Patient‐reported symptoms and signs of moderate‐to‐severe psoriasis treated with guselkumab or adalimumab: results from the randomized VOYAGE 1 trial

Abstract

BackgroundHow patients experience the symptoms/signs of psoriasis is highly relevant for assessing treatment response.ObjectivesCompare outcomes with guselkumab, placebo and adalimumab utilizing the novel, validated Psoriasis Symptoms and Signs Diary (PSSD).Methods VOYAGE 1 is an ongoing, phase III, double‐blinded, controlled trial of patients with moderate‐to‐severe psoriasis. Patients were randomized to guselkumab 100 mg every 8 weeks; placebo‐to‐guselkumab 100 mg every 8 weeks; or adalimumab 40 mg every 2 weeks. The PSSD was self‐administered to assess symptoms (i.e. itch, skin tightness, burning, stinging and pain) and signs (i.e. dryness, cracking, scaling, shedding/flaking, redness and bleeding) of psoriasis (0–10 [absent‐to‐worst‐imaginable]) every 24 h. Symptom and sign summary scores were derived (0–100) based on average scores of the individual symptoms and signs. Proportions of patients with clinically meaningful improvements and symptom‐ and sign‐free scores of 0 were evaluated across treatment groups at weeks 16, 24 and 48.ResultsAt baseline, 652 of 837 randomized patients had PSSD scores. The proportion of patients achieving clinically meaningful improvements in PSSD summary scores was significantly higher in the guselkumab group compared with the placebo group at week 16 (P < 0.001) and compared with the adalimumab group at weeks 24 (P = 0.002) and 48 (P < 0.001). The proportions of patients achieving PSSD symptom and sign summary scores of 0 (i.e. symptom‐ and sign‐free) were significantly higher for guselkumab vs. placebo at week 16 and vs. adalimumab at weeks 24 and 48 (all P < 0.001).ConclusionsBased on PSSD scores, greater improvements in symptoms and signs of psoriasis were reported by patients treated with guselkumab compared with placebo at week 16 or adalimumab through 48 weeks.

European S2k Guideline on Chronic Pruritus

“…Pruritus-reducing effects of biologic treatment on psoriatic pruritus have been reported (393)(394)(395)(396)(397)(398)(399)(400)(401). One single report of cases referred to persistent CP (402).…”

Pruritus in Autoimmune and Inflammatory Dermatoses

“…Nevertheless, UVB phototherapy and cyclosporine were also noted to be effective. Some studies showed the favorable effects of ustekinumab (anti-IL12) (37) and anti-IL23 (38) on pruritus. A topical inhibitor of nerve growth factor (NGF) receptor has also been shown to be effective for the treatment of pruritus due to psoriasis (39).…”

Emerging Therapeutic Options for Chronic Pruritus

“…The efficacy and safety of guselkumab treatment for psoriasis was demonstrated in three phase III trials (VOYAGE 1, VOYAGE 2, NAVIGATE) [ 126 – 128 ]. Furthermore, Papp et al [ 129 ] revealed that patients receiving guselkumab ( n = 249) experienced higher improvement of itch severity (assessed using the Psoriasis Symptoms and Signs Diary) than in the placebo ( n = 129) and adalimumab ( n = 274) groups ( p < 0.001).…”