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Balancing benefits and risks in the era of biologics

Adami G1Saag KG2Chapurlat RD3Guañabens N4Haugeberg G5Lems WF6Matijevic R7Peel N8Poddubnyy D9Geusens P10.

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




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.

Conclusion After more than a decade of experience with biologics in inflammatory rheumatic, skin, and GI diseases and osteoporosis, the benefit–risk ratio of many biologics is generally considered favorable for most of patients with serious inflammatory arthritis or with severe osteoporosis at high fracture risk. Importantly, we have learned how to reduce the risk with the use of our most commonly used biologics. For newer biologics in osteoporosis, such as romosozumab, additional risk mitigation strategies are proposed that could offer similarly favorable benefit–risk ratios for those at the highest risk of fractures.