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In people with atopic dermatitis,
crisaborole exhibited superior efficacy when compared to topical calcineurin
inhibitors such as pimecrolimus and tacrolimus.
The findings of the unanchored matching-adjusted indirect comparison revealed that the odds of attaining an improvement in Investigator’s Static Global Assessment (ISGA) scores of 0/1 is higher with crisaborole topical ointment when compared to pimecrolimus or tacrolimus in subjects aged ≥ two years having atopic dermatitis.
Howard Thom et al. undertook this study to determine the effectiveness of 2% crisaborole (a nonsteroidal, topical anti-inflammatory phosphodiesterase-4 inhibitor) relative to topical calcineurin inhibitors such as 1% pimecrolimus, 0.03% tacrolimus and 0.1% tacrolimus for atopic dermatitis management. Improvement in ISGA scores (clear or almost clear) was evaluated.
ISGA was chosen as the major efficacy outcome given the Food and Drug Administration’s suggestion on ISGA usage for assessing global severity in atopic dermatitis and for aligning with efficacy estimations in the crisaborole registration trials. As a result of the differences in the outcome definitions across the studies, assessment of safety endpoints was not possible.
With the aid of the individual patient data from two pivotal phase 3 randomized controlled trials, the effectiveness of crisaborole was assessed. Utilizing the published trials incorporated in a prior network meta-analysis, the effectiveness of comparators was determined.
As a result of differences in the ingredients and population imbalance, the vehicle controls were not similar. Thus, an unanchored matching-adjusted indirect comparison was utilized that reweighted the individual patient data for crisaborole for estimating the absolute response in the comparator populations.
In participants with
mild-to-moderate atopic dermatitis, the odds of attaining an improvement in
ISGA score was more with 2% crisaborole when compared to 1% pimecrolimus (odds ratio [OR] 2.03;
effective sample size = 627, decreased from 1021) and for 2% crisaborole versus
0.03% tacrolimus (OR 1.50; effective
sample size = 311, decreased from 1021).
Findings of this study displayed
consistency with the outcomes from the previously issued network meta-analysis,
that utilized a distinct approach to conduct indirect therapeutic comparisons,
concluded the study authors.
Dermatology and Therapy
Matching-Adjusted Indirect Comparison of Crisaborole Ointment 2% vs. Topical Calcineurin Inhibitors in the Treatment of Patients with Mild-to-Moderate Atopic Dermatitis
Howard Thom et al.
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