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Review

Biologics versus Immunomodulators for the Treatment of Ulcerative Colitis: A Review of Comparative Clinical Effectiveness and Cost-Effectiveness [Internet]

Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Apr 17.
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Review

Biologics versus Immunomodulators for the Treatment of Ulcerative Colitis: A Review of Comparative Clinical Effectiveness and Cost-Effectiveness [Internet]

Yi-Sheng Chao et al.
Free Books & Documents

Excerpt

Inflammatory bowel disease: Inflammatory bowel disease (IBD) is a disease involving inflammation conditions located in colon and small intestines. Ulcerative colitis (UC) and Crohn’s disease (CD) are two primary types of IBD with different characteristics. UC is a mucosal disease that often affects the rectum and all or part of the colon. Sometimes it is difficult to distinguish UC and CD clinically. The symptoms commonly seen in the patients with UC include diarrhea, rectal bleeding, tenesmus, passage of mucus, and crampy abdominal pain. The inflammation may cause major consequences, particularly a fibrostenotic obstructing pattern or a penetrating fistulous pattern. Depending on disease severity, the options of conventional treatment for IBD include 5-aminosalicylic acid agents, glucocorticoids, antibiotics, and immunomodulators. Immunomodulators include azathioprine, 6-mercaptopurine, methotrexate, and cyclosporine, and modify the activities of the immune system. The use of immunomodulators are associated with minor or severe adverse events, such as headache, infection, and certain cancers. Due to such risks, the use of immunomodulators needs to be closely monitored.

Conventionally, a “step-up” treatment strategy usually include a sequential use of aminosalicylates, steroids, immunomodulators, and finally biologics. Medications such as 5-aminosalicylic acids or prednisolone are tried first. Biologics or pharmacological immunomodulators are particularly useful when patients are not responsive to steroids for induction or relapse prevention.

Biologics: Recent advances in IBD treatment include biologics (also called biologic agents or biologic therapies), particularly for patients unresponsive to conventional therapy. Biologics are protein-based molecules that can block inflammation in several immune-related diseases., The first biologic approved for IBD is infliximab, a chimeric immunoglobulin (IgG)1 antibody against tumor necrosis factor (TNF)-α. The usual dose of infliximab is to repeat infusion 5mg/kg every eight weeks. Infliximab was approved by Health Canada to treat rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, CD, fistulizing Crohn disease (FCD), and UC. Currently, three types of biologics are approved for the treatment of one or both primary types of IBD: anti-TNF agents (infliximab, adalimumab, and golimumab), anti-integrin agents (vedolizumab) and anti-interleukin (IL) 12/23 IgG1 kappa agents (ustekinumab).,

Place in therapy: Health Canada has approved several biologics or biosimilars for the treatment of ulcerative colitis in patients without adequate response to conventional therapy, including infliximab and vedolizumab. Although, infliximab and other biologics are often reserved for patients unresponsive to conventional therapy,, some practitioners argue that early adoption of biologics or immunomodulators may be beneficial to patients with IBD. The benefits of early adoption may include avoiding toxic effects of immunomodulators and fewer adverse effects related to conventional therapy. It is uncertain whether early adoption of biologics or immunomodulators may be beneficial to patients with UC. This study aims to review the literature and understand the effectiveness and cost-effectiveness of biologics and immunomodulators among UC patients naïve to both types of drugs.

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Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.

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