Similar response to biologic therapy across racial and ethnic groups among patients with psoriasis enrolled in the CorEvitas Psoriasis Registry

To the Editor: Psoriasis impacts 7 million Americans of all ethnoracial backgrounds. Racial/ethnic differences in response to biologic therapy for psoriasis have been described in clinical trials1Adsit S. Zaldivar E.R. Sofen H. et al.Secukinumab is efficacious and safe in Hispanic patients with moderate-to-severe plaque psoriasis: pooled analysis of four phase 3 trials.Adv Ther. 2017; 34: 1327-1339Crossref PubMed Scopus (21) Google Scholar; yet, these findings do not reflect real-world outcomes.2Mason K.J. Barker J.N.W.N. Smith C.H. et al.Comparison of drug discontinuation, effectiveness, and safety between clinical trial eligible and ineligible patients in BADBIR.JAMA Dermatol. 2018; 154: 581-588Crossref PubMed Scopus (60) Google Scholar Data from clinical practice are needed to further our understanding of potential variability in the effectiveness of biologics. We used data from the CorEvitas Psoriasis Registry,3Strober B. Karki C. Mason M. et al.Characterization of disease burden, comorbidities, and treatment use in a large, US-based cohort: results from the Corrona Psoriasis Registry.J Am Acad Dermatol. 2018; 78: 323-332Abstract Full Text Full Text PDF PubMed Scopus (58) Google Scholar an observational cohort of patients evaluated in dermatology clinics, to better understand the response to biologics across racial/ethnic groups. This study included patients who initiated an interleukin (IL) 17 inhibitor, IL-12/23 inhibitor, IL-23 inhibitor, or tumor necrosis factor inhibitor and completed a 6-month follow-up (5-9 month window) between April 2015 and March 2021. Patients were classified by self-identified race/ethnicity: White (non-Hispanic), Black (non-Hispanic), Asian, Hispanic, or Other (Native American, Hawaiian/Pacific Islander, Other, or multiracial). Demographics, disease characteristics, and treatment history at biologic initiation were compared using standardized effect sizes. In addition, disease activity outcomes (Psoriasis Area and Severity Index [PASI] [PASI75, PASI90], Investigator Global Assessment [IGA] [IGA 0/1]) and patient-reported outcomes (Dermatology Life Quality Index [DLQI] [DLQI 0/1]) were assessed at 6-months. Patients with an IGA score of >1 and a DLQI score of >1 at initiation were included in analyses of achievement of IGA 0/1 and DLQI 0/1 at 6-months, respectively. Poisson regression was used to calculate multivariable-adjusted relative risk and 95% CIs for outcome achievement for each racial/ethnic group using Whites as the reference group. A total of 3684 biologic initiations from 3249 unique patients were included: 2772 (75.2%) in White patients, 113 (3.1%) in Black patients, 331 (9.0%) in Asian patients, 345 (9.4%) in Hispanic patients, and 123 (3.3%) in Other patients. Demographics, comorbidities, and psoriasis severity at initiation were similar across the groups (Table I). About one-third of patients were biologic-naïve.Table IBaseline demographics, disease characteristics, and treatment history at biologic initiation for patients with psoriasis included in 6-month effectiveness analysesCharacteristicsWhiteN = 2772BlackN = 113AsianN = 331HispanicN = 345Other∗Other races/ethnicities include multiracial, Native American, Native Hawaiian, other Pacific Islander, or Other.N = 123Standardized effect size†Standardized effect sizes are Cohen’s w or f for categorical or continuous measures, respectively. Small, medium, and large differences are indicated by 0.1, 0.3, and 0.5 for Cohen’s w and 0.1, 0.25, and 0.4 for Cohen’s f.Age, mean (SD), y50.9 (14.4)51.4 (14.1)49.6 (15.7)46.3 (12.6)45.6 (15.9)0.113Female, n (%)1399 (50.5%)70 (61.9%)114 (34.4%)162 (47.0%)55 (44.7%)0.104Health insurance type, n (%) Private2039 (73.6%)79 (69.9%)211 (63.7%)249 (72.2%)67 (54.5%)0.095 Medicare or Medicaid666 (24.0%)33 (29.2%)99 (29.9%)66 (19.1%)39 (31.7%)0.065College or higher education, n (%)1100 (39.8%)27 (24.1%)178 (53.8%)98 (28.5%)50 (40.7%)0.124Work status—full time, n (%)1614 (58.4%)65 (58.6%)192 (58.0%)232 (67.6%)63 (51.2%)0.062Smoking history, n (%)0.175 Never1255 (45.6%)70 (64.2%)223 (67.8%)217 (65.4%)60 (49.2%) Former smoker1000 (36.3%)27 (24.8%)63 (19.1%)83 (25.0%)33 (27.0%) Current smoker499 (18.1%)12 (11.0%)43 (13.1%)32 (9.6%)29 (23.8%)Current alcohol use, n (%)0.142 None/occasional1444 (55.4%)71 (68.9%)240 (76.4%)193 (61.3%)64 (57.1%) Moderate430 (16.5%)10 (9.7%)36 (11.5%)51 (16.2%)18 (16.1%) Daily731 (28.1%)22 (21.4%)38 (12.1%)71 (22.5%)30 (26.8%)BMI (kg/m2), n (%)0.209 <25 (underweight/normal)459 (16.9%)13 (12.1%)129 (39.3%)39 (11.9%)24 (20.0%) 25-30 (overweight)769 (28.3%)28 (26.2%)118 (36.0%)87 (26.5%)40 (33.3%) >30 (obese)1492 (54.9%)66 (61.7%)81 (24.7%)202 (61.6%)56 (46.7%)Comorbid conditions, n (%) Infection1094 (39.5%)34 (30.1%)132 (39.9%)116 (33.6%)55 (44.7%)0.052 Cardiovascular disease312 (11.3%)17 (15.0%)23 (6.9%)27 (7.8%)19 (15.4%)0.061 Hypertension1054 (38.0%)56 (49.6%)126 (38.1%)107 (31.0%)43 (35.0%)0.061 Hyperlipidemia769 (27.8%)34 (30.1%)108 (32.6%)80 (23.2%)27 (22.0%)0.052 Diabetes mellitus411 (14.8%)24 (21.2%)69 (20.8%)71 (20.6%)33 (26.8%)0.083 Depression630 (22.7%)15 (13.3%)27 (8.2%)51 (14.8%)31 (25.2%)0.118 Anxiety692 (25.0%)13 (11.5%)21 (6.3%)62 (18.0%)33 (26.8%)0.141Psoriasis duration, mean (SD), y15.9 (14.0)11.7 (12.0)12.4 (9.9)11.7 (10.4)12.1 (12.1)0.128Psoriatic arthritis, n (%)1141 (41.2%)43 (38.1%)100 (30.2%)97 (28.1%)52 (42.3%)0.096BSA (% involvement), mean (SD)13.4 (15.3)15.5 (18.6)16.3 (15.8)15.6 (16.2)17.4 (19.6)0.076BSA, n (%)0.118 Mild: 0-<3419 (15.1%)18 (16.2%)23 (6.9%)36 (10.5%)15 (12.2%) Moderate: 3-101344 (48.6%)50 (45.0%)141 (42.6%)145 (42.2%)46 (37.4%) Severe: >10-1001005 (36.3%)43 (38.7%)167 (50.5%)163 (47.4%)62 (50.4%)PASI (Score: 0-72), mean (SD)7.5 (7.0)9.0 (9.3)10.9 (8.2)10.0 (9.2)10.6 (8.9)0.164PASI, categorical, n (%)0.171 Mild: 0-51279 (46.2%)47 (42.3%)86 (26.0%)106 (30.7%)38 (30.9%) Moderate: >5-121009 (36.5%)37 (33.3%)132 (39.9%)145 (42.0%)48 (39.0%) Severe: >12-72480 (17.3%)27 (24.3%)113 (34.1%)94 (27.2%)37 (30.1%)IGA >1, n (%)2518 (91.0%)99 (89.2%)323 (97.6%)318 (92.7%)118 (95.9%)0.076Biologic-naïve, n (%)977 (35.2%)42 (37.2%)120 (36.3%)147 (42.6%)46 (37.4%)0.045Prior number of nonbiologic systemics, n (%)0.098 01183 (42.7%)63 (55.8%)136 (41.1%)191 (55.4%)58 (47.2%) 11087 (39.2%)38 (33.6%)148 (44.7%)116 (33.6%)46 (37.4%) ≥2502 (18.1%)12 (10.6%)47 (14.2%)38 (11.0%)19 (15.4%)Biologic class, n (%)0.067 TNFi465 (16.8%)27 (23.9%)46 (13.9%)61 (17.7%)24 (19.5%) IL-17i1102 (39.8%)41 (36.3%)159 (48.0%)123 (35.7%)46 (37.4%) IL-23i or IL-12/23i1205 (43.5%)45 (39.8%)126 (38.1%)161 (46.7%)53 (43.1%)BMI, Body mass index; BSA, body surface area; IGA, Investigator Global Assessment; IL-17i, interleukin 17 inhibitor; IL-23i, interleukin 23 inhibitor; PASI, Psoriasis Area and Severity Index; TNFi, tumor necrosis factor inhibitor.∗ Other races/ethnicities include multiracial, Native American, Native Hawaiian, other Pacific Islander, or Other.† Standardized effect sizes are Cohen’s w or f for categorical or continuous measures, respectively. Small, medium, and large differences are indicated by 0.1, 0.3, and 0.5 for Cohen’s w and 0.1, 0.25, and 0.4 for Cohen’s f. Open table in a new tab BMI, Body mass index; BSA, body surface area; IGA, Investigator Global Assessment; IL-17i, interleukin 17 inhibitor; IL-23i, interleukin 23 inhibitor; PASI, Psoriasis Area and Severity Index; TNFi, tumor necrosis factor inhibitor. Comparable proportions of patients achieved PASI75 (55-64%), PASI90 (37-47%), and IGA 0/1 (45-56%) across all racial/ethnic groups at 6-months (Table II). In multivariable-adjusted analyses, likelihoods of achieving disease activity outcomes did not vary significantly across groups. However, Asian participants were 23% less likely to achieve a DLQI of 0/1 than Whites.Table IIResponse in disease activity and Dermatology Life Quality Index score at 6-months follow-up among psoriasis patients who initiated biologic therapy, for each race/ethnicity groupOutcomes% RespondersAdjusted RR (95% CI)P value∗P values originating from a Poisson regression assessing no difference in each outcome among any of the race/ethnicity groups. Models are adjusted for body mass index, comorbid disease, duration of disease, health insurance status, age, sex, baseline PASI, and biologic history (bio-naïve or bio-experienced) at the index visit.PASI 75.511 White1563 (59.4%)Ref Black63 (59.4%)1.03 (0.88-1.21) Asian203 (64.0%)0.97 (0.88-1.07) Hispanic174 (54.9%)0.91 (0.81-1.02) Other74 (63.2%)0.99 (0.84-1.16)PASI 90.118 White1173 (44.5%)Ref Black49 (46.2%)1.11 (0.90-1.38) Asian144 (45.4%)0.90 (0.78-1.03) Hispanic118 (37.2%)0.85 (0.72-0.99) Other55 (47.0%)0.96 (0.76-1.20)IGA 0/1†Analysis restricted to patients who had an IGA of >1 (n = 3376) or a DLQI of >1 (n = 3200) at initiation for each respective outcome..351 White1303 (51.7%)Ref Black52 (52.5%)1.11 (0.92-1.34) Asian166 (51.4%)0.95 (0.84-1.06) Hispanic143 (45.0%)0.94 (0.83-1.07) Other66 (55.9%)1.10 (0.92-1.32)DLQI 0/1†Analysis restricted to patients who had an IGA of >1 (n = 3376) or a DLQI of >1 (n = 3200) at initiation for each respective outcome..006 White1087 (45.6%)Ref Black37 (37.8%)0.87 (0.68, 1.12) Asian105 (35.6%)0.77 (0.65, 0.90) Hispanic122 (39.0%)0.88 (0.76, 1.03) Other56 (50.9%)1.12 (0.91, 1.37)DLQI, Dermatology Life Quality Index; IGA, Investigator Global Assessment; PASI, Psoriasis Area and Severity Index; Ref, reference; RR, relative risk.∗ P values originating from a Poisson regression assessing no difference in each outcome among any of the race/ethnicity groups. Models are adjusted for body mass index, comorbid disease, duration of disease, health insurance status, age, sex, baseline PASI, and biologic history (bio-naïve or bio-experienced) at the index visit.† Analysis restricted to patients who had an IGA of >1 (n = 3376) or a DLQI of >1 (n = 3200) at initiation for each respective outcome. Open table in a new tab DLQI, Dermatology Life Quality Index; IGA, Investigator Global Assessment; PASI, Psoriasis Area and Severity Index; Ref, reference; RR, relative risk. Prior investigations of the effectiveness of tumor necrosis factor inhibitor and IL-17 inhibitor in patients with psoriasis across racial/ethnic groups reported variable findings.1Adsit S. Zaldivar E.R. Sofen H. et al.Secukinumab is efficacious and safe in Hispanic patients with moderate-to-severe plaque psoriasis: pooled analysis of four phase 3 trials.Adv Ther. 2017; 34: 1327-1339Crossref PubMed Scopus (21) Google Scholar,4Shah S.K. Arthur A. Yang Y.C. Stevens S. Alexis A.F. A retrospective study to investigate racial and ethnic variations in the treatment of psoriasis with etanercept.J Drugs Dermatol. 2011; 10: 866-872PubMed Google Scholar However, using real-world data, we demonstrated a similar likelihood of disease activity response across racial/ethnic groups after 6-months of biologic therapy. Asian patients in our study were significantly less likely to achieve a DLQI of 0/1 than White patients, similar to data on etanercept therapy.4Shah S.K. Arthur A. Yang Y.C. Stevens S. Alexis A.F. A retrospective study to investigate racial and ethnic variations in the treatment of psoriasis with etanercept.J Drugs Dermatol. 2011; 10: 866-872PubMed Google Scholar Variations in the DLQI score may reflect cultural differences in disease perception or cross-cultural biases of the DLQI tool.5Nijsten T. Meads D.M. de Korte J. et al.Cross-cultural inequivalence of dermatology-specific health-related quality of life instruments in psoriasis patients.J Invest Dermatol. 2007; 127: 2315-2322Abstract Full Text Full Text PDF PubMed Scopus (75) Google Scholar Study limitations include the definitions of racial/ethnic groups used, which are specific to the United States. Because CorEvitas dermatologists and patients participate voluntarily, the racial/ethnic makeup of the registry may differ from population-based samples and have limited generalizability. Additionally, we considered biologics as an overall treatment class. Further investigation is needed to understand the effectiveness of each biologic class across races/ethnicities. Our study highlights a critical concept that patients with psoriasis of all racial and ethnic backgrounds may experience improved disease outcomes with biologic therapy. With an increasingly diverse US population, it is critical to continue to develop tools to assess potential differences in treatment response. These improved techniques can advance health equity and guide treatment decisions. Dr Enos has served as a consultant on an advisory board for UCB and Amgen; Dr McLean, Sima, Kohl, and Eckmann are employees at CorEvitas, LLC; Dr Van Voorhees reports grant/research support from Celgene, Lilly, and AbbVie and is a consultant for Amgen, Boehringer Ingelheim, BMS, UCB, Novartis; author Yi has no conflicts of interest to declare. The authors thank the participating providers and patients for contributing data to CorEvitas’ Psoriasis Registry. Letter from the editor: Diversity and inclusion in clinical trialsJournal of the American Academy of DermatologyVol. 87Issue 5PreviewIn this issue of the Journal of the American Academy of Dermatology, Enos et al report similar responses to biologic therapy across racial and ethnic groups among patients with psoriasis enrolled in the CorEvitas Psoriasis Registry. Studies of this type are essential to determine the safety and efficacy of medications in various populations. The inclusion of women, pediatric, and minority populations in clinical trials is critical to judge responses and outcomes in these groups. However, the attempts to improve representation in clinical trials have had varied results, and large gaps remain. Full-Text PDF