What is the incidence of elevated liver enzymes in patients treated with Tremfya (guselkumab)?

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Last updated: November 10, 2026 • View editorial policy

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Incidence of Elevated Liver Enzymes with Tremfya

Elevated liver enzymes occur in approximately 2.6% of patients treated with Tremfya (guselkumab), compared to 1.9% in placebo-treated patients, based on pooled data from pivotal clinical trials. 1

Clinical Trial Data

In the 16-week placebo-controlled period of pooled psoriasis trials (PsO1 and PsO2) involving 823 patients receiving Tremfya:

  • 2.6% of Tremfya-treated patients experienced elevated liver enzymes
  • 1.9% of placebo-treated patients had similar elevations
  • Of the 21 patients with elevated liver enzymes in the Tremfya group, all events except one were mild to moderate in severity
  • No patients discontinued Tremfya due to liver enzyme elevations 1

Severity and Clinical Significance

The FDA label emphasizes that these elevations were generally not clinically concerning:

  • Almost all cases were mild to moderate (CTCAE Grade 1-2)
  • No treatment discontinuations occurred
  • The safety profile remained consistent through 48 weeks of treatment 1

Special Populations

Patients with latent tuberculosis (LTBI) receiving concurrent preventive treatment showed higher rates of transaminase elevations:

  • Through Year 1: ≤2% of LTBI+ patients had Grade 3 elevations versus 0.5% of LTBI- patients
  • No Grade 4 elevations occurred in LTBI+ patients
  • After Year 1 (when ~98% completed LTBI treatment), transaminase elevations normalized to rates similar to LTBI- patients 2

This pattern suggests the elevations in LTBI+ patients were primarily related to concurrent isoniazid or rifampicin therapy rather than guselkumab itself.

Guideline Recommendations

The AAD-NPF guidelines note that "rare cases of increased liver transaminase levels have occurred with use of IL-23 inhibitors" 3. However, routine monitoring beyond baseline hepatitis screening is not mandated, reflecting the low clinical significance of these elevations.

Clinical Implications

  • Liver enzyme elevations with Tremfya are uncommon (2.6%) and typically mild
  • The slight increase over placebo (0.7% absolute difference) is not clinically significant in most patients
  • Routine liver enzyme monitoring is not required unless other risk factors are present
  • Patients on concurrent hepatotoxic medications (particularly TB prophylaxis) may warrant closer monitoring during the first year

References

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