Balancing benefits and risks in the era of biologics

Giovanni Adami; Kenneth G Saag; Roland D Chapurlat; Nuria Guañabens; Glenn Haugeberg; Willem F Lems; Radmila Matijevic; Nicola Peel; Denis Poddubnyy; Piet Geusens

doi:10.1177/1759720X19883973

Balancing benefits and risks in the era of biologics

Ther Adv Musculoskelet Dis. 2019 Oct 24:11:1759720X19883973. doi: 10.1177/1759720X19883973. eCollection 2019.

Authors

Affiliations

¹ Rheumatology Unit, University of Verona, Pz Scuro 10, 37135, Verona, Italy.
² Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.
³ INSERM UMR 1033, Université de Lyon, Hôpital E Herriot, Lyon, France.
⁴ Rheumatology Department, Hospital Clinic, CIBERehd, IDIBAPS, University of Barcelona, Barcelona, Spain.
⁵ Division of Rheumatology, Medicine Department, Southern Hospital Trust, Trondheim, Norway.
⁶ Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.
⁷ University of Novi Sad, Faculty of Medicine, Novi Sad, Serbia.
⁸ Metabolic Bone Centre, Northern General Hospital Sheffield, UK.
⁹ Department of Gastroenterology, Infectious Diseases, and Rheumatology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
¹⁰ CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, the Netherlands.

Abstract

Biologics are substances synthetized from biological sources used in the prevention and treatment of several diseases. Rheumatologists have many years of experience with biologics for the treatment of immune-mediated diseases and osteoporosis. Randomized clinical trials and postmarketing studies have demonstrated that treatment with biologics can result, albeit infrequently, in serious adverse events. To date, several risk mitigation strategies have been identified and implemented. The objective of the present perspective review is to examine the risk mitigation strategies of biologic treatments, with special focus on anti-tumor necrosis factors and denosumab.

Keywords: benefit–risk ratio; biologics; denosumab; romosozumab.

Publication types

Review