Emerging biologics in inflammatory bowel disease.
Early biologic therapy is recommended in patients with inflammatory bowel disease and poor prognostic factors and in those refractory to conventional medications. Anti-tumor necrosis factor (anti-TNF) agents are the most commonly used biologic agents. However, some patients may not have an initial response to anti-TNF therapy, and one-third will develop loss of response over time. Anti-TNF drugs can also be associated with side effects. In addition, the use of biologics is currently limited by their cost, especially in developing countries. A number of new therapeutic targets, including novel small molecules, and cellular therapy are available or under investigation. These novel molecules include oral Janus kinase (JAK) inhibitor (tofacitinib), interleukin inhibitor (ustekinumab), oral SMAD7 antisense oligonucleotide (mongersen), and anti-integrin inhibitors (vedolizumab). Here, we review the mechanisms of action, the efficacy, and the safety data of these novel agents. Biological products that are highly similar to reference biologic products whose patents have expired-also known as "biosimilars"-can be produced at lower cost with similar efficacy, and are also available for the treatment of IBD. We review the efficacy data for such agents as well.
Department of Medicine and Therapeutics, Institute of Digestive Disease, The Chinese University of Hong Kong, Sha Tin, Hong Kong.
Heyson Chi-Hey
HC
Chan
Department of Medicine and Therapeutics, Institute of Digestive Disease, The Chinese University of Hong Kong, Sha Tin, Hong Kong. siewchienng@cuhk.edu.hk.
Siew Chien
SC
Ng
D000818:Animals; D001688:Biological Products / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001691:Biological Therapy / Q000009:adverse effects / Q000379:methods; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy* / Q000473:pathology; D011379:Prognosis; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha
Biologics; Biosimilar; Crohn’s disease; Ulcerative colitis