Outcomes in Ixekizumab Patients Following Exposure to Secukinumab and Other Biologics in the CorEvitas Psoriasis Registry.

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

Healthcare Costs Among Patients with Psoriasis Treated with Ixekizumab Versus Secukinumab in Real-World Settings Over 24 Months.

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

Real-World Biologic Adherence, Persistence, and Monotherapy Comparisons in US Patients with Psoriasis: Results from IBM MarketScan® Databases.

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

Healthcare resource utilization and costs among patients with psoriasis treated with ixekizumab or adalimumab over 2 years of follow-up in real-world settings.

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

Treatment patterns and health care costs among patients with psoriatic arthritis treated with biologic or targeted synthetic disease-modifying antirheumatic drugs.

BACKGROUND: Biologic and targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies are used in management of psoriatic arthritis (PsA). Although previous studies have demonstrated that rates of adherence, persistence, discontinuation, and switching, as well as health care costs, are variable among treatments, limited published data exist on more recently approved therapies. OBJECTIVE: To describe adherence, persistence, discontinuation, reinitiation, switching, dosing patterns, and health care costs among PsA patients treated with biologics and tsDMARDs. METHODS: This was a real-world, retrospective administrative claims study. Adult PsA patients with at least 1 claim for an approved PsA biologic (adalimumab, certolizumab, etanercept, golimumab, infliximab, secukinumab, or ustekinumab) or tsDMARD (apremilast or tofacitinib) between January 1, 2015, and June 30, 2019, were selected from the IBM MarketScan administrative claims databases. The first claim for one of the study treatments determined the index date and drug cohort. Patients were required to be continuously enrolled in their health plans for 12 months before and after the index date and to have at least 1 claim with a diagnosis of PsA in the 12 months before or on the index date. Adherence (measured by proportion of days covered [PDC] and medication possession ratio [MPR]), persistence (< 60-day gap in treatment), discontinuation (> 90-day gap), reinitiation of index drug, switching, and dosing patterns for each index drug were assessed during the 12-month follow-up period. Health care costs were reported per patient per month (PPPM) during the 12-month follow-up and assessed after adjusting PsA treatment costs by the Institute for Clinical and Economic Review discount factors to account for discounts and rebates not usually reflected in claims data and by adherence. RESULTS: Overall, 6,674 patients met the selection criteria. The top 3 index drugs were adalimumab (37%), apremilast (26%), and etanercept (18%). Over 12 months of follow-up, 31%-59% of patients remained persistent on the index drug, whereas 35%-56% discontinued, 13%-29% switched to a different biologic or tsDMARD, and 3%-15% reinitiated the index therapy, depending on the index drug. The mean PDC ranged from 0.51 to 0.69 during the 12-month follow-up and 0.80 to 0.93 during the follow-up period before discontinuation. Dose values were largely consistent with prescribing information, with the exception of secukinumab. Index drug costs PPPM ranged from $2,361 (apremilast) to $6,528 for ustekinumab after adjustment for discounts and adherence. CONCLUSIONS: Results from this real-world analysis suggest that there is substantial variability in persistence, discontinuation, adherence, reinitiating, and switching patterns among the different biologic and tsDMARD treatment options for PsA patients. In addition, this study provides real-world cost data for biologics and tsDMARDs among patients with PsA. DISCLOSURES: This study was funded by Eli Lilly Inc., which participated in analysis and interpretation of data, drafting, reviewing, and approving the publication. All authors contributed to the development of the publication and maintained control over the final content. Murage, Malatestinic, Zhu, Atiya, Kern, Stenger, and Sprabery are employees and stockholders of Eli Lilly Inc. Princic and Park are employed by IBM Watson Health, which received funding from Eli Lilly Inc. to conduct this study. Ogdie has received consulting fees from Amgen, AbbVie, Bristol-Myers Squibb, Celgene, Corrona, Janssen, Lilly, Novartis, and Pfizer and has also received grant support from Pfizer, Novartis, and Amgen. Portions of these data have been presented in poster form at the virtual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2020 and Congress of Clinical Rheumatology (CCR) West 2020 conferences.

Disease response and patient-reported outcomes among initiators of ixekizumab.

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

Assessment of the benefit of achieving complete versus almost complete skin clearance in psoriasis: a patient's perspective.

BACKGROUND: Psoriasis is characterized by thick and scaly plaques. The Dermatology Life Quality Index (DLQI) and Physician Global Assessment (PGA) can be used to define its severity. OBJECTIVE: To assess the impact of complete clearance of skin versus almost clear skin across various disease measures. METHODS: Data were collected in a survey of US dermatologists and patients with psoriasis from November 2016-January 2017. Dermatologists completed a 6-point PGA (0 = clear skin, 1 = almost clear skin). Patients completed the DLQI and Work Productivity and Activity Impairment questionnaire (WPAI). Patients with clear and almost clear skin were compared using analysis of covariance for continuous variables, and multivariate logistic regression analysis for categorical variables. RESULTS: Data for 99 and 160 patients with clear and almost clear skin, respectively, were included in the analyses. Patients with clear skin reported less frequent and lower intensity itching, lower total DLQI score (indicating better health-related quality of life), and less impairment of overall work productivity than patients with almost clear skin (all: p < 0.05). LIMITATIONS: Limitations relating to general survey methodology. CONCLUSION: Patients perceived a meaningful difference between clear and almost clear skin. Clear skin is now a realistic treatment target with newer biologics approved in psoriasis.

Comparison of two-year treatment adherence, persistence, discontinuation, reinitiation, and switching between psoriasis patients treated with ixekizumab or secukinumab in real-world settings.

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.

Comparison of Real-World Treatment Patterns Among Biologic-Experienced Patients with Psoriasis Treated with Ixekizumab or Secukinumab Over 18 Months.

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.

Real-World Treatment Patterns and Healthcare Costs in Patients with Psoriatic Arthritis Treated with Ixekizumab: A Retrospective Study.

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 (<60-day gap), discontinuation (≥90-day gap), switching, and dosing patterns were reported. Health care costs were reported per patient per month (PPPM) during follow-up and were assessed after adjusting PsA treatment costs for discount rates reported by the Institute for Clinical and Economic Review (ICER). RESULTS: A total of 496 patients met the selection criteria (mean age, 51.1 years; 50.4% female). Over the 12-month follow-up, 52.8% remained persistent, 38.7% discontinued, 13.5% had no other treatment, 4.6% restarted, and 20.6% switched to a new biologic/traditional synthetic disease-modifying antirheumatic drug. 70.6%of patients were identified as highly adherent (i.e. PDC > 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.

Drug survival of ixekizumab, TNF inhibitors, and other IL-17 inhibitors in real-world patients with psoriasis: The Corrona Psoriasis Registry.

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.

Understanding characteristics of patients newly initiating ixekizumab: findings from the Corrona Psoriasis Registry.

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.

Ixekizumab treatment patterns and healthcare utilization and costs for patients with psoriasis.

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

Evaluation of Changes in Skin and Joint Outcomes and Associated Treatment Changes in Psoriatic Arthritis (PsA): Experience From the Corrona PsA/SpA Registry.

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.

Comparison of Real-World Treatment Patterns Among Psoriasis Patients Treated with Ixekizumab or Adalimumab.

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.

Comparison of real-world treatment patterns among patients with psoriasis prescribed ixekizumab or secukinumab.

BACKGROUND: Real-world data on treatment patterns associated with use of interleukin-17A inhibitors in psoriasis are lacking. OBJECTIVE: To compare treatment patterns between ixekizumab or secukinumab users in clinical practice. METHODS: 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. RESULTS: 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. LIMITATIONS: Disease severity and clinical outcomes were unavailable. CONCLUSION: 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.

Comparison of Health Care Costs Among Patients with Psoriasis Initiating Ixekizumab, Secukinumab, or Adalimumab.

BACKGROUND: 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). OBJECTIVE: To compare the real-world health care costs of patients with PsO initiating IXE with those of patients initiating either SEC or ADA. METHODS: 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. RESULTS: 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 (P = 0.002) and mean PsO-related costs were $6,303 and $5,437 (P < 0.001), for IXE and SEC users, respectively. Similarly, mean monthly all-cause health care costs were $6,535 and $5,557 (P = 0.026) and mean PsO-related costs were $5,792 and $4,754 (P = 0.017), for IXE and ADA users, respectively. After applying ICER adjustments, mean monthly PsO-related costs were comparable between groups: $3,637/IXE versus $3,443/SEC (P = 0.132) and $3,320/IXE versus $3,287/ADA (P = 0.907). CONCLUSIONS: 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. DISCLOSURES: 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 Sharp & Dohme, 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.

Treatment patterns, adherence, and persistence among psoriasis patients treated with biologics in a real-world setting, overall and by disease severity.

PURPOSE: Describe treatment patterns by disease severity among biologic-treated psoriasis patients. MATERIALS AND METHODS: We selected our study cohort in the IQVIA PharMetrics Plus adjudicated claims database linked to Electronic Health Record data from Modernizing Medicine Data Services. Patients were classified as having mild, moderate, or severe psoriasis based on a hierarchy of available severity measures. Patients were followed for 360 days to assess combination therapy, therapy switching and restarting, adherence and persistence. RESULTS: The cohort comprised 2130 biologic-treated patients (mean age: 47.6 years; 45.4% female); 447 (21%) had available disease severity measures. Compared to patients with mild (N = 282) psoriasis, more patients with moderate (N = 116) or severe (N = 49) disease used combination therapy (21.3% vs. 34.5% and 32.7%, respectively), switched therapies (12.1% vs. 19.8% and 22.4%), and discontinued biologics (18.4% vs. 27.6% and 36.7%). Mean adherence was <75% by Medication Possession Ratio (MPR) (73.9%) and Proportion of Days Covered (PDC) (70.2%). Overall, 52.2% had a mean MPR >80%. Mean persistence to biologics was 297.6 days. Persistence and adherence decreased with increasing disease severity. CONCLUSIONS: Biologic-treated psoriasis patients had inadequate adherence (i.e., MPR <80%) and modest persistence to biologics, with moderate and severe patients demonstrating lower adherence and persistence than mild patients.

Treatment patterns among patients with psoriasis using a large national payer database in the United States: a retrospective study.

AIM: To characterize treatment patterns of psoriasis patients in a large US managed care database. MATERIALS AND METHODS: 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. RESULTS: 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 comprised <5% of the treatment patterns observed. LIMITATIONS: 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. CONCLUSIONS: 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.

Medication adherence and persistence in patients with rheumatoid arthritis, psoriasis, and psoriatic arthritis: a systematic literature review.

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.