Alert Card for Patients on Biologicals and Immunosuppressives: An <scp>EAACI</scp> Position Paper

Biologicals and immunosuppressives revolutionized the treatment of immune-mediated diseases but are associated with complex risks such as infection susceptibility and reduced vaccine responses. In specific situations or emergencies, the detailed product information can be difficult to assess quickly. Alert systems like medical bracelets and allergy cards have proven effective in chronic conditions like diabetes, epilepsy, or anaphylaxis, underscoring the value of concise medical information. In 2017, the European Medicines Agency recommended educational materials like patient alert cards (PACs) as risk minimization tools to enhance safety and usability. PACs have already improved awareness, knowledge of drug-related risks, and response behavior in areas like rheumatology, anticoagulation, and hematologic conditions, and practicality across diverse healthcare systems [1-5]. However, these remain largely condition-specific, leaving a gap to the growing category of patients on biologicals and immunosuppressives. To address this gap, the EAACI Working Group on Biologicals developed a compact, customizable, wallet-friendly PAC, containing concise information for patients and medical staff, treatment details, travel certificate, and physician or hospital contacts. (Figure 1). The PAC provides guidance for key clinical scenarios such as fever, infections, live vaccinations, treatment changes, surgery, malignancy, or pregnancy. Its wording is deliberately flexible to accommodate different mechanisms of action and—if applicable—immunosuppressive risk. Irrelevant instructions in certain medications can be crossed out. To ensure global use, the PAC is in English. Furthermore, it has been professionally translated by a validated medical translation service (Novalins, NVLS INTERNATIONAL SL, Spain) into multiple languages in accompanying patient brochures (German, Italian, French, Spanish, Portuguese, Turkish, Figure S1; Swedish, Finnish, Russian, Greek, Arabic, Chinese (simplified), Japanese, Figure S2). For further translations or information, please contact the corresponding author. The PAC and brochures were developed by an EAACI Task Force with experts across specialties like dermatology, allergy, respiratory medicine, and rheumatology, aligned with EMA recommendations, and approved by the European Academy of Allergy and Clinical Immunology (EAACI). To assess patients' perceptions, a four-question smiley-based Likert scale survey (Figure S3) was developed, translated into multiple languages, and distributed across participating centers. The Cantonal Ethics Committee of Zurich, Switzerland, confirmed that the survey does not fall within the scope of the Human Research Act and, therefore, does not require ethics approval (2018–00461). Seventy patients (39 female; mean age 45.5 years) from Switzerland, Finland, Turkey, the United Kingdom, and Greece completed the survey (Table S1). Among them, 48 (69%) were on biological monotherapy, 8 (11%) on immunosuppressive monotherapy, and 14 (20%) on combination therapy. Most strongly agreed or agreed on its usefulness (97%), clearness and simplicity (94%), appreciated the translations (94%), and 76% carried the PAC alongside, with 13% being undecided (Figure 2). The lower response rate for carrying the PAC might be attributed to the fact that patients received the PAC and the survey simultaneously, with no follow-up possible due to the anonymous nature of the assessment. Our earlier research showed that patient concerns can affect adherence [6], which highlights the importance of accessible, patient-centered tools to support shared decision-making. An adaptable online version of the PAC is in development, with more features such as side effects, drug interaction warnings, and integration into electronic medical records or mobile health wallets being explored to enhance portability and long-term use. In summary, this PAC provides patients and HCPs clear and practical guidance on the use of biologics and immunosuppressives, without replacing specialist advice. Our data support the value of concise, multilingual educational materials—like PACs and brochures—in improving patient understanding, promoting adherence, and enhancing safety across diverse healthcare settings. Methodology: Adam Chaker, Antonios G.A. Kolios. Investigation: Paula Kauppi, Sevim Bavbek, Alexia Chatzipetrou, Apostolos Bossios, Davide Firinu, Barbara Rogala, Andrea Matucci, Alessandra Vultaggio, Oliver Pfaar, Oscar Palomares, Mohamed Shamji, Thomas Eiwegger, Petr Panzner, Wojciech Feleszko, Ron Eliashar, Ioanna Agache, Adam Chaker, Antonios G.A. Kolios. Funding acquisition: Antonios G.A. Kolios. Conceptualization, project administration and supervision: Antonios G.A. Kolios. Writing – original draft: Adam Chaker, Antonios G.A. Kolios. Writing – review and editing: all authors. This Position Paper was supported by the European Academy of Allergy and Clinical Immunology (EAACI) under the EAACI IG Biologicals and Task force “Patient Card Biologicals/Immunsuppressives” (#40243, 2017–2018). Open access publishing facilitated by Universitat Zurich, as part of the Wiley - Universitat Zurich agreement via the Consortium Of Swiss Academic Libraries. Informed consent was not required as this study does not fall within the scope of the Human Research Act (HRA) (approval BASEC number 2018–00461). A.C. reports grants, speaker honoraria, consultancy or advisory fees and/or research support and other, all via Technical University of Munich from Allergopharma, ALK Abello, Astra Zeneca, Bencard/Allergen Therapeutics, GSK, Novartis, Hippo Dx, LETI, Roche, Zeller, Sanofi, Regeneron, Thermo Fisher, European Institute of Technology (EIT Health) and Federal Ministery of Research and Education Germany. Consultancy or speaker honoria GSK, Swedish Orphan Biovitrum, Sanofi, AstraZeneca. Principal investigator: Theravance, MSD. Other: Chair of the Finnish Respiratory Society. speaker honoraria, consultancy or advisory fees and/or research support from GSK, AstraZeneca and Novartis. A.B. reports a grant from AstraZeneca, honoraria, and lecture fees from AstraZeneca, Chiesi, and GSK paid to his institution outside the submitted work. A.C. reports speaker honoraria from Astra Zeneca, Pfizer, GSK. Advisory fees and/or research support from Takeda, CSL Behring, GSK and Novartis. B.R. and A.M. declare no conflicts of interest for this work. A.V. received speaker honoraria, consultancy or advisory fees from GSK, AstraZeneca, Sanofi Genzyme. P.P. declares no conflicts of interest for this work. W.F. received speaker's honoraria from Astra Zeneca. R.E. declares no conflict of interests for this work. I.A. Deputy editor Allergy journal. L.K., M.T. and O.P. declare no conflicts of interest for this work. O.P. received research grants from MINECO, Ministerio de Ciencia e Innovación, Inmunotek S.L., Novartis, and AstraZeneca and fees for giving scientific lectures or participation in Advisory Boards from: AstraZeneca, Pfizer, GlaxoSmithKline, Inmunotek S.L, Novartis, Sanofi-Genzyme and Regeneron. M.S. declares no conflict of interests for this work. T. Eiwegger reports to act/recently acted as local PI for company sponsored trials by DBV Therapeutics, Greer Stallergens, Novartis, and sub-investigator for Regeneron and ALK-Abelló. He/his lab received unconditional/in-kind contributions from Macro Array. Diagnostics and ALK-Abelló and he is co-I in an investigator-initiated trial with in-kind support from Novartis. He holds advisory board roles for ALK-Abelló, Sanofi and Nutricia/Danone. T.E. reports lecture fees from Novartis, ThermoFisher, Nutricia/Danone, MADX, ALK-Abelló. A.G.A.K. declares no conflict of interests for this work. The data that support the findings of this study are available from the corresponding author upon reasonable request. Figure S1. Patient brochure version A (German, Italian, French, Spanish, Portuguese, Turkish). Figure S2. Patient brochure version B (Swedish, Finnish Russian, Greek, Arabic, Chinese (simplified), Japanese). Figure S3. Questionnaire English. Table S1. Evaluation of patient responses to the questionnaire. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

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