Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7

Abstract

Introduction: Skin pain (described as discomfort or soreness) is increasingly recognized as a symptom of atopic dermatitis which impacts patient quality of life. This analysis examined the effect of baricitinib on skin pain in atopic dermatitis in three phase 3 studies (BREEZE-AD1, -AD2, and -AD7).

Methods: Patients were randomly assigned 2:1:1:1 to receive once-daily placebo, baricitinib 1 mg, 2 mg, or 4 mg in BREEZE-AD1 (N = 624) and -AD2 (N = 615) and 1:1:1 to receive once-daily placebo, baricitinib 2 mg, or 4 mg, with topical corticosteroids, in BREEZE-AD7 (N = 329) for 16 weeks. Patients recorded their skin pain severity using the Skin Pain Numerical Rating Scale (NRS) via an electronic daily diary. Data were analyzed by study as least squares mean change from baseline in daily scores for the randomly assigned patients using mixed model repeated measures analysis. Analysis of Skin Pain NRS response was done using logistic regression using non-responder imputation.

Results: Baricitinib produced significant percentage change from baseline compared with placebo in patient-reported skin pain severity by day 2 in BREEZE-AD1 (baricitinib 4 mg - 11.9%, p < 0.001; baricitinib 2 mg - 6.4%, p = 0.016; baricitinib 1 mg - 6.2%, p = 0.016), -AD2 (baricitinib 4 mg - 12.6%, p < 0.001; baricitinib 2 mg - 5.6%, p = 0.036; baricitinib 1 mg - 6.9%, p = 0.011), and -AD7 (baricitinib 4 mg - 6.9%, p = 0.04; baricitinib 2 mg - 7.9%, p = 0.018). A greater proportion of patients treated with baricitinib reported at least a 4-point reduction in Skin Pain NRS score at week 16 (Skin Pain NRS responders) in BREEZE-AD1 (baricitinib 4 mg 25.3%, p < 0.001), -AD2 (baricitinib 4 mg 20.0%, p < 0.001; baricitinib 2 mg 19.0%, p < 0.001), and -AD7 (baricitinib 4 mg 48.8%, p < 0.001; baricitinib 2 mg 45.2%, p = 0.004) compared to placebo. A significantly higher proportion of Skin Pain NRS responders also achieved at least a 4-point improvement in Dermatology Life Quality Index at week 16 when compared with Skin Pain NRS non-responders in BREEZE-AD1 (89.2%, p < 0.0001), -AD2 (92.5%, p < 0.0001), and -AD7 (88.3%, p < 0.0001).

Conclusion: Baricitinib improved patient-reported skin pain severity as early as day 2. CLINICALTRIALS.

Gov identifiers: BREEZE-AD1, NCT03334396; BREEZE-AD2, NCT03334422; BREEZE-AD7, NCT03733301.

Keywords: Atopic dermatitis; Baricitinib; Patient-reported outcomes; Skin pain.

© 2021. The Author(s).

Figures

Fig. 1

Least squares mean change from baseline in Skin Pain NRS during 16 weeks of treatment in BREEZE-AD1 (a), BREEZE-AD2 (b), and BREEZE-AD7 (c). *p ≤ 0.05 compared with placebo; **p ≤ 0.01 compared with placebo; ***p < 0.001 compared with placebo. Bari baricitinib, LSM least squares mean, NRS numerical rating scale, PBO placebo, SE standard error, TCS topical corticosteroids

Fig. 2

Least squares mean percentage change from baseline in Skin Pain NRS during the first week of treatment in BREEZE-AD1 (a), BREEZE-AD2 (b), and BREEZE-AD7 (c). *p ≤ 0.05 compared with placebo; **p ≤ 0.01 compared with placebo; ***p < 0.001 compared with placebo; arrows indicate the first day of treatment administration. Bari baricitinib, LSM least squares mean, NRS numerical rating scale, PBO placebo, TCS topical corticosteroids

Fig. 3

Percent response of patients achieving at least a 4-point improvement from baseline in Skin Pain NRS during 16 weeks of treatment in BREEZE-AD1 (a), BREEZE-AD2 (b), and BREEZE-AD7 (c). *p ≤ 0.05 compared with placebo; **p ≤ 0.01 compared with placebo; ***p < 0.001 compared with placebo. Bari baricitinib, CI confidence interval, NRS numerical rating scale, PBO placebo, TCS topical corticosteroids

Fig. 4

Patients achieving at least a 4-point improvement in DLQI among Skin Pain NRS responders (at least a 4-point improvement in Skin Pain NRS) vs non-responders (less than a 4-point improvement in Skin Pain NRS) at week 16 in BREEZE-AD1 (a), BREEZE-AD2 (b), and BREEZE-AD7 (c). ***p < 0.0001. CI confidence interval, DLQI Dermatology Life Quality Index, NRS numerical rating scale