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PMCPA Case

LEO: Tralokinumab (Adtralza) symposium EASI-100 figures found misleading and unsubstantiated (AUTH/3838/10/23 & AUTH/3840/10/23)

📅 8 March 2026 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numbersAUTH/3838/10/23 and AUTH/3840/10/23
CompanyLEO
ProductTralokinumab (Adtralza)
SettingLEO-sponsored promotional symposium at BDNG annual conference (Harrogate)
IssueEASI-100 patient numbers presented on slides/verbatim did not match supporting analysis; cited publication did not provide absolute EASI-100 figures
Key discrepancy notedWeek 16: slide/speaker 17/252 vs analysis 16/252; Week 32: slide/speaker 34/252 vs analysis 33/252
Applicable Code2021
Complaint received12 October 2023 (AUTH/3838/10/23); 24 October 2023 (AUTH/3840/10/23)
Case completed3 February 2025
Breach clausesClause 6.1; Clause 6.2
SanctionsUndertaking received; Additional sanctions: Not stated
AppealNo appeal

Download the full case report (PDF)

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

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  • Two anonymous, non-contactable complainants raised concerns about EASI-100 (Eczema Area and Severity Index) results for tralokinumab (Adtralza) presented at a LEO promotional symposium at the BDNG annual conference (Harrogate, September 2023).
  • The complaints alleged there was no clear evidence to support the EASI-100 data and that it was presented quickly with limited explanation.
  • LEO said the symposium materials were certified in advance and that EASI-100 appeared within waterfall plots adapted from a post hoc analysis (Silverberg JI et al. Am J Clin Dermatol 2022;23:547–559).
  • On the symposium slides, EASI-50/75/90 figures were referenced to the publication, but the EASI-100 patient numbers shown in text boxes were not referenced.
  • LEO provided an internal analysis of EASI-100 counts underpinning the waterfall plots; this showed a discrepancy of 1 patient at weeks 16 and 32 versus the numbers stated on the slides and spoken by the presenter.
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Outcome

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  • Breach of Clause 6.1 Making a misleading claim.
  • Breach of Clause 6.2 Making an unsubstantiated claim.
  • No appeal.
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