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Background  How patients experience the symptoms/signs of psoriasis is highly relevant for assessing treatment response.    Objectives  Compare 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.    Results  At 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).    Conclusions  Based 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.

journal of the european academy of dermatology and venereology

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