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Real-world utilization patterns of systemic immunosuppressants among US adult patients with atopic dermatitis
5510
5541
Real world use of secukinumab for the treatment of plaque psoriasis and psoriatic arthritis. The experience of Hospital Virgen Del Rocıo in Seville Lourdes Rodriguez Fernandez Freire, MD, Hospital Virgen del Rocio; Pablo Martin Carrasco, Hospital Virgen del Rocıo; Mercedes Morillo Andujar, Hospital Virgen del Rocio; Roman Barabash Neila, Hospital Virgen del Rocıo; Julian Conejo Mir, Hospital Virgen del Rocıo Introduction: Worldwide, there is an increasing trend to use real-world data to inform decision making in health care. The data regarding appropriate drug use, effectiveness, and cost-effectiveness in real-world clinical practice is intended to complement the findings from clinical trials, and to evaluate a drug’s real-world value. Secukinumab is a fully humanized anti interleukin (IL)-17A antibody that specifically binds to Interleukin (IL)-17A receptors. In recent years, IL-17A has been recognized to play an important role in the disease pathology. The IL-17A is a proinflammatory cytokine that is produced majorly by Th17 cells and has been isolated from the plaque lesion of psoriatic patients. Secukinumab safety and efficacy has been evaluated in several clinical trials, building around this new drug one of the widest clinical developments ever. There is a need to confirm results from clinical trials in a real world setting, to give us light on the real effectiveness and security profile of secukinumab. Methods: Our objective is to evaluate the safety and effectiveness of secukinumab in patients with psoriasis and psoriatic arthritis who were treated in our Dermatology Unit. We have analyzed data from 14 patients which had received at least one dose of secukinumab in the period from November 2015 to September 2016. Our data includes PASI 75, PASI 90, presence or absence of psoriatic arthritis, presence and description of other comorbidities, patient demographics, DLQI, pruritus score, and history of prior systemic or biologic therapies.
Real-world disease burden in US adults with moderate-to-severe atopic dermatitis eligible for treatment with systemic immunosuppressants April Armstrong, Keck School of Medicine at University of Southern California; Rachel Moon, Adelphi Real World; David Bell, Adelphi Real World; Stuart Blackburn, Adelphi Real World; Wenhui Wei, Sanofi; Jingdong Chao, Regeneron Pharmaceuticals, Inc. Introduction: US clinical guidelines recommend off-label systemic immunosuppressants (IMs) for atopic dermatitis (AD) refractory to topical treatment, yet little data support IM use. This real-world study examined nonsteroidal IM use among moderate-to-severe AD patients eligible for IM therapy, and compared disease burden outcomes between IM-treated and eligible for but not treated with IMs (‘IMeligible-untreated’) patients.
Results: Complete data will be presented at the AAD Meeting. Commercial support: None identified.
Methods: Adult ($18 years) moderate-to-severe AD patients were identified in the 2014 Adelphi AD Disease-Specific Programme, a cross-sectional survey of US physicians and their patients. Patients were considered IM-eligible if the physician answered ‘‘Yes’’ to the question, ‘‘Does this patient’s current clinical status make them a suitable candidate for systemic IM therapy?’’ Disease burden outcomes compared between IM-treated and IM-eligible-untreated patients included: % patients with uncontrolled AD (defined as currently flaring, deteriorating/changeable AD, or physician dissatisfaction with current control), % body surface area (BSA) affected, % patients treated with systemic corticosteroids (SCSs), patient-reported AD severity on Patient-Oriented Eczema Measure (POEM), and % work impairment on Work Productivity and Activity Index (WPAI). Results: Among 652 patients with current moderate-to-severe AD (mean age, 40.0 years; 53.8% female), 194 (29.8%) were IM-eligible, of whom 79 (40.7%) were IMtreated. Of the 115 IM-eligible-untreated patients, 58 (50.4%) were untreated due to physician safety concerns and 51 (44.3%) due to patient reluctance. Disease control was poor in both IM-treated and IM-eligible-untreated patients (uncontrolled AD, 68.4% vs 70.4%, respectively). Use of SCSs was significantly higher among IMeligible-untreated vs IM-treated patients (43.1% vs 26.6%; P ¼ .02). Other disease burden outcomes were similar in both groups and indicative of moderate-to-severe disease (mean[SD]): percent BSA affected, 20.0% (15.9) vs 23.6% (20.1); POEM score, 12.5 (7.0) vs 13.4 (6.1); WPAI, 27.2% (25.0) vs 30.7% (26.5). Conclusions: In this RW setting, the majority of IM-eligible moderate-to-severe AD patients were untreated, mainly due to safety concerns and patient reluctance. Most IMeligible patients, regardless of treatment status, had poor disease control. IM-eligibleuntreated patients had significantly higher SCS use. These results suggest an unmet need for effective and safe long-term treatments for moderate-to-severe AD patients. Commercial support: Pharmaceuticals Inc.
5437 Real-world burden of comorbidities in US patients with psoriasis Kamal Shah, MD, Bio-Pharma Life Cycle Management LLC; Maria Paris, MD, Celgene Corporation; Lillian Mellars, MS, Celgene Corporation; Arun Changolkar, PhD, Celgene Corporation Background: Understanding the background rate of comorbidities in psoriasis is important to provide perspective for adverse events associated with new therapies. Medical insurance claims databases represent a source of real-world population data to assess comorbidity rates in the psoriasis population. The main caveats for this method are its dependence on the International Classification of Diseases (ICD) codes, patient (pt) retention, and that this represents only a certain insured population. Methods: The extent of selected comorbidities in psoriasis pts was assessed using the Truven Health Analytics MarketScan database, which comprises commercial claims representative of a large insured US population. The database contains ;220 million pts-lives since 1995, with 67 million inpatient hospital discharges in the United States. MarketScan had ;1.22 million pts with $1 claim with a diagnosis of psoriasis between January 1, 2008, and December 31, 2014. Pts aged $18 years who had $2 health claims in any diagnosis field for psoriasis (ICD-9-CM: 696.1) with an index date (psoriasis diagnosis date) between July 1, 2008, and June 30, 2014, were included to allow follow-up observation time; the full population included 469,097 pts. In addition to the full population, 292,999 pts meeting the minimum continuous enrollment criterion of 12 months (6 months pre- and post-index date) were selected. Results: Prevalence and incidence of 24 comorbidities associated with the US psoriasis pt population in the MarketScan database were assessed; those occurring most commonly in the full population include hyperlipidemia (45.64% and 30.83%, respectively), hypertension (42.19% and 24.19%), depression (17.91% and 12.68%), type 2 diabetes mellitus (17.45% and 8.44%), and obesity (14.38% and 11.57%). Excluding depression, these comorbidities may be grouped into a diagnosis of metabolic syndrome. Conclusions: The prevalence and incidence presented are aligned with rates described in the literature and support the concept that psoriasis pts have high rates of cardiometabolic comorbidities. This analysis highlights the potential utility of very large insurance databases for determining the prevalence of comorbidities in psoriasis, which may be helpful to US health care providers in managing psoriasis. Additional research is needed to evaluate the prevalence of comorbidities in other regions and the potential contribution of the various psoriasis therapies to the comorbidity rate. Commercial support: 100% is sponsored by Celgene Corporation.
JUNE 2017
This analysis was
funded
by Sanofi/Regeneron
5523 Real-world utilization patterns of systemic immunosuppressants among US adult patients with atopic dermatitis April Armstrong, Keck School of Medicine at University of Southern California; Ahong Huang, STATinMED Research/SIMR, Inc.; Li Wang, STATinMED Research; Raymond Miao, Sanofi; Miraj Patel, Sanofi; Wenhui Wei, Sanofi Introduction: Current US treatment guidelines recommend off-label systemic immunosuppressants (IMs) for atopic dermatitis (AD) refractory to topical treatment. However, little data exist on IM use by AD patients in the real-world clinical setting. The objective of this study was to examine real-world IM treatment patterns among AD patients. Methods: This retrospective analysis used data from the Truven Health MarketScan database to identify adults ($18 years old) diagnosed with AD who used IMs (cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil) between 30Jun-2010 and 30-Sept-2014, and had continuous health plan enrolment for at least the 6-month pre-index (baseline) period through the 12-month post-index (followup) period. Treatment outcomes evaluated during the follow-up period included: IM dose escalation, IM discontinuation, switching/additional IMs, systemic steroid use, and phototherapy use. Results: A total of 4204 adult AD patients (female, 67.5%; mean (SD) age, 50.9 [15.5] years) who used IMs were included in the analysis, of whom 611 (14.5%) received azathioprine, 712 (16.9%) received cyclosporine, 2155 (51.3%) received methotrexate, and 726 (17.3%) received mycophenolate mofetil. There was a high prevalence of AD-related comorbidities: chronic pulmonary disease (24.3%), allergic rhinitis (22.2%), asthma (18.8%), chronic rhinosinusitis (15.6%) and allergic urticaria (10.7%). During the 1-year follow-up, 1524 (36.3%) required IM dose escalation, while 116 (2.8%) of patients switched IMs and 319 (7.6%) required additional IMs. In addition, 2878 patients (68.5%) discontinued IM treatment; and the mean (SD) time to IM discontinuation was 88.1 (70.7) days. Systemic steroid use was observed in 3039 (72.3%) patients. The mean (SD) number of steroid claims per patient was 4.6 (3.9). Only 2.4% of patients utilized phototherapy. Conclusions: Among adult AD patients treated with IMs in this real-world clinical setting, IM dose escalation and early discontinuation of IM therapy within one year was common. In addition, there was a high rate of systemic steroid use, involving multiple courses per patient. These results suggest that treatment with systemic IMs are inadequate for many patients with AD, and highlight an unmet need for effective long-term treatments for AD. Commercial support: Pharmaceuticals Inc.
This analysis was
funded
by Sanofi/Regeneron
J AM ACAD DERMATOL
AB215
5541
Real world use of secukinumab for the treatment of plaque psoriasis and psoriatic arthritis. The experience of Hospital Virgen Del Rocıo in Seville Lourdes Rodriguez Fernandez Freire, MD, Hospital Virgen del Rocio; Pablo Martin Carrasco, Hospital Virgen del Rocıo; Mercedes Morillo Andujar, Hospital Virgen del Rocio; Roman Barabash Neila, Hospital Virgen del Rocıo; Julian Conejo Mir, Hospital Virgen del Rocıo Introduction: Worldwide, there is an increasing trend to use real-world data to inform decision making in health care. The data regarding appropriate drug use, effectiveness, and cost-effectiveness in real-world clinical practice is intended to complement the findings from clinical trials, and to evaluate a drug’s real-world value. Secukinumab is a fully humanized anti interleukin (IL)-17A antibody that specifically binds to Interleukin (IL)-17A receptors. In recent years, IL-17A has been recognized to play an important role in the disease pathology. The IL-17A is a proinflammatory cytokine that is produced majorly by Th17 cells and has been isolated from the plaque lesion of psoriatic patients. Secukinumab safety and efficacy has been evaluated in several clinical trials, building around this new drug one of the widest clinical developments ever. There is a need to confirm results from clinical trials in a real world setting, to give us light on the real effectiveness and security profile of secukinumab. Methods: Our objective is to evaluate the safety and effectiveness of secukinumab in patients with psoriasis and psoriatic arthritis who were treated in our Dermatology Unit. We have analyzed data from 14 patients which had received at least one dose of secukinumab in the period from November 2015 to September 2016. Our data includes PASI 75, PASI 90, presence or absence of psoriatic arthritis, presence and description of other comorbidities, patient demographics, DLQI, pruritus score, and history of prior systemic or biologic therapies.
Real-world disease burden in US adults with moderate-to-severe atopic dermatitis eligible for treatment with systemic immunosuppressants April Armstrong, Keck School of Medicine at University of Southern California; Rachel Moon, Adelphi Real World; David Bell, Adelphi Real World; Stuart Blackburn, Adelphi Real World; Wenhui Wei, Sanofi; Jingdong Chao, Regeneron Pharmaceuticals, Inc. Introduction: US clinical guidelines recommend off-label systemic immunosuppressants (IMs) for atopic dermatitis (AD) refractory to topical treatment, yet little data support IM use. This real-world study examined nonsteroidal IM use among moderate-to-severe AD patients eligible for IM therapy, and compared disease burden outcomes between IM-treated and eligible for but not treated with IMs (‘IMeligible-untreated’) patients.
Results: Complete data will be presented at the AAD Meeting. Commercial support: None identified.
Methods: Adult ($18 years) moderate-to-severe AD patients were identified in the 2014 Adelphi AD Disease-Specific Programme, a cross-sectional survey of US physicians and their patients. Patients were considered IM-eligible if the physician answered ‘‘Yes’’ to the question, ‘‘Does this patient’s current clinical status make them a suitable candidate for systemic IM therapy?’’ Disease burden outcomes compared between IM-treated and IM-eligible-untreated patients included: % patients with uncontrolled AD (defined as currently flaring, deteriorating/changeable AD, or physician dissatisfaction with current control), % body surface area (BSA) affected, % patients treated with systemic corticosteroids (SCSs), patient-reported AD severity on Patient-Oriented Eczema Measure (POEM), and % work impairment on Work Productivity and Activity Index (WPAI). Results: Among 652 patients with current moderate-to-severe AD (mean age, 40.0 years; 53.8% female), 194 (29.8%) were IM-eligible, of whom 79 (40.7%) were IMtreated. Of the 115 IM-eligible-untreated patients, 58 (50.4%) were untreated due to physician safety concerns and 51 (44.3%) due to patient reluctance. Disease control was poor in both IM-treated and IM-eligible-untreated patients (uncontrolled AD, 68.4% vs 70.4%, respectively). Use of SCSs was significantly higher among IMeligible-untreated vs IM-treated patients (43.1% vs 26.6%; P ¼ .02). Other disease burden outcomes were similar in both groups and indicative of moderate-to-severe disease (mean[SD]): percent BSA affected, 20.0% (15.9) vs 23.6% (20.1); POEM score, 12.5 (7.0) vs 13.4 (6.1); WPAI, 27.2% (25.0) vs 30.7% (26.5). Conclusions: In this RW setting, the majority of IM-eligible moderate-to-severe AD patients were untreated, mainly due to safety concerns and patient reluctance. Most IMeligible patients, regardless of treatment status, had poor disease control. IM-eligibleuntreated patients had significantly higher SCS use. These results suggest an unmet need for effective and safe long-term treatments for moderate-to-severe AD patients. Commercial support: Pharmaceuticals Inc.
5437 Real-world burden of comorbidities in US patients with psoriasis Kamal Shah, MD, Bio-Pharma Life Cycle Management LLC; Maria Paris, MD, Celgene Corporation; Lillian Mellars, MS, Celgene Corporation; Arun Changolkar, PhD, Celgene Corporation Background: Understanding the background rate of comorbidities in psoriasis is important to provide perspective for adverse events associated with new therapies. Medical insurance claims databases represent a source of real-world population data to assess comorbidity rates in the psoriasis population. The main caveats for this method are its dependence on the International Classification of Diseases (ICD) codes, patient (pt) retention, and that this represents only a certain insured population. Methods: The extent of selected comorbidities in psoriasis pts was assessed using the Truven Health Analytics MarketScan database, which comprises commercial claims representative of a large insured US population. The database contains ;220 million pts-lives since 1995, with 67 million inpatient hospital discharges in the United States. MarketScan had ;1.22 million pts with $1 claim with a diagnosis of psoriasis between January 1, 2008, and December 31, 2014. Pts aged $18 years who had $2 health claims in any diagnosis field for psoriasis (ICD-9-CM: 696.1) with an index date (psoriasis diagnosis date) between July 1, 2008, and June 30, 2014, were included to allow follow-up observation time; the full population included 469,097 pts. In addition to the full population, 292,999 pts meeting the minimum continuous enrollment criterion of 12 months (6 months pre- and post-index date) were selected. Results: Prevalence and incidence of 24 comorbidities associated with the US psoriasis pt population in the MarketScan database were assessed; those occurring most commonly in the full population include hyperlipidemia (45.64% and 30.83%, respectively), hypertension (42.19% and 24.19%), depression (17.91% and 12.68%), type 2 diabetes mellitus (17.45% and 8.44%), and obesity (14.38% and 11.57%). Excluding depression, these comorbidities may be grouped into a diagnosis of metabolic syndrome. Conclusions: The prevalence and incidence presented are aligned with rates described in the literature and support the concept that psoriasis pts have high rates of cardiometabolic comorbidities. This analysis highlights the potential utility of very large insurance databases for determining the prevalence of comorbidities in psoriasis, which may be helpful to US health care providers in managing psoriasis. Additional research is needed to evaluate the prevalence of comorbidities in other regions and the potential contribution of the various psoriasis therapies to the comorbidity rate. Commercial support: 100% is sponsored by Celgene Corporation.
JUNE 2017
This analysis was
funded
by Sanofi/Regeneron
5523 Real-world utilization patterns of systemic immunosuppressants among US adult patients with atopic dermatitis April Armstrong, Keck School of Medicine at University of Southern California; Ahong Huang, STATinMED Research/SIMR, Inc.; Li Wang, STATinMED Research; Raymond Miao, Sanofi; Miraj Patel, Sanofi; Wenhui Wei, Sanofi Introduction: Current US treatment guidelines recommend off-label systemic immunosuppressants (IMs) for atopic dermatitis (AD) refractory to topical treatment. However, little data exist on IM use by AD patients in the real-world clinical setting. The objective of this study was to examine real-world IM treatment patterns among AD patients. Methods: This retrospective analysis used data from the Truven Health MarketScan database to identify adults ($18 years old) diagnosed with AD who used IMs (cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil) between 30Jun-2010 and 30-Sept-2014, and had continuous health plan enrolment for at least the 6-month pre-index (baseline) period through the 12-month post-index (followup) period. Treatment outcomes evaluated during the follow-up period included: IM dose escalation, IM discontinuation, switching/additional IMs, systemic steroid use, and phototherapy use. Results: A total of 4204 adult AD patients (female, 67.5%; mean (SD) age, 50.9 [15.5] years) who used IMs were included in the analysis, of whom 611 (14.5%) received azathioprine, 712 (16.9%) received cyclosporine, 2155 (51.3%) received methotrexate, and 726 (17.3%) received mycophenolate mofetil. There was a high prevalence of AD-related comorbidities: chronic pulmonary disease (24.3%), allergic rhinitis (22.2%), asthma (18.8%), chronic rhinosinusitis (15.6%) and allergic urticaria (10.7%). During the 1-year follow-up, 1524 (36.3%) required IM dose escalation, while 116 (2.8%) of patients switched IMs and 319 (7.6%) required additional IMs. In addition, 2878 patients (68.5%) discontinued IM treatment; and the mean (SD) time to IM discontinuation was 88.1 (70.7) days. Systemic steroid use was observed in 3039 (72.3%) patients. The mean (SD) number of steroid claims per patient was 4.6 (3.9). Only 2.4% of patients utilized phototherapy. Conclusions: Among adult AD patients treated with IMs in this real-world clinical setting, IM dose escalation and early discontinuation of IM therapy within one year was common. In addition, there was a high rate of systemic steroid use, involving multiple courses per patient. These results suggest that treatment with systemic IMs are inadequate for many patients with AD, and highlight an unmet need for effective long-term treatments for AD. Commercial support: Pharmaceuticals Inc.
This analysis was
funded
by Sanofi/Regeneron
J AM ACAD DERMATOL
AB215