LEO Pharma: Protopic ‘At a glance’ HCP webpage – misleading maintenance-therapy graph and sun-exposure imagery (AUTH/3501/4/21) | PMCPA Case

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Key facts

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Case	AUTH/3501/4/21
Parties	Complainant v LEO
Material	‘At a glance’ section (ref MAT-21383) of uk.dermaworld.eu (UK/Ireland HCP website)
Medicine	Protopic (tacrolimus) ointment
Main issues upheld	Sun-exposure implication in imagery; proactive/maintenance flare-delay claim lacked study context; graph contained incorrect median time values vs SPC
Breach clauses	3.2; 7.2; 7.4; 9.1
No breach clauses (as listed)	2; 3.2; 7.2; 7.4; 7.6; 7.9; 29
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	09 April 2021
Case completed	27 January 2022
Applicable Code year	2019
Appeal	No appeal

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

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What happened

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An anonymous complainant challenged multiple claims and visuals on the ‘At a glance’ section (ref MAT-21383) of uk.dermaworld.eu (intended for UK/Ireland health professionals) promoting Protopic (tacrolimus) ointment.
Sun-exposure imagery: A “before/after” style image showed a man moving from rain (long sleeves, umbrella open) to brighter weather (short sleeves, umbrella closed). The Panel considered this implied patients need not be concerned about sunlight exposure while using Protopic, which was inconsistent with SPC warnings to minimise sunlight/avoid UV exposure.
Maintenance/proactive flare-delay claim and graph: The page claimed “Protopic 0.1% delays time to next flare when used proactively” with a graph adapted from the SPC. The Panel found the page lacked key study-design context (including the initial reactive phase up to 6 weeks, the maintenance indication context, and the dosing frequency once daily twice weekly).
Incorrect efficacy numbers: The graph stated median time to first disease exacerbation as 15 days (vehicle) vs 142 days (Protopic 0.1%), whereas the SPC stated 14 vs 123 days. LEO said this was an error (mixing in “requiring substantial intervention”).
Other allegations (eg “moving beyond topical corticosteroids”, “designed for moderate to severe AD”, “targets inflammation/supports repair of skin barrier”, before/after photos at 4 weeks, omission of sun warning in a different section, SPC reference date) were largely not upheld on the evidence provided.
The complainant also alleged breach of an undertaking from a prior case (AUTH/2418/7/11) given by Astellas before divestment to LEO; the Panel ruled Clause 29 did not apply to LEO (undertaking was not LEO’s), but noted the similarity when considering high standards.

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Outcome

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Breach: Clause 3.2 (sun-exposure implication in imagery inconsistent with SPC particulars).
Breach: Clause 7.2 (insufficient study-design context for proactive/maintenance claim; and misleading error in median time to exacerbation).
Breach: Clause 3.2 (graph inconsistent with SPC data).
Breach: Clause 7.4 (incorrect data in graph incapable of substantiation).
Breach: Clause 9.1 (high standards not maintained, including in relation to the sun-exposure imagery and the graph errors).
No breach: Clause 2.
No breach: Clause 29 (undertaking was given by Astellas, not LEO).
No appeal.

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LEO Pharma: Protopic ‘At a glance’ HCP webpage – misleading maintenance-therapy graph and sun-exposure imagery (AUTH/3501/4/21)

Key facts

What happened

Outcome

Clauses

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