Filgotinib once daily | ||||
---|---|---|---|---|
Placebo N=72 | 50 mg N=72 | 100 mg N=70 | 200 mg N=69 | |
ACR20† | ||||
W12, n (%) | 21 (29.2) | 48 (66.7)*** | 46 (65.7)*** | 50 (72.5)*** |
W24, n (%) | – | 41 (56.9) | 55 (78.6) | 46 (66.7) |
ACR50† | ||||
W12, n (%) | 8 (11.1) | 25 (34.7)*** | 26 (37.1)*** | 30 (43.5)*** |
W24, n (%) | – | 24 (33.3) | 27 (38.6) | 31 (44.9) |
ACR70† | ||||
W12, n (%) | 2 (2.8) | 6 (8.3) | 13 (18.6)** | 9 (13.0)* |
W24, n (%) | – | 14 (19.4) | 18 (25.7) | 17 (24.6) |
ACR-N‡ | ||||
W12, mean change (SE) | 16.28 (2.723) | 35.03 (3.178)*** | 38.35 (3.533)*** | 41.00 (3.477)*** |
W24, mean change (SE) | – | 38.75 (3.748) | 46.32 (3.295) | 46.78 (3.648) |
CRP‡ | ||||
W12, mean change (SE), mg/L | −8.71 (4.273) | −4.43 (4.741) | −12.25 (4.516)* | −14.85 (2.680)** |
W24, mean change (SE), mg/L | – | −9.16 (3.119) | −14.81 (4.211) | −15.17 (2.515) |
TJC68‡ | ||||
W12, mean change (SE) | −5.8 (1.48) | −12.7 (1.38)*** | −15.1 (1.53)*** | −17.4 (1.48)*** |
W24, mean change (SE) | – | −13.9 (1.48) | −20.3 (1.64) | −19.1 (1.55) |
TJC28‡ | ||||
W12, mean change (SE) | −4.1 (0.88) | −7.6 (0.80)*** | −8.8 (0.95)*** | −10.7 (0.86)*** |
W24, mean change (SE) | – | −8.0 (0.80) | −12.0 (0.85) | −11.5 (0.89) |
SJC66‡ | ||||
W12, mean change (SE) | −4.1 (1.22) | −9.3 (1.00)*** | −11.4 (1.20)*** | −10.5 (0.98)*** |
W24, mean change (SE) | – | −10.2 (1.12) | −13.8 (1.20) | −11.9 (0.95) |
SJC28‡ | ||||
W12, mean change (SE) | −3.7 (0.78) | −7.2 (0.72)*** | −8.1 (0.79)*** | −7.4 (0.66)*** |
W24, mean change (SE) | −7.6 (0.76) | −9.6 (0.68) | −8.6 (0.64) | |
DAS28 (CRP)‡ | ||||
W12, mean change (SE) | −0.99 (0.162) | −1.75 (0.145)*** | −2.04 (0.162)*** | −2.32 (0.155)*** |
W24, mean change (SE) | – | −1.95 (0.168) | −2.61 (0.163) | −2.62 (0.165) |
DAS28 (CRP) LDA‡ | ||||
W12, n (%) | 5 (7) | 8 (11) | 9 (13) | 19 (28) |
W24, n (%) | – | 12 (17) | 20 (29) | 13 (19) |
DAS28 (CRP) remission† | ||||
W12, n (%) | 5 (6.9) | 9 (12.5) | 10 (14.3) | 12 (17.4) |
W24, n (%) | – | 14 (19.4) | 15 (21.4) | 17 (24.6) |
DAS28 (CRP) remission/LDA† | ||||
W12, n (%) | 10 (13.9) | 17 (23.6) | 19 (27.1) | 31 (44.9)*** |
W24, n (%) | – | 25 (34.7) | 35 (50.0) | 29 (42.0) |
DAS28 (CRP) EULAR response‡§ | ||||
W12, n (%) | ||||
Moderate | 27 (38) | 33 (46) | 37 (53) | 28 (41) |
Good | 10 (14) | 17 (24)* | 19 (27)*** | 31 (45)*** |
W24, n (%) | ||||
Moderate | – | 26 (36) | 29 (41) | 30 (43) |
Good | – | 26 (36) | 35 (50) | 32 (46) |
ACR/EULAR remission† | ||||
W12, n (%) | 1 (1.4) | 1 (1.4) | 3 (4.3) | 3 (4.3) |
W24, n (%) | – | 6 (8.3) | 6 (8.6) | 6 (8.7) |
SDAI‡ | ||||
N | 71 | 70 | 70 | 68 |
W12, mean change (SE) | −12.6 (1.98) | −21.4 (1.80)*** | −25.3 (1.99)*** | −26.5 (1.75)*** |
W24, mean change (SE) | – | −23.2 (1.94) | −31.0 (1.77) | −29.6 (1.86) |
SDAI LDA‡ | ||||
W12, n (%) | 7 (10) | 20 (28) | 14 (20) | 23 (33) |
W24, n (%) | – | 21 (29) | 26 (37) | 26 (38) |
SDAI remission† | ||||
W12, n (%) | 2 (2.8) | 2 (2.8) | 5 (7.1) | 5 (7.2) |
W24, n (%) | – | 8 (11.1) | 8 (11.4) | 8 (11.6) |
CDAI‡ | ||||
W12, mean change (SE) | −11.7 (1.88) | −21.0 (1.72) | −24.0 (1.97) | −25.1 (1.74) |
W24, mean change (SE) | – | −22.3 (1.86) | −29.5 (1.69) | −28.1 (1.82) |
CDAI LDA‡ | ||||
W12, n (%) | 8 (11) | 21 (29) | 16 (23) | 21 (30) |
W24, n (%) | – | 20 (28) | 25 (36) | 23 (33) |
CDAI remission‡ | ||||
W12, n (%) | 2 (2.8) | 2 (2.8) | 4 (5.7) | 6 (8.7) |
W24, n (%) | – | 9 (12.5) | 8 (11.4) | 9 (13.0) |
HAQ-DI‡ | ||||
W12, mean change (SE) | −0.226 (0.07) | −0.661 (0.08)*** | −0.677 (0.08)*** | −0.739 (0.08)*** |
W24, mean change (SE) | −0.690 (0.09) | −0.786 (0.08) | −0.850 (0.08) |
*p<0.05; **p<0.01; ***p<0.001. Percentage responders was calculated based on the total number of subjects per group with a response (yes/no) at that time.
†NRI (ITT population).
‡LOCF (ITT population).
§Good: DAS28 (CRP) of ≤3.2 and improvement of >1.2; moderate: DAS28 (CRP) of >3.2 and improvement of >1.2 or DAS28 (CRP) of ≤5.1 and improvement of >0.6–1.2.
ACR, American College of Rheumatology; ACR-N, ACR N% improvement; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS-28, Disease Activity Score based on 28 joints and C reactive protein; HAQ-DI, Health Assessment Questionnaire-Disability Index; EULAR, European League Against Rheumatism; 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; SJC28, swollen joint count based on 28 joints; SJC66, swollen joint count based on 66 joints; TJC28, tender joint count based on 28 joints; TCJ68, tender joint count based on 68 joints.