Atopic Dermatitis: Update Bulletin #2 [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; Pfizer’s announcement of initiation of the global Phase III JADE development program for the Janus Kinase 1 (JAK1) inhibitor, PF 04965842, in patients as young as 12 with moderate to severe AD; AbbVie’s presentation of new positive Phase IIb data concerning the JAK1-selective inhibitor, upadacitinib, indicating efficacy across all dosage strengths in adult patients with moderate to severe AD; and Dermira’s initiation of a Phase IIb dose-ranging study evaluating the safety and efficacy of the anti-interleukin-13 (anti-IL-13) monoclonal antibody (mAb), lebrikizumab, following promising Phase II results in adult patients with moderate to severe AD.
Business Questions:
Business Questions:
- In December 2017, Pfizer announced initiation of the Phase III JADE global development program investigating the safety and efficacy of the Janus Kinase 1 (JAK1) inhibitor PF 04965842 in the treatment of moderate to severe atopic dermatitis (AD), but how do KOLs view this novel therapy, and what advantages does it offer over existing treatments?
- How robust is Pfizer’s Phase III trial design and how significant is the decision to include patients as young as 12 years of age?
- How promising is the Phase IIb data for AbbVie’s JAK1 inhibitor upadacitinib, presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego?
- What concerns, if any, do KOLs have with regard to the use of JAK1 inhibitors for the treatment of moderate to severe AD?
- Where will JAK1 inhibitors sit within the current treatment paradigm, given the recent approval of the monoclonal antibody (MAb) Dupixent (dupilumab; Sanofi/Regeneron) for the indication of AD?
- Can the AD market accommodate multiple JAK inhibitors and how will prescribers differentiate between them?
- How do KOLs perceive the anti-interleukin-13 (anti-IL-13) MAb lebrikizumab, following Dermira’s publication of data from the Phase II proof-of-concept TREBLE study?
- Do KOLs have any concerns regarding the potential of lebrikizumab for the treatment of AD, particularly given the decision to terminate further development of the product for the indication of asthma?
- How successfully will lebrikizumab compete with Dupixent, the first MAb therapy to receive approval for the treatment of AD?