AbbVie breached ABPI Code over Rinvoq webpages: imagery implied strenuous activity and omitted prominent pregnancy/contraception warnings

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Key facts

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Case	AUTH/3712/11/22
Company	AbbVie Ltd
Product	Rinvoq (upadacitinib)
Material	Two AbbViePro promotional webpages (RA and PsA)
Main issues	Imagery implying unrealistic outcomes (PsA surfing) and omission of prominent pregnancy contraindication/contraception warning alongside imagery of women of childbearing potential
Complainant	Health professional (initially contactable, later non-contactable)
Applicable Code	2021
Complaint received	22 November 2022
Case completed	8 August 2023
Appeal	No appeal
Breach clauses	2, 5.1, 6.1, 6.2, 6.3
No breach clauses (as ruled)	6.1, 6.2, 6.3 (in relation to specific allegations: menarche warning omission for adult-only pages; RA swing image representativeness)
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

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A health professional complained about two AbbViePro promotional webpages for Rinvoq (upadacitinib) in rheumatoid arthritis (RA) and psoriatic arthritis (PsA).
The pages used imagery of young women (RA: woman on a swing; PsA: woman surfing).
The complainant alleged the imagery implied suitability for all females (including pregnant/breastfeeding) despite Rinvoq being contraindicated in pregnancy and having contraception and lactation considerations; Rinvoq is a black triangle medicine.
The complainant also alleged the images were not representative of typical moderate to severe RA/PsA patients (eg, surfing/strenuous activity).
AbbVie argued relevant safety information was available via linked prescribing guide/prescribing information and safety profile content elsewhere on the site, and that the images were appropriate for adult indications.
The Panel assessed the immediate overall impression to a busy health professional and treated imagery as capable of being a claim.

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Breach found for use of a woman of childbearing potential on each webpage without prominent reference on the face of the webpages to pregnancy contraindication and contraception advice (misleading; insufficiently complete; artwork issues; unsubstantiated impression).
Breach found for PsA surfing image: implied patients taking Rinvoq could perform strenuous exercise; compounded by the nearby claim “rapid and sustained joint efficacy”; not representative of typical moderate to severe PsA and not substantiated.
No breach for not including the menarche-related warning (Panel considered it potentially irrelevant/misleading for RA/PsA adult-only webpages in the circumstances).
No breach for RA swing image being unrepresentative (complainant did not establish it was not representative; activity did not appear to require particular joint stability/strength).

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Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 6.1 Failing to ensure material was sufficiently complete and not misleading
Breach of Clause 6.2 Making an unsubstantiated claim
Breach of Clause 6.3 Failing to ensure artwork conformed to the letter and spirit of the Code
No Breach of Clause 6.1 Requirement that material must be sufficiently complete and not be misleading
No Breach of Clause 6.2 Requirement that claims and information must be capable of substantiation
No Breach of Clause 6.3 Requirement that all artwork must conform to the letter and spirt of the Code

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