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Post Hoc Analyses of the Effect of Crisaborole Topical Ointment, 2% on Atopic Dermatitis: Associated Pruritus from Phase 1 and 2 Clinical Studies.
J Drugs Dermatol. 2016 Feb; 15(2):172-6.JD

Abstract

BACKGROUND

Two post hoc analyses assessed the antipruritic activity of crisaborole topical ointment, 2% (crisaborole; Anacor Pharmaceuticals, Inc., Palo Alto, CA), a first-in-class boron-based phosphodiesterase-4 inhibitor in development for treatment of mild to moderate atopic dermatitis (AD).

METHODS

Two pooled analyses included data from 4 studies evaluating crisaborole in AD (study 1, phase 1b, systemic exposure, safety, and pharmacokinetics [PK] under maximal-use conditions in children and adolescents; study 2, phase 2a, safety and PK in adolescents; study 3, phase 2a, efficacy and safety in adults; study 4, phase 2, efficacy and safety in adolescents). Pooled data from studies 1 and 2 included whole body assessments; studies 3 and 4 included target lesion assessments. Pruritus severity was evaluated using a 4-point rating scale (0=none to 3=severe). Efficacy assessments included percent change from baseline in pruritus severity scores at days 8 (first pooled assessment), 15, 22, and 29 (whole body assessments) or days 15 (first pooled assessment), 22, and 29 (target lesions). Paired t-tests comparing change from baseline against zero were used to calculate P values. Categorical shifts in pruritus severity were also assessed (no to mild pruritus, 0-1.5; moderate to severe pruritus, 2-3).

RESULTS

In the pooled analysis of studies 1 and 2 (N=57), the percent change from baseline in pruritus severity scores were 63.0% and 64.9% at days 8 and 29, respectively (P<0.001 for each). Similar results were observed in the pooled analysis of studies 3 and 4 (N=67). In both analyses, most patients had mild to no pruritus from the first time point assessed through the remainder of treatment.

CONCLUSIONS

Treatment with crisaborole topical ointment, 2% resulted in statistically significant reductions in pruritus severity at the first time point evaluated in both analyses. These findings provide preliminary evidence of the antipruritic activity of crisaborole topical ointment, 2%.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26885784

Citation

Draelos, Zoe Diana, et al. "Post Hoc Analyses of the Effect of Crisaborole Topical Ointment, 2% On Atopic Dermatitis: Associated Pruritus From Phase 1 and 2 Clinical Studies." Journal of Drugs in Dermatology : JDD, vol. 15, no. 2, 2016, pp. 172-6.
Draelos ZD, Stein Gold LF, Murrell DF, et al. Post Hoc Analyses of the Effect of Crisaborole Topical Ointment, 2% on Atopic Dermatitis: Associated Pruritus from Phase 1 and 2 Clinical Studies. J Drugs Dermatol. 2016;15(2):172-6.
Draelos, Z. D., Stein Gold, L. F., Murrell, D. F., Hughes, M. H., & Zane, L. T. (2016). Post Hoc Analyses of the Effect of Crisaborole Topical Ointment, 2% on Atopic Dermatitis: Associated Pruritus from Phase 1 and 2 Clinical Studies. Journal of Drugs in Dermatology : JDD, 15(2), 172-6.
Draelos ZD, et al. Post Hoc Analyses of the Effect of Crisaborole Topical Ointment, 2% On Atopic Dermatitis: Associated Pruritus From Phase 1 and 2 Clinical Studies. J Drugs Dermatol. 2016;15(2):172-6. PubMed PMID: 26885784.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post Hoc Analyses of the Effect of Crisaborole Topical Ointment, 2% on Atopic Dermatitis: Associated Pruritus from Phase 1 and 2 Clinical Studies. AU - Draelos,Zoe Diana, AU - Stein Gold,Linda F, AU - Murrell,Dedee F, AU - Hughes,Matilda H, AU - Zane,Lee T, PY - 2016/2/18/entrez PY - 2016/2/18/pubmed PY - 2017/1/11/medline SP - 172 EP - 6 JF - Journal of drugs in dermatology : JDD JO - J Drugs Dermatol VL - 15 IS - 2 N2 - BACKGROUND: Two post hoc analyses assessed the antipruritic activity of crisaborole topical ointment, 2% (crisaborole; Anacor Pharmaceuticals, Inc., Palo Alto, CA), a first-in-class boron-based phosphodiesterase-4 inhibitor in development for treatment of mild to moderate atopic dermatitis (AD). METHODS: Two pooled analyses included data from 4 studies evaluating crisaborole in AD (study 1, phase 1b, systemic exposure, safety, and pharmacokinetics [PK] under maximal-use conditions in children and adolescents; study 2, phase 2a, safety and PK in adolescents; study 3, phase 2a, efficacy and safety in adults; study 4, phase 2, efficacy and safety in adolescents). Pooled data from studies 1 and 2 included whole body assessments; studies 3 and 4 included target lesion assessments. Pruritus severity was evaluated using a 4-point rating scale (0=none to 3=severe). Efficacy assessments included percent change from baseline in pruritus severity scores at days 8 (first pooled assessment), 15, 22, and 29 (whole body assessments) or days 15 (first pooled assessment), 22, and 29 (target lesions). Paired t-tests comparing change from baseline against zero were used to calculate P values. Categorical shifts in pruritus severity were also assessed (no to mild pruritus, 0-1.5; moderate to severe pruritus, 2-3). RESULTS: In the pooled analysis of studies 1 and 2 (N=57), the percent change from baseline in pruritus severity scores were 63.0% and 64.9% at days 8 and 29, respectively (P<0.001 for each). Similar results were observed in the pooled analysis of studies 3 and 4 (N=67). In both analyses, most patients had mild to no pruritus from the first time point assessed through the remainder of treatment. CONCLUSIONS: Treatment with crisaborole topical ointment, 2% resulted in statistically significant reductions in pruritus severity at the first time point evaluated in both analyses. These findings provide preliminary evidence of the antipruritic activity of crisaborole topical ointment, 2%. SN - 1545-9616 UR - https://www.unboundmedicine.com/medline/citation/26885784/Post_Hoc_Analyses_of_the_Effect_of_Crisaborole_Topical_Ointment_2_on_Atopic_Dermatitis:_Associated_Pruritus_from_Phase_1_and_2_Clinical_Studies_ L2 - http://jddonline.com/articles/dermatology/S1545961616P0172X DB - PRIME DP - Unbound Medicine ER -