Extended safety analysis across eight studies helps further define the known safety profile of Olumiant 2-mg in atopic dermatitis

TORONTO,?April 30, 2021?/CNW/ - Through new analyses of BREEZE-AD5 Phase 3 clinical trial data and an extended safety analysis across multiple trials, Eli Lilly and Company and Incyte's Olumiant? (baricitinib) 2-mg tablet taken once daily showed improvement in key measured treatment outcomes compared to placebo, and helped further characterize the long-term safety profile in adults with moderate- to severe atopic dermatitis (AD). In one BREEZE-AD5 analysis, Olumiant provided concurrent improvements in the severity and extent of AD, other key symptoms and quality of life as early as one week, as measured by per cent change from baseline compared to placebo. In a separate BREEZE-AD5 analysis, adults with AD on 10-50% of their bodies at baseline who were treated with Olumiant showed significant improvements in the severity and extent of disease compared to placebo. In the integrated safety analysis of eight AD studies of Olumiant, there were no increases in rates for treatment-emergent adverse events, serious adverse events or serious infections with long-term Olumiant therapy compared to the placebo-controlled period. These results were presented virtually at the American Academy of Dermatology's Virtual Meeting Experience (AAD VMX),?April 23-25, 2021.

"The new analyses of the BREEZE-AD5 Phase 3 study data are very encouraging," says Dr.?Doron Sagman, vice president, R&D and Medical Affairs, Eli Lilly Canada. "Improvement in key symptoms such as itch and pain as early as week one in the moderate- to severe patient population is welcome news for the health care community and many Canadians who live with the debilitating physical and mental impacts of atopic dermatitis."

Olumiant 2-mg concurrently improved extent, severity and key symptoms of AD in as early as one week¹

In a post-hoc analysis of BREEZE-AD5, patients treated with Olumiant 2-mg showed statistically significant and concurrent improvements in the extent and severity of AD, as well as key symptoms such as itch, nighttime awakenings due to itch, skin discomfort and pain, and quality of life, as early as one week as measured by per cent change from baseline compared to placebo. Patients taking Olumiant had statistically significant improvements from baseline (p<0.05) across all measures compared to placebo at one week and four weeks:

• Skin Measures:
  • Eczema Area and Severity Index (EASI), which is a validated, clinical scoring system measuring the extent and severity of AD:
    • At one week: 25.3% for Olumiant vs. 7.2% for placebo
    • At four weeks: 50.9% for Olumiant vs. 24.0% for placebo

• Key Symptoms:
  • Itch Numeric Rating Scale (NRS):
    • At one week: 13.5% for Olumiant vs. -0.2% for placebo
    • At four weeks: 29.0% for Olumiant vs. 12.5% for placebo
  • Skin Pain NRS (Skin discomfort and pain):
    • At one week: 12.0% for Olumiant vs. 2.6% for placebo
    • At four weeks: 27.6% for Olumiant vs. 13.6% for placebo
  • AD Sleep Scale (ADSS) Item 2 (number of nighttime awakenings due to itch):
    • At one week: 20.9% for Olumiant vs. 3.9% for placebo
    • At four weeks: 37.6% for Olumiant vs. 14.1% for placebo

• Composite Outcomes, Including Quality of Life:
  • Dermatology Life Quality Index (DLQI):
    • At one week: 27.2% for Olumiant vs. 12.9% for placebo
    • At four weeks: 40.4% for Olumiant vs. 17.5% for placebo
  • Patient Oriented Eczema Measure (POEM):
    • At one week: 18.0% for Olumiant vs. 6.7% for placebo
    • At four weeks: 29.3% for Olumiant vs. 10.8% for placebo

For methodology, see "About the analyses" section below.

Patients with AD on 10-50% of their bodies at baseline treated with Olumiant 2-mg experienced significant improvements in severity and extent of AD²

A post-hoc analysis of BREEZE-AD5 was conducted to evaluate the efficacy of Olumiant 2-mg based on baseline Body Surface Area (BSA), which measures the extent to which a patient's skin is affected by AD. At two weeks, 2 out of 10 patients with a BSA 10-50% at baseline who were treated with Olumiant saw significant improvements in the severity and extent of their AD compared to placebo (20.2% vs. 5.9%, p=0.01), as measured by a 75% improvement in Eczema Area Severity Index (EASI 75).

At 16 weeks, nearly 4 out of 10 patients with a BSA 10-50% at baseline who were treated with Olumiant saw significant improvements in the severity and extent of their AD compared to placebo (37.5% vs. 9.9%, p=0.001) as measured by EASI 75.

At 16 weeks, approximately 3 out of 10 patients with a BSA 10-50% at baseline who were treated with Olumiant saw significant improvements in the severity and extent of the AD compared to placebo (31.7% vs. 6.9%, p=0.001) based on achievement of clear or almost clear skin, as measured by the validated Investigator Global Assessment for Atopic Dermatitis [vIGA-AD (0,1)].

Olumiant was also evaluated in patients with BSA >50% at baseline. Among these patients, results for Olumiant were numerically higher but not statistically significant compared to placebo. Safety for the baseline BSA 10-50% subgroup was consistent with the overall safety population across the Olumiant clinical program in AD.

For methodology, see "About the analyses" section below.

Long-term analysis supports safety profile of Olumiant 2-mg in AD³

The safety profile for Olumiant 2-mg was evaluated in eight AD clinical studies (six double-blind, randomized, placebo-controlled studies and two long-term extension studies). In the 16-week placebo-controlled period, there was no observed increase in rates of serious adverse events or serious infections with Olumiant therapy compared to placebo, and rates remained similar in the long-term extensions. There were no reports of deep vein thrombosis and pulmonary embolism across these studies.

Olumiant showed no increase in anemia, neutropenia, lymphopenia or elevated liver enzymes compared to placebo as measured by mean change from baseline, and there was no additional increase in these lab changes with long-term therapy. There was no increase in risk of eczema herpeticum with Olumiant compared to placebo (0.2% vs. 0.4%), but an increase in cases of herpes simplex (2.0% vs. 0.9%) was observed.

For methodology, see "About the analyses" section below.

About the analyses

• Rapid and concurrent improvements in the signs and symptoms of atopic dermatitis with baricitinib in the Phase 3 study, BREEZE-AD5
  • 440 patients from the Phase 3 BREEZE-AD5 trial were randomized 1:1:1 to once-daily placebo or Olumiant 1-mg or 2-mg. Per cent changes from baseline were assessed for the following measures in the first four weeks of the study: EASI, itch NRS, skin pain NRS, ADSS item 2, DLQI and POEM. P-values shown above were not adjusted for multiplicity.

• Efficacy of baricitinib 2-mg stratified by baseline body surface area in adults with moderate- to severe atopic dermatitis
  • In a post-hoc analysis, 293 patients from the Phase 3 BREEZE-AD5 trial were divided into subgroups of baseline BSA 10-50% and >50%. Subgroups were evaluated for the proportion of patients achieving a =75% reduction in EASI (EASI 75) and vIGA-AD? (0,1). Safety was also assessed in the subgroup of patients with BSA 10-50% at baseline. P-values shown above were not adjusted for multiplicity.

• Extended safety analysis of baricitinib 2-mg in adult patients with atopic dermatitis: An integrated analysis from eight randomized clinical trials
  • Olumiant 2-mg was studied in six double-blind, randomized, placebo-controlled studies and two long-term extension studies. Incidence rates (IR)/100 patient-years at risk (PYR) were calculated. The analysis included 1,598 patients who received Olumiant 2-mg for 1,434.2 combined patient years of exposure (median 330 days).

About Olumiant? (baricitinib)
Olumiant is a once-daily, oral Janus Kinase (JAK) inhibitor. In Canada, Olumiant, in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms of moderate- to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs). Olumiant can be used as a monotherapy in cases of intolerance to MTX.^4?Olumiant is not currently approved in?Canada?for the treatment of atopic dermatitis.

In?December 2009,?Lilly?and?Incyte?announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

About Lilly in Dermatology
By following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

About Incyte
Incyte is a?Wilmington, Delaware-based global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

About?Lilly Canada
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the?University of Toronto?which eventually produced the world's first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about?Lilly Canada, please visit us at?www.lilly.ca.

For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA and @LillyMedicalCA.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Olumiant (baricitinib) as a treatment for patients with rheumatoid arthritis and a possible treatment for patients with atopic dermatitis and other conditions and reflects Lilly's and Incyte's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, and that Olumiant will receive additional regulatory approvals, or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

To read Lilly's 2021 AAD disclosures,?click here.

SOURCE Eli Lilly Canada Inc.

For further information: Media Contact: Samira Rehman,?Rehman_Samira@lilly.com, 647-617-1994

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