DISCREET phase III post hoc analysis: Apremilast in patients with moderate-to-severe genital psoriasis

Results from a post hoc analysis of the multicenter, randomized phase III DISCREET trial (NCT03777436), evaluating apremilast in patients with moderate-to-severe genital psoriasis (N = 289), were published in the Journal of the European Academy of Dermatology and Venereology by Merola et al. Week 32 results were previously reported by the PsOPsA Hub. Post hoc analyses included outcomes by sex and agreements between clinical and quality of life (QoL) improvements.  

Key data: A total of 229 patients entered the apremilast extension phase (male, 70.3%; female, 29.7%), with 201 patients completing 32 weeks of treatment. Full genital skin clearance at Week 32 was demonstrated in 29.9% of patients overall, 31.9% of patients in the placebo/apremilast group (n = 97), and 28.2% of patients in the apremilast/apremilast group (n = 104). Dermatology Life Quality Index (DLQI) scores ≤1 were demonstrated by 27.4% of patients overall at Week 32. Both male and female patients experienced QoL improvements with apremilast; at Week 32, 44.7% of males and 48.5% of females had a modified genital Physician’s Global Assessment (PGA) response, 28.6% and 39.7% had an overall static (s)PGA response, and 42.0% and 58.5% had a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) responses. At Week 32, mean DLQI change from baseline was −5.6 for male patients and −9.3 for female patients. Agreement between clinical and QoL improvements was greatest with GPI-NRS response, with 20.2% of patients demonstrating a GPI-NRS response and a DLQI score ≤1 at Week 32.  

Key learning: Apremilast demonstrated consistent QoL improvements over 32 weeks in both male and female patients with moderate-to-severe genital psoriasis. While greater improvements were observed in female patients, the majority of patients in this study were male, which may have impacted the results of the subgroup analysis. These findings support apremilast as an effective oral systemic therapy for the treatment of moderate-to-severe genital psoriasis