Lilly Announces Top-Line Phase 3 Results for Baricitinib in Patients with Moderate to Severe Atopic Dermatitis
INDIANAPOLIS, Eli Lilly and Company(NYSE: LLY) and?Incyte Corporation?(NASDAQ: INCY) announced today that baricitinib met the primary endpoint in BREEZE-AD1 and BREEZE-AD2, two Phase 3 studies evaluating the efficacy and safety of baricitinib monotherapy for the treatment of adult patients with moderate to severe atopic dermatitis (AD). In both investigational trials, compared to patients treated with placebo, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint at Week 16 defined by the Investigator's Global Assessment for AD (IGA) score of clear or almost clear (IGA 0,1). These are two of five studies that will be part of the placebo-controlled data program intended to support global registrations.
In the 16-week placebo-controlled phase of BREEZE-AD1 and BREEZE-AD2, the incidence of treatment-emergent adverse events and serious adverse events with baricitinib treatment was similar to placebo, and the most common treatment-emergent adverse events observed were nasopharyngitis and headache. No venous thromboembolic events (VTEs), major adverse cardiovascular events (MACE), or deaths were reported.
"Atopic dermatitis is a chronic inflammatory skin disease that can negatively impact the quality of life for patients, and unfortunately there are limited treatment options, particularly oral medications," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "We are encouraged that baricitinib met the primary endpoints in these two studies, and look forward to seeing the collective results of all five studies."
Lilly plans to share the full data results from both the BREEZE-AD1 and BREEZE-AD2 studies at future scientific venues and in peer-reviewed journals, as well as the topline data from other ongoing Phase 3 trials later this year.
Baricitinib is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in more than 50 countries, including the U.S., member states of the EU and?Japan, and is marketed as OLUMIANT?.
Indication and Usage for OLUMIANT (baricitinib) tablets (in?the United States) for RA patients
OLUMIANT??(baricitinib) 2 mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.?Limitation of Use: Use of OLUMIANT in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) tablets?
WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS
SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:
- Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. Treatment for latent infection should be considered prior to Olumiant use.
- Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
- Bacterial, viral, and other infections due to opportunistic pathogens.
- with chronic or recurrent infection
- who have been exposed to TB
- with a history of a serious or an opportunistic infection
- who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
- with underlying conditions that may predispose them to infection.