SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• STAR (NCT04929210) is an ongoing phase 4, randomized, double-blind, placebo-controlled, multicenter prospective study designed to evaluate the efficacy and safety of TREMFYA in adult patients who are biologic-naïve with active psoriatic arthritis (PsA) and magnetic resonance imaging (MIR)-confirmed axial disease. Results are not currently available. Details regarding the study status and study design of STAR can be found on clinicaltrials.gov and are summarized below.^1,2

CLINICAL STUDY

STAR (NCT04929210)

Gladman et al (2022)¹ described a phase 4, randomized, double-blind, placebo-controlled, multicenter prospective study to assess the efficacy and safety of TREMFYA compared with placebo in adult patients who are biologic-naive with active PsA and MIR-confirmed axial disease.

Study Design/Methods

• Eligibility criteria of the STAR trial:
  • Adult patients (≥18 years of age) with a diagnosis of PsA for ≥6 months
  • Presence of active PsA (≥3 swollen joints and ≥3 tender joints and C-reactive protein [CRP] ≥0.3 mg/dL) despite non-biologic disease-modifying antirheumatic drugs (DMARDs), apremilast, and/or non-steroidal anti-inflammatory drugs (NSAIDs)
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4
  • Visual analog scale (VAS) score ≥4 for spinal pain
  • Documented history of or active plaque psoriasis (PsO) (≥1 plaque of ≥2 cm and/or psoriatic nail changes)  
  • MRI-confirmed axial disease (positive MRI of spine and/or sacroiliac joints (SIJ), defined as a Spondyloarthritis Research Consortium of Canada [SPARCC] score of ≥3 in either the spine or the sacroiliac joints)
  • No history of latent or active tuberculosis at screening
  • Concomitant use of stable doses of NSAIDs (≥2 weeks prior to first study agent administration); oral corticosteroids (equivalent to ≤10mg/day for ≥2 weeks prior to first study agent administration); and one conventional synthetic DMARD, limited to methotrexate (≤ 25mg/week), sulfasalazine (≤3 g/day), hydroxychloroquine (≤400 mg/day), and leflunomide (≤20 mg/day), will be permitted.
• Key exclusion criteria include previous use of any biologic or Janus kinase (JAK) inhibitor therapy; use of systemic immunosuppressants, corticosteroids, or apremilast within 4 weeks of first administration of study medication; use of >2 non-biologic DMARDs; and diagnosis of other inflammatory diseases (rheumatoid arthritis, ankylosing spondylitis, lupus).
• Data from DISCOVER-1 and DISCOVER-2 were used for the power calculation to detect in mean changes in BASDAI scores.
• A target of 405 eligible patients will be randomly assigned in a 1:1:1 ratio to 1 of the 3 treatment arms shown below:
  • TREMFYA 100 mg subcutaneously (SC) at weeks 0 and 4, then every 4 weeks (q4w) through week 48 or
  • TREMFYA 100 mg SC at week 0 and 4, then every 8 weeks (q8w) through week 48 or
  • Placebo SC at week 0, then q4w through week 20. At week 24, patients will cross over to receive TREMFYA 100 mg SC, then q8w through week 48.
• MRIs will be centrally read, with readers blinded to treatment groups and timepoint, using methods specifically designed to assess axial inflammation, including SPARCC score, Canada-Denmark (CAN-DEN) score, and Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis MRI Scoring System (PsAMIRS).
• Efficacy and safety will be evaluated through week 52 and week 60, respectively. Please refer to Table: Study Objectives and Endpoints.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 31 October 2024.