Summary

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to the local labeling for clinical data on the use of TREMFYA in adult patients with moderate to severe plaque psoriasis (PsO).
• The VOYAGE 2 study, a phase 3, randomized, double-blind, placebo- and active comparator-controlled clinical trial, evaluated the efficacy and safety of TREMFYA in patients with moderate to severe plaque PsO. Analyses from the VOYAGE 2 study in patients with a medical history or current diagnosis of depression were included.¹ Data specific to Hospital Anxiety and Depression Scale-Depression (HADS-D) is summarized below.
• An analysis from the VOYAGE 2 study evaluated the improvement in symptoms of anxiety and depression with TREMFYA vs placebo and adalimumab from baseline through week 24 in patients with moderate-to-severe plaque PsO.²
  • At weeks 8 and 16, a significantly greater improvement in the HADS-D score was observed in patients treated with TREMFYA vs placebo (P<0.001).
  • At week 24, a greater improvement in the HADS-D score was observed in patients treated with TREMFYA vs adalimumab (P=0.06).
• Two additional analyses reported improvement in HADS-D scores from the VOYAGE 2 study.
  • Improvement in HADS-D score was observed with continuous treatment with TREMFYA through week 204. At baseline, 27.7% of all patients had depression (HADS-D score of ≥8), and among patients treated with TREMFYA, 16.6% and 21.0% had depression at weeks 100 and 204, respectively.³
  • At week 100, 56.8% of patients with a baseline HADS-D score of ≥8 reported an HADS-D score of <8, and the results were maintained through week 252.⁴

clinical data

VOYAGE 2: Results through Week 24

Gordon et al (2018)² presented results from the VOYAGE 2 study on improvement in symptoms of anxiety and depression with TREMFYA vs placebo and adalimumab from baseline through week 24 in patients with moderate-to-severe plaque PsO.

Study Design/Methods

• Patients were randomized (2:1:1) to receive TREMFYA (100 mg subcutaneously [SC] at weeks 0, 4, 12, and 20), placebo (at weeks 0, 4, and 12 followed by TREMFYA 100 mg SC at weeks 16 and 20), or adalimumab (80 mg SC at week 0, 40 mg at week 1, and 40 mg every 2 weeks [q2w]) through week 23.
• Hospital Anxiety and Depression Scale (HADS), which consists of 2 subscales measuring patient-reported anxiety (Hospital Anxiety and Depression Scale-Anxiety [HADS-A]) and depression (HADS-D), was used to assess anxiety and depression. The scores range from 0 to 21, with higher scores indicating more severe symptoms.
  • Patients with an HADS-D score of ≥8 were identified to have mild symptoms, and those with an HADS-D score of ≥11 were identified to have severe clinical symptoms.

Results

• A total of 992 patients were randomized to each treatment group. The mean HADS-D scores were similar between the treatment groups; see Table: Baseline HADS-D Scores.
• At baseline, 3.7% of patients reported use of antidepressant medication and 2.4% used benzodiazepines.

• At weeks 8 and 16, a significantly greater improvement in the HADS-D score was observed in patients treated with TREMFYA vs placebo (P<0.001).
• At week 24, a greater improvement in the HADS-D score was observed in patients treated with TREMFYA vs adalimumab (P=0.06); see Table: Change in the HADS-D Scores from Baseline at Weeks 8, 16, and 24.

• Among patients treated with TREMFYA vs placebo, 59.2% vs 27% with a baseline HADS-D score of ≥8 achieved an HADS-D score of <8 at week 16 (P<0.001); see Table: HADS-D Scores at Weeks 16 and 24 in Patients with a Baseline HADS-D Score of <8 or ≥8 and <11 or ≥11.

• During the 16-week placebo-controlled period, 1 (0.2%) patient in the TREMFYA group reported an adverse event (AE) of generalized anxiety disorder and 2 (0.8%) patients in the adalimumab group and none in the placebo group reported an AE of anxiety.
  • No events of depression, suicidal ideation, or suicidal behavior were reported in the TREMFYA group. One (0.4%) event of suicide attempt was reported in the adalimumab group.
  • One (0.2%) event of suicidal ideation was reported in the TREMFYA group during the 28-week active comparator-controlled period.
  • Both AEs in the TREMFYA group were non-serious, moderate in severity, and did not result in treatment discontinuation.

VOYAGE 2: HADS-D Results through Week 204

Reich et al (2020)³ presented results from the VOYAGE 2 study on the maintenance of responses, including impact of moderate to severe plaque PsO on HRQoL, with continuous treatment with TREMFYA through week 204.

• At baseline, 27.7% of all patients had depression (HADS-D score of ≥8), and among patients treated with TREMFYA, 16.6% and 21.0% had depression at weeks 100 and 204, respectively.
  • Among patients who crossed over from adalimumab to TREMFYA (adalimumab→TREMFYA), 15.6% had depression at week 204.

VOYAGE 2: HADS-D Results through Week 252

Reich et al (2021)⁴ reported results from the VOYAGE 2 study on improvements in HRQoL, anxiety and depression, and work productivity through week 252 of treatment with TREMFYA.

• At week 100, 56.8% of patients with a baseline HADS-D score of ≥8 reported an HADS-D score of <8, and the results were maintained through week 252; see Table: Proportion of Patients Achieving an HADS-D Score of <8 at Weeks 100 and 252.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 02 April 2024.