- Email: [email protected]
Development of a metastatic risk index for cutaneous squamous cell carcinoma (cSCC): A pilot study
1685
1972
Development of a metastatic risk index for cutaneous squamous cell carcinoma (cSCC): A pilot study Melinda Chu, MD, Saint Louis University Department of Dermatology, Saint Louis, MO, United States; Eric Armbrecht, PhD, Saint Louis University Center for Outcomes Research, Saint Louis, MO, United States; Scott Fosko, MD, Saint Louis University Department of Dermatology, Saint Louis, MO, United States
Epidemiologic update on angiolymphoid hyperplasia with eosinophilia— systematic literature review of over 800 patient cases Brandon Adler, Albert Einstein College of Medicine, Bronx, NY, United States; Hadar Lev-Tov, MD, Albert Einstein College of Medicine, Bronx, NY, United States; Aimee Krausz, Albert Einstein College of Medicine, Bronx, NY, United States; Jonathan Silverberg, MD, PhD, Northwestern University Feinberg School of Medicine, Chicago, IL, United States; Adam Friedman, MD, Albert Einstein College of Medicine, Bronx, NY, United States Angiolymphoid hyperplasia with eosinophilia (ALHE) is an uncommon benign vasoproliferative disorder of indeterminate etiology, first described by Wells and Whimster in 1969. Although numerous case reports and multiple case series are found in the literature, no evidence-based studies exist for this condition with regard to epidemiology. A systematic review of the literature was conducted in 2014 according to PRISMA guidelines. Medline, Embase, Web of Science, and Google Scholar were searched for ALHE and synonymous terms for this condition. Over 800 cases meeting criteria were identified in case series and case reports. There was near sex parity in distribution of cases of ALHE. Lesions were most commonly biopsied in the fourth decade of life. Duration of lesions ranged from weeks to decades prior to diagnosis. The most frequent locations for lesions of ALHE were ear/periauricular area, face/scalp, extremities, and forehead. Pruritus was the most commonly reported symptom, followed by pain/tenderness and bleeding with minor trauma. This is the largest data set on ALHE to date. Further epidemiologic investigation into potential associations of ALHE with traumatic injury, hormonal influences, and systemic illness is warranted.
Background: At the time of initial cSCC diagnosis, the presence of nodal metastases is the most important prognostic factor. Clinical uncertainty surrounds the identification of patients with subclinical nodal disease, who could benefit from sentinel lymph node biopsy, and early aggressive management. Aim: To compare the ability of different statistical models to detect metastatic status of cSCC. Methods: Data regarding 6 candidate variables (anatomic risk: high, medium, low, moderate/ poor differentiation, perineural invasion (PNInv), rapid growth (on head & neck), recurrent, size by location) were collected from 800 cSCC tumors treated at Saint Louis University from January 2010-March 2012. Five models using 4 statistical approaches were studied: multivariable logistic regression (MLR), discriminant classification (DC), pattern classification (PC) and sum score method. Two models using the sum score method were created with a different number of tumor factors used to merit assignment to metastatic cohort in each: 2 factors (S2) or [2 factors (S2+). For each model, sensitivity (SN), specificity (SP), and positive predictive value (PPV) were calculated. Results: The SN, SP, and PPV for each model were: MLR analysis: SN 4%, SP 97%, PPV 16%; DC analysis: SN 48%, SP 98%, PPV 41%; S2 method: SN 78%, SP 84%, PPV 13%; S2+ method: SN 61%, SP 97% PPV 34%; PC analysis: SN 74%, SP 96%, PPV 35%.
Commercial support: None identified.
Discussion: The ideal prognostic test would be the most accurate (highest SN, SP, and PPV) and the most user-friendly. From a statistical standpoint, PC was the most accurate with relatively high values for all 3 measures. Interestingly, MLR, the method here that is most familiar to clinicians had the lowest SN suggesting that while useful in calculating the odds ratio for a risk factor, it is inadequate as a metastatic risk calculator. In addition to evaluating a model’s SN, SP, or PPV, ease of use in clinical practice must also be considered. Thus, while the SN of S2+ is lower (61%) compared to that seen with PC (74%), a straightforward approach like the S2+ method (where one need only count up the risk factors present) may be preferable because it is more feasible to implement. Study limitations include that the data are based on a small cohort from one institution. As such, these results are considered to be preliminary and intended to stimulate further discussion and research into the development of a precise and workable approach to cSCC metastatic risk assessment. Commercial support: None identified.
1142 Economic evaluation of apremilast in the treatment of moderate to severe psoriasis in the United States Tom Tencer, Celgene Corporation, Warren, NJ, United States; Zoe Clancy, Celgene Corporation, Warren, NJ, United States; Vidya Damera, OptumInsight, Uxbridge, Middlesex, United Kingdom; Frank Zhang, Celgene Corporation, Warren, NJ, United States; Sandrine Cure, OptumInsight, Uxbridge, Middlesex, United Kingdom; Steven Feldman, Wake Forest University School of Medicine, Winston-Salem, NC, United States Background: Previous studies have shown suboptimal persistence to systemic and biologic therapies in the treatment of psoriasis. Apremilast, an oral PDE4 inhibitor that works intracellularly to regulate inflammatory mediators, is currently being studied in the treatment of moderate to severe psoriasis. Objectives: We assessed the cost-effectiveness of placing apremilast before biologics for patients with moderate to severe plaque psoriasis. Methods: A 10-year Markov state transition cohort model was developed to compare 2 treatment sequences in the base case: (1) apremilast (APR) followed by etanercept (ETN) followed by adalimumab (ADA), and (2) ETN followed by ADA. Patients who failed ADA were assumed to receive best supportive care (BSC). BSC is defined as total healthcare costs following failure of biologic treatment. Response was assessed using 75% improvement in Psoriasis Area and Severity Index (PASI75) at the end of the trial periods (12 to 16 weeks, depending on study drug). Nonresponders moved to the next line of therapy. A 20% annual dropout rate was assumed for each drug. Efficacy inputs were obtained from a network meta-analysis (31.9% for APR, 52.6% for ETN, 65.9% for ADA). Drug costs were sourced from 2014 wholesale acquisition cost, and a 3% annual discount rate was applied to costs and quality-adjusted lifeyears (QALYs). BSC costs were sourced from a published US study. Apremilast was assumed to be priced at an approximately 35% discount to biologics. Utilities were estimated from PASI response using published economic evaluations. Results: Apremilast was estimated to provide an additional 0.74 years (5.00 vs 4.26 years) in which patients achieved a PASI75 and an additional 0.14 QALYs (6.87 vs 6.73 QALYs). Total time on biologics was reduced by 0.56 years (4.26 vs 4.82 years) and time spent in BSC was reduced by 1.04 years (3.96 vs 5.00 years). Under basecase assumptions, placing apremilast before biologics was dominant (lower costs, higher QALYs). Sensitivity analyses indicated that several parameters (eg, utility gains by PASI response, BSC costs, discount rate) influence the incremental costeffectiveness ratio, with results ranging from dominant to cost-effective (\50 k/QALY). Similar results were obtained when different combinations of ETN, ADA, and ustekinumab were used. Conclusion: Placing apremilast before biologics results in more QALYs and is potentially cost-saving in the treatment of moderate to severe plaque psoriasis. 100% is Sponsored by Celgene Corporation.
MAY 2015
1884 Epidemiology of dermatologic disorders at a referral skin center in Mexico City Marıa Jose Cervantes-Gonzalez, MD, Centro Dermatol ogico ‘‘Dr Ladislao de la Pascua,’’ Mexico City, Mexico; Martha Alejandra Morales-Sanchez, MD, Centro Dermatol ogico ‘‘Dr Ladislao de la Pascua,’’ Mexico City, Mexico; Fermın JuradoSanta Cruz, MD, Centro Dermatol ogico ‘‘Dr Ladislao de la Pascua,’’ Mexico City, Mexico Background: Dermatologic disorders are extremely common worldwide and are among the major reasons people seek medical care. There are no recent epidemiologic studies describing the distribution of the most frequent skin diseases in Mexico. The aim of this study was to determine the current spectrum of dermatologic disorders in our country. Methods: A retrospective study was conducted at the main referral center for skin diseases in Mexico City, Centro Dermatol ogico ‘‘Dr Ladislao de la Pascua.’’ Detailed information about patients, who attended to this center from January to December of 2013, was collected. Electronic medical records were reviewed searching for patients’ age, gender and diagnosis according to the ICD-10. Data were analyzed using SPSS program version 19. Results: From all patients that were treated during 2013, 40,000 were diagnosed with a skin disease for the first time (32%), 60% females and 40% males. The most frequent skin condition was acne (11%) followed by atopic dermatitis, warts, seborrheic dermatitis and melasma (4.17%, 2.9%, 2.35% and 2.32%, respectively). The next 5 diseases that completed the top-ranking positions were, in descending order of incidence, vitiligo, alopecia areata, melanocytic nevus, psoriasis and rosacea. Females showed a greater incidence of melasma, 863 females vs. 65 males. Only one infectious disease, warts, was included in the top-ranking and was most frequently diagnosed in pediatric population. Patients’ mean age was 26.5 years (SD 23.1 years). Acne was the most prevalent condition seen in adolescents, 67%. Conclusions: The most prevalent skin conditions found in our skin center were similar to previous reports of other countries in America and Europe. Ninety percent of these diseases are noninfectious. This study highlights the present situation regarding dermatologic outpatients in Mexico City. Commercial support: None identified.
J AM ACAD DERMATOL
AB97
1972
Development of a metastatic risk index for cutaneous squamous cell carcinoma (cSCC): A pilot study Melinda Chu, MD, Saint Louis University Department of Dermatology, Saint Louis, MO, United States; Eric Armbrecht, PhD, Saint Louis University Center for Outcomes Research, Saint Louis, MO, United States; Scott Fosko, MD, Saint Louis University Department of Dermatology, Saint Louis, MO, United States
Epidemiologic update on angiolymphoid hyperplasia with eosinophilia— systematic literature review of over 800 patient cases Brandon Adler, Albert Einstein College of Medicine, Bronx, NY, United States; Hadar Lev-Tov, MD, Albert Einstein College of Medicine, Bronx, NY, United States; Aimee Krausz, Albert Einstein College of Medicine, Bronx, NY, United States; Jonathan Silverberg, MD, PhD, Northwestern University Feinberg School of Medicine, Chicago, IL, United States; Adam Friedman, MD, Albert Einstein College of Medicine, Bronx, NY, United States Angiolymphoid hyperplasia with eosinophilia (ALHE) is an uncommon benign vasoproliferative disorder of indeterminate etiology, first described by Wells and Whimster in 1969. Although numerous case reports and multiple case series are found in the literature, no evidence-based studies exist for this condition with regard to epidemiology. A systematic review of the literature was conducted in 2014 according to PRISMA guidelines. Medline, Embase, Web of Science, and Google Scholar were searched for ALHE and synonymous terms for this condition. Over 800 cases meeting criteria were identified in case series and case reports. There was near sex parity in distribution of cases of ALHE. Lesions were most commonly biopsied in the fourth decade of life. Duration of lesions ranged from weeks to decades prior to diagnosis. The most frequent locations for lesions of ALHE were ear/periauricular area, face/scalp, extremities, and forehead. Pruritus was the most commonly reported symptom, followed by pain/tenderness and bleeding with minor trauma. This is the largest data set on ALHE to date. Further epidemiologic investigation into potential associations of ALHE with traumatic injury, hormonal influences, and systemic illness is warranted.
Background: At the time of initial cSCC diagnosis, the presence of nodal metastases is the most important prognostic factor. Clinical uncertainty surrounds the identification of patients with subclinical nodal disease, who could benefit from sentinel lymph node biopsy, and early aggressive management. Aim: To compare the ability of different statistical models to detect metastatic status of cSCC. Methods: Data regarding 6 candidate variables (anatomic risk: high, medium, low, moderate/ poor differentiation, perineural invasion (PNInv), rapid growth (on head & neck), recurrent, size by location) were collected from 800 cSCC tumors treated at Saint Louis University from January 2010-March 2012. Five models using 4 statistical approaches were studied: multivariable logistic regression (MLR), discriminant classification (DC), pattern classification (PC) and sum score method. Two models using the sum score method were created with a different number of tumor factors used to merit assignment to metastatic cohort in each: 2 factors (S2) or [2 factors (S2+). For each model, sensitivity (SN), specificity (SP), and positive predictive value (PPV) were calculated. Results: The SN, SP, and PPV for each model were: MLR analysis: SN 4%, SP 97%, PPV 16%; DC analysis: SN 48%, SP 98%, PPV 41%; S2 method: SN 78%, SP 84%, PPV 13%; S2+ method: SN 61%, SP 97% PPV 34%; PC analysis: SN 74%, SP 96%, PPV 35%.
Commercial support: None identified.
Discussion: The ideal prognostic test would be the most accurate (highest SN, SP, and PPV) and the most user-friendly. From a statistical standpoint, PC was the most accurate with relatively high values for all 3 measures. Interestingly, MLR, the method here that is most familiar to clinicians had the lowest SN suggesting that while useful in calculating the odds ratio for a risk factor, it is inadequate as a metastatic risk calculator. In addition to evaluating a model’s SN, SP, or PPV, ease of use in clinical practice must also be considered. Thus, while the SN of S2+ is lower (61%) compared to that seen with PC (74%), a straightforward approach like the S2+ method (where one need only count up the risk factors present) may be preferable because it is more feasible to implement. Study limitations include that the data are based on a small cohort from one institution. As such, these results are considered to be preliminary and intended to stimulate further discussion and research into the development of a precise and workable approach to cSCC metastatic risk assessment. Commercial support: None identified.
1142 Economic evaluation of apremilast in the treatment of moderate to severe psoriasis in the United States Tom Tencer, Celgene Corporation, Warren, NJ, United States; Zoe Clancy, Celgene Corporation, Warren, NJ, United States; Vidya Damera, OptumInsight, Uxbridge, Middlesex, United Kingdom; Frank Zhang, Celgene Corporation, Warren, NJ, United States; Sandrine Cure, OptumInsight, Uxbridge, Middlesex, United Kingdom; Steven Feldman, Wake Forest University School of Medicine, Winston-Salem, NC, United States Background: Previous studies have shown suboptimal persistence to systemic and biologic therapies in the treatment of psoriasis. Apremilast, an oral PDE4 inhibitor that works intracellularly to regulate inflammatory mediators, is currently being studied in the treatment of moderate to severe psoriasis. Objectives: We assessed the cost-effectiveness of placing apremilast before biologics for patients with moderate to severe plaque psoriasis. Methods: A 10-year Markov state transition cohort model was developed to compare 2 treatment sequences in the base case: (1) apremilast (APR) followed by etanercept (ETN) followed by adalimumab (ADA), and (2) ETN followed by ADA. Patients who failed ADA were assumed to receive best supportive care (BSC). BSC is defined as total healthcare costs following failure of biologic treatment. Response was assessed using 75% improvement in Psoriasis Area and Severity Index (PASI75) at the end of the trial periods (12 to 16 weeks, depending on study drug). Nonresponders moved to the next line of therapy. A 20% annual dropout rate was assumed for each drug. Efficacy inputs were obtained from a network meta-analysis (31.9% for APR, 52.6% for ETN, 65.9% for ADA). Drug costs were sourced from 2014 wholesale acquisition cost, and a 3% annual discount rate was applied to costs and quality-adjusted lifeyears (QALYs). BSC costs were sourced from a published US study. Apremilast was assumed to be priced at an approximately 35% discount to biologics. Utilities were estimated from PASI response using published economic evaluations. Results: Apremilast was estimated to provide an additional 0.74 years (5.00 vs 4.26 years) in which patients achieved a PASI75 and an additional 0.14 QALYs (6.87 vs 6.73 QALYs). Total time on biologics was reduced by 0.56 years (4.26 vs 4.82 years) and time spent in BSC was reduced by 1.04 years (3.96 vs 5.00 years). Under basecase assumptions, placing apremilast before biologics was dominant (lower costs, higher QALYs). Sensitivity analyses indicated that several parameters (eg, utility gains by PASI response, BSC costs, discount rate) influence the incremental costeffectiveness ratio, with results ranging from dominant to cost-effective (\50 k/QALY). Similar results were obtained when different combinations of ETN, ADA, and ustekinumab were used. Conclusion: Placing apremilast before biologics results in more QALYs and is potentially cost-saving in the treatment of moderate to severe plaque psoriasis. 100% is Sponsored by Celgene Corporation.
MAY 2015
1884 Epidemiology of dermatologic disorders at a referral skin center in Mexico City Marıa Jose Cervantes-Gonzalez, MD, Centro Dermatol ogico ‘‘Dr Ladislao de la Pascua,’’ Mexico City, Mexico; Martha Alejandra Morales-Sanchez, MD, Centro Dermatol ogico ‘‘Dr Ladislao de la Pascua,’’ Mexico City, Mexico; Fermın JuradoSanta Cruz, MD, Centro Dermatol ogico ‘‘Dr Ladislao de la Pascua,’’ Mexico City, Mexico Background: Dermatologic disorders are extremely common worldwide and are among the major reasons people seek medical care. There are no recent epidemiologic studies describing the distribution of the most frequent skin diseases in Mexico. The aim of this study was to determine the current spectrum of dermatologic disorders in our country. Methods: A retrospective study was conducted at the main referral center for skin diseases in Mexico City, Centro Dermatol ogico ‘‘Dr Ladislao de la Pascua.’’ Detailed information about patients, who attended to this center from January to December of 2013, was collected. Electronic medical records were reviewed searching for patients’ age, gender and diagnosis according to the ICD-10. Data were analyzed using SPSS program version 19. Results: From all patients that were treated during 2013, 40,000 were diagnosed with a skin disease for the first time (32%), 60% females and 40% males. The most frequent skin condition was acne (11%) followed by atopic dermatitis, warts, seborrheic dermatitis and melasma (4.17%, 2.9%, 2.35% and 2.32%, respectively). The next 5 diseases that completed the top-ranking positions were, in descending order of incidence, vitiligo, alopecia areata, melanocytic nevus, psoriasis and rosacea. Females showed a greater incidence of melasma, 863 females vs. 65 males. Only one infectious disease, warts, was included in the top-ranking and was most frequently diagnosed in pediatric population. Patients’ mean age was 26.5 years (SD 23.1 years). Acne was the most prevalent condition seen in adolescents, 67%. Conclusions: The most prevalent skin conditions found in our skin center were similar to previous reports of other countries in America and Europe. Ninety percent of these diseases are noninfectious. This study highlights the present situation regarding dermatologic outpatients in Mexico City. Commercial support: None identified.
J AM ACAD DERMATOL
AB97