Supplementary Table 6.
Odds ratios for secukinumab 150 mg and adalimumab 40 mg using a possible statistical interpretation in acknowledgment of the American Statistical Association guidance
| Principal analysis (SEC vs. ADA) | Sensitivity analysis (SEC vs. ADA) | ||||||
|---|---|---|---|---|---|---|---|
|
|
|
||||||
| ASAS 20 | ASAS 40 | ASAS 5/6 | ASAS PR | ASAS 20 | ASAS 40 | ASAS 5/6 | ASAS PR |
| Week 8 (placebo-adjusted) | |||||||
| 0.91 (0.44–1.89) p=0.795 | NR | NR | NR | 0.99 (0.47–2.06) p=0.971 | NR | NR | NR |
| Week 12 (placebo-adjusted) | |||||||
| 0.60 (0.28–1.28) p=0.185 | 0.93 (0.39–2.21) p=0.867 | 0.50 (0.22–1.18) p=0.115 | 0.97 (0.23–4.04) p=0.961 | 0.67 (0.31–1.44) p=0.304 | 0.96 (0.40–2.30) p=0.927 | 0.52 (0.22–1.21) p=0.129 | 0.97 (0.23–4.08) p=0.972 |
| Week 16 (non-placebo-adjusted) | |||||||
| 1.60 (1.01–2.54) p=0.047 | NR | NR | NR | 1.70 (1.06–2.73) p=0.028 | NR | NR | NR |
| Week 24 (non-placebo-adjusted) | |||||||
| 1.76 (1.11–2.79) p=0.017 | 1.79 (1.14–2.82) p=0.012 | 1.51 (0.96–2.38) p=0.072 | 1.34 (0.80–2.25) p=0.265 | 1.87 (1.17–3.01) p=0.009 | 1.85 (1.17–2.94) p=0.009 | 1.55 (0.98–2.46) p=0.060 | 1.37 (0.81–2.31) p=0.239 |
| Week 52 (non-placebo-adjusted) | |||||||
| 1.48 (0.98–2.22) p=0.062 | 1.54 (1.06–2.23) p=0.023 | 1.42 (0.97–2.07) p=0.072 | 0.71 (0.47–1.08) p=0.110 | 1.53 (1.00–2.34) p=0.048 | 1.52 (1.04–2.23) p=0.031 | 1.40 (0.95–2.07) p=0.089 | 0.72 (0.47–1.11) p=0.137 |
Data are OR (95% CI). We avoid strict thresholds when interpreting statistical p values, as per the American Statistical Association definition (7 March 2016) (25), but loosely interpret p values (two-sided) between 0.1 and 0.001 as increasing evidence (weak through moderate to strong) and p values (two-sided) below 0.001 as strong evidence (27). All p values (two-sided) are shown. Italic format indicates differences with p values between 0.1 and 0.001. At week 52, SEC populations were pooled (i.e., patients receiving active treatment plus those switching to active treatment from placebo) and missing data were derived using LOCF imputation to match the ADA patient population in ATLAS
ADA: adalimumab, ASAS 20/40: 20%/40% improvement in the Assessment of SpondyloArthritis International Society response criteria, ASAS 5/6: 20% improvement in any five of the six domains in the Assessment of SpondyloArthritis International Society response criteria, ASAS PR: Assessment of SpondyloArthritis International Society partial remission, CI: confidence interval, LOCF: last observation carried forward, NR: not reported, OR: odds ratio, SEC: secukinumab