Digital Features for this article can be found at https://doi.org/10.6084/m9.figshare.24030489. |
Atopic dermatitis is a chronic inflammatory disease that can be difficult to evaluate because of its heterogenous presentation. Investigator’s Global Assessment of clear/almost clear skin is a required endpoint in most atopic dermatitis clinical trials, but it does not fully reflect the overall patient experience and can underestimate clinically meaningful treatment effects. |
A post hoc analysis of patients who did not achieve the co-primary endpoint (Investigator’s Global Assessment of clear/almost clear skin at week 16 without rescue medication) in the monotherapy ECZTRA 1 and 2 clinical trials showed greater proportions of tralokinumab-treated patients, compared with placebo, achieved clinically meaningful responses. |
Utilization of validated outcome measures of both itch severity and quality of life, in addition to Investigator’s Global Assessment scores, more comprehensively assesses the full benefit of tralokinumab treatment. |
1 Introduction
2 Methods
2.1 Study Design and Patient Population
2.2 Endpoints
2.3 Statistical Analysis
3 Results
3.1 Patient Disposition and Baseline Characteristics
IGA >1a At week 16 | IGA 0/1b At week 16 | |||||
---|---|---|---|---|---|---|
NRI dataset | AO datasetc | NRI and AO datasetsd | ||||
Tralo (N = 966) | PBO (N = 362) | Tralo (N = 901) | PBO (N = 328) | Tralo (N = 226) | PBO (N = 36) | |
Mean age, years (SD) | 38.0 (14.3) | 37.4 (15.0) | 38.1 (14.3) | 37.2 (14.4) | 37.5 (14.1) | 35.1 (13.1) |
Male, n (%) | 587 (60.8) | 214 (59.1) | 555 (61.6) | 193 (58.8) | 121 (53.5) | 22 (61.1) |
Race, n (%) | ||||||
White | 629 (65.2) | 240 (66.9) | 590 (65.6) | 221 (68.0) | 167 (74.2) | 20 (55.6) |
Black or African American | 65 (6.7) | 22 (6.1) | 52 (5.8) | 16 (4.9) | 19 (8.4) | 12 (33.3) |
Asian | 238 (24.7) | 88 (24.5) | 229 (25.4) | 81 (24.9) | 36 (16.0) | 4 (11.1) |
American Indian or Alaska Native | 3 (0.3) | 0 (0.0) | 3 (0.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Native Hawaiian or other Pacific Islander | 5 (0.5) | 0 (0.0) | 2 (0.2) | 0 (0.0) | 1 (0.4) | 0 (0.0) |
Other | 25 (2.6) | 9 (2.5) | 24 (2.7) | 7 (2.2) | 2 (0.9) | 0 (0.0) |
Missing data | 1 | 3 | 1 | 3 | 1 | 0 |
Mean duration of AD, years (SD) | 28.1 (15.2) | 29.0 (15.0) | 28.1 (15.2) | 29.3 (14.7) | 28.0 (15.3) | 23.1 (14.0) |
Mean BSA involvement with AD, % (SD) | 55.4 (24.8) | 55.4 (25.1) | 55.5 (24.6) | 55.8 (24.8) | 40.7 (21.3) | 35.9 (19.0) |
IGA, n (%) | ||||||
IGA 3 (moderate) | 444 (46.0) | 168 (46.4) | 408 (45.3) | 150 (45.7) | 157 (69.5) | 27 (75.0) |
IGA 4 (severe) | 522 (54.0) | 194 (53.6) | 493 (54.7) | 178 (54.3) | 69 (30.5) | 9 (25.0) |
Mean EASI (SD) | 33.6 (14.4) | 33.6 (13.9) | 33.7 (14.4) | 33.7 (13.8) | 25.9 (10.2) | 23.8 (9.4) |
Mean weekly average worst daily pruritus NRS (SD) | 7.9 (1.4), n = 958 | 7.9 (1.3), n = 360 | 7.8 (1.4), n = 896 | 7.9 (1.3), n = 326 | 7.5 (1.5), n = 224 | 7.2 (1.6), n = 35 |
Mean SCORAD (SD) | 71.3 (13.1) | 71.9 (12.2) | 71.4 (13.1) | 71.9 (12.1) | 65.5 (12.5) | 62.5 (10.7) |
Mean DLQI (SD) | 17.6 (7.1), n = 956 | 17.8 (6.8), n = 359 | 17.6 (7.1), n = 893 | 17.8 (6.8), n = 326 | 15.6 (6.9), n = 222 | 13.4 (7.8), n = 35 |
Mean eczema-related sleep interference (sleep) NRS (SD) | 7.1 (2.0), n = 958 | 7.1 (2.0), n = 360 | 7.1 (2.0), n = 896 | 7.1 (2.0), n = 326 | 6.8 (2.0), n = 224 | 6.1 (2.4), n = 35 |