Abstract
Introduction
Psoriasis body surface area (BSA) of 10% or more has been a major criterion for determining systemic therapy eligibility. However, patients with BSA < 10% and even ≤ 3% may have high disease burden and difficulties accessing biologics. To assess psoriasis burden among patients with BSA ≤ 10%, this study characterized patient-reported outcomes (PROs) across BSA categories among systemic treatment-naïve patients initiating biologic therapy.
Methods
Patients from the CorEvitas Psoriasis Registry initiating biologics between April 2015 and September 2023 were categorized according to low (< 3%), medium (3–10%), or high (> 10%) BSA involvement. Measures assessed at initiation of biologic therapy included health-related quality of life, itch, pain, fatigue, psoriatic arthritis, psoriasis disease characteristics, and medical history. Overlap between BSA groups for each outcome was calculated via non-parametric Mann–Whitney statistic transformation (range 0.0–1.0; 0.5 indicates complete similarity [i.e., for a comparison between low and high BSA groups, overlap of 0.5 means there is 50% probability that a randomly selected patient with low BSA would have the same or greater PRO burden as one with high BSA]; 0 or 1 indicates complete dissimilarity) to determine whether each measure differed in randomly selected patients with low or medium versus high BSA.
Results
Of 1640 patients who initiated biologics, 7.0% had low BSA, 46.9% had medium BSA, and 46.2% had high BSA involvement. PRO overlap statistics ranged from 0.52 to 0.59 and from 0.60 to 0.70 for randomly selected patients with high versus medium and low BSA, respectively, indicating patients with high and medium BSA are likely to have similar levels of disease burden, and patients with high BSA are slightly more likely to have higher disease burden than those with low BSA. Near complete overlap (range 0.44–0.58) was observed for psoriasis disease characteristics and medical history in the low versus high and medium BSA groups.
Conclusion
Observed overlap in PROs across BSA categories shows that patients with low BSA can experience similarly poor quality of life and high symptom burden to those with higher BSA. These findings support the appropriateness of considering biologic therapies for patients with low BSA and indicators of high disease burden.
Trial Registration
ClinicalTrials.gov: NCT02707341.
Keywords: Biologics, Body surface area, Patient-reported outcomes, Psoriasis
Key Summary Points
| Why carry out this study? |
| The extent of psoriasis body surface area (BSA) involvement is commonly used to determine psoriasis disease severity, and BSA > 10% is often used as a criterion to identify patients who are eligible for systemic treatment. |
| However, many patients with BSA ≤ 3% have reported high disease burden, and patients with BSA < 10% may have difficulty accessing effective treatments if BSA criteria are used exclusively to define disease severity and treatment eligibility. |
| What was learned from the study? |
| This study used data from the CorEvitas Psoriasis Registry to characterize patient-reported outcome measures across the spectrum of BSA involvement among systemic treatment-naïve patients with psoriasis who were initiating biologic therapy. |
| Overlap statistics showed that the likelihood of experiencing negative quality-of-life effects and high symptom burden was similar across patients with low, medium, and high BSA involvement at the time of initiating biologic treatment for plaque psoriasis. |
| These results support the appropriateness of considering biologic therapies for patients with psoriasis with low BSA involvement and indicators of high disease burden. |
Introduction
Psoriasis is a chronic, immune-mediated, inflammatory disease that affects approximately 3% of the US adult population [1]. The disease burden of psoriasis can vary according to factors including anatomical location of plaques (e.g., face, scalp, genitals, hands, feet, and intertriginous areas), severity of symptoms such as itch and pain, impact on quality of life, treatment history, ethnicity, and other demographic characteristics [2–7]. As a result, creating accurate definitions of mild, moderate, and severe psoriasis has been a long-standing challenge for patients, healthcare practitioners, researchers, and payers; and use of definitions that may underestimate disease burden can restrict access to warranted systemic treatments [2–5, 8, 9].
In clinical trials, mild, moderate, and severe psoriasis have often been defined as disease affecting body surface area (BSA) of < 3%, 3% to 10%, and > 10%, respectively [2, 3]. However, > 50% of patients with only limited skin involvement (BSA ≤ 3%) rate their disease as moderate or severe, and patients often rate their level of BSA involvement as higher than physicians, mainly as a result of psoriasis affecting high-impact sites, failure of current or past treatments, and/or negative impact of psoriasis on quality of life [10, 11].
To test the hypothesis that patients with limited psoriasis BSA involvement may suffer with high levels of disease burden, this study used data from the CorEvitas Psoriasis Registry to characterize patient-reported outcome (PRO) measures across the BSA spectrum among systemic treatment-naïve patients with psoriasis who were initiating biologic therapy.
Methods
Study Setting
Launched in April 2015 in collaboration with the National Psoriasis Foundation, the CorEvitas Psoriasis Registry (ClinicalTrials.gov: NCT02707341) is an independent, prospective, multicenter, non-interventional study that enrolls adults (≥ 18 years of age) who have been diagnosed with psoriasis, are willing and able to provide written informed consent for participation, and started on or switched to an eligible psoriasis treatment (US Food and Drug Administration [FDA]-approved biologic and non-biologic systemic therapies) at enrollment or ≤ 12 months before enrollment [12]. Longitudinal effectiveness and PRO data are collected from dermatologists and patients during routine outpatient visits, which occur approximately every 6 months from initiation.
Study Population
This analysis included patients in the CorEvitas Psoriasis Registry who were enrolled at a study site in the USA, had private insurance, were systemic therapy-naïve, and initiated treatment with a biologic therapy between April 2015 and September 2023. Initiated biologics included in this analysis were adalimumab, certolizumab, etanercept, infliximab, ustekinumab, secukinumab, ixekizumab, brodalumab, bimekizumab, guselkumab, risankizumab, tildrakizumab, and available biosimilars (adalimumab, etanercept, and infliximab). Patients were excluded if they initiated both a biologic and a non-biologic at a registry visit or if they had missing BSA data.
Ethical Approval
This study was performed in accordance with the Declaration of Helsinki and Guidelines for Good Pharmacoepidemiology Practice (GPP). All participating investigators were required to obtain full board approval for conducting noninterventional research involving human subjects with a limited dataset. Sponsor approval and continuing review were obtained through a central institutional review board (IRB; Advarra, Protocol number is Pro00051221). For academic investigative sites that did not receive a waiver to use the central IRB, full board approval was obtained from the respective governing IRBs, and documentation of approval was submitted to CorEvitas, LLC, prior to the initiation of any study procedures. All patients in the registry were required to provide written informed consent and authorization prior to participating.
Assessments
At the time of enrollment in the registry, each patient’s percentage of BSA with psoriasis was determined using the handprint method, with which their fully extended palm, fingers, and thumb together represented 1% of their total BSA [13–15]. BSA involvement was categorized as low (< 3%), medium (3–10%), or high (> 10%).
Patient-reported outcomes and other measures were assessed cross-sectionally at initiation of biologic therapy and included the following: Dermatology Life Quality Index (DLQI), itch visual analog scale (VAS), skin pain VAS, fatigue VAS, Psoriasis Epidemiology Screening Tool (PEST), psoriasis disease characteristics, and medical history. The DLQI is a 10-item patient-administered questionnaire that assesses dermatology-specific health-related quality of life across six domains of symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment, on a scale from 0 to 30, with scores of 0–1 indicating no impact of disease on quality of life and scores of > 10 indicating large impact [16, 17]. The itch VAS [18], skin pain VAS [19], and fatigue VAS [20] are 0–100 mm horizontal lines on which patients place a mark representing their perceived worst itch, pain, and fatigue, respectively, within the past week from 0 (none) to 100 (most severe). The PEST is a validated five-item questionnaire used to screen patients with psoriasis for psoriatic arthritis (PsA) [21], with scores of ≥ 3 indicating that referral to a rheumatologist should be considered. Psoriasis disease and medical history characteristics included psoriasis disease duration, history of psoriasis in a difficult-to-treat area (scalp, genitals, nails, palms and soles, or inverse/intertriginous areas), history of non-plaque psoriasis (guttate, erythrodermic, or pustular), and the number of previous topical therapies used (corticosteroids, tacrolimus, pimecrolimus, calcipotriene/calcitriol, vitamin D3 analogue/steroid combination, tar, anthralin, tazarotene, roflumilast, or tapinarof).
Statistical Analyses
Demographic, disease, and symptom characteristics were summarized separately for each BSA group. A transformation of the non-parametric Mann–Whitney statistic [22] was used to describe the overlap in each study outcome measure between separate baseline BSA groups (low vs medium vs high BSA) to determine whether each measure in a randomly selected patient in one BSA group exceeded that in a patient in a different BSA group. This statistic ranges from 0 to 1.0, with a value of 0.50 indicating that two groups are completely similar, and values of 0 or 1.0 indicating the groups are completely dissimilar.
Results
A total of 1640 patients who initiated biologic therapy at registry enrollment met inclusion criteria for this analysis. At the time of initiation of biologic therapy, 7.0% (114/1640) of patients had low BSA involvement, 46.9% (769/1640) had medium BSA involvement, and 46.2% (757/1640) had high BSA involvement. In the overall study population, mean (standard deviation [SD]) age was 45.8 (14.4) years, roughly half of patients were men (53.0%), and most patients were white (80.2%) and were not Hispanic or Latino (87.2%). The most frequently initiated biologic class was interleukin (IL)-23 inhibitors (41.0% [673/1640]), followed by IL-17 (34.4% [564/1640]), tumor necrosis factor (16.4% [269/1640]), and IL-12/23 (8.2% [134/1640]) inhibitors.
Patients with higher BSA involvement were more likely to be older, men, and a current smoker; and to have more comorbidities, including obesity and depression (Table 1). On average, patients with higher BSA involvement tended to have worse psoriasis-related quality of life and greater symptom burden than those with lower BSA involvement; however, patients with low BSA had a higher prevalence of PsA based on a dermatologist’s diagnosis or PEST score ≥ 3 (Table 2). Substantial proportions of patients had psoriasis affecting high-impact sites (scalp, nail, palms and soles, and/or inverse/intertriginous areas) in the low (46.5%), medium (47.6%), and high (41.1%) BSA groups (Table 2). Although mean disease activity measure scores were generally higher in patients with higher BSA involvement, there was overlap in the distributions of DLQI scores (Fig. 1), as well as itch, skin pain, and fatigue VAS scores (Fig. 2).
Table 1.
Sociodemographic characteristics at initiation of biologic therapy, stratified by BSA involvement
| Characteristic | Low BSA involvement (n = 114) |
Medium BSA involvement (n = 769) |
High BSA involvement (n = 757) |
|---|---|---|---|
| Age, years | n = 114 | n = 769 | n = 757 |
| Mean (SD) | 44.3 (13.2) | 45.2 (14.0) | 46.7 (14.9) |
| Sex, n (%) | n = 114 | n = 769 | n = 757 |
| Male | 52 (45.6%) | 391 (50.8%) | 427 (56.4%) |
| Female | 62 (54.5%) | 378 (49.2%) | 330 (43.6%) |
| Race, n (%) | n = 112 | n = 766 | n = 754 |
| White | 90 (80.4%) | 621 (81.1%) | 598 (79.3%) |
| Black or African American | 4 (3.6%) | 41 (5.4%) | 41 (5.4%) |
| Asian | 7 (6.3%) | 57 (7.4%) | 61 (8.1%) |
| Other | 11 (9.8%) | 47 (6.1%) | 54 (7.2%) |
| Ethnicity, n (%) | n = 112 | n = 754 | n = 750 |
| Hispanic or Latino | 11 (9.8%) | 95 (12.6%) | 101 (13.5%) |
| Not Hispanic or Latino | 101 (90.2%) | 659 (87.4%) | 649 (86.5%) |
| Body mass index category, n (%) | n = 113 | n = 753 | n = 735 |
| Underweight or normal weight | 24 (21.2%) | 172 (22.8%) | 167 (22.7%) |
| Overweight | 49 (43.4%) | 250 (33.2%) | 218 (29.7%) |
| Obese | 40 (35.4%) | 331 (44.0%) | 350 (47.6%) |
| Education level at enrollment, n (%) | n = 113 | n = 766 | n = 755 |
| Less than 9th grade | 1 (0.9%) | 4 (0.5%) | 6 (0.8%) |
| Less than high school/GED | 5 (4.4%) | 22 (2.9%) | 29 (3.8%) |
| High school graduate/GED | 22 (19.5%) | 141 (18.4%) | 181 (24.0%) |
| Some college or associates degree | 33 (29.2%) | 238 (31.1%) | 225 (29.8%) |
| College graduate or higher | 52 (46.0%) | 361 (47.1%) | 314 (41.6%) |
| Primary work status, n (%) | n = 113 | n = 765 | n = 756 |
| Full time | 87 (77.0%) | 586 (76.6%) | 550 (72.8%) |
| Part time | 7 (6.2%) | 49 (6.4%) | 45 (6.0%) |
| Unemployed | 6 (5.3%) | 39 (5.1%) | 36 (4.8%) |
| Student | 6 (5.3%) | 32 (4.2%) | 32 (4.2%) |
| Disabled | 2 (1.8%) | 14 (1.8%) | 14 (1.9%) |
| Retired | 5 (4.4%) | 45 (5.9%) | 79 (10.4%) |
| Provider region (US Census Bureau), n (%) | n = 114 | n = 769 | n = 757 |
| Northeast | 32 (28.1%) | 267 (34.7%) | 272 (35.9%) |
| Midwest | 19 (16.7%) | 125 (16.3%) | 159 (21.0%) |
| South | 46 (40.4%) | 282 (36.7%) | 262 (34.6%) |
| West | 17 (14.9%) | 95 (12.4%) | 64 (8.5%) |
| Smoking history, n (%) | n = 113 | n = 765 | n = 747 |
| Never smoked | 71 (62.8%) | 449 (58.7%) | 392 (52.5%) |
| Former smoker | 31 (27.4%) | 223 (29.2%) | 224 (30.0%) |
| Current smoker | 11 (9.7%) | 93 (12.2%) | 131 (17.5%) |
| Alcohol use history, n (%) | n = 107 | n = 722 | n = 705 |
| None/occasional | 44 (41.1%) | 332 (46.0%) | 343 (48.7%) |
| 1–3 drinks per week | 23 (21.5%) | 137 (19.0%) | 132 (18.7%) |
| ≥ 1 drink per day | 40 (37.4%) | 253 (35.0%) | 230 (32.6%) |
| Number of comorbidities, n (%)a | n = 114 | n = 769 | n = 757 |
| 0 | 107 (93.9%) | 661 (86.0%) | 643 (84.9%) |
| 1 | 6 (5.3%) | 101 (13.1%) | 102 (13.5%) |
| ≥ 2 | 1 (0.9%) | 7 (0.9%) | 12 (1.6%) |
| Depression, n (%) | n = 113 | n = 767 | n = 753 |
| Yes | 11 (9.7%) | 138 (18.0%) | 132 (17.5%) |
| No | 102 (90.3%) | 629 (82.0%) | 621 (82.5%) |
BSA body surface area, SD standard deviation
aIncludes history of myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease (stroke or transient ischemic attack), chronic obstructive pulmonary disease, peptic ulcer disease, diabetes mellitus, lymphoma, solid tumor cancer (excluding nonmelanoma skin cancer), and liver disease
Table 2.
Psoriasis disease activity measures at initiation of biologic therapy, stratified by BSA involvement
| Characteristic | Low BSA involvement (n = 114) |
Medium BSA involvement (n = 769) |
High BSA involvement (n = 757) |
|---|---|---|---|
| Psoriasis duration, years | n = 113 | n = 762 | n = 750 |
| Mean (SD) | 10.1 (11.3) | 9.1 (10.9) | 9.2 (12.0) |
| DLQI, 0–30 | n = 114 | n = 767 | n = 755 |
| Mean (SD) | 6.6 (6.1) | 7.8 (5.3) | 9.6 (5.8) |
| Itch VAS, 0–100 | n = 113 | n = 769 | n = 755 |
| Mean (SD) | 37.7 (32.7) | 55.1 (30.8) | 61.0 (30.2) |
| Skin pain VAS, 0–100 | n = 113 | n = 768 | n = 754 |
| Mean (SD) | 20.9 (27.0) | 32.9 (31.4) | 40.8 (32.4) |
| Fatigue VAS, 0–100 | n = 113 | n = 769 | n = 755 |
| Mean (SD) | 25.5 (25.8) | 33.5 (29.2) | 36.1 (30.1) |
| PEST score, n (%) | n = 114 | n = 765 | n = 752 |
| 0 | 42 (36.8%) | 311 (40.7%) | 290 (38.6%) |
| 1 | 16 (14.0%) | 135 (17.6%) | 154 (20.5%) |
| 2 | 7 (6.1%) | 91 (11.9%) | 88 (11.7%) |
| ≥ 3 or dermatologist diagnosis of PsA | 49 (43.0%) | 228 (29.8%) | 220 (29.3%) |
| History of difficult-to-treat psoriasis, n (%)a | n = 114 | n = 769 | n = 757 |
| Yes | 53 (46.5%) | 366 (47.6%) | 311 (41.1%) |
| No | 61 (53.5%) | 403 (52.4%) | 446 (58.9%) |
| History of non-plaque morphology, n (%)b | n = 114 | n = 769 | n = 757 |
| Yes | 3 (2.6%) | 50 (6.5%) | 72 (9.5%) |
| No | 111 (97.4%) | 719 (93.5%) | 685 (90.5%) |
| Number of previous topical therapies, n (%) | n = 114 | n = 769 | n = 757 |
| 0 | 22 (19.3%) | 100 (13.0%) | 111 (14.7%) |
| 1 | 33 (28.9%) | 164 (21.3%) | 164 (21.7%) |
| ≥ 2 | 59 (51.8%) | 505 (65.7%) | 482 (63.7%) |
BSA body surface area, DLQI Dermatology Life Quality Index, PEST Psoriasis Epidemiology Screening Tool, PsA psoriatic arthritis, SD standard deviation, VAS visual analog scale
aIncludes psoriasis of the scalp, nails, palmoplantar, and inverse/intertriginous areas
bIncludes guttate, erythrodermic, and pustular psoriasis
Fig. 1.
Distribution of DLQI scores at initiation of biologic therapy, stratified by BSA involvement (high vs low, high vs medium, and medium vs low). BSA body surface area, DLQI Dermatology Life Quality Index. Low BSA Extent, n = 114; Medium BSA Extent, n = 767; High BSA Extent, n = 755. Medians and interquartile ranges are denoted by solid and dashed lines, respectively. Patients with greater BSA involvement tended to have higher DLQI, but there is a large amount of overlap in distribution of scores
Fig. 2.
Distribution of itch, skin pain, and fatigue scores at initiation of biologic therapy, comparing a high vs medium BSA involvement and b high vs low BSA involvement. BSA body surface area, VAS visual analog scale. Itch: Low BSA Extent, n = 113; Medium BSA Extent, n = 769; High BSA Extent, n = 755. Skin Pain: Low BSA Extent, n = 113; Medium BSA Extent, n = 768; High BSA Extent, n = 754. Fatigue: Low BSA Extent, n = 113; Medium BSA Extent, n = 769; High BSA Extent, n = 755. Medians and interquartile ranges are denoted by solid and dashed lines, respectively. Patients with greater BSA involvement tended to have greater symptom burden, but there is a large amount of overlap in distribution of scores
Overlap statistics comparing PRO measures in patients with high versus medium BSA involvement ranged from 0.52 to 0.59 (Fig. 3). These statistics are interpreted as similar likelihood that a randomly selected patient with high BSA involvement would have at least the same or greater impairment in quality of life and symptom burden as a randomly selected patient with medium BSA involvement (i.e., a randomly selected patient with high BSA will have the same or greater burden as a patient with medium BSA in 52–59% of comparisons). Overlap statistics were higher (range 0.60–0.70) when comparing PRO measures in patients with high versus low BSA involvement, indicating that a randomly selected patient with high BSA involvement would have at least the same or greater impairment in quality of life and symptom burden as a patient with low BSA involvement in 60–70% of comparisons. Overlap statistics showed high levels of similarity (range 0.44–0.58) when comparing other psoriasis disease characteristics and medical history across BSA groups, and most confidence intervals included 0.50, indicating complete overlap (Fig. 3).
Fig. 3.
Overlap statistics with 95% confidence intervals comparing PRO measures (above the blue line) and disease activity measures (below the blue line) among patients with low, medium, and high BSA involvement at the time of initiation of biologic therapy. BSA body surface area, DLQI Dermatology Life Quality Index, PEST Psoriasis Epidemiology Screening Tool, PRO patient-reported outcome, VAS visual analog scale. In the overall analysis population, Low BSA Extent, n = 114; Medium BSA Extent, n = 769; High BSA Extent, n = 757. Overlap statistics comparing PRO measures ranged from 0.52 to 0.59 for comparisons of patients with high versus medium BSA involvement and from 0.60 to 0.70 for comparisons of patients with high versus low BSA involvement. Overlap statistics show high levels of similarity (range 0.44–0.58) in psoriasis disease characteristics and medical history across BSA involvement groups; most confidence intervals included 0.50, indicating complete overlap
Discussion
Published data on the use of biologics for the treatment of psoriasis in patients with low BSA involvement are limited, creating knowledge gaps in understanding disease features in this population, and potentially resulting in undertreatment and suboptimal clinical outcomes [9, 23]. Patients with limited overall BSA involvement may have isolated moderate or severe psoriasis at high-impact sites, which can be difficult to treat with topical therapies. Biologics targeting IL-17 or IL-23 are effective treatments for psoriasis affecting high-impact areas, including the scalp, nails, hands, and feet [24–27]. However, patients with low BSA psoriasis and burdensome symptoms who are candidates for biologic therapy (according to the clinician’s judgement) may not meet a payer’s criteria for eligibility to receive advanced psoriasis treatment options [4, 9, 23, 28]
Current International Psoriasis Council (IPC), American Academy of Dermatology, and National Psoriasis Foundation treatment guidelines recommend that indicators of psoriasis disease burden beyond BSA, including involvement of high-impact sites and failure of topical therapies, be considered when determining whether patients are eligible for systemic treatment [3, 4]. In the current analysis, many (46.5%) of the patients with low BSA had high-impact site involvement, including the scalp, nails, palms and soles, and/or intertriginous areas, and 80.7% had prior but not current use of topical therapy at the time of initiation of biologic therapy. Overall, characterization of PRO measures across the BSA spectrum showed that the burden of psoriasis was similar in patients with low, medium, and high BSA involvement at the time of initiating biologic therapy, suggesting that treatment decisions are being made to use biologics in appropriate patients with low BSA involvement.
Results from this analysis are consistent with findings from another CorEvitas Psoriasis Registry study that evaluated systemic treatment eligibility based on IPC guidelines [28]. In that analysis, among 2265 candidates for systemic therapy, only 56.2% had high BSA involvement. However, many candidates met other criteria for eligibility: 53.2% had a history of psoriasis affecting high-impact sites, and 55.2% reported prior but not current use of topical therapy [28]. Other criteria, such as the presence of or risk factors for development of PsA, should also be considered when assessing disease severity in patients with low BSA involvement [29].
Strengths and Limitations
The current study used robust registry data and novel methodology to describe the high disease burden that is often experienced by patients with psoriasis, regardless of their level of BSA involvement, at the time of initiation of biologic therapy. The CorEvitas Psoriasis Registry collects longitudinal real-world data from > 20,000 patients and > 650 dermatologists related to psoriasis treatment, as well as a range of patient- and physician-reported disease outcome measures that may not be available in other data sources, such as claims data. The large size and extensive number of outcomes assessed in the registry allowed for statistical comparison of data between patients with low, medium, and high BSA involvement at the time of initiation of biologic therapy. The time point used in this analysis provides a unique perspective that may be especially helpful for patients and clinicians who are making decisions about starting biologic therapy.
A limitation of this analysis is that per registry inclusion criteria, patients could have started or switched to a biologic therapy within 12 months prior to the enrollment date. Therefore, true baseline data at the time of initiating biologic treatment may not have been captured, and psoriasis BSA involvement and PRO measures may have improved before enrollment in the registry. The smaller sample size of the low BSA group (n = 114) compared with the medium and high BSA groups (both n > 750) reduced the statistical power of comparisons of low versus medium and high BSA groups, resulting in larger confidence intervals than for comparisons between the medium and high BSA groups (Fig. 3). Additionally, the smaller sample size of the low BSA group may indicate that dermatologists are selective in their decisions to prescribe biologics in patients with low BSA, reserving them for patients with indicators of more severe disease burden. Yet another limitation of this analysis is that the higher prevalence of PsA in the low BSA group may have confounded overlap statistical results for some variables (e.g., fatigue). However, the higher prevalence of PsA in the low BSA group is consistent with recommendations to reserve biologics for patients with more severe disease, including those who may have less skin involvement but burdensome joint symptoms [29].
Conclusions
The observed overlap in PRO measures across BSA groups shows that at the time of initiation of biologic therapy, patients with low BSA have similarly poor quality of life and high symptom burden compared with patients with higher BSA involvement. These outcomes support the use of biologics as appropriate treatments for patients with high disease burden, regardless of BSA involvement.
Acknowledgements
The CorEvitas Psoriasis Registry was developed in collaboration with the National Psoriasis Foundation (NPF). We thank the patients in the CorEvitas Psoriasis Registry for their participation in the study.
Medical Writing, Editorial and Other Assistance
Editorial and writing support was provided by Cherie Koch, PhD, an employee of Johnson & Johnson, under the direction of the authors in accordance with Good Publication Practice guidelines (Ann Intern Med 2022;175:1298–1304).
Author Contributions
Study conception and design or acquisition of data: April W. Armstrong, Steven R. Feldman, Timothy Fitzgerald, Theodore Alkousakis, Adam Sima, Alvin Li, Hyung-Joo Kang, Sandra I. Main, Saakshi Khattri, Linda Stein Gold. Data analysis: Adam Sima, Alvin Li, Hyung-Joo Kang, Sandra I. Main. Data interpretation: April W. Armstrong, Steven R. Feldman, Timothy Fitzgerald, Theodore Alkousakis, Adam Sima, Alvin Li, Hyung-Joo Kang, Sandra I. Main, Saakshi Khattri, Linda Stein Gold. Drafting the article or revising it critically for important intellectual content: April W. Armstrong, Steven R. Feldman, Timothy Fitzgerald, Theodore Alkousakis, Adam Sima, Alvin Li, Hyung-Joo Kang, Sandra I. Main, Saakshi Khattri, Linda Stein Gold. Final approval of the version to be published: April W. Armstrong, Steven R. Feldman, Timothy Fitzgerald, Theodore Alkousakis, Adam Sima, Alvin Li, Hyung-Joo Kang, Sandra I. Main, Saakshi Khattri, Linda Stein Gold. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved: April W. Armstrong, Steven R. Feldman, Timothy Fitzgerald, Theodore Alkousakis, Adam Sima, Alvin Li, Hyung-Joo Kang, Sandra I. Main, Saakshi Khattri, Linda Stein Gold.
Funding
This study was sponsored by CorEvitas, LLC, and the analysis and all manuscript-related activities were funded by Johnson & Johnson. Access to study data was limited to CorEvitas, and CorEvitas statisticians completed all the analysis; all authors contributed to the interpretation of the results. CorEvitas has been supported through contracted subscriptions in the last two years by AbbVie, Amgen, Arena, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, Eli Lilly, Genentech, GSK, Johnson & Johnson, LEO, Novartis, Ortho Dermatologics, Pfizer, Sun, and UCB. The journal’s Rapid Service Fees were paid by Johnson & Johnson.
Data Availability
Data are available from CorEvitas, LLC through a commercial subscription agreement and are not publicly available. No additional data are available from the authors.
Declarations
Conflict of Interest
April W. Armstrong has served as a research investigator and/or consultant to AbbVie, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly, Johnson & Johnson, KHK, Leo, Modernizing Medicine, Novartis, Ortho Dermatologics, Regeneron, Sanofi, Sun Pharma, and UCB. Steven R. Feldman has received research, speaking and/or consulting support from: AbbVie, Accordant, Almirall, Amgen, Arcutis, Arena, Argenx, Biocon, Boehringer Ingelheim, Bristol Myers Squibb, Caremark, Celgene, Dermavant, Eli Lilly, Eurofins, Forte, Galderma, GlaxoSmithKline/Stiefel, Helsinn, Informa, Johnson & Johnson, Leo Pharma, Menlo, Merck, Mylan, Novan, Novartis, Ortho Dermatology, Pfizer, Qurient, Regeneron, Samsung, Sanofi, Sun Pharma, Teladoc, the National Biological Corporation, the National Psoriasis Foundation, UCB, UpToDate, and vTv Therapeutics. He is founder and part owner of Causa Research and holds stock in Sensal Health. Steven R. Feldman is an Editorial Board member of Dermatology and Therapy. Steven R. Feldman was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Timothy Fitzgerald and Theodore Alkousakis are employees and shareholders of Johnson & Johnson. Adam Sima is an employee of CorEvitas, LLC, and a shareholder of Thermo Fisher Scientific. Hyung-Joo Kang is an employee of CorEvitas, LLC. Alvin Li is an employee of CorEvitas, LLC, and a stockholder of Eli Lilly. Sandra I. Main is a former employee of CorEvitas, LLC. She is currently an employee of the Health Plan of San Joaquin. Saakshi Khattri has received support for research from Bristol Myers Squibb, Celgene, LEO, Pfizer, and Takeda; as a speaker from AbbVie, Arcutis, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, LEO, Pfizer, Regeneron, Sanofi, and UCB; and as a consultant for AbbVie, Eli Lilly, Johnson & Johnson, Regeneron, Sanofi, and UCB. Linda Stein Gold is an investigator/advisor and/or speaker for AbbVie, Amgen, Arcutis, Bristol Myers Squibb, Dermavant, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, and UCB.
Ethical Approval
This study was performed in accordance with the Declaration of Helsinki and Guidelines for Good Pharmacoepidemiology Practice (GPP). All participating investigators were required to obtain full board approval for conducting noninterventional research involving human subjects with a limited dataset. Sponsor approval and continuing review was obtained through a central institutional review board (IRB; Advarra, Protocol number is Pro00051221). For academic investigative sites that did not receive a waiver to use the central IRB, full board approval was obtained from the respective governing IRBs, and documentation of approval was submitted to CorEvitas, LLC, prior to the initiation of any study procedures. All patients in the registry were required to provide written informed consent and authorization prior to participating.
Footnotes
Prior Presentation: Portions of this work were presented in poster format at Maui Derm NP + PA Summer 2024, June 19–22, 2024, Colorado Springs, Colorado, USA.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Data are available from CorEvitas, LLC through a commercial subscription agreement and are not publicly available. No additional data are available from the authors.