From the Guidelines
The treatment of ulcerative colitis involves a stepwise approach based on disease severity, with 5-aminosalicylates (5-ASAs) like mesalamine as first-line therapy for mild to moderate disease, and biologic agents including anti-TNF drugs, anti-integrin therapies, and JAK inhibitors for moderate to severe disease, as recommended by the most recent guidelines 1. The goal of therapy is to achieve complete remission, defined as both symptomatic and endoscopic remission without corticosteroid therapy, as stated in the Toronto consensus 1. For mild to moderate disease, oral and rectal 5-ASA are recommended as first-line therapy, with corticosteroid therapy for those who fail to achieve remission 1. Patients with moderate to severe disease should undergo a course of oral corticosteroid therapy, with transition to 5-ASA, thiopurine, anti-TNF, or vedolizumab maintenance therapy in those who successfully achieve symptomatic remission 1. Biologic agents, including anti-TNF drugs (infliximab, adalimumab), anti-integrin therapies (vedolizumab), and JAK inhibitors (tofacitinib), are effective for moderate to severe disease, as recommended by the AGA clinical practice guidelines 1. Treatment goals include inducing and maintaining remission, preventing complications, and improving quality of life, with regular monitoring of disease activity, medication side effects, and screening for complications like colorectal cancer being essential 1. Lifestyle modifications, including stress management and dietary adjustments, may help manage symptoms, and surgery (colectomy) may be necessary for refractory disease, severe complications, or dysplasia/cancer development 1. The treatment approach should be individualized based on disease extent, severity, patient preferences, and comorbidities, as recommended by the British Society of Gastroenterology consensus guidelines 1. Some key points to consider in the treatment of ulcerative colitis include:
- The use of ozanimod, a small molecule therapy, for the treatment of ulcerative colitis, which provides advantages including oral administration and little to no risk of immunogenicity 1
- The importance of timely assessments of response and remission to ensure optimal outcomes 1
- The need for regular monitoring of disease activity, medication side effects, and screening for complications like colorectal cancer 1
- The potential benefits of lifestyle modifications, including stress management and dietary adjustments, in managing symptoms 1
From the FDA Drug Label
ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). Recommended Dosage in Adults with Ulcerative Colitis and Crohn’s Disease Week 0: 300 mg infused intravenously over approximately 30 minutes. Week 2: 300 mg infused intravenously over approximately 30 minutes. Week 6: Patients may remain on ENTYVIO intravenous therapy or switch to subcutaneous injection after receiving two ENTYVIO intravenous doses administered at Week 0 and Week 2 Intravenous Infusion: 300 mg infused over approximately 30 minutes and then every eight weeks thereafter. Subcutaneous Injection: 108 mg subcutaneously once every two weeks.
Treatment of Ulcerative Colitis: Vedolizumab (ENTYVIO) is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.
- The recommended dosage is 300 mg infused intravenously over approximately 30 minutes at weeks 0 and 2.
- After week 6, patients may remain on intravenous therapy or switch to subcutaneous injection.
- Intravenous infusion is administered every 8 weeks, while subcutaneous injection is administered every 2 weeks. 2
From the Research
Treatment Options for Ulcerative Colitis
- Mesalamine is a 5-aminosalicylic acid compound that is the first-line therapy to induce and maintain clinical remission in patients with mild-to-moderate ulcerative colitis 3, 4
- For patients who are refractory to mesalamine or have more severe disease, steroids, azathioprine/mercaptopurine, cyclosporine, or infliximab may be used to induce and/or maintain remission 3, 5
- The various formulations of mesalamine available are primarily differentiated by the methods of delivery of the active compound of the drug to the colon 3, 6
Management Approaches
- A time-structured approach is required for appropriate management of ulcerative colitis, with consideration of the probable pattern of disease progression 5
- Complete remission, defined as durable symptomatic and endoscopic remission without corticosteroid therapy, is the desired treatment goal 7
- Comprehensive treatment algorithms for daily clinical practice have been developed based on published guidelines and current literature 7
Considerations for Treatment
- The optimal dose for induction of response and how to maintain patient adherence are areas of uncertainty with the use of mesalamine in patients with ulcerative colitis 4
- The role of mesalamine in cancer chemoprophylaxis is also an area of consideration 4
- Different oral mesalazine formulations may not be bioequivalent, and factors such as drug delivery methods and systemic absorption may influence the selection of one agent above another 6