Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes

M J Cork, A McMichael, J Teng, H Valdez, R Rojo, G Chan, F Zhang, D E Myers, M DiBonaventura, M J Cork, A McMichael, J Teng, H Valdez, R Rojo, G Chan, F Zhang, D E Myers, M DiBonaventura

Abstract

Background: A significant improvement in clinical signs was demonstrated with abrocitinib relative to placebo in adolescents with moderate-to-severe atopic dermatitis (AD) in three phase 3, randomized, double-blinded, placebo-controlled studies (JADE TEEN [ClinicalTrials.gov, NCT03796676], JADE MONO-1 [NCT03349060] and JADE MONO-2 [NCT03575871]).

Objectives: To evaluate the impact of abrocitinib on patient-reported signs/symptoms, including sleep loss and quality of life among adolescents with moderate-to-severe AD.

Methods: JADE TEEN, JADE MONO-1 and JADE MONO-2 were conducted in the Asia-Pacific region, Europe and North America and included patients aged 12-17 years with moderate-to-severe AD and inadequate response to ≥ 4 consecutive weeks of topical medication or treatment with systemic therapy for AD. Patients were randomly assigned (1 : 1 : 1, JADE TEEN; 2 : 2 : 1, JADE MONO-1/-2) to receive once-daily oral abrocitinib (200 or 100 mg) or placebo for 12 weeks in combination with topical therapy (JADE TEEN) or as monotherapy (JADE MONO-1/-2). Data from adolescent patients in JADE MONO-1/-2 were pooled for these analyses.

Results: At week 12, more adolescents treated with abrocitinib (200 or 100 mg) vs. placebo achieved a ≥ 4-point improvement from baseline in the Patient-Oriented Eczema Measure in JADE TEEN (83.9% and 77.0% vs. 60.2%) and JADE MONO-1/-2 (83.0% and 69.4% vs. 43.5%) and a ≥ 6-point improvement from baseline in the Children's Dermatology Life Quality Index in JADE TEEN (73.8% and 67.5% vs. 56.5%) and JADE MONO-1/-2 (70.0% and 57.1% vs. 19.0%). Significant improvements in SCORing Atopic Dermatitis Visual Analog Scale for sleep loss scores were demonstrated with abrocitinib vs. placebo at weeks 2-12 in JADE TEEN and JADE MONO-1/-2.

Conclusions: Patient-reported signs/symptoms, including reduction of sleep loss and quality of life, were substantially improved with abrocitinib monotherapy or combination therapy relative to placebo in adolescents with moderate-to-severe AD.

© 2021 Pfizer Inc.. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.

Figures

Figure 1
Figure 1
Proportion of patients achieving a ≥ 6‐point improvement from baseline in POEM over time in (a) JADE TEEN and (b) pooled adolescent population from JADE MONO‐1/‐2. *P < 0.05, **P < 0.0001. Conclusion of statistical significance was not controlled for multiplicity. Assessed among patients with ≥ 6 points at baseline. CI, confidence interval; POEM, Patient‐Oriented Eczema Measure; QD, once daily.
Figure 2
Figure 2
Proportion of patients achieving POEM score of 0‐7 (clear/almost clear or mild) over time in (a) JADE TEEN and (b) pooled adolescent population from JADE MONO‐1/‐2. *P < 0.05, **P < 0.0001. Conclusion of statistical significance was not controlled for multiplicity. Assessed among patients with ≥ 8 points at baseline. CI, confidence interval; POEM, Patient‐Oriented Eczema Measure; QD, once daily.
Figure 3
Figure 3
Proportion of patients with ≥ 6‐point improvement from baseline in CDLQI over time in (a) JADE TEEN and (b) pooled adolescent population from JADE MONO‐1/‐2. *P < 0.05, **P < 0.0001. Conclusion of statistical significance was not controlled for multiplicity. Assessed among patients with ≥ 6 points at baseline. CDLQI, Children’s Dermatology Life Quality Index; CI, confidence interval; QD, once daily.
Figure 4
Figure 4
Proportion of patients achieving a CDLQI score of 0‐6 (no or small effect) over time in (a) JADE TEEN and (b) pooled adolescent population from JADE MONO‐1/‐2. *P < 0.05, **P < 0.0001. Conclusion of statistical significance was not controlled for multiplicity. Assessed among patients with ≥ 7 points at baseline. CDLQI, Children’s Dermatology Life Quality Index; CI, confidence interval; QD, once daily.
Figure 5
Figure 5
Proportion of patients with ≥ 1‐point improvement from baseline in PSAAD over time in (a) JADE TEEN and (b) pooled adolescent population from JADE MONO‐1/‐2. *P < 0.05, **P < 0.0001. Conclusion of statistical significance was not controlled for multiplicity. Assessed among patients with ≥ 1 point at baseline. CI, confidence interval; PSAAD, Pruritus and Symptoms Assessment for Atopic Dermatitis; QD, once daily.
Figure 6
Figure 6
SCORAD VAS sleep loss over time in (a) JADE TEEN and (b) pooled adolescent population from JADE MONO‐1/‐2. *P < 0.05, **P < 0.0001. Conclusion of statistical significance was not controlled for multiplicity. CI, confidence interval; QD, once daily; SCORAD, SCORing Atopic Dermatitis; VAS, Visual Analog Scale.

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Source: PubMed

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