Hanauer S. The Evolving Therapeutic Paradigm in IBD: Optimal Positioning of New and Emerging Agents. Presented at: Interdisciplinary Autoimmune Summit; July 10-12, 2020 (virtual meeting).
Hanauer reports he is a consultant for and a speaker for AbbVie, Janssen, Pfizer and Takeda; he is a consultant for Allergan, Amgen, Celgene, Genetech. Gilieas, Lilly, Prometheus, Receptos and UCS Pharma; and is a consultant and speaker for Merck and Samsung Bioepis and a consultant for Boehringer Ingeleim, Celltrion, Hospira, Salix, Seres Health, Shire. Tigenez and VHsquared.
There are currently many new and emerging therapies treating inflammatory bowel disease.
In a virtual presentation for the Interdisciplinary Autoimmune Summit, Stephen B. Hanauer, MD, professor of Medicine at Northwestern University in Chicago, said gastroenterologists need to begin to use biologic agents that are more highly effective overall.
Hanauer also said there are potential considerations to evaluate when choosing the best treatment for patients with IBD, such as how quickly a patient needs to get back to remission, early signs of nonresponse to treatment, individual preference based on the safety profile and risk aversion.
“We need to consider immunogenicity vs. the lack of immunogenicity and the potential to start and stop with conventional agents such as tofacitinib (Xeljanz, Pfizer) as well as data on mucosal healing and extraintestinal manifestations,” Hanauer said. “We need to consider the patient’s age, whether they have had a history of cancer, whether they are pregnant, whether they are responsive is mild to moderate disease, extraintestinal manifestations, prior biologic failures and whether or not they are sick enough to be in the hospital.”
Patients who present with deep ulcers or extensive disease are automatically considered to have moderate risk. In UC, other features of moderate to severe risk include young age at diagnosis and elevated series of biomarkers and patients who require corticosteroid steroids, patients who require hospitalizations and patients with complications or infections are at greater risk for disease progression or colectomy, according to Hanauer.
He said patients who fail corticosteroid therapy or are steroid dependent go back to biologic therapies such as TNF inhibitors or vedolizumab and tofacitinib if TNF therapy failed or if patients are hospitalized, they may be given cyclosporine.
“For maintenance remission we don’t really separate efficacy amongst these different agents, all aimed at weening patients off corticosteroid therapy for long-term therapy,” he said. “Our ultimate goal is to achieve and maintain remission without corticosteroids in the setting of UC and CD.”
Hanauer said Entyvio (vedolizumab, Takeda) can be used as a monotherapy or in combination therapy and seems to be safe on long-term basis. Additionally, Stelara (ustekinumab, Janssen) has a good safety profile, rapid response in clinical trials, low rate of immunogenicity and patients with cirrhosis may be ideal candidates. Tofacitinib should be used for patients with UC or patients who have inadequate response to TNF inhibitors.
“There are a number of promising new agents and new classes under investigation,” he said. “Each of these seem to be the same as the predecessor compounds and may have more or less safety advantages that are yet to be determined. Our biggest concern is loss of control of the disease that leads to hospitalizations, surgeries or colon cancer in the setting of ulcerative colitis. We need to modify therapy or at least look at the risk of infections and keep in mind the thrombosis risk.”