What is the standard maintenance dose of Skyrizi (Risankizumab) for ulcerative colitis (UC)?

Standard Maintenance Dose of Skyrizi for Ulcerative Colitis

The standard maintenance dose of Skyrizi (risankizumab) for ulcerative colitis is 180 mg or 360 mg administered subcutaneously every 8 weeks, starting at Week 12 after completing the induction regimen. 1

Dosing Regimen for Ulcerative Colitis

Induction Phase

• Induction dosage: 1,200 mg administered by intravenous infusion
• Timing: Weeks 0,4, and 8
• Administration: Infused over a period of at least two hours 1

Maintenance Phase

• Maintenance dosage: 180 mg or 360 mg administered subcutaneously
• First maintenance dose: Week 12
• Subsequent doses: Every 8 weeks thereafter
• Important note: Use the lowest effective dosage needed to maintain therapeutic response 1

Efficacy Data

Recent clinical trials demonstrate the effectiveness of this maintenance dosing regimen:

• In a phase 3 randomized clinical trial, clinical remission rates at week 52 were:

  • 40.2% for 180 mg of risankizumab
  • 37.6% for 360 mg of risankizumab
  • 25.1% for placebo 2

• Both maintenance doses showed statistically significant improvement compared to placebo:

  • 180 mg vs placebo: 16.3% difference (97.5% CI, 6.1%-26.6%, P < .001)
  • 360 mg vs placebo: 14.2% difference (97.5% CI, 4.0%-24.5%, P = .002) 2

Administration Considerations

• The maintenance dose is administered using a single-dose 180 mg or 360 mg prefilled cartridge with an on-body injector
• Patients may self-inject after proper training in subcutaneous injection technique
• Before using the on-body injector, allow the medication to reach room temperature (45 to 90 minutes) out of direct sunlight 1

Safety Profile

• No new safety signals were detected in clinical trials of risankizumab for UC 2
• Common adverse reactions (≥3%) reported in the maintenance phase include:
  • Arthralgia (5.3% with 180 mg, 9.6% with 360 mg)
  • Pyrexia (4.7% with 180 mg, 4.0% with 360 mg)
  • Rash (4.1% with 180 mg) 1

Clinical Considerations

• The dosing for UC differs from other indications like plaque psoriasis or psoriatic arthritis, which use different dosing regimens 1
• Skyrizi selectively targets the p19 subunit of IL-23, providing a different mechanism of action compared to other biologics used for UC 2
• The FDA label specifically recommends using "the lowest effective dosage needed to maintain therapeutic response" for UC maintenance therapy 1

Monitoring Recommendations

• Evaluate clinical response at regular intervals
• Monitor for adverse reactions, particularly infections
• Consider periodic assessment of lipid parameters, as elevations in total cholesterol and LDL-C have been observed 1