Table 1.
FINCH 1 | ||||
FIL200+MTX (n=475) | FIL100+MTX (n=480) | ADA+MTX (n=325) | PBO+MTX (n=475) | |
Treatment duration* | 52 weeks | 52 weeks | 52 weeks | 24 weeks |
Duration of VAS pain score ≤10 mm | n=472 | n=475 | n=322 | n=474 |
Number of weeks: | ||||
mean (SD) | 13.2 (17.36) | 10.6 (15.32) | 10.1 (15.04) | 1.5 (3.77) |
median (min, max) | 0.7 (0, 52) | 0.1 (0, 50) | 0.0 (0, 50) | 0.0 (0, 22) |
% of total duration: | ||||
mean (SD) | 26.3 (34.18) | 21.6 (30.12) | 20.4 (30.07) | 6.2 (15.81) |
median (min, max) | 1.6 (0, 100) | 0.3 (0, 96) | 0.0 (0, 96) | 0.0 (0, 93) |
Duration of VAS pain score ≤20 mm | n=459 | n=467 | n=314 | n=467 |
Number of weeks: | ||||
mean (SD) | 20.5 (19.98) | 17.6 (18.27) | 17.1 (18.01) | 3.4 (5.82) |
median (min, max) | 14.6 (0, 52) | 10.2 (0, 51) | 11.9 (0, 51) | 0.0 (0, 24) |
% of total duration: | ||||
mean (SD) | 40.7 (38.82) | 35.6 (35.68) | 34.4 (35.33) | 14.4 (24.54) |
median (min, max) | 30.1 (0, 99) | 23.5 (0, 100) | 25.3 (0, 99) | 0.0 (0, 99) |
FINCH 2 | ||||
FIL200 (n=147) | FIL100 (n=153) | PBO (n=148) | ||
Treatment duration | 24 weeks | 24 weeks | 24 weeks | |
Duration of VAS pain score ≤10 mm | n=146 | n=150 | n=146 | |
Number of weeks: | ||||
mean (SD) | 3.7 (6.07) | 2.8 (5.68) | 1.0 (3.23) | – |
median (min, max) | 0.0 (0, 23) | 0.0 (0, 23) | 0.0 (0, 23) | |
% of total duration: | ||||
mean (SD) | 16.0 (25.93) | 11.6 (23.26) | 4.6 (14.73) | – |
median (min, max) | 0.0 (0, 97) | 0.0 (0, 89) | 0.0 (0, 93) | |
Duration of VAS pain score ≤20 mm | n=143 | n=146 | n=143 | |
Number of weeks: | ||||
mean (SD) | 7.3 (8.18) | 5.6 (7.99) | 2.3 (4.89) | – |
median (min, max) | 2.0 (0, 23) | 0.0 (0, 25) | 0.0 (0, 23) | |
% of total duration: | ||||
mean (SD) | 31.3 (34.64) | 23.5 (33.31) | 10.0 (21.29) | – |
median (min, max) | 13.1 (0, 96) | 0.0 (0, 96) | 0.0 (0, 95) | |
FINCH 3 | ||||
FIL200+MTX (n=416) | FIL100+MTX (n=207) | FIL200 (n=210) | MTX (n=416) | |
Treatment duration | 52 weeks | 52 weeks | 52 weeks | 52 weeks |
Duration of VAS pain score ≤10 mm | n=407 | n=203 | n=209 | n=411 |
Number of weeks: | ||||
mean (SD) | 16.4 (18.37) | 13.0 (17.97) | 12.5 (17.49) | 9.0 (14.10) |
median (min, max) | 7.4 (0, 52) | 0.0 (0, 51) | 0.6 (0, 51) | 0.0 (0, 50) |
% of total duration: | ||||
mean (SD) | 32.9 (35.63) | 26.4 (35.57) | 25.2 (34.32) | 17.8 (27.66) |
median (min, max) | 16.0 (0, 98) | 0.0 (0, 98) | 1.8 (0, 97) | 0.0 (0, 97) |
Duration of VAS pain score ≤20 mm | n=394 | n=199 | n=206 | n=397 |
Number of weeks: | ||||
mean (SD) | 23.5 (19.77) | 18.3 (19.39) | 18.8 (19.23) | 14.5 (17.08) |
median (min, max) | 22.1 (0, 52) | 10.9 (0, 52) | 11.8 (0, 52) | 4.4 (0, 52) |
% of total duration: | ||||
mean (SD) | 47.8 (38.17) | 37.2 (38.38) | 38.0 (37.62) | 28.9 (33.36) |
median (min, max) | 49.9 (0, 99) | 21.3 (0, 99) | 24.9 (0, 98) | 10.1 (0, 99) |
For each patient, the total duration of VAS pain score ≤10 or ≤20 mm (weeks) was defined as the sum of all time periods, where VAS score ≤threshold. Linear interpolation between study visits was used to determine the start and endpoints of these periods. For each patient, the percentage of time being ≤threshold was calculated by dividing the total duration of VAS pain score ≤10 or ≤20 mm by the time from first to last completion of VAS pain assessment.
*In FINCH 1, the efficacy data through week 52 were included for the filgotinib and adalimumab groups; the efficacy data through week 24 were included for the placebo group.
ADA, adalimumab; FIL100/200, filgotinib 100/200 mg; MTX, methotrexate; PBO, placebo; VAS, visual analogue scale.