Should I start with 180mg of Skyrizi (Risankizumab) after completing the induction regimen for ulcerative colitis?

Risankizumab Maintenance Dosing for Ulcerative Colitis

Yes, you should start with 180mg of Skyrizi (risankizumab) after completing the induction regimen for ulcerative colitis. This is the appropriate maintenance dose following the induction phase of treatment 1.

Dosing Protocol for Ulcerative Colitis

Induction Phase

• 1,200 mg administered by intravenous infusion over a period of at least two hours at Week 0, Week 4, and Week 8 1

Maintenance Phase

• Begin with 180 mg administered by subcutaneous injection at Week 12
• Continue with 180 mg every 8 weeks thereafter 1
• The alternative maintenance dose is 360 mg every 8 weeks, but the FDA label recommends using "the lowest effective dosage needed to maintain therapeutic response" 1

Evidence Supporting This Recommendation

The 2024 AGA clinical practice guideline for pharmacological management of moderate-to-severe ulcerative colitis strongly recommends risankizumab for the treatment of moderately to severely active ulcerative colitis 2. The guideline states that risankizumab demonstrated efficacy in both induction and maintenance of remission.

Recent phase 3 clinical trial data published in JAMA (2024) showed that:

• Patients who received 180 mg of risankizumab subcutaneously every 8 weeks achieved a clinical remission rate of 40.2% at week 52
• This was significantly higher than the placebo group's remission rate of 25.1%
• The adjusted between-group difference was 16.3% (97.5% CI, 6.1%-26.6%, P < .001) 3

Dose Selection Considerations

Starting with the 180 mg maintenance dose is appropriate because:

1. The FDA label specifically recommends using "the lowest effective dosage needed to maintain therapeutic response" 1
2. Clinical trials demonstrated that both 180 mg and 360 mg doses were effective for maintenance therapy, with clinical remission rates of 40.2% and 37.6% respectively 3
3. Starting with the lower effective dose may reduce the risk of potential adverse events while still providing therapeutic benefit

Monitoring Recommendations

• Evaluate for symptomatic response to therapy between 8 and 14 weeks after starting maintenance therapy 2
• Monitor liver enzymes and bilirubin levels as recommended in the drug label 1
• Be vigilant for potential adverse events, though clinical trials showed risankizumab was generally well-tolerated 3

Important Considerations

• Prior to initiating treatment, ensure you've completed TB screening and appropriate vaccinations 1
• The subcutaneous maintenance dose is administered using the on-body injector with prefilled cartridge
• Patients may self-inject after proper training in subcutaneous injection technique 1

If the 180 mg dose proves insufficient to maintain remission, the dose can be increased to 360 mg every 8 weeks as needed based on clinical response 1, 3.