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Pharmacovigilance

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Biologic and Systemic Agents in Dermatology

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Abstract

Long-term safety and efficacy of therapy is of primary importance in the treatment of a chronic disease such as psoriasis. Clinical trials for approval are useful to determine short-term efficacy and side effects but with the relatively low numbers of patients may not provide realistic data on rare adverse events. In addition, a significant percentage of patients not eligible for clinical trials are placed on biologic therapy post-approval. Continued pharmacovigilance via long-term registries for biologics is crucial in identifying new safety signals. Various registries exist for monitoring biologics including ESPRIT, OBSERVE-5, PSOLAR, and various country-based registries such as BIOBADADERM and Psonet. Reassuringly the overall safety data for biologic therapy is very favorable. There has not been an increase in malignancy and major adverse cardiovascular events (MACE). Although no new safety signals were identified from analysis of registry information, a possible higher risk of serious infections was reported for patients taking adalimumab and infliximab.

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  1. Suny At Buffalo School of Medicine, Buffalo, NY, USA

    Robert E. Kalb MD

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  1. Division of Dermatology, David Geffen School of Medicine a UCLA, Los Angeles, California, USA

    Paul S. Yamauchi

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Kalb, R.E. (2018). Pharmacovigilance. In: Yamauchi, P. (eds) Biologic and Systemic Agents in Dermatology. Springer, Cham. https://doi.org/10.1007/978-3-319-66884-0_9

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