Abstract
Introduction
Tildrakizumab is an interleukin-23 p19 inhibitor approved for the treatment of adults with moderate-to-severe plaque psoriasis. While clinical trials have demonstrated tildrakizumab efficacy, studies reporting real-world treatment patterns and outcomes for tildrakizumab initiators in North America are needed.
Methods
This analysis included patients who initiated tildrakizumab (October 2018 to April 2024) at or after enrollment in the PPD™ CorEvitas™ Psoriasis Registry, an independent observational study of patients with psoriasis under dermatologic care. Drug survival was analyzed using Kaplan-Meier analysis. Effectiveness was assessed by changes from baseline to 12 (± 3) months in outcomes, including Psoriasis Area Severity Index (PASI), Dermatology Life Quality Index (DLQI), and patient-reported skin pain, itch, and fatigue (scales, 0–100). Results were presented overall and by prior experience with biologic treatments.
Results
There were 728 tildrakizumab initiators with mean age 58.4, mean PASI 7.7 (standard deviation [SD] 7.3), mean DLQI 7.3 (SD 6.2), and mean patient-reported skin pain, itch, and fatigue scores of 29.7 (SD 32.5), 46.0 (SD 34.4), and 32.3 (SD 29.4), respectively; 47.7% were female, and 383 (52.6%) were biologic-experienced. Restricted mean drug survival for all, biologic-naïve, and biologic-experienced initiators with follow-up was 35.2, 43.3, and 29.5 months, respectively; overall 12-month persistence was 72.8%. Patients with 12 months follow-up (n = 330) had mean improvements from baseline in PASI (4.9, SD 7.0), DLQI (3.9, SD 5.9), and skin pain (mean 13.1, SD 29.9), itch (mean 22.1, SD 34.7), and fatigue (mean 6.7, SD 29.1); 71.3% and 52.9% achieved PASI ≤ 3 and ≤ 1, respectively.
Conclusions
Based on clinician- and patient-reported outcomes and a mean drug survival of almost 3 years, tildrakizumab was effective among real-world patients with plaque psoriasis.
Supplementary Information
The online version contains supplementary material available at https://doi.org/10.1007/s13555-026-01843-6.
Keywords: Psoriasis, Real-world evidence, Tildrakizumab
Key Summary Points
| Why carry out this study? | |
| • Limited evidence exists about the real-world effectiveness of tildrakizumab in North American patients with moderate-to-severe plaque psoriasis. | |
| • This study evaluated drug survival, effectiveness, and treatment patterns among patients who initiated tildrakizumab (tildrakizumab initiators) in the United States (US) and Canada, overall and by biologic experience. | |
| What was learned from the study? | |
| • Tildrakizumab had a mean drug survival of almost three years, and both biologic-naïve and biologic-experienced initiators had improvements in clinician- and patient-reported outcomes at one year after tildrakizumab initiation. | |
| • The findings support tildrakizumab effectiveness among real-world patients with plaque psoriasis. |
Introduction
Psoriasis is a chronic inflammatory disease characterized by skin lesions with epidermal hyperproliferation, abnormal keratinocyte differentiation, and lymphocyte infiltration, which can affect numerous aspects of patients’ health-related quality of life (HRQoL) [1, 2]. Treatment for psoriasis may be based on disease severity, location, presence of psoriatic arthritis, other comorbidities, and multiple other factors [3]. Topical treatment is often sufficient for patients with mild disease, while patients with > 10% of their body surface area (BSA) affected, with lesions on the scalp, face, palms/soles, or genitals, or who do not respond to topical therapy should receive systemic therapy [1]. Conventional disease-modifying anti-rheumatic drugs (DMARDs) have long been a mainstay, but newer agents drastically changed psoriasis treatment by targeting specific inflammatory mediators, such as tumor necrosis factor (TNF), interleukin (IL)-17, and IL-23 [1].
Tildrakizumab, an IL-23 p19 inhibitor, was approved for the treatment of adults with moderate-to-severe plaque psoriasis in the USA in March 2018 and in Europe in September 2018. Data from two pivotal trials demonstrated that tildrakizumab was well tolerated and efficacious up to 5 years after initiation [4], while several real-world studies in European countries [5–10] also have been promising. However, studies on the real-world effectiveness of tildrakizumab in North American populations are limited [11, 12].
To address this need for real-world evidence, this study evaluated effectiveness, drug survival, and treatment patterns among patients who initiated tildrakizumab (tildrakizumab initiators) in the US and Canada, overall and by biologic experience.
Methods
Source Population
Launched in April 2015, the PPD™ CorEvitas™ Psoriasis Registry is a prospective, multicenter, non-interventional registry of patients with psoriasis under the care of a dermatologist in the US and Canada. The Registry collects longitudinal data from both clinicians and patients using standardized questionnaires during routine outpatient clinical encounters; approval has been obtained for the use of all clinician- and patient-reported outcome measures as needed.
To be eligible for enrollment into the Registry, a patient must satisfy the following inclusion criteria: be aged ≥ 18 years, provide written informed consent for participation, and start or switch to an eligible systemic psoriasis treatment at or within 12 months before enrollment. Briefly, eligible medications have changed over time and include approved biologic treatments: TNF inhibitors (TNFi), IL-12/23 inhibitors (IL-12/23i), IL-23 inhibitors (IL-23i), IL-17 inhibitors (IL-17i), and the nonbiologic systemic small-molecule inhibitors apremilast and deucravacitinib. Further details about the Registry have been previously described [13].
Study Population
Tildrakizumab initiators (99% with 100 mg) between October 2018 and April 2024 with valid baseline and follow-up visits were identified from the CorEvitas Psoriasis Registry (Supplemental Figure S1). Patients were assessed overall and stratified by history of any prior biologic treatment for psoriasis: biologic-naïve, i.e., patients without prior biologic treatment, or biologic-experienced, i.e., patients with a history of biologic treatment prior to tildrakizumab initiation.
Measures
Baseline measures included sociodemographic characteristics, history of comorbidities, psoriasis disease characteristics and severity, patient-reported outcomes, and prior and concomitant medications. Outcomes of interest included persistence and drug survival as measured by time to discontinuation of tildrakizumab, as well as clinician-reported (e.g., Psoriasis Area and Severity Index [PASI], BSA, Investigator’s Global Assessment [IGA, used with permission from Novartis]) and patient-reported (e.g., Dermatology Life Quality Index [DLQI, © Dermatology Life Quality Index. A Y Finlay, G K Khan, April 1992, used with permission], visual analog scales [VAS] for pain, itch, and fatigue) outcomes. All baseline and outcome measures are detailed in Supplemental Table S1.
Statistical Analysis
Baseline characteristics were summarized overall and stratified by biologic experience. Kaplan-Meier plots were used to assess time to discontinuation of tildrakizumab; log-rank tests were used to determine whether differences by biologic experience were statistically significant. Restricted mean survival time estimates, median time to discontinuation, and proportion of initiators who were persistent up to 24 months after initiation were calculated. Mean changes from baseline to 12 (± 3)-month follow-up (follow-up minus baseline) were calculated for continuous clinician- and patient-reported outcomes. Achievement rates at 12 (± 3) months were calculated for binary outcomes. Differences between strata were assessed for significance using paired Student’s t-tests for continuous measures or chi-square (χ2) tests for dichotomous measures. R version 4.2.3 (The R Foundation for Statistical Computing, Vienna, Austria) was used for all analyses.
Ethics
The study was performed in accordance with the Declaration of Helsinki and the Guidelines for Good Pharmacoepidemiology Practice. All participating investigators were required to obtain full board approval for conducting research involving human subjects. Sponsor approval and continuing review were obtained through a central institutional review board (IRB, Advarra, protocol no. Pro00051221). For academic investigative sites that did not receive a waiver to use the central IRB, approval was garnered from the respective governing IRBs, and documentation of approval was submitted to the Sponsor before initiating any study procedures. All Registry participants provided written informed consent for participation and publication.
Results
Of 728 tildrakizumab initiators, 345 (47.4%) were biologic-naïve and 383 (52.6%) were biologic-experienced, with an overall mean [standard deviation (SD)] age of 58.4 [15.8] years. At baseline, patients with biologic experience had a higher mean age (59.2 [15.1] years vs. 57.5 [16.6] years), a greater proportion of female patients (49.6% vs. 45.5%), longer disease duration (20.0 [16.1] years vs. 12.2 [15.2] years), a higher prevalence of psoriatic arthritis (44.4% vs. 16.1%), and lower disease burden based on many disease activity and patient-reported outcome measures than patients without biologic experience (Table 1). Among patients with biologic experience, immediate prior treatment included IL-17i (30.2%), TNFi (21.0%), IL-23i (20.2%), and IL-12/23i (16.3%).
Table 1.
Selected baseline patient characteristics for tildrakizumab initiators in the PPD CorEvitas Psoriasis Registry, overall and by biologic experience
| Overall N = 728 |
Biologic-naïve N = 345 |
Biologic-experienced N = 383 |
Standardized differencesa | |
|---|---|---|---|---|
| Age (years), mean (SD) | 58.4 (15.8) | 57.5 (16.6) | 59.2 (15.1) | 0.105 |
| Sex, n (%) | ||||
| Female | 347 (47.7%) | 157 (45.5%) | 190 (49.6%) | 0.041 |
| Male | 381 (52.3%) | 188 (54.5%) | 193 (50.4%) | |
| Race, n (%) | ||||
| White | 592 (81.3%) | 271 (78.6%) | 321 (83.8%) | 0.072 |
| Black/African American | 30 (4.1%) | 18 (5.2%) | 12 (3.1%) | |
| Other | 106 (14.6%) | 56 (16.2%) | 50 (13.1%) | |
| Ethnicity (Hispanic), n (%) | 61 (8.6%) | 32 (9.5%) | 29 (7.8%) | 0.032 |
| BMI (kg/m2), mean (SD) | 30.6 (7.3) | 30.1 (7.4) | 31.0 (7.1) | 0.118 |
| PsO duration (years), mean (SD) | 16.3 (16.1) | 12.2 (15.2) | 20.0 (16.1) | 0.497 |
| Psoriatic arthritis (PsA), n (%) | 223 (31.0%) | 55 (16.1%) | 168 (44.4%) | 0.306 |
| PASI (0–72), mean (SD) | 7.7 (7.3) | 9.6 (7.7) | 5.9 (6.3) | 0.535 |
| BSA (%), mean (SD) | 13.6 (15.3) | 16.0 (15.0) | 11.5 (15.3) | 0.300 |
| IGA, mean (SD) | 2.6 (1.0) | 2.9 (0.8) | 2.3 (1.2) | 0.594 |
| DLQI (0–30), mean (SD) | 7.3 (6.2) | 8.2 (5.9) | 6.4 (6.4) | 0.282 |
| Itch/pruritus (VAS range 0–100), mean (SD) | 46.0 (34.4) | 51.5 (32.8) | 41.1 (35.2) | 0.305 |
| Fatigue (VAS range 0–100), mean (SD) | 32.3 (29.4) | 32.1 (28.6) | 32.4 (30.1) | 0.009 |
| Skin pain (VAS range 0–100), mean (SD) | 29.7 (32.5) | 33.4 (33.3) | 26.3 (31.4) | 0.221 |
aStandardized differences calculated as Cohen’s w or Cohen’s d statistics for categorical or continuous characteristics, respectively
BMI body mass index, BSA body surface area, DLQI Dermatology Life Quality Index, IGA Investigator’s Global Assessment, PASI Psoriasis Area and Severity Index, PsO psoriasis, SD standard deviation, VAS visual analog scale
Among tildrakizumab initiators with at least one follow-up after initiation (n = 481), the mean time to discontinuation was 35.2 months overall, 43.3 months for biologic-naïve initiators, and 29.5 months for biologic-experienced initiators (Table 2, Supplemental Figure S2). Overall, 87.4% of initiators were persistent on therapy at 6 months (95.0% biologic-naïve and 81.3% biologic-experienced), 72.8% were persistent at 12 months (85.6% biologic-naïve and 63.3% biologic-experienced), 65.7% were persistent at 18 months (82.5% biologic-naïve and 53.4% biologic-experienced), and 61.2% were persistent at 24 months (76.2% biologic-naïve and 50.1% biologic-experienced) (Table 2, Supplemental Figure S3).
Table 2.
Persistence of therapy for tildrakizumab initiators with follow-up visits in the CorEvitas Psoriasis Registry, overall and by biologic experience
| Proportion (95% CI) persistent at | ||||||
|---|---|---|---|---|---|---|
| Restricted mean survival time (months) | Median (95% CI) time (months) | 6 months | 12 months | 18 months | 24 months | |
| All initiators | 35.2 |
34.3 (30.3, NAa) |
0.874 (0.844, 0.904) |
0.728 (0.686, 0.771) |
0.657 (0.611, 0.706) |
0.612 (0.562, 0.665) |
| Biologic-naïve | 43.3 |
NAa (34.3, NAa) |
0.950 (0.921, 0.981) |
0.856 (0.805, 0.909) |
0.825 (0.769, 0.885) |
0.762 (0.693, 0.838) |
| Biologic-experienced | 29.5 |
24.9 (16.1, 34.5) |
0.813 (0.768, 0.861) |
0.633 (0.576, 0.697) |
0.534 (0.472, 0.605) |
0.501 (0.437, 0.574) |
a NA indicates that the median or upper confidence interval limit cannot be calculated because of a low number of failures
Among initiators with 12-month follow-up (n = 330), both patients with and without biologic experience had improvements in many clinician- and patient-reported outcomes, including PASI, BSA, DLQI, skin pain, and itch (Table 3). Overall, mean (SD) reductions from baseline were − 4.9 (7.0) for PASI, − 9.5% (14.0%) for BSA, − 3.9 (5.9) for DLQI, − 13.1 (29.9) for skin pain, and − 22.1 (34.7) for itch. Moreover, 56.1% achieved PASI 75, 32.2% achieved PASI 100, 71.2% achieved BSA ≤ 3%, 52.0% achieved DLQI 0/1, and 68.8% and 72.0% achieved decreases of ≥ 20 points in skin pain and itch, respectively, at 12 months. Results stratified by biologic experience are shown in Table 3; patients without biologic experience had significantly greater improvements in all disease activity outcomes as well as DLQI, skin pain, and itch.
Table 3.
Changes from baseline to 12-month follow-up for tildrakizumab initiators in the CorEvitas Psoriasis Registry, overall and by biologic experience
| Outcomea | Overall | Biologic-naïve | Biologic-experienced | p-value |
|---|---|---|---|---|
| All initiators with 12-month follow-up | 330 | 138 | 192 | |
| PASI, mean (SD) | −4.9 (7.0) | −7.6 (7.6) | −2.7 (5.7) | <0.001 |
| PASI 75, n/N (%) | 148/264 (56.1%) | 85/125 (68.0%) | 63/139 (45.3%) | <0.001 |
| PASI 90, n/N (%) | 110/264 (41.7%) | 67/125 (53.6%) | 43/139 (30.9%) | <0.001 |
| PASI 100, n/N (%) | 85/264 (32.2%) | 49/125 (39.2%) | 36/139 (25.9%) | 0.021 |
| PASI ≤3, n/N (%) | 107/150 (71.3%) | 60/75 (80.0%) | 47/75 (62.7%) | 0.019 |
| PASI ≤1, n/N (%) | 101/191 (52.9%) | 56/92 (60.9%) | 45/99 (45.5%) | 0.033 |
| BSA, mean (SD) | −9.5 (14.0) | −12.7 (13.3) | −6.8 (13.9) | <0.001 |
| BSA ≤3%, n/N (%) | 153/215 (71.2%) | 89/105 (84.8%) | 64/110 (58.2%) | <0.001 |
| IGA, mean (SD) | −1.3 (1.3) | −1.9 (1.2) | −0.8 (1.3) | <0.001 |
| IGA 0/1, n/N (%) | 142/239 (59.4%) | 86/121 (71.1%) | 56/118 (47.5%) | <0.001 |
| DLQI, mean (SD) | −3.9 (5.9) | −5.7 (5.8) | −2.4 (5.5) | <0.001 |
| DLQI 0/1, n/N (%) | 117/225 (52.0%) | 70/113 (61.9%) | 47/112 (42.0%) | 0.003 |
| Skin pain, mean (SD) | −13.1 (29.9) | −20.5 (30.3) | −6.9 (28.2) | <0.001 |
| Skin pain decrease ≥20 points, n/N | 88/128 (68.8%) | 53/62 (85.5%) | 35/66 (53.0%) | <0.001 |
| Itch, mean (SD) | −22.1 (34.7) | −32.8 (34.7) | −13.2 (32.1) | <0.001 |
| Itch decrease ≥20 points, n/N | 131/182 (72.0%) | 81/93 (87.1%) | 50/89 (56.2%) | <0.001 |
| Fatigue, mean (SD) | −6.7 (29.1) | −9.1 (30.5) | −4.6 (27.9) | 0.193 |
| Fatigue decrease ≥20 points, n/N | 85/168 (50.6%) | 47/74 (63.5%) | 38/94 (40.4%) | 0.003 |
| Health state, mean (SD) | 1.5 (17.3) | 2.8 (18.2) | 0.4 (16.5) | 0.249 |
| EQ-5D-3L, mean (SD) b | 0.0 (0.1) | 0.0 (0.1) | 0.0 (0.1) | 0.423 |
aFor continuous outcomes, change from baseline to 12-month follow-up is calculated as 12-month value minus baseline value, respectively. P-values from Student’s t-test. For binary outcomes, we report the proportion of the population not achieving the outcome state at baseline who do achieve the outcome state at follow-up. P-values from chi-square tests
bEQ-5D-3L © The Medical Outcomes Trust (MOT), Health Assessment Lab (HAL) and QualityMetric Inc., used with permission
BSA body surface area, DLQI Dermatology Life Quality Index, EQ-5D-3L Euro-Quality of Life 5-Dimension 3 Level, IGA Investigator’s Global Assessment, PASI Psoriasis Area and Severity Index, SD standard deviation
Discussion
This real-world study described the effectiveness of tildrakizumab both overall and stratified by biologic experience. Overall, the restricted mean tildrakizumab survival was almost 3 years, but patients without biologic experience had a significantly longer mean time on drug and higher proportions with persistent use at 6, 12, 18, and 24 months than patients with biologic experience. Although improvements in many outcomes were greater for patients without biologic experience than for those with biologic experience, clinician- and patient-reported outcomes at 12 months were favorable for all tildrakizumab initiators.
Current findings are largely similar to those from other real-world patient populations within [11, 12] and outside of North America [5–10]. Becher et al. [5] evaluated 122 adults with psoriasis in the UK and reported that the probability of a patient persisting on tildrakizumab after 1 year was 73%, which is essentially identical to current results from this North American study. An analysis of 813 Canadian adults by Prajapati et al. demonstrated a higher probability of 1-year persistence at 88% [12]. Becher et al. also showed significant decreases in median PASI (from 12 to 0.35) and DLQI (from 20 to 0) at 12 months and beyond, with better response among patients who used tildrakizumab as a first- or second-line biologic therapy. In an uncontrolled, open-label trial in the US (N = 55), Heim et al. [11] found improvements in PASI for up to 1 year, with 33% achieving PASI100. Studies of patients in Germany (N = 150) [6] and Italy (N = 53; N = 237) [7, 9] also demonstrated improvements in PASI at 12 months; the former showed a mean decrease in PASI of > 6 points from baseline, while in the latter two, 77% and 59% of patients, respectively, achieved PASI100. DLQI was also measured in two of these studies and had a mean decrease of approximately 10 points from baseline in both [6, 7].
Differences in persistence and effectiveness between North American and European populations, as well as within-Registry differences between patients with and without biologic experience, may be attributable to differences in patient population characteristics at baseline. Younger age, lower weight, no prior biologic experience, and absence of psoriatic arthritis were associated with higher tildrakizumab efficacy in the randomized reSURFACE 1 and reSURFACE 2 clinical trials [14]. On the whole, these and other patient characteristics differed between the current and prior real-world study populations [5–8, 12]. The current North American study population was older and had a larger proportion of females than the Canadian and European studies described above and also had a greater percentage of patients with psoriatic arthritis than those from Canada, the UK, and Italy. The mean BMI was similar across studies, but the proportions of biologic-experienced patients varied from 7% to 53% (with both the current study and the Campione et al. [7] study at the upper bound of that range). Within the current North American population, patients with biologic experience were older, had a greater percentage of psoriatic arthritis, and had longer disease duration than patients without biologic experience.
Patient population characteristics also differed between the tildrakizumab initiators described here compared with initiators of other IL-23i in the CorEvitas Psoriasis Registry. For example, the mean age at tildrakizumab initiation, 58 years, is older than the risankizumab and guselkumab initiator ages (47–50 years) described in prior Registry publications [15–17]. Differences in patient characteristics must be considered when comparing IL-23i performance in a real-world setting, as such differences could influence drug effectiveness and survival.
Strengths of this study include analysis of patients from the CorEvitas Psoriasis Registry, a unique resource with large sample size and longitudinal follow-up on the real-world use of treatments for psoriasis in the US and Canada. The Registry enabled examination of treatment patterns using a large set of patient histories and characteristics, including clinical data (e.g., disease activity scores, comorbidities, and patient-reported outcomes) that are not available in all observational databases. Additional strengths of this work were the larger sample size compared with previous real-world studies of tildrakizumab [5–10], follow-up data beyond 2 years for drug survival analysis, and near-complete clinical data availability (≤ 1.5% missing data across all outcome measures).
Potential limitations of the study include those unique to the Registry and those common among observational cohorts. Patients in the CorEvitas Psoriasis Registry are not necessarily representative of all adults with psoriasis in the US and Canada; selection bias may be introduced if certain subgroups of patients (e.g., healthier or sicker patients) are routinely included or excluded from the Registry. In addition, the reasons for visits are not captured, although the assumption that the visit with a dermatologist was “psoriasis-related” is likely. Additionally, history of biologic medication use prior to enrollment is derived from patient and physician reports. Patients may not be able to recall their entire medication history, leading to potential misclassification of prior therapies. It is also possible that drug benefits, design, and formulary status changes could affect utilization patterns, particularly for patients for whom public insurance in the US limits biologic options, which would also affect the number of patients who switch medications. In addition, the Registry captures physician-reported prescribing, but there are no measures of treatment compliance. Given that effectiveness analyses included all initiators, without consideration of adherence or persistence, the benefit of tildrakizumab may be underestimated.
Conclusion
This descriptive study of real-world tildrakizumab initiators from the CorEvitas Psoriasis Registry found a mean drug survival of almost 3 years. Patients without biologic experience had a longer duration of time on tildrakizumab than those with biologic experience; underlying differences in risk factors, such as age, sex, disease duration, and comorbid psoriatic arthritis, likely contributed to this finding. As both biologic-naïve and biologic-experienced initiators showed improvements in clinician- and patient-reported outcomes 1 year after tildrakizumab initiation, the results of this study support the effectiveness of tildrakizumab among real-world patients with moderate-to-severe plaque psoriasis in North America.
Supplementary Information
Below is the link to the electronic supplementary material.
Acknowledgements
The authors would like to thank all the investigators, their clinical staff, and patients who participate in the CorEvitas Psoriasis Registry.
Medical Writing/Editorial Assistance
Medical writing assistance was provided by Kelly Strutz, PhD, and editorial assistance by Justine Long and Megan Phillips, all of Thermo Fisher Scientific and funded by Sun Pharmaceutical Industries Limited. Additional feedback on the manuscript was provided by Jennifer Evans, DVM, MPH, of Thermo Fisher Scientific.
Author Contributions
Jerry Bagel contributed to the conception of the work, interpretation of data, and critical revision of the manuscript. Ranga Gogineni contributed to the conception and design of the work, interpretation of data, and critical revision of the manuscript. Asif Shaikh contributed to the conception and design of the work, interpretation of data, and critical revision of the manuscript. Taylor Blachley contributed to the design of the work, acquisition, analysis, and interpretation of data, and drafting and critical revision of the manuscript. Thomas Eckmann contributed to the analysis and interpretation of data and critical revision of the manuscript. Alicia Beeghly contributed to the design of the work, interpretation of data, and drafting and critical revision of the manuscript. Mark G Lebwohl contributed to the conception of the work, interpretation of data, and critical revision of the manuscript. All authors approve the final version of the manuscript.
Funding
This study was sponsored by the PPD™ clinical research business of Thermo Fisher Scientific, and the analysis (including the supplement) was funded by Sun Pharmaceutical Industries Limited. The journal’s Rapid Service Fee was funded by Sun Pharmaceutical Industries Ltd. Access to study data was limited to PPD™ CorEvitas™ Clinical Registries and our statisticians completed all the analysis; all authors contributed to the interpretation of the results. CorEvitas has been supported through contracted subscriptions in the last 2 years by AbbVie, Amgen, Inc., Arena, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, Eli Lilly and Company, Genentech, GSK, Janssen Pharmaceuticals, Inc., LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Inc., Sun Pharmaceutical Industries Limited., and UCB S.A. The CorEvitas Psoriasis Registry was developed in collaboration with the National Psoriasis Foundation (NPF).
Data Availability
Data are available from the PPD™ clinical research business of Thermo Fisher Scientific through a commercial subscription agreement and are not publicly available. No additional data are available from the authors.
Declarations
Conflicts of Interest
Jerry Bagel has received research funds for the Psoriasis Treatment Center from AbbVie, Amgen, Arcutis Biotherapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Celgene Corporation, Corrona LLC, Dermavant Sciences, Dermira, Lilly, Glenmark Pharmaceuticals Ltd, Janssen, Kadmon Corporation, LEO Pharma, Lycera Corp, Menlo Therapeutics, Novartis, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sun Pharma, Taro Pharmaceutical Industries Ltd, and UCB; is or has been a consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene Corporation, Lilly, Janssen, Novartis, Sun Pharma, and UCB; and is or has been a speaker for AbbVie, Celgene Corporation, Eli Lilly, Janssen, and Novartis. Ranga Gogineni and Asif Shaikh are employees of Sun Pharmaceutical Industries, Inc. Taylor Blachley, Thomas Eckmann, and Alicia Beeghly are employees and shareholders of Thermo Fisher Scientific. Mark G Lebwohl is an employee of Mount Sinai and receives research funds from AbbVie, Arcutis Biotherapeutics, Avotres Therapeutics, Boehringer Ingelheim, Cara Therapeutics, Clexio, Dermavant Sciences, Eli Lilly, Incyte, Inozyme, Janssen, Pfizer, Sanofi-Regeneron, and UCB; and is a consultant for Almirall; AltruBio; Apogee; Arcutis Biotherapeutics; AstraZeneca; Atomwise; Avotres Therapeutics; Boehringer Ingelheim; Bristol Myers Squibb; Castle Biosciences; Celltrion; PPD™ CorEvitas™ Clinical Registries, Thermo Fisher Scientific; Dermavant Sciences; Dermsquared; Evommune; Facilitation of International Dermatology Education; Forte Biosciences; Galderma; Genentech; Incyte; LEO Pharma; Meiji Seika Pharma; Mindera; Pfizer; Sanofi-Regeneron; Seanergy; Strata; Takeda; Trevi; and Verrica. Mark G Lebwohl is an Editorial Board member of Dermatology and Therapy. Mark G Lebwohl was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.
Ethical Approval
The study was performed in accordance with the Declaration of Helsinki and the Guidelines for Good Pharmacoepidemiology Practice. All participating investigators were required to obtain full board approval for conducting research involving human subjects. Sponsor approval and continuing review were obtained through a central institutional review board (IRB, Advarra, protocol no. Pro00051221). For academic investigative sites that did not receive a waiver to use the central IRB, approval was garnered from the respective governing IRBs and documentation of approval was submitted to the Sponsor prior to initiating any study procedures. All Registry participants provided written informed consent for participation and publication.
Footnotes
Prior publication: An earlier version of this analysis was presented at the American Academy of Dermatology Annual Meeting, Orlando, FL, March 7-11, 2025, poster #62638.
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Data Availability Statement
Data are available from the PPD™ clinical research business of Thermo Fisher Scientific through a commercial subscription agreement and are not publicly available. No additional data are available from the authors.