Physician Views: Can Dermira's lebrikizumab dethrone Dupixent?

On the back of new Phase IIb data, Dermira has bullishly suggested that its IL-13 inhibitor lebrikizumab may represent a 'best in disease' therapy for moderate-to-severe atopic dermatitis (AD); assuming of course that similar results can be replicated in larger Phase III studies.

Analysis - ViewPoints: Little Dermira has Dupixent in its sights

However, a number of notable equity analysts are more circumspect about lebrikizumab's chances of displacing Sanofi and Regeneron Pharmaceuticals' established biologic therapy Dupixent, which was approved two years ago, but has quickly become recognised as the gold standard treatment.

To get a better understanding of what impact lebrikizumab could theoretically have on the AD market we are snap-polling US and EU3 (France, Germany and the UK) based dermatologists with the following questions…

________

Q1. Positive data have been announced from a 280-patient, Phase IIb study of the IL-13 inhibitor lebrikizumab in moderate-to-severe atopic dermatitis (AD).

Lebrikizumab showed a dose-dependent and statistically significant improvement in the primary endpoint: a mean percent change in EASI score from baseline to week 16. The improvement in EASI score was 69.2% for patients receiving lebrikizumab 250 mg every four weeks and 72.1% for patients receiving lebrikizumab 250 mg every two weeks compared to 41.1% for patients receiving placebo.

The most common adverse events reported across all lebrikizumab dosing arms were upper respiratory tract infection (7.5% versus 5.8% for placebo), nasopharyngitis (6.6% versus 3.8% for placebo), headache (3.1% versus 5.8% for placebo) and injection site pain (3.1% versus 1.9% for placebo). Rates of conjunctivitis (2.6% compared to no reports for placebo) and herpes infections (2.2% compared to no reports for placebo) were low.

Versus current standard of care therapy for moderate-to-severe AD, how compelling are these data?

Not compelling

Slightly compelling

Moderately compelling

Very compelling

Extremely compelling

________

Q2. Patients treated with lebrikizumab at the 250 mg dose every four weeks not only achieved the primary endpoint of an improvement in EASI score, but also achieved statistically significant improvements in other key efficacy measures compared to placebo after 16 weeks of treatment.

33.7% of patients achieved clearing or near-clearing of skin lesions, as measured by an investigator's global assessment (IGA) score of 0 or 1, and a reduction of at least 2 points from baseline, compared to 15.3% with placebo; 56.1% of patients achieved a reduction of at least 75% from baseline in EASI score (EASI-75), compared to 24.3% on placebo; and 36.1% of patients achieved a reduction of at least 90% from baseline in EASI score (EASI-90), compared to 11.4% on placebo.

Taking into account that current standard of care Dupixent (dupilumab) is dosed every other week, how compelling are these four-week dosing Phase IIb data for lebrikizumab? 

Not compelling

Slightly compelling

Moderately compelling

Very compelling

Extremely compelling

________

Q3. Lebrikizumab's developer Dermira has suggested that its Phase III study design could incorporate initial treatment with lebrikizumab 250mg every two weeks (to ensure a rapid dose response) before patients are potentially transitioned to receiving lebrikizumab 250mg every four weeks in a 'maintenance' setting. Physicians could have the option of returning to the two week dosing schedule if disease severity increases or 'flares' up.

Assuming that lebrikizumab demonstrates broadly similar data in Phase III studies, could this flexible dosing schedule be considered practice changing for the treatment of moderate-to-severe AD?

Yes

No

________

Q4. If effective oral therapies for moderate-to-severe AD reach the market in the next few years, to what extent do you think the availability of these will limit the opportunity for less frequently administered biologic (injectable) treatments?

None

Slight impact

Moderate impact

Significant impact

Very significant impact

________

Q5. At this juncture, taking into account the potential advantages of less frequent dosing, but that data for lebrikizumab is from a Phase IIb study and the product is unlikely to reach the market until 2022 at the earliest, how much of a competitive threat do you think lebrikizumab poses to Dupixent?

None

Slight threat

Moderate threat

Significant threat

Very significant threat

________

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

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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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