Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors.

Alcohol consumption Brodalumab Obesity Psoriasis QoL Skin clearance Smoking Ustekinumab

Journal

Dermatology and therapy
ISSN: 2193-8210
Titre abrégé: Dermatol Ther (Heidelb)
Pays: Switzerland
ID NLM: 101590450

Informations de publication

Date de publication:
Dec 2021
Historique:
received: 06 07 2021
accepted: 16 09 2021
pubmed: 5 10 2021
medline: 5 10 2021
entrez: 4 10 2021
Statut: ppublish

Résumé

Obesity, smoking, and alcohol consumption are prevalent in psoriasis patients and have been associated with increased disease severity and reduced treatment adherence and response. This post hoc analysis of pooled data from the phase 3 AMAGINE-2 and -3 trials compared the efficacy of brodalumab versus ustekinumab in psoriasis patients with aggravating and potentially treatment-confounding lifestyle risk factors. This post hoc analysis evaluated complete skin clearance, as measured by a 100% reduction of Psoriasis Area and Severity Index (PASI100) and quality of life (QoL), as measured by a Dermatology Life Quality Index (DLQI) score of 0/1, by the presence of risk factors (obesity, tobacco or alcohol use). A competing risk model assessed cumulative incidence over 52 weeks with outcomes of PASI100 or inadequate response. This analysis included 929 patients (brodalumab 210 mg, n = 339; ustekinumab, n = 590) with moderate-to-severe psoriasis. At week 52, odds ratios (95% confidence intervals [CIs]) for complete clearance with brodalumab versus ustekinumab were 2.50 (1.14-5.46, P = 0.0186), 4.64 (2.80-7.69, P < 0.0001), 2.06 (1.25-3.40, P = 0.0045), and 2.55 (0.55-11.91, P = 0.2117) in patients with no, one, two, or three risk factors, respectively. Corresponding odds ratios (ORs) (95% CIs) for DLQI 0/1 with brodalumab versus ustekinumab were 1.72 (0.78-3.79, P = 0.1883), 2.49 (1.54-4.02, P < 0.0002), 1.57 (0.97-2.54, P = 0.0666), and 2.07 (0.45-9.57, P = 0.3438). The 52-week cumulative incidence of patients achieving PASI100 was consistently higher for brodalumab versus ustekinumab, regardless of number of risk factors (P < 0.0001 for one or two risk factors and P = 0.0029 for three risk factors). Higher levels of complete skin clearance and QoL were achieved and maintained with brodalumab versus ustekinumab in patients with moderate-to-severe psoriasis, regardless of the presence of lifestyle risk factors. AMAGINE-2 (NCT01708603); AMAGINE-3 (NCT01708629).

Identifiants

pubmed: 34606048
doi: 10.1007/s13555-021-00618-5
pii: 10.1007/s13555-021-00618-5
pmc: PMC8611142
doi:

Banques de données

ClinicalTrials.gov
['NCT01708603', 'NCT01708629']

Types de publication

Journal Article

Langues

eng

Pagination

2027-2042

Informations de copyright

© 2021. The Author(s).

Références

Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol. 2001;137(3):280–4.
pubmed: 11255325
Greb JE, Goldminz AM, Elder JT, Lebwohl MG, Gladman DD, Wu JJ, et al. Psoriasis. Nat Rev Dis Primers. 2016;2:16082.
doi: 10.1038/nrdp.2016.82
Kamiya K, Kishimoto M, Sugai J, Komine M, Ohtsuki M. Risk factors for the development of psoriasis. Int J Mol Sci. 2019;20(18):4347.
doi: 10.3390/ijms20184347
Capon F (2017) The genetic basis of psoriasis. Int J Mol Sci. 18(12):2526
Parisi R, Webb RT, Carr MJ, Moriarty KJ, Kleyn CE, Griffiths CEM, et al. Alcohol-related mortality in patients with psoriasis: a population-based cohort study. JAMA Dermatol. 2017;153(12):1256–62.
doi: 10.1001/jamadermatol.2017.3225
Svanström C, Lonne-Rahm SB, Nordlind K. Psoriasis and alcohol. Psoriasis (Auckl). 2019;9:75–9.
Gupta MA, Schork NJ, Gupta AK, Ellis CN. Alcohol intake and treatment responsiveness of psoriasis: a prospective study. J Am Acad Dermatol. 1993;28(5 Pt 1):730–2.
doi: 10.1016/0190-9622(93)70101-X
Armstrong AW, Armstrong EJ, Fuller EN, Sockolov ME, Voyles SV. Smoking and pathogenesis of psoriasis: a review of oxidative, inflammatory and genetic mechanisms. Br J Dermatol. 2011;165(6):1162–8.
doi: 10.1111/j.1365-2133.2011.10526.x
Armstrong AW, Harskamp CT, Dhillon JS, Armstrong EJ. Psoriasis and smoking: a systematic review and meta-analysis. Br J Dermatol. 2014;170(2):304–14.
doi: 10.1111/bjd.12670
Naldi L. Psoriasis and smoking: links and risks. Psoriasis (Auckl). 2016;6:65–71.
Richer V, Roubille C, Fleming P, Starnino T, McCourt C, McFarlane A, et al. Psoriasis and smoking: a systematic literature review and meta-analysis with qualitative analysis of effect of smoking on psoriasis severity. J Cutan Med Surg. 2016;20(3):221–7.
doi: 10.1177/1203475415616073
Thorneloe RJ, Bundy C, Griffiths CE, Ashcroft DM, Cordingley L. Adherence to medication in patients with psoriasis: a systematic literature review. Br J Dermatol. 2013;168(1):20–31.
doi: 10.1111/bjd.12039
Warren RB, Smith CH, Yiu ZZN, Ashcroft DM, Barker J, Burden AD, et al. Differential drug survival of biologic therapies for the treatment of psoriasis: a prospective observational cohort study from the British Association of Dermatologists Biologic Interventions Register (BADBIR). J Invest Dermatol. 2015;135(11):2632–40.
doi: 10.1038/jid.2015.208
Paroutoglou K, Papadavid E, Christodoulatos GS, Dalamaga M. Deciphering the association between psoriasis and obesity: current evidence and treatment considerations. Curr Obes Rep. 2020;9(3):165–78.
doi: 10.1007/s13679-020-00380-3
World Health Organization. Body mass index-BMI. Available from: https://www.euro.who.int/en/health-topics/disease-prevention/nutrition/a-healthy-lifestyle/body-mass-index-bmi . Accessed Aug 2020.
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(1):132–9.
doi: 10.1111/bjd.16008
Warren RB, Marsden A, Tomenson B, Mason KJ, Soliman MM, Burden AD, et al. Identifying demographic, social and clinical predictors of biologic therapy effectiveness in psoriasis: a multicentre longitudinal cohort study. Br J Dermatol. 2019;180(5):1069–76.
doi: 10.1111/bjd.16776
Jabbar-Lopez ZK, Yiu ZZN, Ward V, Exton LS, Mohd Mustapa MF, Samarasekera E, et al. Quantitative evaluation of biologic therapy options for psoriasis: a systematic review and network meta-analysis. J Invest Dermatol. 2017;137(8):1646–54.
doi: 10.1016/j.jid.2017.04.009
Mrowietz U, Steinz K, Gerdes S. Psoriasis: to treat or to manage? Exp Dermatol. 2014;23(10):705–9.
doi: 10.1111/exd.12437
Russell CB, Rand H, Bigler J, Kerkof K, Timour M, Bautista E, et al. Gene expression profiles normalized in psoriatic skin by treatment with brodalumab, a human anti-IL-17 receptor monoclonal antibody. J Immunol. 2014;192(8):3828–36.
doi: 10.4049/jimmunol.1301737
Frieder J, Kivelevitch D, Menter A. Secukinumab: a review of the anti-IL-17A biologic for the treatment of psoriasis. Ther Adv Chronic Dis. 2018;9(1):5–21.
doi: 10.1177/2040622317738910
Syed YY. Ixekizumab: a review in moderate to severe plaque psoriasis. Am J Clin Dermatol. 2017;18(1):147–58.
doi: 10.1007/s40257-017-0254-4
Papp KA, Reich K, Paul C, Blauvelt A, Baran W, Bolduc C, et al. A prospective phase III, randomized, double-blind, placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2016;175(2):273–86.
doi: 10.1111/bjd.14493
Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373(14):1318–28.
doi: 10.1056/NEJMoa1503824
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):1–10.
doi: 10.1007/s00403-010-1080-1
Papp KA, Leonardi CL, Blauvelt A, Reich K, Korman NJ, Ohtsuki M, et al. Ixekizumab treatment for psoriasis: integrated efficacy analysis of three double-blinded, controlled studies (UNCOVER-1, UNCOVER-2, UNCOVER-3). Br J Dermatol. 2018;178(3):674–81.
doi: 10.1111/bjd.16050
Blauvelt A, Reich K, Tsai TF, Tyring S, Vanaclocha F, Kingo K, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: results from the CLEAR study. J Am Acad Dermatol. 2017;76(1):60-9.e9.
doi: 10.1016/j.jaad.2016.08.008
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(3):405–17.
doi: 10.1016/j.jaad.2016.11.041
Gordon KB, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650–61.
doi: 10.1016/S0140-6736(18)31713-6
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(3):418–31.
doi: 10.1016/j.jaad.2016.11.042
Strober B, Papp KA, Lebwohl M, Reich K, Paul C, Blauvelt A, et al. 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
Viswanathan HN, Mutebi A, Milmont CE, Gordon K, Wilson H, Zhang H, et al. Measurement properties of the psoriasis symptom inventory electronic daily diary in patients with moderate to severe plaque psoriasis. Value Health. 2017;20(8):1174–9.
doi: 10.1016/j.jval.2016.11.020
Viswanathan HN, Chau D, Milmont CE, Yang W, Erondu N, Revicki DA, et al. Total skin clearance results in improvements in health-related quality of life and reduced symptom severity among patients with moderate to severe psoriasis. J Dermatolog Treat. 2015;26(3):235–9.
doi: 10.3109/09546634.2014.943687
Finlay AY, Khan GK. 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
Aalen OO, Johansen S. An empirical transition matrix for non-homogeneous Markov chains based on censored observations. Scand J Stat. 1978;5(3):141–50.
Fine JP, Gray RJ. A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc. 1999;94(446):496–509.
doi: 10.1080/01621459.1999.10474144
Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16(3):1141–54.
doi: 10.1214/aos/1176350951
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(3):450–8.
doi: 10.1111/bjd.17738
Di Lernia V, Ricci C, Lallas A, Ficarelli E. Clinical predictors of non-response to any tumor necrosis factor (TNF) blockers: a retrospective study. J Dermatolog Treat. 2014;25(1):73–4.
doi: 10.3109/09546634.2013.800184
Kokolakis G SNV, Faurby MD, Carrascosa JM. Brodalumab versus ustekinumab: complete skin clearance and improvements in quality of life—A subgroup analysis according to lifestyle factors (tobacco and alcohol). EADV 2019. Poster P0438.
Gisondi P, Del Giglio M, Di Francesco V, Zamboni M, Girolomoni G. Weight loss improves the response of obese patients with moderate-to-severe chronic plaque psoriasis to low-dose cyclosporine therapy: a randomized, controlled, investigator-blinded clinical trial. Am J Clin Nutr. 2008;88(5):1242–7.
pubmed: 18996858
Gelfand JM, Abuabara K. Diet and weight loss as a treatment for psoriasis. Arch Dermatol. 2010;146(5):544–6.
doi: 10.1001/archdermatol.2010.92
Ko SH, Chi CC, Yeh ML, Wang SH, Tsai YS, Hsu MY. Lifestyle changes for treating psoriasis. Cochrane Database Syst Rev. 2019;7(7): Cd011972.
Karczewski J, Poniedziałek B, Rzymski P, Adamski Z. Factors affecting response to biologic treatment in psoriasis. Dermatol Ther. 2014;27(6):323–30.
doi: 10.1111/dth.12160

Auteurs

Georgios Kokolakis (G)

Clinic of Dermatology, Venereology and Allergology, Psoriasis Research and Treatment Centre, Charité-Universitätsmedizin Berlin, Luisenstrasse 2, 10117, Berlin, Germany. Georgios.kokolakis@charite.de.

Kasper Vadstrup (K)

LEO Pharma A/S, Industriparken 55, 2750, Ballerup, Denmark.

Jes B Hansen (JB)

LEO Pharma A/S, Industriparken 55, 2750, Ballerup, Denmark.

Jose Manuel Carrascosa (JM)

Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma of Barcelona, IGTP, Carretera de Canyet, s/n, 08916, Badalona, Barcelona, Spain.

Classifications MeSH