TREMFYA - Use in Adult Patients with Plaque Psoriasis or Psoriatic Arthritis and Comorbid Diabetes Mellitus

SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Phase 3 clinical trials for moderate to severe plaque psoriasis (PsO; VOYAGE 1, VOYAGE 2, NAVIGATE, ECLIPSE, ORION, and VISIBLE) and for active psoriatic arthritis (PsA; DISCOVER-1 and DISCOVER-2) included patients with a medical history of diabetes mellitus.^1-9
• Adult patients with plaque PsO or PsA and comorbid diabetes mellitus treated with TREMFYA have been analyzed in a prospective study, retrospective studies, and in patient registry-based studies.^10-15

CLINICAL Data in moderate to severe plaque psoriasis

VOYAGE 1 and VOYAGE 2

Blauvelt et al (2017)¹⁶ and Reich et al (2017)¹⁷ reported results from VOYAGE 1 and VOYAGE 2, respectively, phase 3, multicenter, randomized, double-blind, placebo (PBO) and active comparator-controlled studies evaluating the efficacy and safety of TREMFYA compared to PBO and adalimumab in patients with moderate to severe plaque PsO.

Results

Patient Characteristics

• Patients with a medical history of diabetes mellitus at baseline are noted in Table: Patients with Medical History and Current Diagnoses of Diabetes Mellitus in VOYAGE 1 and VOYAGE 2.

NAVIGATE

Langley et al (2018)¹⁸ evaluated the safety and efficacy of TREMFYA in NAVIGATE, a phase 3, randomized, double-blind, active comparator-controlled study in patients with moderate to severe plaque PsO with an adequate response to ustekinumab.

Results

Patient Characteristics

• Patients with a medical history of diabetes mellitus at baseline are noted in Table: Patients with Medical History and Current Diagnoses of Diabetes Mellitus in NAVIGATE.

ECLIPSE

Reich et al (2019)¹⁹ reported results from ECLIPSE, a phase 3, multicenter, randomized, double-blind, comparator-controlled study evaluating the superiority of clinical response at week 48 for TREMFYA over that of secukinumab in patients with moderate to severe plaque PsO.

Results

Patient Characteristics

• The proportion of patients with a medical history and current diagnosis of diabetes mellitus is presented in Table: Patients with Medical History and Current Diagnoses of Diabetes Mellitus in ECLIPSE.

ORION

Ferris et al (2020)²⁰ reported results from ORION, a phase 3, multicenter, randomized, double-blind, PBO-controlled study evaluating the efficacy, safety, and pharmacokinetics of TREMFYA vs PBO (both delivered via the One-Press device) in patients with moderate to severe PsO.

Results

Patient Characteristics

• The proportion of patients with a medical history and current diagnosis of diabetes mellitus is presented in Table: Patients with Medical History and Current Diagnoses of Diabetes Mellitus in ORION.

VISIBLE

Stein Gold et al (2025)^8,9 presented results from VISIBLE, a multicenter, double-blind, randomized, phase 3b clinical trial evaluating the safety and efficacy of TREMFYA compared with PBO in patients with skin of color (self-identified as non-White) with predominantly moderate to severe body plaque PsO (cohort A) or scalp PsO (cohort B).

Results

Patient Characteristics

• The proportion of patients with diabetes mellitus at baseline is presented in Table: Patients with Diabetes Mellitus at Baseline in VISIBLE.

Prospective Study - G-EPOSS

Gerdes et al (2025)¹⁴ presented results from G-EPOSS, a noninterventional, multicenter German study that evaluated the efficacy and impact of TREMFYA on quality of life in patients with moderate to severe plaque PsO. The study enrolled 304 patients across 44 sites, with disease duration data available for 294 patients.

Results

Patient Characteristics

• The proportion of patients with diabetes mellitus at baseline is presented in Table: Patients with Diabetes Mellitus at Baseline in G-EPOSS.

Retrospective Studies

Mortato et al (2025)¹⁵ evaluated super responders (SR) (patients who achieved a Psoriasis Area and Severity Index [PASI] 100 response by week 20 of treatment) in a retrospective, longitudinal study of patients with moderate to severe plaque PsO treated with at least 3 doses of TREMFYA monotherapy. The study aimed at identifying predictive factors for a SR status and its long-term clinical implications.

• A total of 1008 patients treated at 10 Italian treatment centers between January and October 2024 were included, with 581 (57.6%) patients classified as SR and 427 (42.4%) classified as non-super responders (nSR).
• Patients with a current diagnosis of diabetes mellitus are noted in Table: Patients with Diabetes Mellitus at Baseline.

Marcelli et al (2024)¹⁰ evaluated patients who were SR (defined as patients who achieved PASI 0 score by week 20 of treatment) in a retrospective, observational, cross-sectional, “snapshot,” single-center study that included adult patients with moderate to severe chronic plaque PsO treated with at least 3 doses of TREMFYA monotherapy.

• Inclusion criteria:
  • Patients (age ≥18 years) who were receiving at least 3 doses of TREMFYA monotherapy for moderate to severe chronic plaque PsO and not responding to or showing contraindications or side effects to ≥1 conventional systemic therapy
  • Patients with PASI score ≥10 and body surface area (BSA) ≥10% at baseline, or with PASI score <10 and BSA <10% at baseline, as well as involvement of specific sensitive areas (ie, face, scalp, hands, nails, soles of the feet, or genital areas), according to Italian law
• PASI 90/100 responses were evaluated at baseline, week 4 of treatment, and every 8 weeks thereafter.
• A total of 232 patients treated with TREMFYA monotherapy for at least 28 weeks (from November 2018 to November 2023) were included in this study.
• At baseline, 12.1% (28/232) of patients were reported to have comorbid diabetes mellitus.

Menéndez Sánchez et al (2023)¹¹ evaluated patients who were SR (defined as achieving PASI 0 at weeks 16 and 24 of treatment) in a retrospective, observational, bicentric study that included adult patients with moderate to severe plaque PsO treated with TREMFYA.

• A total of 86 patients were included, of whom 49 received TREMFYA, 24 received risankizumab, and 13 received tildrakizumab.
• Patients with a medical history of diabetes mellitus at baseline are noted in Table: Patients with Medical History of Diabetes Mellitus.

CorEvitas PsO Registry

Armstrong et al (2023)¹² reported results from the CorEvitas (previously known as Corrona) PsO Registry, a prospective, observational cohort of adult patients with moderate to severe plaque PsO.

• The analysis from July 2017 to March 2020 included 113 adult patients with moderate to severe plaque PsO who initiated TREMFYA at or after enrollment and had a follow-up visit after 9-12 months of treatment with TREMFYA.
• At baseline, 18.6% (21/113) of patients had a history of diabetes mellitus.

CLINICAL Data in active psoriatic arthritis

DISCOVER-1 and DISCOVER-2

Deodhar et al (2020)²¹ and Mease et al (2020)²² evaluated the efficacy and safety of TREMFYA in DISCOVER-1 and DISCOVER-2, respectively, phase 3, randomized, multicenter, double-blind, PBO-controlled studies in adult patients with active PsA.

Results

Patient Characteristics

• Patients with a medical history of diabetes mellitus at baseline are noted in Table: Patients with Medical History and Current Diagnoses of Diabetes Mellitus From DISCOVER-1 and DISCOVER-2.

CorEvitas PsA/Spondyloarthritis Registry

Mease et al (2022)^13,23 reported characteristics of patients with rheumatologist-diagnosed PsA treated with TREMFYA from the CorEvitas PsA/Spondyloarthritis Registry, a United States prospective, observational, noninterventional registry.

• Inclusion criteria²³:
  • Patients (age ≥18 years) who had a diagnosis of PsA and initiated on a United States Food and Drug Administration (USFDA)-approved PsA medication at the enrollment.
  • Patients who met Assessment of Spondyloarthritis International Society (ASAS) criteria for radiographic or nonradiographic axial spondyloarthritis (AxSpA), and initiated on a USFDA-approved biologic or biosimilar treatment of ankylosing spondylitis (AS) or AxSpA at the enrollment
  • Patients who met the modified New York classification criteria for AS and initiated on a USFDA-approved biologic and biosimilar for the treatment of AS or AxSpA at enrollment
• During routine clinical visits every 6 months, patients and providers complete questionnaires on patient demographics, disease characteristics, PsA medication history, medical history and lifestyle characteristics, disease activity and severity, comorbidities, and adverse events (including infections, hospitalizations, and other targeted safety outcomes).¹³ 
• The analysis from March 2017 to September 2021 included biologic-naïve and biologic-experienced patients who initiated TREMFYA at or after enrollment.
• There were 113 patients diagnosed with PsA and treated with TREMFYA, of which 26% (29/113) had comorbid diabetes mellitus.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 03 April 2026.