Table 2. Primary and Ranked Secondary End Points.
End point | Time point | Dupilumab, 300 mg (n = 331) | Upadacitinib, 30 mg (n = 342) | Difference | P value |
---|---|---|---|---|---|
Primary end point | |||||
Achievement of EASI75a | Week 16 | 207 (62.6) [57.4 to 67.8] | 248 (72.4) [67.6 to 77.2] | 9.7 | .007 |
Secondary end points in order of ranking | |||||
% Change from baseline in worst pruritus NRSb | Week 16 | −49.6(2.0) [–53.5 to −45.7] | −67.8 (1.9) [–71.5 to −64.0] | −18.21 | <.001 |
No. | 239 | 252 | |||
Achievement of EASI100a | Week 16 | 26 (7.9) [5.0 to 10.8] | 97 (28.4) [23.6to 33.2] | 20.4 | <.001 |
Achievement of EASI90a | Week 16 | 133 (40.3) [35.0 to 45.6] | 211 (61.6) [56.4 to 66.8] | 21.2 | <.001 |
% Change from baseline in Worst Pruritus NRSb | Week 4 | −32.4 (2.3) [–36.9 to −27.9] | −60.4 (2.2) [–64.7 to −56.1] | −28.0 | <.001 |
No. | 297 | 327 | |||
Achievement of EASI75a | Week 2 | 60 (18.2) [14.0 to 22.4] | 152 (44.3) [39.1 to 49.6] | 26.1 | <.001 |
% Change from baseline in Worst Pruritus NRSb | Week 1 | −8.9 (1.8) [–12.5 to −5.3] | −32.0 (1.8) [–35.4 to −28.5] | −23.0 | <.001 |
No. | 314 | 331 | |||
Worst Pruritus NRS improvement ≥4 pointsa,c | Week 16 | 117 (36.4) [31.1 to 41.6] | 188 (56.1) [50.8 to 61.5] | 19.8 | <.001 |
No. | NA | 323 | 334 | NA | NA |
Abbreviations: EASI75, 75% improvement in the Eczema Area and Severity Index; NA, not applicable; NRS, Numerical Rating Scale.
No. (%) [95% CI].
Least-squares mean (SE) [95% CI].
Analyzed for patients with Worst Pruritus NRS of 4 points or higher at baseline.