From the Guidelines
The recommended treatment for ulcerative colitis typically follows a step-up approach based on disease severity, with 5-aminosalicylates (5-ASAs) like mesalamine being first-line therapy for mild to moderate cases. For mild to moderate cases, 5-ASAs like mesalamine (doses ranging from 2-3 grams/day) are first-line therapy, available as oral tablets or topical formulations (suppositories or enemas) for distal disease 1.
Key Considerations
- The AGA recommends using either standard dose mesalamine or diazo-bonded 5-ASA rather than low dose mesalamine, sulfasalazine or no treatment for patients with extensive mild-moderate ulcerative colitis 1.
- For patients with mild-moderate ulcerative colitis with suboptimal response to standard-dose mesalamine or diazo-bonded 5-ASA, the AGA suggests using high-dose mesalamine (>3 grams/day) with rectal mesalamine 1.
- Corticosteroids such as prednisone or budesonide MMX are used for flares but not for maintenance due to side effects.
- For moderate to severe disease or those not responding to initial therapy, immunomodulators like azathioprine or 6-mercaptopurine may be added.
- Biologic agents including anti-TNF drugs (infliximab, adalimumab), anti-integrins (vedolizumab), and JAK inhibitors (tofacitinib) are effective for moderate to severe disease, with the AGA recommending their use over no treatment 1.
Treatment Goals
- Treatment aims to induce and maintain remission by controlling inflammation in the colon, preventing complications, and improving quality of life.
- Regular monitoring of disease activity, medication side effects, and periodic colonoscopies for cancer surveillance are essential components of management.
- Lifestyle modifications including stress management and dietary adjustments may provide symptomatic relief for some patients.
From the FDA Drug Label
- 3 Ulcerative Colitis RENFLEXIS is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
- 3 Ulcerative Colitis The recommended dose of RENFLEXIS is 5 mg/kg given as an intravenous induction regimen at 0,2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adult patients with moderately to severely active ulcerative colitis.
The recommended treatment for ulcerative colitis is infliximab (IV), specifically RENFLEXIS, at a dose of 5 mg/kg given as an intravenous induction regimen at 0,2, and 6 weeks, followed by a maintenance regimen of 5 mg/kg every 8 weeks. This treatment is indicated for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy 2.
- Key points:
- Indication: Moderately to severely active ulcerative colitis
- Dose: 5 mg/kg
- Administration: Intravenous induction regimen at 0,2, and 6 weeks, followed by a maintenance regimen every 8 weeks
- Patient population: Adult patients with inadequate response to conventional therapy
From the Research
Treatment Options for Ulcerative Colitis
The treatment for ulcerative colitis (UC) typically involves a combination of medications and lifestyle changes to manage symptoms and induce remission. The goals of management are to induce and maintain clinical remission and to screen for complications of this disease 3.
Medications Used to Treat Ulcerative Colitis
- Mesalamine: a 5-aminosalicylic acid compound that is the first-line therapy to induce and maintain clinical remission in patients with mild-to-moderate UC 3, 4.
- Steroids: such as prednisone, may be used to reduce inflammation in patients with moderate to severe UC 5.
- Azathioprine/mercaptopurine: immunosuppressants that may be used to maintain remission in patients with UC 5.
- Cyclosporine: an immunosuppressant that may be used to treat severe UC that is not responsive to other treatments 5, 6.
- Infliximab: a biologic therapy that may be used to treat moderate to severe UC that is not responsive to other treatments 5, 6.
- Adalimumab and golimumab: new anti-tumor necrosis factor (TNF) agents that have been shown to be effective in induction of remission and maintenance of remission in patients with extensive UC 6.
Route of Administration
- Oral: mesalamine can be taken orally in the form of tablets or capsules 3, 4.
- Topical: mesalamine can be applied directly to the affected area in the form of suppositories or enemas 5, 7.
- Combined oral and topical: some studies suggest that combining oral and topical mesalamine may be more effective than either alone 7.
Dosing and Efficacy
- High-dose oral mesalamine (≥3.3 g/day) has been shown to be effective in inducing remission in patients with UC 7, 4.
- Combined therapy with oral and topical mesalamine has been shown to be effective in inducing and maintaining remission in patients with UC 7.
- The efficacy of mesalamine in preventing relapse of UC has been demonstrated in several studies 7, 4.