Baricitinib effective for treating moderate to severe atopic dermatitis, reveal clinical trial results
Baricitinib, an oral JAK inhibitor, has met its primary endpoint for the treatment of moderate to severe atopic dermatitis (AD) in adults, in BREEZE-AD7 -- the third pivotal Phase 3 clinical trial in the BREEZE-AD program to be completed in 2019.
Baricitinib (OLUMIANT) 4 mg and 2 mg both met the primary endpoint on BREEZE-AD1 and BREEZE-AD2 clinical trials disclosed earlier this year.
The results were announced by the pharmaceutical companies Eli Lilly and Incyte Corporation.
The investigational study BREEZE-AD7 evaluated the efficacy and safety of baricitinib for the treatment of moderate to severe AD in adults. The disease severity was measured by the validated Investigator's Global Assessment for AD (vIGA) score of "clear or almost clear" skin (vIGA 0, 1), the primary endpoint of the study at 16 weeks.
The study found that the addition of baricitinib to standard-of-care topical corticosteroids significantly improved disease severity.
Key findings include
- Safety data were consistent with the known safety profile of baricitinib.
- The most common treatment-emergent adverse events observed were nasopharyngitis, upper respiratory tract infection and folliculitis.
- One pulmonary embolism was reported in the baricitinib group. One opportunistic infection was reported in the placebo group.
- No malignancies, major adverse cardiovascular events (MACE), or deaths were reported in the study.
"Despite recent scientific advances, moderate to severe atopic dermatitis remains a disease with significant unmet treatment needs. Atopic dermatitis is a chronic, relapsing condition that can vary greatly from person to person, and yet there are few medicines to address the different signs and symptoms in each patient," Lotus Mallbris, vice president of immunology development at Lilly said in a press release. "Today's baricitinib results in combination therapy reveal important additional clinical information in a chronic disease where patients currently have limited oral treatment options."
Lilly plans to share the detailed 16-week data and analyses from BREEZE-AD7 at future scientific venues and in peer-reviewed journals later this year. Top-line data from the remaining two Phase 3 trials will be announced later this year or early next year.
Baricitinib is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.
There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases. OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known. OLUMIANT is approved in more than 60 countries.
About Atopic Dermatitis
Atopic Dermatitis or Eczema is a chronic condition of the skin characterized by itchy and red skin. It is common in children but can occur at any age. AD is long-lasting and tends to flare periodically. It may be accompanied by asthma or hay fever.
Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin. Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.