Table 2. Loss of Response and Achievement of EASI 75 at Week 52 by Week 16 Response Status (ITT Population).
UPA 15 mg | UPA 30 mg | |||
---|---|---|---|---|
No.a | No. (%) [95% CI] | No.a | No. (%) [95% CI] | |
Proportion of patients who experienced loss of response after wk 16 up to wk 52 among wk-16 EASI 75 and vIGA-AD 0/1 responders a , b | ||||
Measure Up 1 | ||||
Overallc | 133 | 4 (3.0) [0.1-5.9] | 176 | 6 (3.4) [0.7-6.1] |
Week 20 | 131 | 0 | 170 | 2 (1.2) [0-2.8] |
Week 24 | 120 | 0 | 166 | 1 (0.6) [0-1.8] |
Week 32 | 126 | 4 (3.2) [0.1-6.2] | 160 | 1 (0.6) [0-1.8] |
Week 40 | 120 | 1 (0.8) [0-2.5] | 159 | 1 (0.6) [0-1.9] |
Week 52 | 121 | 0 | 161 | 2 (1.2) [0-3.0] |
Measure Up 2 | ||||
Overallc | 107 | 6 (5.6) [1.2-10.0] | 142 | 7 (4.9) [1.4-8.5] |
Week 20 | 106 | 0 | 139 | 0 |
Week 24 | 102 | 2 (2.0) [0-4.7] | 139 | 3 (2.2) [0-4.6] |
Week 32 | 102 | 2 (2.0) [0-4.7] | 135 | 1 (0.7) [0-2.2] |
Week 40 | 101 | 0 | 133 | 2 (1.5) [0-3.6] |
Week 52 | 100 | 3 (3.0) [0-6.3] | 129 | 4 (3.1) [0.1-6.1] |
Proportion of patients achieving EASI 75 at wk 52 among wk-16 EASI 75 responders d | ||||
Measure Up 1 | 175 | 153 (87.4) [82.5-92.3] | 207 | 183 (88.4) [84.0-92.8] |
Measure Up 2 | 157 | 137 (87.3) [82.0-92.5] | 189 | 172 (91.0) [86.9-95.1] |
Integrated population | 332 | 290 (87.3) [83.8-90.9] | 396 | 355 (89.6) [86.6-92.6] |
Proportion of patients achieving EASI 75 at wk 52 among wk-16 EASI 75 nonresponders e | ||||
Measure Up 1 | 57 | 37 (64.9) [52.5-77.3] | 24 | 14 (58.3) [38.6-78.1] |
Measure Up 2 | 73 | 45 (61.6) [50.5-72.8] | 35 | 16 (45.7) [29.2-62.2] |
Integrated population | 130 | 82 (63.1) [54.8-71.4] | 59 | 30 (50.8) [38.1-63.6] |
Abbreviations: EASI 75, 75% or greater improvement in Eczema Area and Severity Index; ITT, intention to treat for the main study; UPA, upadacitinib; vIGA-AD 0/1, Validated Investigator Global Assessment for Atopic Dermatitis of clear (0) or almost clear (1) with 2 or more grades of reduction.
Loss of response was defined as loss of 50% or greater of the week-16 EASI response and vIGA-AD 2 or greater after week 16.
Responders were defined as patients who achieved EASI 75 and vIGA-AD 0/1 at week 16.
At any time between week 16 up to week 52.
Responders were defined as patients who achieved EASI 75 at week 16.
Nonresponders were defined as patients who did not achieve EASI 75 at week 16.