Tags

Type your tag names separated by a space and hit enter

Magnitude of benefit for topical crisaborole in the treatment of atopic dermatitis in children and adults does not look promising: a critical appraisal.
Br J Dermatol. 2018 03; 178(3):659-662.BJ

Abstract

AIM

To assess the efficacy and safety of crisaborole ointment, a phosphodiesterase 4 inhibitor, for the treatment of mild or moderate atopic dermatitis (AD) in two phase III studies (AD-301 and AD-302).

DESIGN AND SETTING

Two identically designed multicentre, double-blind randomized controlled trials were conducted in the U.S.A. Participants were randomized 2 : 1 to receive crisaborole or vehicle treatment. In total 47 and 42 investigational centres were identified for AD-301 and AD-302, respectively.

STUDY PARTICIPANTS

Inclusion criteria were identified as age ≥ 2 years, clinical diagnosis of AD (as per the Hanifin and Rajka criteria), ≥ 5% body surface area involvement, and baseline Investigator's Static Global Assessment (ISGA) mild or moderate. Exclusion criteria included previous use of biologics or systemic corticosteroids (within the last 28 days) or a topical calcineurin inhibitor/corticosteroid (within the last 14 days), and active skin infection.

EXPOSURES

Participants were instructed to apply the study drug twice daily to all lesions identified at baseline, and all new lesions identified after day 1 (with weekly review of application instructions). Bland emollients were permitted to be used on skin not treated with the study drug.

PRIMARY OUTCOME

The primary outcome was defined as ISGA clear or almost clear at day 29, with a 2-grade or more improvement from baseline.

OUTCOMES

Secondary outcomes included the proportion of patients with an ISGA score of clear or almost clear at day 29, and time to success in ISGA score. Additional outcomes included pruritus severity and signs of AD (erythema, exudation, excoriation, induration/papulation and lichenification), and were measured on a 4-point scale (none, mild, moderate, severe). Adverse events were also recorded.

RESULTS

More participants in the crisaborole-treated group achieved ISGA scores of clear or almost clear with ≥ 2-grade improvement than in the vehicle-treated group (AD-301, 32·8% vs. 25·4%, P = 0·38; AD-302, 31·4% vs. 18·0%, P < 0·001). Greater percentages of clear and almost clear scores were observed in the treatment groups (51·7% vs. 40·6%, P = 0·005; 48·5% vs. 29·7%; P < 0·001), as well as earlier success in ISGA score and improvement in pruritus (P ≤ 0·001). No serious treatment-related adverse events were identified.

CONCLUSIONS

Based on the study results, the authors suggest that crisaborole is a safe treatment that improves disease severity, pruritus and clinical signs associated with AD.

Authors+Show Affiliations

Department of Dermatology, Watford General Hospital, Watford, U.K.Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London, WC1N 3JH, U.K.Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, U.K.

Pub Type(s)

Journal Article
Comment

Language

eng

PubMed ID

29205284

Citation

Ahmed, A, et al. "Magnitude of Benefit for Topical Crisaborole in the Treatment of Atopic Dermatitis in Children and Adults Does Not Look Promising: a Critical Appraisal." The British Journal of Dermatology, vol. 178, no. 3, 2018, pp. 659-662.
Ahmed A, Solman L, Williams HC. Magnitude of benefit for topical crisaborole in the treatment of atopic dermatitis in children and adults does not look promising: a critical appraisal. Br J Dermatol. 2018;178(3):659-662.
Ahmed, A., Solman, L., & Williams, H. C. (2018). Magnitude of benefit for topical crisaborole in the treatment of atopic dermatitis in children and adults does not look promising: a critical appraisal. The British Journal of Dermatology, 178(3), 659-662. https://doi.org/10.1111/bjd.16046
Ahmed A, Solman L, Williams HC. Magnitude of Benefit for Topical Crisaborole in the Treatment of Atopic Dermatitis in Children and Adults Does Not Look Promising: a Critical Appraisal. Br J Dermatol. 2018;178(3):659-662. PubMed PMID: 29205284.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Magnitude of benefit for topical crisaborole in the treatment of atopic dermatitis in children and adults does not look promising: a critical appraisal. AU - Ahmed,A, AU - Solman,L, AU - Williams,H C, Y1 - 2017/12/03/ PY - 2017/12/6/pubmed PY - 2019/2/23/medline PY - 2017/12/6/entrez SP - 659 EP - 662 JF - The British journal of dermatology JO - Br. J. Dermatol. VL - 178 IS - 3 N2 - AIM: To assess the efficacy and safety of crisaborole ointment, a phosphodiesterase 4 inhibitor, for the treatment of mild or moderate atopic dermatitis (AD) in two phase III studies (AD-301 and AD-302). DESIGN AND SETTING: Two identically designed multicentre, double-blind randomized controlled trials were conducted in the U.S.A. Participants were randomized 2 : 1 to receive crisaborole or vehicle treatment. In total 47 and 42 investigational centres were identified for AD-301 and AD-302, respectively. STUDY PARTICIPANTS: Inclusion criteria were identified as age ≥ 2 years, clinical diagnosis of AD (as per the Hanifin and Rajka criteria), ≥ 5% body surface area involvement, and baseline Investigator's Static Global Assessment (ISGA) mild or moderate. Exclusion criteria included previous use of biologics or systemic corticosteroids (within the last 28 days) or a topical calcineurin inhibitor/corticosteroid (within the last 14 days), and active skin infection. EXPOSURES: Participants were instructed to apply the study drug twice daily to all lesions identified at baseline, and all new lesions identified after day 1 (with weekly review of application instructions). Bland emollients were permitted to be used on skin not treated with the study drug. PRIMARY OUTCOME: The primary outcome was defined as ISGA clear or almost clear at day 29, with a 2-grade or more improvement from baseline. OUTCOMES: Secondary outcomes included the proportion of patients with an ISGA score of clear or almost clear at day 29, and time to success in ISGA score. Additional outcomes included pruritus severity and signs of AD (erythema, exudation, excoriation, induration/papulation and lichenification), and were measured on a 4-point scale (none, mild, moderate, severe). Adverse events were also recorded. RESULTS: More participants in the crisaborole-treated group achieved ISGA scores of clear or almost clear with ≥ 2-grade improvement than in the vehicle-treated group (AD-301, 32·8% vs. 25·4%, P = 0·38; AD-302, 31·4% vs. 18·0%, P < 0·001). Greater percentages of clear and almost clear scores were observed in the treatment groups (51·7% vs. 40·6%, P = 0·005; 48·5% vs. 29·7%; P < 0·001), as well as earlier success in ISGA score and improvement in pruritus (P ≤ 0·001). No serious treatment-related adverse events were identified. CONCLUSIONS: Based on the study results, the authors suggest that crisaborole is a safe treatment that improves disease severity, pruritus and clinical signs associated with AD. SN - 1365-2133 UR - https://www.unboundmedicine.com/medline/citation/29205284/Magnitude_of_benefit_for_topical_crisaborole_in_the_treatment_of_atopic_dermatitis_in_children_and_adults_does_not_look_promising:_a_critical_appraisal_ DB - PRIME DP - Unbound Medicine ER -