LEO Pharma – Kyntheum promotional website: misleading efficacy/safety messaging, missing black triangle, and problematic testimonials (AUTH/3503/4/21) | PMCPA Case

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Key facts

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Case	AUTH/3503/4/21
Company	LEO
Medicine / activity	Kyntheum (brodalumab) promotional website for UK health professionals
Therapy area	Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy
Applicable Code	2019
Complaint received	13 April 2021
Case completed	8 December 2022
Complainant	Anonymous (later non-contactable)
Scale of review	102 Points (plus an overall point)
Clause 2 breaches	Points 35, 64, 65, 92
Appeal	By respondent (LEO)
Appeal outcome highlights	Successful at Points 55 and 101; partially successful at Point 85; unsuccessful at Points 13, 14, 66, 67, 73, 79, 80, 87
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

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An anonymous complainant challenged a UK HCP promotional website for Kyntheum (brodalumab) (uk.dermaworld.eu), alleging numerous Code issues across pages, charts, documents and videos.
The case covered 102 numbered Points (plus an overall point), largely about misleading, unsubstantiated and/or exaggerated claims across the site.
Key themes included:
- Post hoc / pooled analyses presented without adequate context (eg speed-of-onset claim).
- Patient images and “representative” language that implied atypically rapid or high levels of clearance.
- Testimonials (HCP and patient) implying near-universal response, very rapid clearance, or broader life outcomes.
- Safety information issues, including unbalanced presentation around suicidal ideation/behaviour and inflammatory bowel disease (Crohn’s/IBD) where the website content was not updated to match the current SPC.
- Black triangle omission on at least one page (Mode of Action).
- PMCPA noted it was difficult to know exactly what was live at the time due to discrepancies in certification/control; the Panel was “extremely concerned” about certification and control of the website.
LEO said it had a generally robust approval process, but acknowledged some issues and stated it took the website down pending comprehensive review and correction.

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Case considered under the 2019 Code.
The Panel ruled breaches at Points: 8, 13, 14, 17, 20, 21, 24, 28, 35, 55, 64, 65, 66, 67, 68, 69, 72, 73, 75, 77, 79, 80, 81, 85, 86, 87, 92 and 101.
The Panel ruled breaches of Clause 2 (a sign of particular censure) at Points 35, 64, 65 and 92 (including safety-related matters).
LEO appealed Panel rulings at Points 13, 14, 55, 66, 67, 73, 79, 80, 85, 87 and 101.
Appeal outcomes:
- Successful at Points 55 and 101.
- Partially successful at Point 85 (Clause 3.2 overturned; breaches of Clauses 7.2 and 7.10 upheld).
- Unsuccessful at Points 13, 14, 66, 67, 73, 79, 80 and 87.
The complainant became non-contactable and could not appeal any “no breach” rulings.

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