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.
• Interim results of the GULLIVER study summarized the effectiveness and safety of TREMFYA in adult patients with facial and/or genital psoriasis (PsO) in real-world settings.¹
• Additional observational studies and a case report have reported on the use of TREMFYA for the treatment of genital PsO.^2-4

CLINICAL DATA

Observational Study (GULLIVER)

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

Study Design/Methods

• Adult patients with PsO requiring systemic treatment with a significant involvement (static physician global assessment [sPGA] score of ≥3) of the genital and/or facial area receiving TREMFYA were included in the study.
• Select inclusion criteria: age ≥18 years with confirmed PsO, requiring systemic treatment with significant involvement 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.⁵
• Select exclusion criteria: contraindication to the use of TREMFYA, as stated in the current summary of product characteristics of the product approved in Italy; received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of TREMFYA treatment.⁵
• Effectiveness was evaluated using sPGA score (clear, 0; almost clear, 1; mild, 2; moderate to severe, 4; severe, 5) in the individual components (erythema, scaling, thickness).
• The primary outcomes were the proportion of patients achieving sPGA score 0/1 and ≥2 grade improvement for the genital and facial regions at week 52.⁵
• The select secondary outcomes were the proportion of patients achieving sPGA score 0/1 and ≥2 grade improvement for the genital region at weeks 12 and 28.⁵

Results

Baseline Patient Characteristics

• A total of 204/351 patients with genital PsO were included in the interim analysis. See Table: Baseline Characteristics from GULLIVER.

Effectiveness at Weeks 12 and 28

• At weeks 12 and 28, 76.5% and 93.1% of patients with genital PsO achieved an sPGA score of 0/1 and ≥2 grade improvement, respectively.
• Among patients with a moderate to severe sPGA score at baseline, an improved score of 0/1 in terms of thickness, scaling, and erythema was achieved in patients with genital PsO. See Table: Proportion of Patients with an sPGA Score of 0/1 in the sPGA Individual Components.

Safety

No new safety signals were identified at Week 12.⁶

Retrospective Study

Mastorino et al (2023)² evaluated the effectiveness of anti-IL-17 and anti-IL-23 agents, including TREMFYA, in difficult-to-treat psoriasis areas in a retrospective, observational, real-world study.

Study Design/Methods

• Patients with psoriasis who were treated with an anti-IL-17 (secukinumab, ixekizumab, brodalumab) or anti-IL-23 (TREMFYA, risankizumab, tildrakizumab) agent were identified from the University of Turin Psocare SS-Dermo-20 registry during January 2017 to June 2022.
• Included patients presented with at least one of the difficult-to-treat areas of genital, scalp, and palmoplantar sites.
• Patients with missing data at baseline were not included.
• All patients received anti-IL-17 and anti-IL-23 agents at the approved local labeling dosage and underwent a washout period of previous biologic treatment.
• For patients with genital psoriasis, static Physician’s Global Assessment of Genitalia (sPGA-G) was observed.

Results

• A total of 136 patients had involvement in the genital area. See Table: Baseline Characteristics of Anti-IL-17 and Anti-IL-23 Agents.

• Mean sPGA-G and sPGA-G 0/1 outcomes were observed over time in Table: Mean sPGA-G and sPGA-G 0/1 Results at Weeks 16, 28 and 52.

Prospective Study (PSoHO)

Piaserico et al (2023)³ reported week 12 results from Psoriasis Study of Health Outcomes (PSoHO), an international, prospective, non-interventional study, that compared the effectiveness of biologics in patients with moderate to severe psoriasis and special area involvement.

Study Design/Methods

• The PSoHO study enrolled adult patients from 23 countries with a confirmed diagnosis of moderate to severe psoriasis (≥6 months from baseline) and with special area involvement of the scalp, genital, nails, face, and/or neck, or palms and/or soles. Patients initiated or switched biologic treatment during routine medical care.
• Analysis for this study included treatment groups with more than 100 patients: ixekizumab, secukinumab, adalimumab, ustekinumab, TREMFYA, and risankizumab.
• Analyses were completed for patients with special area involvement at baseline and a valid result at week 12.

Results

• Of the 1978 patients with psoriasis and special area involvement, 25.6% (n=506) patients had genital area involvement. See Table: PSoHO Baseline Demographics and Diseases Characteristics.

• Genital clearance response rates and comparative adjusted odds ratios of ixekizumab to studied biologic treatments are shown in Table: Unadjusted Genital Clearance Response Rates and Comparative Adjusted Odds Ratios of Ixekizumab vs Other Biologics in Patients with Baseline Genital Involvement at Week 12.

Case Report

Galluzzo et al (2020)⁴ described a case of a male patient with moderate-to-severe chronic plaque PsO in the genital region from a retrospective longitudinal study of 52 patients.

Study Design/Methods

• Data from patients with moderate-to-severe plaque PsO who were treated with TREMFYA for at least 12 weeks from November 2018 to March 2020 were reviewed retrospectively over a period of 12 months (52 weeks).
• Fifty-two-week data were not available for all patients due to different time of treatment initiation during the study.
• Patients with moderate-to-severe PsO (Psoriasis Area Severity Index [PASI] >10) who had treatment failure, had side effects or were contraindicated to at least one conventional treatment, including systemic therapy or phototherapy were included.
• Patients with a baseline PASI <10 and involvement of sensitive areas (i.e., face, scalp, hands, or genital) were also included.
• Patients with other autoimmune/inflammatory diseases (i.e., Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and ankylosing arthritis), patients who had less than 4 weeks of biologic treatment or had received systemic treatment or phototherapy in combination with biologic agent within 4 weeks of the first visit, and patients with guttate, erythrodermic, or pustular psoriasis were excluded.
• TREMFYA 100 mg was administered subcutaneously at weeks 0 and 4, and every 8 weeks thereafter.
• Measured outcomes included PASI 75, PASI 90, and PASI 100 at week 4, 12, 20, 28, 36, 44, and 52.
• Safety, tolerability, clinical laboratory tests and vital signs were evaluated over the duration of the study.

Results

Efficacy in Difficult-to-Treat Locations

• A male patient with psoriasis in the suprapubic area and penis foreskin, umbilicus/periumbilical, and perianal regions experienced complete clearance (PASI 100) of plaques after 12 weeks of treatment with TREMFYA.

Safety

• Treatment with TREMFYA was well-tolerated among 52 patients with no evidence of cumulative toxicity or organ toxicity.
• No discontinuation due to adverse events was reported.
• Clinical laboratory tests and control of vital signs showed no alteration.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT^® (and/or other resources, including internal/external databases) was conducted on 04 April 2024.