Editorial There has been great progress towards the development of new agents for the treatment of Infammatory Bowel Disease (IBD). New therapeutic avenues have become possible, including the development of agents that target specifc genetic pathways found to be relevant in patients with IBD. Moderate-to-severe IBD patients have required an infusion or subcutaneous injection therapies in the past, but there is an infux of new oral medications in development and a promising one is already approved by the FDA, tofacitinib. We will summarize this progress in this editorial. IBD is a chronic and progressive immune mediated condition of the Gastrointestinal (GI) tract infuenced by both genetic and envi- ronmental factors. IBD is comprised of Chronic Ulcerative Colitis (CUC) and Crohn’s Disease (CD). While both autoimmune disorders affect the GI tract, CUC is limited to the colon and rectum, whereas CD may affect any part of the GI tract. Patients with these condi- tions require lifelong medical therapy, or sometime surgery, depend- ing on their disease severity and complications. It is recommended that moderate-to-severe IBD patients be treated with a combination *Corresponding author: Atilla Ertan, The UTMMS-MHH Ertan Digestive Disease Center and Gastroenterology Center of Excellence, USA, Tel: +1 7137045928; +1 7137043450; Fax: +1 7137043485; E-mail: atilla.ertan@uth.tmc.edu Citation: Ertan A, Stewart J (2018) Revolutionary Therapies in Patients with Moderate-to-Severe IBD in 2018. J Gastroenterol Hepatology Res 3: 023. Received: November 22, 2018; Accepted: November 26, 2018; Published: December 14, 2018 Copyright: © 2018 Ertan A and Stewart J. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. of anti-TNF agents’ with immunomodulatory therapy to increase the likelihood of a steroid-free induction and mucosal healing with long-term remission [1]. Since 1997, where the frst randomized con- trolled trial showed the effectiveness of infiximab, there has been a signifcant improvement in IBD patients’ management. This has led to the introduction of many other anti-TNF biological agents such as adalimumab, certolizumab and golimumab. Anti-TNFs induce ap- proximately 30% clinical remission and 50% clinical response in pa- tients with moderate-to-severe CD. Moreover, the secondary loss of response may vary between 10 to 50% depending on the maintenance treatment follow-up period. According to our own experience and general census, the treat-to target strategy with anti-TNFs is a crucial approach to changing the natural history of moderate-to-severe IBD patients. Earlier intervention with a top-down therapy may be future direction in the selected patients with a close therapeutic drug concen- tration monitoring as needed [1-6]. Although therapies with anti-TNFs have reduced relapse rates, al- lowed mucosal healing and, as a result, improved long-term outcomes in substantial portions of moderate-to-severe IBD patients, there is a need for new agents. Therefore, the gut-selective humanized mono- clonal antibody against alfa-4-beta-7 integrin (Vedolizumab) is now FDA approved as another effective and safe treatment option for both moderate-to-severe CUC and CD patients either before or after an- ti-TNFs refractory patients’ management [7,8]. Another biologic agent, ustekinumab (Stelara), an anti-IL 12/23, became FDA approved in September 2016 for patients with moder- ate-to-severe Crohn’s disease. This fully human IgG1k monoclonal antibody binds the p40 subunit of IL-12 and IL-23. In addition to initial promising studies with ustekinumab, current evidence shows very encouraging results with ustekinumab in moderate-to-severe CD patients refractory to anti-TNFs, with signifcantly increased rates of clinical response and remission compared to placebo [9,10]. In addi- tion, both ustekinumab and vedolizumab are attractive options with a relatively low immunogenicity, a favorable safety profle, relatively lesser risks of infections and malignancies [7-10]. Tofacitinib is a Janus Kinases (JAK) 1-3 inhibitor that results in suppression of B and T cells as an important target in IBD. This oral agent has been studied in various autoimmune conditions, including rheumatoid arthritis and psoriasis with good overall effcacy and an acceptable safety profle. Also, tofacitinib is most recently approved by the FDA to be used in moderate-to-severe CUC patients with sig- nifcant clinical remission and response rates compared to placebo [11]. However, tofacitinib did not exhibit better results than place- bo in patients with CD [12] by the doses used in the research trials. The reported adverse events were nasopharyngitis, opportunistic in- fections, lymphopenia, hyperlipidemia, transient serum transaminase and creatinine elevations [11,12]. Biosimilars have been produced to closely resemble the anti-TNFs whose patent have expired and are manufactured with the same amino acid sequences as a reference anti-TNF. While they may reduce cost (possibly around 40%), biosimilars are not identical to anti-TNFs. Ertan A and Stewart J, J Gastroenterol Hepatology Res 2018, 3: 023 DOI: 10.24966/GHR-2566/100023 HSOA Journal of Gastroenterology & Hepatology Research Editorial Atilla Ertan 1 * and Jamie Stewart 2 1 Infammatory Bowel Diseases Center, Ertan Digestive Disease Center, USA 2 Gastroenterology, Hepatology and Nutrition Division and Memorial Hermann Hospital-Texas Medical Center, University of Texas Health McGovern Medical School (UTMMS), USA Revolutionary Therapies in Patients with Moderate-to- Severe IBD in 2018