Table 2.
Ratios of no radiographic progression (mTSS change ≤ 0.5) among MTX-IR patients [23]
| Estimated BL yearly progression, n | FIL200 + MTX | FIL100 + MTX | ADA + MTX | PBO + MTX | ||||
|---|---|---|---|---|---|---|---|---|
| e-RRP (n = 155) | e-NRRP (n = 320) | e-RRP (n = 155) | e-NRRP (n = 325) | e-RRP (n = 108) | e-NRRP (n = 217) | e-RRP (n = 140) | e-NRRP (n = 335) | |
| Percent with no radiographic progression at week 24 (95% CI) | 87.7% (81.8%, 93.5%) | 97.0% (94.8%, 99.2%) | 88.5% (82.8%, 94.2%) | 92.5% (89.1%, 95.8%) | 87.9% (80.7%, 95.2%) | 93.9% (90.1%, 97.7%) | 76.2% (67.4%, 85.0%) | 91.6% (88.0%, 95.2%) |
| OR for FIL vs MTX | 2.22 | 2.97 | 2.40 | 1.12 | NA | NA | NA | NA |
| p value vs MTX | 0.024 | 0.012 | 0.014 | 0.747 | NA | NA | NA | NA |
| p value vs ADA | 1.000 | 0.150 | 1.000 | 0.705 | NA | NA | NA | NA |
| p value (e-RRP vs e-NRRP) | < 0.001 | 0.200 | 0.100 | < 0.001 | ||||
| Estimated BL yearly progression, n | FIL200 + MTX | FIL100 + MTX | ADA + MTX | PBO + MTX to FIL200 + MTX | PBO + MTX to FIL100 + MTX | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| e-RRP (n = 155) | e-NRRP (n = 320) | e-RRP (n = 155) | e-NRRP (n = 325) | e-RRP (n = 108) | e-NRRP (n = 217) | e-RRP (n = 50) | e-NRRP (n = 140) | e-RRP (n = 57) | e-NRRP (n = 134) | |
| Percent with no radiographic progression at week 52 (95% CI) | 87.5% (81.6%, 93.4%) | 94.3% (91.4%, 97.2%) | 76.8% (69.4%, 84.2%) | 92.3% (89.0%, 95.7%) | 83.5% (75.3%, 91.7%) | 91.2% (86.8%, 95.6%) | 65.3% (51.0%, 79.7%) | 90.8% (85.5%, 96.2%) | 69.1% (56.0%, 82.2%) | 90.2% (84.6%, 95.9%) |
| OR for FIL vs ADA | 1.25 | 1.33 | 0.86 | 0.87 | NA | NA | NA | NA | NA | NA |
| p value vs ADA | 0.567 | 0.505 | 0.696 | 0.721 | NA | NA | NA | NA | NA | NA |
| p value (e-RRP vs e-NRRP) | 0.020 | < 0.001 | 0.069 | < 0.001 | < 0.001 | |||||
FAS includes patients who were randomized and received ≥ 1 dose of study drug. Observed case: Only observed values were used for analysis. No missing data imputation was performed. ORs between treatments at week 24 were calculated using a 2 × 2 table, and the 95% exact confidence limits were provided; week 24 p values between treatments and e-RRP and e-NRRP groups were based on Fisher’s exact test. Week 52 ORs and p values between treatments were based on a linear mixed effects model; week 52 p values between e-RRP and e-NRRP groups were based on Fisher’s exact test
Adapted from Tanaka et al. [23], Springer Nature (link to license)
ADA adalimumab, BL baseline, CI confidence interval, e-NRRP estimated nonrapid radiographic progression, e-RRP estimated rapid radiographic progression, FAS full analysis set, FIL filgotinib, FIL100 FIL 100 mg, FIL200 FIL 200 mg, IR inadequate response, mTSS modified total Sharp score, MTX methotrexate, NA not applicable, OR odds ratio, PBO placebo