Efficacy and Safety Trends with Continuous, Long-Term Crisaborole Use in Patients Aged ≥ 2 Years with Mild-to-Moderate Atopic Dermatitis

Bob Geng, Adelaide A Hebert, Liza Takiya, Lauren Miller, John L Werth, Chuanbo Zang, Paul Sanders, Mark G Lebwohl, Bob Geng, Adelaide A Hebert, Liza Takiya, Lauren Miller, John L Werth, Chuanbo Zang, Paul Sanders, Mark G Lebwohl

Abstract

Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease often requiring long-term treatment. Crisaborole significantly improved global AD signs and symptoms in 28-day phase 3 studies of patients aged ≥ 2 years with mild-to-moderate AD (Investigator's Static Global Assessment [ISGA] 2 or 3). A post hoc analysis of a long-term, open-label extension study was conducted to assess efficacy and safety trends of crisaborole in patients stratified by the number of initial consecutive crisaborole treatment cycles, defined as the number of treatment cycles completed before achievement of ISGA 0 (clear)/1 (almost clear).

Methods: Patients completing phase 3 studies without drug-related safety issues that precluded further crisaborole treatment were analyzed. Patients with ISGA 0/1 at baseline (the end of a 28-day cycle) did not receive crisaborole for the next 28-day cycle (off-treatment), whereas patients with ISGA ≥ 2 received crisaborole for the next 28-day cycle (on-treatment). Patients were stratified by number of initial consecutive crisaborole treatment cycles. Efficacy was assessed by achievement and maintenance of ISGA 0/1, and safety was assessed by incidence of treatment-emergent adverse events (TEAEs) and treatment-related AEs (TRAEs).

Results: Overall, 418 patients were included in exclusive cohorts based on number of consecutive on-treatment cycles (1 on-treatment cycle, n = 133; 2 consecutive on-treatment cycles, n = 106; 3 consecutive on-treatment cycles, n = 106; 4 consecutive on-treatment cycles, n = 73). After one to four initial consecutive on-treatment cycles, 77.6, 76.3, 59.4, and 43.1% of patients, respectively, achieved ISGA 0/1. Of these patients, 49.5, 37.8, 44.4, and 45.2%, respectively, maintained ISGA 0/1 at the end of a 28-day cycle off-treatment. Incidence of TRAEs was 4.5, 4.7, 3.8, and 1.4% for patients receiving one to four consecutive on-treatment cycles, respectively. One patient discontinued because of AEs.

Conclusion: These results support the efficacious and safe continuous, long-term use of crisaborole for the management of mild-to-moderate AD.

Trial registration: ClinicalTrials.gov: NCT02118766, NCT02118792.

Keywords: Atopic dermatitis; Crisaborole; Eczema; Long-term; Maintenance therapy.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Study design. BID twice daily, ISGA Investigator’s Static Global Assessment
Fig. 2
Fig. 2
Patient disposition. Other reasons for discontinuation included sponsor closure of the study, investigator decision not related to safety, long-term prohibited medication needed, use of prohibited medication per protocol, and nonadherence to study visits
Fig. 3
Fig. 3
Proportion of patients achieving ISGA 0/1 at the end of their on-treatment period (a) and after 28 days off treatment (b) among those who previously achieved ISGA 0/1. ISGA Investigator’s Static Global Assessment

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