real-world treatment switching patterns for patients with

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FUNDING AND DISCLOSURES AbbVie sponsored the study; contributed to the design; participated in collection, analysis, and interpretation of data; and in writing, reviewing, and approval of the final version. All authors had access to the data results, and participated in the development, review, and approval of this poster. No honoraria or payments were made for authorship. Jashin J. Wu is or has been an investigator, consultant, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America LLC, and Zerigo Health. Manish Patel, Vishvas Garg, and Weihua Gao are employees of AbbVie and may own AbbVie stock or options. Shiyin Jiao is a PhD candidate at the University of Chicago and was a contractor at AbbVie when the study was performed. Monika Salkar is a PhD candidate at the University of Mississippi and was a research intern at AbbVie when the study was performed. Presented at Innovations in Dermatology 2021, Virtual Spring Conference, March 16 – 20, 2021 Real-World Treatment Switching Patterns for Patients with Psoriasis Using Targeted Immunomodulators Jashin J Wu, MD 1 , Manish Patel, PharmD, MS 2 , Shiyin Jiao, MHS 2,3 , Vishvas Garg, PhD 2 , Weihua Gao, MS, PhD 2 , Monika Salkar, MS 4 1 Dermatology Research and Education Foundation, Irvine, California, USA; 2 AbbVie Inc., North Chicago, Illinois, USA; 3 University of Chicago, Chicago, Illinois, USA; 4 University of Mississippi, Oxford, Mississippi, USA BACKGROUND For patients with plaque psoriasis (PsO), the National Psoriasis Foundation recommends a target response of a body surface area (BSA) ≤1% at 3 months after treatment initiation and maintenance of this BSA at 6-month intervals thereafter. If a patient does not reach or maintain this target, treatment modification, including switching therapy, should be considered 1 Previous real-world studies have reported a broad range (~5 – 25%) for switch rates among targeted immunomodulators (TIMs) within 1 year of initiation 2–4 ; however, there is an evidence gap as these studies did not evaluate more recently approved biologics, such as the interleukin (IL)-23 inhibitors OBJECTIVE • To quantify real-world treatment switching rates for patients with PsO initiating TIMs over 24 months accounting for the recent advancements in treatment. In addition, patient demographics, and clinical and treatment characteristics associated with switching were identified METHODS DATA SOURCE • The IBM ® MarketScan ® Research Databases These data include health insurance claims across the continuum of care (e.g., inpatient, outpatient, outpatient pharmacy, carve-out behavioral healthcare) as well as enrollment data This administrative claims database includes a variety of fee-for-service, preferred provider organizations, capitated, and Medicare supplemental health plans STUDY POPULATION (Figure 1) Adult patients (age ≥18 years) At least two medical claims for PsO based on International Classification of Diseases (ICD)-9 (696.1) and ICD-10 (L40.0, L40.1, L40.2, L40.3, L40.4, L40.8, L40.9) codes Initiated a TIM approved for the treatment of PsO between 01/01/2017 and 08/31/2020. Initiation of TIM was considered the “index date” At least 6 months of continuous enrollment before and after index date Exclusion criteria: Patients with evidence of other autoimmune conditions Figure 1. Study design and study population Database: IBM ® MarketScan ® Databases PsO, psoriasis; Rx, prescription; TIM, targeted immunomodulator. STUDY OUTCOMES Treatment switch rate: proportion of patients who switched to (or added) a new TIM in the 24 months after treatment initiation This study did not consider discontinuation or non-adherence in the switch definition Combination therapy was not differentiated from switch; addition of another TIM was considered a switch Switch rates were calculated for the overall population and by class of TIM • Switching patterns and characteristics associated with switching were also evaluated REFERENCES 1. Armstrong AW, et al. J Am Acad Dermatol. 2017;76:290–8. 2. Kaplan DL, et al. Clinicoecon Outcomes Res. 2020;12:369–77. 3. Feldman SR, et al. J Manag Care Spec Pharm. 2015;21:201–9. 4. Foster SA, et al. J Manag Care Spec Pharm. 2016;22:396–405. CONCLUSIONS • In this real-world study, switching a among patients with PsO using TIMs was common over 24 months Significant differences existed in switch rates based on the class TIMs (ranging from 13.2–38.7%); IL-23 inhibitors demonstrated the lowest risk of switching over 24 months Among switchers, the most common classes switched to were IL-17 and IL-23 inhibitors Prior TIM use is an important predictor of switching a This study did not consider discontinuation or non-adherence in the switch definition ACKNOWLEDGMENTS Medical writing support was provided by Joann Hettasch of Fishawack Facilitate Ltd., part of Fishawack Health, and was funded by AbbVie. METHODS (CONTINUED) ANALYTIC APPROACH • Descriptive analyses were conducted to assess demographic, clinical, and treatment characteristics of the cohort Kaplan–Meier methods were used to estimate switch rates Multivariable Cox regression analyses were performed adjusting for baseline demographic, clinical, and treatment characteristics RESULTS STUDY POPULATION A total of 10,174 patients with PsO were included in this study Mean age of study population was 46.2 years and half were women (Table 1) Table 1. Baseline characteristics Characteristic Overall (N=10,174) Age, mean ± SD 46.2 ± 13.2 Female, n (%) 5096 (50.1) Region, n (%) a Midwest 2103 (22.8) Northeast 1774 (19.2) South 4245 (46.0) West 1114 (12.1) Insurance, n (%) Commercial 9728 (95.6) Medicare 446 (4.4) Comorbidities, n (%) Anxiety or depression 1594 (15.7) Hypertension 2714 (26.7) Major adverse cardiovascular event b 558 (5.5) Obesity 1517 (14.9) Diabetes 1288 (12.7) a N=9236 (missing region data for 938 patients); b includes myocardial infarction, stroke, and heart failure SD, standard deviation. Of 10,174 patients, 37% were treated with phosphodiesterase-4 inhibitor (PDE-4), 29% with tumor necrosis factor (TNF) inhibitors, 14% with IL-17 inhibitors, 10% with IL-12/23 inhibitor, and 9% with IL-23 inhibitors (Figure 2) Figure 2. Sample size by mechanism of action IL, interleukin; PDE-4, phosphodieasterase-4; TNF, tumor necrosis factor. RESULTS (CONTINUED) PsO TREATMENT SWITCH RATES Across all TIMs, the treatment switch rate was 16.4% at 12 months and 29.4% at 24 months (Figure 3) Figure 3. Overall PsO treatment switch rate over time 12 months 24 months Survival Switch rate Survival Switch rate All TIMs 0.836 16.4% 0.706 29.4% Note: censoring was defined during the 24 months of follow-up as first switch to another TIM or end of continuous enrollment, whichever occurred first. TIMs, targeted immunomodulators. PsO TREATMENT SWITCH RATES BY CLASS OF TIM Significant differences in switch rates exist between classes of TIMs over 24 months of follow-up (range at 12 and 24 months was 7.1– 23.2% and 13.2–38.7%, respectively; P<0.0001) with the IL-23 inhibitors associated with the lowest switch rates (Figure 4) Figure 4. PsO treatment switch rates over time by class of TIM 12 months 24 months TIM class Survival Switch rate Survival Switch rate IL-23 inhibitors 0.929 7.1% 0.868 13.2% IL-12/23 inhibitor 0.886 11.4% 0.770 23.0% IL-17 inhibitors 0.884 11.6% 0.743 25.7% PDE-4 inhibitor 0.839 16.1% 0.730 27.0% TNF inhibitors 0.768 23.2% 0.613 38.7% IL, interleukin; PDE-4, phosphodiesterase-4; TIM, targeted immunomodulator; TNF, tumor necrosis factor. Patients treated with TNF, PDE-4, IL-17, and IL-12/23 inhibitors were 3.5, 2.3, 1.9, and 1.7 times as likely, respectively, to switch therapy as those treated with IL-23 inhibitors (P<0.001, all pairwise unadjusted comparisons) Similarly, adjusted analyses showed significantly higher risks of switching with TNF, PDE-4, IL-17, and IL-12/23 inhibitors, respectively, compared with IL-23 inhibitors (P<0.001, Figure 5) LIMITATIONS Claims data used for billing health plans were analyzed in this study and may be subject to data errors (e.g., miscoding) The presence of a claim for a filled prescription may not indicate actual use of the drug by a patient; however, it is expected that this potential issue would be present equally among the drugs of interest Figure 5. Adjusted risk of switching therapy by class of TIM IL-23 inhibitors is the reference group. P value based on Cox multivariable regression models adjusting for baseline demographics (region, gender, age), clinical (comorbidities) and treatment characteristics (previous treatment and index class). CI, confidence interval; HR, hazard ratio; IL, interleukin; PDE-4, phosphodiesterase-4; TIM, targeted immunomodulator; TNF, tumor necrosis factor. CHARACTERISTICS ASSOCIATED WITH SWITCHING (Table 2) Patients with prior TIM use were 1.37 times as likely to switch than TIM-naïve patients (P<0.0001) Females (vs males) and age groups 35 – 50 and 51 – 64 (vs 18 – 34) were associated with higher risks of switching (HR=1.28, 1.20, and 1.19, respectively; P<0.01) Table 2. Risk of switching TIM therapy: adjusted results from Cox multivariable regression analysis Covariates Hazard ratio (95% CI) P value Geographic region (reference: Midwest) Northeast 1.03 (0.90–1.18) 0.6419 South 0.98 (0.88–1.10) 0.7429 West 0.86 (0.73–1.01) 0.0647 Gender (reference: males) Females 1.28 (1.16–1.39) <0.0001 Age groups (reference: 18–34 years) 35–50 years 1.20 (1.06–1.36) 0.0046 51–64 years 1.19 (1.05–1.36) 0.0083 65+ years 0.87 (0.63–1.19) 0.3834 Presence of baseline comorbidities (reference: no presence) Anxiety or depression 1.03 (0.91–1.16) 0.6605 Major adverse cardiovascular event 1.00 (0.82–1.23) 0.9803 Hypertension 1.02 (0.91–1.14) 0.7549 Obesity 1.08 (0.95–1.22) 0.2524 Diabetes 1.03 (0.90–1.19) 0.6448 Prior TIM use (reference: TIM-naïve) Prior TIM use 1.37 (1.19–1.57) <0.0001 P value based on Cox multivariable regression models adjusting for baseline demographics, and clinical and treatment characteristics. CI, confidence interval; IL, interleukin; PDE-4, phosphodiesterase-4; TIM, targeted immunomodulator; TNF, tumor necrosis factor. In addition to the covariates listed in Table 2, the classes of TIMs were also included in this model (Figure 5). SWITCHING PATTERNS Among switchers, the most common classes switched to were IL-17 and IL-23 inhibitors (33% and 26%, respectively; Figure 6) Figure 6. Switching patterns by TIM class IL, interleukin; PDE-4, phosphodiesterase-4; TIM, targeted immunomodulator; TNF, tumor necrosis factor. Adjusted HR 95% CI P value TNF inhibitors 3.5 2.7, 4.5 <0.0001 PDE-4 inhibitor 2.3 1.8, 3.0 <0.0001 IL-17 inhibitors 1.8 1.3, 2.4 <0.0001 IL-12/23 inhibitor 1.7 1.2, 2.2 0.0007

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Page 1: Real-World Treatment Switching Patterns for Patients with

FUNDING AND DISCLOSURESAbbVie sponsored the study; contributed to the design; participated in collection, analysis, and interpretation of data; and in writing, reviewing, and approval of the final version. All authors had access to the data results, and participated in the development, review, and approval of this poster. No honoraria or payments were made for authorship.Jashin J. Wu is or has been an investigator, consultant, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America LLC, and Zerigo Health.Manish Patel, Vishvas Garg, and Weihua Gao are employees of AbbVie and may own AbbVie stock or options.Shiyin Jiao is a PhD candidate at the University of Chicago and was a contractor at AbbVie when the study was performed.Monika Salkar is a PhD candidate at the University of Mississippi and was a research intern at AbbVie when the study was performed.

Presented at Innovations in Dermatology 2021, Virtual Spring Conference, March 16 – 20, 2021

Real-World Treatment Switching Patterns for Patients with Psoriasis Using Targeted ImmunomodulatorsJashin J Wu, MD1, Manish Patel, PharmD, MS2, Shiyin Jiao, MHS2,3, Vishvas Garg, PhD2, Weihua Gao, MS, PhD2, Monika Salkar, MS4

1Dermatology Research and Education Foundation, Irvine, California, USA; 2AbbVie Inc., North Chicago, Illinois, USA; 3University of Chicago, Chicago, Illinois, USA; 4University of Mississippi, Oxford, Mississippi, USA

BACKGROUND• For patients with plaque psoriasis (PsO), the National Psoriasis

Foundation recommends a target response of a body surface area (BSA) ≤1% at 3 months after treatment initiation and maintenance of this BSA at 6-month intervals thereafter. If a patient does not reach or maintain this target, treatment modification, including switching therapy, should be considered1

• Previous real-world studies have reported a broad range (~5 – 25%) for switch rates among targeted immunomodulators (TIMs) within 1 year of initiation2–4; however, there is an evidence gap as these studies did not evaluate more recently approved biologics, such as the interleukin (IL)-23 inhibitors

OBJECTIVE• To quantify real-world treatment switching rates for patients with

PsO initiating TIMs over 24 months accounting for the recent advancements in treatment. In addition, patient demographics, and clinical and treatment characteristics associated with switching were identified

METHODSDATA SOURCE• The IBM® MarketScan® Research Databases

– These data include health insurance claims across the continuum of care (e.g., inpatient, outpatient, outpatient pharmacy, carve-out behavioral healthcare) as well as enrollment data

– This administrative claims database includes a variety of fee-for-service, preferred provider organizations, capitated, and Medicare supplemental health plans

STUDY POPULATION (Figure 1)• Adult patients (age ≥18 years)• At least two medical claims for PsO based on International

Classification of Diseases (ICD)-9 (696.1) and ICD-10 (L40.0, L40.1, L40.2, L40.3, L40.4, L40.8, L40.9) codes

• Initiated a TIM approved for the treatment of PsO between 01/01/2017 and 08/31/2020. Initiation of TIM was considered the “index date”

• At least 6 months of continuous enrollment before and after index date• Exclusion criteria:

– Patients with evidence of other autoimmune conditions

Figure 1. Study design and study populationDatabase: IBM® MarketScan® Databases

PsO, psoriasis; Rx, prescription; TIM, targeted immunomodulator.

STUDY OUTCOMES• Treatment switch rate: proportion of patients who switched to

(or added) a new TIM in the 24 months after treatment initiation – This study did not consider discontinuation or non-adherence in the switch definition

– Combination therapy was not differentiated from switch; addition of another TIM was considered a switch

– Switch rates were calculated for the overall population and by class of TIM• Switching patterns and characteristics associated with switching were

also evaluated

REFERENCES1. Armstrong AW, et al. J Am Acad Dermatol. 2017;76:290–8.2. Kaplan DL, et al. Clinicoecon Outcomes Res. 2020;12:369–77.3. Feldman SR, et al. J Manag Care Spec Pharm. 2015;21:201–9.4. Foster SA, et al. J Manag Care Spec Pharm. 2016;22:396–405.

CONCLUSIONS• In this real-world study, switchinga among patients with PsO using

TIMs was common over 24 months• Significant differences existed in switch rates based on the class TIMs

(ranging from 13.2–38.7%); IL-23 inhibitors demonstrated the lowest risk of switching over 24 months

• Among switchers, the most common classes switched to were IL-17 and IL-23 inhibitors

• Prior TIM use is an important predictor of switching a This study did not consider discontinuation or non-adherence in the switch definition

ACKNOWLEDGMENTSMedical writing support was provided by Joann Hettasch of Fishawack Facilitate Ltd., part of Fishawack Health, and was funded by AbbVie.

METHODS (CONTINUED)

ANALYTIC APPROACH• Descriptive analyses were conducted to assess demographic, clinical,

and treatment characteristics of the cohort• Kaplan–Meier methods were used to estimate switch rates• Multivariable Cox regression analyses were performed adjusting for

baseline demographic, clinical, and treatment characteristics

RESULTSSTUDY POPULATION• A total of 10,174 patients with PsO were included in this study • Mean age of study population was 46.2 years and half were women

(Table 1)

Table 1. Baseline characteristicsCharacteristic Overall (N=10,174)

Age, mean ± SD 46.2 ± 13.2

Female, n (%) 5096 (50.1)

Region, n (%)a

Midwest 2103 (22.8)

Northeast 1774 (19.2)

South 4245 (46.0)

West 1114 (12.1)

Insurance, n (%)

Commercial 9728 (95.6)

Medicare 446 (4.4)

Comorbidities, n (%)

Anxiety or depression 1594 (15.7)

Hypertension 2714 (26.7)

Major adverse cardiovascular eventb 558 (5.5)

Obesity 1517 (14.9)

Diabetes 1288 (12.7)a N=9236 (missing region data for 938 patients); bincludes myocardial infarction, stroke, and heart failure SD, standard deviation.

• Of 10,174 patients, 37% were treated with phosphodiesterase-4 inhibitor (PDE-4), 29% with tumor necrosis factor (TNF) inhibitors, 14% with IL-17 inhibitors, 10% with IL-12/23 inhibitor, and 9% with IL-23 inhibitors (Figure 2)

Figure 2. Sample size by mechanism of action

IL, interleukin; PDE-4, phosphodieasterase-4; TNF, tumor necrosis factor.

RESULTS (CONTINUED)

PsO TREATMENT SWITCH RATES• Across all TIMs, the treatment switch rate was 16.4% at 12 months

and 29.4% at 24 months (Figure 3)Figure 3. Overall PsO treatment switch rate over time

12 months 24 monthsSurvival Switch rate Survival Switch rate

All TIMs 0.836 16.4% 0.706 29.4%

Note: censoring was defined during the 24 months of follow-up as first switch to another TIM or end of continuous enrollment, whichever occurred first.TIMs, targeted immunomodulators.

PsO TREATMENT SWITCH RATES BY CLASS OF TIM• Significant differences in switch rates exist between classes of TIMs

over 24 months of follow-up (range at 12 and 24 months was 7.1–23.2% and 13.2–38.7%, respectively; P<0.0001) with the IL-23 inhibitors associated with the lowest switch rates (Figure 4)

Figure 4. PsO treatment switch rates over time by class of TIM

12 months 24 monthsTIM class Survival Switch rate Survival Switch rateIL-23 inhibitors 0.929 7.1% 0.868 13.2%IL-12/23 inhibitor 0.886 11.4% 0.770 23.0%IL-17 inhibitors 0.884 11.6% 0.743 25.7%PDE-4 inhibitor 0.839 16.1% 0.730 27.0%TNF inhibitors 0.768 23.2% 0.613 38.7%

IL, interleukin; PDE-4, phosphodiesterase-4; TIM, targeted immunomodulator; TNF, tumor necrosis factor.

• Patients treated with TNF, PDE-4, IL-17, and IL-12/23 inhibitors were 3.5, 2.3, 1.9, and 1.7 times as likely, respectively, to switch therapy as those treated with IL-23 inhibitors (P<0.001, all pairwise unadjusted comparisons)

• Similarly, adjusted analyses showed significantly higher risks of switching with TNF, PDE-4, IL-17, and IL-12/23 inhibitors, respectively, compared with IL-23 inhibitors (P<0.001, Figure 5)

LIMITATIONS• Claims data used for billing health plans were analyzed in this study and

may be subject to data errors (e.g., miscoding)• The presence of a claim for a filled prescription may not indicate actual

use of the drug by a patient; however, it is expected that this potential issue would be present equally among the drugs of interest

Figure 5. Adjusted risk of switching therapy by class of TIM

IL-23 inhibitors is the reference group. P value based on Cox multivariable regression models adjusting for baseline demographics (region, gender, age), clinical (comorbidities) and treatment characteristics (previous treatment and index class).CI, confidence interval; HR, hazard ratio; IL, interleukin; PDE-4, phosphodiesterase-4; TIM, targeted immunomodulator; TNF, tumor necrosis factor.

CHARACTERISTICS ASSOCIATED WITH SWITCHING (Table 2)• Patients with prior TIM use were 1.37 times as likely to switch than

TIM-naïve patients (P<0.0001) • Females (vs males) and age groups 35 – 50 and 51 – 64 (vs 18 – 34)

were associated with higher risks of switching (HR=1.28, 1.20, and 1.19, respectively; P<0.01)

Table 2. Risk of switching TIM therapy: adjusted results from Cox multivariable regression analysisCovariates Hazard ratio (95% CI) P valueGeographic region (reference: Midwest)

Northeast 1.03 (0.90–1.18) 0.6419South 0.98 (0.88–1.10) 0.7429West 0.86 (0.73–1.01) 0.0647

Gender (reference: males)Females 1.28 (1.16–1.39) <0.0001

Age groups (reference: 18–34 years)35–50 years 1.20 (1.06–1.36) 0.004651–64 years 1.19 (1.05–1.36) 0.008365+ years 0.87 (0.63–1.19) 0.3834

Presence of baseline comorbidities (reference: no presence)Anxiety or depression 1.03 (0.91–1.16) 0.6605Major adverse cardiovascular event 1.00 (0.82–1.23) 0.9803Hypertension 1.02 (0.91–1.14) 0.7549Obesity 1.08 (0.95–1.22) 0.2524Diabetes 1.03 (0.90–1.19) 0.6448

Prior TIM use (reference: TIM-naïve)Prior TIM use 1.37 (1.19–1.57) <0.0001

P value based on Cox multivariable regression models adjusting for baseline demographics, and clinical and treatment characteristics. CI, confidence interval; IL, interleukin; PDE-4, phosphodiesterase-4; TIM, targeted immunomodulator; TNF, tumor necrosis factor.In addition to the covariates listed in Table 2, the classes of TIMs were also included in this model (Figure 5).

SWITCHING PATTERNS• Among switchers, the most common classes switched to were IL-17

and IL-23 inhibitors (33% and 26%, respectively; Figure 6)

Figure 6. Switching patterns by TIM classIL, interleukin; PDE-4, phosphodiesterase-4; TIM, targeted immunomodulator; TNF, tumor necrosis factor.

Adjusted HR 95% CI P valueTNF inhibitors 3.5 2.7, 4.5 <0.0001

PDE-4 inhibitor 2.3 1.8, 3.0 <0.0001

IL-17 inhibitors 1.8 1.3, 2.4 <0.0001

IL-12/23 inhibitor 1.7 1.2, 2.2 0.0007