Guselkumab for scalp psoriasis: Analysis of VOYAGE-2

Approximately 80% of individuals with psoriasis experience scalp involvement, which is associated with increased disease severity, and decreased quality of life.¹ Despite the available treatment options including topicals, phototherapy, systemic therapy, biologics, and oral small molecules, scalp psoriasis remains difficult-to-treat.¹ VOYAGE-2 was a phase III, multicenter, randomized trial, which evaluated guselkumab, anti-IL-23 antibody, compared with placebo and an active comparator (adalimumab).¹

Here, we summarize a post hoc analysis of VOYAGE-2 by Sonkoly et al.¹ published in Acta Dermato-Venereologica, that evaluated scalp response and its association with skin response and patient-reported outcomes.

Study design¹

• This analysis included three subsets of patients with scalp psoriasis:

1. 1. 1. Responder continuation group, who achieved a 90% improvement in the Psoriasis Area and Severity Index (PASI90) response at Week 28 and continued guselkumab
      2. Non-responder continuation group, who did not achieve a PASI90 response at Week 28 but continued guselkumab
      3. Responder withdrawal group, who achieved a PASI90 response at Week 28 and were re-randomized to placebo

• Skin efficacy was assessed by total PASI scores and scalp efficacy using the scalp-specific Investigator’s Global Assessment (ss-IGA).
• Patient-reported outcomes were measured using the Psoriasis Symptoms and Signs Diary (PSSD) and Dermatology Life Quality Index (DLQI).

Key findings¹

• A total of 407 patients with moderate-to-severe plaque psoriasis were included.

• • The majority of patients were male (71.8%). 
  • Mean ss-IGA of 2.9, the mean PASI scores and mean DLQI were similar across the subsets.

• Total PASI scores and head PASI scores improved from baseline to Week 24 across all subgroups.
• Mean ss-IGA scores improved from baseline to Week 24, and remained stable to Week 48 in all subgroups, while the scores worsened in the responder withdrawal group from Week 24 through Week 48 (Figure 1).
• Similarly, total PASI and head PASI scores remained stable from Week 24 to Week 48 across all subgroups apart from the responder withdrawal group.
• Mean PASI head score remained stable from Week 48 (0.1) to Week 252 (0.1) in the responder continuation group and improved in the non-responder continuation group (0.3 and 0.1 at Weeks 48 and 252, respectively).
  • In the responder withdrawal group, the mean PASI head score worsened after treatment withdrawal at Week 28 (0.1) through Week 48 (0.6) and improved slightly through Week 72 (0.5). After retreatment with guselkumab at Week 72, scores improved rapidly through Week 84 (0.1) and remained stable through Week 252 (0.1).
• Quality of life, as measured by DLQI, and PSSD itch scores, improved across all subgroups from baseline to Week 24.
• Within-subject correlations were 0.83 between ss-IGA and PASI head scores and 0.78 between ss-IGA and PSSD itch scores.

ss-IGA, scalp-specific Investigator’s Global Assessment.
*Data from Sonkoly, et al.¹

 

Key Learnings

Treatment with guselkumab resulted in improved skin and scalp outcomes, along with reduced itch and improved quality of life over 48 weeks. Scalp improvements were maintained through 5 years, including for patients who discontinued and resumed treatment. The study is limited by its post hoc nature and predominant use of descriptive statistics. Further studies with specific focus on scalp psoriasis are warranted.