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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 [R2adj], 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 (R2adj = .72, RMSE = 2.93) and only marginally worse than models including additional variables (R2adj 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.

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.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.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.Patients with moderate-to-severe PsO overwhelmingly remained on ixekizumab treatment for more than 2 years while participating in a PSP.

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.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.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.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.

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.Patients who newly initiated IXE, adalimumab (ADA), etanercept (ETN), secukinumab (SEC), or ustekinumab (UST) in IBM MarketScanA 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.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.

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).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].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.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.

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.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).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.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.In real-world settings, how consistently patients take a drug (adherence) and how long they continue taking it (persistence) are thought to reflect patients’ satisfaction with the combination of efficacy and tolerability of the treatment. In this study of patients with psoriasis, we compared these measures—regularity of prescription refills and continued time on drug—between patients receiving ixekizumab or guselkumab for their psoriasis. This information was taken from a large insurance claims database, and so reflects results among commercially insured patients in the United States. We found that patients taking ixekizumab more consistently obtained prescription refills during the study period. Patients taking ixekizumab or guselkumab continued treatment for similar lengths of time when we allowed a longer gap of 90 days between prescription refills, but when a shorter gap of 60 days was allowed, those on ixekizumab spent a longer time on treatment. The findings were consistent regardless of prior treatment with other similar drugs (biologics). Overall, these findings indicate that for ixekizumab, which is dosed once every 4 weeks, and guselkumab, which is dosed once every 8 weeks, patients took ixekizumab more regularly and continued on the drug for about the same or a longer amount of time compared to patients taking guselkumab. These results may help dermatology practitioners in selecting biologic drugs for their patients with psoriasis.

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).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.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].For complete and almost-complete skin clearance, ixekizumab and risankizumab provided the greatest cumulative clinical benefits over 1 year.

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.

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.Patients with psoriasis diagnosis were identified from IBM Watson Health MarketScanOverall, 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).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.

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.

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_AUCW16). 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_AUCW16. 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. Graphic Abstract Electronic supplementary material The online version of this article (10.1007/s13555-020-00441-4) contains supplementary material, which is available to authorized users.

Background Cumulative clinical improvement and speed of improvement are important to psoriasis patients. Objective Compare cumulative benefits of biologics over 12 to 16 weeks in the treatment of moderate to severe psoriasis. Methods A systematic literature review identified phase III trial data on Psoriasis Area and Severity Index (PASI) responses for biologics during 12 and 16 weeks of treatment. Cumulative clinical benefit, measured by the area under the curve for PASI ≥75% improvement (PASI 75), ≥90% improvement (PASI 90), and 100% improvement (PASI 100), was compared using the network meta-analysis and Bayesian methodology on the relative probability of achieving percentage of maximum area under the curve. Results Among biologics approved for psoriasis treatment, anti–interleukin-17 biologics demonstrated consistently greater cumulative clinical benefits on PASI 75, PASI 90, and PASI 100 over the 12- or 16-week period than anti–interleukin-23 and other biologics. For biologics with 12-week data, ixekizumab and brodalumab showed greater cumulative benefits for PASI 75, PASI 90, and PASI 100 than secukinumab, followed by guselkumab, infliximab, adalimumab, ustekinumab, and etanercept. Ixekizumab showed greater cumulative benefits than all other biologics reporting 16-week data. Limitations Recently approved biologics were not included. Conclusion Ixekizumab (at 12 weeks and 16 weeks) and brodalumab (at 12 weeks) had greater cumulative clinical benefit than all of other biologics studied.

Real-world data on treatment patterns associated with use of interleukin-17A inhibitors in psoriasis are lacking.To compare treatment patterns between ixekizumab or secukinumab users in clinical practice.A retrospective cohort study included patients with psoriasis aged ≥18 years treated with ixekizumab or secukinumab between March 1, 2016, and May 31, 2018 in IBM MarketScan (IBM Corp, Armonk, NY) databases. Inverse probability of treatment weighting and multivariable models were used to address cohort imbalances and estimate the risks of nonpersistence (60-day gap), discontinuation (≥90-day gap), switching, and the odds of adherence.The study monitored 645 ixekizumab users for 13.7 months and 1152 secukinumab users for 16.3 months. Ixekizumab users showed higher persistence rate (54.8% vs 45.1%, P .001) and lower discontinuation rate (37.8% vs 47.5%, P .001) than secukinumab. After multivariable adjustment, ixekizumab users had lower risks of nonpersistence (hazard ratio, 0.82; 95% confidence interval, 0.71-0.95) and discontinuation (hazard ratio, 0.82; 95% confidence interval, 0.70-0.96), and higher odds of high adherence to treatment measured by a medication possession ratio ≥80% (hazard ratio, 1.31; 95% confidence interval, 1.07-1.60). The risk of switching was similar between cohorts.Disease severity and clinical outcomes were unavailable.Ixekizumab users demonstrated longer drug persistence, lower discontinuation rate and risk of discontinuation, higher likelihood of adherence, and similar risk of switching compared with secukinumab users in clinical practices.

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.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.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%;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.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.

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.A retrospective observational study was conducted using IBM Watson Health MarketScanreg; databases. Adult patients with psoriasis havingge;1 claim for IXE or ADA from March 1, 2016ndash; 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.The final cohorts comprised 475 IXE users and 3159 ADA users over 24 months. IXE users demonstrated higher adherence (36.3% vs 28.8%; Plt;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: 1.24ndash;1.87), a lower risk of non-persistence (HR=0.84, 95% CI: 0.75ndash;0.95), and a lower risk of discontinuation (HR=0.83, 95% CI: 0.74ndash;0.94), respectively. Switching rates were similar in both groups (31.2% vs 30.0%; P=0.608).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.

Objective To evaluate the effect of ixekizumab on self-reported functioning and health in patients with active nonradiographic axial spondyloarthritis (SpA). Methods COAST-X was a randomized, controlled trial conducted in patients with nonradiographic axial SpA over 52 weeks. Participants were randomized at a ratio of 1:1:1 to receive 80 mg of ixekizumab subcutaneously every 4 weeks or 2 weeks or placebo for 52 weeks. Self-reported functioning and health end points included the Medical Outcomes Study Short Form 36 (SF-36) health survey, Assessment of Spondyloarthritis International Society (ASAS) health index, and European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) health-utility descriptive system. Results Compared to placebo, ixekizumab treatment resulted in improvement of SF-36 physical component summary scores from baseline, with a score of 4.7 improving to 8.9 with ixekizumab therapy every 4 weeks (P < 0.05) and a score of 9.3 with ixekizumab therapy every 2 weeks (P < 0.01); the greatest improvements were observed in the domains of physical functioning, role-physical, and bodily pain at weeks 16 and 52. A higher proportion of patients receiving ixekizumab therapy every 2 weeks reported >= 3 improvements based on the ASAS health index from baseline to weeks 16 and 52 (P < 0.05). Significantly more patients receiving ixekizumab every 4 weeks reported improvements in "good health status" on the ASAS health index (ASAS score of

Background There is lack of real-world treatment pattern comparison data between ixekizumab and adalimumab which are approved for the treatment of moderate-to-severe plaque psoriasis. Objective To compare real-world treatment patterns among psoriasis patients initiating ixekizumab or adalimumab in the United States. Methods Psoriasis patients with ≥1 claim for ixekizumab or adalimumab between March 1, 2016, and May 31, 2018, were identified (index date = date of first ixekizumab or adalimumab claim) from the IBM Watson Health MarketScan® databases. Patients were required to be continuously enrolled for ≥12 months before the index date and followed for a minimum of 6 months until inpatient death, enrollment end, or study end, whichever occurred first. Treatment persistence, adherence, discontinuation, restart, and switching were analyzed. Inverse probability of treatment weighting and multivariable regression modeling were employed to address cohort imbalances and estimate the adjusted risk of non-persistence, discontinuation, and switching, and the odds of adherence. Results A total of 646 ixekizumab and 3668 adalimumab users were included and followed for a mean of 14.0 and 16.5 months, respectively. Compared to adalimumab, ixekizumab was associated with 19% lower risk of non-persistence (hazard ratio [HR]=0.81, 95% confidence interval [CI]: 0.69-0.95), 26% lower risk of discontinuation (HR=0.74, 95% CI: 0.62-0.88), and 28% lower risk of switching (HR=0.72, 95% CI: 0.57-0.91). Ixekizumab users had higher odds of medication possession ratio ≥80% (odds ratio [OR]=1.36, 95% CI: 1.10-1.69) but similar odds by proportion of days covered ≥80% (OR=1.22, 95% CI: 0.98-1.53). Conclusion Psoriasis patients treated with ixekizumab demonstrated longer persistency, higher adherence and were less likely to discontinue or switch treatment compared to adalimumab users. However, while patients achieving highly adherent threshold significantly differed by MPR ≥80%, it did not by PDC ≥80%; hence, further analysis using fixed-length follow-up is required.

Although alopecia areata (AA) severity is often defined by the degree of scalp hair loss, its impact on QOL can also be a defining measure of severity. In this cross-sectional study (AA Disease Specific Program), 259 patients were surveyed for demographics, AA illness characteristics, QOL (Skindex-16 AA), and daily impairment (Work Productivity and Activity Impairment). The association between patient demographics and illness variables, the Skindex-16 AA scores, and the Work Productivity and Activity Impairment scores were analyzed using regression analyses. The mean age of patients was 39 years (51% female). Self-reported severity of current AA was rated as mild (21%), moderate (54%), and severe (25%). The highest impairment was observed for the Skindex-16 AA emotions and the Work Productivity and Activity Impairment daily activity performance scores. Although the degree of scalp hair loss (physician Severity of Alopecia Tool score) was not predictive of QOL, patients' self-report of moderate or severe disease, sex (females more impacted), and eyebrow and eyelash involvement were predictors of diminished QOL, consistently and incrementally. The present results suggest patients' perception of severity as well as the presence of eyelash and eyebrow hair loss are also impactful and should be considered in defining the severity of disease.

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.

Introduction Alopecia areata (AA) is an autoimmune disorder causing sudden, non-scarring hair loss. There are currently no drugs approved for AA treatment. This study assessed prevalence of comorbidities, treatments, and healthcare costs and resource utilization among patients with AA in the USA. Methods Patients diagnosed with AA between January 2011 and December 2018 were identified in IBM MarketScan® Research Databases. Eligible patients had no other hair loss-related disorders and were continuously enrolled with medical and pharmacy benefits at least 12 months before and after AA diagnosis. Descriptive statistics were used to summarize comorbid conditions, treatments related to AA or other autoimmune/inflammatory conditions, and all-cause and AA-specific healthcare costs and resource utilization identified from claims data. Results A total of 68,121 patients with AA were identified. Mean (SD) age was 40.3 (17.8) years and 61.0% were female. The most common comorbidities included hyperlipidemia (22.4%), hypertension (21.8%), thyroid disorders (13.1%), contact dermatitis or eczema (10.8%), depression (9.5%), and anxiety (8.4%). Comorbid autoimmune diseases included atopic dermatitis (2.8%), psoriasis (2.1%), chronic urticaria (1.5%), and rheumatoid arthritis (1.1%). During the 12-month follow-up period, 37,995 patients (55.8%) were prescribed treatment for their AA or other comorbid autoimmune/inflammatory disease; 44.9% of treated patients were prescribed therapy within 7 days of AA diagnosis. Of patients receiving treatment, 80.3% received topical steroids and 30.0% received oral steroids. Mean (SD) total healthcare costs were $11,241.21 ($43,839.69) for all-causes and $419.12 ($1534.99) for AA. AA-related expenses were driven by outpatient and prescription costs. Conclusion Patients with AA have a high comorbidity burden and lack of treatment. Current AA treatments, including systemic therapies other than oral steroids, were not frequently utilized in this study population. Healthcare costs incurred by patients with AA went beyond AA-related expenses. Longitudinal data are needed to better understand treatment trajectories and the disease burden in patients with AA. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01845-0.

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.

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.

Background: Psoriasis is a chronic immune-mediated inflammatory skin condition that has a significant negative impact on the physical, emotional, and psychosocial well-being of those affected. Ixekizumab (IXE) has demonstrated an early and high-level treatment response in the real-world setting. This study aimed to assess the rapidity and long-term disease severity and quality of life (QOL) outcomes among IXE-treated plaque psoriasis patients. Method: A retrospective cohort study was conducted at a single US dermatology referral center. Medical charts were reviewed for adult psoriasis patients starting IXE (index date) between March 22, 2016, and February 28, 2018. Disease severity and QOL data were abstracted up to one-year pre-IXE initiation and up to 35 months post-IXE initiation. Static Physician Global Assessment (sPGA), Body Surface Area (BSA), and Dermatology Life Quality Index (DLQI) were summarized at 1-month post-index and at 3-month intervals. Logistic regressions were performed to evaluate the 1-month response in relation to long-term sPGA, BSA, DLQI outcomes. Subgroup analysis were conducted to compare outcomes among biologic naïve and biologic experienced patients.Results: A total of 153 patients (median age at index: 47.7 years; 65.4% male; 93.5% Caucasian) were included in the study. Majority of patients (69%; n=106) were biologic experienced prior to IXE initiation. In the total study cohort, at 1-month post-index 58.8% of patients achieved sPGA (0,1), 55.9% achieved DLQI (0,1), and 66.9% achieved BSA≤1%. Patients with sPGA (0,1) at 1-month post-index had greater odds of remaining sPGA (0,1) and BSA≤1% at 24-month (sPGA 0,1: OR=10.1; 95% CI: 2.1-47.9; BSA≤1%: OR=13.3; 95% CI: 2.2-80.2). Among patients who achieved sPGA (0,1) at 1-month post-index, the proportion of patients with sPGA (0,1), DLQI (0,1), and BSA≤1% remained largely the same for the 24-month follow-up. Among biologic experienced and naïve patients, more than half achieved sPGA (0,1), DLQI (0,1), and BSA≤1% at 1-month after IXE initiation. Conclusion: This real-word study demonstrated that majority of patients initiating IXE achieved sPGA (0, 1), DLQI (0, 1) and BSA ≤1% targets within the first month of treatment and were able to maintain treatment response for up to 24 months independent of prior biologic exposure.

Background: Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, has shown superiority to ustekinumab (UST) and etanercept in skin clearance from randomiz...

Item does not contain fulltext BACKGROUND: Psoriasis symptoms may decrease quality of life for patients. Skin-related personal relationship difficulties in psoriasis patients are common, under-reported and poorly understood. OBJECTIVE: To assess the effect of ixekizumab (IXE) treatment on skin-related personal relationship difficulties in patients with moderate-to-severe psoriasis. METHODS: Pooled data (N = 2570) on skin-related relationship problems were obtained from two large phase 3 trials (UNCOVER-2 and UNCOVER-3) in patients with moderate-to-severe plaque psoriasis randomized to subcutaneous placebo (PBO, N = 361), etanercept (ETN; 50 mg twice weekly, N = 740), or 80 mg IXE as one injection every 4 (IXEQ4W, N = 733) or 2 weeks (IXEQ2W, N = 736) for 12 weeks, following a 160-mg initial dose. The Dermatology Life Quality Index (DLQI) Personal Relationships Domain (PRD) (Items 8 and 9) was used to assess how much the skin caused any personal relationship difficulties at weeks 0, 2, 4 and 12. Improvement was compared for IXE vs PBO and ETN using logistic models. Factors associated with improvement were assessed using multiple linear regressions. DLQI Item 9, assessing sexual difficulties, was also analysed separately. RESULTS: PRD scores (mean +/- standard deviation) at baseline were similar across all treatment groups (PBO: 1.8 +/- 1.9; ETN: 1.7 +/- 1.8; IXEQ4W: 1.6 +/- 1.8; IXEQ2W: 1.7 +/- 1.8). Treatment with IXE rapidly and significantly improved the mean PRD score compared to PBO and ETN (P < 0.001 at all time points). Baseline PRD score was the strongest negative predictor of improvement. IXE enabled significantly more patients with moderate-to-severe plaque psoriasis to reduce their skin-related sexual difficulties at Week 12 compared to PBO (P < 0.001) or ETN (P < 0.001). CONCLUSION: Ixekizumab improves patient-reported skin-related PRD difficulties in patients with moderate-to-severe psoriasis.

Background A significant gap exists in how psoriasis severity is related to validated patient-reported outcomes (PROs), which are critical in characterizing disease burden. Objective Determine the association between psoriasis severity and PROs, including health-related quality of life (HRQoL), depression, and work productivity, from patients’ perspectives. Methods An online survey using validated PRO instruments was administered in 2013. PROs included the Dermatology Life Quality Index, Quick Inventory of Depressive Symptoms-Self-Report (16 items) (QIDS-SR16), and Work Productivity and Activity Impairment Questionnaire-Psoriasis. Results The survey was completed by 1109 patients, 42% of whom had psoriatic arthritis. Respondents reported worse HRQoL and work productivity impairment with greater psoriasis severity ( p < 0.05). Similarly, there was a greater proportion of participants with moderate-or-greater depressive symptoms (QIDS-SR16 total score) among patients with increasing psoriasis severity ( p < 0.05). Conclusion Greater levels of impairment in HRQoL, work productivity, and depressive symptoms were associated with increased psoriasis severity.

Background and Objective Previous large studies have highlighted the impact of psoriasis on health-related quality of life (HRQoL) but not on interpersonal touch. This survey assessed the prevalence of touch avoidance among psoriasis patients, and its relationship to clinical characteristics and HRQoL. Methods Using an online, cross-sectional study with a standardized questionnaire, psoriasis patients reported their level of touch avoidance. The relationships between touch avoidance, patient-reported outcome measures, and patient demographics were analyzed using linear models for continuous outcomes and logistic models for categorical outcomes. Results Touch avoidance was reported by 48.2% of participants. Higher levels of touch avoidance were associated with worse HRQoL, depression, and itch outcomes (pConclusion Nearly half of psoriasis patients report avoidance of touch. Those who had worse disease severity, HRQoL, and depression reported higher levels of touch avoidance.

As more biologics become available for the treatment of psoriasis (PsO), there is a lack of direct comparisons of health care costs between patients who are treated by different medications, including ixekizumab (IXE), secukinumab (SEC), and adalimumab (ADA).To compare the real-world health care costs of patients with PsO initiating IXE with those of patients initiating either SEC or ADA.Patients diagnosed with PsO between July 1, 2015, and May 31, 2018, were identified from the IBM MarketScan commercial and Medicare databases. Two weighted patient sample sets were constructed based on drug claims between March 1, 2016, and May 31, 2018: IXE versus SEC and IXE versus ADA. Within each sample, the first claim of eligible drugs was set as the index date. Patients were aged ≥ 18 years and had ≥ 12 months of continuous eligibility before and after the index date. Patients with other indications for the index drug in the preperiod or with use of the index drug within 90 days before the index date were excluded. Inverse probability of treatment weighting (IPTW) was employed to balance cohorts. All-cause and PsO-related health care costs per member per month (PMPM) incurred during the 12-month follow-up period were assessed. Monthly PsO-related pharmacy costs were adjusted using drug discount rates published by the Institute for Clinical and Economic Review (ICER). Annual index drug costs were estimated by adjusting for medication possession ratio and ICER discount rates. All costs were weighted by IPTW.Two study samples were identified: 357 IXE users were compared with 763 SEC users, and 388 IXE users were separately compared with 2,578 ADA users. Before weighting, IXE users were demographically and clinically similar to SEC users but were older and had worse health status than ADA users. Cohorts were balanced postweighting. After weighting, mean monthly all-cause health care costs were $7,313 and $6,477 (After adjusting for drug discount programs (through application of ICER discount rate), this real-world study estimated that average monthly PsO-related costs during the first year of treatment were similar between patients treated with IXE compared with those treated with SEC or ADA.Funding for this study was provided to IBM Watson Health by Eli Lilly and Company. The analysis was conducted independently by IBM Watson Health. Eli Lilly and Company and IBM Watson Health collaborated on study design and interpretation of results. Shi, Lew, and Zimmerman were employed by IBM Watson Health and received funding from Eli Lilly and Company to conduct this study. Zhu, Burge, Malatestinic, Lin, Goldblum, and Murage were employed by Eli Lilly and Company while this study was conducted. Blauvelt has served as a scientific adviser and/or clinical study investigator for AbbVie, Aclaris, Akros, Allergan, Almirall, Amgen, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly and Company, FLX Bio, Galderma, Genentech/Roche, GlaxoSmithKline, Janssen, Leo, Meiji, Merck SharpDohme, Novartis, Pfizer, Purdue Pharma, Regeneron, Revance, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB Pharma, Valeant, and Vidac, and as a paid speaker for AbbVie, Regeneron, and Sanofi Genzyme. A portion of these results were presented at the 2019 International Society for Pharmacoeconomics and Outcomes Research Annual Meeting; May 18-22, 2019; New Orleans, LA, and the 2019 Academy of Managed Care Pharmacy Annual Meeting; March 25-28, 2019; San Diego, CA.