SUMMARY  

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• The safety and efficacy of TREMFYA in adult patients with plaque psoriasis (PsO) was evaluated in five phase 3 multicenter, randomized, double-blind clinical studies (VOYAGE 1, VOYAGE 2, NAVIGATE, ORION, ECLIPSE). Patients with a history or current signs or symptoms of severe, progressive, or uncontrolled hematologic disturbances were excluded.^1-5
• The safety and efficacy of TREMFYA in adult patients with psoriatic arthritis (PsA) was evaluated in two phase 3 multicenter, randomized, double-blind clinical studies (DISCOVER-1, DISCOVER-2). Patients with a history or current signs or symptoms of severe, progressive, or uncontrolled hematologic disturbances were excluded.^6,7
• A post hoc analysis of pooled data from DISCOVER-1 and DISCOVER-2 assessed the effect of TREMFYA on anemia in patients with PsA through 1 year. The results are summarized below.⁸

CLINICAL DATA

DISCOVER-1 and DISCOVER-2 Pooled Analysis

Kavanaugh et al (2021)⁸ evaluated the effect of TREMFYA on anemia in a post hoc analysis of pooled data from DISCOVER-1 and DISCOVER-2 studies.

Study Design/Methods

• Patients with active PsA who were enrolled in DISCOVER-1 and DISCOVER-2 were assessed for mean hemoglobin (Hgb) levels and number of patients with anemia (Hgb<13.5 g/dL males; Hgb<12.0 g/dL females) through 52 weeks.  
• Patients were randomized to treatment with TREMFYA 100 mg every 4 weeks; TREMFYA 100 mg at week 0, week 4, and every 8 weeks; or placebo with crossover to TREMFYA 100 mg every 4 weeks at week 24.
• The binary endpoint was anemia responder status at week 24. Age, sex, swollen/tender joint count, and C-reactive protein (CRP) were also assessed.
• A logistic regression model estimated odds ratios (ORs) and 95% confidence interval (CI) for achieving anemia resolution (i.e., anemia at baseline but not week 24).

Results

• A total of 1074 patients were assessed in the post hoc analysis and 24% were anemic at baseline (136 male; 120 female).
• In the TREMFYA treatment groups, mean Hgb level increased by week 52, particularly among patients with anemia at baseline.
• Mean Hgb levels for patients treated with placebo through week 24 remained unchanged. Following crossover from placebo to TREMFYA at week 24, Hgb levels increased similarly to those who were randomized to receive TREMFYA.
• The proportion of patients meeting criteria for anemia decreased by week 24 (TREMFYA vs placebo in males: OR=0.38 [95% CI: 0.17-0.85]; TREMFYA vs placebo in females: OR=0.47 [95% CI: 0.24-0.92]).

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 24 January 2025.