Patients with Persistent Mild Psoriasis after Treatment with Ustekinumab Achieved Greater Improvements in Skin Clearance and Patient-reported Outcomes after Switching to Guselkumab in the Phase 3 NAVIGATE Trial

Authors

  • Enzo Errichetti University Hospital "Santa Maria della Misericordia," Udine, Italy
  • Peter Wolf Department of Dermatology, Medical University of Graz, Graz, Austria
  • Saakshi Khattri Mount Sinai Doctors, New York, NY, USA
  • Patricia Gorecki Janssen-Cilag Ltd, High Wycombe, UK
  • Megan Miller Janssen Research and Development, LLC, Spring House, PA, USA
  • Jingzhi Jiang Janssen Research and Development, LLC, Spring House, PA, USA
  • Chenglong Han Janssen Global Services, LLC, Malvern, PA, USA
  • Brian Kirby St. Vincent’s University Hospital and Charles Institute of Dermatology, University College Dublin, Ireland

DOI:

https://doi.org/10.2340/actadv.v104.41053

Keywords:

psoriasis, biologic therapy, patient-reported outcome measures, quality of life, guselkumab, ustekinumab

Abstract

Mild psoriasis may be burdensome; if symptoms are inadequately controlled, switching therapy may be warranted. In the Phase 3 NAVIGATE trial, patients with moderate-to-severe plaque psoriasis received ustekinumab for 16 weeks. Patients with inadequate response (Investigator’s Global Assessment [IGA] ≥ 2) were randomized to switch to guselkumab or continue ustekinumab. This post-hoc analysis evaluated the patient subgroup with residual mild psoriasis (IGA = 2) after initial ustekinumab therapy. Outcomes assessed included the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and Psoriasis Symptoms and Signs Diary (PSSD). Initially, 871 patients received ustekinumab. At Week 16, 161 randomized patients had residual mild psoriasis (IGA = 2). Among guselkumab- vs ustekinumab-treated patients at Week 28, 59.0% vs 27.7% achieved PASI 90, and 50.0% vs 21.0% achieved DLQI 0/1. Mean changes from baseline in PSSD score were –44 vs –28 and –50 vs –32, respectively, with thresholds of –40 considered clinically meaningful. Mean changes in PSSD itch score were –4.6 vs –2.9, with reductions ≥ 4.0 considered clinically meaningful. Treatment differences were maintained/increased through Week 52. Among patients with residual mild psoriasis after 16 weeks of ustekinumab, those switching to guselkumab had greater improvements in skin clearance, health-related quality of life, and patient-reported symptoms and signs than those continuing ustekinumab.

Downloads

Download data is not yet available.

References

Korman NJ, Malatestinic W, Goldblum OM, Murage MJ, Renda L, Lin C-Y, et al. Assessment of the benefit of achieving complete versus almost complete skin clearance in psoriasis: a patient's perspective. J Dermatolog Treat 2022; 33: 733-739.

https://doi.org/10.1080/09546634.2020.1772454

Puig L, Thom H, Mollon P, Tian H, Ramakrishna GS. Clear or almost clear skin improves the quality of life in patients with moderate-to-severe psoriasis: a systematic review and meta-analysis. J Eur Acad Dermatol Venereol 2017; 31: 213-220.

https://doi.org/10.1111/jdv.14007

Fairchild AO, Reed SD, Johnson FR, Anglin G, Wolka AM, Noel RA. What is clearance worth? Patients' stated risk tolerance for psoriasis treatments. J Dermatolog Treat 2017; 28: 709-715.

https://doi.org/10.1080/09546634.2017.1329499

Carretero G, Puig L, Carrascosa JM, Ferrándiz L, Ruiz-Villaverde R, de la Cueva P, et al. Redefining the therapeutic objective in psoriatic patients candidates for biological therapy. J Dermatolog Treat 2018; 29: 334-346.

https://doi.org/10.1080/09546634.2017.1395794

Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol 2013; 149: 1180-1185.

https://doi.org/10.1001/jamadermatol.2013.5264

Lebwohl M, Langley RG, Paul C, Puig L, Reich K. van de Kerkhof P, et al. Evolution of patient perceptions of psoriatic disease: results from the Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) survey. Dermatol Ther (Heidelb) 2022; 12: 61-78.

https://doi.org/10.1007/s13555-021-00635-4

Gupta S, Garbarini S, Nazareth T, Khilfeh I, Costantino H, Kaplan D. Characterizing outcomes and unmet needs among patients in the United States with mild-to-moderate plaque psoriasis using prescription topicals. Dermatol Ther (Heidelb) 2021; 11: 2057-2075.

https://doi.org/10.1007/s13555-021-00620-x

Korman NJ, Zhao Y, Pike J, Roberts J, Sullivan E. Increased severity of itching, pain, and scaling in psoriasis patients is associated with increased disease severity, reduced quality of life, and reduced work productivity. Dermatol Online J 2015; 21: 13030/qt1x16v3dg.

https://doi.org/10.5070/D32110028943

Strober B, Greenberg JD, Karki C, Mason M, Guo N, Hur P, et al. Impact of psoriasis severity on patient-reported clinical symptoms, health-related quality of life and work productivity among US patients: real-world data from the Corrona Psoriasis Registry. BMJ Open 2019; 9: e027535.

https://doi.org/10.1136/bmjopen-2018-027535

Menter A, Strober BE, Kaplan DH, Kivelevitch D, Prater EF, Stoff B, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019; 80: 1029-1072.

https://doi.org/10.1016/j.jaad.2018.11.057

Langley RG, Tsai T-F, Flavin S, Song M, Randazzo B, Wasfi Y, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol 2018; 178: 114-123.

https://doi.org/10.1111/bjd.15750

Stelara. (ustekinumab) [package insert]. Horsham, PA: Janssen Pharmaceutical Companies; 2022.

Tremfya. (guselkumab) [package insert]. Horsham, PA: Janssen Pharmaceutical Companies; 2020.

United States Department of Health and Human Services FaDA. Enrichment strategies for clinical trials to support approval of human drugs and biological products. U.S. Department of Health and Human Services, 2019. Available from: https://www.fda.gov/media/121320/download (last accessed May 24, 2024).

Langley RGB, Feldman SR, Nyirady J, van de Kerkhof P, Papavassilis. The 5-point Investigator's Global Assessment (IGA) Scale: a modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat 2015; 26: 23-31.

https://doi.org/10.3109/09546634.2013.865009

Fredriksson T, Pettersson U. Severe psoriasis - oral therapy with a new retinoid. Dermatologica 1978; 157: 238-244.

https://doi.org/10.1159/000250839

Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI) - a simple practical measure for routine clinical use. Clin Exp Dermatol 1994; 19: 210-216.

https://doi.org/10.1111/j.1365-2230.1994.tb01167.x

Feldman SR, Mathias SD, Schenkel B, Colwell HH, McQuarrie K, Randazzo B, et al. Development of a patient-reported outcome questionnaire for use in adults with moderate-to-severe plaque psoriasis: the Psoriasis Symptoms and Signs Diary. J Dermatol and Dermatol Treat 2016; 20: 19-26.

https://doi.org/10.1016/j.jdds.2015.07.004

Armstrong A, Puig L, Langley R, Tsai TF, Song M, Wasfi Y, et al. 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 2019; 30: 27-34.

https://doi.org/10.1080/09546634.2017.1364694

Pariser D, Schenkel B, Carter C, Farahi K, Brown TM, Ellis CN for the Psoriasis Patient Interview Study Group. A multicenter, non-interventional study to evaluate patient-reported experiences of living with psoriasis. J Dermatolog Treat 2016; 27: 19-26.

https://doi.org/10.3109/09546634.2015.1044492

van Ee I, Deprez E, Egeberg A, Augustin M, Conrad C, Corazza V, et al. Freedom from disease in psoriasis: a Delphi consensus definition by patients, nurses and physicians. J Eur Acad Dermatol Venereol 2022; 36: 403-412.

https://doi.org/10.1111/jdv.17829

Feldman SR, Regnier SA, Chirilov A, Hey F, Gilloteau I, Cella D. Patient-reported outcomes are important elements of psoriasis treatment decision making: a discrete choice experiment survey of dermatologists in the United States. J Am Acad Dermatol 2019; 80: 1650-1657.

https://doi.org/10.1016/j.jaad.2019.01.039

US Food and Drug Administration (FDA) guidance document for PRO Development USDoHaHSF, 2009. Available from: https://www.fda.gov/media/77832/download (last accessed May 24, 2024).

Elewski B, Alexis AF, Lebwohl M, Stein Gold L, Pariser D, Del Rosso J, et al. Itch: an under-recognized problem in psoriasis. J Eur Acad Dermatol Venereol 2019; 33: 1465-1476.

https://doi.org/10.1111/jdv.15450

Miyagi T, Kanai Y, Murotani K, Okubo Y, Honma M, Kobayashi S, et al. Itch as a critical factor in impaired health-related quality of life in patients with plaque psoriasis achieving clear or almost-clear skin: analysis of the single-arm, open-label, multicenter, prospective ProLOGUE study. JAAD Int 2022; 8: 146-153.

https://doi.org/10.1016/j.jdin.2022.06.013

Pithadia DJ, Reynolds KA, Lee EB, Wu JJ. Psoriasis-associated itch: etiology, assessment, impact, and management. J Dermatolog Treat 2020; 31: 18-26.

https://doi.org/10.1080/09546634.2019.1572865

Lebwohl M, Yeilding N, Szapary P, Wang Y, Li S, Zhu Y, et al. Impact of weight on the efficacy and safety of ustekinumab in patients with moderate to severe psoriasis: rationale for dosing recommendations. J Am Acad Dermatol 2010; 63: 571-579.

https://doi.org/10.1016/j.jaad.2009.11.012

Blauvelt A, Armstrong AW, Langley RG, Gebauer K, Thaҫi D, Bagel J, et al. Efficacy of guselkumab versus secukinumab in subpopulations of patients with moderate-to-severe plaque psoriasis: results from the ECLIPSE study. J Dermatolog Treat 2022; 33: 2317-2324.

https://doi.org/10.1080/09546634.2021.1959504

Gordon KB, Blauvelt A, Foley P, Song M, Wasfi Y, Randazzo B, et al. Efficacy of guselkumab in subpopulations of patients with moderate-to-severe plaque psoriasis: a pooled analysis of the phase III VOYAGE 1 and VOYAGE 2 studies. Br J Dermatol 2018; 178: 132-139.

https://doi.org/10.1111/bjd.16008

Lebwohl MG, Merola JF, Rowland K, Miller M, Yang Y-W, Yu J, et al. Safety of guselkumab treatment for up to 5 years in patients with moderate-to-severe psoriasis: pooled analyses across seven clinical trials with greater than 8600 patient-years of exposure. Br J Dermatol 2023; 189: 42-52.

https://doi.org/10.1093/bjd/ljad115

Kimball AB, Papp KA, Wasfi Y, Chan D, Bissonnette R, Sofen H, et al. Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study. J Eur Acad Dermatol Venereol 2013; 27: 1535-1545.

https://doi.org/10.1111/jdv.12046

Published

2024-09-05

How to Cite

Errichetti, E., Wolf, P., Khattri, S., Gorecki, P., Miller, M., Jiang, J., … Kirby, B. (2024). Patients with Persistent Mild Psoriasis after Treatment with Ustekinumab Achieved Greater Improvements in Skin Clearance and Patient-reported Outcomes after Switching to Guselkumab in the Phase 3 NAVIGATE Trial. Acta Dermato-Venereologica, 104, adv41053. https://doi.org/10.2340/actadv.v104.41053

Issue

Section

Articles

Categories