- Email: [email protected]
Efficacy and safety results of ABT-874 versus etanercept and placebo in patients with moderate to severe chronic plaque psoriasis
P3355
P3357
Resource utilization and costs associated with adalimumab or etanercept for moderate to severe psoriasis in a real-world setting Kim Papp, Probity Medical Research, Waterloo, Ontario, Canada; Annie Guerin, Analysis Group, Montreal, Quebec, Canada; Shiraz Gupta, Abbott Laboratories, Abbott Park, IL, United States; Yanjun Bao, Abbott Laboratories, Abbott Park, IL, United States
Efficacy and safety outcomes for psoriasis patients who interrupt, then resume, adalimumab therapy Kim Papp, Probity Medical Research, Waterloo, Ontario, Canada; Jeffrey Crowley, Bakersfield Dermatology, Bakersfield, CA, United States; Martin Okun, Abbott Laboratories, Abbott Park, IL, United States; Yihua Gu, Abbott Laboratories, Abbott Park, IL, United States
Objective: To compare health care resource utilization and costs in patients treated with adalimumab or etanercept for moderate to severe psoriasis.
Aims: To determine the efficacy and safety of interruption, followed by resumption, of adalimumab therapy in patients with moderate to severe psoriasis.
Methods: The Ingenix Impact National Managed Care Database (2007/Q12009/Q1) was used to select continuously enrolled adult patients with psoriasis who initiated treatment with adalimumab or etanercept after January 18, 2008 (approval date of adalimumab for psoriasis); index date was when the first prescription was filled. Outcomes were measured during the 6 months after index date and included number of health care services, health care costs, and dose-escalation pattern. Adjusted incidence rate ratios (IRRs) and incremental costs (2008 US$) between the two cohorts were estimated using Poisson models and generalized nonlinear models, respectively. Cox proportional hazards models were used to estimate adjusted dose-escalation rates. Models controlled for age, sex, and 6-month preindex characteristics (comorbidities, resource utilization, and conventional psoriasis therapies). Results: Compared with the adalimumab cohort (N ¼ 419), the etanercept cohort (N ¼ 373) was more likely to have urgent care services, including inpatient admissions and emergency department visits (IRR ¼ 1.48; P ¼ .0047). Overall, the etanercept cohort incurred an incremental 6-month total cost of $2977 (P \.0001) over the adalimumab cohort, which was mainly related to an incremental inpatient cost of $1209 (P ¼.0295) and an incremental biologic treatment cost of $1915 (P \ .0001). Greater etanercept treatment costs may be related in part to the significantly greater 6-month dose-escalation rate in the etanercept cohort versus the adalimumab cohort (hazard ratio ¼ 1.67; 95% confidence interval ¼ 1.03-2.72; P ¼ .0393). Conclusions: Compared with adalimumab, etanercept treatment for moderate to severe psoriasis was associated with greater rates of dose escalation, increased medical resource utilization, and greater costs.
Methods: Patients enrolled in a long-term adalimumab open-label extension study (NCT00195676) achieving a Physician’s Global Assessment (PGA) score of mild (2), minimal (1), or clear (0) were withdrawn from adalimumab and monitored for relapse to PGA of moderate (3) or worse. Relapsing patients were retreated with adalimumab (80 mg at week 0, followed by 40 mg every other week (eow) starting at week 1). In February 2009, all remaining (nonrelapsed) patients reinitiated adalimumab therapy (dosing as described above). This analysis focuses on the subset of patients with stable psoriasis control (PGA of 0 or 1 for $ 12 weeks on eow dosing before withdrawal). Missing values were imputed as nonresponse. Results: Five hundred twenty-five patients interrupted adalimumab therapy. Of these patients, 285 had stable psoriasis control: 178/285 patients relapsed and 107/285 were nonrelapsed before treatment reinitiation. Median time to relapse was 141 days. Among patients with previous stable psoriasis control, the proportion with PGA of 0 or 1 following 16 weeks of adalimumab retreatment was 76.5% (218/285): 69.1% (123/178) for relapsers, and 88.8% (95/107) for nonrelapsers. Including those not achieving stable control before withdrawal, 53.1% (279/525) were PGA 0 or 1. Overall, the proportion of patients with serious adverse events was 3.0% (16/525). No rebound or allergic reactions were noted. Conclusion: Interruption of adalimumab therapy in moderate to severe psoriasis patients resulted in disease relapse over the course of several months. After retreatment with adalimumab, a high proportion of patients who had previous stable psoriasis control reachieved psoriasis control. The safety profile for patients who interrupted, then resumed, adalimumab therapy was similar to that observed in phase III adalimumab trials.
Commercial support: This study was funded by Abbott Laboratories. Commercial support: This study was funded by Abbott Laboratories.
P3356 Efficacy and safety results of ABT-874 versus etanercept and placebo in patients with moderate to severe chronic plaque psoriasis Alice Gottlieb, Tufts Medical Center, Boston, MA, United States; Craig Leonardi, Central Dermatology, Saint Louis, MO, United States; Joaquin Valdes, Abbott Laboratories, Abbott Park, IL, United States; Yihua Gu, Abbott Laboratories, Abbott Park, IL, United States Objective: To compare the efficacy and safety of ABT-874 to etanercept (ETN) and placebo in subjects with moderate to severe chronic plaque psoriasis over 12 weeks. Methods: In this phase III, double-blind, double-dummy, multicenter, randomized study, psoriasis patients with an affected body surface area of $ 10% and a Physician’s Global Assessment (PGA) of at least moderate ( $ 3) and Psoriasis Area and Severity Index (PASI) score of $ 12 at baseline were randomized 2:2:1 at week 0 to receive: (1) 200 mg ABT-874 subcutaneous (SC) at weeks 0 and 4 followed by 100 mg ABT-874 SC at week 8; (2) 50 mg ETN SC twice weekly; or (3) matching placebo SC. The proportion of patients achieving a PGA score of ‘‘clear’’ or ‘‘minimal’’ (0/1) and the proportion of patients achieving a PASI 75 response at week 12 were the primary endpoints. Secondary endpoints included the proportion of patients achieving PASI 90 or 100 responses at week 12.
P3358 Ustekinumab use and experience outside of the clinical trial setting: A comprehensive, retrospective chart review of a small, private practice Melodie Young, NP, Modern Dermatology, a Baylor Health Texas Affiliate, Dallas, TX, United States; Elizabeth Horn, PhD, Modern Research Associates, Dallas, TX, United States; Jennifer Cather, MD, Baylor University Medical Center, Dallas, TX, United States; Sterling Whittemore, University of Texas at Austin, Dallas, TX, United States
Results: Baseline demographics and clinical characteristics were similar across treatment groups (placebo, N ¼ 68; ETN, N ¼ 141; ABT-874, N ¼ 138). At week 12, a statistically significantly greater (P \.001) percentage of patients in the ABT-874 treatment group achieved PGA scores of 0/1 and PASI 75 responses (71.0% and 81.9%, respectively) compared to placebo (2.9% and 7.4%, respectively) and ETN (39.7% and 56.0%, respectively). PASI 90 and 100 responses were achieved by a statistically significantly greater percentage of patients in the ABT-874 treatment group (59.4% and 37.0%, respectively) compared to patients receiving placebo (1.5% and 0, respectively) or ETN (23.4% and 7.1%, respectively). No deaths, no major adverse cardiac events (MACE) and a comparable low incidence of malignancies were reported across groups. Incidence of adverse events (AEs) for ABT-874 (49.3%) and ETN (53.9%) was similar; and slightly lower for placebo (45.6%). Number of serious AEs was low: ABT-874 (4), ETN (1), and placebo (1), and the most frequently reported treatment-emergent AEs in the ABT-874 and ETN groups were nasopharyngitis, upper respiratory tract infection, injection site reaction and headache. Conclusion: ABT-874 was superior to both placebo and ETN at week 12 as shown by the statistically significant result of the primary endpoints PGA 0/1 (P \.001) and PASI 75 (P \.001).
Our practice has evaluated 1142 patients diagnosed with psoriasis (PsO) between January 2006 and May 2010, many with more severe disease receiving systemic or biologic therapy. Chart reviews were conducted for those treated with ustekinumab, postapproval, between October 1, 2009 and May 31, 2010 (n ¼ 72). All (30 men and 42 women) had PsO, and 19% (n ¼ 14) had concomitant psoriatic arthritis (PsA). At baseline, patients reported ethanol use (44%), high blood pressure (33%), tobacco use (25%), and depression and/or anxiety (24%). Many were overweight (20%) or obese (44%) based on body mass index. Patients received ustekinumab therapy for an average of 19 weeks (maximum of 33 weeks), and most had been seen in our clinic within the past 1 (36%), 2 (31%), or 3 months (21%). Nearly two-thirds (62%) have received two to three injections to date. Only 12 were taking ustekinumab in combination with other systemic therapies, including acitretin (4), methotrexate (3), or transitioning from cyclosporine (5). Side effects reported by four patients included fatigue (2), GI upset (1), dizziness (1), increased hand arthralgia after injections (1), and severe itching (1). Ustekinumab was discontinued by one patient because of increased joint pain. Before receiving ustekinumab, patients had tried, on average, three different systemic treatments. Nearly all (99%) have previously been prescribed biologic therapy, and 79% have received one or two other biologics in the past. Our results represent an ustekinumab population in a small, private practice outside of the traditional, clinical trial setting.
Commercial support: This study was funded by Abbott Laboratories.
Commercial support: None identified.
FEBRUARY 2011
J AM ACAD DERMATOL
AB159
P3357
Resource utilization and costs associated with adalimumab or etanercept for moderate to severe psoriasis in a real-world setting Kim Papp, Probity Medical Research, Waterloo, Ontario, Canada; Annie Guerin, Analysis Group, Montreal, Quebec, Canada; Shiraz Gupta, Abbott Laboratories, Abbott Park, IL, United States; Yanjun Bao, Abbott Laboratories, Abbott Park, IL, United States
Efficacy and safety outcomes for psoriasis patients who interrupt, then resume, adalimumab therapy Kim Papp, Probity Medical Research, Waterloo, Ontario, Canada; Jeffrey Crowley, Bakersfield Dermatology, Bakersfield, CA, United States; Martin Okun, Abbott Laboratories, Abbott Park, IL, United States; Yihua Gu, Abbott Laboratories, Abbott Park, IL, United States
Objective: To compare health care resource utilization and costs in patients treated with adalimumab or etanercept for moderate to severe psoriasis.
Aims: To determine the efficacy and safety of interruption, followed by resumption, of adalimumab therapy in patients with moderate to severe psoriasis.
Methods: The Ingenix Impact National Managed Care Database (2007/Q12009/Q1) was used to select continuously enrolled adult patients with psoriasis who initiated treatment with adalimumab or etanercept after January 18, 2008 (approval date of adalimumab for psoriasis); index date was when the first prescription was filled. Outcomes were measured during the 6 months after index date and included number of health care services, health care costs, and dose-escalation pattern. Adjusted incidence rate ratios (IRRs) and incremental costs (2008 US$) between the two cohorts were estimated using Poisson models and generalized nonlinear models, respectively. Cox proportional hazards models were used to estimate adjusted dose-escalation rates. Models controlled for age, sex, and 6-month preindex characteristics (comorbidities, resource utilization, and conventional psoriasis therapies). Results: Compared with the adalimumab cohort (N ¼ 419), the etanercept cohort (N ¼ 373) was more likely to have urgent care services, including inpatient admissions and emergency department visits (IRR ¼ 1.48; P ¼ .0047). Overall, the etanercept cohort incurred an incremental 6-month total cost of $2977 (P \.0001) over the adalimumab cohort, which was mainly related to an incremental inpatient cost of $1209 (P ¼.0295) and an incremental biologic treatment cost of $1915 (P \ .0001). Greater etanercept treatment costs may be related in part to the significantly greater 6-month dose-escalation rate in the etanercept cohort versus the adalimumab cohort (hazard ratio ¼ 1.67; 95% confidence interval ¼ 1.03-2.72; P ¼ .0393). Conclusions: Compared with adalimumab, etanercept treatment for moderate to severe psoriasis was associated with greater rates of dose escalation, increased medical resource utilization, and greater costs.
Methods: Patients enrolled in a long-term adalimumab open-label extension study (NCT00195676) achieving a Physician’s Global Assessment (PGA) score of mild (2), minimal (1), or clear (0) were withdrawn from adalimumab and monitored for relapse to PGA of moderate (3) or worse. Relapsing patients were retreated with adalimumab (80 mg at week 0, followed by 40 mg every other week (eow) starting at week 1). In February 2009, all remaining (nonrelapsed) patients reinitiated adalimumab therapy (dosing as described above). This analysis focuses on the subset of patients with stable psoriasis control (PGA of 0 or 1 for $ 12 weeks on eow dosing before withdrawal). Missing values were imputed as nonresponse. Results: Five hundred twenty-five patients interrupted adalimumab therapy. Of these patients, 285 had stable psoriasis control: 178/285 patients relapsed and 107/285 were nonrelapsed before treatment reinitiation. Median time to relapse was 141 days. Among patients with previous stable psoriasis control, the proportion with PGA of 0 or 1 following 16 weeks of adalimumab retreatment was 76.5% (218/285): 69.1% (123/178) for relapsers, and 88.8% (95/107) for nonrelapsers. Including those not achieving stable control before withdrawal, 53.1% (279/525) were PGA 0 or 1. Overall, the proportion of patients with serious adverse events was 3.0% (16/525). No rebound or allergic reactions were noted. Conclusion: Interruption of adalimumab therapy in moderate to severe psoriasis patients resulted in disease relapse over the course of several months. After retreatment with adalimumab, a high proportion of patients who had previous stable psoriasis control reachieved psoriasis control. The safety profile for patients who interrupted, then resumed, adalimumab therapy was similar to that observed in phase III adalimumab trials.
Commercial support: This study was funded by Abbott Laboratories. Commercial support: This study was funded by Abbott Laboratories.
P3356 Efficacy and safety results of ABT-874 versus etanercept and placebo in patients with moderate to severe chronic plaque psoriasis Alice Gottlieb, Tufts Medical Center, Boston, MA, United States; Craig Leonardi, Central Dermatology, Saint Louis, MO, United States; Joaquin Valdes, Abbott Laboratories, Abbott Park, IL, United States; Yihua Gu, Abbott Laboratories, Abbott Park, IL, United States Objective: To compare the efficacy and safety of ABT-874 to etanercept (ETN) and placebo in subjects with moderate to severe chronic plaque psoriasis over 12 weeks. Methods: In this phase III, double-blind, double-dummy, multicenter, randomized study, psoriasis patients with an affected body surface area of $ 10% and a Physician’s Global Assessment (PGA) of at least moderate ( $ 3) and Psoriasis Area and Severity Index (PASI) score of $ 12 at baseline were randomized 2:2:1 at week 0 to receive: (1) 200 mg ABT-874 subcutaneous (SC) at weeks 0 and 4 followed by 100 mg ABT-874 SC at week 8; (2) 50 mg ETN SC twice weekly; or (3) matching placebo SC. The proportion of patients achieving a PGA score of ‘‘clear’’ or ‘‘minimal’’ (0/1) and the proportion of patients achieving a PASI 75 response at week 12 were the primary endpoints. Secondary endpoints included the proportion of patients achieving PASI 90 or 100 responses at week 12.
P3358 Ustekinumab use and experience outside of the clinical trial setting: A comprehensive, retrospective chart review of a small, private practice Melodie Young, NP, Modern Dermatology, a Baylor Health Texas Affiliate, Dallas, TX, United States; Elizabeth Horn, PhD, Modern Research Associates, Dallas, TX, United States; Jennifer Cather, MD, Baylor University Medical Center, Dallas, TX, United States; Sterling Whittemore, University of Texas at Austin, Dallas, TX, United States
Results: Baseline demographics and clinical characteristics were similar across treatment groups (placebo, N ¼ 68; ETN, N ¼ 141; ABT-874, N ¼ 138). At week 12, a statistically significantly greater (P \.001) percentage of patients in the ABT-874 treatment group achieved PGA scores of 0/1 and PASI 75 responses (71.0% and 81.9%, respectively) compared to placebo (2.9% and 7.4%, respectively) and ETN (39.7% and 56.0%, respectively). PASI 90 and 100 responses were achieved by a statistically significantly greater percentage of patients in the ABT-874 treatment group (59.4% and 37.0%, respectively) compared to patients receiving placebo (1.5% and 0, respectively) or ETN (23.4% and 7.1%, respectively). No deaths, no major adverse cardiac events (MACE) and a comparable low incidence of malignancies were reported across groups. Incidence of adverse events (AEs) for ABT-874 (49.3%) and ETN (53.9%) was similar; and slightly lower for placebo (45.6%). Number of serious AEs was low: ABT-874 (4), ETN (1), and placebo (1), and the most frequently reported treatment-emergent AEs in the ABT-874 and ETN groups were nasopharyngitis, upper respiratory tract infection, injection site reaction and headache. Conclusion: ABT-874 was superior to both placebo and ETN at week 12 as shown by the statistically significant result of the primary endpoints PGA 0/1 (P \.001) and PASI 75 (P \.001).
Our practice has evaluated 1142 patients diagnosed with psoriasis (PsO) between January 2006 and May 2010, many with more severe disease receiving systemic or biologic therapy. Chart reviews were conducted for those treated with ustekinumab, postapproval, between October 1, 2009 and May 31, 2010 (n ¼ 72). All (30 men and 42 women) had PsO, and 19% (n ¼ 14) had concomitant psoriatic arthritis (PsA). At baseline, patients reported ethanol use (44%), high blood pressure (33%), tobacco use (25%), and depression and/or anxiety (24%). Many were overweight (20%) or obese (44%) based on body mass index. Patients received ustekinumab therapy for an average of 19 weeks (maximum of 33 weeks), and most had been seen in our clinic within the past 1 (36%), 2 (31%), or 3 months (21%). Nearly two-thirds (62%) have received two to three injections to date. Only 12 were taking ustekinumab in combination with other systemic therapies, including acitretin (4), methotrexate (3), or transitioning from cyclosporine (5). Side effects reported by four patients included fatigue (2), GI upset (1), dizziness (1), increased hand arthralgia after injections (1), and severe itching (1). Ustekinumab was discontinued by one patient because of increased joint pain. Before receiving ustekinumab, patients had tried, on average, three different systemic treatments. Nearly all (99%) have previously been prescribed biologic therapy, and 79% have received one or two other biologics in the past. Our results represent an ustekinumab population in a small, private practice outside of the traditional, clinical trial setting.
Commercial support: This study was funded by Abbott Laboratories.
Commercial support: None identified.
FEBRUARY 2011
J AM ACAD DERMATOL
AB159