Laboratory Monitoring for Patients on Skyrizi (Risankizumab)
No routine blood test monitoring is required for patients receiving Skyrizi for plaque psoriasis, as the FDA label does not mandate any specific laboratory surveillance during treatment. 1
Baseline Testing Requirements
Before initiating Skyrizi, the following assessments are essential:
- Tuberculosis screening is mandatory prior to treatment initiation, as Skyrizi may increase infection risk 1
- Hepatitis B and C virus screening should be performed before starting therapy, following standard practices for immunosuppressive biologics 2
- HIV testing is recommended for patients with risk factors 2
Disease-Specific Monitoring Considerations
For Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
Liver function monitoring is specifically required when Skyrizi is used for inflammatory bowel disease, unlike its use in psoriasis. 1
- Baseline liver enzymes and bilirubin must be obtained before starting treatment 1
- During induction therapy, monitor liver function tests at least through the first 12 weeks of treatment 1
- After induction, continue monitoring according to routine patient management 1
- Avoid use in patients with liver cirrhosis—consider alternative treatment options 1
This heightened hepatic monitoring requirement stems from a serious adverse reaction of drug-induced liver injury (ALT 54× ULN, AST 30× ULN, total bilirubin 2.2× ULN) that occurred in a Crohn's disease patient receiving intravenous Skyrizi 1
For Plaque Psoriasis
No specific laboratory monitoring is mandated during ongoing treatment for psoriasis. 1 The FDA label for psoriasis does not include requirements for routine blood count, liver function, or renal function monitoring during maintenance therapy 1
Important Clinical Pitfalls
- Do not confuse monitoring requirements across indications: The hepatotoxicity warning and associated liver monitoring apply specifically to inflammatory bowel disease treatment, not psoriasis 1
- Interrupt treatment immediately if drug-induced liver injury is suspected in IBD patients, pending exclusion of this diagnosis 1
- Instruct patients to seek immediate medical attention for symptoms of hepatic dysfunction (jaundice, dark urine, severe fatigue, right upper quadrant pain) when treating IBD 1
- Monitor for signs of active tuberculosis during and after treatment, even if latent TB prophylaxis was given 1
- Do not administer live vaccines during Skyrizi treatment 1
Safety Profile from Clinical Trials
Long-term safety data through 6 years (324 weeks) in psoriasis patients showed consistently low rates of treatment-emergent adverse events, with no new safety signals emerging over time 3 The most common adverse reactions in psoriasis trials were upper respiratory infections (13.0%), headache (3.5%), and fatigue (2.5%) 1