- Email: [email protected]
Treatment of recalcitrant von Zumbusch pustular psoriasis with etanercept
P2751
P2753
Quality of life results from a large community-based trial assessing clobetasol propionate 0.05% spray as monotherapy and add-on therapy John Koo, MD, University of California Medical Center, San Francisco, CA, United States
Treatment of recalcitrant von Zumbusch pustular psoriasis with etanercept Annamaria Mazzotta, MD, Department of Dermatology, University of Rome Tor Vergata, Rome, Italy; Maria Esposito, MD, Department of Dermatology, University of Rome Tor Vergata, Rome, Italy; Arianna Zangrilli, MD, Department of Dermatology, University of Rome Tor Vergata, Rome, Italy; Sergio Chimenti, MD, Department of Dermatology - University of Rome Tor Vergata, Rome, Italy Background: The broad spectrum of clinical presentation of psoriasis includes generalized pustular psoriasis (von Zumbusch type). This chronic condition, characterized by recurrent, sterile, pustular eruptions, presents many clinical and genetic differences from psoriasis vulgaris. Generalized pustular psoriasis is a disabling and potentially life-threatening condition that is difficult to treat and may, when untreated, lead to serious morbidity and even mortality. Etanercept is a fully human TNF-a receptor that modulates biologic responses induced by tumor necrosis factor-alpha (TNF-a). Etanercept has been shown to be effective in patients with rheumatoid arthritis, psoriatic arthritis, and in patients with psoriasis vulgaris. The aim of the present study was to evaluate the efficacy and safety of etanercept in patients with generalized pustular psoriasis.
Psoriasis is a debilitating disorder often causing serious social and psychological issues and nearly always resulting in reduced quality of life for those who are afflicted. Although topical therapies are available, patients who require more aggressive systemic therapies can also suffer reduced quality of life due to the stresses and side effects associated with treatment. Clobetasol propionate is a class I steroid which has been shown to be quite effective in the treatment of plaque psoriasis. Traditionally, clobetasol propionate-containing agents have been approved for use up to 2 weeks in duration. The new clobetasol propionate 0.05% spray has been approved for use up to 4 weeks in duration due to increased efficacy in the additional 2 weeks without significant sacrifices in tolerability. Because of the expanded indication for this formulation, a community based trial was organized to assess the efficacy, tolerability and patient satisfaction with the newly FDA-approved clobetasol propionate 0.05% spray. The CoBRA (Community-Based Research Assessment) trial was a phase 4, open-label, community-based trial. Quality of life was analyzed by two different validated instruments (Koo-Menter Psoriasis Instrument and Dermatology Life Quality Index). These results are expected to further understanding regarding quality of life challenges in psoriasis patients. Study and poster support were provided by Galderma Laboratories, L.P.
Methods: We conducted an open-label study on 9 patients, (6 men, 3 women), affected by generalized pustular psoriasis who were unresponsive to conventional treatments. They were selected to receive etanercept 50 mg subcutaneously administered twice weekly for 24 weeks. Mean age of patients was 45,8 years (range, 18-74, SD: 19.9). Exclusion criteria were: patients aged \18 years, serious infections, and other significant concurrent medical conditions. Efficacy and safety were assessed at week-12 and -24. Psoriasis area and severity index (PASI) was used to assess patients’ clinical condition. The primary efficacy endpoint was the proportion of patients with an improvement of at least 75% in the PASI score (PASI-75). Results: At week-12, 2/9 (22.2%) patients receiving etanercept achieved PASI-75, while 3/9 (33.3%) of patients reached an improvement ranging between 50% and 75% (PASI-50). Efficacy continued to improve at week-24, when 5/9 (55.5%) of patients achieved PASI-75, and other 3/9 (33.3%) patients achieved PASI-50. Four (4) patients were unresponsive at week-12, subsequently at week-24, 3 of them reached PASI-50. Etanercept was well tolerated. No cases of injection site reaction (ISR), severe infection or laboratory abnormalities occurred. Conclusions: Our results evidence that etanercept is an effective treatment option for generalized pustular psoriasis, demonstrating rapid and significant clinical response with a good safety profile. Commercial support: None identified.
P2752 Association between psoriasis severity and household income Elizabeth Horn, PhD, National Psoriasis Foundation, Portland, OR, United States; Vaishali Patel, PharmD, MS, Amgen, Thousand Oaks, CA, United States; Kathleen Fox, MHS, PhD, Strategic Healthcare Solutions, LLC, Monkton, MD, United States; Frank Dann, MD, Amgen, Thousand Oaks, CA, United States Objective: There are many studies reporting impact of psoriasis on patients’ physical and emotional wellbeing. However, there is limited evidence of whether psoriasis impacts the economic aspect of patient lives. This study examined whether psoriasis severity may have an association with patient household income. Methods: Semi-annual patient surveys (2003-2005) from the National Psoriasis Foundation were analyzed to determine whether household income differed across psoriasis severity level. Patients who were [30 years of age and answered survey questions pertaining to current household income, psoriasis severity, age, age at onset were included. Patients reporting both psoriasis and psoriatic arthritis were excluded. Severity was categorized by patient-reported body surface area (BSA) as mild (\3%), moderate (3-10%) and severe ([10%). Household income was categorized as \$30,000 (one-third below national median household income) vs. [$30,000. Logistic regression analyses were conducted to study association between household income and psoriasis severity, adjusting for age, age at onset, gender, race, work status, geographic residence, and drug treatment. Results: Of 2,671 patient respondents, 1,444 were eligible for study inclusion with 32% mild, 40% moderate, and 27% severe psoriasis. About 54% were working fulltime, 87% White, mean age of 52 years and 48% male. The probability of low income (\$30,000) was significantly greater among severe patients than moderate or mild patients (p = 0.0002). Severe patients had significantly higher odds of low income compared to mild patients (OR = 2.1, 95% CI = 1.2 - 3.7) after adjusting for patient characteristics. Moderate patients also had higher odds of low income compared to mild patients although the odds were not statistically significant (OR = 1.4, 95% CI = 0.8-2.5). Conclusions: Patients with severe psoriasis were more likely to have low household income (\ $30,000) than moderate or mild patients, possibly indicating that severe psoriasis may affect a person’s probability of attaining promotions or advancements. Lower income may affect psoriasis patients’ ability to seek treatment and pay for their prescriptions, especially among severe patients who are in greatest need. Study limitations include patient-reported disease severity and not all potential confounding variables were collected. Data analysis was funded by Amgen.
FEBRUARY 2007
P2754 Safety analyses of calcitriol ointment for the treatment of chronic plaque psoriasis Ronald W. Gottschalk, MD, Galderma Laboratories, Fort Worth, TX, United States; Lori A. Johnson, PhD, Galderma Laboratories, Fort Worth, TX, United States Psoriasis is a lifelong disorder that affects men and women equally and afflicts almost all races in varying frequency rates. Psoriasis usually appears first between the ages of 15 and 30 years and may occur anywhere on the body. Treatment of the disorder has a considerable impact on patient’s quality of life. Calcitriol (1alpha, 25-dihydroxyvitamin D3) ointment has been shown to be effective in several clinical studies for the treatment of plaque psoriasis and has been approved for this use in Europe. Studies evaluating the irritancy, phototoxicity, contact sensitization, and photo allergy potential have been conducted. Systemic safety has also been evaluated. These safety analyses have been combined and will be presented. Briefly, calcitriol ointment 3 mg/g was found to have a lower potential for irritation than other preparations tested and was better tolerated. No evidence of phototoxicity, photoallergy or sensitization was found. Systemic safety analyses found no adverse systemic events from treatment with calcitriol ointment. Even patients with extensive psoriatic lesions (up to 35% BSA) required just over half of the maximum tolerated dose for effectiveness. Results from these studies provide strong evidence for the approval of calcitriol for use in the United States. In fact, a formulation containing 3 mg/g for twice-daily application is expected to be approved by the FDA in 2007. Study and poster support were provided by Galderma Laboratories, L.P.
J AM ACAD DERMATOL
AB187
P2753
Quality of life results from a large community-based trial assessing clobetasol propionate 0.05% spray as monotherapy and add-on therapy John Koo, MD, University of California Medical Center, San Francisco, CA, United States
Treatment of recalcitrant von Zumbusch pustular psoriasis with etanercept Annamaria Mazzotta, MD, Department of Dermatology, University of Rome Tor Vergata, Rome, Italy; Maria Esposito, MD, Department of Dermatology, University of Rome Tor Vergata, Rome, Italy; Arianna Zangrilli, MD, Department of Dermatology, University of Rome Tor Vergata, Rome, Italy; Sergio Chimenti, MD, Department of Dermatology - University of Rome Tor Vergata, Rome, Italy Background: The broad spectrum of clinical presentation of psoriasis includes generalized pustular psoriasis (von Zumbusch type). This chronic condition, characterized by recurrent, sterile, pustular eruptions, presents many clinical and genetic differences from psoriasis vulgaris. Generalized pustular psoriasis is a disabling and potentially life-threatening condition that is difficult to treat and may, when untreated, lead to serious morbidity and even mortality. Etanercept is a fully human TNF-a receptor that modulates biologic responses induced by tumor necrosis factor-alpha (TNF-a). Etanercept has been shown to be effective in patients with rheumatoid arthritis, psoriatic arthritis, and in patients with psoriasis vulgaris. The aim of the present study was to evaluate the efficacy and safety of etanercept in patients with generalized pustular psoriasis.
Psoriasis is a debilitating disorder often causing serious social and psychological issues and nearly always resulting in reduced quality of life for those who are afflicted. Although topical therapies are available, patients who require more aggressive systemic therapies can also suffer reduced quality of life due to the stresses and side effects associated with treatment. Clobetasol propionate is a class I steroid which has been shown to be quite effective in the treatment of plaque psoriasis. Traditionally, clobetasol propionate-containing agents have been approved for use up to 2 weeks in duration. The new clobetasol propionate 0.05% spray has been approved for use up to 4 weeks in duration due to increased efficacy in the additional 2 weeks without significant sacrifices in tolerability. Because of the expanded indication for this formulation, a community based trial was organized to assess the efficacy, tolerability and patient satisfaction with the newly FDA-approved clobetasol propionate 0.05% spray. The CoBRA (Community-Based Research Assessment) trial was a phase 4, open-label, community-based trial. Quality of life was analyzed by two different validated instruments (Koo-Menter Psoriasis Instrument and Dermatology Life Quality Index). These results are expected to further understanding regarding quality of life challenges in psoriasis patients. Study and poster support were provided by Galderma Laboratories, L.P.
Methods: We conducted an open-label study on 9 patients, (6 men, 3 women), affected by generalized pustular psoriasis who were unresponsive to conventional treatments. They were selected to receive etanercept 50 mg subcutaneously administered twice weekly for 24 weeks. Mean age of patients was 45,8 years (range, 18-74, SD: 19.9). Exclusion criteria were: patients aged \18 years, serious infections, and other significant concurrent medical conditions. Efficacy and safety were assessed at week-12 and -24. Psoriasis area and severity index (PASI) was used to assess patients’ clinical condition. The primary efficacy endpoint was the proportion of patients with an improvement of at least 75% in the PASI score (PASI-75). Results: At week-12, 2/9 (22.2%) patients receiving etanercept achieved PASI-75, while 3/9 (33.3%) of patients reached an improvement ranging between 50% and 75% (PASI-50). Efficacy continued to improve at week-24, when 5/9 (55.5%) of patients achieved PASI-75, and other 3/9 (33.3%) patients achieved PASI-50. Four (4) patients were unresponsive at week-12, subsequently at week-24, 3 of them reached PASI-50. Etanercept was well tolerated. No cases of injection site reaction (ISR), severe infection or laboratory abnormalities occurred. Conclusions: Our results evidence that etanercept is an effective treatment option for generalized pustular psoriasis, demonstrating rapid and significant clinical response with a good safety profile. Commercial support: None identified.
P2752 Association between psoriasis severity and household income Elizabeth Horn, PhD, National Psoriasis Foundation, Portland, OR, United States; Vaishali Patel, PharmD, MS, Amgen, Thousand Oaks, CA, United States; Kathleen Fox, MHS, PhD, Strategic Healthcare Solutions, LLC, Monkton, MD, United States; Frank Dann, MD, Amgen, Thousand Oaks, CA, United States Objective: There are many studies reporting impact of psoriasis on patients’ physical and emotional wellbeing. However, there is limited evidence of whether psoriasis impacts the economic aspect of patient lives. This study examined whether psoriasis severity may have an association with patient household income. Methods: Semi-annual patient surveys (2003-2005) from the National Psoriasis Foundation were analyzed to determine whether household income differed across psoriasis severity level. Patients who were [30 years of age and answered survey questions pertaining to current household income, psoriasis severity, age, age at onset were included. Patients reporting both psoriasis and psoriatic arthritis were excluded. Severity was categorized by patient-reported body surface area (BSA) as mild (\3%), moderate (3-10%) and severe ([10%). Household income was categorized as \$30,000 (one-third below national median household income) vs. [$30,000. Logistic regression analyses were conducted to study association between household income and psoriasis severity, adjusting for age, age at onset, gender, race, work status, geographic residence, and drug treatment. Results: Of 2,671 patient respondents, 1,444 were eligible for study inclusion with 32% mild, 40% moderate, and 27% severe psoriasis. About 54% were working fulltime, 87% White, mean age of 52 years and 48% male. The probability of low income (\$30,000) was significantly greater among severe patients than moderate or mild patients (p = 0.0002). Severe patients had significantly higher odds of low income compared to mild patients (OR = 2.1, 95% CI = 1.2 - 3.7) after adjusting for patient characteristics. Moderate patients also had higher odds of low income compared to mild patients although the odds were not statistically significant (OR = 1.4, 95% CI = 0.8-2.5). Conclusions: Patients with severe psoriasis were more likely to have low household income (\ $30,000) than moderate or mild patients, possibly indicating that severe psoriasis may affect a person’s probability of attaining promotions or advancements. Lower income may affect psoriasis patients’ ability to seek treatment and pay for their prescriptions, especially among severe patients who are in greatest need. Study limitations include patient-reported disease severity and not all potential confounding variables were collected. Data analysis was funded by Amgen.
FEBRUARY 2007
P2754 Safety analyses of calcitriol ointment for the treatment of chronic plaque psoriasis Ronald W. Gottschalk, MD, Galderma Laboratories, Fort Worth, TX, United States; Lori A. Johnson, PhD, Galderma Laboratories, Fort Worth, TX, United States Psoriasis is a lifelong disorder that affects men and women equally and afflicts almost all races in varying frequency rates. Psoriasis usually appears first between the ages of 15 and 30 years and may occur anywhere on the body. Treatment of the disorder has a considerable impact on patient’s quality of life. Calcitriol (1alpha, 25-dihydroxyvitamin D3) ointment has been shown to be effective in several clinical studies for the treatment of plaque psoriasis and has been approved for this use in Europe. Studies evaluating the irritancy, phototoxicity, contact sensitization, and photo allergy potential have been conducted. Systemic safety has also been evaluated. These safety analyses have been combined and will be presented. Briefly, calcitriol ointment 3 mg/g was found to have a lower potential for irritation than other preparations tested and was better tolerated. No evidence of phototoxicity, photoallergy or sensitization was found. Systemic safety analyses found no adverse systemic events from treatment with calcitriol ointment. Even patients with extensive psoriatic lesions (up to 35% BSA) required just over half of the maximum tolerated dose for effectiveness. Results from these studies provide strong evidence for the approval of calcitriol for use in the United States. In fact, a formulation containing 3 mg/g for twice-daily application is expected to be approved by the FDA in 2007. Study and poster support were provided by Galderma Laboratories, L.P.
J AM ACAD DERMATOL
AB187