. 2019 Jul 4;12(5):445–459. doi: 10.1007/s40271-019-00373-y

Table 2.

FDA PRO label language for noncorticosteroid products recently approved for AD

Drug/PRO measure	Indication	Claim language	PRO results in label/DAP
Dupixent (dupilumab) Peak Pruritus NRS	Indicated for adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable	All three trials assessed … reduction in itch as defined by at least a 4-point improvement in the Peak Pruritus NRS from baseline to week 16	Label: “Other endpoints included the … reduction in itch as defined by at least a 4-point improvement in the Peak Pruritus NRS from baseline to week 16” Percentage of subjects with improvement in Peak Pruritus NRS ≥ 4 points for each of three trials, for the dupilumab and placebo groups, with no indication of statistical significance
Protopic (tacrolimus) Pruritus (VAS based on the DAP medical review)	Second-line therapy for the short-term and noncontinuous chronic treatment of moderate-to-severe atopic dermatitis in non-immunocompromised adults and children who have not responded adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable	In both the Protopic ointment treatment groups in adults and the Protopic ointment 0.03% treatment group in pediatric patients, a significantly greater improvement compared with vehicle (p < 0.001) was observed in the secondary efficacy endpoints of percentage body surface area involved, patient evaluation of pruritus, erythema, edema, excoriation, oozing, scaling, and lichenification	Label: No further results on pruritus improvement in the label DAP medical review: “The amount and intensity of pruritus experienced during the previous 24-h period was assessed using a 10-cm VAS, where 0 cm = ‘no itch’ and 10 cm = ‘worst itch imaginable’
Elidel (pimecrolimus) Pruritus (assessment not described in the label or DAP)	Elidel (pimecrolimus) cream 1% is indicated as second-line therapy for the short-term and noncontinuous chronic treatment of mild-to-moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have not responded adequately to other topical prescription treatments, or when those treatments are not advisable	The improvement in pruritus occurred in conjunction with the improvement of the patients’ atopic dermatitis	Label: More Elidel patients (57%) had mild or no pruritus at 6 weeks compared with vehicle patients (34%) [Means of assessing this outcome not reported]

Drug/PRO measure

Indication

Claim language

PRO results in label/DAP

Dupixent (dupilumab)

Peak Pruritus NRS

Indicated for adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable

All three trials assessed …

reduction in itch as defined by at least a 4-point improvement in the Peak Pruritus NRS from baseline to week 16

Label: “Other endpoints included the … reduction in itch as defined by at least a 4-point improvement in the Peak Pruritus NRS from baseline to week 16”

Percentage of subjects with improvement in Peak Pruritus NRS ≥ 4 points for each of three trials, for the dupilumab and placebo groups, with no indication of statistical significance

Protopic (tacrolimus)

Pruritus (VAS based on the DAP medical review)

Second-line therapy for the short-term and noncontinuous chronic treatment of moderate-to-severe atopic dermatitis in non-immunocompromised adults and children who have not responded adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable

In both the Protopic ointment treatment groups in adults and the Protopic ointment 0.03% treatment group in pediatric patients, a significantly greater improvement compared with vehicle (p < 0.001) was observed in the secondary efficacy endpoints of percentage body surface area involved, patient evaluation of pruritus, erythema, edema, excoriation, oozing, scaling, and lichenification

Label: No further results on pruritus improvement in the label

DAP medical review: “The amount and intensity of pruritus experienced during the previous 24-h period was assessed using a 10-cm VAS, where 0 cm = ‘no itch’ and 10 cm = ‘worst itch imaginable’

Elidel (pimecrolimus)

Pruritus (assessment not described in the label or DAP)

Elidel (pimecrolimus) cream 1% is indicated as second-line therapy for the short-term and noncontinuous chronic treatment of mild-to-moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have not responded adequately to other topical prescription treatments, or when those treatments are not advisable

The improvement in pruritus occurred in conjunction with the improvement of the patients’ atopic dermatitis

Label: More Elidel patients (57%) had mild or no pruritus at 6 weeks compared with vehicle patients (34%)

[Means of assessing this outcome not reported]

AD atopic dermatitis, DAP drug approval package, FDA US Food and Drug Administration, NRS Numeric Rating Scale, PRO patient-reported outcome, VAS visual analog scale