Improvement in sleep and itch and enhanced quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a phase 3 trial of baricitinib therapy

Lio, Peter; Simpson, Eric L.; Han, George; Soung, Jennifer; Ball, Susan; Sun, Luna; Casillas, M.; DeLozier, Amy M.; Ding, Yuxin; Eichenfield, Lawrence F.

doi:10.1080/09546634.2021.1914308

Cited by 12 publications

(6 citation statements)

References 18 publications

(20 reference statements)

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“…Data in support of the impact of baricitinib treatment on DLQI and work productivity were reported for the originating study BREEZE‐AD5 9 . More recently, it was demonstrated that improvements in itch and sleep with baricitinib translate into meaningful improvements in patients' daily lives 23 . Taken together, these findings indicate that alleviation of these core symptoms of AD with baricitinib contribute toward important improvements in overall disease burden for patients.…”

Section: Discussionmentioning

confidence: 72%

Baricitinib 2 mg for the treatment of atopic dermatitis in North America : Long‐term efficacy and patient‐reported outcomes

Simpson

Armstrong

Boguniewicz

et al. 2022

Dermatologic Therapy

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To address the need for long-term efficacy and patient-reported outcomes (PROs) data for patients with atopic dermatitis (AD) treated with baricitinib 2 mg, a study was conducted to evaluate the efficacy of baricitinib 2 mg in adult patients with moderateto-severe AD. Data presented here provided efficacy and outcomes data for patients treated for 52 weeks. Patients who participated in the originating study, BREEZE-AD5 (NCT03435081), and met additional eligibility criteria could enroll in the multicenter, open-label, Phase 3, long-term extension study BREEZE-AD6 (NCT03559270). Patients received baricitinib 2 mg for the duration of BREEZE-AD6. In BREEZE-AD6, the proportion of patients who achieved a 75% improvement in the Eczema Area and Severity Index (EASI75) and validated Investigator Global Assessment for AD (vIGA-AD™) of 0 (clear) or 1 (almost clear) were assessed through 52 weeks, in addition to several PROs. At week 52, the proportion of patients treated with baricitinib 2 mg daily achieving EASI75 was 48.6% (70/144), and 31.3% (45/144) of patients achieved a vIGA-AD score of 0 or 1 (clear or almost clear). Improvements in PROs such as SCORing Atopic Dermatitis (SCORAD, itch and sleep) scores, Dermatology Life Quality Index (DLQI) total score, and DLQI ≤5 response were observed, and these responses were sustained through 52 weeks. Long-term efficacy of baricitinib in patients with AD was demonstrated by both clinician and patient-reported outcome measures.

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Section: Discussionmentioning

confidence: 72%

Baricitinib 2 mg for the treatment of atopic dermatitis in North America : Long‐term efficacy and patient‐reported outcomes

Simpson

Armstrong

Boguniewicz

et al. 2022

Dermatologic Therapy

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“…For patients with a baseline Atopic Dermatitis Sleep Scale score ≥1.5, a decrease of at least 1.5 points in the number of nighttime awakenings caused by itch was observed for both 1 mg ( P =.04) and 2 mg ( P <.001) versus placebo. Adverse effects were not mentioned [ 15 ].…”

Section: Resultsmentioning

confidence: 99%

Integrative Approaches to Sleep Management in Skin Disease: Systematic Review

Kulkarni,

Mojica,

Gamsarian

et al. 2023

JMIR Dermatol

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Background Dermatological conditions, especially when severe, can lead to sleep disturbances that affect a patient’s quality of life. However, limited research exists on the efficacy of treatments for improving sleep parameters in skin conditions. Objective The objective was to perform a systematic review of the literature on dermatological conditions and the treatments available for improving sleep parameters. Methods A literature review was performed using the PubMed, Ovid MEDLINE, Embase, Cochrane, and ClinicalTrials.gov databases from 1945 to 2021. After filtering based on our exclusion criteria, studies were graded using the SORT (Strength of Recommendation Taxonomy) algorithm, and only those receiving a grade of “2” or better were included. Results In total, 25 treatment studies (n=11,025) assessing sleep parameters related to dermatological conditions were found. Dupilumab appeared to be the best-supported and most effective treatment for improving sleep in atopic dermatitis (AD) but had frequent adverse effects. Topical treatments for AD were mostly ineffective, but procedural treatments showed some promise. Treatments for other conditions appeared efficacious. Conclusions The evaluation of sleep parameter changes in dermatological treatments is predominantly restricted to AD. Systemic interventions such as dupilumab and procedural interventions were the most efficacious. Sleep changes in other dermatoses were limited by a paucity of available studies. The inclusion of a sleep assessment component to a broader range of dermatological treatment studies is warranted.

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“…The primary end point was the percentage of patients with a vIGA-AD of 0-1 at week 32, 52, and 68 of continuous therapy, and both dosages of baricitinib provided long-term efficacy [35]. Baricitinib plus TCSs has also proven its efficacy in controlling disease-related sleep and itch and positively impacted the QoL of patients with moderate-to-severe AD [36][37][38].…”

Section: Baricitinibmentioning

confidence: 99%

Emerging Systemic Treatments for Atopic Dermatitis

Ferrucci

Tavecchio

Marzano

et al. 2023

Dermatol Ther (Heidelb)

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Atopic dermatitis (AD) is a chronic or chronically relapsing inflammatory skin disease which results from a complex, multifaceted interaction between environmental factors in genetically predisposed patients. Epidermal barrier impairment, alteration of the cutaneous microbiota, effect of external antigens, neurosensory dysfunction, and inflammatory and immune dysregulation all play a pivotal role in inducing and maintaining AD lesions. AD significantly impacts the patient's quality of life and general well-being and is often associated with anxiety and/or depressive symptoms. Classical treatment options include topical corticosteroids and calcineurin inhibitors, phototherapy, and systemic immunosuppression with oral corticosteroids, cyclosporine, methotrexate, and azathioprine in more severe cases. A turning point in facing AD was accomplished when the efficacy and safety of dupilumab, a monoclonal antibody targeting the interleukin (IL)-4 receptor a subunit, led to its approval for the treatment of moderate-tosevere or severe AD in children, adolescents, and adults. Subsequently, a more extensive understanding of AD etiology and pathogenesis has allowed the development of several topical and systemic novel therapy options. Most of these drugs are monoclonal antibodies which interfere with the type 2 inflammatory cascade, especially its key cytokines IL-4 and IL-13, or its downstream Janus kinase signaling pathway. However, considering the relevance of other subtypes of T helper (Th) cells, such as Th1 and Th22, and the important role of specific cytokines (IL-31) in generating pruritus, the horizon of potential therapeutic targets has widened extremely. In this review, we aim to present the most promising systemic agents currently under investigation and illustrate the most significant aspects of their efficacy, safety, and tolerability.

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Improvement in sleep and itch and enhanced quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a phase 3 trial of baricitinib therapy

Cited by 12 publications

References 18 publications

Baricitinib 2 mg for the treatment of atopic dermatitis in North America : Long‐term efficacy and patient‐reported outcomes

Baricitinib 2 mg for the treatment of atopic dermatitis in North America : Long‐term efficacy and patient‐reported outcomes

Integrative Approaches to Sleep Management in Skin Disease: Systematic Review

Emerging Systemic Treatments for Atopic Dermatitis

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