Guselkumab in Patients with Scalp Psoriasis: A post hoc Analysis of the VOYAGE 2 Phase III Randomized Clinical Trial
DOI:
https://doi.org/10.2340/actadv.v104.18672Keywords:
antibodies, monoclonal, dermatologic agents, psoriasis, quality of life, scalp dermatoses, severity of illness indexAbstract
Scalp psoriasis affects approximately 80% of patients with psoriasis and can negatively impact their quality of life. This post hoc analysis of the VOYAGE 2 Phase III randomized clinical trial evaluated scalp response to guselkumab treatment and its association with skin response and patient-reported outcomes. The study included patients with moderate-to-severe plaque psoriasis and baseline scalp psoriasis who were initially randomized to receive guselkumab. Patients were divided into 3 groups based on their achievement of a Psoriasis Area and Severity Index 90 response at week 28: responder continuation, non-responder continuation and responder withdrawal. In all 3 groups, mean Psoriasis Area and Severity Index head and scalp-specific Investigator’s Global Assessment scores improved through week 28. In the responder withdrawal group, these scores worsened after treatment withdrawal at week 28, but remained stable through week 48 in both continuation groups. Trends in Dermatology Life Quality Index and Psoriasis Symptoms and Signs Diary itch scores mirrored those of mean scalp-specific Investigator’s Global Assessment scores through week 48. Within-subject correlations were 0.83 between scalp-specific Investigator’s Global Assessment and Psoriasis Area and Severity Index head scores and 0.78 between scalp-specific Investigator’s Global Assessment and Psoriasis Symptoms and Signs Diary itch scores. Through week 252, Psoriasis Area and Severity Index head scores remained stable in the responder continuation group, improved in the non-responder continuation group and rapidly improved by week 84 in the responder withdrawal group after retreatment.
Downloads
References
Chan CS, Van Voorhees AS, Lebwohl MG, Korman NJ, Young M, Bebo BF, Jr., et al. Treatment of severe scalp psoriasis: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol 2009; 60: 962-971.
https://doi.org/10.1016/j.jaad.2008.11.890 DOI: https://doi.org/10.1016/j.jaad.2008.11.890
Papp K, Berth-Jones J, Kragballe K, Wozel G, de la Brassinne M. Scalp psoriasis: a review of current topical treatment options. J Eur Acad Dermatol Venereol 2007; 21: 1151-1160.
https://doi.org/10.1111/j.1468-3083.2007.02424.x DOI: https://doi.org/10.1111/j.1468-3083.2007.02424.x
Leong WC, Tang JJ. Scalp psoriasis and Dermatology Life Quality Index: a retrospective study based on 12-year data from the Malaysian Psoriasis Registry. Malays Fam Physician 2022; 17: 84-88.
https://doi.org/10.51866/oa.146 DOI: https://doi.org/10.51866/oa.146
Wilson FC, Icen M, Crowson CS, McEvoy MT, Gabriel SE, Kremers HM. Incidence and clinical predictors of psoriatic arthritis in patients with psoriasis: a population-based study. Arthritis Rheum 2009; 61: 233-239.
https://doi.org/10.1002/art.24172 DOI: https://doi.org/10.1002/art.24172
Svedbom A, Mallbris L, Larsson P, Nikamo P, Wolk K, Kjellman P, et al. Long-term outcomes and prognosis in new-onset psoriasis. JAMA Dermatol 2021; 157: 1-8.
https://doi.org/10.1001/jamadermatol.2021.0734 DOI: https://doi.org/10.1001/jamadermatol.2021.0734
Mosca M, Hong J, Hadeler E, Brownstone N, Bhutani T, Liao W. Scalp psoriasis: a literature review of effective therapies and updated recommendations for practical management. Dermatol Ther (Heidelb) 2021; 11: 769-797.
https://doi.org/10.1007/s13555-021-00521-z DOI: https://doi.org/10.1007/s13555-021-00521-z
Nast A, Smith C, Spuls PI, Avila Valle G, Bata-Csorgo Z, Boonen H, et al. EuroGuiDerm guideline on the systemic treatment of psoriasis vulgaris - Part 1: Treatment and monitoring recommendations. J Eur Acad Dermatol Venereol 2020; 34: 2461-2498.
https://doi.org/10.1111/jdv.16915 DOI: https://doi.org/10.1111/jdv.16915
Nast A, Smith C, Spuls PI, Avila Valle G, Bata-Csorgo Z, Boonen H, et al. EuroGuiDerm guideline on the systemic treatment of psoriasis vulgaris - Part 2: Specific clinical and comorbid situations. J Eur Acad Dermatol Venereol 2021; 35: 281-317.
https://doi.org/10.1111/jdv.16926 DOI: https://doi.org/10.1111/jdv.16926
Camela E, Ocampo-Garza SS, Cinelli E, Villani A, Fabbrocini G, Megna M. Therapeutic update of biologics and small molecules for scalp psoriasis: a systematic review. Dermatol Ther 2021; 34: e14857.
https://doi.org/10.1111/dth.14857 DOI: https://doi.org/10.1111/dth.14857
Reich K, Armstrong AW, Foley P, Song M, Wasfi Y, Randazzo B, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the Phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol 2017; 76: 418-431.
https://doi.org/10.1016/j.jaad.2016.11.042 DOI: https://doi.org/10.1016/j.jaad.2016.11.042
Nogueira M, Torres T. Guselkumab for the treatment of psoriasis - evidence to date. Drugs Context 2019; 8: 212594.
https://doi.org/10.7573/dic.212594 DOI: https://doi.org/10.7573/dic.212594
Foley P, Gordon K, Griffiths CEM, Wasfi Y, Randazzo B, Song M, et al. Efficacy of guselkumab compared with adalimumab and placebo for psoriasis in specific body regions: a secondary analysis of 2 randomized clinical trials. JAMA Dermatol 2018; 154: 676-683.
https://doi.org/10.1001/jamadermatol.2018.0793 DOI: https://doi.org/10.1001/jamadermatol.2018.0793
Langley RG, Feldman SR, Nyirady J, van de Kerkhof P, Papavassilis C. 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 DOI: https://doi.org/10.3109/09546634.2013.865009
Lanna C, Galluzzi C, Zangrilli A, Bavetta M, Bianchi L, Campione E. Psoriasis in difficult to treat areas: treatment role in improving health-related quality of life and perception of the disease stigma. J Dermatolog Treat 2022; 33: 531-534.
https://doi.org/10.1080/09546634.2020.1770175 DOI: https://doi.org/10.1080/09546634.2020.1770175
Gerdes S, Brau B, Hoffmann M, Korge B, Mortazawi D, Wiemers F, et al. Real-world effectiveness of guselkumab in patients with psoriasis: health-related quality of life and efficacy data from the noninterventional, prospective, German multicenter PERSIST trial. J Dermatol 2021; 48: 1854-1862.
https://doi.org/10.1111/1346-8138.16128 DOI: https://doi.org/10.1111/1346-8138.16128
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 DOI: https://doi.org/10.1111/j.1365-2230.1994.tb01167.x
Bland JM, Altman DG. Statistics notes: calculating correlation coefficients with repeated observations: Part 1 - correlation within subjects. BMJ 1995; 310: 446.
https://doi.org/10.1136/bmj.310.6977.446 DOI: https://doi.org/10.1136/bmj.310.6977.446
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 DOI: https://doi.org/10.1111/bjd.16008
Blauvelt A, Papp KA, Griffiths CE, Randazzo B, Wasfi Y, Shen YK, et al. 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 comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol 2017; 76: 405-417.
https://doi.org/10.1016/j.jaad.2016.11.041 DOI: https://doi.org/10.1016/j.jaad.2016.11.041
Megna M, Tommasino N, Potestio L, Battista T, Ruggiero A, Noto M, et al. Real-world practice indirect comparison between guselkumab, risankizumab, and tildrakizumab: results from an Italian 28-week retrospective study. J Dermatolog Treat 2022; 33: 2813-2820.
https://doi.org/10.1080/09546634.2022.2081655 DOI: https://doi.org/10.1080/09546634.2022.2081655
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 DOI: https://doi.org/10.1016/j.jaad.2018.11.057
Sánchez-Regaña M, Aldunce Soto MJ, Belinchón Romero I, Ribera Pibernat M, Lafuente-Urrez RF, Carrascosa Carrillo JM, et al. Evidence-based guidelines of the Spanish Psoriasis Group on the use of biologic therapy in patients with psoriasis in difficult-to-treat sites (nails, scalp, palms, and soles). Actas Dermosifiliogr 2014; 105: 923-934. DOI: https://doi.org/10.1016/j.adengl.2014.10.004
https://doi.org/10.1016/j.ad.2014.02.015 DOI: https://doi.org/10.1016/j.ad.2014.02.015
Mrowietz U, Kragballe K, Reich K, Spuls P, Griffiths CE, Nast A, et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res 2011; 303: 1-10.
https://doi.org/10.1007/s00403-010-1080-1 DOI: https://doi.org/10.1007/s00403-010-1080-1
Strober B, Ryan C, van de Kerkhof P, van der Walt J, Kimball AB, Barker J, et al. Recategorization of psoriasis severity: Delphi consensus from the International Psoriasis Council. J Am Acad Dermatol 2020; 82: 117-122.
https://doi.org/10.1016/j.jaad.2019.08.026 DOI: https://doi.org/10.1016/j.jaad.2019.08.026
Bagel J, Duffin KC, Moore A, Ferris LK, Siu K, Steadman J, et al. The effect of secukinumab on moderate-to-severe scalp psoriasis: results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study. J Am Acad Dermatol 2017; 77: 667-674.
https://doi.org/10.1016/j.jaad.2017.05.033 DOI: https://doi.org/10.1016/j.jaad.2017.05.033
Fotiadou C, Lazaridou E, Sotiriou E, Kyrgidis A, Apalla Z, Ioannides D. Scalp psoriasis and biologic agents: a retrospective, comparative study from a tertiary psoriasis referral centre. J Eur Acad Dermatol Venereol 2016; 30: 2091-2096.
https://doi.org/10.1111/jdv.13780 DOI: https://doi.org/10.1111/jdv.13780
Narcisi A, Valenti M, Cortese A, Toso F, Pavia G, Gargiulo L, et al. Anti-IL17 and anti-IL23 biologic drugs for scalp psoriasis: a single-center retrospective comparative study. Dermatologic Therapy 2022; 35: e15228.
https://doi.org/10.1111/dth.15228 DOI: https://doi.org/10.1111/dth.15228
Thaci D, Unnebrink K, Sundaram M, Sood S, Yamaguchi Y. Adalimumab for the treatment of moderate to severe psoriasis: subanalysis of effects on scalp and nails in the BELIEVE study. J Eur Acad Dermatol Venereol 2015; 29: 353-360.
https://doi.org/10.1111/jdv.12553 DOI: https://doi.org/10.1111/jdv.12553
Menter MA, Murakawa GJ, Glover H, Mendelsohn AM, Parno J, Rozzo SJ, et al. Clearance of head and neck involvement in plaque psoriasis with tildrakizumab treatment in the Phase III reSURFACE 1 study. J Eur Acad Dermatol Venereol 2020; 34: e803-e805.
https://doi.org/10.1111/jdv.16648 DOI: https://doi.org/10.1111/jdv.16648
Galluzzo M, Talamonti M, Cioni A, Maffei V, Shumak RG, Tofani L, et al. Efficacy of tildrakizumab for the treatment of difficult-to-treat areas: scalp, nail, palmoplantar and genital psoriasis. J Clin Med 2022; 11: 2631.
https://doi.org/10.3390/jcm11092631 DOI: https://doi.org/10.3390/jcm11092631
Papp KA, Blauvelt A, Bukhalo M, Gooderham M, Krueger JG, Lacour JP, et al. Risankizumab versus ustekinumab for moderate-to-severe plaque psoriasis. N Engl J Med 2017; 376: 1551-1560.
https://doi.org/10.1056/NEJMoa1607017 DOI: https://doi.org/10.1056/NEJMoa1607017
Yan D, Ahn R, Leslie S, Liao W. Clinical and genetic risk factors associated with psoriatic arthritis among patients with psoriasis. Dermatol Ther (Heidelb) 2018; 8: 593-604.
https://doi.org/10.1007/s13555-018-0266-x DOI: https://doi.org/10.1007/s13555-018-0266-x
Eder L, Polachek A, Rosen CF, Chandran V, Cook R, Gladman DD. The development of psoriatic arthritis in patients with psoriasis is preceded by a period of nonspecific musculoskeletal symptoms: a prospective cohort study. Arthritis Rheumatol 2017; 69: 622-629.
https://doi.org/10.1002/art.39973 DOI: https://doi.org/10.1002/art.39973
Singh S, Facciorusso A, Singh AG, Vande Casteele N, Zarrinpar A, Prokop LJ, et al. Obesity and response to anti-tumor necrosis factor-alpha agents in patients with select immune-mediated inflammatory diseases: a systematic review and meta-analysis. PLoS One 2018; 13: e0195123.
https://doi.org/10.1371/journal.pone.0195123 DOI: https://doi.org/10.1371/journal.pone.0195123
Shan J, Zhang J. Impact of obesity on the efficacy of different biologic agents in inflammatory diseases: a systematic review and meta-analysis. Joint Bone Spine 2019; 86: 173-183.
https://doi.org/10.1016/j.jbspin.2018.03.007 DOI: https://doi.org/10.1016/j.jbspin.2018.03.007
Mourad A, Straube S, Armijo-Olivo S, Gniadecki R. Factors predicting persistence of biologic drugs in psoriasis: a systematic review and meta-analysis. Br J Dermatol 2019; 181: 450-458.
https://doi.org/10.1111/bjd.17738 DOI: https://doi.org/10.1111/bjd.17738
Blauvelt A, Armstrong AW, Langley RG, Gebauer K, Thaci 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 DOI: https://doi.org/10.1080/09546634.2021.1959504
Lebwohl MG, Leonardi CL, Mehta NN, Gottlieb AB, Mendelsohn AM, Parno J, et al. Tildrakizumab efficacy, drug survival, and safety are comparable in patients with psoriasis with and without metabolic syndrome: long-term results from 2 Phase III randomized controlled studies (reSURFACE 1 and reSURFACE 2). J Am Acad Dermatol 2021; 84: 398-407.
https://doi.org/10.1016/j.jaad.2020.09.047 DOI: https://doi.org/10.1016/j.jaad.2020.09.047
Armstrong AW, Fitzgerald T, McLean RR, Teeple A, Uy JP, Olurinde M, et al. The effectiveness of guselkumab by BMI category among patients with moderate-to-severe plaque psoriasis in the CorEvitas psoriasis registry. Adv Ther 2023; 40: 2493-2508.
https://doi.org/10.1007/s12325-023-02467-4 DOI: https://doi.org/10.1007/s12325-023-02467-4
Additional Files
Published
How to Cite
License
Copyright (c) 2024 Enikö Sonkoly, Julia-Tatjana Maul, Matteo Megna, Patricia Gorecki, Edmée Crombag, Jozefien Buyze, Laura Savage
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All digitalized ActaDV contents is available freely online. The Society for Publication of Acta Dermato-Venereologica owns the copyright for all material published until volume 88 (2008) and as from volume 89 (2009) the journal has been published fully Open Access, meaning the authors retain copyright to their work.
Unless otherwise specified, all Open Access articles are published under CC-BY-NC licences, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material for non-commercial purposes, provided proper attribution to the original work.
