Quality, safety, and practical considerations of using biologic therapies

Abstract

Biologic medications including anti-TNF, anti-integrin, and anti-IL12/23 therapies induce remission and clinical response among patients with inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC). Although generally safe, biologics may place the patient at a small increased risk for developing infections and malignancy, the latter likely more relevant when in combination with thiopurines. The US Food and Drug Administration (FDA) has added “boxed warnings” about the increased risk of serious infections and malignancy for anti-TNF agents, although subsequent experience and research have demonstrated that these medications are safe when used appropriately. Successful and safe use of biologic therapies requires an understanding of contraindications, appropriate patient education, screening and baseline lab testing, and vaccination schedules prior to initiation or during biologic therapy. In addition, drug selection, proper administration, safety monitoring during treatment, and monitoring after treatment discontinuation are important to understand the appropriate use of these medications. The purpose of this chapter is to provide quality, safety, and practical considerations when using biologic therapies in patients with IBD.