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Introduction: Several current therapies for autoimmune diseases do not provide sustained remission. Therapies that focus on the restoration of homeostasis within the immune system (i.e., immune resolution) could overcome the limitations of current therapies and provide more durable remission. However, there is no established consensus on appropriate clinical trial designs and endpoints to evaluate such therapies. Therefore, we conducted a systematic literature review (SLR) focusing on five index diseases (asthma, atopic dermatitis, rheumatoid arthritis, systemic lupus erythematosus [SLE], and ulcerative colitis) to explore published literature on 1) expert opinion on immune-resolution outcomes that should be measured in clinical trials; and 2) quantification of immune resolution in previous clinical trials., Methods: The SLR was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Embase and MEDLINE databases were systematically searched (2013-2023) for published English language articles. Conference proceedings (2020-2022) from American Academy of Dermatology, American College of Rheumatology, Digestive Disease Week, European Alliance of Associations for Rheumatology, and European Academy of Dermatology and Venereology were searched to include relevant abstracts. The study protocol was registered in PROSPERO (CRD42023406489)., Results: The SLR included 26 publications on 20 trials and 12 expert opinions. Expert opinions generally lacked specific recommendations on the assessment of immune resolution in clinical trials and instead suggested targets or biomarkers for future therapies. The targets included thymic stromal lymphopoietin ( TSLP ) in asthma; T helper (Th)2 and Th22 cells and their respective cytokines (interleukin [IL]-4R and IL-22) in atopic dermatitis; inhibitory/regulatory molecules involved in T-cell modulation, and protein tyrosine phosphatase, non-receptor type 22 ( PTPN22 ) in rheumatoid arthritis; low-dose IL-2 therapy in SLE; and pro-resolution mediators in ulcerative colitis and asthma. In the interventional studies, direct biomarker assessments of immune resolution were the number/proportion of regulatory T-cells (Treg) and the ratio Th17/Treg in SLE and rheumatoid arthritis; the number of T follicular helper cells (Tfh), Th1, Th2, Th17, and Th22 in atopic dermatitis, rheumatoid arthritis, and SLE; and mucosal proinflammatory gene signatures (tumor necrosis factor [ TNF ], interleukin 1 alpha [ IL1A ], regenerating family member 1 alpha [ REG1A ], IL8 , interleukin 1 beta [ IL1B ], and leukocyte immunoglobulin-like receptors A [ LILRA ]) in ulcerative colitis. Several studies reported a statistically significant relationship between clinical remission and immune-resolution biomarkers, suggesting a link between T-cell homeostasis, cytokine production, and disease activity in autoimmune diseases., Discussion: Existing literature does not offer clear guidance on the evaluation of immune resolution in interventional studies. Further research and consensus are needed to assess a treatment's ability to induce long-term remission or low disease activity., Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023406489, identifier CRD42023406489., Competing Interests: PK: Employment and stockholder, Eli Lilly and Company. LL: Employment, Evidera Inc. BM: Employment and stockholder, Eli Lilly and Company. II: Employment, Evidera Inc. RB: Employment and stockholder, Eli Lilly and Company. AC: Employment and stockholder, Eli Lilly and Company. JP: Employment and stockholder, Eli Lilly and Company. AN: Former employee and stockholder, Eli Lilly and Company. Work related to the systematic literature review was performed during his tenure at Eli Lilly and Company. The authors declare that this study received funding from Eli Lilly and Company, United States. The funder had the following involvement in the study: Funding for the study and all support for the manuscript., (Copyright © 2024 Klekotka, Lavoie, Mitchell, Iheanacho, Burge, Cohee, Puckett and Nirula.)

Hidradenitis suppurativa (HS) is an inflammatory skin disease associated with high morbidity and disability that has limited treatment options. People from racial and ethnic minority groups may experience greater disease severity and delay to diagnosis. This study assessed the impact of race/ethnicity on HS diagnosis and management in real-world clinical settings. Data were derived from the Adelphi Real World Hidradenitis Suppurativa Disease Specific Programme, a survey of dermatologists and their consulting HS patients in five European countries and the USA in 2020/2021. Dermatologists returned demographic and clinical data, and treatment goals and satisfaction for their next five to seven consulting patients. Patients completed a questionnaire on disease history and diagnosis, disease burden, and treatment satisfaction. Groups were compared with bivariate tests. In total, 312 physicians returned data on 1787 patients; 57.6% were female and 77.7% White. People from racial and ethnic minority groups were younger than White patients (32.9 ± 11.6 vs. 34.9 ± 12.4, mean ± standard deviation) and reported symptoms at a younger age (23.3 ± 10.8 vs. 26.2 ± 11.1), but their time to first consultation was longer than for White patients (2.6 ± 5.7 vs. 1.2 ± 2.5 years). People from racial and ethnic minority groups took longer to receive a correct diagnosis following first consultation (2.7 ± 5.3 vs. 1.5 ± 4.1 years) and were more likely to be misdiagnosed with boils (73.5% vs. 40.4%). People from racial and ethnic minority groups had a greater disease awareness at diagnosis and reported wanting greater support. People from racial and ethnic minority groups reported a greater impact on life, more severe pain, and a greater level of activity impairment in the Work Productivity and Activity Impairment: General Health (27.0 ± 25.2 vs. 20.0 ± 20.6). All P values were ≤0.05. These data show evidence of delayed diagnosis and higher HS symptom burden amongst people from racial and ethnic minority groups, highlighting health disparities in HS., (© 2024 Eli Lilly and Company. Adelphi Real World and The Author(s). The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.)

Background: Hidradenitis suppurativa (HS) has unique symptoms and physical features among skin diseases. Patient reported outcome measures (PROMs) agnostic to specific skin diseases may not fully characterise the influence of HS on quality of life (QoL). A HS-specific PROM is needed to capture the impact of HS on QoL in the real-world setting., Objective: To validate the Hidradenitis Suppurativa Quality of Life Questionnaire (HiSQOL) as a HS-specific PROM by comparing it to the Dermatology Life Quality Index (DLQI) in clinical practice., Methods: Data were drawn from the Adelphi HS Disease Specific Programme™, a cross-sectional survey of physicians and patients conducted in France, Germany, Italy, Spain, and the United States between November, 2020 and April, 2021. Practicing physicians each provided demographic and clinical data for 5-7 consecutively evaluated HS patients aged at least 10 years receiving any treatment for HS, and an additional 3 patients undergoing biologic treatment; only patients aged at least 18 years were included in this study. Patients completed the DLQI and HiSQOL. Construct validity was assessed by Pearson's correlation between DLQI and HiSQOL scores. The HiSQOL item discrimination was assessed by comparing differences in item responses between the highest and lowest 25% of HiSQOL scores. Multivariable linear regressions assessed relationships between individual PROM item responses and the total score of the other PROM., Results: In total, 677 patients [mean age of 34.3 (11.3) years; female (57.3%, n=388)] completed both the HiSQOL and DLQI. There was strong correlation between HiSQOL and DLQI total scores (Pearson's correlation 0.87 [95% confidence interval: 0.85-0.89, p<0.001]). The HiSQOL items that had the biggest impact on QoL related to "Embarrassment", "Depression" and "Anxiety", items that also had among the lowest relationship to total DLQI score., Conclusions: The HiSQOL is a valid tool for assessing QoL in HS patients in the real-world setting. Furthermore, the HiSQOL better captures those aspects of HS that have the highest impact on QoL, including depression and anxiety, which are not captured by the DLQI., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists.)

Background: Psoriasis involving challenging body areas, such as the scalp, face, palmoplantar surfaces, or nails, can be challenging to treat and negatively affects patient outcomes., Objective: To assess clear responses and cumulative clinical benefits over 5 years of ixekizumab treatment of moderate-to-severe plaque psoriasis in patients with and without baseline involvement of challenging body areas., Methods: This post hoc analysis included patients treated with ixekizumab in the UNCOVER-3 trial. We assessed PASI100 responses through the week (W) 264 and cumulative clinical benefits at W264 (calculated as least-squares mean of the percentage of maximum area under the curve for PASI100 and PASI% improvement and expressed as cumulative clearance days). Statistical differences were calculated via ANCOVA., Results: A total of 385 patients were analyzed: 349 with scalp involvement, 152 with facial involvement, 96 with palmoplantar involvement, and 229 with nail involvement. Proportions of patients achieving PASI100 were numerically similar between patients with and without scalp and nail involvement. More patients without facial and palmoplantar involvement achieved PASI100 at W60 (only palmoplantar), W108, W156, W204, and W264 (only palmoplantar). At W264, cumulative clinical benefits for PASI100 and PASI% improvement were high and similar in both patient groups, with and without challenging body areas. A significant difference (P=0.006) was only observed for PASI% improvement between patients with and without nail involvement., Conclusion: For most efficacy measures, patients treated with ixekizumab over 5 years achieved similar clear responses and cumulative clinical benefits regardless of baseline involvement of challenging body areas. J Drugs Dermatol. 2024;23(8):619-625.&nbsp; doi:10.36849/JDD.8160.

Introduction: Atopic dermatitis is associated with intense itch, which has been shown to cause sleep disruption that significantly impacts the lives of patients with atopic dermatitis. Despite this, little is known about its burden to the healthcare system and society. This study aimed to quantify the economic burden of itch-related sleep loss in moderate-to-severe atopic dermatitis in the UK., Methods: A literature-based decision-analytic model was developed from a healthcare payer and societal perspective. The model quantifies the economic burden by linking the severity of itch to the number of days of sleep disruption. The model captures the direct costs of healthcare resource utilization and treatment alongside the indirect costs of productivity loss from absenteeism and presenteeism at work over a 5-year time horizon. The patient population considered was patients aged ≥ 15 years with moderate-to-severe atopic dermatitis and itch-related sleep disruption., Results: The model estimated that itch-related sleep disruption as a result of moderate-to-severe atopic dermatitis would affect an average of 821,142 people over the time horizon (2022 to 2026). This translates into an average net economic burden of £3.8 billion (£4687 per patient), with an average of 172 million days being affected by sleep disruption per year in the UK. The greatest contributor to the annual average net economic burden was productivity loss from absenteeism and presenteeism, each accounting for 34%. The direct costs (treatment costs and healthcare resource use) accounted for 32% of the net economic burden. The results showed a high and gradually increasing economic burden over the 5-year time horizon., Conclusions: Sleep disruption has a high economic burden and reducing itch may provide substantial direct and indirect savings. Quantifying the economic burden of itch-related sleep loss may provide support for analyses to inform public health policies for treatment of atopic dermatitis, particularly within the moderate-to-severe level., (© 2024. The Author(s).)

Introduction: Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for the treatment of moderate-to-severe plaque psoriasis. Since scalp psoriasis can be burdensome and challenging to treat with non-systemic therapies, this post hoc analysis focused on scalp psoriasis in patients with moderate-to-severe plaque psoriasis and baseline scalp involvement. The analysis considered a holistic concept of clearance through 5 years of ixekizumab treatment., Methods: Ixekizumab-treated patients with baseline scalp involvement were pooled from three multicenter, randomized, double-blind, placebo-controlled, phase 3 trials (integrated UNCOVER-1/2 and UNCOVER-3). Analyses were performed on a subpopulation of patients who achieved complete resolution of scalp psoriasis at Week 60 (i.e., Week 60 Psoriasis Scalp Severity Index [PSSI-0] responders) and on the overall patient population (i.e., Week 60 PSSI-0 responders and non-responders), which was used as a reference. Clinical outcomes (PSSI), patient-reported outcomes (Itch Numeric Rating Scale [NRS] score, Skin Pain Visual Analogue Scale [VAS]), quality of life (Dermatology Life Quality Index [DLQI]), and concurrent outcomes were assessed from baseline through 5 years. Descriptive statistics of observed data were reported., Results: After 60 weeks of ixekizumab treatment, 88.4% (UNCOVER-1/2) and 75.9% (UNCOVER-3) of patients with baseline scalp involvement achieved complete clearance (PSSI-0) of scalp psoriasis. Substantial improvements in the clinical outcomes (PSSI), patient-reported outcomes (Itch NRS, Skin Pain VAS), and quality of life (DLQI) were achieved by Week 60 and sustained through Week 264 in the Week 60 PSSI-0 responders and in the overall patient population. Additionally, a significant proportion of Week 60 PSSI-0 responders achieved concurrent complete scalp and skin clearance and quality of life improvement through 5 years., Conclusions: Continued treatment with ixekizumab provided long-term sustained scalp clearance over 5 years to patients with moderate-to-severe plaque psoriasis and baseline scalp involvement, and holistic improvements occurred across clinical outcomes, patient-reported outcomes, and quality of life., Clinical Trial Numbers: NCT01474512 (UNCOVER-1), NCT01597245 (UNCOVER-2), and NCT01646177 (UNCOVER-3)., (© 2024. The Author(s).)

Background: Electronic health records (EHRs) offer the possibility of using data entry templates to simultaneously document routine clinical care and capture disease-specific measures as discrete data elements that can be used for health services research (HSR). The objective of this study was to determine factors associated with meaningful treatment escalation (MTE) of psoriasis as a pilot study for future real-world HSR studies., Methods: We conducted a retrospective, observational cohort study of psoriasis patients by using data collected during routine clinical care from an EHR using EpiCare® SmartForms. The psoriasis SmartForm records psoriasis disease severity measures and descriptive findings to generate visit notes. These data were extracted and analyzed to identify factors associated with MTE, defined as changing or adding, phototherapy, systemic, or biologic therapy., Results: 473 psoriasis patients met study criteria; 239 underwent MTE between their first and third observed visits. Patients who experienced MTE had more severe disease at Visit 1-assessed by BSA, pPGA, oPGA, and a patient-reported disease severity measure--than patients who did not experience MTE. Other factors associated with MTE included use of topicals only or no active treatment at Visit 1, palmoplantar disease, and involvement of other difficult-to-treat body areas. Patients who underwent MTE experienced larger improvements in disease severity than those who did not., Conclusions: This study highlights how data collected during routine clinical practice can be readily used for real-world retrospective HSR when disease measures are captured as discrete elements. This approach could provide a cost-effective platform to conduct real-world HSR., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: WM and RB are employees and minor shareholders of Eli Lily and Company. JLWR has received consulting fees from Eli Lilly and Company, Boehringer Ingelheim, Genentech, and Argenx. KCD has received grants and personal fees from Eli Lilly and Company, Amgen, Janssen, Pfizer, UCB, Novartis, Celgene, AbbVie and Sienna; and has received personal fees from Ortho Dermatologica. MLG is an employee of Evidera Inc., an independent research company that received payment from Eli Lilly and Company for the conduct of this study and the development of this manuscript. MLG is a minor shareholder of Thermo Fisher Scientific., (© The Author(s) 2023.)

Introduction: Ixekizumab, a highly selective interleukin-17A monoclonal antibody, was approved for the treatment of moderate-to-severe psoriasis (PsO) in 2016. Limited real-world data are available on its effectiveness from a patient's perspective shortly (2 to 4 weeks) after initiation and upon continuation for 24 weeks., Objective: To describe patient-reported clinical and quality-of-life outcomes after initiating ixekizumab using data collected from the United States Taltz® Customer Support Program., Methods: This was a 24-week prospective, observational study of commercially insured diagnosis-confirmed adults with PsO. Surveys were completed at weeks 0 (baseline), 2, 4, 8, 12, and 24 and included the Patient Report of Extent of Psoriasis Involvement questionnaire to assess the extent of body surface area (BSA) affected by PsO, itch and pain numeric rating scales, Patient Global Assessment of Disease Severity (PatGA), and Dermatology Life Quality Index (DLQI)., Results: 523 patients were included in the analysis. Proportions of patients with ≤ 2% BSA involvement were 34.5%, 40.1%, 50.9%, and 79.9% at weeks 0, 2, 4, and 24, respectively; 54.8% and 75.1% achieved National Psoriasis Foundation preferred (BSA ≤ 1%) and acceptable (BSA ≤ 3% or ≥ 75% improvement) responses at week 12, respectively. Improvements of ≥ 4 points in itch and pain were seen by week 2 in 21.1% and 28.0% of patients, respectively, which increased to 63.1% and 64.8% at week 24. Proportions of patients with PatGA scores of 0 (clear) or 1 were 13.4%, 24.1%, 34.0%, and 69.6% at weeks 0, 2, 4, and 24, respectively; and proportions with DLQI total scores of 0 or 1 [no or minimal impact] were 8.4%, 17.6%, 27.3%, and 53.8% at weeks 0, 2, 4, and 24, respectively., Conclusion: Patient-reported improvements in BSA, itch, skin pain, dermatology-specific quality of life, and overall PsO severity were seen as early as 2 weeks after initiation and continued through week 24., (© 2023. The Author(s).)

Introduction: Psoriasis is a chronic systemic inflammatory disease manifesting as erythematous and desquamative dermatoses., Objectives: This study estimated the cost per responder (CPR) for the treatment of moderate-to-severe plaque psoriasis with biologic therapies approved by the Colombian regulatory agency., Methods: This secondary study used a modeling based CPR estimation to evaluate psoriasis therapies in Colombia. We calculated CPR of achieving Psoriasis Area and Severity Index (PASI) scores of 75, 90, and 100 for biological treatments based on the number needed to treat (NNT), reported in previously published network meta-analyses. We calculated CPR for the first year and for the maintenance period. We ranked alternatives using the estimated CPR from each literature source using the Borda count method., Results: Adalimumab, infliximab and etanercept were the least expensive alternatives. Ixekizumab, guselkumab and secukinumab were the treatments with the lowest NNT for PASI 75, 90, and 100. For both first year and maintenance periods, adalimumab, infliximab, guselkumab and ixekizumab had the lowest CPR. Sensitivity analyzes showed consistent results., Conclusions: The application of CPR analysis of biologics to treat plaque psoriasis demonstrated that adalimumab, infliximab, guselkumab, and ixekizumab had the lowest CPR in the first year of treatment and during the maintenance period.

Background: Dermatologists would benefit from an easy to use psoriasis severity assessment tool in the clinic., Objective: To develop psoriasis assessment tools to predict PASI and Dermatology Life Quality Index (DLQI) using simple measures typically collected in clinical practice., Methods: Data included 33 605 dermatology visits among plaque psoriasis patients enrolled in the CorEvitas Psoriasis Registry (4/15/15-7/11/20). Performance (adjusted coefficient of determination [R 2 adj ], root mean square error [RMSE]) in predicting PASI and DLQI was assessed for 16 different linear regression models (specified a priori based on combinations of BSA, Investigator's Global Assessment [IGA], itch, skin pain, patient global assessment, age, sex, BMI, comorbidity index, prior biologic use), and 2 stepwise selection models and 1 elastic net model based on 56 available variables. For each prediction model, concordance (sensitivity, specificity) of predicted PASI75, PASI90 and DLQI 0/1 with observed values was evaluated., Results: Mean (SD) age, BSA, and PASI were 51 (14) years, 6 (11), and 4 (6), respectively; 46% were women, and 87% were biologic experienced. A model predicting PASI using BSA plus IGA performed best among a priori specified models (R 2 adj = .72, RMSE = 2.93) and only marginally worse than models including additional variables (R 2 adj range .64-.74, RMSE range 2.82-3.36). Models including IGA had the best concordance between predicted and observed PASI75 (sensitivity range 83-85%, specificity range 88-91%) and PASI90 (sensitivity range 76-82%, specificity range 94-98%). DLQI prediction was limited., Conclusion: An assessment tool for psoriasis including BSA and IGA may be an ideal option to predict PASI in a clinic setting., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: WG-Grants/research support: AbbVie, Amgen, Eli Lilly, Novartis, Pfizer. Honoraria for Ad Boards/Invited Talks/Consultation: AbbVie, Actelion, Amgen, Arylide, Bausch Health, Boehringer, Celgene, Cipher, Eli Lilly, Galderma, Janssen, LEO Pharma, Merck, Novartis, PeerVoice, Pfizer, Sanofi-Genzyme, Tribute, UCB, Valeant. Other: Clinical trials (study fees): AbbVie, Asana Biosciences, Astellas, Boerhinger-Ingleheim, Celgene, CorEvitas/National Psoriasis Foundation, Devonian, Eli Lilly, Galapagos, Galderma, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, UCB; KS, BZ, BK, RB-Employee/Stock, Eli Lilly and Company; RWH, RRM, SJK (former), Employee of CorEvitas, LLC (formerly Corrona, LLC); CL-Consultant/Advisory Board for Abbvie, Amgen, Boehringer-Ingelheim, Dermira, Eli Lilly, Janssen, Leo, Pfizer, Sandoz, UCB and Vitae, Investigator for Actavis, Abbvie, Allergan, Amgen, Boehringer-Ingelheim, Celgene, Coherus, Cellceutix, CorEvitas, Dermira, Eli Lilly, Galderma, Glenmark, Janssen, Leo Pharma, Merck, Novartis, Novella, Pfizer, Sandoz, Sienna, Stiefel, UCB and Wyeth, Speaker bureau for Abbvie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Ortho Dermatologics, Sun Pharmaceuticals, and UCB., (© The Author(s) 2023.)

Background and Objective: Data on real-world healthcare costs for ixekizumab (IXE) and secukinumab (SEC) in biologic-experienced patients with psoriasis are limited. This study compared real-world costs and healthcare resource utilization between IXE and SEC in biologic-experienced patients with psoriasis over an 18-month follow-up period in the USA., Methods: Adult patients with a diagnosis of psoriasis between 1 March, 2015 and 31 October, 2019 were identified using health insurance claims data from IBM Watson Health MarketScan ® . The index date was the date of the first IXE or SEC claim. Biologic-experienced patients with one or more pre-period claims for biologic drugs were identified. Inverse probability of treatment weighting was used to reduce cohort imbalances. All-cause and psoriasis-related direct healthcare costs along with index drug costs were estimated during the follow-up and reported as per patient per month. Discount factors published by the Institute for Clinical and Economic Review were applied to psoriasis-related biologics to adjust pharmacy costs., Results: A total of 411 IXE and 780 SEC users were included. After weighting, all-cause inpatient admissions were similar between IXE (9.5%) and SEC users (10.3%). Weighted, mean ± standard deviation per patient per month all-cause healthcare costs were higher in IXE users ($6670 ± $2910) than in SEC users ($6239 ± $3903; p = 0.049). Psoriasis-related and monthly index drug costs were higher in IXE users ($5609 ± $2009; p < 0.001 and $4688 ± $1994; p < 0.001, respectively) than in SEC users ($5095 ± $2291 and $3853 ± $1977, respectively). After Institute for Clinical and Economic Review adjustment, mean per patient per month all-cause ($4363 ± $2576 vs $4398 ± $3517) and psoriasis-related costs ($3302 ± $1264 vs $3253 ± $1504) were similar between the groups. Institute for Clinical and Economic Review- and adherence-adjusted mean per patient per month index drug costs were similar between IXE and SEC users (p = 0.339)., Conclusions: Institute for Clinical and Economic Review-adjusted all-cause and psoriasis-related costs were comparable between IXE and SEC users among biologic-experienced patients over an 18-month follow-up period., (© 2023. The Author(s).)

Introduction: Patients with psoriasis (PsO) should adhere to and be persistent with treatment to maintain disease control. Patient support programs (PSPs) are useful to support patients with disease management. We aimed to understand the real-world patient profile and persistence of ixekizumab-initiating Canadian patients with moderate-to-severe PsO using PSP data., Methods: This retrospective observational study was conducted utilizing a Canadian PSP database (May 2016 to March 2020). Inclusion criteria were: age ≥ 18 years with moderate-to-severe PsO, initiated ixekizumab, enrolled in the PSP for ≥ 6 months, and provided informed consent. Psoriasis Area Severity Index (PASI), body surface area (BSA) involvement, and Dermatology Life Quality Index (DLQI) were collected at PSP entry. Adherence [using the proportion of days covered (PDC)] and persistence (using Kaplan-Meier curves) were assessed after 1-year and 2-year follow-ups. Differences in persistence between biologic-naïve and biologic-experienced patients were compared using Cox proportional hazards model after adjusting baseline parameters., Results: In total, 1891 ixekizumab-treated moderate-to-severe patients with PsO were included. The mean [standard deviation (SD)] age was 52.3 (13.3) years; 51.1% of patients were 45-65 years old and 61.4% were male. At baseline, the mean (SD) PASI score was 14.3 (8.1), the DLQI score was 16.5 (7.7), and BSA % was 17.4 (15.1). PsO lesions were commonly located on the hands (33.4%), face (28.6%), and feet (23.8%). Ixekizumab-treated patients were highly adherent [PDC ≥ 80%: 1-year (92.0%), 2-year (87.7%)] and persistent [1-year (90.4%), 2-year (85.6%)]. Biologic-naïve patients were more adherent (1-year, 94.6% versus 87.3%; 2-year, 90.3% versus 83.5%) than biologic-experienced patients. Significantly higher persistence in biologic-naïve versus biologic-experienced patients for 1-year (p < 0.01) and 2-year (p = 0.010) follow-up periods was observed after adjusting for baseline parameters., Conclusion: Patients with moderate-to-severe PsO overwhelmingly remained on ixekizumab treatment for more than 2 years while participating in a PSP., (© 2022. The Author(s).)

Background: Galcanezumab (GMB) improved quality-of-life and reduced disability of patients with episodic (EM) and chronic migraine (CM) in Phase 3 trials., Aim: To estimate indirect cost savings associated with GMB treatment in patients with migraine in the United States (US)., Methods: We analyzed data of patients from the US from three randomized, Phase 3, double-blind, placebo (PBO)-controlled GMB studies: EVOLVE-1 and EVOLVE-2 (EM patients), REGAIN (CM patients). Annual indirect costs were calculated using items of the Migraine Disability Assessment (MIDAS) questionnaire: lost time/productivity at work/school, household work, and leisure time. All costs were annualized and expressed in 2019 US dollars. While the main analysis considered lost time/productivity at work/school and household work as a full day, a sensitivity analysis was performed by discounting them by half. For EM, annual indirect costs savings were estimated using mixed model repeated measures analysis. For CM, ANCOVA models were used to estimate annual indirect costs savings as change from baseline., Results: The analysis included 805 patients with EM (mean age = 41.4 years; PBO = 534; GMB = 271) and 423 patients with CM (mean age = 38.9 years; PBO = 279; GMB = 144). Compared to PBO, GMB significantly reduced annual indirect costs among patients with EM at 3 months (least square mean [95% confidence interval] work/school = $1,883.6 [603.64-3,163.65], p  = .0040, household work = $628.9 [352.95-904.88], p  <.0001, and leisure activity = $499.17 [42.36-955.98], p  = .0323) and 6 months (work/school = $2,382.29 [1,065.48-3,699.10], p  = .0004, household work = $559.45 [268.99-849.90], p  = .0002, and leisure activity = $753.81 [334.35-1,173.27], p  = .0004), whereas a significant difference was not observed among patients with CM. Sensitivity analysis results were similar to primary analysis results., Conclusions: GMB treatment versus PBO resulted in significantly greater indirect cost savings in patients with EM through improved productivity at work/school, household work, and leisure days. Patients with CM receiving GMB versus PBO attained greater cost savings, although not statistically significant, through reduced lost productivity at work/school.

Introduction: Real-world data are limited comparing Asian and White patients with psoriasis using biologic therapy. This study compared the 6-month effectiveness of biologic therapy between Asian and White plaque patients with psoriasis in the CorEvitas Psoriasis Registry., Methods: Analyses included biologic initiations and 6-month follow-up visits from self-identified Asian (n = 293) and White (n = 2314) patients in the USA/Canada (4/2015-4/2020). Outcomes included: Psoriasis Area Severity Index (PASI) 75, disease activity measures [body surface area (BSA) ≤ 1, BSA ≤ 3, PASI90, PASI100, Investigator's Global Assessment (IGA) 0/1], and patient-reported outcomes [Dermatology Life Quality Index (DLQI) 0/1, itch, fatigue, skin pain, EuroQoL visual analog scale (EQ-VAS), patient global assessment, Work Productivity Activity and Impairment (WPAI) domains]. Unadjusted regression models were used to calculate odds ratios (OR) and 95% confidence intervals (CI) for achievement of binary outcomes and difference in mean change in continuous outcomes (β, 95% CI) at 6 months, followed by adjustment for age, sex, body mass index, alcohol, smoking, health insurance, education, comorbidities, scalp psoriasis morphology, psoriatic arthritis, biologic class, previous biologics, and baseline outcome value., Results: Asians had lower proportions of women (32.8% versus 49.1%) and obesity (27.3% versus 54.5%), and higher proportions on Medicaid (19.9% versus 8.8%), graduated college (50.9% versus 40.1%) and never smoked (67.1% versus 44.1%). In unadjusted analyses, Asians had 52% higher odds of achieving PASI75 versus White patients (OR 1.52; 95% CI 1.15, 2.02). After adjustment, the association was attenuated (OR 1.11; 0.81, 1.52). Secondary outcomes experienced similar patterns except for DLQI: Asians had 33% lower odds of achieving DLQI 0/1 in both the unadjusted (OR 0.67; 0.50, 0.90) and adjusted (OR 0.67; 0.49, 0.92) models., Conclusion: Unadjusted differences in biologic therapy effectiveness between Asians compared with White patients were likely explained by differences in demographic, lifestyle, and psoriatic disease characteristics between groups. However, Asians still experienced lesser improvements in skin-related quality of life, even after adjustment., (© 2022. The Author(s).)

Introduction: The aim of this work is to describe real-world biologic-experienced psoriasis patients initiating ixekizumab by prior biologic therapy status and compare the effectiveness of ixekizumab between patients who previously failed secukinumab and those who failed other biologics. We hypothesized that (1) clinical outcomes and patient-reported outcomes would improve following a switch to IXE, and (2) there would be no differences in responses between patients who previously failed secukinumab and those who failed other biologics., Methods: Participants (n = 419) included adult psoriasis patients enrolled in the CorEvitas Psoriasis Registry through 9/10/20 who switched to ixekizumab after discontinuing another biologic. Patients were classified by the biologic used immediately prior to ixekizumab and reason for discontinuation: prior secukinumab failure; prior secukinumab non-failure; prior other biologic failure; and prior other biologic non-failure. Discontinuations for efficacy reasons were considered failures; all others were considered non-failures. Baseline descriptive statistics were calculated. Multivariable Poisson regression models estimated the likelihood of response of other failure relative to secukinumab failure., Results: Mean age was 51 years; 48% were women. Psoriasis disease characteristics were similar across prior biologic groups. At 6-month follow-up, disease severity improved for all who initiated ixekizumab after discontinuing another biologic. Secukinumab failure patients who switched to ixekizumab achieved BSA ≤ 1 (49%), BSA ≤ 3 (59%), PASI75 (46%), PASI ≤ 3 (64%), and IGA ≤ 1 (40%). Other failure patients achieved BSA ≤ 1 (55%), BSA ≤ 3 (72%), PASI75 (59%), PASI ≤ 3 (74%), and IGA ≤ 1 (54%). In regression modeling, we observed patients in the other biologics failure group had an increased likelihood of achieving response for BSA ≤ 3, PASI75, PASI90, PASI100, and IGA ≤ 1 compared to patients who failed secukinumab., Conclusions: These findings suggest that patients with psoriasis who switch to ixekizumab after discontinuing another biologic demonstrate improvement in disease severity after six months. Patients who discontinued biologics other than secukinumab may be more likely to respond to ixekiziumab compared to those who switched from secukinumab., (© 2022. The Author(s).)

Purpose: Clinical trials have produced promising results for disease-modifying therapies (DMTs) for Alzheimer's disease (AD); however, the evidence on their potential cost-effectiveness is limited. This study assesses the cost-effectiveness of a hypothetical DMT with a limited treatment duration in AD., Methods: We developed a Markov state-transition model to estimate the cost-effectiveness of a hypothetical DMT plus best supportive care (BSC) versus BSC alone among Americans living with mild cognitive impairment (MCI) due to AD or mild AD. AD states included MCI due to AD, mild AD, moderate AD, severe AD, and death. A hypothetical DMT was assumed to confer a 30% reduction in progression from MCI and mild AD. The base case annual drug acquisition cost was assumed to be $56,000. Other medical and indirect costs were obtained from published literature or list prices. Utilities for patients and caregivers were obtained from the published literature and varied by AD state and care setting (community care or long-term care). We considered 3 DMT treatment strategies: (1) treatment administered until patients reached severe AD (continuous strategy), (2) treatment administered for a maximum duration of 18 months or when patients reached severe AD (fixed-duration strategy), and (3) 40% of patients discontinuing treatment at 6 months because of amyloid plaque clearance and the remaining patients continuing treatment until 18 months or until they reached severe AD (test-and-discontinue strategy). Incremental cost-effectiveness ratios (ICERs) were calculated as the incremental cost per quality-adjusted life-year (QALY) gained., Findings: From the health care sector perspective, continuous treatment with a hypothetical DMT versus BSC resulted in an ICER of $612,354 per QALY gained. The ICER decreased to $157,288 per QALY gained in the fixed-duration strategy, driven by large reductions in treatment costs. With 40% of patients discontinuing treatment at 6 months (test-and-discontinue strategy), the ICER was $125,631 per QALY gained. In sensitivity and scenario analyses, the ICER was the most sensitive to changes in treatment efficacy, treatment cost, and the initial population AD state distribution. From the modified societal perspective, ICERs were 6.3%, 20.4%, and 25.1% lower than those from the health care sector perspective for the continuous, fixed-duration, and test-and-discontinue strategies, respectively., Implications: Under a set of assumptions for annual treatment costs and the magnitude and duration of treatment efficacy, DMTs used for a limited duration may deliver value consistent with accepted US cost-effectiveness thresholds., Competing Interests: Declaration of Interest M. Boustani and L.P. Garrison report fees from Eli Lilly and Company during conduct of this study. E.G. Doty, M. Belger, R. Burge, J.K. Wall, and J.A. Johnston are employees and minor shareholders of Eli Lilly and Company. L.J. Smolen, T.M. Klein, D.R. Murphy are employees of Medical Decision Modeling Inc, which received compensation from Eli Lilly for the research that contributed to this article. The authors have indicated that they have no other conflicts of interest regarding the content of this article., (Copyright © 2022 Eli Lilly and Company. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to compare healthcare costs between ixekizumab (IXE)-treated and secukinumab (SEC)-treated patients with psoriasis over a 24-month follow-up period in the United States., Methods: Patients with psoriasis diagnosis were identified from IBM Watson Health MarketScan ® Research Databases; those with one or more claim for index drug (IXE or SEC) between March 1, 2016 and October 31, 2019 were included. Included patients were ≥ 18 years old and had continuous enrollment with medical and pharmacy benefits ≥ 6 months before and ≥ 24 months after index date. Patients were classified as IXE or SEC users based on drug received at index. Per patient per month (PPPM) all-cause, psoriasis-related, and index drug costs for IXE and SEC users were estimated over 24 months of follow-up. Institute for Clinical and Economic Review (ICER) discount factors were applied to adjust pharmacy costs. Index drug costs were additionally adjusted for adherence. Inverse probability of treatment weighting was used to address cohort imbalances. Chi-square/t tests were used to compare IXE versus SEC users; p value < 0.05 was considered statistically significant., Results: Overall, 1461 patients (IXE users, n = 471; SEC users, n = 990) were included. IXE versus SEC users had higher weighted PPPM all-cause, psoriasis-related, and index drug costs (p ≤ 0.001). IXE versus SEC users had comparable ICER-adjusted mean PPPM all-cause costs (US$4172 ± 3349 vs US$3978 ± 2619; p = 0.227) and psoriasis-related costs (US$2950 ± 1332 vs US$2899 ± 1152; p = 0.447). After applying ICER and adherence adjustments, index drug costs were similar between IXE and SEC users (US$3794 ± 1822 vs US$3766 ± 1973; p = 0.795)., Conclusions: All-cause and psoriasis-related costs were comparable between IXE and SEC users after ICER adjustments; index drug costs were similar after ICER and adherence adjustments., (© 2022. The Author(s).)

Introduction: Limited real-world data are available comparing multiple biologics on their adherence, persistence, and the use of concomitant biologics in the treatment of moderate-to-severe psoriasis in clinical practice. The objective was to compare persistence of and adherence to ixekizumab (IXE) treatment, as monotherapy or with concomitant medication, versus patients receiving other commonly prescribed biologics., Methods: Patients who newly initiated IXE, adalimumab (ADA), etanercept (ETN), secukinumab (SEC), or ustekinumab (UST) in IBM MarketScan ® databases with diagnosis of psoriasis were identified. Treatment comparisons on medication persistence, adherence, and monotherapy were based on balanced samples after inverse probability of treatment weighting (IPTW)., Results: A higher proportion of patients receiving IXE had had previous biologic therapies (50.3%) versus other biologics (ADA: 9.1%, ETN: 10.9%, SEC: 33.9%, UST: 19.7%). Patients treated with IXE showed statistically (p < 0.001) greater persistence than patients treated with SEC, ADA, UST, or ETN at both 1-year follow-up and up to 3 years of follow-up. Adherence for patients treated with IXE was significantly (p < 0.001) higher compared to ADA, ETN, and UST at both 1-year follow-up and up to 3 years of follow-up. There was no significantly higher adherence in patients treated with IXE compared to those treated with SEC at 1-year follow-up, but IXE had higher adherence than SEC (p < 0.05) at 1-3 year follow-up. IXE showed longer time on monotherapy than ADA (p < 0.001), ETN (p < 0.001), SEC (p < 0.05), and UST (p < 0.001) for both 1-year and 1-3 year follow-up. Sensitivity analyses on persistence, adherence, and monotherapy with further model adjustments after IPTW confirmed the findings., Conclusions: Patients treated with IXE were more persistent on and adherent to treatment and remained on monotherapy longer compared to those on all other commonly prescribed biologics combined or with individual biologics., (© 2022. The Author(s).)

Introduction: This cross-sectional survey was conducted with National Psoriasis Foundation (NPF) to capture treatment perspectives and expectations in patients with psoriasis (PsO) using Patient Needs Questionnaire (PNQ) of Patient Benefit Index (PBI)., Methods: Adult participants with self-reported diagnosis of PsO responded to the PNQ portion of PBI by indicating how much they valued different treatment attributes. All the treatment goals were captured on a five-point Likert scale (0 = "Not important", 4 = "Very important"). Treatment goals were obtained for overall population and subgroups based on severity of disease Patient Global Assessment (PGA), age, gender, and Dermatology Life Quality Index (DLQI) total score. All data were expressed as mean and standard deviation [SD]., Results: A total of 1200 participants completed the survey (mean age 51.5 years). Top treatment goal in the overall population was "to have confidence in the therapy" (3.46 [1.01]). Unique to the higher severity subgroup (PGA ≥ 3), "to find a clear diagnosis and therapy" was a top five goal and "to get better skin quickly" was for those with lesser severity (PGA < 3). "To be free of itching" (3.36 [0.99]) was the unique goal in the < 40 age group whereas it was "to get better skin quickly" (3.27 [1.12]) in the ≥ 40 group. In women and men, "to be free of itching" (3.38 [1.13]) and "to get better skin quickly" (3.20 [1.09]) were top five goals, respectively. Patients with ≥ 10 DLQI scores expressed higher treatment goal "to regain control of the disease" (3.66 [0.67]) compared to those with ≤ 10 DLQI scores who expressed "to have confidence in the therapy" (3.40 [1.11]) as the topmost treatment goal., Conclusion: Our results suggest that in patients with PsO, treatment preferences can vary with different characteristics such as age, severity, and gender as measured by using PNQ. Further exploration of this data will help inform treatment decisions and optimize patient outcomes., (© 2022. The Author(s).)

Objective: To assess treatment patterns of Ixekizumab (IXE) and evaluate the speed of onset and long-term clinical and quality-of-life outcomes among a subset of patients who switched from adalimumab (ADA) and secukinumab (SEC) to IXE in a real-world setting., Method: A retrospective chart review study was conducted at a single US dermatology referral center., Result: 153 patients were included in the study, 69.3% of patients were biologic-experienced. ADA was the most commonly used biologic prior to IXE initiation. 66.7% of patients remained on IXE at the study end. 47.7% of patients received concomitant methotrexate, and usage decreased consistently after 1 month. IXE treatment duration was longer among patients who were early responders (achieved sPGA (0,1) at 1 month) vs. non-early responders. 69.4% and 43.3% of patients who switched from ADA and SEC to IXE achieved sPGA (0,1) by week 4, respectively., Conclusion: Patients who switched to IXE, specifically from ADA or SEC, had rapid treatment response as well as desirable long-term outcomes. IXE persistence was longer among early responders than non-early responders. Concomitant usage of methotrexate prior to switching to IXE and as a concomitant bridging treatment was reduced after IXE initiation while the proportion of patients achieving treatment targets remained high.

Objectives: There is limited real-world evidence on using ixekizumab in psoriasis patients. Therefore, we characterized patients with psoriasis initiating ixekizumab and report 6-month changes in disease and patient-reported outcomes., Methods: Adult patients with psoriasis who initiated ixekizumab and completed a 6-month follow-up visit were enrolled from the Corrona Psoriasis Registry. Disease characteristics and outcomes were assessed at ixekizumab initiation. Outcomes included the mean 6-month change in Psoriasis Area and Severity Index (PASI), body surface area (BSA), Investigator Global Assessment (IGA), and IGA*BSA., Results: From baseline to follow-up in all patients ( n  = 136), means decreased for IGA*BSA (-45.5) and BSA (-12.4), and a higher % achieved an absolute PASI ≤ 5 (84.6%), BSA 0-3 (72.1%), and IGA 0/1 (50.7%). Within stratified groups, means decreased for PASI <12 for IGA*BSA (-21.1) and BSA (-6.3); PASI≥12 for IGA*BSA (-94.8) and BSA (-24.6); weight <100 kg for IGA*BSA (-45.1) and BSA (-12.4); weight ≥100 kg for IGA*BSA (-46.2) and BSA (-12.3); concomitant PsA for IGA*BSA (-56.0) and BSA (-15.3); and in no concomitant PsA for IGA*BSA (-36.9) and BSA (-10.0)., Conclusions: We provide real-world evidence on the benefits of ixekizumab for treating psoriasis, regardless of baseline disease severity, weight, or concomitant PsA.

Background: The content validity (appropriateness and acceptability) of patient-reported outcome (PRO) measures for scalp hair loss, eyebrow loss, eyelash loss, nail damage and eye irritation has been demonstrated in adults with alopecia areata (AA) but not adolescents., Objectives: To explore the content validity of the suite of AA PRO measures and accompanying photoguides in an adolescent sample., Methods: Semi-structured, 90-min, combined concept elicitation and cognitive interviews were conducted face-to-face with adolescents who experienced ≥ 50% AA-related scalp hair loss. Transcripts underwent thematic and framework analysis., Results: Eleven adolescents (aged 12-17 years, 55% female, 45% nonwhite) diagnosed with AA for 5·9 years (mean) participated. Participants had 69·6% scalp hair (mean) and current eyebrow (82%) and/or eyelash loss (82%) and/or nail involvement (36%). Adolescents reported scalp, eyebrow and eyelash hair loss as their top three most bothersome signs/symptoms. Despite mostly accepting their AA, impacts related to visible areas of hair loss were prominent. Participants demonstrated good understanding and appropriate use of the PRO measures, and advocated including hair loss percentages alongside descriptive categories in the Scalp Hair Assessment PRO™. Results confirmed treatment success thresholds established with adults: achievement of ≤ 20% scalp hair loss, no/minimal eyebrow and eyelash loss, no/a little nail damage and eye irritation (PRO measure categories 0 or 1)., Conclusions: The Scalp Hair Assessment PRO™, PRO Measure for Eyebrows™, PRO Measure for Eyelashes™, PRO Measure for Nail Appearance™ and PRO Measure for Eye Irritation™ and accompanying photoguides are fit-for-purpose self-reported measures of AA signs/symptoms that are impactful to adolescents with AA., (© 2022 Eli Lilly and Company. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

Introduction: Number needed to treat (NNT) estimates are a practical metric to help identify the most effective therapies. Our objective is to compare 11 biologic drugs for moderate-to-severe psoriasis in terms of NNT., Methods: The NNT data were obtained from a Bayesian network meta-analysis of 42 double-blind, randomized, phase 3 clinical trials for 11 biologics (adalimumab, brodalumab, certolizumab pegol, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab). We determined NNT to achieve Psoriasis Area and Severity Index (PASI) 75/90/100 responses at weeks 4, 8, 12, 16, and 48/52 and Dermatology Life Quality Index (DLQI) response 0, 1 at week 12., Results: Highest efficacy (lowest NNT) was with brodalumab and ixekizumab for PASI 90 at weeks 4, 8, and 12; ixekizumab for PASI 90/100 at week 16; and brodalumab for PASI 100 at week 12. After 48/52 weeks, risankizumab had the highest efficacy for PASI 90/100 overlapping with guselkumab, brodalumab, and ixekizumab for PASI 90 and with brodalumab and ixekizumab for PASI 100. Ixekizumab had the highest efficacy for DLQI (0,1) at week 12., Conclusions: Brodalumab and ixekizumab had the lowest NNTs for achieving PASI responses at early time points and were not significantly different than risankizumab and guselkumab after 48/52 weeks., (© 2022. The Author(s).)

Background: There is a paucity of long-term real-world evidence comparing the effectiveness of ixekizumab (IXE) and adalimumab (ADA). We compared real-world treatment patterns of IXE-treated and ADA-treated patients with psoriasis over 24 months in the United States., Methods: A retrospective observational study was conducted using IBM Watson Health MarketScan&reg; databases. Adult patients with psoriasis having &ge;1 claim for IXE or ADA from March 1, 2016 &ndash; October 31, 2019 were identified. Inverse probability of treatment weighting (IPTW) was used to address cohort imbalances. Cox proportional hazards models were used to estimate the risks of non-persistence, discontinuation, and switching. Logistic regression was used to estimate odds of high adherence. Persistence, adherence, discontinuation, reinitiation, and dosing and switching rates were also analyzed., Results: The final cohorts comprised 475 IXE users and 3159 ADA users over 24 months. IXE users demonstrated higher adherence (36.3% vs 28.8%; P&lt;0.001) and persistence rates (35.2% vs 28.8%; P=0.004), and a lower discontinuation rate (59.1% vs 65.3%; P=0.007) compared to ADA users. IXE users had a higher likelihood of being treatment-adherent compared to ADA users (OR=1.52, 95% CI: 1.24&ndash;1.87), a lower risk of non-persistence (HR=0.84, 95% CI: 0.75&ndash;0.95), and a lower risk of discontinuation (HR=0.83, 95% CI: 0.74&ndash;0.94), respectively. Switching rates were similar in both groups (31.2% vs 30.0%; P=0.608)., Conclusion: IXE users had better treatment adherence and persistence, and a lower risk of discontinuation compared to ADA users over 24 months. There was no difference in the risk of switching between IXE and ADA. J Drugs Dermatol. 2022;21(4):399-407. doi:10.36849/JDD.6336.

Introduction: The lifetime incidence of nail psoriasis in patients with psoriasis is 80-90%, with 23-27% of patients having nail psoriasis at any given time. Nail psoriasis is even more prevalent in patients with comorbid psoriatic arthritis. Complete psoriasis clearance, an achievable therapeutic goal, should ideally include the resolution of nail psoriasis. Here, we assessed simultaneous skin and nail clearance in patients with psoriasis across five head-to-head trials comparing ixekizumab with other biologics., Methods: Data were assessed in patients with moderate-to-severe psoriasis (with or without psoriatic arthritis) with nail psoriasis at baseline from the IXORA-R, IXORA-S, UNCOVER-2, UNCOVER-3, and SPIRIT-H2H trials. Ixekizumab patients received IXEQ2W to week 12 and IXEQ4W beyond week 12. PASI 100 depicted complete skin clearance, and PGA-F 0 (IXORA-R) or NAPSI 0 (all other trials) depicted complete nail clearance. Treatment comparisons were evaluated using the Cochran-Mantel-Haenszel test. Non-responder imputation was used for missing data., Results: Ixekizumab achieved significantly greater simultaneous skin and nail complete clearance than etanercept (UNCOVER-2: p < 0.001 and UNCOVER-3: p < 0.001) at week 12, demonstrating an efficacious and rapid response. Across all five head-to-head trials, ixekizumab achieved a high rate of simultaneous skin and nail clearance (range: 28.6-45.9% of patients) by week 24 that was maintained up to week 52 (range: 40.5-51.4% of patients). Ixekizumab achieved numerically greater simultaneous complete clearance than guselkumab at week 24 (p = 0.079), but statistically significant greater simultaneous clearance compared to ustekinumab (p < 0.001) and adalimumab (p = 0.006) at week 24 and week 52 (p < 0.001 and p = 0.007, respectively)., Conclusion: In five head-to-head trials, ixekizumab-treated patients had higher rates of simultaneous complete skin and nail clearance compared to etanercept, guselkumab, ustekinumab, and adalimumab, thereby reinforcing ixekizumab's ability to achieve high levels of efficacy in multiple domains of psoriatic disease., Trial Registration: NCT01474512, NCT01597245, NCT01646177, NCT03573323, NCT02561806, and NCT03151551., (© 2022. The Author(s).)

Introduction: Both early clinical improvement and long-term maintenance of clinical efficacy of treatments matter to patients with psoriasis. We compared cumulative clinical benefits of treatment with biologics over 1 year based on the area under the curve (AUC) for Psoriasis Area and Severity Index (PASI) 100 and PASI 90 responses in patients with moderate-to-severe psoriasis using a network meta-analysis (NMA)., Methods: Published phase 3 randomized, placebo- or active-controlled clinical trial data for biologics approved for the treatment of moderate-to-severe psoriasis were obtained from a systematic literature review up to 30 September 2020. Eighteen clinical trials that included data from baseline to 48 or 52 weeks where AUC could be calculated were included. Data were compared using a fixed-effect model with a separate random-effect baseline model to account for effects of the placebo arm. Cumulative clinical benefit was estimated using the AUC for PASI 100 and PASI 90 responses (complete and almost-complete skin clearance, respectively). Normalized AUC was compared using Bayesian NMA. Cumulative days of response were calculated using normalized AUC and study duration., Results: Interleukin (IL)-17 and IL-23 inhibitors demonstrated greater cumulative clinical benefits for both PASI 100 and PASI 90 versus IL-12/23 and tumor necrosis factor inhibitors. Over 52 weeks, cumulative days with PASI 100 were greatest with ixekizumab [158.7 (95% credible interval, 147.4, 170.0) days] followed by risankizumab [154.0 (144.9, 163.4) days]; PASI 90 days were greatest with risankizumab [249.3 (239.5, 259.2) days] followed by ixekizumab [238.8 (227.1, 250.8) days]. Both ixekizumab and risankizumab showed greater cumulative days with PASI 100 or PASI 90 responses versus secukinumab [117.9 (110.7, 125.2) and 215.5 (208.2, 223.1) days, respectively] and greater cumulative days with PASI 100 versus guselkumab [130.7 (120.5, 140.9) days]., Conclusion: For complete and almost-complete skin clearance, ixekizumab and risankizumab provided the greatest cumulative clinical benefits over 1 year., (© 2022. The Author(s).)

Background: Real-world data on long-term treatment patterns associated with interleukin-17A inhibitors in plaque psoriasis are lacking., Objective: To compare ixekizumab or secukinumab treatment patterns over a 24-month period among plaque psoriasis patients., Methods: Adult patients with psoriasis who had 1 or more claims for ixekizumab or secukinumab between March 1, 2016, and October 31, 2019, and with 24 months of follow-up after starting treatment were identified from IBM MarketScan claims databases. Inverse probability of treatment weighting and multivariable models were employed to balance cohorts and estimate the risks of nonpersistence, discontinuation, and switching and odds of highly adherent treatment (proportion of days covered ≥ 80%)., Results: A total of 471 ixekizumab and 990 secukinumab users were included. Compared to secukinumab, ixekizumab use was associated with a 20% lower risk of nonpersistence (hazard ratio, 0.80; 95% CI, 0.70-0.92), a 17% lower risk of discontinuation (hazard ratio, 0.83; 95% CI, 0.72-0.96), and a 42% higher odds of being highly adherent to treatment (odds ratio, 1.42; 95% CI, 1.12-1.80). No difference in risk of switching was observed (hazard ratio, 0.83; 95% CI, 0.68-1.01)., Limitations: Disease severity and clinical outcomes were unavailable., Conclusion: Over 24 months, ixekizumab users exhibited better persistence and adherence, and a lower risk of discontinuation than secukinumab users in real-world settings., Competing Interests: Conflicts of interest Dr Blauvelt had received honoraria as a scientific adviser/clinical study investigator from AbbVie, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Eli Lilly and Company, Evommune, Forte, Galderma, Incyte, Janssen, Leo, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB Pharma, but none related to this work. Drs Shi and Lew and Author Zimmerman are employees of IBM Watson Health, which was compensated by Eli Lilly and Company for conducting this research. Drs Somani, Burge, Zhu, Atiya, and Murage, and Author Ridenour are employees of Eli Lilly and Company and hold stock in Eli Lilly and Company., (Copyright © 2021 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Introduction: Persistence and adherence to psoriasis treatments reflect overall drug effectiveness, tolerability, and convenience. Limited data are available on the treatment patterns of ixekizumab, an interleukin (IL)-17A antagonist, vs. guselkumab, an IL-23 inhibitor. Our objective was to evaluate real-life psoriasis drug treatment patterns with ixekizumab vs. guselkumab., Methods: This retrospective observational study used United States insurance claims data from IBM Watson MarketScan Databases to analyze treatment patterns (including adherence, persistence, time on monotherapy, switching, and use of concomitant medications) for patients with 1 year, ≥ 6 months, and up to 30 months of follow-up. Outcomes were compared between ixekizumab and guselkumab on the balanced sample after applying inverse probability of treatment weighting (IPTW)., Results: Data for 1414 eligible patients (ixekizumab, N = 674 and guselkumab, N = 740) were assessed. Over the 1-year follow-up, adherence was greater for ixekizumab vs. guselkumab when evaluated by proportion of days covered ≥ 80% [odds ratio (OR) 1.77 (95% confidence interval, 1.41, 2.21), p < 0.001] and by medication possession ratio ≥ 80% [OR = 1.92 (1.54, 2.38), p < 0.001]. Persistence was longer for ixekizumab vs. guselkumab with a 60-day allowable gap [non-persistence hazard ratio (HR) (95% confidence interval): 0.80 (0.69, 0.93), p = 0.005], but there were no differences with a 90-day allowable gap [HR = 0.98 (0.83, 1.17), p = 0.850]. Results assessed in patients with ≥ 6 months follow-up confirmed these findings. This retrospective analysis of a United States claims database used prescription refill data to estimate persistence/adherence., Conclusions: Based on real-world evidence using claims data, patients with psoriasis treated with ixekizumab had a greater adherence to and an equal or greater persistence with therapy vs. patients treated with guselkumab., (© 2022. The Author(s).)

Purpose: Alopecia areata (AA) is a common disorder of patchy hair loss which carries a substantial psychological burden for patients. The current understanding of AA prevalence, disease course and burden is limited, and further research is needed to improve patient care. This prospective cohort of AA patients within the Danish Skin Cohort was established to provide data that can serve as a tool in future studies of for example, AA epidemiology and disease burden., Participants: A total of 1494 patients with dermatologist-verified AA were included in the cohort. Patients were invited and included through electronic or phone-based questionnaires. Information regarding demographics, biometrics, lifestyle factors, skin type, AA onset and development, health-related quality of life and self-reported severity assessment was collected., Findings to Date: The mean (SD) age of AA onset was 32.7 (17.6) years. The mean body mass index and history of cigarette smoking was comparable with the general population. The majority (92.5%) of participants were Caucasian. In total, 72.4% of patients received their diagnosis by a physician within a year after onset of symptoms, and 66.9% reported to still have symptoms of AA within the past year. A total of 12% reported to have a first-degree family member with AA. In total, 31.4% of patients were missing all or nearly all hairs on their scalp, 32.2% had no or barely no eyelashes and 36.2% had no or barely no eyebrow hairs. Overall, most patients (55.7%) did not experience irritated eyes, but 30% reported slight eye irritation and 47.2% reported no damage to finger nails or toenails., Future Plans: Observational studies regarding comorbidities, psychosocial burden of AA and efficacy of pharmacological interventions will be carried out and additional data will be linked from nationwide registries of routinely collected data. Furthermore, follow-up survey data will be added for longitudinal analyses., Competing Interests: Competing interests: Dr YMFA has received research funding from Kgl Hofbundtmager Aage Bang Foundation and AP Moller Foundation. Ms. LN has nothing to declare. Dr RTB, Mrs. AMD and Mrs. EE-H are employees and stockholders of Eli Lilly and Company. Dr AE has received research funding from Pfizer, Eli Lilly, Novartis, Bristol-Myers Squibb, AbbVie, Janssen Pharmaceuticals, the Danish National Psoriasis Foundation, the Simon Spies Foundation and the Kgl Hofbundtmager Aage Bang Foundation and honoraria as consultant and/or speaker from AbbVie, Almirall, Leo Pharma, Galápagos NV, Sun Pharmaceuticals, Samsung Bioepis, Ltd, Pfizer, Eli Lilly and Company, Novartis, Galderma, Dermavant, UCB, Mylan, Bristol-Myers Squibb and Janssen Pharmaceuticals., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Data on real-world experiences for patients treated with ixekizumab is currently limited., Objectives: Describe characteristics of ixekizumab-treated psoriasis patients and provide evidence of clinical outcomes using disease severity scores Body Surface Area (BSA) and Psoriasis Area and Severity Index (PASI) in the real world., Methods: Chart review was performed for adult patients treated with ixekizumab at a single Canadian dermatology clinic (February 2017-August 2018). The cohort was stratified into responders (patients who remained on ixekizumab) and non-responders (patients who discontinued ixekizumab). Subgroup analyses were performed for responders to assess clinical improvement stratified by previous biologic exposure., Results: Thirty-eight patients were included (mean observational time 32 weeks). At baseline, mean PASI and BSA were 10.8 and 11.6%, respectively. Mean changes in PASI and BSA were -7.8 and -6.7%, respectively, at week 4. PASI 100 was achieved in 70% of patients. Significant differences in mean change of BSA were seen between bio-naïve and bio-experienced patients., Conclusion: This analysis represents the first investigation of early clinical outcomes in a small cohort of Canadian patients treated with ixekizumab. Overall, complete and rapid skin clearance was observed. Future studies including more patients and longer follow-up time are crucial to confirm these findings.

Background: The identification of early treatment factors that predict the long-term success of maintenance therapy for psoriasis may help optimize individual therapy., Objective: To determine early treatment response rates to ixekizumab and ustekinumab and assess whether early response was associated with stable long-term response to these treatments in patients with moderate-to-severe psoriasis., Methods: This post hoc subgroup analysis of the IXORA-S study (NCT02561806) measured disease severity using the Psoriasis Area Severity Index (PASI) and determined the percentage of patients treated with ixekizumab or ustekinumab who showed PASI 50 at week 2 or 4 (early response) and assessed whether early response was associated with maintaining complete (PASI 100) or almost complete (PASI 90) skin clearance at 80% of monthly visits during weeks 16&minus;52 of treatment (stable response). Nonresponder imputation was used for missing PASI response status., Results: A numerically higher portion of patients treated with ixekizumab were early responders and were significantly more likely to achieve a stable PASI 90 response (P&lt;.0001) or PASI 100 response (P&lt;.0001) than patients treated with ustekinumab. Patients treated with ixekizumab or ustekinumab who were early responders were more likely to achieve a stable response of PASI 90 or 100 (odds ratio&gt;1)., Conclusion: In patients with moderate-to-severe psoriasis treated with ixekizumab or ustekinumab, early response was a significant factor in maintaining stable complete or almost complete skin clearance. Therefore, rapid response is a clinically relevant factor to consider when optimizing individual therapeutic strategies. J Drugs Dermatol. 2022;21(2):122-126. doi:10.36849/JDD.6063.

Aims: To compare long-term healthcare resource utilization (HCRU) and costs among patients who initiated ixekizumab (IXE) or adalimumab (ADA) for treatment of psoriasis in the United States., Methods: Adult patients with psoriasis who had ≥1 claim for IXE or ADA were identified from IBM MarketScan claims databases prior to the COVID-19 pandemic (1 March 2016-31 October 2019). The index date was the date of first claim for the index drug of interest. Inverse probability of treatment weighting was employed to balance treatment cohorts. All-cause and psoriasis-related HCRU and costs were examined for 24 months of follow-up. Costs were reported as per patient per month. Costs of psoriasis-related biologics were adjusted using published Institute for Clinical and Economic Review (ICER) discount factors. Index drug costs were adjusted for adherence and ICER discount rates., Results: The analyses included 407 IXE and 2,702 ADA users. IXE users had significantly higher inpatient admission rate (all-cause HCRU: 14.9% vs. 11.0%; p  =0.012) and greater mean length of stay per admission (days, 6.6 vs. 4.1; p  =0.004) than ADA users. ICER-adjusted costs were significantly higher in IXE than ADA users (all-cause costs: $4,132 vs. $3,610; p  <0.001; psoriasis-related costs $3,077 vs. $2,700; p  <0.001). After adjusting for ICER and adherence, IXE and ADA drug costs were comparable ($3,636 vs. $3,677; p  =0.714)., Limitations: Study relied on administrative claims data, subjected to data coding limitations and data entry errors. Rebates, patient assistance programs, and commission to wholesalers are not always captured in claims. Adjustment made by ICER discount factors may lead to double-discounting if the discounts have been applied in claim payments., Conclusions: All-cause HCRU was higher in IXE than ADA users. Healthcare costs were also higher in IXE than ADA users after ICER adjustment, over 24 months. Cost differences were largely driven by higher treatment adherence associated with IXE. Index drug costs were comparable after ICER and adherence adjustments.

Introduction: Baricitinib-remdesivir (BARI-REM) combination is superior to remdesivir (REM) in reducing recovery time and accelerating clinical improvement among hospitalized patients with coronavirus disease 2019 (COVID-19), specifically those receiving high-flow oxygen/noninvasive ventilation. Here we assessed the cost-effectiveness of BARI-REM versus REM in hospitalized patients with COVID-19 in the USA., Methods: A three-state model was developed addressing costs and patient utility associated with COVID-19 hospitalization, immediate post hospital care, and subsequent lifetime medical care. Analysis was performed from the perspective of a payer and a hospital. Both perspectives evaluated two subgroups: all patients and patients who required oxygen. The primary measures of benefit in the model were patient quality-adjusted life years (QALYs) accrued during and after hospitalization, cost per life years gained, cost per death avoided, and cost per use of mechanical ventilation avoided., Results: In the base-case payer perspective with a lifetime horizon, treatment with BARI-REM versus REM resulted in an incremental total cost of $7962, a gain of 0.446 life years and gain of 0.3565 QALYs over REM. The incremental cost-effectiveness ratios of using BARI-REM were estimated as $22,334 per QALY and $17,858 per life year. The base-case and sensitivity analyses showed that the total incremental cost per QALY falls within the reduced willingness-to-pay threshold of $50,000/QALY applied under health emergencies. In all hospitalized patients, treatment with BARI-REM versus REM reduced total hospital expenditures per patient by $1778 and total reimbursement payments by $1526, resulting in a $252 reduction in net costs per patient; it also resulted in a net gain of 0.0018 QALYs and increased survival of COVID-19 hospitalizations by 2.7%., Conclusion: Our study showed that BARI-REM is cost-effective compared to using REM for hospitalized patients with COVID-19. The base-case results of this cost-effectiveness model were most sensitive to average annual medical costs for recovered patients., (© 2021. The Author(s).)

Objectives: Psoriasis (PsO) is a chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations. The disease is also associated with lower quality of life, lower work productivity, and higher healthcare costs. The objective of this study was to conduct a systematic literature review of the disease burden for PsO in Argentina, Brazil, Colombia, and Mexico., Methods: PubMed/MEDLINE, Web of Science, SciELO, and LILACS were searched for publications in English, Spanish, or Portuguese from 2003 to July 2018., Results: A total of 680 records were retrieved and 13 articles were included. In Latin America, PsO has a negative impact on the physical and mental well-being as shown by substantially lower scores on measures of quality of life (eg, 12-item Short-Form Health Survey) for patients than the general population. Patients with PsO reported higher levels of presenteeism, activity impairment, and work productivity loss. The estimated annual costs per patient with PsO in Colombia were $3497.58 and $2160.92 for the private sector and public scenario, respectively., Conclusions: Although evidence on the full cost and impact of PsO in Latin America is scarce and further research is needed, the burden in these regions is significant and comparable with that in other parts of the world., (Copyright © 2021. Published by Elsevier Inc.)

Introduction: Real-world data comparing effectiveness of ixekizumab (IXE) and secukinumab (SEC) among biologic-experienced patients are limited. This study compared treatment patterns over 18 months among biologic-experienced patients with psoriasis receiving IXE or SEC in the USA., Methods: A retrospective observational study using administrative claims data from IBM ® Watson Health MarketScan ® Research Databases included adult patients with ≥ 1 inpatient or ≥ 2 non-diagnostic (≥ 30 days apart) outpatient claim/s with diagnosis of psoriasis between March 1, 2015 and October 31, 2019, and ≥ 1 claim/s for index drugs, IXE or SEC, between March 1, 2016 and October 31, 2019. Patients had to have ≥ 1 claim/s for biologics indicated for psoriasis in the 6-month pre-period. During the 18-month follow-up, treatment adherence (proportion of days covered [PDC]), high adherence (PDC ≥ 80%), persistence, discontinuation, reinitiation, and switching were assessed. To address cohort imbalances, inverse probability of treatment weighting was employed. Logistic regression was used to estimate odds ratio for high adherence. Cox proportional hazard models were used to estimate hazard ratio for non-persistence, discontinuation, and switching., Results: Overall, 411 IXE and 780 SEC users were included. After weighting, IXE users had significantly higher rate of high treatment adherence (42% vs. 35%, p = 0.019), higher persistence rate (44.9% vs. 36.9%, p = 0.007), lower discontinuation rate (48.4% vs. 56.0%, p = 0.012), and lower switching rate (26.6% vs. 34.0%, p = 0.009) compared with SEC users. After multivariable adjustment, compared with SEC, IXE use was associated with 36% higher odds of high treatment adherence (OR 1.36, 95% CI 1.05-1.74), 20% lower risk of treatment non-persistence (HR 0.80, 95% CI 0.68-0.93), 19% lower risk of discontinuation (HR 0.81, 95% CI 0.68-0.96), and 25% lower risk of switching (HR 0.75, 95% CI 0.60-0.93)., Conclusion: This study suggests that IXE treatment is associated with significantly higher adherence rates and significantly lower non-persistence, discontinuation, and switching compared with SEC treatment., (© 2021. The Author(s).)

Introduction: Reliable cost and resource use data for COVID-19 hospitalizations are crucial to better inform local healthcare resource decisions; however, available data are limited and vary significantly., Methods: COVID-19 hospital admissions data from the Premier Healthcare Database were evaluated to estimate hospital costs, length of stay (LOS), and discharge status. Adult COVID-19 patients (ICD-10-CM: U07.1) hospitalized in the US from April 1 to December 31, 2020, were identified. Analyses were stratified by patient and hospital characteristics, levels of care during hospitalization, and discharge status. Factors associated with changes in costs, LOS, and discharge status were estimated using regression analyses. Monthly trends in costs, LOS, and discharge status were examined., Results: Of the 247,590 hospitalized COVID-19 patients, 49% were women, 76% were aged ≥ 50, and 36% were admitted to intensive care units (ICU). Overall median hospital LOS, cost, and cost/day were 6 days, US$11,267, and $1772, respectively; overall median ICU LOS, cost, and cost/day were 5 days, $13,443, and $2902, respectively. Patients requiring mechanical ventilation had the highest hospital and ICU median costs ($47,454 and $41,510) and LOS (16 and 11 days), respectively. Overall, 14% of patients died in hospital and 52% were discharged home. Older age, Black and Caucasian race, hypertension and obesity, treatment with extracorporeal membrane oxygenation, and discharge to long-term care facilities were major drivers of costs, LOS, and risk of death. Admissions in December had significantly lower median hospital and ICU costs and LOS compared to April., Conclusion: The burden from COVID-19 in terms of hospital and ICU costs and LOS has been substantial, though significant decreases in cost and LOS and increases in the share of hospital discharges to home were observed from April to December 2020. These estimates will be useful for inputs to economic models, disease burden forecasts, and local healthcare resource planning., (© 2021. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.)

Purpose: In the Phase III COV-BARRIER (Efficacy and Safety of Baricitinib for the Treatment of Hospitalised Adults With COVID-19) trial, treatment with baricitinib, an oral selective Janus kinase 1/2 inhibitor, in addition to standard of care (SOC), was associated with significantly reduced mortality over 28 days in hospitalized patients with coronavirus disease-2019 (COVID-19), with a safety profile similar to that of SOC alone. This study assessed the cost-effectiveness of baricitinib + SOC versus SOC alone (which included systemic corticosteroids and remdesivir) in hospitalized patients with COVID-19 in the United States., Methods: An economic model was developed to simulate inpatients' stay, discharge to postacute care, and recovery. Costs modeled included payor costs, hospital costs, and indirect costs. Benefits modeled included life-years (LYs) gained, quality-adjusted life-years (QALYs) gained, deaths avoided, and use of mechanical ventilation avoided. The primary analysis was performed from a payor perspective over a lifetime horizon; a secondary analysis was performed from a hospital perspective. The base-case analysis modeled the numeric differences in treatment effectiveness observed in the COV-BARRIER trial. Scenario analyses were also performed in which the clinical benefit of baricitinib was limited to the statistically significant reduction in mortality demonstrated in the trial., Findings: In the base-case payor perspective model, an incremental total cost of 17,276 US dollars (USD), total QALYs gained of 0.6703, and total LYs gained of 0.837 were found with baricitinib + SOC compared with SOC alone. With the addition of baricitinib, survival was increased by 5.1% and the use of mechanical ventilation was reduced by 1.6%. The base-case incremental cost-effectiveness ratios were 25,774 USD/QALY gained and 20,638 USD/LY gained; a "mortality-only" scenario analysis yielded similar results of 26,862 USD/QALY gained and 21,433 USD/LY gained. From the hospital perspective, combination treatment with baricitinib + SOC was more effective and less costly than was SOC alone in the base case, with an incremental cost of 38,964 USD per death avoided in the mortality-only scenario., Implications: In hospitalized patients with COVID-19 in the United States, the addition of baricitinib to SOC was cost-effective. Cost-effectiveness was demonstrated from both the payor and the hospital perspectives. These findings were robust to sensitivity analysis and to conservative assumptions limiting the clinical benefits of baricitinib to the statistically significant reduction in mortality demonstrated in the COV-BARRIER trial., Competing Interests: Disclosure K.K. and T.K. are employees of Medical Decision Modeling Inc and received funding from Eli Lilly and Company to conduct the study. P.L.M., T.S., R.B., and M.B. are employees of Eli Lilly and Company. The authors have indicated that they have no other conflicts of interest with regard to the content of this article., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is an approved treatment for plaque psoriasis. This study aimed to use animated visualizations as a tool to simplify complex data from ixekizumab clinical trials., Methods: Animated visualizations were developed to show outcomes from ixekizumab clinical trials and a Bayesian network meta-analysis of 11 approved biologics. The visualizations simultaneously highlighted both aggregate scores and the individual progression of patients over the course of treatment., Results: The animations provided key messages and information from the complex data in efficient and scientific ways that were also visually pleasing and simple to understand. The animations highlighted (1) rapid reduction in disease severity from baseline; (2) sustained efficacy of ixekizumab in the treatment of skin and nail psoriasis; (3) side-by-side comparisons of treatment efficacy and clinical improvement across trials; (4) simultaneous visual presentation of individual results with summary response over time; and (5) indirect comparison of relative treatment effects with other biologics based on Bayesian network meta-analysis., Conclusion: The rapid and sustained efficacy of ixekizumab in the treatment of psoriasis was demonstrated using multiple dynamic visualizations with different clinical endpoints. Animated visualizations provided a simpler and more comprehensive understanding of complex data than conventional static figures., (© 2021. The Author(s).)

Introduction: Psoriasis Area Severity Index (PASI) assessment is complex and time-consuming. A simpler assessment measure more sensitive to changes in symptom severity and predictive of patients' quality of life (Dermatology Life Quality Index, DLQI) is needed. This study aims to evaluate the Optimal Psoriasis Assessment Tool (OPAT) as an alternative to PASI., Methods: This integrated analysis of three UNCOVER trials (NCT01474512, NCT01597245, and NCT01646177) randomized patients (N = 3866) with moderate-to-severe psoriasis to subcutaneously administered ixekizumab 80 mg Q2W or Q4W, or placebo or etanercept 50 mg Q2W. Pearson correlations were computed for clinical and patient-reported measures with PASI and DLQI., Results: As the correlations with PASI and BSA were high and not much higher when adding severity, body surface area (BSA) was used for the clinical measure. BSA was the main measure influencing OPAT. Week 12 regression analyses results showed that PASI had a higher correlation with BSA combined with patient assessments than with BSA alone. Sensitivity analyses were also completed for PASI 75 and 90. For DLQI, correlations with the combined measures were even stronger than with BSA alone. A comprehensive model selection procedure was conducted, which illustrated that the two-term models are preferred., Conclusion: The OPAT is a simple and time-saving alternative to PASI. It can be derived using BSA and patient-reported assessments having strong correlation with PASI and moderate correlation with DLQI., (© 2021. The Author(s).)

Introduction: The content validity and treatment success thresholds of clinical outcome assessments (COAs) for alopecia areata (AA)-including the Alopecia Areata-Investigator Global Assessment™ (AA-IGA™), Scalp Hair Assessment Patient-Reported Outcome™ (PRO), and clinician-reported outcome (ClinRO) and PRO measures for eyebrows, eyelashes, eye irritation, and nails-were established in interviews with dermatologists and patients in North America. This study aimed to confirm the content validity and treatment success thresholds of these measures with clinicians and patients in Japan., Methods: Qualitative interviews were conducted in Japan with dermatologists with AA expertise and adults with AA who experienced ≥ 50% scalp hair loss. Interviews included concept elicitation and cognitive interview questions. Data were analyzed using thematic and framework techniques., Results: Seven dermatologists and 15 patients participated. Scalp hair loss was the most important sign/symptom of AA and the greatest treatment priority. Dermatologists and patients understood the AA-IGA™, Scalp Hair Assessment PRO™, and other COAs, and found these measures to be appropriate, relevant, and clinically meaningful. Dermatologists and patients confirmed that achieving ≤ 20% scalp hair loss (AA-IGA™/Scalp Hair Assessment PRO™ categories 0 or 1) indicated treatment success for patients with ≥ 50% scalp hair loss. Categories 0 or 1 on the other COAs represented treatment success., Conclusion: This study confirmed the content validity and treatment success thresholds of the AA-IGA™, Scalp Hair Assessment PRO™, and other ClinRO and PRO measures for AA in Japan. These findings were aligned with interview results in North America and support the use of these measures in AA treatment studies.

Objective: We describe patient-reported outcomes and quality of life through 5 years of treatment in patients with moderate-to-severe plaque psoriasis in the UNCOVER-1 and -2 studies., Methods: This analysis included patients who were randomized to ixekizumab every 2 weeks then received ixekizumab every 4 weeks during the maintenance period, and who achieved static physician global assessment (0,1) at week 12, completed week 60, and entered the long-term extension period (weeks 60&ndash;264). Outcomes measures included responses in itch numeric rating scale (NRS), skin pain visual analog scale (VAS), and dermatology life quality index (DLQI) (0,1), and mean change from baseline in short form health survey (SF-36) mental (MCS) and physical component summaries (PCS), psoriasis skin appearance bothersomeness (PSAB), and work productivity activity impairment (WPAI)., Results: At week 264 in UNCOVER-1 and -2, the observed itch NRS &ge;4 responses were 82.4% and 93.1%, respectively, the itch NRS=0 responses were 51.7% and 58.5%, respectively, the skin pain VAS=0 responses were 59.3% and 63.1%, respectively, and the DLQI (0,1) responses were 75.0% and 88.1%, respectively. The observed mean changes from baseline at week 264 in UNCOVER-1 and UNCOVER-2 were 3.4 and 6.5, respectively, for SF-36 MCS, 4.4 and 4.8, respectively, for SF-36 PCS, and -21.3 and -22.0, respectively, for PSAB. WPAI psoriasis item scores improved from baseline in both UNCOVER-1 and -2., Conclusion: Ixekizumab provided clinically meaningful and sustained improvements in itch, skin pain, DLQI, PSAB, SF-36 PCS, SF-36 MCS, and WPAI through 5 years of treatment in patients with moderate-to-severe plaque psoriasis. J Drugs Dermatol. 20(4):394-401. doi:10.36849/JDD.5821Visit the JDD Psoriasis Resource Center for more.

To compare drug survival of ixekizumab to other IL-17 inhibitors (IL-17i) and TNF inhibitors (TNFi) among patients with psoriasis (PsO) in a real-world setting. Participants included adult PsO patients enrolled in the Corrona Psoriasis Registry who initiated ixekizumab, TNFi, or other IL-17i between 16 March 2016 to 10 August 2019 and completed ≥1 follow-up visit. Multivariable adjusted hazard ratios (HR) were calculated to estimate the risk for drug discontinuation in the ixekizumab group relative to the other drugs. Among the 1604 drug initiations, 552 initiated ixekizumab, 450 initiated TNFi, and 602 initiated other IL-17i. Mean age was 51 years, 49% were women, and 52% were obese (BMI > 30). Ixekizumab patients had a higher proportion of patients with PASI >12 at drug initiation (24%) than TNFi (15%) and other IL-17i (19%). Over a median of 11 months of follow-up, 723/1604 (45%) drug discontinuations occurred. Persistence of ixekizumab, TNFi, and other IL-17i at 24-months were 68%, 33%, and 46%, among biologic-naïve patients (n = 543), and 46%, 23%, and 36%, for biologic-experienced patients (n = 1061), respectively. Ixekizumab patients had a 64% lower risk of discontinuation vs TNFi (HR = 0.36; 95% CI 0.27-0.47) and a 31% lower risk vs other IL-17i (HR = 0.69, 95% CI 0.55-0.87) after adjustment for biologic experience and other covariates. HRs were similar when limited to patients with moderate-to-severe PsO (BSA > 3, PASI > 3, and IGA > 1, n = 1076) at initiation. In our study of real-world patients with PsO, initiators of ixekizumab had more prolonged drug survival than both initiators of TNFi and other IL-17i up to 2 years of follow-up., (© 2021 The Authors. Dermatologic Therapy published by Wiley Periodicals LLC.)

Background/objectives: Psoriasis is a chronic, immune-mediated dermatologic disorder with a prevalence among children estimated at 0.1%-0.45%, and a median age of onset at approximately 7-10 years. Pediatric psoriasis is known to have negative impacts on health-related quality of life. Among the most bothersome symptoms, itch has been measured using the Itch Numeric Rating Scale (NRS). This study explored the symptom and impacts of itch with pediatric psoriasis patients and evaluated the content validity of the Itch NRS in children., Methods: Semi-structured qualitative interviews were conducted among a sample of pediatric patients diagnosed with plaque psoriasis., Results: Concept elicitation interviews were completed with 22 children (ages 7-17 years). When asked about most frequent symptoms, 61% reported itching (n = 14) and 65% reported flaking (n = 15). The majority reported itching as bothersome; about half described impacts on their regular activities. Cognitive interviews were completed with 25 children (ages 8-17 years). Most reported that independently completing the Itch NRS would be easy, and all described the meaning of the response options similar to the intended value. Overall, the Itch NRS was received favorably, with comments that the scale was easy or relevant to their experience with psoriasis., Conclusions: This qualitative study supports the content validity of the Itch NRS for use in a pediatric psoriasis population aged 8-17. Given the established importance of itch to pediatric psoriasis patients, future research exploring the impact of itch on the lives of pediatric psoriasis patients may provide a valuable contribution to the field., (© 2020 Wiley Periodicals LLC.)

Background: Real-world data on patients newly initiating ixekizumab is limited. Our study describes the characteristics of patients who initiated ixekizumab and other biologics for psoriasis treatment in North American dermatological practices. Materials & methods: Characteristics of patients ascertained at registry enrollment are described via means and frequencies. Results: Compared with other biologic initiators, ixekizumab initiators had: longer disease duration (17.1 vs 15.1 years); more were considered least severe by body surface area (33 vs 26%); moderate-to-severe by IGA (56 vs 48%); were biologic-experienced (80 vs 52%); obese (54 vs 47%); and experienced greater impact in work productivity (5.3 vs 2.9%) versus other biologic initiators. Conclusion: Psoriasis patients initiating ixekizumab had more severe disease, biologic experience, and worse patient-reported outcomes than those initiating other biologics.

Objectives: To describe ixekizumab treatment patterns, all-cause healthcare utilization, and costs among psoriasis patients. Methods: Adults diagnosed with psoriasis having ≥1 ixekizumab claim were selected from MarketScan ® databases between March 01, 2016 and July 31, 2017. Patients were continuously enrolled for ≥6 months prior and ≥3 months after the index date (first ixekizumab claim) and followed until inpatient death, end of enrollment, or end of data. Treatment patterns included persistence, switching, and re-initiation. All-cause utilization and costs were reported per-patient-per-month (PPPM). Results: 801 patients (mean age 49 years; 55.8% male; median follow-up 201 days) were included. Among all patients, 87.4% were persistent (mean (median) duration 86 (75) days) Of the 12.6% of patients who discontinued ixekizumab, 11.9% re-initiated and 6.9% switched treatments. Mean (median) time to switching was 208 (206) days. Mean number of all-cause inpatient admissions and physician office visits PPPM were 0.01 and 0.72, respectively. Mean total cost PPPM was $8,371, of which pharmacy comprised $7,792. Ixekizumab costs, $7,079, occurred primarily during induction and were paid predominantly by health plans ($6,810 [96.2%]). Conclusion: Most (87.4%) ixekizumab users remained persistent during follow-up. Pharmacy was the primary driver of total healthcare costs, with the majority covered by health plans and <4% as patient out-of-pocket expense.

BACKGROUND: Measuring cumulative clinical treatment benefit over time captures speed and magnitude of effects. Assessing the cost of biologics relative to their cumulative clinical benefits versus a single time point represents an alternative to evaluate the value of a given biologic used to treat psoriasis. OBJECTIVE: To compare cumulative benefit and cost per cumulative benefit of biologics in treatment of moderate to severe psoriasis from a network meta-analysis (NMA). METHODS: Biologics included in the analysis were ixekizumab, adalimumab, guselkumab, ustekinumab, secukinumab, risankizumab, and certolizumab pegol. Psoriasis Area and Severity Index (PASI) responses over the initial 16-week treatment period were obtained from 31 articles. Cumulative benefits for PASI 75, PASI 90, and PASI 100 responses were measured as area under the curve (AUC) using the trapezoidal method. Bayesian-based NMA modeled percent maximum AUC through week 16 (%Max&#95;AUC W16 ). The AUC estimates over 16 weeks were converted to total skin clearance threshold days achieved for PASI 75, PASI 90, and PASI 100 with each biologic. Cost per cumulative benefit was estimated by multiplying number of doses (per FDA label) by nationally representative discounted wholesale acquisition costs (WACs) for 16 weeks of treatment divided by %Max&#95;AUC W16 . The primary cost analysis used WACs, including week 16 doses. Co-primary cost analysis used discounted WACs, including week 16 doses. Sensitivity analysis was conducted using WACs and discounted WACs, excluding doses administered at week 16. RESULTS: Among biologics with available week 16 AUC data for PASI 90 and PASI 100, cumulative benefits over the initial 16-week treatment period ranged from 20.2% (certolizumab pegol) to 47.0% (ixekizumab) for PASI 90 and from 7.4% (adalimumab) to 22.2% (ixekizumab) for PASI 100. The total number of estimated PASI 90 and PASI 100 days achieved over the first 16 weeks of treatment was highest with ixekizumab (53 days and 25 days, respectively). In the primary analysis, guselkumab had the lowest cost per cumulative benefit (95% credible interval [CrI]; $99,742 [$89,941-$111,653]), followed by ixekizumab ($108,906 [$95,928-$126,093]) and adalimumab ($111,233 [$97,549-$129,022]) for PASI 90, and ixekizumab had the lowest cost per cumulative benefit ($230,884 [$191,611-$291,115]), followed by secukinumab ($238,945 [$204,029-$288,072]) and risankizumab ($279,968 [$250,683-$316,872]) for PASI 100 responses. In the co-primary analysis, ixekizumab had the lowest discounted cost per AUC (95% CrI; $60,988 [$53,719-$70,612]), followed by guselkumab ($66,827 [$60,260-$74,807]) and secukinumab ($69,622 [$61,783-$79,786]) for PASI 90, and ixekizumab had the lowest cost per cumulative benefit ($129,295 [$107,302-$163,024]), followed by secukinumab ($148,146 [$126,498-$178,605]) and guselkumab ($188,190 [$166,791-$215,969]) for PASI 100 responses. Conclusions: Among biologics studied, ixekizumab demonstrated the greatest cumulative clinical benefit, maintaining the lowest cost per cumulative benefit for PASI 100 responses and lowest discounted cost per cumulative benefit for PASI 90 and PASI 100 responses for moderate to severe psoriasis over the initial 16-week treatment period. DISCLOSURES: This study was funded by Eli Lilly and Company (Indianapolis, IN). Blauvelt has served as a scientific adviser and/or clinical study investigator for AbbVie, Aclaris, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dermira, Eli Lilly and Company, Forte, Galderma, Incyte, Janssen, Leo, Novartis, Ortho, Pfizer, Rapt, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, and UCB Pharma and as a paid speaker for AbbVie. Burge, Zhu, Malatestinic, Brnabic, Guo, and Janardhanan are employees and shareholder of Eli Lilly and Company.

Introduction: Ixekizumab has demonstrated rapid onset of action, high levels of skin clearance, and improvements in quality of life in patients with moderate-to-severe psoriasis, including plaque, erythrodermic, or generalized pustular psoriasis., Methods: This was a post hoc analysis of UNCOVER-J, a phase 3, multicenter, single-arm, open-label study of ixekizumab for treatment of Japanese patients with psoriasis. The objective was to assess the proportion of patients who achieved Dermatology Life Quality Index (DLQI) (0,1) and Itch Numeric Rating Scale (NRS) (0) at weeks 4 and 12 according to Psoriasis Area and Severity Index (PASI) percentage improvement levels. All intent-to-treat patients with plaque, erythrodermic, or generalized pustular psoriasis were analyzed., Results: A total of 91 patients were treated with ixekizumab and included in the analysis. Rapid improvements in PASI at weeks 4 and 12 were associated with improvements in DLQI (0,1) response at week 4 and at week 12. Complete skin clearance (PASI 100) achieved either at week 4 or week 12 was associated with a higher Itch NRS (0) response at week 12., Conclusions: Patients with rapid improvement in clinical symptoms of psoriasis had better patient outcomes than those with slower responses. These findings highlight the clinical importance of achieving a fast response in patients with psoriasis, which may lead to better treatment outcomes., Trial Registration: ClinicalTrials.gov identifier, NCT01624233.

BACKGROUND : Rapid improvements in health-related quality of life (HRQoL) and psoriasis severity have been reported in patients treated with ixekizumab (IXE), an interleukin (IL)-17A antibody. OBJECTIVE : We assessed the relationship between early Psoriasis Area and Severity Index (PASI) response and long-term Dermatology Life Quality Index (DLQI) improvement in patients in the randomized clinical trial IXORA-S (NCT0256186) treated with IXE or IL-12/23 (ustekinumab [UST]). METHODS : The proportion of patients achieving DLQI (0,1), an outcome equivalent to the patient's skin condition having no impact on HRQoL after 52 weeks of IXE or UST by PASI response at Weeks 4, 12, and 24 was quantified. Optimal thresholds for PASI response by treatment to predict Week 52 DLQI (0,1) were calculated based on Youden's Index. RESULTS : Early and higher levels of skin clearance were associated with improved patient outcomes regardless of treatment. Patients treated with IXE achieved faster and more pronounced PASI response than patients treated with UST. The optimal thresholds at Weeks 4, 12, and 24 for predicting DLQI (0,1) at Week 52 were ~PASI 75 for IXE versus ~PASI 50 for UST at Week 4, PASI 90 for IXE versus PASI 75 for UST at Week 12, and ~PASI 100 for IXE versus ~PASI 90 for UST at Week 24. Among patients achieving these thresholds, the probability of achieving a DLQI (0,1) was significantly higher. CONCLUSION : Earlier and higher levels of skin clearance are associated with improved patient outcomes over the long term, regardless of treatment., Competing Interests: FUNDING:The study was sponsored by Eli Lilly and Company. DISCLOSURES:Professor Reich has served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Centocor, Covagen, Eli Lilly and Company, Forward Pharma, Fresenius Medical Care, Galapagos NV, GlaxoSmithKline, Janssen-Cilag, Kyowa Kirin, Leo, Medac, Merck Sharp & Dohme, Novartis, Miltenyi Biotec, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB, Valeant, and Xenoport. Dr. Puig has received grants/research supports or participation in clinical trials (paid to Institution). Drs. Zhu, Burge, Shrom, Dong, Shen, and Mallbris are employees and minor stockholders of Eli Lilly and Company., (Copyright © 2020. Matrix Medical Communications. All rights reserved.)

Background: Psoriasis is a chronic inflammatory skin disease. Objective: To establish content validity and assess psychometric properties of the Psoriasis Symptoms Scale (PSS) in patients with moderate-to-severe psoriasis (Ps). Methods: The PSS is an eight-item patient-completed questionnaire assessing symptoms (itch, pain, stinging, burning), signs (redness, scaling, cracking), and discomfort. Content validity was established during interviews of patients ( n  = 14) with Ps. PSS Symptoms and Signs domain scores were evaluated for reliability, construct validity, and responsiveness using data from a clinical study (NCT02899988) in Ps ( n  = 205). Results: Patients confirmed content validity; the PSS was understandable and relevant. Cronbach's alphas were 0.84 (Symptoms) and 0.86 (Signs), demonstrating internal consistency reliability. Test-retest reliability was confirmed in patients before receiving study drug (intraclass coefficient: 0.82 [Symptoms]; 0.81 [Signs]). Convergent and discriminant validity were demonstrated at baseline and Week 16 by large (≥0.50) correlations between PSS Symptoms and Signs domain scores and Dermatology Life Quality Index total and symptoms and feelings domain scores, and small (<0.30) correlations with Short Form-36 Mental Component Summary score, respectively. Symptoms and Signs scores responded to clinical changes ( p < .001). Conclusions: The PSS Symptoms and Signs domains are valid and reliable assessments of patient-reported symptoms and signs, useful for assessing treatment efficacy.

Purpose: Teriparatide is used to treat patients with established osteoporosis but is often reserved for patients who have inadequate response to antiresorptive therapy. Biosimilar teriparatide, which is believed to have efficacy and safety similar to the originator product, is now available in Colombia. However, little is known about patients' preferences for originator biologic and biosimilar treatments. Our objective was to quantify the relative importance that patients in Colombia place on features of injectable osteoporosis treatments including whether the treatment is an originator biologic or a biosimilar., Patients and Methods: We used a discrete choice experiment (DCE) to elicit preferences of patients with osteoporosis treatment devices in Colombia. The survey was completed by 200 respondents at high risk of fracture, with or without teriparatide experience. Each treatment alternative within the DCE was characterized by five attributes: type of medicine (originator biologic, biosimilar), needle length, angle of injection, how to measure the medicine dose, and how long the medicine can be left unrefrigerated. A random parameters logit regression was used to estimate preferences and conditional relative attribute importance, while controlling for preference heterogeneity., Results: A total of 200 patients (mean age = 58.3 years) completed the survey. Most were female (84.5%) and married (54.5%); 50.5% had secondary education or less, 21% had current teriparatide exposure. The attribute with the highest conditional relative importance estimate (standard error) was biologic versus biosimilar (10 [1.11]), followed by needle length (8.06 [1.11]), dose measurement (6.38 [0.87]), refrigeration (3.81 [1.18]), and angle of injection (1.30 [0.66]). Unobserved preference heterogeneity was present and controlled for in the analyses., Conclusion: Despite the availability of biosimilar teriparatide in Colombia, patients expressed a strong preference for an originator biologic osteoporosis medicine over a biosimilar osteoporosis medicine, when the efficacy, safety, and cost of the two options were assumed to be the same., Competing Interests: Dr Peita Graham-Clarke reports being an Employee and Shareholder of Eli Lilly; Dr Brett Hauber is an employee of RTI Health Solutions during the conduct of the study; Dr Marco Boeri report Marco Boeri is an employee of RTI Health Solutions; Dr Russel Burge is a Salaried employee and stockholder of Eli Lilly and Company during the conduct of the study; Dr Maria Fernandez is an employee of RTI-HS which received funding from Eli Lilly & Co. to conduct the study which is the subject of this manuscript; Ms Antje Tockhorn-Heidenreich is an Employee and minor stockholder of Eli Lilly and Company during the conduct of the study; Dr Sandra Florez report personal fees from Eli Lilly, during the conduct of the study and is an employee of Eli Lilly; Felice Leonardi is an employee of Eli Lilly and Company. The analysis reported in this manuscript was funded by Eli Lilly and Company through a research contract with RTI Health Solutions. The authors report no other conflicts of interest in this work., (© 2020 Graham-Clarke et al.)