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Clinical Trial
. 2018 Sep;32(9):1515-1522.
doi: 10.1111/jdv.14910. Epub 2018 Apr 10.

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

K A Papp  1 , A Blauvelt  2 , A B Kimball  3 , C Han  4 , B Randazzo  4   5 , Y Wasfi  4 , Y-K Shen  4 , S Li  4 , C E M Griffiths  6
Affiliations
Clinical Trial

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

K A Papp et al. J Eur Acad Dermatol Venereol. 2018 Sep.

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.

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Figures

Figure 1
Figure 1
Study Schema.
Figure 2
Figure 2
Proportion of patients achieving a clinically meaningful improvement (≥40 points) in PSSD symptom and sign summary scores at (a) week 24 and (b) week 48. PSSD, Psoriasis Symptoms and Signs Diary.
Figure 3
Figure 3
Proportion of patients achieving PSSD symptom and sign summary scores of 0 at (a) week 24 and (b) week 48. PSSD, Psoriasis Symptoms and Signs Diary.
Figure 4
Figure 4
Mean improvements from baseline in PSSD (a) symptom and (b) sign summary scores in the placebo, guselkumab, placebo → guselkumab and adalimumab groups through week 48. PSSD, Psoriasis Symptoms and Signs Diary.
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References

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