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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.

The aim of this study was to characterize employment, work productivity, and biologic disease-modifying anti-rheumatic drug (bDMARD) treatment in a predominantly female population of axial spondyloarthritis (axSpA) patients in a real-world setting.This was a cross-sectional study of axSpA participants within the ArthritisPower registry. Outcomes were assessed with surveys (Work Productivity and Activity Impairment [WPAI], Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], and Patient-Reported Outcomes Measurement Information System instruments) and compared between subgroups (employed vs. not employed; taking vs. not taking a bDMARD).Among the 195 participants, 117 (60.0%) were employed and 78 (40.0%) were not employed entirely or partially due to axSpA. The mean age of the participants was 47.6 years and 86.7% were female. Current bDMARD use was reported by 57.4% of those surveyed (59.8% employed vs. 53.9% not employed; p = 0.408). Compared to not employed participants, employed participants had more favorable disease activity (BASDAI 6.0 vs. 7.6; p 0.001) and overall health (self-rated health 2.5 vs. 1.8; p 0.001). Employed participants, compared to not employed participants, were diagnosed at an earlier age (36.0 vs. 42.5 years, respectively) and experienced a shorter time between symptom onset and diagnosis (9.5 vs. 13.6 years, respectively). Employed participants reported missing on average 6.5 days of work and experienced a 52.7% impairment on work productivity due to axSpA over a 3-month period. Absenteeism and presenteeism were statistically similar between participants taking a bDMARD versus those not taking a bDMARD.Although bDMARD treatment rates were similar between employed and not employed participants, disease activity and overall health were better in employed than non-employed participants. Employed participants experienced substantial work productivity impairment due to axSpA.

Objective Aims were to 1) to characterize patient decision-making with treatment for axial spondyloarthritis (axSpA) and 2) to explore relationships among decision-making, treatment satisfaction, and biologic disease modifying antirheumatic drugs (bDMARDs). Methods ArthritisPower participants with physician-diagnosed axSpA were invited to complete an online survey about their treatment and their most recent physician visit. Analysis compared treatment decision by satisfaction and bDMARD status. Results Among the 274 participants, 87.2% were female, and the mean age was 50 years. Of participants, 79.5% had researched treatment before their most recent physician visit, and 56.9% discussed treatment change at their most recent physician visit. Of treatment-change discussions, 69.2% of them were related to escalation, compared with deescalation (27.6%) and/or switching (39.1%). Among those participants who discussed a change, 73.7% agreed to it because they felt that their disease was not being controlled (54.9%) or felt that it could be better controlled on new treatment (20.3%). Top symptoms prompting change were back/buttock pain (63.3%), other joint pain (55.1%), and fatigue (54.1%). Among bDMARD-treated participants (n = 128), important factors for treatment decisions were prevention of long-term axSpA consequences (92.9%) and doctor's advice (87.5%). Among 43.4% of participants reporting treatment dissatisfaction, 37% did not discuss treatment change. Current bDMARD use was more common in satisfied (61.9%) than dissatisfied participants (26.9%). Conclusion In this cross-sectional study of a predominantly female axSpA population, patients frequently researched treatment options and discussed escalation with their providers. Under two-thirds of participants who were dissatisfied with treatment discussed changes at their most recent visit. Current bDMARD use was associated with higher satisfaction, and bDMARD users considered prevention of long-term consequences and doctor's advice to be very important for decision-making.

Objective To describe adherence, persistence, discontinuation, restarting, switching, dosing, and health care costs among patients with psoriatic arthritis (PsA) treated with ixekizumab (IXE). Methods MarketScan administrative claims databases were used to select adults (≥18 years) initiating IXE between January 1, 2016, and June 30, 2019, for this retrospective study (earliest IXE claim = index). Eligible patients had one or more PsA diagnoses during the 12 months preceding the index and had 12 months of follow‐up time after the index. Adherence (measured by proportion of days covered [PDC]) persistence ( 0.80)to IXE prior to discontinuation. Dose values were consistent with prescribing information for patients with and without comorbid psoriasis. Although IXE costs ($5233 [SD = $2497]) accounted for 85.6% of PsA‐related health care costs, only 3.5% of IXE costs were patient out‐of‐pocket expenses. Adjusting for the ICER discounts decreased all‐cause and PsA‐related costs by $2509 PPPM. Conclusion Results from this real‐world analysis suggest that treatment patterns and costs among patients with PsA initiating IXE are consistent with prior literature for other biologics.

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.

Background Electronic health records (EHRs) offer the possibility of using data entry templates to simultaneously perform routine documentation during clinical care and to 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 of psoriasis as a pilot study for future real-world retrospective and prospective comparative effectiveness studies, including pragmatic clinical trials. Methods We conducted a retrospective, observational cohort study of patients with psoriasis by using data collected in the course of routine clinical care from an EHR using EpiCare® SmartForms customized for psoriasis. The Psoriasis SmartForm records body surface area (BSA) affected, plaque and overall Physician Global Assessments (pPGA and oPGA), and a patient-reported severity rating scale as well as descriptive findings (e.g., lesion locations, symptoms such as itch or pain) to generate visit notes. These clinical data were extracted and analyzed to identify factors associated with meaningful treatment escalation (MTE), defined as changing or adding phototherapy or systemic oral or biologic therapy. Results We identified 473 patients with psoriasis who had at least three consecutive visits between October 2015 and October 2018; 239 patients underwent MTE between their first (Visit 1) and third (Visit 3) observed visits, while 234 patients did not. Patients who experienced MTE had more severe disease at Visit 1 as assessed by BSA, pPGA, oPGA, and the patient-reported measure than patients who did not experience MTE. Other factors associated with MTE included use of topical medications only or no active treatment at Visit 1, palmoplantar disease phenotype and involvement of other difficult-to-treat body areas. After adjusting for potential confounding factors, we found that 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 studies when disease measures are captured discretely. This approach could provide a cost-effective platform to conduct retrospective and prospective real-world studies, pragmatic trials, and comparative effectiveness research.

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.

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.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.From baseline to follow-up in all patients (We provide real-world evidence on the benefits of ixekizumab for treating psoriasis, regardless of baseline disease severity, weight, or concomitant PsA.

Introduction Enthesitis is a core outcome domain assessed in psoriatic arthritis (PsA) clinical trials. Limited evidence describes the impact of enthesitis on patient-reported outcomes (PROs) and physician satisfaction with current treatment options. The objective of this analysis is to characterize the impact of enthesitis on PROs and physician satisfaction with currently available treatment in clinical practice settings. Methods Cross-sectional survey of rheumatologists, dermatologists, and their consulting patients with PsA in Australia, Canada, European Union (EU5), and the USA conducted in 2018. Physicians assessed current presence and severity of enthesitis, overall disease severity, other symptoms experienced, and their satisfaction with the current treatment. PsA participant self-reported data included current pain level, EQ5D, Psoriatic Arthritis Impact of Disease (PsAID12), Health Assessment Questionnaire Disability Index (HAQ-DI), and Work Productivity and Activity Impairment Index (WPAI-SHP). Bivariate descriptive analyses were conducted to describe features and outcomes in participants with and without enthesitis. Results Rheumatologists (454) and dermatologists (238) provided information for 3157 participants with PsA. Mean participant age was 49.2 years, and 45.9% were female. Enthesitis was present currently in 6.5% (205) of participants with PsA. Those with enthesitis had worse overall disease severity compared to those without enthesitis (12.2% vs 2.2% severe) and had more extraarticular manifestations, including nail psoriasis, dactylitis, and sacroiliitis. Enthesitis was associated with more pain, worse quality of life (QoL), increased disability, and a negative impact on work. Participants with enthesitis had higher NSAIDs and opioid pain medication use but similar biologic use. Physicians were significantly less satisfied with current PsA treatment in participants with enthesitis versus without enthesitis. Conclusions Participants with psoriatic arthritis with enthesitis experienced significantly higher disease burden than those without enthesitis but were not more likely to receive advanced therapies. Physicians were significantly more dissatisfied with treatment in patients with enthesitis than in those without it. Electronic Supplementary Material The online version of this article (10.1007/s40744-020-00242-3) contains supplementary material, which is available to authorized users.

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.

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.

This study describes the current treatment landscape in adult atopic dermatitis (AD), overall and by disease severity. Adult patients with an AD diagnosis in dermatology-specific electronic medical records during 2018 were identified and linked to an administrative claims database. Disease severity was determined using Physician’s Global Assessment (PGA). Written and dispensed prescriptions, within and between class cycling for AD therapies occurring in 2018 were assessed. In total, 4,364 patients were included. Among patients with available PGA, 43.2% had clear-to-mild, 37.3% had moderate, and 19.6% had severe disease. Most patients (71.0%) had written prescriptions for topical therapies only in 2018. Among the patients with claims for topical therapies alone, 80.7% used topical corticosteroids only. Within and between class cycling was observed in 33.7% and 12.8% of topical users, respectively. In patients with systemic therapy (40.6%), nearly 84.9% also used topical therapy, 25.8% cycled within systemic drug classes, and 24.8% cycled between systemic drug classes. Overall, cycling was more prevalent in patients with more severe disease. Cycling within and between both topical and systemic drug classes was more common in patients with more severe disease, indicating difficulty of managing these patients and highlighting a need for more treatment options.

Background Treatment for atopic dermatitis (AD) is complex, particularly in patients with inadequate response to topical therapies. Currently, there is little clinical guidance for the treatment of these patients. Methods A real-world retrospective study utilizing electronic medical records (EMR) and administrative claims data selected patients with AD between January 01 2016 and June 30 2018. Patients had a written prescription for a topical therapy (first observed script = index date) and no prior systemic treatment. Disease severity at index, follow-up treatment response and prescriptions patterns were assessed. A subset of patients linked to claims was evaluated for treatment patterns. Results We identified 137,214 adult topical-treated AD patients with no prior systemic therapy. Among the 16,035 patients with available Physician Global Assessment (PGA) at index, 8169 (50.9%) had the moderate-to-severe disease. Among these patients, 60% had an inadequate response to topical therapy. Of 4475 patients linked to claims, 13.0% had claims for systemic therapy during follow-up, most initiated systemic steroids (95.2%), and oral immunosuppressants and biologics were initiated in 3.3% and 3.8%, respectively. Conclusion In this real-world study, inadequate response to topical therapy among moderate-to-severe AD patients was high and initiation of systemic treatment was low which suggests a need for additional AD-indicated systemic treatment options in this patient population.

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.

Objective.To characterize skin severity and joint activity outcomes and associated treatment changes in patients with psoriatic arthritis (PsA) through 12 months of follow-up after enrollment in the Corrona Psoriatic Arthritis/Spondyloarthritis (PsA/SpA) Registry.Methods.Patients ≥ 18 years of age with a diagnosis of PsA and a history of psoriasis between March 21, 2013, and September 30, 2016, were enrolled (n = 647). Demographics, clinical features, and treatment characteristics were collected and stratified by skin severity and joint activity. Change in joint and skin from enrollment to the 12-month visit was classified by change in category of Clinical Disease Activity Index (CDAI) or body surface area (BSA). Tests of association evaluated the relationship between changes in therapy and changes in skin severity and joint activity.Results.Patients with improvement in both joint activity and skin severity saw the largest median reduction in both CDAI and BSA, while those who worsened in both had the greatest median increase in both CDAI and BSA. The majority of PsA patients (> 50%) had no change in skin severity regardless if they had reduced therapy (50%), no therapy changes (54%), or increased therapy (56%; P = 0.5875). However, there was a significant association between changes in therapy and changes in joint activity (P < 0.001). Patients who increased therapy were more likely to have improvement in joint activity (32%) compared to patients who reduced therapy (22%) or had no therapy changes (11%).Conclusion.The clinical implication for our findings suggests the assessment and incorporation of both skin and joint components may be advisable.

Purpose Proper adherence and persistence to medications are crucial for better quality of life and improved outcomes in rheumatoid arthritis (RA), psoriasis (PsO), and psoriatic arthritis (PsA). We systematically describe current adherence and persistence patterns for RA, PsO, and PsA, with a focus on biologics and identifying factors associated with adherence and persistence. Patients and methods Using various databases, a systematic literature review of US-based studies published from 2000 to 2015 on medication adherence and persistence to biologics and associated factors was conducted among patients with RA, PsO, and PsA. Results Using the medication possession ratio or the percentage of days covered >80%, RA and PsO adherence rates for etanercept, adalimumab, and infliximab ranged from 16% to 73%, 21% to 70%, and 38% to 81%, respectively. Using the criteria of a ≥45-day gap, RA persistence rates for etanercept, adalimumab, and infliximab ranged from 46% to 89%, 42% to 94%, and 41% to 76%, respectively. In PsO, persistence rates for etanercept and adalimumab ranged from 34% to 50% and 50% to 62%, respectively. Similar persistence rates were observed in PsA. Experienced biologics users showed better adherence and persistence. Younger age, female gender, higher out-of-pocket costs, greater disease severity, and more comorbidities were associated with lower adherence and persistence rates. Qualitative surveys revealed that nonpersistence was partly due to perceived ineffectiveness and safety/tolerability concerns. Conclusion Biologic adherence and persistence rates in RA, PsO, and PsA in the United States were low, with significant opportunity for improvement. Various factors - including decrease in disease severity; reduction of comorbidities; lower out-of-pocket costs; refilling at specialty pharmacies; and awareness of drug effectiveness, safety, and tolerability - can inform targeted approaches to improve these rates.

Background Little is known regarding real-world health outcomes data among US psoriasis patients, but electronic health records (EHR) that collect structured data at point-of-care may provide opportunities to investigate real-world health outcomes among psoriasis patients. Our objective was to investigate patient-perceived treatment effectiveness, patterns of medication use (duration, switching, and/or discontinuation), healthcare resource utilization, and medication costs using real-world data from psoriasis patients. Methods Data for adults (≥18-years) with a dermatology provider-given diagnosis of psoriasis from 9/2014–9/2015 were obtained from dermatology practices using a widely used US dermatology-specific EHR containing over 500,000 psoriasis patients. Disease severity was captured by static physician’s global assessment and body surface area. Patient-perceived treatment effectiveness was assessed by a pre-defined question. Treatment switching and duration were documented. Reasons for discontinuations were assessed using pre-defined selections. Healthcare resource utilization was defined by visit frequency and complexity. Results From 82,621 patients with psoriasis during the study period, patient-perceived treatment effectiveness was investigated in 2200 patients. The proportion of patients reporting “strongly agree” when asked if their treatment was effective was highest for biologics (73%) and those reporting treatment adherence (55%). In 16,000 patients who received oral systemics and 21,087 patients who received biologics, median treatment duration was longer for those who received biologics (160 vs. 113 days, respectively). Treatment switching was less frequent among patients on systemic monotherapies compared to those on combination therapies. The most common reason for discontinuing biologics was loss of efficacy; the most common reason for discontinuing orals was side effects. In 28,754 patients, higher disease severity was associated with increased healthcare resource utilization (increased visit frequency and complexity). When compared between treatment groups (n = 10,454), healthcare resource utilization was highest for phototherapy. Annual medication costs were higher for biologics ($21,977) than oral systemics ($3413). Conclusions Real-world research using a widely implemented dermatology EHR provided valuable insights on patient perceived treatment effectiveness, patterns of medication usage, healthcare resource utilization, and medication costs for psoriasis patients in the US. This study and others utilizing EHRs for real-world research may assist clinical and payer decisions regarding the management of psoriasis. Electronic supplementary material The online version of this article (10.1186/s12895-018-0072-2) contains supplementary material, which is available to authorized users.

Background:Biologic disease-modifying antirheumatic drug (bDMARD) therapy has been shown to be effective in the treatment of axial spondyloarthritis (axSpA).1,2 Little is understood about patients’ experience of axSpA treatment from their own perspective.Objectives:To characterize patient experiences and perspectives with bDMARD treatments for axSpA, including satisfaction, and use of supplementary treatments when wear-off between doses is perceived among those currently treated with bDMARD therapy.Methods:Adult US participants (pts) within the ArthritisPower registry with physician-diagnosed axSpA were invited to complete electronic PRO measures, such as the BASDAI (0-10 scale, score ≥4 indicates suboptimal disease control), and an online survey about their perspectives of treatment. Analysis compared pt characteristics and treatment satisfaction by whether or not pt reported wear-off between bDMARD doses.Results:128 pts with axSpA and on bDMARD therapy met inclusion criteria of whom 82.8% were female, with mean age of 47 years. Mean BASDAI scores indicated poor disease control (6.4, SD 1.8), worse for those perceiving wear-off between doses compared with those who did not [6.8 (1.6) vs. 5.9 (2.0), p=0.01]. A majority of pts on a bDMARD reported being somewhat (57.8%) or very satisfied (26.6%) with their current axSpA treatment, and about 53.1% were satisfied with how well it controls axSpA-related pain. However, 60.9% (n=78) of pts reported that their current bDMARD typically wears off before the next dose. Treatment satisfaction was lower for pts experiencing wear-off compared to pts without wear-off (highly satisfied: 21.8% vs. 34%; somewhat satisfied: 60.3% vs. 54%; dissatisfied: 17.9% vs. 12%). 82.1% (n=64) of pts reporting wear-off used additional medications or supplements when that happened, chiefly NSAIDs (68.8%, n=44), muscle relaxers (42.2%, n=27) and/or opioids (37.5%, n=24). Among the 20 pts not satisfied with current axSpA treatment, side effects (6/20, 30.0%), or worry about risk of side effects (2/20, 10%) were the main reasons.Conclusion:In a predominantly female sample of bDMARD-treated axSpA patients with high disease activity, most expressed satisfaction with treatment. However, most experienced wear-off between doses and took supplementary medications, including opioids, to manage.References:[1]Dubash S, et al. Ther Adv Chronic Dis. 2018;9(3):77–8.[2]Van Der Heijde D, et al. Ann Rheum Dis. 2017;76(6):978–91.Table 1.Demographic and clinical characteristics by wear-off between bDMARD doses (n=128)Pts currently on bDMARD(N=128)Wear-off between bDMARD oses(N=78)No wear-off / Not sure(N=50)p-valueNumber or mean (% or SD)Age46.9 (10.3)46.1 (9.2)48.2 (11.8)0.25Female106 (82.8)69 (88.5)37(74.0)0.03White115 (89.8)70 (89.7)45 (90.0)0.96Body Mass Index30.9 (7.8)31.2 (8.5)30.4 (6.6)0.57Current Medications, addition to bDMARDConventional Synthetic DMARD (e.g. methotrexate, sulfasalazine)17 (13.3)15 (19.2)2 (4.0)0.01Prescription NSAID59 (46.1)39 (50.0)20 (40.0)0.27Other prescription medication¥70 (54.7)44 (56.4)26 (52.0)0.62Noticed improvement in symptoms related to axSpA since starting current bDMARD80 (62.5)51 (65.4)29 (58.0)0.40Noticed improvement in symptoms NOT related to axSpA since starting current bDMARD40 (31.3)22 (28.2)18 (36.0)0.35BASDAI‡6.4 (1.8)6.8 (1.6)5.9 (2.0)0.01PROMIS Pain Interference ł65.3 (5.7)66.0 (5.1)64.3 (6.4)0.09PROMIS Physical Function ł36.7 (5.6)36.1 (5.3)37.7 (5.8)0.11PROMIS Sleep Disturbance ł59.8 (8.5)61.2 (7.7)57.6 (9.3)0.02* Statistical significance between groups of pts who experienced wear-off between bDMARD or not, p < 0.05¥ Other prescription medications: muscle relaxers, nerve pain medications or anti-depressants, and opioids‡ BASDAI is scored on a 0-10 scale with score ≥4 indicating suboptimal control of diseaseł PROMIS measures use T-score metric in which 50 is mean, 10 is standard deviation (SD), of US population; higher T-score = more of concept measuredAcknowledgements:This study was sponsored by Eli Lilly and Company. We thank the patients who participated in this study.Disclosure of Interests:W. Benjamin Nowell Grant/research support from: Full-time employee of Global Healthy Living Foundation, an independent nonprofit research organization, which received funding pursuant to a contract from Eli Lilly to conduct the study that is the subject of this abstract; Principal Investigator for studies with grant support from AbbVie, Amgen and Eli Lilly, Kelly Gavigan Grant/research support from: Full-time employee of Global Healthy Living Foundation, an independent nonprofit research organization, which received funding pursuant to a contract from Eli Lilly to conduct the study that is the subject of this abstract, Theresa Hunter Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, William Malatestinic Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jeffrey Lisse Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Carol Himelein Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jeffrey Curtis Consultant of: AbbVie, Amgen, BMS, Corrona, Eli Lilly, Janssen, Myriad, Pfizer, Roche, Regeneron, Radius, UCB, Grant/research support from: AbbVie, Amgen, BMS, Corrona, Eli Lilly, Janssen, Myriad, Pfizer, Roche, Regeneron, Radius, UCB, Jessica A. Walsh Consultant of: AbbVie, Amgen, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Merck, Pfizer

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.

ObjectiveTo compare the characteristics of patients with psoriatic arthritis among patient groups stratified by degree of skin and joint involvement, and to evaluate the relationship between skin severity and joint activity.MethodsBody surface area (BSA) and Clinical Disease Activity Index (CDAI) at enrolment were analysed. Patient characteristics were stratified by skin severity and joint activity. Baseline patient characteristics, clinical and disease characteristics and patient-reported outcomes were compared. The strength of the relationship of skin severity and joint activity was evaluated using methods for categorical variables (χ2 test, Cramer’s V) and continuous variables (linear regression).Results1542 adult patients in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry enrolled between 21 May 2013 and 20 September 2016 were analysed. Most patients in the BSA >3%/CDAI moderate/high subgroup had worse clinical and patient-reported outcomes. A significant (pConclusionSkin severity is modestly correlated with joint activity, and patients with higher skin severity are two times more likely to have increased joint involvement. Clinicians need to address both skin severity and joint activity in treatment decisions.

To characterize treatment patterns of psoriasis patients in a large US managed care database.Adults with newly-diagnosed psoriasis were identified from July 3, 2006-August 31, 2014. Patients had continuous enrollment with medical and pharmacy benefits for ≥6 months prior to and ≥1 year following the index date. The index date was the point at which any of the following inclusion criteria were satisfied: first psoriasis diagnosis by a dermatologist, ≥ 2 psoriasis diagnoses ≥30 days apart, or a diagnosis of psoriasis followed by a claim for psoriasis therapy. Of primary interest was to measure and describe the following psoriasis treatment patterns: utilization rates, time to treatment discontinuation, and lines of therapy for various therapeutic classes of pharmacologic therapies.From the 128,308 patients identified, 53% were female, mean ± SD age was 50 ± 16 years, with median 3 years follow-up. Topicals were received by 86% of patients, non-biologic systemics by 13%, biologics by 6%, phototherapy by 5%, and 13% received no psoriasis-related medication. Median time from index to first treatment was 0 days for topical, 6 months for non-biologic systemic, and 6 months for biologic. Of those treated, first-line therapies included topical (95%), non-biologic systemic (4%), and biologic (2%). For those with second-line treatment, non-biologic systemic (71%) and biologic (30%) therapies were more common. The most common treatment pattern was topicals only (83%), while all other patterns comprised5% of the treatment patterns observed.Like other observational studies, limitations to consider when interpreting results include the 6-month pre-index period of no psoriasis or the psoriasis medication claim may not perfectly select only incident user of psoriasis medications, claims-based algorithms may not accurately represent true treatment patterns, absence of over-the-counter medications data, and having no trend analyses over time or between groups.While the majority of patients with psoriasis initiated a pharmacological therapy, a significant portion did not have a claim for any psoriasis medication. Topical treatments are the most commonly used treatments for psoriasis. Non-biologic systemic and biologic therapies were rarely used first line, but became more common in later lines of treatment.

Introduction Genital psoriasis (GenPs) is common and distressing for patients, but is often not discussed with physicians, and no previous clinical trials have assessed the effects of biologics specifically on GenPs and its associated symptoms. Aim To report results for novel patient-reported outcomes (PROs) for the assessment of symptoms and the sexual impact of GenPs before and after treatment in the IXORA-Q study. Methods IXORA-Q (NCT02718898) was a phase III, randomized, double-blind, placebo-controlled study of ixekizumab (80 mg/2 weeks after 160-mg initial dose) vs placebo for GenPs. Men and women ≥18 years old with moderate-to-severe GenPs and body surface area (BSA) ≥1% were assessed through 12 weeks. Main Outcome Measure GenPs symptoms were assessed using the 8-item Genital Psoriasis Symptoms Scale (GPSS), Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ), and Genital Psoriasis Sexual Impact Scale (GPSIS) (validation data presented in the supplemental materials), and the Dermatology Life Quality Index (DLQI) item 9. Results For patients receiving ixekizumab (N = 75) vs placebo (N = 74), statistically significant improvement in GenPs symptoms were seen from week 1 onward (GPSS total and individual items, all P < .005). Sexual activity avoidance owing to GenPs symptoms (GPSIS) decreased significantly with ixekizumab from week 4 onward (all P Clinical Implications Both GenPs symptoms and impact on sexual activity improved rapidly and significantly with ixekizumab vs placebo through 12 weeks in patients with moderate-to-severe GenPs and BSA ≥1%. Strength & Limitations To our knowledge, this is the first phase III, randomized, placebo-controlled, double-blinded clinical trial to evaluate the effect of any treatment on the symptoms and sexual impact related to GenPs. The study did not include an active comparator owing to the lack of any well-established treatment for moderate-to-severe GenPs, and the period assessed herein was of relatively short duration. Conclusion These validated PRO measures may aid in future clinical studies of GenPs and in facilitating discussions of GenPs symptoms and their impact between patients and clinicians.

To quantify healthcare costs in patients with psoriasis overall and in psoriasis patient sub-groups, by level of disease severity, presence or absence of psoriatic arthritis, or use of biologics.Administrative data from Truven Health Analytics MarketScan Research Database were used to select adult patients with psoriasis from January 2009 to January 2014. The first psoriasis diagnosis was set as the index date. Patients were required to have ≥6 months of continuous enrollment with medical and pharmacy benefits pre-index and ≥12 months post-index. Patients were followed from index until the earliest of loss to follow-up or study end. All-cause healthcare costs and outpatient pharmacy costs were calculated for the overall psoriasis cohort and for the six different psoriasis patient sub-groups: (a) patients with moderate-to-severe disease and mild disease, (b) patients with psoriatic arthritis and those without, and (c) patients on biologics and those who are not. Costs are presented per-patient-per-year (PPPY) and by years 1, 2, 3, 4, and 5 of follow-up, expressed in 2014 US dollars.A total of 108,790 psoriasis patients were selected, with a mean age of 46.0 years (52.7% females). Average follow-up was 962 days. All-cause healthcare costs were $12,523 PPPY. Outpatient pharmacy costs accounted for 38.6% of total costs. All-cause healthcare costs were highest for patients on biologics ($29,832), then for patients with psoriatic arthritis ($23,427) and those with moderate-to-severe disease ($21,481). Overall, all-cause healthcare costs and outpatient pharmacy costs presented an upward trend over a 5-year period.Psoriasis is associated with significant economic burden, which increases over time as the disease progresses. Patients with moderate-to-severe psoriasis, those with psoriatic arthritis, or use of biologics contributes to higher healthcare costs. Psoriasis-related pharmacy expenditure is the largest driver of healthcare costs in patients with psoriasis.

Background Prior studies have shown inconsistent relationships between skin and joint symptoms in patients with comorbid psoriasis (PsO) and psoriatic arthritis (PsA) 1–3 . Objectives To characterize the relationship between skin severity and joint activity in patients with comorbid PsA and PsO at enrollment. Methods Data from the U.S. Corrona PsA/spondyloarthritis (PsA/SpA) registry were obtained from the period 3/21/2013– 9/30/2016. Inclusion criteria included a diagnosis of PsA, a history of PsO, and age greater than 18 years. PsA patients were evaluated for skin severity as defined by Body Surface Area (BSA) and joint activity as defined by the level of clinical disease activity index (CDAI). Patient characteristics, including current and prior PsA medication use, were obtained during the enrollment visit. We evaluated the relationship of skin severity (BSA) and joint activity (CDAI) with multi-variable linear regression. Results 1,542 patients met inclusion criteria: 52.9% were women with mean (SD) age 53.7 (13.2) years, with median 9.0 years PsA disease duration, and 71 (4.6%) with fibromyalgia. 266 (18%) patients were on no DMARD therapy, 430 (29%) were on csDMARDs only, 616 (42%) were on first line biologic/targeted synthetic (ts)DMARD therapy, and 172 (12%) were on second line biologic/tsDMARD therapy. The relationship between skin severity and joint activity was statistically significant (p Conclusions The relationship between skin severity and joint activity is statistically significant and varies by age, gender, MDA, HAQ, and patient reported pain and fatigue. This suggests degree of skin involvement is important to take into account when evaluating PsA patients. References Gottlieb AB, Mease PJ, Mark Jackson J, Eisen D, Amy Xia H, Asare C, Stevens SR: Clinical characteristics of psoriatic arthritis and psoriasis in dermatologists9 offices. J Dermatolog Treat 2006;17:279–287. Jones SM, Armas JB, Cohen MG, Lovell CR, Evison G, McHugh NJ: Psoriatic arthritis: outcome of disease subsets and relationship of joint disease to nail and skin disease. Br J Rheumatol 1994;33:834–839. Cohen MR, Reda DJ, Clegg DO: Baseline relationships between psoriasis and psoriatic arthritis: analysis of 221 patients with active psoriatic arthritis. Department of Veterans Affairs Cooperative Study Group on Seronegative Spondyloarthropathies. J Rheumatol 1999;26:1752–1756. Acknowledgements Corrona, LLC has been supported through contracted subscriptions in the last two years by AbbVie, Amgen, AstraZeneca, BMS, Crescendo, Eli Lilly and Company, Genentech, GSK, Horizon Pharma USA, Janssen, Momenta Pharmaceuticals, Novartis, Pfizer, Roche and UCB. Disclosure of Interest P. Mease Grant/research support from: Celgene, Novartis, Abbvie, Amgen, BMS, Janssen, Lilly, Pfizer, Sun, UCB, Consultant for: AbbVie, Amgen, BMS, Crescendo, Celgene, Corrona, Demira, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, Sun, Zynerba, Speakers bureau: Abbvie, Amgen, BMS, Celgene, Crescendo, Genentech, Janssen, Novartis, Pfizer, UCB, C. Etzel Consultant for: Merk, Employee of: Corrona, LLC, J. Lisse Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, A. Armstrong Grant/research support from: AbbVie, Janssen, Lilly; speaker9s bureau: AbbVie, Lilly, Consultant for: AbbVie, Amgen, Janssen, Merck, Lilly, Celgene, Novartis, and Pfizer, W. Huster Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, S. Rebello Employee of: Corrona, LLC, R. Dodge Employee of: Corrona, LLC, T. Muram Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, S. Al Sawah-Folian Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, M. Murage Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, J. Greenberg Shareholder of: Corrona, LLC, Consultant for: Genentech, Janssen, Novartis and Pfizer, Eli Lilly, Employee of: Corrona, LLC, W. Malatestinic Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company

Dermatologists are frustrated by payer constraints that limit their ability to optimize patient treatment. They can benefit from understanding the payer formulary process and places in that process where they can exert influence.pCollaboration between dermatologists and payers could improve access to medication not only for individual patients, but for the entire dermatologic patient population./ppemJ Drugs Dermatol. 2017;16(3):228-232./em/p.

Clinical trials impose exclusion criteria that may limit the generalizability of results.To (a) determine the percentage of real-world patients who would qualify for psoriasis randomized controlled trials; (b) ascertain differences between moderate-to-severe psoriasis patients who would be eligible, ineligible, or potentially eligible for clinical trials; and (c) compare their biologic treatment patterns.Moderate-to-severe psoriasis patients were identified from the U.S. Department of Defense health care database from January 1, 2008, to October 31, 2013. Eligibility classification for psoriasis trials was based on common trial exclusion criteria involving medical conditions and recent treatment history. Patient characteristics and treatment patterns of 4 biologics (adalimumab, etanercept, infliximab, and ustekinumab) were compared between groups. Adherence was measured by medication possession ratio and persistence as continuous time on drug with ≤ 90-day gap between supply times.Among 16,284 qualifying psoriasis patients, 4,677 (28.7%) were medically ineligible, and 8,466 (52.0%) had ineligibility-related treatments that could be stopped prior to trial entry; the latter patients were considered potentially eligible for psoriasis trials. Common reasons for medical ineligibility included malignancies and hematologic disorders; treatment ineligibilities included use of topical corticosteroids and phototherapy. Medically ineligible patients were older and had more comorbidities, while potentially eligible patients were younger and healthier than trial-eligible patients. Most treatment patterns were similar across groups, except that, compared with the trial-eligible group, medically ineligible patients had greater adherence to infliximab and potentially trial-eligible patients had greater adherence and persistence to adalimumab.This large real-world study found that patients who may be ineligible for psoriasis trials differ in important respects (e.g., comorbidities, prior treatments) from their trial-eligible counterparts. Regardless of their differences at baseline, adherence, persistence, and switching of biologic medications are largely similar, with few differences noted among groups.Financial support for this study was provided by Lilly USA. Wu has received research funding from AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Coherus Biosciences, Dermira, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Regeneron, Sandoz, and Sun Pharmaceutical Industries, and he is a consultant for AbbVie, Amgen, Celgene, Dermira, Eli Lilly, Pfizer, Regeneron, and Sun Pharmaceutical Industries. Malatestinic, Goldblum, Solotkin, Lin, Johnston, and Araujo are employees and/or stock owners of Lilly. Nordstrom, Kistler, and Fraeman are employees of Evidera, which received funding from Lilly to conduct this study. LCDR Hawley is a military service member. This work was prepared as part of her official duties. Title 17 U.S.C. 105 provides that "copyright protection under this title is not available for any work of the United States Government." Title 17 U.S.C. 101 defines a U.S. government work as a work prepared by a military service member or employee of the U.S. government as part of that person's official duties. Research data were derived from an approved Naval Medical Center, Portsmouth, Virginia, institutional review board protocol. The views expressed in this work are those of the authors and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the U.S. government. Study concept and design were contributed by Malatestinic and Araujo, along with the other authors. Nordstrom, Kistler, Fraeman, and Sicignano collected the data, and data interpretation was performed by Wu, Lin, and Hawley, along with Malatestinic, Nordstrom, Solotkin, and Araujo. The manuscript was written by Johnston, Malatestinic, Kistler, Wu, and Araujo, along with Nordstrom, Goldblum, Solotkin, Hawley, and Sicignano, and revised by Goldblum, Solotkin, Malatestinic, and Araujo, along with Nordstrom, Wu, Fraeman, Johnston, Hawley, and Sicignano.

Introduction Le psoriasis genital (PG) est une manifestation frequente du psoriasis caracterisee par un prurit, des douleurs, et d’autres symptomes qui contribuent a l’apparition de troubles sexuels et a une baisse de la qualite de vie. Notre objectif etait d’evaluer l’ixekizumab (IXE), un anticorps monoclonal de haute affinite ciblant de facon selective l’interleukine-17A versus placebo (PBO), sur les symptomes du PG pendant 12 semaines dans un essai de phase 3b, randomise, en double aveugle. Materiel et methodes Cent quarante patients atteints d’un PG modere a severe ont ete randomises (1 :1) pour recevoir un PBO ou 80 mg d’IXE toutes les 2 semaines (dose initiale de 160 mg). Les symptomes du PG ont ete mesures a l’aide de l’echelle des symptomes du psoriasis genital (Genital Psoriasis Symptom Scale [GPSS]) rapportes par le patient, composee d’echelles numeriques (Numeric Rating Scale [NRS]) de 0 a 10 (0 = aucun symptome, 10 = les pires symptomes imaginables) pour 8 symptomes frequents (demangeaisons, douleurs, gene, picotements, brulures, rougeurs, desquamation, et fissures). Pour les items du score GPSS et les scores totaux, des comparaisons entre groupes de traitement ont ete effectuees a l’aide de modeles mixtes pour l’analyse de mesures repetees. Pour les patients ayant un score de baseline NRS ≥ 3 pour les demangeaisons genitales, le pourcentage atteignant une amelioration ≥ 3 points par rapport a la baseline a ete analyse au moyen d’une analyse de regression logistique et d’une imputation d’absence de reponse. Resultats IXE a permis d’obtenir une amelioration significative (p Conclusion Sur 12 semaines, les patients recevant de l’IXE ont eu des ameliorations de la severite des symptomes de PG rapides et significativement plus importantes versus PBO.

Psoriasis is a chronic, incurable, and immune-mediated skin disorder that is characterized by erythematous scaly papules and plaques. Understanding of psoriasis at the molecular level has led to the development of biologic agents that target disease-specific inflammatory mediators in psoriatic lesions. Biologic agents have become important components of the psoriasis armamentarium, but some patients become refractory to these agents over time or fail to respond to subsequent biologics.To (a) evaluate demographic and clinical characteristics of psoriasis patients who have treatment patterns suggestive of failure to a newly initiated biologic agent (treatment-regimen failures) compared with those who do not (non-treatment-regimen failures) and (b) to assess health care-related resource utilization and costs in non-treatment-regimen failures and treatment-regimen failures.In this retrospective observational cohort study, patients were selected from the MarketScan claims database of commercially insured individuals and individuals with Medicare supplemental insurance. The index event was a newly initiated biologic agent for the treatment of psoriasis (etanercept, adalimumab, ustekinumab, or infliximab) between January 2010 and December 2011. The analysis included psoriasis patients aged ≥ 18 years with ≥ 1 prescription claim for a biologic and continuous enrollment 12 months pre- and post-index date. Patients with claims for a biologic in the pre-index period were excluded. Patients were divided into treatment-regimen-failure and non-treatment-regimen-failure groups based on their treatment patterns post-index date. The treatment-regimen-failure group included patients who switched to another biologic, discontinued the biologic without restarting, increased the dose of the biologic, or augmented treatment with a nontopical psoriasis medication during the post-index period. Between-group patient characteristics and medication use were compared using analysis of variance for continuous variables and chi-square tests for categorical variables without adjustment. Cost differences were compared using the propensity score-adjusted bin bootstrapping method.Overall, 2,146 patients met the enrollment criteria. The mean age was 45.1 years. Of these patients, 41.5% were considered treatment-regimen failures. Among treatment-regimen failures, 53% were females, and among non-treatment-regimen failures, 61% were male. Patients who experienced treatment-regimen failure had higher incidences of comorbid cerebrovascular disease, hypertension, chronic pulmonary disease, depression, and anxiety in the pre-index period and were more likely to use concomitant topicals (67.0% vs. 58.4%; P0.001), methotrexate (20.2% vs. 7.3%; P0.001), and cyclosporine (3.1% vs. 1.0%; P0.001) in the post-index period. Mean total all-cause health care costs were higher in patients with treatment-regimen failure versus non-treatment-regimen failure during the pre-index period ($8,024 vs. $6,637; P = 0.002), but patients with non-treatment-regimen failure had higher all-cause costs ($30,759 vs. $28,012; P = 0.002) and psoriasis-related costs ($25,286 vs. $19,625; P0.001) during the post-index period.The results of the current study demonstrated that psoriasis patients with treatment patterns suggestive of treatment-regimen failure on an index biologic had different characteristics and incurred higher all-cause health care costs than did patients without treatment-regimen failure during the pre-index period. This study was supported by Eli Lilly and Company. Foster, Zhu, Guo, Nikai, Malatestinic, Ojeh, and Goldblum are full-time employees and stockholders of Eli Lilly and Company. Kornberg is a full-time employee of INC Research, which was contracted by Eli Lilly to assist with medical writing. Wu has received research funding from AbbVie, Amgen, Coherus Biosciences, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Regeneron, and Sandoz; he is a consultant for AbbVie, Amgen, Celgene, Dermira, DUSA Pharmaceuticals, Eli Lilly, and Pfizer. Study concept was developed by Foster, Ojeh, Malatestinic, and Goldblum. Zhu and Guo, along with Foster, took the lead in data collection, and data interpretation was performed by Nikai, Wu, and Foster, with assistance from the other authors. The manuscript was primarily written by Kornberg, along with Foster, with assistance from the other authors. All of the authors were involved with manuscript revision.

Severe sepsis (SS) is defined as the presence of infection, a systemic inflammatory response, and acute organ dysfunction.[1][1] SS is the leading cause of death in noncardiac intensive care units (ICUs) in the United States[2][2] and drives a disproportionate share of costs, estimated at $16.7

The fundamental goal of health care is to increase longevity and optimize physical, psychological, and social well-being at the individual, community, and society levels. An optimal healthcare system should fulfill these goals in an efficient and cost-effective manner. Although we believe that our healthcare system in the United States is going in the right direction, there is certainly room for improvement.1 In the present article, we review some of the shortcomings of the present system and offer an alternative philosophy that might facilitate a more viable and efficient approach to healthcare expenditure. In the present environment, health care is generally viewed as an expense, and, because “costs” are managed by budgets, this translates into a fiscal mindset in managing health care. Naturally, this attitude generates a pattern of fragmented thinking. That is, the individual components of healthcare cost, such as pharmacy and hospital inpatient admissions, are considered independently, whereas total healthcare value and other important patient outcomes are overlooked. This fiscal mindset also does little to encourage the provision of quality care because reimbursement is based more on quantity. The natural consequence of this is exemplified by the results of a recent study in which patients received only 55% of the recommended care.2 The failure of the current system to promote quality care is also apparent in the infrequent use of incentives for preventive care or proactive disease management. Indeed, such services are often not reimbursed. In short, the focus is on episodic care rather than on encouraging proactive health management. This contributes to the current environment in which 50% of Medicare dollars are being spent on 5% of the Medicare population.3 Finally, a cost-based system fails to consider broader societal benefits of improving health, such as increased productivity and improved quality of life. Our criticism of …

Recent literature reporting the epidemiology, economics, and disease characteristics of sepsis aims to improve the understanding of the condition, costs of care, and disease characteristics. Sepsis is a frequently observed condition associated with death in 30% to 50% of affected patients, and costs associated with sepsis are expected to increase as evidenced by increased nationwide incidence. To make optimal patient care decisions, save lives, and manage resource demands, it is important for all clinicians involved in the care of these patients to understand the condition, its incidence, economics, and disease characteristics.

The history of the Medicare reimbursement system, how it works, and issues related to fraud and abuse are discussed. The statutory charge of Medicare is to ensure adequate reimbursement through a Prospective Payment System (PPS) to cover the costs for providing a given service to Medicare beneficiaries. The PPS was introduced as a way to change hospital behavior through financial incentives that encourage cost-efficient management of resources. The system utilizes a rate of payment in which a hospital is paid a fixed amount that is expected to cover the costs of care while treating a typical patient in a particular diagnosis-related group (DRG). The PPS uses DRGs as payment categories and Major Diagnostic Categories (MDCs) for classifying the DRGs into similar groupings. One of the first steps in DRG assignment is identification of the principal diagnosis represented by an International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code. The secondary diagnoses (referred to as complications or comorbidities), presence or absence of surgery, age of the patient, and discharge status are the other pieces of information making up assignment of a specific DRG to a patient. A basic knowledge of the Medicare program will help in the understanding of how hospitals will be reimbursed for patient care, as well as how changes in Medicare payment may affect reimbursement. Medicare is one of the largest health insurance providers in the United States. A basic understanding of the Medicare system will provide valuable insights into Medicare reimbursement and the influence it has on a hospital's bottom line.