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

ABSTRACT: 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.

SUBMITTER: Papp KA

PROVIDER: S-EPMC6174988 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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

Papp K A KA Blauvelt A A Kimball A B AB Han C C Randazzo B B Wasfi Y Y Shen Y-K YK Li S S Griffiths C E M CEM

Journal of the European Academy of Dermatology and Venereology : JEADV 20180410 9

<h4>Background</h4>How patients experience the symptoms/signs of psoriasis is highly relevant for assessing treatment response.<h4>Objectives</h4>Compare outcomes with guselkumab, placebo and adalimumab utilizing the novel, validated Psoriasis Symptoms and Signs Diary (PSSD).<h4>Methods</h4>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 eve ...[more]

PMID: 29512196

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Project description:BackgroundEpithelial surface disruption in genital psoriatic lesions may manifest as erosions, fissures and/or ulcers, causing pain and significantly impacting a patient's sexual health.ObjectiveTo evaluate the impact of erosions, fissures and/or ulcers in genital psoriatic lesions on pain and sexual activity in patients with moderate-to-severe genital psoriasis (GenPs) and treatment responses to ixekizumab vs. placebo until Week 12.MethodsThis post hoc subgroup analysis of patients presenting with and without erosions, fissures and/or ulcers in genital lesions from a phase IIIb multicentre, randomized, double-blind, placebo-controlled study (IXORA-Q; NCT02718898) in 149 adults with moderate-to-severe GenPs treated with subcutaneous ixekizumab (80 mg every 2 weeks; n = 75) or placebo (n = 74) evaluated outcomes for clinician-rated GenPs severity (static Physician's Global Assessment of Genitalia; sPGA-G) and patient-reported genital pain and itch (Genital Psoriasis Symptoms Scale; GPSS) and sexual health (Genital Psoriasis Sexual Frequency Questionnaire; GenPs-SFQ).ResultsAt baseline, 38% (n = 57) of patients presented with genital erosions, fissures and/or ulcers independent of overall body surface area involvement (<10% or ≥10%). These signs were associated with higher scores for disease severity (sPGA-G) and pain (GPSS) but not sexual health (GenPs-SFQ). Complete resolution of these signs was observed in 62% of ixekizumab-treated patients (25% for placebo) at Week 1 and 83% (21% for placebo) at Week 12. Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline.ConclusionIxekizumab led to rapid and sustained resolution of erosions, fissures and/or ulcers and significant improvements in GenPs severity, genital pain and sexual health. Ixekizumab may help to improve the well-being of patients with GenPs.

Dataset Information

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

Publications

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

Similar Datasets

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