- Email: [email protected]
Comorbidity risks increase over time in patients with psoriasis
PD02- PSORIASIS AND HAIR P200 Classical and nonclassical calciphylaxis, and a lesson in chemistry Suyin Ong, MBBCh, Department of Dermatology, Burnley General Hospital, Burnley, Lancashire, United Kingdom; Caroline Owen, MBChB, Department of Dermatology, Royal Blackburn Hospital, Blackburn, Lancashire, United Kingdom; Ian H Coulson, MBBS, Department of Dermatology, Burnley General Hospital, Burnley, Lancashire, United Kingdom Calciphylaxis occurs when calcium salts are deposited in the microvascular network, causing an obliterative vasculopathy. In the skin, this appears as reticulate purpura that breaks down to form painful ulcers as the skin undergoes ischaemic necrosis. Calciphylaxis classically occurs because of secondary hyperparathyroidism in chronic kidney disease, but it is now recognized that calciphylaxis can also occur in patients with normal parathyroid and renal function. The overall mortality of calciphylaxis is greater than 80%. We present two contrasting cases who both presented with leg ulcers: a 63-year-old woman with calciphylaxis caused by primary hyperparathyroidism but normal renal function, and a 79-year-old woman in whom the syndrome occurred despite normal renal and parathyroid function. In both cases, the leg ulcers had surrounding livedo reticularis and were exquisitely painful. The nonclassical case in particular required high-dose opioids in addition to amitryptiline, gabapentin, and a lumbar sympathectomy for analgesia. Histology confirmed luminal obliteration and calcification of subcutaneous vessel walls in both patients. The classical case responded to parathyroid adenectomy, conventional treatment with intravenous pamidronate infusions, broad-spectrum antibiotics, and surgical debridement. The nonclassical case however, was normocalcaemic and had no renal dysfunction. Because warfarin and amlodipine have been associated with nonclassical calciphylaxis, they were switched to aspirin and ramipril, respectively. Intravenous pamidronate did not halt the worsening ulceration. Intravenous sodium thiosulfate infusions (25 g via peripherally inserted central catheter over 60 min, thrice weekly) were administered intermittently over a 6-month period. She received intensive wound care. Her ulcers became less painful over the first 2 months and healed completely over the next 8 months. Sodium thiosulfate (Na2S2O3) liberates calcium ions from calcium salt deposits by forming calcium thiosulfate, which is 250 to 100000 times more soluble in aqueous solution compared to other calcium salts (phosphate, sulphate, citrate, and oxalate). The obliterative vasculopathy caused by calcification therefore improves when calcium thiosulfate is renally excreted or dialyzed. These two cases illustrate the management of classical and nonclassical calciphylaxis with cutaneous ulceration and support the use of sodium thiosulfate in the treatment of this life- and limbthreatening condition.
P202 Comorbidity risks increase over time in patients with psoriasis Alexa Kimball, Harvard Medical School, Boston, MA, United States; Andrew Yu, Analysis Group, Boston, MA, United States; Parvez Mulani, Abbott Laboratories, Abbott Park, IL, United States; Yanjun Bao, Abbott Laboratories, Abbott Park, IL, United States Objective: To assess the comorbidity burden over time for patients (pts) with psoriasis (Ps) versus pts without Ps and to determine whether Ps-associated comorbidity risks increase over time. Methods: The MarketScan claims database (2000-2006) was used to identify new pts with Ps using the following criteria: those with $ 2 Ps diagnosis codes (ICD-9-CM: 696.1x) whose first diagnosis was $ 1 year after the beginning of eligibility and who did not receive a diagnosis of psoriatic arthritis (ICD-9-CM: 696.0x) or any biologic treatment before their first Ps diagnosis. The index date was defined as the date of the first Ps diagnosis plus 180 days. Each pt with Ps was matched 1:1 to a Ps-free control pt based on age, sex, and region of residence. Control pts were assigned a random index date that achieved $ 180 days of preindex (baseline) eligibility. All pts were continuously enrolled for $ 2 years and had $ 1 medical claim after the index date. Pts were followed from the index date until the end of eligibility or the initiation of a biologic treatment, whichever occurred first. Chi-square tests and Kaplan-Meier survival analyses were used to compare the prevalence rates of comorbidities over time. Results: A total of 5723 pts with Ps and 5723 controls were selected. At baseline, pts with Ps had a greater prevalence of comorbidities compared with Ps-free control pts. During the study period, pts with Ps had significantly greater rates of hypertension (relative risk ratio [RRR] ¼ 1.1), cardiovascular diseases (RRR ¼ 1.2), depression (RRR ¼ 1.1), diabetes mellitus (RRR ¼ 1.1), hyperlipidemia (RRR ¼ 1.1), and obesity (RRR ¼ 1.5; all P \ .05). Over time, pts with Ps had a consistently greater comorbidity prevalence than pts who did not have Ps. Furthermore, Kaplan-Meier estimates showed that the differences in comorbidity rates increased over a 4-year period, with the greatest differences for hyperlipidemia (3.0 percentage point increase), obesity (1.2 percentage point increase), and depression (1.1 percentage point increase). For depression and obesity, the rate differences between Ps and non-Ps patients increased each year. Ascertainment biases and other biases may affect this analysis. Conclusions: Over time, pts with Ps are at increased risk of developing major comorbidities, particularly hyperlipidemia, depression, and obesity. Commercial support: This study is sponsored by Abbott Laboratories.
Commercial support: None identified.
P203
P201 Potential drugedrug interactions of oral systemic therapies for psoriasis have adverse outcomes in a real-world setting Jean-Hilaire Saurat, Hoˆpital Cantonal Universitaire de Gene`ve, Geneva, Switzerland; Annie Gue´rin, Analysis Group, Boston, MA, United States; Parvez Mulani, Abbott Laboratories, Abbott Park, IL, United States; Shiraz Gupta, Abbott Laboratories, Abbott Park, IL, United States Objective: To investigate the health care outcomes associated with methotrexate (MTX) or cyclosporine (CYC) used concurrently with medications that could have potential drugedrug interactions (PDDI drugs). Methods: The Ingenix Impact National Managed Care Database (1999-2007) was used to select continuously enrolled adult patients with psoriasis who initiated MTX/CYC (ie, index). Two groups were stratified: (1) the at-risk (AR) group, which included patients using PDDI drugs within 30 days before and 30 days after index; and (2) the not-at-risk (NAR) group, which included patients without concurrent use of PDDI drugs during the 30 days before the index and the 6-month study period after the index. Study outcomes included adverse events (AEs) of toxicities, resource utilization, and health care costs. Adjusted odds ratios (ORs), incidence rate ratios (IRRs), and incremental costs between the two groups were estimated using logistic regression models, negative binomial models, and gamma regression models with log link function, respectively; all controlled for age, sex, baseline comorbidities, resource utilization, and psoriasis therapies.
Cost per responder for biologic treatment of psoriasis: Matching-adjusted comparisons of adalimumab with etanercept, infliximab, and ustekinumab James Signorovitch, Analysis Group, Boston, MA, United States; Parvez Mulani, Abbott Laboratories, Abbott Park, IL, United States; Shiraz Gupta, Abbott Laboratories, Abbott Park, IL, United States; Yanjun Bao, Abbott Laboratories, Abbott Park, IL, United States Objectives: No randomized trial has directly compared adalimumab with other biologic treatments for moderate to severe psoriasis. Accounting for differences in patient populations across trials, this study provided matching-adjusted indirect comparisons of the cost per responder of adalimumab with that of etanercept, infliximab, and ustekinumab.
Results: The analysis included 7955 patients with psoriasis using MTX/CYC (42.4% NAR and 57.6% AR). Nonsteroidal antiinflammatory drugs and antibiotics were the most commonly used PDDI drugs. Compared with the NAR group, the AR group was significantly more likely to experience renal toxicity (OR: 2.86; P ¼ .0064), gastrointestinal toxicity (OR: 1.42; P ¼ .0075), and pulmonary toxicity (OR: 1.28; P ¼ .0064). The AR group also used significantly more resources, such as hospitalizations (IRR: 1.61; P \ .0001) and emergency department visits (IRR: 1.31; P ¼ .0022), and incurred $1722 (P \.0001) greater adjusted total health care costs than the NAR group ($711 greater pharmacy costs and $539 greater outpatient costs [both P \.0001]). Conclusions: More than half of patients with psoriasis treated with MTX/CYC used PDDI drugs concurrently. These patients were at greater risk of AEs, used more resources, and incurred greater health care costs.
Methods: Patient-level data from two placebo-controlled trials of adalimumab (REVEAL and M02-528) were reweighted in separate analyses to exactly match their average baseline characteristics and placebo-group responses to those from published placebo-controlled trials of etanercept (Leonardi et al, 2003), infliximab (Reich et al, 2005), and ustekinumab (Leonardi et al, 2008; Papp et al, 2008). For each comparison of adalimumab with another biologic, the characteristics matched included patient age, sex, psoriasis duration, Psoriasis Area and Severity Index (PASI) score, percentage of affected body surface area, percentage of patients with psoriatic arthritis, and treatment history. After matching, cost per patient achieving $ 75% reduction in PASI score was compared for adalimumab versus etanercept and ustekinumab at week 12 and versus infliximab at week 10 (using published PASI 75 response rates for nonadalimumab biologics). Total quantity of adalimumab used in REVEAL and M02-528 was calculated using the observed number of injections. Total drug use in the other biologic trials was estimated from published rates of dropout. Canadian Wholesale Acquisition Costs as of December 2008 were used for each drug. Statistical significance was assessed using the bootstrap method. Results: After matching, drug costs per PASI 75 responder were less for adalimumab than for etanercept, infliximab, and ustekinumab (all P \.0001). Adalimumab cost per PASI 75 responder was Can $8996 less than that of etanercept (Can $7707 vs Can $16703), Can $8292 less than that of infliximab (Can $7625 vs Can $15917), Can $5630 less than that of ustekinumab 45 mg (Can $7666 vs Can $13296), Can $16880 less than that of full-price ustekinumab 90 mg (Can $7666 vs Can $24546), and Can $4607 less than that of ustekinumab 90 mg priced the same as ustekinumab 45 mg (Can $7666 vs Can $12273). Conclusions: After matching average baseline characteristics and placebo group responses, adalimumab therapy for moderate to severe psoriasis had the lowest cost per PASI 75 responder compared with etanercept, infliximab, and ustekinumab.
Commercial support: This study is sponsored by Abbott Laboratories.
Commercial support: This study is sponsored by Abbott Laboratories
MARCH 2010
J AM ACAD DERMATOL
AB3
P202 Comorbidity risks increase over time in patients with psoriasis Alexa Kimball, Harvard Medical School, Boston, MA, United States; Andrew Yu, Analysis Group, Boston, MA, United States; Parvez Mulani, Abbott Laboratories, Abbott Park, IL, United States; Yanjun Bao, Abbott Laboratories, Abbott Park, IL, United States Objective: To assess the comorbidity burden over time for patients (pts) with psoriasis (Ps) versus pts without Ps and to determine whether Ps-associated comorbidity risks increase over time. Methods: The MarketScan claims database (2000-2006) was used to identify new pts with Ps using the following criteria: those with $ 2 Ps diagnosis codes (ICD-9-CM: 696.1x) whose first diagnosis was $ 1 year after the beginning of eligibility and who did not receive a diagnosis of psoriatic arthritis (ICD-9-CM: 696.0x) or any biologic treatment before their first Ps diagnosis. The index date was defined as the date of the first Ps diagnosis plus 180 days. Each pt with Ps was matched 1:1 to a Ps-free control pt based on age, sex, and region of residence. Control pts were assigned a random index date that achieved $ 180 days of preindex (baseline) eligibility. All pts were continuously enrolled for $ 2 years and had $ 1 medical claim after the index date. Pts were followed from the index date until the end of eligibility or the initiation of a biologic treatment, whichever occurred first. Chi-square tests and Kaplan-Meier survival analyses were used to compare the prevalence rates of comorbidities over time. Results: A total of 5723 pts with Ps and 5723 controls were selected. At baseline, pts with Ps had a greater prevalence of comorbidities compared with Ps-free control pts. During the study period, pts with Ps had significantly greater rates of hypertension (relative risk ratio [RRR] ¼ 1.1), cardiovascular diseases (RRR ¼ 1.2), depression (RRR ¼ 1.1), diabetes mellitus (RRR ¼ 1.1), hyperlipidemia (RRR ¼ 1.1), and obesity (RRR ¼ 1.5; all P \ .05). Over time, pts with Ps had a consistently greater comorbidity prevalence than pts who did not have Ps. Furthermore, Kaplan-Meier estimates showed that the differences in comorbidity rates increased over a 4-year period, with the greatest differences for hyperlipidemia (3.0 percentage point increase), obesity (1.2 percentage point increase), and depression (1.1 percentage point increase). For depression and obesity, the rate differences between Ps and non-Ps patients increased each year. Ascertainment biases and other biases may affect this analysis. Conclusions: Over time, pts with Ps are at increased risk of developing major comorbidities, particularly hyperlipidemia, depression, and obesity. Commercial support: This study is sponsored by Abbott Laboratories.
Commercial support: None identified.
P203
P201 Potential drugedrug interactions of oral systemic therapies for psoriasis have adverse outcomes in a real-world setting Jean-Hilaire Saurat, Hoˆpital Cantonal Universitaire de Gene`ve, Geneva, Switzerland; Annie Gue´rin, Analysis Group, Boston, MA, United States; Parvez Mulani, Abbott Laboratories, Abbott Park, IL, United States; Shiraz Gupta, Abbott Laboratories, Abbott Park, IL, United States Objective: To investigate the health care outcomes associated with methotrexate (MTX) or cyclosporine (CYC) used concurrently with medications that could have potential drugedrug interactions (PDDI drugs). Methods: The Ingenix Impact National Managed Care Database (1999-2007) was used to select continuously enrolled adult patients with psoriasis who initiated MTX/CYC (ie, index). Two groups were stratified: (1) the at-risk (AR) group, which included patients using PDDI drugs within 30 days before and 30 days after index; and (2) the not-at-risk (NAR) group, which included patients without concurrent use of PDDI drugs during the 30 days before the index and the 6-month study period after the index. Study outcomes included adverse events (AEs) of toxicities, resource utilization, and health care costs. Adjusted odds ratios (ORs), incidence rate ratios (IRRs), and incremental costs between the two groups were estimated using logistic regression models, negative binomial models, and gamma regression models with log link function, respectively; all controlled for age, sex, baseline comorbidities, resource utilization, and psoriasis therapies.
Cost per responder for biologic treatment of psoriasis: Matching-adjusted comparisons of adalimumab with etanercept, infliximab, and ustekinumab James Signorovitch, Analysis Group, Boston, MA, United States; Parvez Mulani, Abbott Laboratories, Abbott Park, IL, United States; Shiraz Gupta, Abbott Laboratories, Abbott Park, IL, United States; Yanjun Bao, Abbott Laboratories, Abbott Park, IL, United States Objectives: No randomized trial has directly compared adalimumab with other biologic treatments for moderate to severe psoriasis. Accounting for differences in patient populations across trials, this study provided matching-adjusted indirect comparisons of the cost per responder of adalimumab with that of etanercept, infliximab, and ustekinumab.
Results: The analysis included 7955 patients with psoriasis using MTX/CYC (42.4% NAR and 57.6% AR). Nonsteroidal antiinflammatory drugs and antibiotics were the most commonly used PDDI drugs. Compared with the NAR group, the AR group was significantly more likely to experience renal toxicity (OR: 2.86; P ¼ .0064), gastrointestinal toxicity (OR: 1.42; P ¼ .0075), and pulmonary toxicity (OR: 1.28; P ¼ .0064). The AR group also used significantly more resources, such as hospitalizations (IRR: 1.61; P \ .0001) and emergency department visits (IRR: 1.31; P ¼ .0022), and incurred $1722 (P \.0001) greater adjusted total health care costs than the NAR group ($711 greater pharmacy costs and $539 greater outpatient costs [both P \.0001]). Conclusions: More than half of patients with psoriasis treated with MTX/CYC used PDDI drugs concurrently. These patients were at greater risk of AEs, used more resources, and incurred greater health care costs.
Methods: Patient-level data from two placebo-controlled trials of adalimumab (REVEAL and M02-528) were reweighted in separate analyses to exactly match their average baseline characteristics and placebo-group responses to those from published placebo-controlled trials of etanercept (Leonardi et al, 2003), infliximab (Reich et al, 2005), and ustekinumab (Leonardi et al, 2008; Papp et al, 2008). For each comparison of adalimumab with another biologic, the characteristics matched included patient age, sex, psoriasis duration, Psoriasis Area and Severity Index (PASI) score, percentage of affected body surface area, percentage of patients with psoriatic arthritis, and treatment history. After matching, cost per patient achieving $ 75% reduction in PASI score was compared for adalimumab versus etanercept and ustekinumab at week 12 and versus infliximab at week 10 (using published PASI 75 response rates for nonadalimumab biologics). Total quantity of adalimumab used in REVEAL and M02-528 was calculated using the observed number of injections. Total drug use in the other biologic trials was estimated from published rates of dropout. Canadian Wholesale Acquisition Costs as of December 2008 were used for each drug. Statistical significance was assessed using the bootstrap method. Results: After matching, drug costs per PASI 75 responder were less for adalimumab than for etanercept, infliximab, and ustekinumab (all P \.0001). Adalimumab cost per PASI 75 responder was Can $8996 less than that of etanercept (Can $7707 vs Can $16703), Can $8292 less than that of infliximab (Can $7625 vs Can $15917), Can $5630 less than that of ustekinumab 45 mg (Can $7666 vs Can $13296), Can $16880 less than that of full-price ustekinumab 90 mg (Can $7666 vs Can $24546), and Can $4607 less than that of ustekinumab 90 mg priced the same as ustekinumab 45 mg (Can $7666 vs Can $12273). Conclusions: After matching average baseline characteristics and placebo group responses, adalimumab therapy for moderate to severe psoriasis had the lowest cost per PASI 75 responder compared with etanercept, infliximab, and ustekinumab.
Commercial support: This study is sponsored by Abbott Laboratories.
Commercial support: This study is sponsored by Abbott Laboratories
MARCH 2010
J AM ACAD DERMATOL
AB3