"This improvement in skin inflammation was achieved with the 4-mg dose while simultaneously reducing the amount of topical corticosteroids patients," Dr. Kristian Reich of University Medical Center Hamburg-Eppendorf told Reuters Health by email. "This corticosteroid-sparing function will play an important role in clinical practice, where patients with moderate-to-severe AD already present inadequate response to TCS, despite use of a significant amount of moderate- and high- potency TCS on their extensive skin lesions."
As reported in JAMA Dermatology, 329 patients (mean age, 34; 66% men) were recruited from 68 centers across 10 countries in Asia, Australia, Europe and South America. All had moderate-to-severe AD refractory to TCSs. After completing the study, they were followed for up to four weeks or enrolled in a long-term extension study.
The primary endpoint was the proportion of patients achieving a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear), with a 2-point or greater improvement from baseline at week 16.
Participants were randomly assigned to 2 mg of baricitinib once daily, 4 mg of baricitinib once daily, or placebo. They also received moderate- and/or low-potency TCSs or similar topical drugs for active lesions. Rescue therapy with high- or ultra-high-potency TCSs or systemic therapies was permitted for those who experienced worsening and unacceptable AD symptoms after two weeks of treatment.
At week 16, 34 patients (31%) receiving 4-mg baricitinib had a vIGA-AD score of 0 or 1, as did 26 (24%) on 2 mg and 16 (15%) on placebo; odds ratio vs. placebo were 2.8 for the 4-mg group and 1.9 for the 2-mg group.
Further, the proportion of patients who achieved an Eczema Area and Severity Index (EASI75) response at week 16 was 48% in the 4-mg group, 43% in the 2-mg group, and 23% in the placebo group.
"In addition to improvements in skin inflammation, baricitinib has also shown rapid improvement in itch, skin pain, and sleep disturbance in AD, which are the main complaints patients report in clinic," Dr. Reich noted. "Improvements in these symptoms were also rapid, with majority of patients who responded to therapy during the study observing clinically meaningful improvements between two to four weeks of therapy."
Treatment-emergent adverse events occurred in 58% of patients in the 4-mg group, 56% in the 2-mg group, and 38% in the placebo group. Serious adverse events were reported in 4% of those taking 4 mg, 2% of those taking 2-mg group, and 4% of the placebo group. Nasopharyngitis, upper respiratory tract infections, and folliculitis were the most common adverse events.
Dr. Reich said, "Baricitinib recently received a positive opinion from the Committee for Medicinal Products for Human Use, and approval in Europe is anticipated soon. (This would) make baricitinib the first JAK inhibitor approved in dermatology, and the first oral therapy approved for AD since cyclosporine, raising the hopes of better treatments for our patients."
Dr. Emma Guttman-Yassky, incoming chair of the dermatology department at Icahn School of Medicine at Mount Sinai in New York City, and currently Director of the Center for Excellence in Eczema and of the Laboratory of Inflammatory Skin Diseases, commented in an email to Reuters Health, "Due to the fact that it can be stopped and restarted at any time, baricitinib can be used in patients with varying disease severity, including those with milder disease who experience disease flares, or for treatment of more resistant areas, such as the face, in patients who do not have significant body surface area involvement."
"The atopic dermatitis community needs additional oral alternatives that can be utilized in our patients," she said. "The cost will also likely be an important factor in determining the use of the drug in the dermatology community."
Eli Lilly and Company, which funded the study, markets baricitinib as Olumiant for patients with rheumatoid arthritis. The list price of Olumiant is $2,265 for a 30-day supply of 2 mg tablets.
By Marilynn Larkin
SOURCE: https://bit.ly/2SDKBqS JAMA Dermatology, online September 30, 2020.
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