What are the dosing regimens for Adalimumab (Humira) in the treatment of ulcerative colitis?

From the Guidelines

Humira (adalimumab) for ulcerative colitis typically follows a specific dosing regimen, starting with an induction phase of 160 mg on Day 1, followed by 80 mg at Week 2, and then a maintenance dose of 40 mg every other week by subcutaneous injection, as supported by the most recent guidelines 1.

Key Considerations

• The dosing regimen may vary depending on the patient's response to treatment, with some patients benefiting from an increased maintenance dosage to 40 mg every week.
• Patients should be monitored for infections and screened for tuberculosis before starting treatment, as Humira suppresses the immune system.
• The medication should be stored in a refrigerator and allowed to reach room temperature before injection to minimize discomfort.

Evidence-Based Recommendations

• The American Gastroenterological Association (AGA) recommends using infliximab, adalimumab, golimumab, vedolizumab, tofacitinib, or ustekinumab over no treatment for the induction and maintenance of remission in moderate-to-severe ulcerative colitis 1.
• The AGA suggests using infliximab or vedolizumab rather than adalimumab for induction of remission in adult outpatients with moderate-severe ulcerative colitis who are naïve to biologic agents 1.

Important Notes

• Patients should be closely monitored for adverse events, particularly infections, when using Humira or other biologic agents.
• The choice of biologic agent and dosing regimen should be individualized based on patient factors, such as disease severity, prior treatment history, and comorbidities.
• Regular follow-up and assessment of treatment response are crucial to optimize patient outcomes and minimize potential risks associated with biologic therapy.

From the FDA Drug Label

The recommended subcutaneous dosage of HUMIRA for adult patients with ulcerative colitis is 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) continue with a dosage of 40 mg every other week

The recommended subcutaneous dosage of HUMIRA for pediatric patients 5 years of age and older with ulcerative colitis is based on body weight as shown below:

• 20 kg (44 lbs) to less than 40 kg (88 lbs): Day 1: 80 mg Day 8: 40 mg Day 15: 40 mg 40 mg every other week or 20 mg every week
• 40 kg (88 lbs) and greater: Day 1: 160 mg (single dose or split over two consecutive days) Day 8: 80 mg Day 15: 80 mg 80 mg every other week or 40 mg every week

The dosing regimen for Humira in ulcerative colitis is as follows:

• Adults: 160 mg on Day 1,80 mg on Day 15, and 40 mg every other week starting on Day 29.
• Pediatrics (5 years and older):
  • 20-40 kg: 80 mg on Day 1,40 mg on Day 8 and Day 15, and 40 mg every other week or 20 mg every week.
  • 40 kg and greater: 160 mg on Day 1,80 mg on Day 8 and Day 15, and 80 mg every other week or 40 mg every week. Discontinue Humira in adult patients without evidence of clinical remission by eight weeks (Day 57) of therapy 2.

From the Research

Humira Dosing Regimens for Ulcerative Colitis

• The SERENE UC trial evaluated the efficacy of higher adalimumab induction and maintenance dose regimens in patients with ulcerative colitis, finding that higher dosing regimens were generally well tolerated and consistent with the known safety profile of adalimumab in ulcerative colitis 3.
• The study found that 13.3% of patients receiving the higher induction regimen achieved clinical remission at week 8, compared to 10.9% of patients receiving the standard induction regimen 3.
• Among week-8 responders, 39.5% of patients receiving 40 mg every week achieved clinical remission at week 52, compared to 29.0% of patients receiving 40 mg every other week 3.
• The American Gastroenterological Association technical review on the management of moderate to severe ulcerative colitis discussed the use of immunomodulator and/or biologic therapies, including adalimumab, for the treatment of ulcerative colitis 4.
• An indirect treatment comparison meta-analysis found that infliximab was statistically more effective than adalimumab in the induction of remission, response, and mucosal healing at 8 weeks, but that the two treatments were comparable in efficacy at 52 weeks of maintenance treatment 5.
• A treatment algorithm for mild and moderate-to-severe ulcerative colitis recommended the use of adalimumab for the treatment of moderate-to-severe ulcerative colitis that is refractory to conventional therapies 6.
• A review of adalimumab in ulcerative colitis found that it is effective for the induction and maintenance of remission in patients with moderate-severe ulcerative colitis refractory to conventional therapies, and that higher doses may be required for patients with more severe disease 7.

Dosing Regimen Options

• Higher induction regimen: adalimumab 160 mg at weeks 0,1,2, and 3, followed by 40 mg at weeks 4 and 6 3.
• Standard induction regimen: adalimumab 160 mg at week 0 and 80 mg at week 2, followed by 40 mg at weeks 4 and 6 3.
• Maintenance regimen: 40 mg every week or 40 mg every other week 3.