SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to the local labeling on approved uses of TREMFYA.
• Summarized in this response are the interim results of the GULLIVER study, evaluating the effectiveness and safety of TREMFYA in adult patients with facial and/or genital psoriasis (PsO) in real-world settings.^1,2

CLINICAL DATA

Observational Study (GULLIVER)

Bonifati et al (2024)¹ and Bonifati et al (2023)² presented the 12- and 28-week interim results of the prospective GULLIVER study, evaluating the effectiveness and safety of TREMFYA in adult patients with facial and/or genital PsO in real-world settings in Italy.

Study Design/Methods

• Inclusion criteria: age ≥18 years with confirmed PsO diagnosis requiring systemic treatment with significant involvement (static physician global assessment [sPGA] score ≥3) of the facial and/or genital regions; enrolled any time after the first injection of TREMFYA but before completion of the next scheduled visit at week 4 or 12 per common clinical practice.¹
• Exclusion criteria: contraindication to TREMFYA; received an investigational drug (including investigational vaccines); or used an invasive investigational medical device within 30 days before the start of TREMFYA treatment.¹
• Patients received TREMFYA 100 mg at weeks 0,4 and then every 8 weeks through Week 52.¹
• Effectiveness was evaluated through week 12 using sPGA score (clear, 0; almost clear, 1; mild, 2; moderate, 3; moderate to severe, 4; severe, 5) in the individual components (erythema, scaling, and thickness).¹
• The primary endpoint was the proportion of patients achieving sPGA score 0/1 and ≥2 grade improvement for the facial or genital region at week 52.³
• Select secondary outcomes were the proportion of patients achieving sPGA score 0/1 and ≥2 grade improvement for the facial or genital region at week 12 and 28, change in the score of individual facial or genital sPGA components (erythema, thickness and scaling) among patients with a score of ≥3 for each sPGA component at week 12, and the proportion of patients achieving psoriasis area severity index (PASI) 75, 90, and 100 at week 12, among patients with a baseline PASI score of above or below 10.^1,3

Results

Baseline Patient Characteristics

• A total of 351 patients (facial PsO, n=147; genital PsO, n=204) were included in the interim analysis. For baseline patient characteristics, see Table: Baseline Characteristics.
• Results were evaluated at week 12 (n=344) and week 28 (n=331) in patients who completed 28 weeks of treatment.^1,2

Effectiveness at Weeks 12 and 28

• At week 12, a total of 79.4% (273/344) (facial PsO, 83.3% [120/144]; genital PsO, 76.5% [153/200]) of patients had achieved an sPGA score of 0/1 and ≥2 grade improvement, respectively.^1,2
• At week 28, a total of 91.8% (facial PsO, 90.2%; genital PsO, 93.1%) of patients had achieved an sPGA score of 0/1 and ≥2 grade improvement, respectively.²
• Among patients with a score ≥3 in each sPGA analyzed component at baseline, an improved score of 0/1 in terms of thickness, scaling, and erythema was achieved in both the subgroups; see Table: Proportion of Patients with a sPGA Score of 0/1 in the sPGA Individual Components.

• The mean (standard deviation) PASI score in patients with PASI score above 10 was 19.0 (8.3) at baseline and 2.2 (4.8) at week 12, and the mean PASI score in patients with PASI ≤10 was 6.1 (2.3) at baseline and 1.1 (1.6) at week 12.¹
• The proportion of patients achieving PASI 75, 90, and 100 at week 12 among patients with a PASI score ≤10 and >10 at baseline is summarized in Table: Proportion of Patients Achieving PASI 75, 90, and 100 at Week 12 by Baseline PASI Score.

Safety

• At week 12, 44 adverse events (AEs) were observed in 32 patients. One patient in the genital PsO group reported mild and transient treatment-related AEs which included fatigue and nausea. No serious AEs were reported, and no AEs led to discontinuation of the study.¹

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 24 June 2024.