SUMMARY

• The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
• Clinical studies have described the use of TREMFYA in patients with scalp psoriasis (PsO).^1-10

CLINICAL DATA

VISIBLE

McMichael et al (2023 and 2024)^1,2 and Alexis et al (2024)³ presented data at week 16 from VISIBLE, a phase 3b, large-scale, prospective, double-blind, randomized clinical trial evaluating the efficacy of TREMFYA compared with placebo in patients with moderate-to-severe plaque PsO who self-identify as non-White.

Study Design/Methods

• Adult patients (≥18 years of age) with skin PsO who self-identify as non-White, and all Fitzpatrick skin types (I-VI; as determined by colorimetry) were eligible for enrollment. Select inclusion criteria for each cohort were as follows⁴:

• • Cohort A: diagnosis of plaque PsO (with or without psoriatic arthritis [PsA]) for at least 6 months before the first administration of study drug; self-identify as non-white; candidate for phototherapy or systemic treatment for PsO; body surface area (BSA) involvement of ≥10%, psoriasis area and severity index (PASI) ≥12, investigator global assessment (IGA) ≥3 at screening and baseline.
  • Cohort B: scalp surface area ≥30%, psoriasis scalp severity index (PSSI) ≥12, scalp specific investigator global assessment (ss-IGA) ≥3, and at least one plaque outside of the scalp at screening and at baseline.
• Select exclusion criteria: non-plaque form of PsO (eg, erythrodermic, guttate, or pustular); receipt of ustekinumab, ixekizumab, secukinumab, or brodalumab within 12 weeks of first dose of study drug; history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances; history or current serious infection (eg, sepsis, pneumonia, pyelonephritis), or had been hospitalized or received intravenous antibiotics for an infection during the 2 months before screening.⁴
• The study design is shown in Figure: VISIBLE Study Design.

Results

Cohort A – Moderate to Severe Body Plaque Psoriasis

Patient Characteristics

• A total of 82 patients reported scalp PsO at baseline. Of these, 77 patients had at least mild scalp PsO (ss-IGA 2 [mild, 22.1%]; 3 [moderate, 63.6%]; and 4 [severe, 14.3%]), mean baseline PSSI score (0-72) of 21.2, mean scalp surface area (SSA) of 33% and mean scalp itch numeric rating scale (NRS; 0-10) of 6.9.^1,2
• Baseline disease and clinical characteristics of patients with scalp PsO in cohort A are given in Table: Select Baseline Disease and Clinical Characteristics of Cohort A.

Efficacy

• Scalp PsO outcomes at weeks 4, 12, and 16 are given in Table: Scalp PsO Results Among Patients with At Least Mild Scalp PsO at Baseline through Week 16.

Cohort B – Moderate to Severe Scalp Psoriasis

Patient Characteristics

• Cohort B included a total of 108 patients with 102 patients correctly randomized in the efficacy analysis population and all randomized patients (n=108) to the safety analysis population. Baseline characteristics are described in Table: Baseline Demographics and Disease Characteristics of Cohort B (Efficacy Analysis Set).

Efficacy

• At week 16, the coprimary endpoints of ss-IGA score of 0 or 1 and PSSI 90 were achieved by significantly more patients receiving TREMFYA (n=76; 68.4% and 65.8%, respectively) compared to placebo patients (n=26; 11.5% and 3.8%; P<0.001).
• Major secondary endpoints are described in Table: Major Secondary Endpoints of Cohort B at Week 16.

VOYAGE 1

Blauvelt et al (2017)⁶ assessed improvement in scalp PsO in the VOYAGE 1 trial (NCT02207231), a phase 3, randomized, double-blind, placebo and active comparator-controlled, multicenter study conducted at 101 global sites between December 2014 and April 2016, evaluating the efficacy and safety of TREMFYA compared to placebo and adalimumab in 837 patients with moderate to severe plaque PsO.

Study Design/Methods

• Adult patients (≥18 years of age) with a diagnosis of plaque PsO for ≥6 months who were candidates for phototherapy or systemic therapy and had a baseline Investigator Global Assessment (IGA) score ≥3, a Psoriasis Area and Severity Index (PASI) score ≥12, and ≥10% of their body surface area (BSA) involved were eligible for enrollment.

• The study design is shown in Figure: VOYAGE 1 Study Design.

• Improvement in scalp PsO was evaluated by ss-IGA (range from 0-4 [0, absence of disease; 1, very mild disease; 2, mild disease; 3, moderate disease; 4, severe disease]).

Results

Patient Characteristics

• Baseline scalp PsO characteristics are noted in Table: Baseline Scalp Psoriasis Characteristics - Randomized Patients in VOYAGE 1.

Efficacy

• Scalp PsO outcomes at weeks 16, 24, and 48 are noted in Table: Scalp Psoriasis Outcomes at Weeks 16, 24, and 48 - Randomized Patients in VOYAGE 1.
• The proportion of patients in the TREMFYA group achieving ss-IGA 0/1 (absent/very mild scalp PsO) was significantly higher compared with placebo (83.4% vs 14.5%, P<0.001) at week 16; significantly better responses to TREMFYA vs adalimumab were observed at weeks 24 and 48.

VOYAGE 2

Reich et al (2017)⁷ assessed improvement in scalp PsO in the VOYAGE 2 trial (NCT02207244), a phase 3, multicenter, randomized, double-blind, placebo and active comparator-controlled study conducted at 115 global sites between November 2014 and May 2016, evaluating the efficacy and safety of TREMFYA compared to placebo and adalimumab in 992 patients with moderate to severe plaque PsO.

Study Design/Methods

• Adult patients (≥18 years of age) with a diagnosis of plaque PsO for ≥6 months who were candidates for phototherapy or systemic therapy, and had a baseline IGA score ≥3, a PASI score ≥12, and ≥10% of their BSA involved were eligible for enrollment.
• The study design is shown in Figure: VOYAGE 2 Study Design.

• Improvement in scalp PsO was evaluated by ss-IGA.

Results

Patient Characteristics

• Baseline scalp PsO characteristics are noted in Table: Baseline Scalp Psoriasis Characteristics - Randomized Patients in VOYAGE 2.

Efficacy

• Scalp PsO outcomes at weeks 16 and 24 are noted in Table: Scalp Psoriasis Outcomes at Weeks 16 and 24 - Randomized Patients in VOYAGE 2.
• Patients treated with TREMFYA achieved greater improvement in ss-IGA score 0/1 compared with placebo at week 16.
• Greater improvements in ss-IGA score 0/1 were observed at week 24 in patients receiving TREMFYA vs adalimumab.

Sonkoly et al (2022)⁸ evaluated efficacy of TREMFYA in a post hoc analysis of VOYAGE 2 in patients with moderate to severe PsO and scalp disease at baseline.

Study Design/Methods

• For the VOYAGE 2 study design, please refer to Figure: VOYAGE 2 Study Design.
• Patients randomized to receive TREMFYA with moderate to severe PsO and scalp disease at baseline were assigned to the following groups:
  • TREMFYA R Continuation included patients with a ≥90% improvement in PASI (PASI 90) response at week 28 and randomized to continue TREMFYA treatment (n=159)
  • TREMFYA NR Continuation included patients without a PASI 90 response at week 28 and continued TREMFYA treatment (n=84)
  • TREMFYA R Withdrawal included patients with a PASI 90 response at week 28 and re-randomized to placebo (n=164)
• Total PASI (range: 0–72), PASI head (range: 0–7.2), ss-IGA (range: 0–4) and Dermatology Life Quality Index range (DLQI, range: 0–30) scores were assessed at weeks 0, 16, 24 and 48.

Results

Patient Characteristics

• A total of 496 patients were randomized to receive TREMFYA at baseline, of which 407 (82%) had scalp PsO. Baseline characteristics are noted in Table: Baseline Characteristics Among Patients Randomized to Receive TREMFYA with Scalp Psoriasis.

Efficacy

• Mean ss-IGA, PASI, and DLQI scores through week 48 are noted in Table: Clinical Outcomes through Week 48 – Post Hoc Analysis of VOYAGE 2.

POOLED EFFICACY ANALYSIS

Orbai et al (2023)⁹conducted a post hoc analysis evaluating the efficacy of TREMFYA on regional PsO in a subgroup of patients with self-reported psoriatic arthritis (PsA) from VOYAGE 1 and VOYAGE 2.

Study Design/Methods

• For the VOYAGE 1 and VOYAGE 2 study designs, please refer to Figures: VOYAGE 1 Study Design and VOYAGE 2 Study Design.
• The coprimary endpoints in both studies were IGA 0/1 and PASI 90 at week 16. Improvement in scalp PsO was assessed using ss-IGA at weeks 16 and 24.

Results

Patient Characteristics

• Of total 1829 patients randomized in VOYAGE 1 and VOYAGE 2, 153, 106, and 76 in the TREMFYA, adalimumab, and placebo groups, respectively, self-reported having PsA (pooled PsA cohort).
• Baseline characteristics were comparable across the treatment groups,¹¹ see Table: Select Baseline Demographics and Clinical Characteristics of Patients with Self-Reported PsA in the Pooled Analysis.

Efficacy

• The proportion of patients achieving ss-IGA 0/1 (clear/very mild) and ss-IGA 0 at weeks 16 and 24 is given in Table: Proportion of Patients Achieving an ss-IGA 0/1 and ss-IGA 0 at Week 16 and Week 24.

Jo et al (2023)¹⁰ conducted a post hoc analysis evaluating the efficacy of TREMFYA for the treatment of PsO in difficult-to-treat regions, specifically in the Asian subpopulation (Taiwan and South Korea) from VOYAGE 1 and VOYAGE 2.

Study Design/Methods

• For the VOYAGE 1 and VOYAGE 2 study designs, please refer to Figures: VOYAGE 1 Study Design and VOYAGE 2 Study Design.
• The TREMFYA and adalimumab groups were compared with the placebo group at week 16, and the active treatment groups (TREMFYA vs adalimumab) were compared at week 24. Patients who crossed over from placebo to TREMFYA were excluded from the week 24 analysis.
• Efficacy was also evaluated in a pooled subset of patients with or without prior biologic experience from baseline through week 24.
• Endpoint included the proportion of patients achieving clear/near-clear status (scores of 0/1) for ss-IGA (used for grading scalp PsO) at weeks 16 and 24.

Results

Patient Characteristics

• Among the 1829 patients randomized in VOYAGE 1 and VOYAGE 2, 257 were Asian patients of which, 199 were eligible for inclusion in this study.
• Baseline demographics and disease characteristics are summarized in Table: Select Baseline Demographics and Disease Characteristics of Randomized Asian Patients.

Efficacy

• The proportion of Asian patients achieving ss-IGA 0/1 (clear/very mild) and ss-IGA 0 at weeks 16 and 24 is given in Table: Proportion of Asian Patients Achieving an ss-IGA 0/1 and ss-IGA 0 for Regional PsO at Weeks 16 and 24.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 09 March 2024.