GSK breached ABPI Code over ambiguous Trelegy exacerbation-reduction claim on HCP website (AUTH/3781/6/23)

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Key facts

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Case number	AUTH/3781/6/23
Company	GSK
Complainant	Anonymous, contactable complainant (health professional)
Product	Trelegy Ellipta (fluticasone furoate, umeclidinium, vilanterol)
Channel/material	Promotional webpage on GSK.pro (Trelegy Ellipta section), clinical data subsection; webpage ID PM-GB-FVU-WCNT-200013 (V8.0)
Main issue	Ambiguous “vs another” comparator and misleading implication of statistically significant exacerbation reduction
Reference cited on page	Ismaila et al. (2022) (copy not provided to the Panel)
Applicable Code	2021
Complaint received	21 June 2023
Case completed	25 September 2024
Appeal	No appeal
Breach clauses	5.1, 6.1, 6.2
No breach clauses	2
Sanctions	Undertaking received; additional sanctions not stated

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

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An anonymous, contactable health professional complained about a promotional claim on GSK’s HCP website (GSK.pro) for Trelegy Ellipta.
The headline claim stated: “Trelegy demonstrated greater annualised moderate/severe exacerbation reduction vs. another COPD single-inhaler triple therapy”.
The claim referenced a network meta-analysis comparing three UK single-inhaler triple therapies (Trelegy, Trimbow and Trixeo).
Trelegy showed a statistically significant difference vs Trixeo, but only a numerical (not statistically significant) difference vs Trimbow.
The webpage presented a prominent headline claim at the top; the qualifying comparator details and significance context were further down the page and required scrolling.
GSK accepted the claim was misleading and acknowledged breaches of Clauses 6.1, 6.2 and 5.1, but denied Clause 2.
GSK said an experienced signatory had advised the claim should be explicit that significance was only vs Trixeo, but that advice was not followed.
GSK took down/disabled the relevant website content and halted use of materials containing the claim shortly after receiving the complaint.

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Breach of Clause 6.1 Making a misleading claim.
Breach of Clause 6.2 Making an unsubstantiated claim.
Breach of Clause 5.1 Failing to maintain high standards.
No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce the confidence in, the pharmaceutical industry.

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