As an oral selective inhibitor of Januse kinase (JAK) 1 and JAK 2, which may play a role in the inflammatory response of atopic dermatitis (AD), baricitinib is under investigation for the treatment of moderate to severe AD in patients who had an inadequate response to topical corticosteroids. The results of a poster presented at the American Academy of Dermatology Virtual Meeting Experience 2020 showed that baricitinib monotherapy improved the severity of skin diseases as assessed by clinician- and patient-reported outcome measures.
The poster used data from two phase 3 trials, BREEZE-AD1 and BREEZEAD-2, to describe the patient-reported secondary measures of skin symptoms, itch, and quality of life. In these trials, patients who received baricitinib saw clinically relevant improvements in Investigator’s Global Assessment (IGA) vs placebo, and baricitinib showed a safety profile consistent with previous studies. These studies included 624 and 615 patients aged 18 years or older, respectively, who had either an Eczema Area Severity Index score greater than or equal to 16, an IGA 3 or 4, or affected body surface area greater than or equal to 10%. Patients also had inadequate response or intolerance to one or more topical medication less than 6 months prior to study screening.
Over a 16-week treatment period, 10.4% and 11.4% of patients receiving baricitinib 4 mg, 7.3% and 7.3% receiving baricitinib 2 mg, and 5.5% and 4.8% receiving baricitinib 1 mg saw a decrease in SCOring Atopic Dermatitis (SCORAD) values greater than or equal to 75% in BREEZE-AD1 and BREEZE-AD2, respectively.
For SCORAD Pruritus Visual Analog Scale, there was a least squares (LS) mean change from baseline of -2.4, -2.0, and -2.9 in BREEZEAD-1 and -1.9, -2.4, and -2.9 in BREEZEAD-2 for baricitinib 1 mg, 2 mg, and 4 mg, respectively.
Also examined in the study was Patient Global Impression of Severity in Atopic Dermatitis (PGI-S-AD). In LS mean change in PGI-S-AD from baseline, baricitinib demonstrated -0.6, -0.6, and -0.8 in BREEZE-AD1 and -0.5, -0.9, and -1.0 in BREEZE-AD2 for the doses 1 mg, 2 mg, and 4 mg, respectively. Similarly, improvements in the Dermatology Life Quality Index (DLQI) were noted. In BREEZE-AD1, 16.8% of patients who received baricitinib 4 mg reported a DLQI score of 0 or 1; in BREEZE-AD2, 15.4% reported a score of 0 or 1 in the same dosage group. For baricitinib 2 mg, 11.4% in both BREEZE-AD1 and BREEZE-AD2 reported scores of 0 or 1, and 7.9% and 9.6% who received baricitinib 1 mg reported scores of 0 or 1, respectively.
With this data, the authors concluded that baricitinib demonstrated rapid onset of improvement in AD and pruritus severity while showing clinically meaningful improvements in quality of life.
Lio PA, Nosabum A, Cardillo TE, et al. Impact of baricitinib on patient-reported skin symptoms, itch, and quality of life in adult patients with moderate-to-severe atopic dermatitis and an inadequate response to topical therapies from phase 3 trials, BREEZE-AD1 and BREEZE-AD2. Presented at: American Academy of Dermatology Virtual Meeting Experience; June 12-14, 2020.