TREMFYA - Use in Patients 65 Years of Age and Older

SUMMARY

• Please refer to your local labeling for relevant information on the use of TREMFYA in patients 65 years of age and older.
• Data from subgroup analyses of patients with moderate to severe plaque psoriasis (PsO) from VOYAGE 1 and VOYAGE 2 are summarized.
  • Reich et al (2020) assessed the efficacy and safety of TREMFYA in subgroups of patients by baseline age (≥65 years, n=87; <65 years, n=1,742) from the VOYAGE 1 and VOYAGE 2 studies through week 28.¹
  • Blauvelt et al (2019) examined the long-term response observed in subgroups of patients treated with TREMFYA with a baseline age of <45 years, 45-65 years, and ≥65 years at week 156.²
• A subgroup analysis based on baseline age was conducted in patients with moderate to severe PsO from the ECLIPSE study at week 48.³
• Hacınecipoğlu et al (2025) conducted a retrospective analysis evaluating early, mid‑term, and long‑term Psoriasis Area and Severity Index (PASI) responses in patients aged <65 years and ≥65 years treated with interleukin (IL)-17 and IL‑23 inhibitors (including TREMFYA).⁴
• Levavi et al (2025) conducted a single-center, retrospective study evaluating drug survival of TREMFYA in elderly patients with PsO.⁵
• Chiricozzi et al (2024) evaluated the drug survival rates of IL‑17 and IL-23 inhibitors, including TREMFYA, in subgroups of patients aged ≥65 years with plaque PsO from a retrospective, multicentric, multi-country, cohort study.^6,7

COMPANY CORE DATA SHEET

CLINICAL INFORMATION

Special Populations - Elderly (65 Years of Age and Older)

No overall differences in safety or effectiveness were observed between older and younger patients who received TREMFYA in clinical studies. However, the number of patients aged 65 years and older was not sufficient to determine whether they respond differently from younger patients.⁸

PHARMACOKINETIC PROPERTIES

Special Populations - Elderly (65 Years of Age and Older)

Of the 1384 plaque PsO patients exposed to TREMFYA in phase 3 clinical studies and included in the population pharmacokinetic (pop PK) analysis, 70 patients were 65 years of age or older, including 4 patients who were 75 years of age or older. Of the 1411 psoriatic arthritis (PsA) patients exposed to TREMFYA in phase 3 clinical studies and included in the pop PK analysis, a total of 165 patients were 65 years of age or older, and 15 patients were 75 years of age or older. Pop PK analyses indicated there were no apparent changes in oral clearance estimate in subjects ≥65 years of age compared to subjects <65 years of age, suggesting no dose adjustment is needed for elderly patients.⁸

CLINICAL DATA

Prospective Studies

Reich et al (2020)¹assessed the efficacy and safety of TREMFYA in subgroups of patients by baseline age (≥65 years, n=87; <65 years, n=1,742) from the VOYAGE 1 and VOYAGE 2 studies through week 28.

• In the VOYAGE 1 (n=837) and VOYAGE 2 (n=992) studies, patients with moderate to severe plaque PsO were randomized at baseline as follows:
  • TREMFYA 100 mg subcutaneously (SC) at weeks 0, 4 and 12, then every 8 weeks (n=825 pooled).
  • Placebo (PBO) at weeks 0, 4 and 12 followed by a crossover to TREMFYA 100 mg SC at weeks 16, and 20, then every 8 weeks (n=422 pooled).
  • Adalimumab 80 mg SC at week 0, 40 mg at week 1, then 40 mg every 2 weeks through week 47 (VOYAGE 1) or week 23 (VOYAGE 2) (n=582 pooled).
• Efficacy was evaluated using PASI 75, PASI 90, PASI 100 and Investigator’s Global Assessment (IGA) score of cleared or minimal (0/1) or IGA score of cleared (0).
• Among baseline subgroups categorized by age, there were 1742 patients <65 years of age and 87 patients ≥65 years of age.
  • The mean age of patients ≥65 years (n=87) was 68.3 ± 3.79 years.
• Of the 87 patients ≥65 years of age, 41 were randomized to TREMFYA, 27 to adalimumab, and 19 to PBO.
• At week 16, the proportion of patients receiving TREMFYA (n=41) ≥65 years of age who achieved a PASI score of 75/90/100 was 85.4%, 68.3% and 34.1%, respectively. None of the patients randomized to PBO achieved a PASI score of 75/90/100.
  • The proportion of TREMFYA-treated patients (n=784) <65 years of age who achieved a PASI score of 75/90/100 was 88.4%, 71.4% and 35.5%, respectively.
• At week 24, the proportion of patients ≥65 years of age initially randomized to TREMFYA (n=41) who achieved a PASI score of 75/90/100 were 87.8%, 75.6% and 46.3%, respectively. In the PBO crossover to TREMFYA group (n=17), patients who achieved a PASI score of 75/90/100 were 88.2%, 11.8% and 5.9%, respectively.
  • The proportion of patients <65 years of age initially randomized to TREMFYA (n=784) who achieved a PASI score of 75/90/100 were 90.1%, 77.3% and 44.1%, respectively. In the PBO crossover to TREMFYA group (n=381), patients who achieved a PASI score of 75/90/100 were 78.5%, 49.1% and 19.4%, respectively.
• At week 16, patients ≥65 years of age in the TREMFYA-treated group (n=41) who achieved an IGA score of 0/1 and IGA score of 0 were 80.5% and 39.0%, respectively. In the PBO group (n=19), 5.3% of patients achieved an IGA score of 0/1 and no patients achieved an IGA score of 0.
  • The proportion of TREMFYA-treated patients (n=784) <65 years of age who achieved an IGA score of 0/1 and IGA score of 0 were 84.7% and 45.4%, respectively. In the PBO group (n=403), 7.9% of patients achieved an IGA score of 0/1 and 1.0% of patients achieved an IGA score of 0.
• At week 24, patients ≥65 years of age in the TREMFYA-treated group (n=41) who achieved an IGA score of 0/1 and IGA score of 0 were 80.5% and 46.3%, respectively. In the PBO crossover to TREMFYA group (n=17), 82.4% of patients achieved an IGA score of 0/1 and 11.8% achieved an IGA score of 0.
  • The proportion of TREMFYA-treated patients (n=784) <65 years of age who achieved an IGA score of 0/1 and IGA score of 0 were 83.9% and 52.4%, respectively. In the PBO crossover to TREMFYA group (n=381), 76.6% achieved an IGA score of 0/1 and 28.1% achieved an IGA score of 0.
• The safety profile of patients ≥65 years and <65 years of age is depicted in the Table: AEs through Week 28 in Patients ≥65 Years and <65 Years of Age (Pooled VOYAGE 1 and VOYAGE 2).

Blauvelt et al (2019)² examined the long-term response observed in subgroups of patients treated with TREMFYA with a baseline age of <45 years, 45-65 years, and ≥65 years at week 156.

• The VOYAGE 1 and VOYAGE 2 studies included 837 and 992 randomized patients, respectively.
• IGA 0/1 response rates were observed at week 100 and 156, respectively, in subgroups of patients <45 years (83.5% [n=577], 82.3% [n=541]), 45-65 years (83.3% [n=473], 84.9% [n=451]), and ≥65 years (77.4% [n=53], 66.0% [n=50]) of age.

Blauvelt et al (2022)³ conducted a subgroup analysis based on baseline age on patients with moderate to severe PsO from the ECLIPSE study at week 48.

• The ECLIPSE study was a phase 3, 56-week active comparator study of TREMFYA vs secukinumab in patients with moderate to severe PsO.
• Patients were randomized (1:1) to receive:
  • TREMFYA 100 mg SC (n=534) at weeks 0, 4, 12, and every 8 weeks thereafter through week 44.
  • Secukinumab 300 mg SC (n=514) administered as two 150 mg injections at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter through week 44.
• Efficacy was assessed at week 48 based on baseline subpopulations including age and was determined by PASI 90, PASI 100, IGA 0/1 and IGA 0.
• Of the patients treated with TREMFYA who were ≥65 years of age, 81.5% (n=54) achieved PASI 90 and 53.7% (n=54) of patients achieved PASI 100 at week 48.
• IGA 0/1 responses for TREMFYA vs secukinumab at week 48 were:
  • <45 years: 85.8% vs 81.3%, (95% confidence interval [CI], -2.4 to 11.5)
  • 45 to <65 years: 85.4% vs 73.4%, (95% CI, 4.1-19.9)
  • ≥65 years: 79.6% vs 44.4%, (95% CI, 15.1-55.3)
• IGA 0 responses for TREMFYA vs secukinumab at week 48 were:
  • <45 years: 64.6% vs 58.0%, (95% CI, -2.5 to 15.6)
  • 45 to <65 years: 61.4% vs 46.4%, (95% CI, 5.5-24.5)
  • ≥65 years: 55.6% vs 24.4%, (95% CI, 10.8-51.4)

Retrospective Studies

Hacınecipoğlu et al (2025)⁴ conducted a single-center, retrospective study evaluating early (12 weeks for IL-17 inhibitors and 16 weeks for IL-23 inhibitors), mid-term (24 weeks), and long-term (52 weeks) PASI responses in patients aged <65 years versus ≥65 years treated with IL-17 and IL-23 inhibitors.

Study Design/Methods

• This study included adult patients in Turkey with moderate to severe plaque PsO treated with an IL-17 inhibitor (secukinumab or ixekizumab) or an IL-23 inhibitor (TREMFYA or risankizumab).
• Patients with documented baseline PASI scores and ≥1 follow-up assessment (at 12/16, 24, or 52 weeks) were stratified into 2 groups (<65 years, n=78; ≥65 years, n=43).
• Primary endpoints: Proportion of patients achieving PASI 75 and PASI 90 responses.
• Selected secondary endpoints:
  • Proportion of patients achieving an absolute PASI <2
  • Rates of adverse events (AEs)

Results

• A total of 121 patients were included in the study. Of these, 64.5% (78/121) were aged <65 years and 35.5% (43/121) were aged ≥65 years. Baseline characteristics of PsO patients are summarized in Table: Selected Baseline Characteristics by Age Group.

• PASI response rates at 16, 24, and 52 weeks in patients treated with TREMFYA are provided in Table: Early, Mid-Term, and Long-Term PASI Response Rates in Patients Treated with TREMFYA.

Safety

• For a detailed summary of AEs in both groups, see Table: AEs of IL-17 and IL-23 Inhibitors.

Levavi et al (2025)⁵ conducted a single-center, retrospective cohort study evaluating drug survival of TREMFYA in elderly patients with PsO.

Study Design/Methods

• Patients with PsO (aged>65 years) were included if they had received biologic therapy or apremilast.
• Patients were stratified based on their age at biologic treatment initiation, irrespective of their current age, into an adult-start group (<65 years) and an elderly-start group (≥65 years).
• Inclusion criteria:
  • Aged >65 years at the time of data collection
  • Diagnosed with PsO (confirmed by a dermatologist)
  • Treatment with a biologic agent or apremilast

Results

• A total of 149 patients were included in the study, with 83 patients in the elderly-start group and 66 patients in the adult-start group.
• The elderly-start group was subcategorized based on age at biologic treatment initiation as follows:
  • 65-70 years: n=50
  • 70-75 years: n=17
  • >75 years: n=16
• There were no notable differences in the baseline demographics or prevalence of comorbidities at baseline between the 2 groups.
• In the elderly-start group, the mean (SD) age at onset of biologic treatment was 70.3 (4.9).

Drug Survival

• Patients receiving TREMFYA in any treatment sequence exhibited a longer treatment duration in the elderly-start group (P=0.032), particularly among those aged >75 years (P=0.046).

Safety

• AEs in the adult-start group and elderly-start group are summarized in Table: AEs in Elderly-Start Group and Adult-Start Group.

Chiricozzi et al (2024)^6,7 evaluated the drug survival rates of IL-17 and IL-23 inhibitors, including TREMFYA, in subgroups of patients aged ≥65 years with plaque PsO from a retrospective, multicentric, multi-country, cohort study.

Study Design/Methods

• Patients aged ≥65 years with moderate to severe chronic plaque PsO who were treated with an IL-17 inhibitor (secukinumab, ixekizumab, brodalumab) or an IL-23 inhibitor (TREMFYA, tildrakizumab, risankizumab), either as first-line biological treatment or as switching option, were enrolled.
• The primary outcome was the cumulative probability of drug survival for each biologic agent.
• Drug survival was defined as the duration from the initiation of treatment to the withdrawal of treatment (due to lack or loss of effectiveness, safety, patient decision, loss of follow-up, or other reasons) or last clinical observation.

Results

• A total of 4178 patients for 4866 treatment courses were included in the study. Of these, 934 patients were ≥65 years of age (defined as elderly; 1072 treatment courses) and 3244 patients were <65 years of age (defined as younger; 3794 treatment courses). For details, see Table: Selected Baseline Characteristics of Elderly Patients (Aged ≥65 years).

• In elderly patients, IL-23 inhibitors showed superior drug survival compared to IL-17 inhibitors when all causes of discontinuation were considered (log-rank P=0.004); see Figure: Cumulative Probability of Drug Survival for IL-23 Inhibitors Versus IL-17 Inhibitors in Patients Aged ≥65 Years Considering all Causes of Interruption.

• At 24 months, the highest cumulative probabilities of drug survival were reported with TREMFYA (0.85; 95% CI, 0.79-0.90) and risankizumab (0.82; 95% CI, 0.73-0.93), while the lowest were reported for secukinumab (0.74; 95% CI, 0.69-0.79) and ixekizumab (0.77; 95% CI, 0.72-0.83); see Table: Cumulative Probability of Drug Survival of IL-23 and IL-17 Inhibitors at Week 24 in Patients Aged 65 Years.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 05 March 2026.

Summarized in this response are data available from prospective and retrospective studies (total population ≥100 patients) that evaluated the use of TREMFYA in patients 65 years of age and older.