SUMMARY  

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• A post-hoc analysis of the DISCOVER-2 trial assessed the long-term efficacy of TREMFYA in adult patients with active psoriatic arthritis (PsA) and evaluated related conditions, including uveitis.¹ 
  • Four patients reported a history of uveitis with no exacerbation through week 112. 

CLINICAL DATA

Phase 3 Study

Coates et al (2024)¹ evaluated the long-term efficacy of TREMFYA from the DISCOVER-2 trial across Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-recognized domains in adult patients with active PsA. Related comorbidities, including uveitis, were evaluated for exacerbations from baseline through week 112.

Methods

• Eligible patients with active PsA (swollen joint count ≥5, tender joint count ≥5, and serum C-reactive protein (CRP) level ≥0.6 mg/dL) and an inadequate response to, or intolerance of, standard non-biological treatment, were randomized (1:1:1) to receive TREMFYA 100 mg subcutaneous (SC) every 4 weeks (q4w), or at weeks 0, 4, then every 8 weeks (q8w), or placebo with crossover to TREMFYA 100 mg SC q4w at week 24 through week 100.
• Outcomes selected aligned with GRAPPA-recommended domains: 
  • Overall disease activity, peripheral arthritis, skin, dactylitis, enthesitis, axial disease, Investigator’s Global Assessment of psoriasis (IGA), Patient’s Assessment of Skin Disease on Visual Analogue Scale (Skin VAS) through week 100.
  • PsA-related conditions, including uveitis, were evaluated for adverse events (AEs) from baseline through week 112 and included either the occurrence, or an exacerbation in patients. Uveitis was defined by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class Preferred Terms (PTs) as uveitis, iridocyclitis, or iritis.

Results

• Of the 493 patients receiving TREMFYA, treatment was completed by approximately 90% (442/493) through week 100.
• Among patients receiving TREMFYA, 4 had a history of uveitis, and no AE of exacerbation of uveitis was reported through week 12.
• One case of uveitis (iridocyclitis; q8w group at week 70) was reported and resolved with steroidal and non-steroidal anti-inflammatory drugs. No change in the TREMFYA dosing regimen occurred.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and DERWENT^® (and other resources, including internal/external databases) was conducted on 11 November 2024.