SUMMARY  

• Please refer to your local labeling for relevant information on the use of TREMFYA in patients 65 years of age and older.
• Ruggiero et al (2022) reported results from an Italian single center retrospective study evaluating the efficacy and safety of TREMFYA, risankizumab and tildrakizumab in psoriasis (PsO) patients aged 65 years and older.¹
• A subgroup analysis based on baseline age was conducted on patients with moderate to severe PsO from the ECLIPSE study at week 48.²
• Data from subgroup analyses of patients with moderate to severe plaque 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 28.³
  • 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 156.⁴

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.⁵

PHARMACOKINETIC PROPERTIES

Special Populations - Elderly (65 years of age and older)

Of the 1384 plaque psoriasis 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 746 psoriatic arthritis patients exposed to TREMFYA in phase 3 clinical studies and included in the pop PK analysis, a total of 38 patients were 65 years of age or older, and no patients were 75 years of age or older. Pop PK analyses indicated there were no apparent changes in CL/F estimate in subjects ≥65 years of age compared to subjects <65 years of age, suggesting no dose adjustment is needed for elderly patients.⁵

CLINICAL DATA

Retrospective Study

Ruggiero et al (2022)¹ reported results from an Italian single-center retrospective study evaluating the efficacy and safety of TREMFYA, risankizumab and tildrakizumab in patients with plaque PsO aged 65 years and older.

Study Design/Methods

• Patients aged ≥65 years with moderate to severe plaque PsO who were treated with TREMFYA, risankizumab, or tildrakizumab, were enrolled. Patients were expected to receive TREMFYA treatment for a minimum of 40 weeks.
• PsO severity was assessed using the Psoriasis Area and Severity Index (PASI) at weeks 4, 28, and 40.

Results

• A total of 34 patients were enrolled in the study.
• Baseline characteristics of patients treated with TREMFYA that were included in the study are summarized in Table: Baseline Characteristics of Patients Treated with TREMFYA.

Efficacy

• At week 4, 6 patients (30%) treated with TREMFYA achieved PASI 90 and 2 patients (10%) achieved PASI 100.
• At week 28, 13 patients (65%) treated with TREMFYA achieved PASI 90 and 6 patients (30%) achieved PASI 100.
• At week 40, 15 patients (75%) treated with TREMFYA achieved PASI 90 and 11 patients (55%) achieved PASI 100.

Safety

• Two patients (10%) treated with TREMFYA reported pharyngitis and one patient (5%) each reported influenza like illness, headache, and diarrhea as an adverse event.
• One patient discontinued the study due to a diagnosis of bladder cancer 18 weeks after starting TREMFYA.

Prospective Studies

Blauvelt et al (2022)² 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 in a 1:1 ratio 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% 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)

Reich et al (2020)³assessed 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 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 placebo.
• 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 placebo 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 was 87.8%, 75.6% and 46.3%, respectively. In the placebo 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 was 90.1%, 77.3% and 44.1%, respectively. In the placebo 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 0 were 80.5% and 39.0%, respectively. In the placebo 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 0 was 84.7% and 45.4%, respectively. In the placebo group (n=403), 7.9% of patients achieved an IGA score of 0/1 and 1.0% 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 0 were 80.5% and 46.3%, respectively. In the placebo 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 0 was 83.9% and 52.4%, respectively. In the placebo 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 2).

Blauvelt et al (2019)⁴ 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.

• 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.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 10 May 2024.