Improvement in Patient-Reported Outcomes (Dermatology Life Quality Index and the Psoriasis Symptoms and Signs Diary) with Guselkumab in Moderate-to-Severe Plaque Psoriasis: Results from the Phase III VOYAGE 1 and VOYAGE 2 Studies.

Abstract

BACKGROUND:

Health-related quality of life (HRQoL) may be markedly impaired in patients with moderate-to-severe psoriasis.

OBJECTIVES:

Our objectives were to compare improvements in Dermatology Life Quality Index (DLQI) and Psoriasis Symptoms and Signs Diary (PSSD) scores between patients receiving guselkumab compared with placebo or adalimumab and to correlate these improvements with skin clearance.

METHODS:

Pooled phase III VOYAGE 1 and VOYAGE 2 data were evaluated through week 24. At baseline, patients were randomized to guselkumab 100 mg, placebo, or adalimumab 40 mg. At week 16, patients receiving placebo switched to guselkumab. Assessment measures included DLQI percent change from baseline, DLQI 0/1, DLQI minimal clinically important difference (MCID), individual domain scores, PSSD symptoms and signs score = 0, DLQI association with PSSD, Investigator's Global Assessment (IGA), and Psoriasis Area and Severity Index (PASI).

RESULTS:

Significantly greater improvements from baseline DLQI were observed with guselkumab versus placebo (weeks 8 and 16) and versus adalimumab (week 24; p < 0.001). The proportion of patients achieving DLQI 0/1 ("no impact") at week 24 was higher with guselkumab than with adalimumab (58.9 vs. 40.2%; p < 0.001), and more patients attained a ≥ 4-point reduction in DLQI (MCID) at this timepoint (p < 0.001). Changes in individual DLQI domains were significantly greater for patients receiving guselkumab than for those receiving adalimumab, and among patients with individual baseline domain scores = 3 or 6 (severest impact), more guselkumab recipients than those receiving adalimumab achieved a score = 0 across all domains at week 24. DLQI 0/1 scores were associated with a PSSD symptom or sign score = 0 (no impact) and greater improvement of PASI and IGA (week 24).

CONCLUSIONS:

Pooled VOYAGE 1/VOYAGE 2 data demonstrated that guselkumab was superior to adalimumab in improving HRQoL, which was associated with greater skin clearance.

CLINICAL TRIAL REGISTRATION:

NCT02207231 and NCT02207244.

• Authors: April W Armstrong, Kristian Reich, Peter Foley, Chenglong Han, Michael Song, Yaung-Kaung Shen, Yin You, Kim A Papp
• Journal: American journal of clinical dermatology (Am J Clin Dermatol) Vol. 20 Issue 1 Pg. 155-164 (Feb 2019) ISSN: 1179-1888 [Electronic] New Zealand
• PMID: 30417277 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Dermatologic Agents
• IL23A protein, human
• Interleukin-23 Subunit p19
• TNF protein, human
• Tumor Necrosis Factor-alpha
• guselkumab
• Adalimumab

Topics

• Adalimumab (pharmacology, therapeutic use)
• Adult
• Antibodies, Monoclonal (pharmacology, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Dermatologic Agents (pharmacology, therapeutic use)
• Drug Administration Schedule
• Female
• Humans
• Interleukin-23 Subunit p19 (antagonists & inhibitors, immunology)
• Male
• Middle Aged
• Patient Reported Outcome Measures
• Psoriasis (diagnosis, drug therapy, immunology)
• Quality of Life
• Severity of Illness Index
• Treatment Outcome
• Tumor Necrosis Factor-alpha (antagonists & inhibitors, immunology)