SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to the local labeling for information on the recommended dosing and administration of TREMFYA in patients with moderate to severe plaque psoriasis.
• A phase 3, randomized, double-blind, placebo-controlled, multicenter study conducted in Japan evaluated the efficacy and safety of TREMFYA vs placebo in 192 Japanese patients with moderate to severe plaque psoriasis.¹
• A phase 2, randomized, placebo/active comparator-controlled, multicenter, dose-ranging study of TREMFYA vs placebo or adalimumab was conducted in 293 adult patients with moderate to severe plaque psoriasis.²

CLINICAL DATA

Phase 3

Ohtsuki et al (2018)¹ reported results from a 52-week, phase 3, randomized, doubleblind, placebo-controlled, multicenter study conducted in Japan that evaluated the efficacy and safety of TREMFYA vs placebo in 192 Japanese patients with moderate to severe plaque psoriasis.

Study Design/Methods

• Adults (aged ≥20 years) with a diagnosis of moderate to severe plaque psoriasis for ≥6 months who were candidates for phototherapy or systemic therapy and had a Psoriasis Area and Severity Index (PASI) score of ≥12, an Investigator’s Global Assessment (IGA) score of ≥3, and an involved body surface area (BSA) of ≥10% at baseline were included in the study.
• The study consisted of a placebo-controlled period (weeks 0-16), placebo crossover and active treatment period (weeks 16-52), and long-term extension phase.
• Patients (N=192) were randomized (1:1:1) to receive TREMFYA 50 mg (n=65), TREMFYA 100 mg (n=63), or placebo (n=64), with subcutaneous (SC) injections at week 0, week 4, and every 8 weeks (q8w) thereafter. Patients receiving placebo were crossed over to receive (1:1) TREMFYA 50 mg (n=26) or 100 mg (n=26) at weeks 16 and 20 and q8w thereafter.
• The co-primary endpoints were assessed in a multiplicity-adjusted, fixed-sequence testing procedure.
  • Binary efficacy endpoints at week 16, except for psoriatic arthritis (PsA; eg, co-primary endpoints) were analyzed using Fisher’s exact test.
  • Continuous efficacy endpoints at week 16 were evaluated using ANCOVA with treatment as a factor and baseline as a covariate.
  • Categorical efficacy endpoints at week 16 with ≥2 levels were analyzed using the Cochran-Mantel-Haenszel test.
• Patients who discontinued TREMFYA because of lack of efficacy, a treatment emergent adverse event of worsening psoriasis or starting a protocol prohibited psoriasis treatment were considered nonresponders for binary endpoints or had baseline values carried forward for continuous endpoints.
• Last observation was carried forward for other patients with missing data.

Results

Baseline Characteristics

• Overall, 173 of 192 (90.1%) patients completed the study till week 52.
• Patients that received TREMFYA 50 mg (n=65; 67.76 kg ± standard deviation [SD] 15.02) had a lower mean body weight compared to those who received TREMFYA 100 mg (n=63; 74.27 kg ±SD 16.04) and placebo (n=63; 71.56 kg ±SD 14.01).

Efficacy

• Efficacy outcomes are described in Table: Efficacy Outcomes at Week 16 and Week 52 (All Randomized Patients).

Safety

• Safety events are described in Table: Safety Through Week 16 and Through Week 52 (Safety Analysis Set).

Phase 2

Gordon et al (2015)² reported results from X-PLORE, a 52-week, phase 2, randomized, placebo/active-comparator controlled, multicenter, dose-ranging study of TREMFYA vs placebo or adalimumab in 293 adult patients with moderate to severe plaque psoriasis.

Study Design/Methods

• Adults (≥18 years of age) with a diagnosis of plaque psoriasis for ≥6 months who were candidates for phototherapy or systemic therapy, had a baseline PASI score ≥12, and had ≥10% of their body surface area (BSA) involved were eligible.
• The study consisted of a screening phase (weeks -4 to 0), a treatment phase (weeks 0 to 40), and a follow-up phase through 1 year (weeks 40 to 52).
• At baseline, 293 patients were randomly assigned to receive subcutaneously administered placebo (42 patients), 1 of 5 TREMFYA regimens (5 mg at weeks 0 and 4 and every 12 weeks thereafter [41 patients], 15 mg q8w [41 patients], 50 mg at weeks 0 and 4 and every 12 weeks thereafter [42 patients], 100 mg q8w [42 patients], or 200 mg at weeks 0 and 4 and every 12 weeks thereafter [42 patients]), or adalimumab (80 mg at week 0 and 40 mg at week 1 and every other week thereafter through week 39 [43 patients]).
• At week 16, placebo patients crossed-over to receive TREMFYA 100 mg q8w with treatment continuing for all groups through week 40.

Results

Efficacy

• Efficacy outcomes are described in Table: Efficacy Outcomes at Week 16.

• Responses were generally maintained from week 24 to week 40.
• At week 40, the proportion of patients with a PGA score of 0 or 1 was higher in the 50mg, 100-mg, and 200-mg TREMFYA groups than in the adalimumab group: 71%, 77%, and 81%, respectively, vs 49%.

Safety

• Key safety events are described in Table: Key Safety Events From Weeks 0-16 (Placebocontrolled Period) and Weeks 16-52.

• Through week 16:
  • The proportions of patients reporting 1 or more adverse events (AEs) were similar across the treatment groups (placebo, 52% [22/42]; TREMFYA, 50% [103/207]; adalimumab, 56% [24/43]).
  • Infection was the most commonly reported AE (placebo, 14% [6/42]; TREMFYA, 20% [41/207]; adalimumab, 12% [5/43]).
  • Serious infections were reported in 2 patients in the 50-mg TREMFYA group (appendicitis and lung abscess).
  • Injection site reactions occurred in 1%, 1%, and 6% of patients in the placebo, TREMFYA, and adalimumab groups, respectively.
• Weeks 16 to 52
  • AEs were reported in 49% (115/235) of patients treated with TREMFYA and in 61% (23/38) of patients in the adalimumab group.
  • Infections were the most commonly reported AE (30% [70/235] of TREMFYA-treated patients and 37% [14/38] of adalimumab-treated patients). One serious infection (pneumonia) was reported in a patient treated with adalimumab.
  • One malignancy was reported through week 52 in a patient treated with TREMFYA.
  • There were 3 reports of major adverse cardiovascular events (1 in the TREMFYA 5 mg group and 2 in the TREMFYA 100 mg group). One death was reported from myocardial infarction.
  • Antibodies to guselkumab were detected in 6% (15/240) of patients with evaluable serum samples.
  • No events of anaphylaxis or serum sickness-like reactions were reported.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 31 January 2025.