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. 2023 Aug 4:18:1691-1700.
doi: 10.2147/COPD.S410611. eCollection 2023.

Recommendations for the Implementation of the Self-Administration of Alpha-1 Antitrypsin

María Torres-Durán  1 , José Luis López-Campos  2   3 , Myriam Calle Rubio  4 , Carmen Montero-Martínez  5 , Ana Priegue Carrera  6 , Rosanel Amaro Rodríguez  7 , Miriam Barrecheguren  8 , María Ángeles Barrio Guirado  9 , Francisco Javier Callejas-González  10 , Francisco Casas-Maldonado  11 , Layla Diab-Cáceres  12 , Pilar García-Meseguer  9 , José María Hernández-Pérez  13 , Lourdes Lázaro-Asegurado  14 , Cristina Martínez-González  15 , Carlos Martínez Rivera  16 , Francisco Javier Michel  17 , José-Bruno Montoro-Ronsano  18 , Raquel Sánchez  19 , Marta Ortiz-Pica  20 , Isabel Parra  21 , José Pablo Quintero García  22 , María Del Rosario Ruiz-Serrano-de la Espada  23 , Begoña Tortajada-Goitia  24 , Marc Miravitlles  8
Affiliations

Recommendations for the Implementation of the Self-Administration of Alpha-1 Antitrypsin

María Torres-Durán et al. Int J Chron Obstruct Pulmon Dis. .

Abstract

Purpose: Administration of exogenous alpha-1 antitrypsin (AAT) is the only specific therapy for the management of pulmonary morbidity in patients with AAT deficiency. It requires weekly or biweekly intravenous infusions, which may impact patient independence and quality of life. Self-administration of AAT therapy is an alternative to reduce the burden for patients who require AAT therapy. We presented herein experts' recommendations for the implementation of a program for the self-administration of AAT.

Methods: This project was conducted using a modified nominal group technique and was undertaken in two online meetings involving the participation of 25 experts: specialists in pulmonology (n=17), nurses (n=5) and hospital pharmacists (n=3).

Results: The following issues were discussed, and several recommendations were agreed upon on the following topics: a) patient profile and clinical evaluation, establishing selection criteria that should include clinical as well as social criteria; b) role of health care professionals, suggested roles for specialists in pulmonology, nurses, and hospital pharmacists; c) training by the nurse, including recommendations before initiating the training and the content of the training sessions; and d) logistic issues and follow-up, adherence, and patient support.

Conclusion: We expect this proposal to increase awareness of this therapeutic alternative and facilitate the implementation of self-administration programs, thus contributing to optimizing the patient experience with AAT therapy. Further research on the outcomes of these programs, especially from the patient perspective, will also help to improve their design and implementation.

Keywords: alpha-1 antitrypsin deficiency; augmentation therapy; disease burden; self-administration.

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Conflict of interest statement

MT-D: has received consulting fees from CSL Behring and Grifols; payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events from CSL Behring and Grifols; and support for attending meetings and/or travel from CSL Behring, Grifols and Chiesi. JLL-C: has received honoraria during the last 3 years for lecturing, scientific advice, participation in clinical studies or writing for publications from AstraZeneca, Bial, Boehringer Ingelheim, Chiesi, CSL Behring, Ferrer, Gebro, GlaxoSmithKline, Grifols, Menarini, Megalabs, Novartis and Rovi. MCR: has received speaker fees from AstraZeneca, Bial, Chiesi, CSL Behring, GlaxoSmithKline, Menarini, and Grifols; and consulting fees from GlaxoSmithKline, CSL Behring and Bial. CM-M: has received speaker fees and/or consulting fees and/or support to attend congresses from Astra-Zeneca, Boehringer-Ingelheim, Chiesi, CSL Behring, GlaxoSmithKline, Grifols and Menarini. APC: has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from CSL Behring. MB: has received speaker fees from Grifols, Menarini, CSL Behring, GSK, Boehringer Ingelheim and consulting fees from GSK, Novartis, CSL Behring and Boehringer Ingelheim. FJC-G: has received speaker honorarium from GlaxoSmithKline, Chiesi, Boehringer Ingelheim, Mundipharma, Menarini, Pfizer, Novartis, Esteve, Teva Pharmaceutical, Ferrer, Rovi, Roche, Astra Zeneca, Bial, Actelion, Alter, CSL Behring, Faes Farma, Alter, Grifols, Sanofi Genzyme and Gebro Pharma; consulting honorarium from Chiesi, Boehringer Ingelheim, Teva Pharmaceutical, Astra Zeneca, Bial, CSL Behring and Sanofi Genzyme; and travel grants from GlaxoSmithKline, Chiesi, Boehringer Ingelheim, Teva Pharmaceutical, Astra Zeneca and CSL Behring. FC-M: has received speaker fees from AstraZeneca, Bial, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Sanofi, Vertex, CSL Behring and Grifols; and consulting fees from AstraZeneca, Chiesi, GlaxoSmithKline, CSL Behring, and Grifols. JMH-P: Speaker honorarium from Grifols, CSL Behring, Astra-Zeneca, GSK, Bial laboratory, Teva laboratory and FAES Farma. Advisory honorarium from CSL Behring. Travel grants from Grifols and CSL Behring. LL-A: has received speaker honorarium from CSL Behring and Grifols SA; research grants from Grifols SA; consulting honorarium from CSL Behring; and travel grants from CSL Behring and Grifols SA. CMR: has received speaker honorarium from Astra Zeneca, CSL Behring CSL, Chiesi, Gebro, GSK, Mundipharma, TEVA and Sanofi; research grants from AstraZeneca, GSK and TEVA; and consulting and advisory honorarium from Astra Zeneca, CSL Behring, Chiesi, Mundipharma and TEVA. FJM: has received speaker fees and/or consulting fees and/or support to attend congresses from Astra-Zeneca, Boehringer-Ingelheim, Chiesi, CSL Behring, GlaxoSmithKline, Grifols, Menarini, Novartis, Sanofi Aventis and Teva. J-BM-R: has received speaker fees and/or consulting fees and/or support to attend congresses from CSL Behring and Grifols. RS: has received speaker fees and/or consulting fees and/or support to attend congresses from CSL Behring, Astra Zeneca, Chiesi, GlaxoSmithKline, Grifols, Teva, Novartis and Menarini. MO-P: has received speaker honorarium from Biogen, Novartis, Roche, Genzyme Sanofi and Takeda. JPQG: Advisory board member for CSL Behring. MM: has received speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Menarini, Rovi, Bial, Kamada, Takeda, Sandoz, Zambon, CSL Behring, Specialty Therapeutics, Janssen, Grifols and Novartis; consulting fees from AstraZeneca, Atriva Therapeutics, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Bial, Gebro Pharma, CSL Behring, Inhibrx, Laboratorios Esteve, Ferrer, Menarini, Mereo Biopharma, Verona Pharma, Spin Therapeutics, ONO Pharma, pH Pharma, Palobiofarma SL, Takeda, Novartis, Sanofi and Grifols; and research grants from Grifols. RAR, MABG, LD-C, PGM, CM-G, IP, MRR-S-E and BT-G: have no conflict of interest.

Figures

Figure 1
Figure 1
The objectives, steps and recommendations for the implementation of a self-administration program of alpha-1 antitrypsin and the health professionals involved.
See this image and copyright information in PMC

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