Figures & data
Table 1. Demographics and baseline disease characteristics.
Figure 1. Reduction in absolute EASI scores over 16 weeks in patients treated with BARI monotherapy or TCS combination therapy. Least square mean change from baseline to W16 in absolute EASI scores in patients from (A) pooled monotherapy studies (BREEZE-AD1 and BREEZE-AD2) and (B) the TCS combination therapy study (BREEZE-AD7). The proportion of patients achieving EASI ≤ 7 through W16 from (C) pooled monotherapy studies (BREEZE-AD1 and BREEZE-AD2) and (D) the TCS combination therapy study (BREEZE-AD7). *p ≤ 0.05, **p ≤ 0.01, ***p ≤ 0.001 vs. PBO. BARI: baricitinib; EASI: Eczema Area and Severity Index; PBO: placebo; TCS: topical corticosteroid.
Figure 2. Reduction in absolute SCORAD scores in patients treated with BARI monotherapy or TCS combination therapy. Least square mean change from baseline to W16 in absolute SCORAD score in patients from (A) pooled monotherapy studies (BREEZE-AD1 and BREEZE-AD2) and (B) the TCS combination therapy study (BREEZE-AD7). The proportion of patients achieving SCORAD < 25 through W16 from (C) pooled monotherapy studies (BREEZE-AD1 and BREEZE-AD2) and (D) the TCS combination therapy study (BREEZE-AD7). *p ≤ 0.05, **p ≤ 0.01, ***p ≤ 0.001 vs. PBO. BARI: baricitinib; PBO: placebo; SCORAD: SCORing of Atopic Dermatitis; TCS: topical corticosteroid.
Figure 3. Stratification of the proportion of patients achieving MCID by severity category. The proportion of patients achieving an EASI MCID of ≥6.6-point improvement from baseline at W16 was stratified by EASI severity category from (A) pooled monotherapy studies (BREEZE-AD1 and BREEZE-AD2) and (B) the TCS combination therapy study (BREEZE-AD7). The proportion of patients achieving a SCORAD MCID of ≥8.7-point improvement from baseline at W16 was stratified by SCORAD severity category from (C) pooled monotherapy studies (BREEZE-AD1 and BREEZE-AD2) and (D) the TCS combination therapy study (BREEZE-AD7). *p ≤ 0.05, **p ≤ 0.01, ***p ≤ 0.001 vs. PBO. BARI: baricitinib; EASI: Eczema Area and Severity Index; MCID: minimal clinically important difference; PBO: placebo; SCORAD: SCORing of Atopic Dermatitis; TCS: topical corticosteroid.
Figure 4. The proportion of patients achieving a DLQI ≤ 5 as stratified by EASI severity category. Among patients with a baseline DLQI > 5, the proportion of patients achieving a DLQI ≤ 5 at weeks 1, 4, and 16 was stratified by EASI severity category for (A,C,E) pooled monotherapy studies (BREEZE-AD1 and BREEZE-AD2) and (B,D,F) the TCS combination therapy study (BREEZE-AD7). *p ≤ 0.05, **p ≤ 0.01, ***p ≤ 0.001 vs. PBO. BARI: baricitinib; DLQI: Dermatology Life Quality Index; EASI: Eczema Area and Severity Index; PBO: placebo; TCS: topical corticosteroid.
Data availability statement
Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date for data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at https://vivli.org/.