A Descriptive, Post Hoc Analysis of Efficacy and Safety of Risankizumab in Diverse Racial and Ethnic Patient Populations With Moderate-to-Severe Psoriasis.
Diversity
Efficacy
Ethnicity
Psoriasis
Race
Risankizumab
Skin of color
Journal
Dermatology and therapy
ISSN: 2193-8210
Titre abrégé: Dermatol Ther (Heidelb)
Pays: Switzerland
ID NLM: 101590450
Informations de publication
Date de publication:
02 Oct 2024
02 Oct 2024
Historique:
received:
13
07
2024
accepted:
29
08
2024
medline:
3
10
2024
pubmed:
3
10
2024
entrez:
2
10
2024
Statut:
aheadofprint
Résumé
Historically, patients with skin of color are underdiagnosed with psoriasis and underrepresented in clinical trials. In this study, we assess the efficacy and safety of risankizumab in patients with moderate-to-severe plaque psoriasis by race and ethnicity in the open label extension LIMMitless (NCT03047395). Patients received continuous treatment with 150 mg risankizumab through their initial trial and the open label extension. Patients self-identified their race and ethnicity. Efficacy was assessed using Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety is reported by events/100 patient-years. A total of 897 patients (race: 662 White, 196 Asian, 25 Black or African American, 14 Other; ethnicity: 98 Hispanic or Latino, 799 non-Hispanic or Latino) were included in this analysis. Compared to baseline, patients had a mean percent reduction in PASI between 94.6% (Asian) and 99.3% (Black or African American) and reported mean percent improvements in DLQI ranging from 87.1% (Asian and Black or African American) to 93.7% (Hispanic or Latino) at week 100. While the data presented here comprise a small retrospective descriptive analysis and cannot detect statistical differences, efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis appears similar across the racial and ethnic groups studied and no new safety signals were detected.
Identifiants
pubmed: 39358667
doi: 10.1007/s13555-024-01268-z
pii: 10.1007/s13555-024-01268-z
doi:
Banques de données
ClinicalTrials.gov
['NCT03047395']
Types de publication
Journal Article
Langues
eng
Informations de copyright
© 2024. The Author(s).
Références
Gelfand JM, et al. The prevalence of psoriasis in African Americans: results from a population-based study. J Am Acad Dermatol. 2005;52(1):23–6.
doi: 10.1016/j.jaad.2004.07.045
pubmed: 15627076
Alexis AF, Blackcloud P. Psoriasis in skin of color: epidemiology, genetics, clinical presentation, and treatment nuances. J Clin Aesthet Dermatol. 2014;7(11):16–24.
pubmed: 25489378
pmcid: 4255694
Taylor SC. Epidemiology of skin diseases in people of color. Cutis. 2003;71(4):271–5.
pubmed: 12729089
Klopot A, et al. Transcriptome analysis reveals intrinsic proinflammatory signaling in healthy African American Skin. J Investig Dermatol. 2022;142(5):1360-1371.e15.
doi: 10.1016/j.jid.2021.09.031
pubmed: 34757068
Kaufman BP, Alexis AF. Psoriasis in skin of color: insights into the epidemiology, clinical presentation, genetics, quality-of-life impact, and treatment of psoriasis in non-White Racial/Ethnic Groups. Am J Clin Dermatol. 2018;19(3):405–23.
doi: 10.1007/s40257-017-0332-7
pubmed: 29209945
Yan D, et al. A cross-sectional study of the distribution of psoriasis subtypes in different ethno-racial groups. Dermatol Online J. 2018. https://doi.org/10.5070/D3247040909 .
doi: 10.5070/D3247040909
pubmed: 30677812
McKenzie S, et al. Variations in genetics, biology, and phenotype of cutaneous disorders in skin of color. Part II: differences in clinical presentation and disparities in cutaneous disorders in skin of color. J Am Acad Dermatol. 2022;87(6):1261–70.
doi: 10.1016/j.jaad.2022.03.067
pubmed: 35817332
Takeshita J, et al. Health-Related QOL Differs by Race/Ethnicity in North American Patients with Psoriasis: results from PSOLAR. J Investig Dermatol. 2022;142(9):2528-2531.e3.
doi: 10.1016/j.jid.2022.02.013
pubmed: 35304247
Ha MV, Wong C. Racial representation in clinical trials for dermatological new molecular entities. Clin Exp Dermatol. 2022;47(2):386–8.
doi: 10.1111/ced.14871
pubmed: 34346107
Ricardo JW, Lipner SR. Under-representation of racial and ethnic minorities in nail psoriasis randomized clinical trials: a call to action. J Am Acad Dermatol. 2022;86(6):e267–8.
doi: 10.1016/j.jaad.2022.01.043
pubmed: 35124110
Ricardo JW, Qiu Y, Lipner SR. Racial, ethnic, and sex disparities in nail psoriasis clinical trials: a systematic review. Skin Appendage Disord. 2022;8(3):171–8.
doi: 10.1159/000520469
pubmed: 35707283
pmcid: 9149505
Lolic M, et al. Racial and ethnic representation in US clinical trials of new drugs and biologics, 2015–2019. JAMA. 2021;326(21):2201–3.
doi: 10.1001/jama.2021.16680
pubmed: 34874429
pmcid: 8652601
Reid MM, et al. Demographic diversity of US-based participants in GSK-sponsored interventional clinical trials. Clin Trials. 2023;20(2):133–44.
doi: 10.1177/17407745221149118
pubmed: 36744680
pmcid: 10021118
Rottas M, et al. Demographic diversity of participants in Pfizer sponsored clinical trials in the United States. Contemp Clin Trials. 2021;106: 106421.
doi: 10.1016/j.cct.2021.106421
pubmed: 33940253
Narla S, et al. Racial disparities in dermatology. Arch Dermatol Res. 2023;315(5):1215–23.
pubmed: 36508020
Mineroff J, Nguyen JK, Jagdeo J. Racial and ethnic underrepresentation in dermatology clinical trials. J Am Acad Dermatol. 2023;89(2):293–300.
doi: 10.1016/j.jaad.2023.04.011
pubmed: 37062462
Papp KA, et al. Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis: interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up. Br J Dermatol. 2021;185(6):1135–45.
doi: 10.1111/bjd.20595
pubmed: 34157132
pmcid: 9290992
Enos CW, et al. Similar response to biologic therapy across racial and ethnic groups among patients with psoriasis enrolled in the CorEvitas Psoriasis Registry. J Am Acad Dermatol. 2022;87(5):1087–9.
doi: 10.1016/j.jaad.2022.05.038
pubmed: 35643239
Ferguson JE, et al. Racial/ethnic differences in treatment efficacy and safety for moderate-to-severe plaque psoriasis: a systematic review. Arch Dermatol Res. 2023;315(1):41–50.
doi: 10.1007/s00403-022-02324-4
pubmed: 35050396
Alexis AF, et al. Efficacy of dupilumab in different racial subgroups of adults with moderate-to-severe atopic dermatitis in three randomized, placebo-controlled phase 3 trials. J Drugs Dermatol. 2019;18(8):804–13.
pubmed: 31424712
Schwartz AL, et al. Why diverse clinical trial participation matters. N Engl J Med. 2023;388(14):1252–4.
doi: 10.1056/NEJMp2215609
pubmed: 37017480
Perlman KL, et al. Skin of color lacks representation in medical student resources: a cross-sectional study. Int J Womens Dermatol. 2021;7(2):195–6.
doi: 10.1016/j.ijwd.2020.12.018
pubmed: 33937492
pmcid: 8072497
Fischer AH, et al. Health care utilization for psoriasis in the United States differs by race: an analysis of the 2001–2013 medical expenditure panel surveys. J Am Acad Dermatol. 2018;78(1):200–3.
doi: 10.1016/j.jaad.2017.07.052
pubmed: 29241786
pmcid: 6035870
Tripathi R, et al. Association of demographic and socioeconomic characteristics with differences in use of outpatient dermatology services in the United States. JAMA Dermatol. 2018;154(11):1286–91.
doi: 10.1001/jamadermatol.2018.3114
pubmed: 30267073
pmcid: 6248122
Wu KK, Armstrong AW. Differences in face-to-face time spent with a dermatologist among patients with psoriasis based on race and ethnicity. JAMA Dermatol. 2022;158(10):1210–2.
doi: 10.1001/jamadermatol.2022.2426
pubmed: 35921118
pmcid: 9350842
Hodges WT, et al. Biologics utilization for psoriasis is lower in black compared with white patients. Br J Dermatol. 2021;185(1):207–9.
doi: 10.1111/bjd.19876
pubmed: 33567102
Bell MA, et al. Racial and ethnic disparities in access to emerging and frontline therapies in common dermatological conditions: a cross-sectional study. J Natl Med Assoc. 2020;112(6):650–3.
pubmed: 32641259
Yadav G, et al. Unmet need in people with psoriasis and skin of color in Canada and the United States. Dermatol Ther. 2022;12(11):2401–13.
doi: 10.1007/s13555-022-00811-0