Department of Pharmacy Services, University of Michigan Health, Ann Arbor, MI, USA.
Ann Pharmacother. 2023 Sep;57(9):1094-1110. doi: 10.1177/10600280221135177. Epub 2023 Jan 4.
To describe and review the published evidence on use of multiple biologics within specialty pharmacy practice.
A search of PubMed and Embase was conducted from October 2021 through September 2022. Keywords included biologics for immune-mediated conditions along with the terms "dual," "add-on," and "combination."
All human studies in the English language were considered. Published abstracts, case reports, case series, randomized controlled trials, systematic reviews, and meta-analyses were included.
Although evidence is limited, there are published meta-analyses of combined biologic use within gastroenterology and rheumatology. There are also numerous case reports within dermatology. Clinical trials of dual biologics for severe rheumatologic conditions and inflammatory bowel disease are in progress. Existing evidence for use in pulmonology and allergy suggest dual biologic therapy can be safe and effective, but data are limited. Literature describing use of monoclonal antibodies for other overlapping conditions is lacking.
This article reviews the evidence describing combination biologic use and outlines remaining knowledge gaps. It also describes the essential role that specialty pharmacists play in managing therapeutic mAbs.
High-quality evidence describing combination biologic use is limited and long-term safety data are lacking. Pharmacists should utilize their specialized training to assess appropriateness of therapy, provide patient counseling and monitor for safety and efficacy.
描述并回顾专业药房实践中使用多种生物制剂的已发表证据。
2021 年 10 月至 2022 年 9 月,对 PubMed 和 Embase 进行了检索。检索词包括用于免疫介导疾病的生物制剂,以及“双重”、“附加”和“联合”等术语。
考虑了所有英语人类研究。纳入了已发表的摘要、病例报告、病例系列、随机对照试验、系统评价和荟萃分析。
尽管证据有限,但已有关于胃肠病学和风湿病学中联合使用生物制剂的荟萃分析。皮肤科也有许多病例报告。正在进行针对严重风湿病和炎症性肠病的双重生物制剂的临床试验。关于在肺病学和过敏领域使用的现有证据表明,双重生物疗法可能是安全有效的,但数据有限。描述其他重叠疾病中单克隆抗体使用的文献缺乏。
本文综述了描述联合使用生物制剂的证据,并概述了仍存在的知识空白。它还描述了专业药剂师在管理治疗性单克隆抗体方面所发挥的重要作用。
描述联合使用生物制剂的高质量证据有限,缺乏长期安全性数据。药剂师应利用他们的专业培训来评估治疗的适宜性,提供患者咨询,并监测安全性和疗效。