Itch and Sleep Improvements with Baricitinib in Patients with Atopic Dermatitis: A Post Hoc Analysis of 3 Phase 3 Studies

Abstract

Introduction Burdensome symptoms of atopic dermatitis include itch and sleep disturbance. This post hoc analysis reports the effect of baricitinib on itch and sleep disturbance during the first week of treatment in 3 phase 3 studies. Methods Patients were randomized 2:1:1:1 to once-daily placebo or baricitinib 1 mg, 2 mg, or 4 mg in the BREEZE-AD1 and -AD2 studies and 1:1:1 to once-daily placebo or baricitinib 2 mg or 4 mg in the BREEZE-AD7 study. Topical corticosteroids were only allowed in BREEZE-AD7. Patients completed the itch numerical rating scale and atopic dermatitis sleep scale (ADSS) items 1–3 using an electronic daily diary. Data were analyzed by study as least squares mean percent change from baseline in daily scores for the randomized patients. Mixed model repeated measures analysis was used to analyze change from baseline values. Results A total of 624, 615, and 329 patients were randomized in BREEZE-AD1, -AD2, and -AD7, respectively. Itch severity significantly improved with baricitinib 2 mg and 4 mg versus placebo starting at day 2 (1 day after first dose) in BREEZE-AD1 and -AD7 and at day 1 in BREEZE-AD2. Patients’ ability to fall asleep (ADSS item 1) significantly improved with baricitinib 2 mg and 4 mg versus placebo starting at day 2 in all three studies. There were significant improvements in patients waking due to itch (ADSS item 2) with baricitinib 4 mg versus placebo starting at day 2 in all three studies. Patients’ ability to return to sleep after being woken by itch (ADSS item 3) was significantly improved with baricitinib 4 mg versus placebo starting at day 2 in BREEZE-AD1 and -AD2 and at day 4 in BREEZE-AD7. Conclusion Rapid onset of action, typically 1 day after taking the first dose of baricitinib, was observed consistently for the burdensome symptoms of itch and sleep disturbance. ClinicalTrials.gov identifiers BREEZE-AD1, NCT03334396; BREEZE-AD2, NCT03334422; BREEZE-AD7, NCT03733301.

Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7

“…However, the numbers of patients These data further support previous findings that baricitinib provides rapid and durable relief for patients with AD [6,15]. A recent report has also shown rapid improvements in itch severity and sleep disturbance after treatment with baricitinib [16]. Similar to the improvements in skin pain, a significant reduction in itch severity is observed on the first day after first dose administration (day 2), as well as improvements seen in patients' ability to fall asleep, waking due to itch, and ability to return to sleep after being woken by itch.…”

“…The phase 3 randomized, controlled monotherapy studies of baricitinib, BREEZE-AD1 and BREEZE-AD2, and the combination study of baricitinib with TCS, BREEZE-AD7, have shown that baricitinib improved signs and symptoms of AD, and was well tolerated [6,15]. Baricitinib has been shown to have a rapid effect on patient-reported outcomes (PROs) such as itch and sleep [16]. This analysis shows that a rapid improvement can also be achieved in skin pain and associated QoL measures reported through patient diaries in the studies BREEZE-AD1, BREEZE-AD2, and BREEZE-AD7.…”

Baricitinib rapidly and sustainably relieves a patient from chronic pruritus of unknown origin refractory to dupilumab

“…Baricitinib was recently approved in atopic dermatitis 9 and showed rapid effects on the highly bothersome symptoms of itch and sleep disturbance. 10 Its rapid antipruritic properties, as demonstrated in our case study, suggest additional use for refractory chronic pruritus.…”

Baricitinib: A Review in Moderate to Severe Atopic Dermatitis

“…In a post hoc analysis of data from the first week of therapy in BREEZE-AD1 and BREEZE-AD2, baricitinib 4 mg significantly (nominal p ≤ 0.01 vs placebo) improved itch and sleep disturbance as early as day 2 (i.e. one day after the first dose), with these improvements maintained to day 7 [ 25 ]. Baricitinib 2 mg was associated with nominally significant between-groups differences relative to placebo in the proportions of patients achieving a clinically relevant POEM response (Table 2 ) and a DLQI total score of 0 or 1 response (nominal p ≤ 0.05) at week 16 in BREEZE-AD1 and BREEZE-AD2 [ 16 , 24 ].…”