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Etanercept improves symptoms of depression in patients with moderate to severe psoriasis
P2750
P2752
EPIDEMIOLOGY OF PSORIASIS AS OBSERVED FROM THE NATIONAL AMBULATORY MEDICAL CARE SURVEY, 1990-1999 Aditya Gupta, MD, PhD, Mediprobe Research Inc, London, ON, Canada
ETANERCEPT IMPROVES SYMPTOMS OF DEPRESSION IN PATIENTS WITH MODERATE TO SEVERE PSORIASIS Ranga Krishnan, MD, Duke University, Durham, NC, United States; Deepa Lalla, PhD, J. Michael Woolley, PhD, Ralph Zitnik, MD, Amgen Inc., Thousand Oaks, CA, United States
There is renewed interest in psoriasis treatment recently, with the development of the new biologic agents. These agents show promise in treating the more difficult cases of psoriasis, using injection or infusion rather than the standard topical therapies. The National Ambulatory Medical Care Survey (NAMCS) has collected nationwide outpatient data from U.S. non-federally employed physicians for more than 20 years. We analyzed data from 316,928 visits, which, when weighted, estimated the experience of 7.3 billion physician visits between 1990 and 1999. The collection of data by the NAMCS provides an opportunity to look at a wide range of populations in the United States, over a significant period of time, to provide an estimate of psoriasis infection. Psoriasis is recorded in the NAMCS survey diagnosis columns with the ICD-9 code number 696.1. Also considered was psoriatic arthropathy, recorded as code 696.0. Cases in which either of these diagnoses was the primary diagnosis were investigated. The survey, when weighted to produce national estimates, showed a primary diagnosis of psoriasis in 17,643,524 subjects, or 0.24% of all visits represented by the 1990-1999 NAMCS data. Of the 3 diagnoses per visit recorded by the NAMCS, psoriasis was the primary diagnosis in 13,190,229 subjects (75% of diagnoses). Of these primary diagnoses, 90% were made by dermatologists. Psoriatic arthropathy was found in 1,747,748 cases, or 0.02% of visits. In contrast to psoriasis, dermatologists diagnosed fewer than 1% of psoriatic arthropathy cases. The proportion of psoriasis cases diagnosed per year has remained relatively similar from 1990 to 1999. Diagnosis rates for psoriasis are approximately equally distributed across 4 of the major US regions sampled by the NAMCS (Northeast, Midwest, South, and West). The results presented here suggest that there is a large group of psoriasis patients across the United States seeking treatment. Biologic therapies are too new to be captured in this analysis, but the large market for psoriasis products suggests that there is a large potential for use of the new biologics to be captured in future surveys. Nothing to disclose.
Background: Patients with psoriasis often suffer from symptoms of depression because of their disease. Objective: To evaluate the effect of etanercept therapy on symptoms of depression in patients with moderate to severe psoriasis Methods: A 12-week, double-blind, multicenter clinical trial of etanercept therapy was conducted in the United States and Canada. Six hundred eighteen patients with stable, moderate to severe psoriasis were randomized to receive either etanercept 50 mg twice weekly or placebo. The Hamilton Depression Rating Scale (Ham-D) and the Beck Depression Inventory (BDI) were used to assess symptoms of depression. The Ham-D is a 17-item scale assessing the severity of symptoms of depression in patients and is administered by a trained interviewer. The BDI is a patient-completed 21-item instrument used to assess symptoms of depression. The primary analysis was of the mean change from baseline to week 12, while a secondary responder analysis was of the proportion of patients who achieved at least a 50% improvement in scores. All patients who received at least one dose of study drug were included in the analyses, and missing data were imputed using the last observation carried forward. Results: At baseline, 613 patients completed the Ham-D and 609 completed the BDI. Baseline mean scores for both instruments show that patients with moderate to severe psoriasis are mildly depressed (Ham-D = 4.51, BDI = 8.23). Patients on etanercept therapy reported mean improvements on the Ham-D that were statistically significantly superior to those seen in patients on the placebo regimen (1.5 for etanercept vs. 0.4 for placebo; P \.0012), with similar results for the BDI (3.9 for etanercept vs. 2.1 for placebo, P \.0001). Patients on etanercept were more likely to be responders as measured by the Ham-D and the BDI, when compared with patients on placebo (43% vs. 32% for the Ham-D [P\.0048] and 55% vs. 39% for the BDI [P\.0001]). Greater improvements in BDI and Ham-D scores were also seen in patients who achieved more than 75% improvement in the Psoriasis Area and Severity Index (PASI 75). Conclusions: Treatment of psoriasis with etanercept is also associated with an improvement in symptoms of depression. Improvements seen occurred as early as week 4 and were more likely to be seen in patients who were PASI responders. Dr. Krishnan is a consultant for Amgen and Wyeth. Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc., and by Wyeth Research
P2753 P2751 ETANERCEPT IMPROVES NAIL PSORIASIS Phoebe Rich, MD, Oregon Health Sciences University, Portland, OR, United States; Aditya Gupta, MD, University of Toronto and Mediprobe Research Inc., London, ON, Canada; Andrea Wang, MA, Angelika Jahreis, MD, PhD, Amgen Inc., Thousand Oaks, CA, United States Introduction: Approximately half of patients with psoriasis show signs and symptoms of nail psoriasis, which can cause pain and pose limitations on daily activities. Etanercept is approved for the treatment of moderate to severe plaque psoriasis, but to date its effect on nail psoriasis has not been reported. In this study, the effect of etanercept 50 mg twice weekly (BIW) on nail psoriasis was investigated. Methods: Patients with moderate to severe plaque psoriasis received etanercept 50 mg BIW or placebo BIW subcutaneously in a blinded fashion for 3 months. Photoderived Nail Psoriasis Severity Index (NAPSI) assessments1 were done of the dorsal views of 8 fingers, excluding the thumbs, in a subgroup of patients with nail psoriasis whose nails were identified at baseline by the investigator and who consented to having photographs of their nails taken. Photographs were scored before unblinding of the study by a central reader who was blinded to treatment group, time point, and patient identity. Improvement in photograph-derived NAPSI scores from baseline to month 3 was a prespecified study endpoint. Results: A total of 618 patients were randomized and dosed in the 3-month doubleblind study (n = 311 and 307 for etanercept 50 mg BIW and placebo, respectively). A total of 58 patients (31 in the etanercept group and 27 in the placebo group) had photographs available for scoring at both baseline and month 3. At baseline, the mean photoderived NAPSI score was 49.2 in the etanercept group and 50.7 in the placebo group. Results of the photoderived NAPSI at month 3 showed that patients in the etanercept group had a mean improvement from baseline of 8.6 points, compared with a mean worsening of ÿ3.0 points in the placebo group. Photographs of nail psoriasis at baseline and month 3 in these patients clearly illustrate these results. Conclusion: Nail psoriasis is a cumbersome manifestation of psoriasis with few therapeutic options. In this study, etanercept provided clinically meaningful improvement of nail psoriasis.
ETANERCEPT IN PSORIATIC ARTHRITIS: SUSTAINED IMPROVEMENT IN SKIN AND JOINT DISEASE AND INHIBITION OF RADIOGRAPHIC PROGRESSION AT 2 YEARS Mark Lebwohl, MD, Mount Sinai School of Medicine, New York, NY, United States; Alice Gottlieb, MD, PhD, University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical Center, New Brunswick, NJ, United States; Bernard S. Goffe, MD, Minor & James Medical, P.L.L.C., Seattle, WA, United States; Angelika Jahreis, MD, PhD, Amgen Inc., Thousand Oaks, CA, United States Background: Patients with psoriatic arthritis (PsA) and psoriasis participated in a 24week, double-blind study of etanercept 25 mg twice weekly (BIW) or placebo, followed by blinded study drug during a 24-week maintenance period and openlabel etanercept 25 mg BIW during a 1-year extension. As previously reported, over a 1-year period, etanercept was well tolerated, provided clinically significant benefit to patients with PsA and psoriasis, and prevented structural damage.1 Herein we report continued observations through 2 years. Methods: Psoriatic skin lesions were evaluated by the dermatologist’s static global assessments of target lesions (DSGATL) and, for patients with psoriasis involving more than 3% body surface area, by the Psoriasis Area and Severity Index (PASI). PsA was evaluated according to American College of Rheumatology (ACR) criteria and PsA response criteria (PsARC). Radiographic progression was evaluated using a modified Sharp method.2 Results: Of the 205 patients in the double-blind study, 169 (81 originally on placebo; 88 originally on etanercept) entered the open-label extension and received etanercept 25 mg BIW. Improvements in both psoriasis and PsA were sustained throughout the extension period, independent of the initial treatment assignment. After 48 weeks of open-label etanercept therapy (n = 136), 55% of patients had a DSGATL of ‘‘clear’’ or ‘‘almost clear.’’ Of the patients evaluable for the PASI (n = 85), 67% achieved at least 50% improvement from baseline and 38% achieved at least 75% improvement. Symptoms of PsA also were improved, and radiographic progression of disease was shown to be prevented. Etanercept continued to be well tolerated, with no increase in serious adverse events or infections with extended exposure. Conclusion: Etanercept provided sustained improvement in psoriasis and PsA and prevented radiographic progression of joint disease in patients with PsA.
References 1. Mease. Arthritis Rheum 2004;50:2264-72. 2. Sharp. Arthritis Rheum 1985;28:1326-35.
Reference 1. Rich Scher. J Am Acad Dermatol 2003;49:206-11. Dr. Rich is on the Amgen speakers list and is an investigator for Amgen for clinical trials. Dr. Gupta has been a clinical investigator for Amgen. Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc., and by Wyeth Research
P184
J AM ACAD DERMATOL
Dr. Lebwohl has received grant funding from Amgen and Wyeth and is an investigator and consultant for these companies; he has also received an honorarium. Dr. Gottlieb is a consultant, investigator, and speaker for Amgen. Dr. Goffe is a speaker and consultant for Amgen and provided support for the research. Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc., and by Wyeth Research
MARCH 2005
P2752
EPIDEMIOLOGY OF PSORIASIS AS OBSERVED FROM THE NATIONAL AMBULATORY MEDICAL CARE SURVEY, 1990-1999 Aditya Gupta, MD, PhD, Mediprobe Research Inc, London, ON, Canada
ETANERCEPT IMPROVES SYMPTOMS OF DEPRESSION IN PATIENTS WITH MODERATE TO SEVERE PSORIASIS Ranga Krishnan, MD, Duke University, Durham, NC, United States; Deepa Lalla, PhD, J. Michael Woolley, PhD, Ralph Zitnik, MD, Amgen Inc., Thousand Oaks, CA, United States
There is renewed interest in psoriasis treatment recently, with the development of the new biologic agents. These agents show promise in treating the more difficult cases of psoriasis, using injection or infusion rather than the standard topical therapies. The National Ambulatory Medical Care Survey (NAMCS) has collected nationwide outpatient data from U.S. non-federally employed physicians for more than 20 years. We analyzed data from 316,928 visits, which, when weighted, estimated the experience of 7.3 billion physician visits between 1990 and 1999. The collection of data by the NAMCS provides an opportunity to look at a wide range of populations in the United States, over a significant period of time, to provide an estimate of psoriasis infection. Psoriasis is recorded in the NAMCS survey diagnosis columns with the ICD-9 code number 696.1. Also considered was psoriatic arthropathy, recorded as code 696.0. Cases in which either of these diagnoses was the primary diagnosis were investigated. The survey, when weighted to produce national estimates, showed a primary diagnosis of psoriasis in 17,643,524 subjects, or 0.24% of all visits represented by the 1990-1999 NAMCS data. Of the 3 diagnoses per visit recorded by the NAMCS, psoriasis was the primary diagnosis in 13,190,229 subjects (75% of diagnoses). Of these primary diagnoses, 90% were made by dermatologists. Psoriatic arthropathy was found in 1,747,748 cases, or 0.02% of visits. In contrast to psoriasis, dermatologists diagnosed fewer than 1% of psoriatic arthropathy cases. The proportion of psoriasis cases diagnosed per year has remained relatively similar from 1990 to 1999. Diagnosis rates for psoriasis are approximately equally distributed across 4 of the major US regions sampled by the NAMCS (Northeast, Midwest, South, and West). The results presented here suggest that there is a large group of psoriasis patients across the United States seeking treatment. Biologic therapies are too new to be captured in this analysis, but the large market for psoriasis products suggests that there is a large potential for use of the new biologics to be captured in future surveys. Nothing to disclose.
Background: Patients with psoriasis often suffer from symptoms of depression because of their disease. Objective: To evaluate the effect of etanercept therapy on symptoms of depression in patients with moderate to severe psoriasis Methods: A 12-week, double-blind, multicenter clinical trial of etanercept therapy was conducted in the United States and Canada. Six hundred eighteen patients with stable, moderate to severe psoriasis were randomized to receive either etanercept 50 mg twice weekly or placebo. The Hamilton Depression Rating Scale (Ham-D) and the Beck Depression Inventory (BDI) were used to assess symptoms of depression. The Ham-D is a 17-item scale assessing the severity of symptoms of depression in patients and is administered by a trained interviewer. The BDI is a patient-completed 21-item instrument used to assess symptoms of depression. The primary analysis was of the mean change from baseline to week 12, while a secondary responder analysis was of the proportion of patients who achieved at least a 50% improvement in scores. All patients who received at least one dose of study drug were included in the analyses, and missing data were imputed using the last observation carried forward. Results: At baseline, 613 patients completed the Ham-D and 609 completed the BDI. Baseline mean scores for both instruments show that patients with moderate to severe psoriasis are mildly depressed (Ham-D = 4.51, BDI = 8.23). Patients on etanercept therapy reported mean improvements on the Ham-D that were statistically significantly superior to those seen in patients on the placebo regimen (1.5 for etanercept vs. 0.4 for placebo; P \.0012), with similar results for the BDI (3.9 for etanercept vs. 2.1 for placebo, P \.0001). Patients on etanercept were more likely to be responders as measured by the Ham-D and the BDI, when compared with patients on placebo (43% vs. 32% for the Ham-D [P\.0048] and 55% vs. 39% for the BDI [P\.0001]). Greater improvements in BDI and Ham-D scores were also seen in patients who achieved more than 75% improvement in the Psoriasis Area and Severity Index (PASI 75). Conclusions: Treatment of psoriasis with etanercept is also associated with an improvement in symptoms of depression. Improvements seen occurred as early as week 4 and were more likely to be seen in patients who were PASI responders. Dr. Krishnan is a consultant for Amgen and Wyeth. Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc., and by Wyeth Research
P2753 P2751 ETANERCEPT IMPROVES NAIL PSORIASIS Phoebe Rich, MD, Oregon Health Sciences University, Portland, OR, United States; Aditya Gupta, MD, University of Toronto and Mediprobe Research Inc., London, ON, Canada; Andrea Wang, MA, Angelika Jahreis, MD, PhD, Amgen Inc., Thousand Oaks, CA, United States Introduction: Approximately half of patients with psoriasis show signs and symptoms of nail psoriasis, which can cause pain and pose limitations on daily activities. Etanercept is approved for the treatment of moderate to severe plaque psoriasis, but to date its effect on nail psoriasis has not been reported. In this study, the effect of etanercept 50 mg twice weekly (BIW) on nail psoriasis was investigated. Methods: Patients with moderate to severe plaque psoriasis received etanercept 50 mg BIW or placebo BIW subcutaneously in a blinded fashion for 3 months. Photoderived Nail Psoriasis Severity Index (NAPSI) assessments1 were done of the dorsal views of 8 fingers, excluding the thumbs, in a subgroup of patients with nail psoriasis whose nails were identified at baseline by the investigator and who consented to having photographs of their nails taken. Photographs were scored before unblinding of the study by a central reader who was blinded to treatment group, time point, and patient identity. Improvement in photograph-derived NAPSI scores from baseline to month 3 was a prespecified study endpoint. Results: A total of 618 patients were randomized and dosed in the 3-month doubleblind study (n = 311 and 307 for etanercept 50 mg BIW and placebo, respectively). A total of 58 patients (31 in the etanercept group and 27 in the placebo group) had photographs available for scoring at both baseline and month 3. At baseline, the mean photoderived NAPSI score was 49.2 in the etanercept group and 50.7 in the placebo group. Results of the photoderived NAPSI at month 3 showed that patients in the etanercept group had a mean improvement from baseline of 8.6 points, compared with a mean worsening of ÿ3.0 points in the placebo group. Photographs of nail psoriasis at baseline and month 3 in these patients clearly illustrate these results. Conclusion: Nail psoriasis is a cumbersome manifestation of psoriasis with few therapeutic options. In this study, etanercept provided clinically meaningful improvement of nail psoriasis.
ETANERCEPT IN PSORIATIC ARTHRITIS: SUSTAINED IMPROVEMENT IN SKIN AND JOINT DISEASE AND INHIBITION OF RADIOGRAPHIC PROGRESSION AT 2 YEARS Mark Lebwohl, MD, Mount Sinai School of Medicine, New York, NY, United States; Alice Gottlieb, MD, PhD, University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical Center, New Brunswick, NJ, United States; Bernard S. Goffe, MD, Minor & James Medical, P.L.L.C., Seattle, WA, United States; Angelika Jahreis, MD, PhD, Amgen Inc., Thousand Oaks, CA, United States Background: Patients with psoriatic arthritis (PsA) and psoriasis participated in a 24week, double-blind study of etanercept 25 mg twice weekly (BIW) or placebo, followed by blinded study drug during a 24-week maintenance period and openlabel etanercept 25 mg BIW during a 1-year extension. As previously reported, over a 1-year period, etanercept was well tolerated, provided clinically significant benefit to patients with PsA and psoriasis, and prevented structural damage.1 Herein we report continued observations through 2 years. Methods: Psoriatic skin lesions were evaluated by the dermatologist’s static global assessments of target lesions (DSGATL) and, for patients with psoriasis involving more than 3% body surface area, by the Psoriasis Area and Severity Index (PASI). PsA was evaluated according to American College of Rheumatology (ACR) criteria and PsA response criteria (PsARC). Radiographic progression was evaluated using a modified Sharp method.2 Results: Of the 205 patients in the double-blind study, 169 (81 originally on placebo; 88 originally on etanercept) entered the open-label extension and received etanercept 25 mg BIW. Improvements in both psoriasis and PsA were sustained throughout the extension period, independent of the initial treatment assignment. After 48 weeks of open-label etanercept therapy (n = 136), 55% of patients had a DSGATL of ‘‘clear’’ or ‘‘almost clear.’’ Of the patients evaluable for the PASI (n = 85), 67% achieved at least 50% improvement from baseline and 38% achieved at least 75% improvement. Symptoms of PsA also were improved, and radiographic progression of disease was shown to be prevented. Etanercept continued to be well tolerated, with no increase in serious adverse events or infections with extended exposure. Conclusion: Etanercept provided sustained improvement in psoriasis and PsA and prevented radiographic progression of joint disease in patients with PsA.
References 1. Mease. Arthritis Rheum 2004;50:2264-72. 2. Sharp. Arthritis Rheum 1985;28:1326-35.
Reference 1. Rich Scher. J Am Acad Dermatol 2003;49:206-11. Dr. Rich is on the Amgen speakers list and is an investigator for Amgen for clinical trials. Dr. Gupta has been a clinical investigator for Amgen. Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc., and by Wyeth Research
P184
J AM ACAD DERMATOL
Dr. Lebwohl has received grant funding from Amgen and Wyeth and is an investigator and consultant for these companies; he has also received an honorarium. Dr. Gottlieb is a consultant, investigator, and speaker for Amgen. Dr. Goffe is a speaker and consultant for Amgen and provided support for the research. Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc., and by Wyeth Research
MARCH 2005