Evidence Supporting High-Dose Use of Biologics in Clinical Practice
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Inflammatory Bowel Disease (G Lichtenstein, Section Editor)
Evidence Supporting High-Dose Use of Biologics in Clinical Practice Sarah E. Shannahan, M.D. Konstantinos Papamichael, Ph.D., M.D. Adam S. Cheifetz, M.D.* Address * Department of Medicine and Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, USA Email: [email protected]
* Springer Science+Business Media, LLC, part of Springer Nature 2020
This article is part of the Topical Collection on Inflammatory Bowel Disease Keywords Biologic therapy I Crohn’s disease I Dose optimization I Inflammatory bowel disease I Therapeutic drug monitoring
Abstract Purpose of review Biologic therapies have transformed the management of inflammatory bowel disease (IBD). However, a significant proportion of patients demonstrate primary non-response (PNR) or develop a secondary loss of response (LOR) to these agents. Studies using therapeutic drug monitoring (TDM) have demonstrated a correlation between drug concentration and improved outcomes and that inadequate drug concentrations may be accountable for a significant proportion of PNR and LOR. This review aims to evaluate the role for high-dose biologic therapy in the treatment of IBD. Recent findings Several studies have demonstrated an important role for dose optimization of anti-TNF agents to achieve desired therapeutic outcomes. More recently, there is also evidence for dose optimization and empiric dose escalation of vedolizumab and ustekinumab. With anti-TNF agents, dose optimization results in improved therapeutic outcomes by controlling inflammation and reducing immunogenicity. Immunogenicity may play less of a role with vedolizumab and ustekinumab. Summary There is a role for TDM to guide dose optimization of biologics in IBD. Further prospective studies are needed to determine if there is a role for accelerated induction therapy with these agents and to evaluate target trough concentrations for vedolizumab and ustekinumab.
Inflammatory Bowel Disease (G Lichtenstein, Section Editor)
Introduction Biologic therapies have transformed the management of inflammatory bowel disease (IBD). There are three approved classes of biologics in the treatment of moderatesevere IBD including the anti-tumor necrosis factor (anti-TNF) agents (infliximab [IFX], adalimumab [ADM], certolizumab pegol [CZP], and golimumab [GOL]), adhesion molecule inhibitors (natalizumab [NAT] and vedolizumab [VDZ]), and the interleukin (IL) 12/23 inhibitor ustekinumab (UST). With each of these therapies, however, there is a percentage of patients who, unfortunately, do not respond. For example, up to 30% of patients with IBD demonstrate a primary non-response (PNR) to anti-TNF agents, the most widely used class for moderate-severe disease. [1– 3] In addition, another 40% of patients on anti-TNF agents develop a secondary loss of response (LOR) to treatment within 1 year, resulting in either escalation or change in therapy. [3–6] Some etiologies of PNR and secondary LOR
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