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Tumor necrosis factor–blocker therapy persistence, gaps, and switching among patients with psoriatic arthritis
Tumor necrosis factoreblocker therapy persistence, gaps, and switching among patients with psoriatic arthritis
Using real-world drug utilization to estimate tumor necrosis factor blocker cost for treated psoriasis patients in a managed care setting
Benjamin Chastek, MS, i3 Innovus, Eden Prairie, MN, United States; Crystal Watson, MS, Amgen, Inc, Thousand Oaks, CA, United States; Kathleen Fox, PhD, Strategic Healthcare Solutions, LLC, Monkton, MD, United States; Shravanthi Gandra, PhD, MBA, Amgen, Inc, Thousand Oaks, CA, United States Background: Treatment with etanercept and adalimumab, 2 of the most commonly prescribed TNF-blockers, has not been well-studied in real-world settings among patients with psoriatic arthritis (PSA). This study examined etanercept (ETN) and adalimumab (ADA) treatment patterns (therapy persistence, gaps in therapy, and switching) among PSA patients in a managed care population.
Machaon Bonafede, PhD, Thomson Reuters Healthcare, Cambridge, MA, United States; Crystal Watson, MS, Amgen, Inc, Thousand Oaks, CA, United States; Kathleen Fox, PhD, Strategic Healthcare Solutions, Inc, Monkton, MD, United States; Shravanthi Gandra, PhD, MBA, Amgen, Inc, Thousand Oaks, CA, United States Background: Differences in administration and dosing (eg, frequency, range of doses) create challenges for estimating TNF-blocker drug costs for psoriasis (PsO) patients using etanercept (ETN), adalimumab (ADA), and infliximab (INF). Objective: To estimate the annual TNF-blocker cost per treated PsO patient for ETN, ADA, and INF using real-world drug utilization in managed care setting.
(Poster reference number 4957)
Methods: A retrospective study using administrative claims data from a large US commercial health plan identified biologic-na€ıve patients with PSA (ICD-9 code 696.0) who initiated either ETN or ADA between 1/1/2006 and 12/31/2008. Patients were excluded if they had a diagnosis for other conditions treated with TNF-blockers (eg, rheumatoid arthritis), cancer, or HIV. Patients had to be continuously enrolled in the plan for 6 months before and $ 12 months after therapy initiation (index date) and were followed until disenrollment from the plan or 12/31/2009, whichever came first. Gaps in therapy were identified as $ 7 days between the run-out of a fill until the next fill date. Persistence was defined as continuous use of index TNFblocker without a gap in therapy $ 60 days. Patients with gaps $ 60 days were classified as discontinuing therapy. Switching TNF-blockers was identified if a patient who discontinued the index TNF-blocker started another TNF-blocker. Results: ETN therapy was initiated by 202 PSA patients, and ADA was initiated by 144 PSA patients. Mean age for each group was 45 and 46 years, 56% to 57% of patients were male, and 74% to 79% received care from a rheumatologist. A similar proportion of ETN and ADA patients were persistent on TNF-blocker therapy (50% ETN, 45% ADA; P ¼ .37) but ETN patients were persistent longer (mean, 434 days) than ADA patients (353 days; P ¼.02). ETN patients had more gaps in therapy (mean, 4.7 gaps) than ADA patients (3.5 gaps; P ¼.004). Discontinuation of therapy (without any other biologics during follow-up) occurred in 25% of ETN and 35% of ADA patients (P ¼.10) but 46% of ETN and 42% of ADA patients restarted their initial TNF-blocker after discontinuation (P ¼ .47). An additional 20% of ETN and 19% of ADA patients switched to another TNF-blocker (P ¼ .88). Conclusion: About 50% of PSA patients were persistent on the initial TNF-blocker for at least 1 year. In addition, multiple gaps in therapy and therapy discontinuation are common but [ 40% of patients restart their index TNF-blocker after discontinuation. Commercial support: Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc, and by Wyeth, which was acquired by Pfizer Inc. in October 2009.
(Poster reference number 5159)
Methods: Adults 18-64 years diagnosed with PsO with $ 1 claim for ETN, ADA, or INF between 2/1/2008 and 6/30/2009 who were biologic-na€ıve or continuing TNFblocker treatment (ie, received a TNF-blocker before the first claim in the study period) were identified in the MarketScan Commercial Database. Patients had to be continuously enrolled for 6 months before (preindex period) the first TNF-blocker claim in the study period (index date) and were followed for 1 year up to 6/30/2010. Patients were excluded if they had a diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn disease, or ulcerative colitis during the preindex period. Discontinuation from index therapy was defined as either switching to another biologic or having a [45 day gap in therapy. Mean monthly dose for the 3 TNF-blocker therapies was calculated when patients were on therapy. Wholesale acquisition costs were applied to the mean monthly dose and the Medicare Physician Fee Schedule was applied to related drug administrations to estimate the cost per treated patient. Results: A total of 1996 PsO patients (1465 ETN, 493 ADA, and 38 INF) were included. Biologic-na€ıve patients consisted of 37% of ETN patients, 65% of ADA patients, and 29% of INF patients. Patient characteristics were similar across the treatment groups with a mean age (SD) of 45 (11) years and 56% male. The total TNFblocker cost per treated patient for all patients was $15,783 for ETN, $16,154 for ADA, and $25,140 for INF. The total TNF-blocker cost per treated patient for biologicna€ıve PsO patient was $15,065 for ETN, $15,546 for ADA, and $23,471 for INF. For PsO patients continuing treatment, the total TNF-blocker cost per treated patient was $16,208 for ETN, $17,260 for ADA, and $25,820 for INF. Conclusion: TNF-blocker cost per treated patient for PsO patients is similar between ETN and ADA when using real-world drug utilization from a large managed care database. The few PsO patients treated with INF had higher costs per treated patient. Commercial support: Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc, and by Wyeth, which was acquired by Pfizer Inc. in October 2009.
Update on the cardiovascular safety of ustekinumab in pooled phase II and III psoriasis clinical trials with up to 4 years of follow-up
(Poster reference number 4932)
K. Reich, Dermatologikum Hamburg, Hamburg, Germany; C. E. M. Griffiths, University of Manchester School of Medicine, Manchester, United Kingdom; M. Lebwohl, Mount Sinai School of Medicine, New York, NY, United States; P. O. Szapary, Centocor Research and Development, Inc, Malvern, PA, United States Objective: To report the rates of cardiovascular adverse events in the ustekinumab clinical trial program based on the 2010 updated safety analysis. Methods: Cardiovascular event rates were evaluated in phase II/III trials [PHOENIX 1 (3 yr, n ¼ 766), PHOENIX 2 (4 yrs, n ¼ 1230), ACCEPT (1yr, n ¼ 903), phase III (T04, 36 wks, n ¼ 320)]; studies are placebo-controlled except ACCEPT (etanerceptcontrolled). Cumulative rates of investigator reported major cardiovascular adverse events (MACE), including cardiovascular death, non-fatal MI, or stroke, were evaluated by dose and over time with up to 4 yrs of follow-up. MI/stroke rates were compared with rates in a general US population based on Framingham Heart Study, a UK psoriasis population in the General Practice Research Database (GPRD), adjusted for selected baseline cardiovascular risk factors, and in the infliximab psoriasis clinical program. Results: 3117 patients (6791 pt years of follow-up [PY]), with 1650 patients, 1129 patients, and 619 patients were treated $ 2, $ 3, and $ 4 yrs, respectively. MACE rates per 100 PY (95% CI) for ustekinumab 45 mg and 90 mg groups were 0.42 (0.22, 0.73) and 0.36 (0.19, 0.60), respectively. Event rates for ustekinumab-treated groups combined were: 0.47 (95% CI, 0.24-0.82), 0.24 (95% CI, 0.07-0.62), 0.34 (0.11-0.79) and 0.44 (0.14-1.03) for Yrs 1, 2, 3, and 4, respectively. MI and stroke events for ustekinumab-treated group was less than expected in the Framingham Study (observed ¼ 24, expected ¼ 47, SIR ¼ 0.51 [0.33-0.76]) and in the GPRD population (observed ¼ 24, expected ¼ 70, SIR ¼ 0.34 [0.22-0.51]) . MACE rate was comparable to the infliximab psoriasis program (0.45 per 100 PY reported for 1373 infliximabtreated patients with 1106 PY follow-up). Conclusion: Rates of MACE events remain low and stable without an observed dose response with up to 4 yrs of follow-up. Observed rates were consistent with or lower than expected in other populations. The impact of ustekinumab on cardiovascular risk will continue to be monitored in ongoing clinical trials and observational registries. Commercial support: This study was sponsored by Centocor Research and Development, Inc.
AB206
J AM ACAD DERMATOL
Ustekinumab treatment in psoriatic patient suffering from chronic hepatitis C
(Poster reference number 5511)
Giovanna Malara, MD, Dermatology Department, Papardo Hospital, Messina, Italy; Elena Giunta, MD, Virology Department, Papardo Hospital, Messina, Italy; Michele Lo Re, MD, Dermatology Department, Papardo Hospital, Messina, Italy Ustekinumab is an IgG1k monoclonal antibody that blocks IL-12 and IL-23 by binding their shared p40 subunit; therapy based on the neutralization of this subunit is expected to alter the release of IL 12 and 23 which are fundamental in the psoriasis pathway. Ustekinumab has been shown to be highly efficacious in treating patients with moderate to severe psoriasis but, being a selective immunosuppressant, ustekinumab may increase the risk of infections. The authors discuss the case of a middle-aged woman with chronic hepatitis who is undergoing treatment with ustekinumab for moderate-severe psoriasis. Before and during the biologic treatment, the patient was constantly monitored by means of general hematologic screening, with particular attention to hepatic enzymes, and specific tests such as quantitative HCV RNA in real-time PCR for liver infection. The patient is still under ustekinumab treatment (week 28) with evident improvement of skin condition and no alteration of general parameters or worsening of liver infection. Psoriatic lesions gradually have improved. Commercial support: None identified.
APRIL 2012
Using real-world drug utilization to estimate tumor necrosis factor blocker cost for treated psoriasis patients in a managed care setting
Benjamin Chastek, MS, i3 Innovus, Eden Prairie, MN, United States; Crystal Watson, MS, Amgen, Inc, Thousand Oaks, CA, United States; Kathleen Fox, PhD, Strategic Healthcare Solutions, LLC, Monkton, MD, United States; Shravanthi Gandra, PhD, MBA, Amgen, Inc, Thousand Oaks, CA, United States Background: Treatment with etanercept and adalimumab, 2 of the most commonly prescribed TNF-blockers, has not been well-studied in real-world settings among patients with psoriatic arthritis (PSA). This study examined etanercept (ETN) and adalimumab (ADA) treatment patterns (therapy persistence, gaps in therapy, and switching) among PSA patients in a managed care population.
Machaon Bonafede, PhD, Thomson Reuters Healthcare, Cambridge, MA, United States; Crystal Watson, MS, Amgen, Inc, Thousand Oaks, CA, United States; Kathleen Fox, PhD, Strategic Healthcare Solutions, Inc, Monkton, MD, United States; Shravanthi Gandra, PhD, MBA, Amgen, Inc, Thousand Oaks, CA, United States Background: Differences in administration and dosing (eg, frequency, range of doses) create challenges for estimating TNF-blocker drug costs for psoriasis (PsO) patients using etanercept (ETN), adalimumab (ADA), and infliximab (INF). Objective: To estimate the annual TNF-blocker cost per treated PsO patient for ETN, ADA, and INF using real-world drug utilization in managed care setting.
(Poster reference number 4957)
Methods: A retrospective study using administrative claims data from a large US commercial health plan identified biologic-na€ıve patients with PSA (ICD-9 code 696.0) who initiated either ETN or ADA between 1/1/2006 and 12/31/2008. Patients were excluded if they had a diagnosis for other conditions treated with TNF-blockers (eg, rheumatoid arthritis), cancer, or HIV. Patients had to be continuously enrolled in the plan for 6 months before and $ 12 months after therapy initiation (index date) and were followed until disenrollment from the plan or 12/31/2009, whichever came first. Gaps in therapy were identified as $ 7 days between the run-out of a fill until the next fill date. Persistence was defined as continuous use of index TNFblocker without a gap in therapy $ 60 days. Patients with gaps $ 60 days were classified as discontinuing therapy. Switching TNF-blockers was identified if a patient who discontinued the index TNF-blocker started another TNF-blocker. Results: ETN therapy was initiated by 202 PSA patients, and ADA was initiated by 144 PSA patients. Mean age for each group was 45 and 46 years, 56% to 57% of patients were male, and 74% to 79% received care from a rheumatologist. A similar proportion of ETN and ADA patients were persistent on TNF-blocker therapy (50% ETN, 45% ADA; P ¼ .37) but ETN patients were persistent longer (mean, 434 days) than ADA patients (353 days; P ¼.02). ETN patients had more gaps in therapy (mean, 4.7 gaps) than ADA patients (3.5 gaps; P ¼.004). Discontinuation of therapy (without any other biologics during follow-up) occurred in 25% of ETN and 35% of ADA patients (P ¼.10) but 46% of ETN and 42% of ADA patients restarted their initial TNF-blocker after discontinuation (P ¼ .47). An additional 20% of ETN and 19% of ADA patients switched to another TNF-blocker (P ¼ .88). Conclusion: About 50% of PSA patients were persistent on the initial TNF-blocker for at least 1 year. In addition, multiple gaps in therapy and therapy discontinuation are common but [ 40% of patients restart their index TNF-blocker after discontinuation. Commercial support: Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc, and by Wyeth, which was acquired by Pfizer Inc. in October 2009.
(Poster reference number 5159)
Methods: Adults 18-64 years diagnosed with PsO with $ 1 claim for ETN, ADA, or INF between 2/1/2008 and 6/30/2009 who were biologic-na€ıve or continuing TNFblocker treatment (ie, received a TNF-blocker before the first claim in the study period) were identified in the MarketScan Commercial Database. Patients had to be continuously enrolled for 6 months before (preindex period) the first TNF-blocker claim in the study period (index date) and were followed for 1 year up to 6/30/2010. Patients were excluded if they had a diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn disease, or ulcerative colitis during the preindex period. Discontinuation from index therapy was defined as either switching to another biologic or having a [45 day gap in therapy. Mean monthly dose for the 3 TNF-blocker therapies was calculated when patients were on therapy. Wholesale acquisition costs were applied to the mean monthly dose and the Medicare Physician Fee Schedule was applied to related drug administrations to estimate the cost per treated patient. Results: A total of 1996 PsO patients (1465 ETN, 493 ADA, and 38 INF) were included. Biologic-na€ıve patients consisted of 37% of ETN patients, 65% of ADA patients, and 29% of INF patients. Patient characteristics were similar across the treatment groups with a mean age (SD) of 45 (11) years and 56% male. The total TNFblocker cost per treated patient for all patients was $15,783 for ETN, $16,154 for ADA, and $25,140 for INF. The total TNF-blocker cost per treated patient for biologicna€ıve PsO patient was $15,065 for ETN, $15,546 for ADA, and $23,471 for INF. For PsO patients continuing treatment, the total TNF-blocker cost per treated patient was $16,208 for ETN, $17,260 for ADA, and $25,820 for INF. Conclusion: TNF-blocker cost per treated patient for PsO patients is similar between ETN and ADA when using real-world drug utilization from a large managed care database. The few PsO patients treated with INF had higher costs per treated patient. Commercial support: Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc, and by Wyeth, which was acquired by Pfizer Inc. in October 2009.
Update on the cardiovascular safety of ustekinumab in pooled phase II and III psoriasis clinical trials with up to 4 years of follow-up
(Poster reference number 4932)
K. Reich, Dermatologikum Hamburg, Hamburg, Germany; C. E. M. Griffiths, University of Manchester School of Medicine, Manchester, United Kingdom; M. Lebwohl, Mount Sinai School of Medicine, New York, NY, United States; P. O. Szapary, Centocor Research and Development, Inc, Malvern, PA, United States Objective: To report the rates of cardiovascular adverse events in the ustekinumab clinical trial program based on the 2010 updated safety analysis. Methods: Cardiovascular event rates were evaluated in phase II/III trials [PHOENIX 1 (3 yr, n ¼ 766), PHOENIX 2 (4 yrs, n ¼ 1230), ACCEPT (1yr, n ¼ 903), phase III (T04, 36 wks, n ¼ 320)]; studies are placebo-controlled except ACCEPT (etanerceptcontrolled). Cumulative rates of investigator reported major cardiovascular adverse events (MACE), including cardiovascular death, non-fatal MI, or stroke, were evaluated by dose and over time with up to 4 yrs of follow-up. MI/stroke rates were compared with rates in a general US population based on Framingham Heart Study, a UK psoriasis population in the General Practice Research Database (GPRD), adjusted for selected baseline cardiovascular risk factors, and in the infliximab psoriasis clinical program. Results: 3117 patients (6791 pt years of follow-up [PY]), with 1650 patients, 1129 patients, and 619 patients were treated $ 2, $ 3, and $ 4 yrs, respectively. MACE rates per 100 PY (95% CI) for ustekinumab 45 mg and 90 mg groups were 0.42 (0.22, 0.73) and 0.36 (0.19, 0.60), respectively. Event rates for ustekinumab-treated groups combined were: 0.47 (95% CI, 0.24-0.82), 0.24 (95% CI, 0.07-0.62), 0.34 (0.11-0.79) and 0.44 (0.14-1.03) for Yrs 1, 2, 3, and 4, respectively. MI and stroke events for ustekinumab-treated group was less than expected in the Framingham Study (observed ¼ 24, expected ¼ 47, SIR ¼ 0.51 [0.33-0.76]) and in the GPRD population (observed ¼ 24, expected ¼ 70, SIR ¼ 0.34 [0.22-0.51]) . MACE rate was comparable to the infliximab psoriasis program (0.45 per 100 PY reported for 1373 infliximabtreated patients with 1106 PY follow-up). Conclusion: Rates of MACE events remain low and stable without an observed dose response with up to 4 yrs of follow-up. Observed rates were consistent with or lower than expected in other populations. The impact of ustekinumab on cardiovascular risk will continue to be monitored in ongoing clinical trials and observational registries. Commercial support: This study was sponsored by Centocor Research and Development, Inc.
AB206
J AM ACAD DERMATOL
Ustekinumab treatment in psoriatic patient suffering from chronic hepatitis C
(Poster reference number 5511)
Giovanna Malara, MD, Dermatology Department, Papardo Hospital, Messina, Italy; Elena Giunta, MD, Virology Department, Papardo Hospital, Messina, Italy; Michele Lo Re, MD, Dermatology Department, Papardo Hospital, Messina, Italy Ustekinumab is an IgG1k monoclonal antibody that blocks IL-12 and IL-23 by binding their shared p40 subunit; therapy based on the neutralization of this subunit is expected to alter the release of IL 12 and 23 which are fundamental in the psoriasis pathway. Ustekinumab has been shown to be highly efficacious in treating patients with moderate to severe psoriasis but, being a selective immunosuppressant, ustekinumab may increase the risk of infections. The authors discuss the case of a middle-aged woman with chronic hepatitis who is undergoing treatment with ustekinumab for moderate-severe psoriasis. Before and during the biologic treatment, the patient was constantly monitored by means of general hematologic screening, with particular attention to hepatic enzymes, and specific tests such as quantitative HCV RNA in real-time PCR for liver infection. The patient is still under ustekinumab treatment (week 28) with evident improvement of skin condition and no alteration of general parameters or worsening of liver infection. Psoriatic lesions gradually have improved. Commercial support: None identified.
APRIL 2012