | 46 (56.1) | 54 (63.5)* | 59 (68.6)** | 49 (57.0) | 51 (60.0) | 66 (78.6)*** |
| Week 24, n (%) | 36 (41.9) | 45 (54.9)* | 52 (61.2)*** | 63 (73.3) | 48 (55.8) | 51 (60.0)* | 67 (79.8)*** |
| ACR50† | |||||||
| Week 12, n (%) | 13 (15.1) | 27 (32.9)* | 32 (37.6)** | 37 (43.0)*** | 24 (27.9)* | 29 (34.1)* | 46 (54.8)*** |
| Week 24, n (%) | 14 (16.3) | 29 (35.4)** | 40 (47.1)*** | 43 (50.0)*** | 30 (34.9)** | 30 (35.3)** | 46 (54.8)*** |
| ACR70† | |||||||
| Week 12, n (%) | 7 (8.1) | 13 (15.9) | 18 (21.2) | 21 (24.4)* | 12 (14.0) | 16 (18.8) | 26 (31.0)** |
| Week 24, n (%) | 8 (9.3) | 18 (22.0)* | 28 (32.9)** | 25 (29.1)** | 18 (20.9)* | 20 (23.5)* | 33 (39.3)*** |
| ACR-N‡ | |||||||
| Week 12, mean (SE) | 23.09 (2.911) | 34.03 (3.335)* | 39.87 (3.449)*** | 42.10 (3.277)*** | 34.12 (3.144)* | 35.86 (3.290)** | 51.17 (3.379)*** |
| Week 24, mean (SE) | 22.06 (2.846) | 37.13 (3.582)** | 50.86 (3.645)*** | 50.40 (3.291)*** | 38.56 (3.384)*** | 40.50 (3.299)*** | 58.69 (3.204)*** |
| CRP‡ | |||||||
| Week 12, mean (SE), mg/L | 2.67 (2.219) | −13.15 (2.890)* | −13.57 (2.771)*** | −17.24 (3.322)*** | −10.26 (2.873)* | −12.97 (2.277)** | −20.54 (2.665)*** |
| Week 24, mean (SE), mg/L | 2.00 (1.776) | −15.22 (3.316)** | −14.89 (2.712)*** | −15.57 (4.112)** | −11.68 (3.020)* | −11.96 (2.488)* | −20.82 (2.264)*** |
| Change from baseline in TJC68‡ | |||||||
| Week 12, mean (SE) change | −9.2 (1.35) | −12.2 (1.34)* | −14.1 (1.33)** | −17.6 (1.33)*** | −14.2 (1.37)** | −15.0 (1.37)** | −18.0 (1.31)*** |
| Week 24, mean (SE) change | −8.9 (1.43) | −12.7 (1.42)* | −17.1 (1.32)*** | −20.6 (1.49)*** | −15.9 (1.51)*** | −18.1 (1.44)*** | −21.4 (1.38)*** |
| Change from baseline in SJC66‡ | |||||||
| Week 12, mean (SE) change | −7.6 (0.89) | −8.5 (1.01) | −9.8 (0.97) | −11.0 (0.95)* | −8.8 (0.87) | −11.0 (1.10) | −12.2 (0.84)*** |
| Week 24, mean (SE) change | −7.3 (1.00) | −9.2 (1.05) | −12.6 (0.91)*** | −13.2 (0.87)*** | −10.2 (0.93)** | −12.9 (1.29)*** | −13.8 (0.85)*** |
| Change from baseline in HAQ-DI | |||||||
| Week 12, mean (SE) change | −0.383 (0.0691) | −0.577 (0.789) | −0.653 (0.0728)* | −0.753 (0.0648)*** | −0.590 (0.0659) | −0.584 (0.0677) | −0.840 (0.0726)*** |
| Week 24, mean (SE) change | −0.365 (0.0671) | −0.633 (0.0795)** | −0.783 (0.0761)*** | −0.818 (0.0675)*** | −0.618 (0.0660)** | −0.659 (0.0702)** | −0.903 (0.0813)*** |
| Change from baseline in DAS28 (CRP)‡ | |||||||
| Week 12, mean (SE) decrease | −1.19 (0.148) | −1.75 (0.152)** | −2.23 (0.151)*** | −2.47 (0.136)*** | −1.88 (0.145)** | −2.10 (0.161)*** | −2.84 (0.146)*** |
| Week 24, mean (SE) decrease | −1.18 (0.163) | −1.98 (0.179)*** | −2.70 (0.156)*** | −2.80 (0.139)*** | −2.19 (0.157)*** | −2.40 (0.175)*** | −3.23 (0.138)*** |
| DAS28 (CRP) LDA‡ | |||||||
| Week 12, n (%) | 6 (7.0) | 10 (12.2) | 10 (11.8) | 13 (15.1) | 11 (12.8) | 9 (10.6) | 12 (14.3) |
| Week 24, n (%) | 8 (9.3) | 10 (12.2) | 12 (14.1) | 22 (25.6) | 14 (16.3) | 12 (14.1) | 20 (23.8) |
| DAS28 (CRP) remission‡ | |||||||
| Week 12, n (%) | 6 (7.0) | 10 (12.2) | 19 (22.4)* | 19 (22.1)* | 13 (15.1) | 15 (17.6) | 30 (35.7)*** |
| Week 24, n (%) | 8 (9.3) | 17 (20.7)* | 31 (36.5)*** | 22 (25.6)* | 20 (23.3)* | 20 (23.5)* | 34 (40.5)*** |
| DAS28 (CRP) remission/LDA‡ | |||||||
| Week 12, n (%) | 12 (14.0) | 20 (24.4) | 29 (34.1)** | 32 (37.2)** | 24 (27.9) | 24 (28.2)* | 41 (50.0)*** |
| Week 24, n (%) | 16 (18.6) | 27 (32.9)* | 43 (50.6)*** | 44 (51.2)*** | 34 (39.5)** | 32 (37.6)* | 54 (64.3)*** |
| DAS 28 (CRP) EULAR response‡ | |||||||
| Week 12, n (%) | |||||||
| Moderate | 39 (45) | 36 (44) | 41 (48) | 47 (55) | 38 (44) | 48 (56) | 36 (43) |
| Good | 12 (14) | 19 (23) | 29 (34)** | 32 (37)*** | 24 (28)* | 24 (28)** | 42 (50)*** |
| Week 24, n (%) | |||||||
| Moderate | 29 (34) | 29 (35) | 32 (38) | 33 (38) | 32 (37) | 42 (49) | 26 (31) |
| Good | 16 (19) | 26 (32) | 43 (51)*** | 44 (51)*** | 34 (40)** | 31 (36)*** | 54 (64)*** |
| ACR/EULAR remission† | |||||||
| Week 12, n (%) | 3 (3.5) | 3 (3.7) | 3 (3.5) | 5 (5.8) | 4 (4.7) | 4 (4.7) | 8 (9.5) |
| Week 24, n (%) | 1 (1.2) | 9 (11.0) | 7 (8.2) | 10 (11.6) | 5 (5.8) | 3 (3.5) | 16 (19.0)* |
| Change from baseline in SDAI‡ | |||||||
| Week 12, mean (SE) decrease | −16.3 (1.84) | −21.0 (1.84)* | −25.2 (1.69)*** | −27.2 (1.55)*** | −22.3 (1.71)* | −24.5 (1.87)*** | −30.6 (1.57)*** |
| Week 24, mean (SE) decrease | −15.8 (2.00) | −22.8 (2.07)** | −30.1 (1.66)*** | −31.0 (1.62)*** | −24.9 (1.85)*** | −27.9 (2.00)*** | −34.4 (1.47)*** |
| SDAI LDA‡ | |||||||
| Week 12, n (%) | 8 (9.3) | 19 (23.2) | 22 (25.9) | 23 (26.7) | 19 (22.1) | 18 (21.2) | 27 (32.1) |
| Week 24, n (%) | 17 (19.8) | 17 (20.7) | 32 (37.6) | 29 (33.7) | 29 (33.7) | 27 (31.7) | 34 (40.5) |
| SDAI remission† | |||||||
| Week 12, n (%) | 4 (4.7) | 6 (7.3) | 6 (7.1) | 10 (11.6) | 7 (8.1) | 8 (9.4) | 14 (16.7) |
| Week 24, n (%) | 1 (1.2) | 13 (15.9)* | 13 (15.3)* | 12 (14.0)* | 10 (11.6)* | 12 (14.1)* | 16 (19.0)* |
| Change from baseline in CDAI‡ | |||||||
| Week 12, mean (SE) decrease | −16.6 (1.84) | −19.7 (1.77) | −23.8 (1.66)** | −25.5 (1.50)*** | −21.3 (1.65)* | −23.2 (1.81)** | −28.5 (1.49)*** |
| Week 24, mean (SE) decrease | −16.0 (1.95) | −21.3 (1.97)** | −28.6 (1.63)*** | −29.4 (1.50)*** | −23.8 (1.75)*** | −26.7 (1.90)*** | −32.4 (1.39)*** |
| CDAI LDA‡ | |||||||
| Week 12, n (%) | 13 (15.1) | 20 (24.4) | 20 (23.5) | 23 (26.7) | 16 (18.6) | 19 (22.4) | 27 (32.1) |
| Week 24, n (%) | 16 (18.6) | 15 (18.3) | 24 (28.2) | 28 (32.6) | 27 (31.4) | 25 (29.4) | 30 (35.7) |
| CDAI remission† | |||||||
| Week 12, n (%) | 2 (2.3) | 6 (7.3) | 7 (8.2) | 9 (10.5) | 9 (10.5) | 7 (8.2) | 15 (17.9)* |
| Week 24, n (%) | 2 (2.3) | 15 (18.3)* | 18 (21.2)** | 13 (15.1)* | 11 (12.8)* | 13 (15.3)* | 16 (19.0)** |
*p<0.05; **p<0.01; ***p<0.001.
†NRI (ITT population).
‡LOCF (ITT population).
ACR, American College of Rheumatology; ACR-N, American College of Rheumatology N% improvement; CDAI, Clinical Disease Activity Index; DAS28 (CRP), Disease Activity Score based on 28 joints and C reactive protein value; EULAR, European League Against Rheumatism; HAQ-DI, Health Assessment Questionnaire-Disability Index; ITT, intent-to-treat; LDA, low-disease activity; LOCF, last observation carried forward; N, number of patients per group; n, number of patients with response/change; NRI, non-responder imputation; SDAI, Simplified Disease Activity Index; SJC66, swollen joint count based on 66 joints; TJC68, tender joint count based on 68 joints.