Physician Views snap poll: Dermatologists assess new Phase III data for Eli Lilly's baricitinib in atopic dermatitis

Potential competition for Regeneron Pharmaceuticals and Sanofi's monoclonal antibody Dupixent in moderate-to-severe atopic dermatitis could emerge in the next few years in the form of JAK inhibitors.

These products, among them drugs developed by Eli Lilly (baricitinib) and Pfizer (abrocitinib), are poised to offer lower efficacy than Dupixent, but the convenience of oral dosing.

See our earlier poll from May - Physician Views snap poll results - Dupixent satisfaction rates sky high, but demand for oral alternatives is real 

With new Phase III data presented for baricitinib at last weekend's World Congress of Dermatology (WCD), we are snap-polling dermatologists based in the US and EU3 (France, Germany and the UK) to evaluate their assessment of these results…

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Data from two Phase III studies presented at the World Congress of Dermatology shows that Eli Lilly's oral JAK inhibitor baricitinib significantly improved the signs and symptoms of moderate-to-severe atopic dermatitis versus placebo. In both studies, significantly more patients treated with baricitinib 4mg and 2mg achieved skin clearance versus placebo at 16 weeks.

In BREEZE-AD1, 16.8% (baricitinib 4mg) and 11.4% (baricitinib 2mg) of patients achieved skin clearance versus 4.8% (placebo).

In BREEZE-AD2, 13.8% (baricitinib 4mg) and 10.6% (baricitinib 2mg) of patients achieved skin clearance versus 4.5% (placebo).

Furthermore, in BREEZ-AD1, 24.8% (baricitinib 4mg) and 18.7% (baricitinib 2mg) of patients achieved an Eczema Area and Severity Index-75 score versus 8.8% (placebo).

In BREEZE-AD2, 21.1% (baricitinib 4mg) and 17.9% (baricitinib 2mg) of patients achieved an Eczema Area and Severity Index-75 score versus 6.1% (placebo).

Versus current standard of care for moderate-to-severe atopic dermatitis, how compelling are these efficacy data?

1 - Not compelling

2

3

4

5 - Extremely compelling

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Across both trials, pooled adverse events were reported in 56% (baricitinib 4mg), 58% (baricitinib 2mg) and 55% (placebo) of patients, with serious adverse events reported in 1.2% (baricitinib 4mg), 1.2% (baricitinib 2mg) and 3% (placebo) of patients.

Also taking into account efficacy data, how compelling is the efficacy/safety trade off demonstrated by baricitinib 4mg and 2mg?

1 - Not compelling

2

3

4

5 - Extremely compelling

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It was also noted that a significant improvement in itch was achieved as early as week 1 for baricitinib 4mg and week 2 for baricitinib 2mg.

Separately, Pfizer has highlighted a rapid onset of action for its oral JAK inhibitor abrocitinib and is running a Phase III study with dupilumab (Dupixent) as an active comparator to potentially show differentiation by this clinical measure (improvement in pruritus numerical rating scale at week 2 is a secondary outcome measure).

How compelling is the concept of an oral agent for moderate-to-severe atopic dermatitis with proven efficacy at rapidly reducing itch?

1 - Not compelling

2

3

4

5 - Extremely compelling

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Pfizer also recently revealed that abrocitinib met its primary and secondary efficacy endpoints versus placebo at week 12 in a Phase III study. It also noted no cases of major cardiovascular events were reported in patients who received abrocitinib, which was well tolerated; discontinuation rates due to adverse events were 5.8% for two doses of abrocitinib versus 9.1% for placebo.

Taking everything you know about oral JAK inhibitors into account, how much of a competitive threat do you think they would pose to dupilumab if approved by regulators?

1 - No threat

2

3

4

5 - Significant threat

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Based on the Phase III efficacy/safety data for baricitinib (including skin clearance rates of 16.8%/13.8% and EASI-75 scores of 24.8%/21.1% for the 4mg dose), can you estimate approximately what percentage of patients you currently treat with dupilumab you would consider switching to this lower efficacy, but oral agent?

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Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions.

Note: FirstWord Physician Views are a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties in major markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com.

Disclaimer: FirstWord follows market research best practices in conducting its Physician Views polls.  However, Physician Views results should be considered directional and clients should use their market research resources for statistical analysis and conclusions required with very high confidence levels.

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