Vaccination in patients under monoclonal antibody treatment: an updated comprehensive review

ABSTRACT

Introduction

Monoclonal antibodies (mAbs) have become an increasing source of biological treatments. Clinicians should make an effort to update their knowledge on mechanisms of action, indications, and adverse events of these novel therapies. Most of them have immunosuppressive effects and, therefore, vaccination is indicated.

Areas covered

vaccination of patients under mAbs therapies.

Expert opinion

Recommendations on vaccination are still based on expert recommendations and have not been updated in recent years. Specific recommendations for each mAb have not been addressed in the current literature. The aim of this comprehensive review was to collect all the therapeutic mAbs approved up to 1 January 2020 and, based on previous recommendations and the pharmaceutical characteristics of each drug, to propose an updated guide with recommendations on vaccination. Influenza, sequential pneumococcal and Hepatitis B vaccination in patients with negative serology were the only consistent recommendations. Hepatitis A vaccination was proposed for mAbs with special hepatotoxic characteristics. Other vaccines are reviewed and discussed. Several non-immunosuppressive mAbs were detected and, therefore, vaccinations not recommended. We hope that this review can serve as a starting point for compiling updated vaccination recommendations and collecting all the therapeutic mAbs approved up to 2020.

KEYWORDS:

• Biologic therapy
• biologics
• vaccine
• vaccine time
• immunosuppression
• monoclonal antibodies
• mAbs

Article highlights

• A collection and in-depth description of currently available mAbs is provided. To date, 72 approved mAbs have been identified, 39 of which are immunosuppressive mAbs (imAbs).

• ImAbs and their characteristics for vaccination are analyzed. All imAbs are considered to potentially generate moderate to severe immunosuppression.

• A list of non-immunosuppressive mAbs is provided. These therapies do not require vaccination, unless immunosuppressive co-adjuvant therapies are added.

• Current vaccine recommendations for patients under imAb are presented in a practical approach. Influenza, sequential pneumococcal, and Hepatits B for patients with negative serology were the only consistent recommendations.

• Hepatitis A vaccine should be included for imAbs that presented hepatotoxic adverse events. Other vaccines not included in this review should also be considered for specific patients and situations.

• The vaccine recommendations and available studies on immunogenicity regarding imAbs are discussed. Several issues discussed remain controversial and more studies are needed to address these challenges.

Acknowledgments

The authors would like to thank the professionals working on vaccination of Preventive Medicine and Public Health Services of the Hospital Universitario Clínico San Cecilio, the Hospital Universitario Virgen de las Nieves and the Hospital Universitario Reina Sofía, for their feedback. We thank Ángela Rivera-Izquierdo for the professional revision of the English language.

Author contributions

M Rivera-Izquierdo, MC Valero-Ubierna and P Nieto Gómez were involved in the conception and design of the study and the drafting of the manuscript. MC Valero-Ubierna, P Nieto Gómez, MD Martínez Bellón, NF Fernández-Martínez and JL Barranco-Quintana were involved in the interpretation of the analysis and ensured its scientific quality, providing expert insight. All authors give their approval to the final version of the study to be published and take accountability for all aspects of the work

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This paper was not funded.