Table 2.
Summary of primary and key secondary end points (ITT population; NRI)a
| Hypothesis | PASI 75 | PASI 90 | PASI 100 | sPGA (0,1) responseb | DLQI (0,1) response |
|---|---|---|---|---|---|
| FAEs (N = 54), n (%) | 12 (22) | 5 (9) | 2 (4) | 7 (13) [N = 53] | 8 (15) |
| MTX (N = 54), n (%) | 38 (70) | 21 (39) | 7 (13) | 27 (52) [N = 52] | 20 (37) |
| IXE (N = 54), n (%) | 49 (91) | 43 (80) | 22 (41) | 45 (87) [N = 52] | 34 (63) |
| IXE vs. FAE, OR (95% CI) | 34·3 (11·2–105) | 38·3 (12·3–119·0) | 17·9 (3·94–81·2) | 42·2 (13·7–131) | 9·78 (3·85–24·8) |
| Hochberg adjusted P‐value | < 0·001 | < 0·001 | < 0·001 | < 0·001 | < 0·001 |
| IXE vs. MTX, OR (95% CI) | 4·13 (1·39–12·3) | 6·14 (2·60–14·5) | 4·62 (1·76–12·1) | 5·95 (2·27–15·6) | 2·89 (1·32–6·31) |
| Hochberg adjusted P‐value | 0·014 | < 0·001 | 0·0041 | < 0·001 | 0·012 |
| MTX vs. FAE, OR (95% CI) | 8·31 (3·49–19·8) | 6·24 (2·14–18·2) | 3·87 (0·77–19·6) | 7·10 (2·71–18·6) | 3·38 (1·33–8·59) |
| Unadjusted P‐value | < 0·001 | < 0·001 | 0·16 | < 0·001 | 0·015 |
CI, confidence interval; DLQI, Dermatology Life Quality Index; FAEs, fumaric acid esters; ITT, intention to treat; IXE, ixekizumab; MTX, methotrexate; NRI, nonresponder imputation; OR, odds ratio; PASI, Psoriasis Area and Severity Index; PASI 75, ≥ 75% improvement in PASI; sPGA, static Physician's Global Assessment. Coprimary PASI 75 comparisons for IXE vs. FAEs and IXE vs. MTX were adjusted via a primary Hochberg procedure at 24 weeks. Key secondary PASI 90, PASI 100, sPGA (0,1) and DLQI (0,1) comparisons for IXE vs. FAEs and IXE vs. MTX were adjusted by a second, separate Hochberg procedure at 24 weeks that was applied when all primary comparisons were statistically significant. aPercentages are based on the ITT population using NRI. bsPGA (0,1) response and ≥ 2‐point improvement from baseline; includes only patients with sPGA ≥ 3 at baseline.