Table 2. Primary and Key Secondary Outcomes in the Intention-to-Treat Populationa.
| Outcome | Placebo and TCSs (n = 109) | 2 mg of Baricitinib and TCSs (n = 109) | 4 mg of Baricitinib and TCSs (n = 111) | ||||
|---|---|---|---|---|---|---|---|
| All | Comparison with placebo (95% CI) | P valueb | All | Comparison with placebo (95% CI) | P valueb | ||
| Primary outcome | |||||||
| vIGA-AD score of 0 or 1c | 16 (15) | 26 (24) | 1.9 (0.9 to 3.9) | .08 | 34 (31) | 2.8 (1.4 to 5.6) | .004 |
| Key secondary outcomes | |||||||
| EASI75c | 25 (23) | 47 (43) | 2.6 (1.4 to 4.8) | NA | 53 (48) | 3.3 (1.8 to 6.0) | <.001 |
| Percent change from baseline in total EASI score, LSM (SE)d | −45.1 (3.8) | −58.2 (3.7) | −13.1 (−23.4 to −2.7) | NA | −67.2 (3.7) | −22.1 (−32.5 to −11.8) | <.001 |
| ≥4-Point improvement in Itch NRS scorec | |||||||
| Day 2 | 2/104 (2) | 5/97 (5) | 2.4 (0.6 to 10.5) | NA | 8/100 (8) | 3.9 (1.0 to 15.8) | NA |
| Week 1 | 4/104 (4) | 8/97 (8) | 2.1 (0.7 to 6.8) | NA | 9/100 (9) | 2.5 (0.8 to 8.0) | NA |
| Week 2 | 16/104 (15) | 23/97 (24) | 1.8 (0.9 to 3.8) | NA | 33/100 (33) | 3.1 (1.5 to 6.2) | NA |
| Week 4 | 11/104 (11) | 33/97 (34) | 4.7 (2.2 to 10.0) | NA | 52/100 (52) | 10.4 (4.9 to 22.2) | <.001 |
| Week 16 | 21/104 (20) | 37/97 (38) | 2.9 (1.5 to 5.6) | NA | 44/100 (44) | 3.8 (2.0 to 7.5) | <.001 |
| Change from baseline, LSM (SE)d | |||||||
| Skin Pain NRS | −2.1 (0.2) | −3.2 (0.2) | −1.2 (−1.8 to −0.5) | NA | −3.7 (0.2) | −1.7 (−2.3 to −1.0) | <.001 |
| Item 2 of the ADSS at week 1 | −0.5 (0.1) | −0.7 (0.1) | −0.2 (−0.5 to 0.0) | NA | −0.9 (0.1) | −0.4 (−0.7 to −0.2) | NA |
| Item 2 of the ADSS at week 16 | −0.5 (0.2) | −1.3 (0.1) | −0.8 (−1.2 to −0.4) | NA | −1.4 (0.1) | −0.9 (−1.3 to −0.5) | NA |
| EASI90c | 15 (14) | 18 (17) | 1.2 (0.6 to 2.6) | NA | 27 (24) | 2.1 (1.0 to 4.2) | NA |
| SCORAD75c | 8 (7) | 12 (11) | 1.5 (0.6 to 3.8) | NA | 20 (18) | 2.7 (1.2 to 6.3) | NA |
Abbreviations: ADSS, Atopic Dermatitis Sleep Scale; EASI, Eczema Area and Severity Index; LSM, least-squares mean; NA, not applicable; NRS, Numeric Rating Scale; SCORAD, SCORing Atopic Dermatitis; TCS, topical corticosteroid; vIGA-AD, validated Investigator Global Assessment for Atopic Dermatitis.
Data are presented as number (percentage) of patients unless otherwise indicated. Data were assessed at week 16 unless otherwise specified. Data were analyzed with a logistic regression model with nonresponder imputation for response rates and mixed-models repeated-measure analysis for LSM change and percent change from baseline. P values are for comparisons of 2 or 4 mg of baricitinib with placebo.
To control the overall familywise type l error rate for multiple comparisons, the primary and key secondary end points were analyzed according to the prespecified statistical analysis plan with a graphical testing procedure. Results are shown for the US and Japan graphical testing procedure.
Comparisons are odds ratios.
Comparisons are LSM difference.