J&J Medical Connect
TREMFYA®

(guselkumab)

+ Save link
J&J Medical Connect

Connect with us

  • Products

This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TREMFYA® (guselkumab)

Medical Information

TREMFYA – Use in Adult Patients with Psoriatic Arthritis and Comorbid Nonalcoholic Fatty Liver Disease (NAFLD)

Last Updated: 12/15/2025

SUMMARY

  • The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
  • A post-hoc analysis of DISCOVER-2 study assessed the 52-week efficacy and safety outcomes of TREMFYA in adult patients with active psoriatic arthritis (PsA)1
    • During a study, a brief description of the use of TREMFYA in a patient with active PsA and comorbid nonalcoholic fatty liver disease (NAFLD) was reported. 

CLINICAL DATA

Phase 3 Study

McInnes et al (2021)1 evaluated efficacy and safety results through 52 weeks from the DISCOVER-2, a phase 3, randomized, multicenter, doubleblind, placebo-controlled study analyzing the use of TREMFYA in biologic-naïve adult patients with active PsA.

DISCOVER-2 Study Design2,3

A diagram of a patient's life AI-generated content may be incorrect.

Abbreviations: CASPAR, Classification Criteria for Psoriatic Arthritis; CRP, Creactive protein; DMARD, disease-modifying antirheumatic drug; EE, early escape; NSAID, nonsteroidal anti-inflammatory drug; PsO, psoriasis; R, randomized; SC, subcutaneously; q4w, every 4 weeks; q8w, every 8 weeks.
a238 patients in the placebo group crossed over to guselkumab q4w; 8 patients received placebo only before study drug discontinuation.
bPatients were eligible to initiate/increase background medications if there was <5% improvement from baseline in tender and swollen joint counts at week 16.

  • Patients were allowed to receive concomitant stable doses of nonbiologic disease-modifying antirheumatic drugs (DMARDs) (methotrexate ≤25 mg/week, sulfasalazine
    ≤3 g/day, hydroxychloroquine ≤400 mg/day, or leflunomide ≤20 mg/day), oral glucocorticoids ≤10 mg/day of prednisone or equivalent dose, and nonsteroidal anti-inflammatory drugs (NSAIDs), or other analgesics.1-3 
  • During the study, a case of grade 1 alanine aminotransferase (ALT) elevation (>1 to 3 times of the upper limit of normal [ULN]) was reported in a patient with a history of NAFLD who switched from placebo to TREMFYA every 4 weeks and discontinued TREMFYA after week 52.1

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 30 November 2025.

 

References

Show
1 McInnes IB, Rahman P, Gottlieb AB, et al. Efficacy and safety of guselkumab, an interleukin‐23p19–specific monoclonal antibody, through one year in biologic‐naive patients with psoriatic arthritis. Arthritis Rheumatol. 2020;73(4):604-616.  
2 Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136.  
3 Mease PJ, Rahman P, Gottlieb AB, et al. Supplement to: Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136.