Anxiety and depression in patients with moderate-to-severe psoriasis and comparison of change from baseline after treatment with guselkumab vs. adalimumab: results from the Phase 3 VOYAGE 2 study

Abstract

Background: Anxiety and depression are clinically significant comorbidities associated with psoriasis. Improvements in psoriasis are known to decrease anxiety and depression. Guselkumab, an anti-interleukin-23 monoclonal antibody, has demonstrated efficacy and safety for the treatment of moderate-to-severe psoriasis.

Objective: Assess improvements in anxiety and depression with guselkumab vs. placebo and adalimumab using the Hospital Anxiety and Depression Scale (HADS).

Methods: In VOYAGE 2, a Phase 3, randomized, double-blind, placebo- and adalimumab-controlled study, patients received placebo (through week 16 followed by crossover to guselkumab), guselkumab, or adalimumab through week 24. HADS consists of two subscales measuring anxiety (HADS-A) and depression (HADS-D), with scores ranging from 0 to 21 and higher scores indicating more severe symptoms. Scores ≥8 indicate instrument-defined anxiety or depression. Severity of psoriasis was assessed using the Psoriasis Area and Severity Index (PASI).

Results: Among 989 patients randomized (with baseline HADS measurements), mean HADS-A and HADS-D scores were 6.8 ± 4.2 and 5.3 ± 4.2, respectively; 38.6% of patients reported HADS-A ≥8 and 27.7% HADS-D ≥8 at baseline. At week 16, a significantly greater proportion of guselkumab patients with baseline HADS-A or HADS-D ≥8 reported HADS-A <8 (51.4% vs. 25.9%; P < 0.001) or HADS-D <8 (59.2% vs. 27.0%; P < 0.001) vs. placebo patients. At week 24, a greater proportion of guselkumab patients with baseline HADS-A or HADS-D ≥8 reported HADS-A <8 (58.4% vs. 42.9%; P = 0.028) or HADS-D <8 (59.8% vs. 46.4%; P = 0.079) vs. adalimumab patients. PASI improvements correlated with improvement in anxiety (r = 0.27; P < 0.0001) and depression (r = 0.25; P < 0.0001) scores in patients with baseline HADS-A or HADS-D ≥8. Greater improvements in HADS were also observed at week 16 in guselkumab-treated patients vs. placebo using a more stringent cut-off of HADS ≥11.

Conclusion: Guselkumab treatment was associated with greater improvements in symptoms of anxiety and depression scores in patients with psoriasis compared with placebo and adalimumab.