(012) Ensuring Safety: A Comprehensive Review of the Subcutaneous Administration of Biologics

Background: Subcutaneous (SC) drug administration is increasingly emerging as an alternative to intravenous biologic therapies. It is imperative to understand the considerations that dictate safe and patient-centric strategies for SC administration

Objectives: This literature review aims to provide a comprehensive overview of three key aspects in the context of the route of administration: safety profile, patient perception, and healthcare professional (HCP) views.

Methods: A comprehensive search was conducted in MEDLINE and Embase to identify peer-reviewed articles published in English from 2010 to December 31, 2023. The search strategy utilized a combination of keywords, synonyms, and MeSH terms, focusing on ‘monoclonal antibodies’ and ‘subcutaneous formulations’. Reviews on SC administration and biologic safety outcomes were selected and synthesized qualitatively.

Results: A total of 155 articles were retrieved. After removing duplicates and excluding non-review articles, small molecule therapies, and non-human studies, 75 articles remained. Out of these articles, 32 were considered eligible for inclusion. During citation review, 4 articles were added, resulting in a total of 36 articles in the final synthesis. Information was extracted and grouped into the three key themes. Immunogenicity, injection site reactions, and injection site pain were central elements related to the SC safety profile, and methods to reduce these were summarized. Overall the incidence and severity of adverse events was comparable when switching between IV and SC administration, with the exception of injection site reactions. Articles addressing patients' perception of SC cited: ease of use, convenience, reduced hospital visits, and increased independence in homecare-based management. HCPs reported reduced drug preparation time, administration time, and the importance of considering both local and systemic injection reactions.

Conclusions: This review highlights the growing importance of SC administration as an alternative treatment modality. We identified several key factors related to drug safety, such as immunogenicity, injection site reactions, and injection site pain. Generally, both patients and HCPs expressed a preference for SC administration. Methodological limitations included a publication bias to SC therapies approved for use in humans. In addition, heterogeneity of the included studies precluded a quantitative analysis. The findings suggest a need for further research to understand challenges in the development of SC formulations, optimize safety outcomes, and explore the potential benefits of SC therapies in the context of patient preferences and healthcare resource utilization.