SUMMARY  

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• AFFINITY (NCT05071664) is a phase 2a, randomized, double-blind, multicenter study designed to evaluate the efficacy and safety of subcutaneous (SC) TREMFYA and SC golimumab combination treatment in adult patients with active psoriatic arthritis (PsA) and inadequate response to a prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) treatment as compared to SC TREMFYA monotherapy.¹
• Results are not currently available. Details regarding the study status and study design of AFFINITY can be found on clinicaltrials.gov. The study design is summarized below.¹

CLINICAL DATA

AFFINITY (NCT05071664)¹ is a phase 2a, randomized, double-blind, multicenter study designed to evaluate the efficacy and safety of SC TREMFYA and SC golimumab as a combination treatment in adult patients with active PsA and inadequate response to a prior anti-TNF-alpha treatment in comparison to SC TREMFYA monotherapy.

Study Design/Methods

• Key inclusion criteria are as follows:
  • Adult patients (18 to 65 years of age) with a diagnosis of PsA for ≥6 months prior to the first study intervention
  • Presence of active PsA (≥3 swollen and ≥3 tender joints) at screening and at baseline
  • Presence of ≥1 of the PsA subsets (distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis)
  • Presence of active plaque psoriasis (PsO) (≥1 psoriatic plaque of ≥2 centimeters diameter or nail changes consistent with PsO)
  • Inadequate response to anti-TNF-alpha therapy, defined as the presence of active PsA despite treatment with either 1 or 2 anti-TNF-alpha agent(s) and the following:
    • a. Lack of benefit to either 1 or 2 prior anti-TNF-alpha agent(s), as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, or certolizumab pegol therapy, or at least 14-weeks of infliximab, or any biosimilar of these 4 therapies. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity
    • b. The last dose of anti-TNF-alpha therapy must have occurred greater than 5 half-lives of the drug before a screening visit
• Key exclusion criteria include a presence of other inflammatory conditions, including but not limited to rheumatoid arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease.
• The total duration of the study will consist of up to 42 weeks, including a screening phase (up to 6 weeks), double-blind phase from weeks 0 to 24, and safety follow-up phase from week 24 to week 36.
• Eligible patients will be randomized into 2 groups (group 1: SC TREMFYA and SC golimumab; and group 2: SC TREMFYA and SC placebo).
• The efficacy and safety outcomes to be evaluated in this trial are summarized in Table: Study Design: Efficacy and Safety Outcomes.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, DERWENT^® (and other resources, including internal/external databases) was conducted on 13 January 2025.