TREMFYA - Overview of the PAMPA Clinical Trial

SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• The Preventing Arthritis in a Multicenter Psoriasis At-risk cohort (PAMPA) study is an ongoing phase 4, multicenter, randomized, double-blind, placebo-controlled, wait-list, interventional trial. PAMPA aims to evaluate the efficacy of TREMFYA in preventing psoriatic arthritis (PsA) and decreasing musculoskeletal, power-doppler ultrasound (MSK-PDUS) abnormalities in adult patients with psoriasis (PsO) who are at increased risk for progression to PsA.^1-3
  • Published study results regarding the outcomes listed below are not currently available.
  • Details regarding the study design of PAMPA are summarized below.^1-3

CLINICAL STUDY

PAMPA (NCT05004727)

Haberman et al (2022)¹ describe an ongoing phase 4, multicenter, randomized, double-blind, placebo-controlled, wait-list, interventional trial to assess the efficacy of TREMFYA in preventing PsA and decreasing MSK-PDUS abnormalities in adult patients with PsO who are at increased risk for progression to PsA.

Study Design/Methods

• Selected inclusion criteria^1-3:
  • Adult patients (≥18 years of age) with a diagnosis of PsO per a dermatologist for ≥2 years (in ≥30% of patients)
  • PsO body surface area (BSA) ≥3%
  • Positive imaging findings on MSK-PDUS defined as a Rochester Modified-PsASon (RM-PsASon) score >3.36
• Selected exclusion criteria^1,3:
  • Evidence of inflammatory joint pain, enthesitis and/or dactylitis
  • Current systemic immunosuppressive medication use (ie, methotrexate, apremilast) at enrollment or current/prior use of biologic therapy
  • Rheumatoid arthritis seropositive (mid to high rheumatoid factor [RF] and/or anti-citrullinated protein antibodies [ACPA] at >2 times the upper limit of normal)
  • A history of symptomatic polyarticular osteoarthritis or other joint conditions (eg, rheumatoid arthritis and gout) that may impair the ability to assess for PsA development
• The study design which includes the 3 randomized arms is summarized in Figure: PAMPA Study Design.

• Secondary outcomes^1,3:
  • Transition to PsA at week 48 (arm 1 vs arm 2)
  • Severity of PsA at the time of synovioentheseal development at week 96 (severity classified as mild, moderate, or severe and additionally by continuous variables [e.g., joint and enthesitis counts]) (arm 1+2 vs arm 3)
  • Change from baseline in the MSK-PDUS composite score of synovitis at week 24 (arm 1 vs arm 2)
  • Change from baseline in the US composite score of enthesitis at week 24 (arm 1 vs arm 2)
  • Change from baseline in BSA at week 24 (arm 1 vs arm 2)
  • Achieved Investigator’s Global Assessment (IGA) score of 0/1 (yes, no) at week 24 (arm 1 vs arm 2)
  • Change in baseline Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at week 24 (arm 1 vs arm 2)
  • Change in baseline EuroQol- 5D (EQ5D) score at week 24 (arm 1 vs arm 2)
  • Change in baseline EQ5D score at week 96 (arm 1+2 vs arm 3)
  • Change in International Dermatology Outcome Measures Musculoskeletal-8 (IDEOM MSK-8) score at week 24
  • Change in US score at week 24
  • Proportion of patients who achieved ≥50% improvement in US score at week 24
• Exploratory outcomes¹:
  • Musculoskeletal domain affected at PsA presentation (enthesitis, axial disease, peripheral arthritis) among those developing clinical PsA
  • Presence and number of risk factors for PsA development at baseline (PsO phenotype; PsO severity; genetic predisposition; comorbidities such as obesity)
  • Association between risk factors and development of PsA at week 96
  • Genetic, immune cell phenotype and microbiome changes (cutaneous and intestinal) and their interactions with study agent

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 18 June 2026.