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.
• In SPECTREM (NCT06039189), an ongoing study of adult patients with low body surface area (BSA), moderate plaque psoriasis (PsO) with ≥1 special site involvement, the secondary endpoint of static Physician’s Global Assessment of Genitalia (sPGA-G) score of 0/1 was achieved by 78% of patients receiving TREMFYA compared to 38% of patients receiving placebo (PBO) at week 16 (P<0.001).¹
• Interim results of the GULLIVER study summarized the effectiveness and safety of TREMFYA in adult patients with facial and/or genital PsO in real-world settings.^2,3
• Additional observational studies and a case report have reported on the use of TREMFYA for the treatment of genital PsO.^4-6

CLINICAL DATA

Gottlieb et al (2024)¹ and Gold et al (2024)⁷ reported week 16 results from SPECTREM, an ongoing, multicenter, randomized, double-blind, PBO-controlled, phase 3b clinical trial evaluating the safety and efficacy of TREMFYA in adult patients with low BSA, moderate plaque PsO with ≥1 special site involvement.

Study Design/Methods

• Key inclusion criteria are as follows^7,8:
  • Patients (≥18 years of age) with a diagnosis of plaque PsO (with or without psoriatic arthritis [PsA]) for at least 6 months prior to administration of study intervention
  • IGA=3
  • BSA=2-15% with ≥1 plaque outside of special site(s)
  • Involvement of ≥1 special site with at least moderate severity (scalp with scalp-specific IGA [ss-IGA] ≥3, face with facial psoriasis IGA [f-IGA] ≥3, intertriginous with intertriginous psoriasis IGA ≥3, and/or genital with static physician global assessment of genitalia [sPGA-G] ≥3)
  • Inadequately controlled with or intolerant of at least 1 prior topical therapy for treatment of PsO
• Key exclusion criteria are as follows⁸:
  • Non-plaque form of PsO (eg, erythrodermic, guttate, or pustular)
  • Patients with palmoplantar involvement with confounding diagnoses
  • Biologic-experienced for the treatment of PsO, PsA, or any other indications that could impact the assessment of PsO
• Primary and secondary outcome measures are described in Table: SPECTREM Clinical Trial Outcome Measures.

Results

Patient Characteristics

• A total of 338 patients were randomized in a 2:1 ratio to receive TREMFYA 100 mg (n=225) or PBO (n=113) subcutaneously at weeks 0, 4, and then every 8 weeks with PBO crossover to TREMFYA at week 16.⁷
• Select baseline characteristics are described in Table: Select Baseline Demographics and Clinical Characteristics.

Efficacy

• At week 16, the primary endpoint of IGA 0/1 was achieved by significantly more patients receiving TREMFYA (74% [167/225]) than those receiving PBO (12% [14/113]; P<0.001).⁷
  • P-value is based on the Cochran-Mantel-Haenszel (CMH) test stratified by special site (scalp, face, intertriginous, genital).
  • Nonresponder imputation (NRI) was used: participants who discontinued study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to designated visit were considered nonresponders from that point forward. Participants with missing data were considered nonresponders.
• At week 16, the major secondary endpoint of sPGA-G 0/1 was achieved by 78% (64/82) of patients receiving TREMFYA compared to 38% (15/40) of patients receiving PBO (P<0.001).¹
  • P-value is based on the chi-squared test, not adjusted for baseline stratification factor. NRI was used.

Safety (Overall Population)

• Through week 16, 37.8% (85/225) of patients receiving TREMFYA and 39.8% (45/113) of patients receiving PBO reported ≥1 adverse event (AE).¹
  • At least 1 serious AE was reported in 1.3% (3/225) of patients in the TREMFYA group and in 0.9% (1/113) of patients in the PBO group.
  • Infection was reported in 22.2% (50/225) of patients receiving TREMFYA and 20.4% (23/113) of patients receiving PBO.
    • Serious infection was reported in 0.9% (1/113) of patients in the PBO group compared to 0 patients in the TREMFYA group.
  • At least 2.7% (6/225) of patients receiving TREMFYA and 0.9% (1/113) of patients receiving PBO reported ≥1 injection site reaction.
  • A major adverse cardiovascular event was reported in 0.4% (1/225) of patients in the TREMFYA group compared to 0 events in the PBO group.
• Through week 16, no cases of deaths, malignancies, active tuberculosis, inflammatory bowel disease, anaphylaxis, or serum sickness were reported in either group.¹

Observational Study (GULLIVER)

Bonifati et al (2025)² and Bonifati et al (2023)³ 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.²
• 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.²
• Patients received TREMFYA 100 mg at weeks 0, 4 and then every 8 weeks through Week 52.²
• 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).²
• 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 52.⁹
• Select secondary outcomes were the proportion of patients achieving sPGA score 0/1 and ≥2 grade improvement for the facial or genital region at weeks 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.^2,9

Results

Baseline Patient Characteristics

• A total of 204/351 patients with genital PsO were included in the interim analysis. For select baseline patient characteristics, see Table: Select Baseline Characteristics.
• Results were evaluated at week 12 (n=344) and week 28 (n=331) in patients who completed 28 weeks of treatment.^2,3

Effectiveness at Weeks 12 and 28

• At weeks 12 and 28, 76.5% (153/200) and 93.1% of patients with genital PsO achieved an sPGA score of 0/1 and ≥2 grade improvement, respectively.^2,3
• 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 patients with genital PsO; see Table: Percentage of Patients with Genital PsO who Achieved a Score of 0/1 for Individual sPGA Components.

• In both groups (facial and genital PsO), 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 12.²
• The proportion of patients in both groups, 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 (Overall Population)

• At week 12, 44 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.²

Retrospective Study

Mastorino et al (2023)⁴ evaluated the effectiveness of anti-IL-17 and anti-IL-23 agents, including TREMFYA, in difficult-to-treat PsO areas in a retrospective, observational, real-world study.

Study Design/Methods

• Patients with PsO 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 PsO, 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)⁵ 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 PsO and special area involvement.

Study Design/Methods

• The PSoHO study enrolled adult patients from 23 countries with a confirmed diagnosis of moderate to severe PsO (≥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 PsO 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)⁶ 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 (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 (ie, face, scalp, hands, or genital) were also included.
• Patients with other autoimmune/inflammatory diseases (ie, 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 PsO 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 PsO 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 AEs was reported.
• Clinical laboratory tests and control of vital signs showed no alteration.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 02 May 2025.