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Atopic Dermatitis : Update Bulletin # 2 [March 2019]

Product Code:
Publication Date:
March 2018

This edition presents key opinion leader (KOL) views on recent developments in the treatment of atopic dermatitis (AD). Topics covered include KOL views on the presentation of topline data from two Phase III studies evaluating the janus kinase (JAK) inhibitor Olumiant (baricitinib; Eli Lilly/Incyte), which showed that a statistically significant proportion of moderate-to severe patients achieved the primary endpoint of clear or almost clear of disease after 16 Weeks of treatment; as measured by Investigator's Global Assessment (IGA) score. KOLs also discuss XBiotech's presentation of results from a Phase II study investigating the safety and efficacy of first-in-class monoclonal antibody (mAb) bermekimab, in which patients with moderate-to-severe AD showed a significant improvement in disease after seven weeks of treatment when treated with a higher dose of the drug. Finally, KOLs share their opinions regarding Glenmark Pharmaceuticals' publication of new post-hoc data from a Phase IIa proof-of-concept study with novel mAb, GBR 830, which inhibits the immune checkpoint regulator OX40.

Business Questions:

  • Eli Lilly and Incyte are developing the janus kinase (JAK) inhibitor Olumiant (baricitinib) for the treatment of moderate-to-severe atopic dermatitis (AD), but how convincing is the positive efficacy data reported from two recent Phase III studies?
  • How concerned are opinion leaders with regard to Olumiant's safety profile, given the known class-wide adverse events associated with JAK inhibitors?
  • If approved, where in the current treatment paradigm will Olumiant sit and how successfully will it compete with established therapies?
  • At the annual American Academy of Dermatology (AAD) conference in March 2019, XBiotech presented data from a Phase II study investigating the anti-interleukin-1-alpha (anti-IL1α) monoclonal antibody (mAb) bermekimab, but how do KOL's interpret the reported rapid onset of action and significant level of patient response?
  • Based on its mechanism of action, how positive are KOLs with regard to bermekimab's potential as a successful treatment for moderate-to-severe AD?
  • XBiotech indirectly suggests that data from bermekimab's Phase II study is indicative of superiority to Dupixent (dupilumab; Sanofi/Regeneron), the only currently approved biologic for this indication, but how do KOLs view the data? Does bermekimab have the potential to successfully compete with this marketed therapy?
  • Glenmark Pharmaceuticals is developing the mAb GBR 830, an inhibitor of the immune checkpoint regulator OX40, but how optimistic are KOLs about this novel mechanism of action in the treatment of AD? Do KOLs have any concerns over potential safety issues with GBR 830?
  • In March 2019, Glenmark Pharmaceuticals published new post-hoc analysis from a Phase IIa proof-of-concept study evaluating GBR 830, which stratified patients according to established AD subtypes? What significance does this new data have and do KOLs feel that stratifying patients is a valuable approach in the development process for new AD therapies?


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