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

Overview

Journal Am J Clin Dermatol

Specialty Dermatology

Date 2018 Nov 13

PMID 30417277

Citations 13

Authors

April W Armstrong

Kristian Reich

Peter Foley

Chenglong Han

Michael Song

Yaung-Kaung Shen

Yin You

Kim A Papp

Affiliations

Soon will be listed here.

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.

Citing Articles

TELEPROM Psoriasis: Enhancing patient-centered care and health-related quality of life (HRQoL) in moderate-to-severe plaque psoriasis.

Mercadal-Orfila G, Lopez Sanchez P, Pou Alonso A, Ibarra-Barrueta O, Monte-Boquet E, Borras Blasco J Front Med (Lausanne). 2024; 11:1465725.

PMID: 39720651 PMC: 11667264. DOI: 10.3389/fmed.2024.1465725.

Progression of Quality of Life in Patients with Plaque Psoriasis Who Achieved Three or More Years of Complete Skin Clearance with Guselkumab Treatment: a Post hoc Analysis of the VOYAGE 1 Clinical Trial.

Puig L, Costanzo A, de Jong E, Torres T, Warren R, Wapenaar R Dermatol Ther (Heidelb). 2024; 14(9):2539-2558.

PMID: 39153060 PMC: 11393255. DOI: 10.1007/s13555-024-01245-6.

Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials.

Armstrong A, Augustin M, Beaumont J, Pham T, Hudgens S, Gordon K Dermatol Ther (Heidelb). 2024; 14(8):2235-2248.

PMID: 39080153 PMC: 11333388. DOI: 10.1007/s13555-024-01224-x.

Automated Machine Learning Analysis of Patients With Chronic Skin Disease Using a Medical Smartphone App: Retrospective Study.

Bibi I, Schaffert D, Blauth M, Lull C, von Ahnen J, Gross G J Med Internet Res. 2023; 25:e50886.

PMID: 38015608 PMC: 10716771. DOI: 10.2196/50886.

Effectiveness of Biologics, Patient-Reported Outcomes, and Clinical Photography in a Subset of Patients with Moderate-to-Severe Psoriasis: Week 12 Results from the Psoriasis Study of Health Outcomes (PSoHO).

Travaglini M, Maul J, Kors C, Zaheri S, Gerwien J, Muller M Clin Cosmet Investig Dermatol. 2023; 16:2971-2983.

PMID: 37881205 PMC: 10595217. DOI: 10.2147/CCID.S426972.

References

Martin M, McCarrier K, Chiou C, Gordon K, Kimball A, Van Voorhees A . Early development and qualitative evidence of content validity for the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure of psoriasis symptom severity. J Dermatolog Treat. 2012; 24(4):255-60. DOI: 10.3109/09546634.2012.759639. View

Kimball A, Jacobson C, Weiss S, Vreeland M, Wu Y . The psychosocial burden of psoriasis. Am J Clin Dermatol. 2005; 6(6):383-92. DOI: 10.2165/00128071-200506060-00005. View

Griffiths C, Reich K, Lebwohl M, van de Kerkhof P, Paul C, Menter A . Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015; 386(9993):541-51. DOI: 10.1016/S0140-6736(15)60125-8. View

Blauvelt A, Papp K, Griffiths C, Randazzo B, Wasfi Y, Shen Y . Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active.... J Am Acad Dermatol. 2017; 76(3):405-417. DOI: 10.1016/j.jaad.2016.11.041. View

Sofen H, Smith S, Matheson R, Leonardi C, Calderon C, Brodmerkel C . Guselkumab (an IL-23-specific mAb) demonstrates clinical and molecular response in patients with moderate-to-severe psoriasis. J Allergy Clin Immunol. 2014; 133(4):1032-40. DOI: 10.1016/j.jaci.2014.01.025. View

Shikiar R, Willian M, Okun M, Thompson C, Revicki D . The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study. Health Qual Life Outcomes. 2006; 4:71. PMC: 1615869. DOI: 10.1186/1477-7525-4-71. View

Lebwohl M, Swensen A, Nyirady J, Kim E, Gwaltney C, Strober B . The Psoriasis Symptom Diary: development and content validity of a novel patient-reported outcome instrument. Int J Dermatol. 2013; 53(6):714-22. DOI: 10.1111/j.1365-4632.2012.05798.x. View

Abrouk M, Nakamura M, Zhu T, Farahnik B, Koo J, Bhutani T . The impact of PASI 75 and PASI 90 on quality of life in moderate to severe psoriasis patients. J Dermatolog Treat. 2017; 28(6):488-491. DOI: 10.1080/09546634.2016.1278198. View

Krueger J, Ferris L, Menter A, Wagner F, White A, Visvanathan S . Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: Safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2015; 136(1):116-124.e7. DOI: 10.1016/j.jaci.2015.01.018. View

10.

Silva M, Rita Parise Fortes M, Miot L, Marques S . Psoriasis: correlation between severity index (PASI) and quality of life index (DLQI) in patients assessed before and after systemic treatment. An Bras Dermatol. 2013; 88(5):760-3. PMC: 3798353. DOI: 10.1590/abd1806-4841.20132052. View

11.

Rencz F, Poor A, Pentek M, Hollo P, Karpati S, Gulacsi L . A detailed analysis of 'not relevant' responses on the DLQI in psoriasis: potential biases in treatment decisions. J Eur Acad Dermatol Venereol. 2017; 32(5):783-790. DOI: 10.1111/jdv.14676. View

12.

Puig L, Augustin M, Blauvelt A, Gottlieb A, Vender R, Korman N . Effect of secukinumab on quality of life and psoriasis-related symptoms: A comparative analysis versus ustekinumab from the CLEAR 52-week study. J Am Acad Dermatol. 2017; 78(4):741-748. DOI: 10.1016/j.jaad.2017.10.025. View

13.

Bronsard V, Paul C, Prey S, Puzenat E, Gourraud P, Aractingi S . What are the best outcome measures for assessing quality of life in plaque type psoriasis? A systematic review of the literature. J Eur Acad Dermatol Venereol. 2010; 24 Suppl 2:17-22. DOI: 10.1111/j.1468-3083.2009.03563.x. View

14.

Armstrong A, Puig L, Langley R, Tsai T, Song M, Wasfi Y . Validation of psychometric properties and development of response criteria for the psoriasis symptoms and signs diary (PSSD): results from a phase 3 clinical trial. J Dermatolog Treat. 2017; 30(1):27-34. DOI: 10.1080/09546634.2017.1364694. View

15.

Strober B, Papp K, Lebwohl M, Reich K, Paul C, Blauvelt A . Clinical meaningfulness of complete skin clearance in psoriasis. J Am Acad Dermatol. 2016; 75(1):77-82.e7. DOI: 10.1016/j.jaad.2016.03.026. View

16.

Finlay A, Khan G . Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994; 19(3):210-6. DOI: 10.1111/j.1365-2230.1994.tb01167.x. View

17.

FREDRIKSSON T, Pettersson U . Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978; 157(4):238-44. DOI: 10.1159/000250839. View

18.

Bundy C, Borthwick M, McAteer H, Cordingley L, Howells L, Bristow P . Psoriasis: snapshots of the unspoken: using novel methods to explore patients' personal models of psoriasis and the impact on well-being. Br J Dermatol. 2014; 171(4):825-31. DOI: 10.1111/bjd.13101. View

19.

Jaeschke R, Singer J, Guyatt G . Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989; 10(4):407-15. DOI: 10.1016/0197-2456(89)90005-6. View

20.

Strand V, Fiorentino D, Hu C, Day R, Stevens R, Papp K . Improvements in patient-reported outcomes with apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of moderate to severe psoriasis: results from a phase IIb randomized, controlled study. Health Qual Life Outcomes. 2013; 11:82. PMC: 3661377. DOI: 10.1186/1477-7525-11-82. View