SUMMARY

• Please refer to the TREMFYA Prescribing Information for relevant information regarding immunogenicity with TREMFYA. Summarized in this response are relevant data on immunogenicity from the PROTOSTAR clinical program in pediatric patients (6 years of age and older) with moderate to severe plaque psoriasis (PsO).¹ 

Clinical Data

PROTOSTAR Study

The efficacy, safety, pharmacokinetics (PK), and immunogenicity of TREMFYA in pediatric patients (≥6 to <18 years of age) with moderate to severe plaque PsO were evaluated in a phase 3, randomized, placebo-controlled clinical trial with an open-label reference arm (etanercept).¹

• Results
• Up to week 44, 18.4% (n=21/114) of pediatric patients 6 years of age and older treated with TREMFYA at the recommended dosage tested positive for anti-guselkumab antibodies.¹ 
  • Of these patients who tested positive for anti-guselkumab antibodies and were evaluable for neutralizing antibodies, none had antibodies that were classified as neutralizing antibodies.¹ 
  • Of the patients who were positive for antibodies to guselkumab, (95%) had low titers (≤1:45).¹ 
• There was no identified effect of anti-drug antibodies on guselkumab PK or clinical response to guselkumab over the treatment duration of 44 weeks.¹ 

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 22 September 2025.