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Epidemiological profile of dermatological changes observed in early postpartum women cared for at São José Hospital in Criciúma, Santa Catarina
3031
3709
Efficacy of ixekizumab therapy: Integrated analysis of 3 double-blind, controlled trials Kim Papp, MD, PhD, K Papp Clinical Research and Probity Medical Research Inc, Waterloo, Ontario, Canada; Craig Leonardi, MD, St. Louis University School of Medicine, St. Louis, MO, United States; Andrew Blauvelt, MD, MBA, Oregon Medical Research Center, Portland, OR, United States; Neil Korman, MD, PhD, Case Western Reserve University School of Medicine, Cleveland, OH, United States; Mamitaro Ohtsuki, MD, Department of Dermatology, Jichi Medical University, Shimotsuki-shi, Japan; Kristian Reich, MD, Dermatology, GeorgAugust-University Gottingen, Gottingen, Germany; Lotus Mallbris, MD, PhD, Eli Lilly and Company, Indianapolis, IN, United States; Susan Ball, PhD, Eli Lilly Company, Indianapolis, IN, United States; Janelle Erickson, PhD, Eli Lilly and Company, Indianapolis, IN, United States; Christopher Griffiths, MD, Dermatology Centre, University of Manchester, Manchester, United Kingdom
Eruptive pruritic papular porokeratosis: A unique presentation of a rare variant John DeNigris, University of South Florida-Department of Dermatology, Tampa, FL, United States; Sheila Jalalat, MD, University of South Florida-Department of Dermatology, Tampa, FL, United States; Michael Saco, MD, University of South Florida-Department of Dermatology, Tampa, FL, United States; Florence Nappi, MD, University of South Florida-Department of Dermatology, Tampa, FL, United States; Douglas Laurain, MD, University of South Florida-Department of Dermatology, Tampa, FL, United States; Neil Fenske, MD, University of South Florida-Department of Dermatology, Tampa, FL, United States
Background and objectives: Ixekizumab (IXE) is an anti-IL-17A IgG4 monoclonal antibody with a high binding affinity in development for the treatment of moderateto-severe psoriasis. In this analysis, we present integrated efficacy results for 2 dosing regimens of IXE compared to placebo (PBO) and high-dose etanercept (ETN) over 12 weeks. A pooled dataset from the Phase 3 trials is provided here to show an overview of clinical outcomes associated with ixekizumab treatment for psoriasis. Methods: Data were integrated from the 12-week induction phase of three phase 3 trials in which patients (intent-to-treat population) were randomized to receive 80 mg IXE every 2 (IXEQ2W; N ¼ 1169) or 4 weeks (IXE Q4W; N ¼ 1165) after a 160-mg starting dose, ETN (50 mg biweekly; in 2 of 3 trials only N ¼ 740), or PBO (N ¼ 792). The coprimary endpoints were the percentage of patients achieving sPGA (0: clear; 1: minimal plaque severity) and PASI 75 at Week 12. All response rates were compared between treatment groups by using Cochran-Mantel-Haenszel test stratified by study. Missing data were imputed as nonresponse. Comparisons to PBO were made using data from all 3 studies, while comparisons to ETN were based on data from the 2 active-controlled studies. Results: The percentage of patients meeting response criteria at Week 12 for the sPGA were: sPGA (0,1): PBO 3.9%, ETN 38.9%, IXE Q4W 75.0%, IXE Q2W 81.8%; sPGA (0): PBO 0.1%, ETN 7.3%, IXE Q4W 34.3%, IXE Q2W 39.5%. The percentage of patients achieving the PASI 75, PASI 90, and PASI 100 response criteria at Week 12 were: PASI 75: PBO 4.4%, ETN 47.7%, IXE Q4W 81.6%, IXE Q2W 88.7%; PASI 90: PBO 1.1%, ETN 22.3%, IXE Q4W 63.3%, IXE Q2W 69.9%; PASI 100: PBO 0.1%, ETN 6.4%, IXE Q4W 33.2%, IXE Q2W 37.6%. Both IXE groups were statistically superior to PBO (P \.001 using data from 3 studies) and ETN (P \.001 using data from 2 studies) for all comparisons. The difference in response rates for sPGA (0,1) and PASI 75 between patients treated with either IXE dosing regimen compared with PBO was significant as early as Week 1. The safety profile in the integrated analyses was comparable to those of the previously reported individual studies. Conclusions: Using the response rates for the sPGA and PASI co-primary measures, we conclude the integrated analyses confirm the rapid onset of action and superiority of both IXE dosing regimens compared to PBO and to ETN.
Background: Disseminated superficial porokeratosis (DSP) is a variant of porokeratosis characterized by an insidious course of asymptomatic diffuse annular lesions. A rare pruritic variant of DSP, eruptive pruritic papular porokeratosis (EPPP), is distinguished from other forms of porokeratosis by repeated acute flares of intensely pruritic papules. EPPP has only been reported in approximately 10 patients in the English literature. Case report: A 79-year-old man presented with an eight-year history of initially asymptomatic erythematous annular papules on the legs. Biopsy at that time revealed findings consistent with porokeratosis. Four years later, the patient developed a diffuse eruption of intensely pruritic 2-4 mm well-demarcated annular erythematous papules that started on his lower extremities and rapidly spread to his trunk and upper extremities. Biopsy revealed hyperkeratosis with cornoid lamella formation and a superficial perivascular infiltrate with diffuse eosinophils. Previous unsuccessful treatments included topical steroids, calcipotriene, and 5-fluorouracil. A three-week prednisone taper led to temporary relief of pruritus, however, symptoms returned soon after discontinuation of the drug. Due to poor renal function, the patient could not be started on acitretin. The patient reported that cryotherapy was the only intervention that helped relieve his pruritus. Accordingly, a treatment plan for cryotherapy to 20-25 lesions per office visit with frequent follow-up was initiated, with the patient reporting significant symptomatic relief thus far. Discussion: On histopathology, DSP and EPPP both reveal a cornoid lamella with a perivascular infiltrate in the upper dermis. Therefore, the distinction between DSP and EPPP is made clinically rather than histologically. Spontaneous regression of the lesions in EPPP generally occurs within 12 months of onset of the eruption. However, our patient has continued to have largely unchanged severe pruritus since the onset of the initial eruption four years prior to starting our current treatment plan of repeated cryotherapy. Only one case of EPPP without spontaneous disease regression has been previously documented, with no evidence of regression after 16 months of follow-up. Since the vast majority of reported cases of EPPP resolved spontaneously, determining appropriate therapeutic regimens is based largely on trial of treatment options typically used for DSP. Commercial support: None identified.
Supported by Eli Lilly and Company.
3916 Epidemiological profile of dermatological changes observed in early postpartum women cared for at S~ ao Jos e Hospital in Crici uma, Santa Catarina Leonrdo de Souza Morais Andrade, MD, Universidade Estadual de Ci^encias da Sa ude de Alagoas, Macei o - Al, Brazil; Natalia Machado Mildner, MD, Universidade Estadual de Ci^encias da Sa ude de Alagoas, Macei o - Al, Brazil; Gisleine Bittencourt Scotti, MD, Universidade do Extremo Sul Catarinense, Crici uma - SC, Brazil; Luiz Felipe de Oliveira Blanco, MD, Universidade do Extremo Sul Catarinense, Crici uma - SC, Brazil; Mariane Soares Viegas Moura Rezende, MD, Universidade Estadual de Ci^ encias da Sa ude de Alagoas, Macei o - Al, Brazil; Edwania Silva dos Santos, MD, Universidade Estadual de Ci^encias da Sa ude de Alagoas, Macei o - Al, Brazil; Catarina Rosa e Silva Santos, MD, Universidade Estadual de Ci^encias da Sa ude de Alagoas, Macei o - Al, Brazil; Patrıcia de Souza Aquino, MD, Universidade Estadual de Ci^encias da Sa ude de Alagoas, Macei o - Al, Brazil,
3341 Erythema induratum related to nontuberculous mycobacterial infection Jennifer Wu, MD, Chang Gung Memorial Hospital, Taipei, Taiwan; Chih-Hsun Yang, Chang Gung Memorial Hospital, Taipei, Taiwan
Methods: Cross-sectional study involving 188 pregnant women. We interviewed and examined women in the early postpartum period at Hospital S~ao Jose, Crici uma, SC Brazil in December 2010. The following variables were considered: age, weight before and at the end of pregnancy, number of pregnancies, hair loss, nail changes, skin blemishes, appearance of stretch marks or pruritic papules. Results: We identified 104 cases of stretch marks (55.31%) and 61 cases of melasma (32.44%). Stretch marks were most often found in the abdomen (71 cases, 51.45%), breasts (35, 25.36%), buttocks (8, 5.8%) and legs (24, 17.39%). Melasma was more frequent in the center-facial region (52, 77.61%) and malar region (7, 10.44%). Conclusions: Young patients who had greater weight gain were the most affected with stretch marks. Melasma struck just over a quarter of the sample and occurred more frequently in younger women.
Erythema induratum (EI) is characterized by chronic, recurrent, tender subcutaneous nodular eruptions that usually occur on the legs of young to middle-aged women. It is regarded, most often, as a form of tuberculoid induced by Mycobacterium tuberculosis (MTB) infection. We herein report a first case in the literature of EI relating to nontuberculous mycobacterial infection. A 74-year-old woman suffering a progressive cough with dirty sputum, drowsy consciousness, intermittent chills, as well as multiple firm erythematous subcutaneous nodules on both legs was presented to the hospital. The initial impression was erythema nodosum as judged by the manifestation of tender nodules on both her shins and calves. The pathological findings including a lobular panniculitis with granulomatous inflammation, an occluded large vein infiltrated by lymphocytes and multinucleated giant cells, septal fibrosis, thickened vessels with mononuclear cell infiltration, and fat necrosis in the lobules were all consistent with the diagnosis of EI. Follow-up confirmatory studies consisted of acid-fast stain of the sputum specimens, sputum culture, and Mycobacterium kansasii infection as isolated and identified by the polymerase chain reaction (PCR) technique. The pulmonary M kansasii infection was confirmed and considered the etiology of EI. The skin lesions regressed rapidly after the administration of a triple anti-mycobacterial therapy combining rifampicin, isoniazid and ethambutol and showed no recurrence in the 6month follow-up. The relation between EI and NTM infection was never identified. In this case, the clinical presentation and histopathology is consistent with EI. Pulmonary M kansasii infection is diagnosed by clinical symptoms, image findings, negative MTB PCR results in sputum samples, positive results in sputum culture, and PCR identification. The clinical findings and positive response to treatment suggest a causative relationship between pulmonary M kansasii infection and EI. Therefore, in addition to tuberculosis, NTM infection could be a trigger for erythema induratum. A high clinical suspicion, early diagnosis by clinicopathologic correlation, identification of the pathogen, and specific antimycobacterial treatment are all essential in the management of EI relating to NTM infection.
Commercial support: None identified.
Commercial support: None identified.
Introduction: During pregnancy a woman’s body undergoes profound hormonal and mechanical modification, the skin also pass through this process. Even this changes been physiological, they can be cause of distress for many pregnant women and need to be carefully studied. Objective: The aim of this study was to determine the prevalence of major skin changes during pregnancy among women cared for at Hospital S~ao Jose, Crici uma, SC - Brazil.
MAY 2016
J AM ACAD DERMATOL
AB53
3709
Efficacy of ixekizumab therapy: Integrated analysis of 3 double-blind, controlled trials Kim Papp, MD, PhD, K Papp Clinical Research and Probity Medical Research Inc, Waterloo, Ontario, Canada; Craig Leonardi, MD, St. Louis University School of Medicine, St. Louis, MO, United States; Andrew Blauvelt, MD, MBA, Oregon Medical Research Center, Portland, OR, United States; Neil Korman, MD, PhD, Case Western Reserve University School of Medicine, Cleveland, OH, United States; Mamitaro Ohtsuki, MD, Department of Dermatology, Jichi Medical University, Shimotsuki-shi, Japan; Kristian Reich, MD, Dermatology, GeorgAugust-University Gottingen, Gottingen, Germany; Lotus Mallbris, MD, PhD, Eli Lilly and Company, Indianapolis, IN, United States; Susan Ball, PhD, Eli Lilly Company, Indianapolis, IN, United States; Janelle Erickson, PhD, Eli Lilly and Company, Indianapolis, IN, United States; Christopher Griffiths, MD, Dermatology Centre, University of Manchester, Manchester, United Kingdom
Eruptive pruritic papular porokeratosis: A unique presentation of a rare variant John DeNigris, University of South Florida-Department of Dermatology, Tampa, FL, United States; Sheila Jalalat, MD, University of South Florida-Department of Dermatology, Tampa, FL, United States; Michael Saco, MD, University of South Florida-Department of Dermatology, Tampa, FL, United States; Florence Nappi, MD, University of South Florida-Department of Dermatology, Tampa, FL, United States; Douglas Laurain, MD, University of South Florida-Department of Dermatology, Tampa, FL, United States; Neil Fenske, MD, University of South Florida-Department of Dermatology, Tampa, FL, United States
Background and objectives: Ixekizumab (IXE) is an anti-IL-17A IgG4 monoclonal antibody with a high binding affinity in development for the treatment of moderateto-severe psoriasis. In this analysis, we present integrated efficacy results for 2 dosing regimens of IXE compared to placebo (PBO) and high-dose etanercept (ETN) over 12 weeks. A pooled dataset from the Phase 3 trials is provided here to show an overview of clinical outcomes associated with ixekizumab treatment for psoriasis. Methods: Data were integrated from the 12-week induction phase of three phase 3 trials in which patients (intent-to-treat population) were randomized to receive 80 mg IXE every 2 (IXEQ2W; N ¼ 1169) or 4 weeks (IXE Q4W; N ¼ 1165) after a 160-mg starting dose, ETN (50 mg biweekly; in 2 of 3 trials only N ¼ 740), or PBO (N ¼ 792). The coprimary endpoints were the percentage of patients achieving sPGA (0: clear; 1: minimal plaque severity) and PASI 75 at Week 12. All response rates were compared between treatment groups by using Cochran-Mantel-Haenszel test stratified by study. Missing data were imputed as nonresponse. Comparisons to PBO were made using data from all 3 studies, while comparisons to ETN were based on data from the 2 active-controlled studies. Results: The percentage of patients meeting response criteria at Week 12 for the sPGA were: sPGA (0,1): PBO 3.9%, ETN 38.9%, IXE Q4W 75.0%, IXE Q2W 81.8%; sPGA (0): PBO 0.1%, ETN 7.3%, IXE Q4W 34.3%, IXE Q2W 39.5%. The percentage of patients achieving the PASI 75, PASI 90, and PASI 100 response criteria at Week 12 were: PASI 75: PBO 4.4%, ETN 47.7%, IXE Q4W 81.6%, IXE Q2W 88.7%; PASI 90: PBO 1.1%, ETN 22.3%, IXE Q4W 63.3%, IXE Q2W 69.9%; PASI 100: PBO 0.1%, ETN 6.4%, IXE Q4W 33.2%, IXE Q2W 37.6%. Both IXE groups were statistically superior to PBO (P \.001 using data from 3 studies) and ETN (P \.001 using data from 2 studies) for all comparisons. The difference in response rates for sPGA (0,1) and PASI 75 between patients treated with either IXE dosing regimen compared with PBO was significant as early as Week 1. The safety profile in the integrated analyses was comparable to those of the previously reported individual studies. Conclusions: Using the response rates for the sPGA and PASI co-primary measures, we conclude the integrated analyses confirm the rapid onset of action and superiority of both IXE dosing regimens compared to PBO and to ETN.
Background: Disseminated superficial porokeratosis (DSP) is a variant of porokeratosis characterized by an insidious course of asymptomatic diffuse annular lesions. A rare pruritic variant of DSP, eruptive pruritic papular porokeratosis (EPPP), is distinguished from other forms of porokeratosis by repeated acute flares of intensely pruritic papules. EPPP has only been reported in approximately 10 patients in the English literature. Case report: A 79-year-old man presented with an eight-year history of initially asymptomatic erythematous annular papules on the legs. Biopsy at that time revealed findings consistent with porokeratosis. Four years later, the patient developed a diffuse eruption of intensely pruritic 2-4 mm well-demarcated annular erythematous papules that started on his lower extremities and rapidly spread to his trunk and upper extremities. Biopsy revealed hyperkeratosis with cornoid lamella formation and a superficial perivascular infiltrate with diffuse eosinophils. Previous unsuccessful treatments included topical steroids, calcipotriene, and 5-fluorouracil. A three-week prednisone taper led to temporary relief of pruritus, however, symptoms returned soon after discontinuation of the drug. Due to poor renal function, the patient could not be started on acitretin. The patient reported that cryotherapy was the only intervention that helped relieve his pruritus. Accordingly, a treatment plan for cryotherapy to 20-25 lesions per office visit with frequent follow-up was initiated, with the patient reporting significant symptomatic relief thus far. Discussion: On histopathology, DSP and EPPP both reveal a cornoid lamella with a perivascular infiltrate in the upper dermis. Therefore, the distinction between DSP and EPPP is made clinically rather than histologically. Spontaneous regression of the lesions in EPPP generally occurs within 12 months of onset of the eruption. However, our patient has continued to have largely unchanged severe pruritus since the onset of the initial eruption four years prior to starting our current treatment plan of repeated cryotherapy. Only one case of EPPP without spontaneous disease regression has been previously documented, with no evidence of regression after 16 months of follow-up. Since the vast majority of reported cases of EPPP resolved spontaneously, determining appropriate therapeutic regimens is based largely on trial of treatment options typically used for DSP. Commercial support: None identified.
Supported by Eli Lilly and Company.
3916 Epidemiological profile of dermatological changes observed in early postpartum women cared for at S~ ao Jos e Hospital in Crici uma, Santa Catarina Leonrdo de Souza Morais Andrade, MD, Universidade Estadual de Ci^encias da Sa ude de Alagoas, Macei o - Al, Brazil; Natalia Machado Mildner, MD, Universidade Estadual de Ci^encias da Sa ude de Alagoas, Macei o - Al, Brazil; Gisleine Bittencourt Scotti, MD, Universidade do Extremo Sul Catarinense, Crici uma - SC, Brazil; Luiz Felipe de Oliveira Blanco, MD, Universidade do Extremo Sul Catarinense, Crici uma - SC, Brazil; Mariane Soares Viegas Moura Rezende, MD, Universidade Estadual de Ci^ encias da Sa ude de Alagoas, Macei o - Al, Brazil; Edwania Silva dos Santos, MD, Universidade Estadual de Ci^encias da Sa ude de Alagoas, Macei o - Al, Brazil; Catarina Rosa e Silva Santos, MD, Universidade Estadual de Ci^encias da Sa ude de Alagoas, Macei o - Al, Brazil; Patrıcia de Souza Aquino, MD, Universidade Estadual de Ci^encias da Sa ude de Alagoas, Macei o - Al, Brazil,
3341 Erythema induratum related to nontuberculous mycobacterial infection Jennifer Wu, MD, Chang Gung Memorial Hospital, Taipei, Taiwan; Chih-Hsun Yang, Chang Gung Memorial Hospital, Taipei, Taiwan
Methods: Cross-sectional study involving 188 pregnant women. We interviewed and examined women in the early postpartum period at Hospital S~ao Jose, Crici uma, SC Brazil in December 2010. The following variables were considered: age, weight before and at the end of pregnancy, number of pregnancies, hair loss, nail changes, skin blemishes, appearance of stretch marks or pruritic papules. Results: We identified 104 cases of stretch marks (55.31%) and 61 cases of melasma (32.44%). Stretch marks were most often found in the abdomen (71 cases, 51.45%), breasts (35, 25.36%), buttocks (8, 5.8%) and legs (24, 17.39%). Melasma was more frequent in the center-facial region (52, 77.61%) and malar region (7, 10.44%). Conclusions: Young patients who had greater weight gain were the most affected with stretch marks. Melasma struck just over a quarter of the sample and occurred more frequently in younger women.
Erythema induratum (EI) is characterized by chronic, recurrent, tender subcutaneous nodular eruptions that usually occur on the legs of young to middle-aged women. It is regarded, most often, as a form of tuberculoid induced by Mycobacterium tuberculosis (MTB) infection. We herein report a first case in the literature of EI relating to nontuberculous mycobacterial infection. A 74-year-old woman suffering a progressive cough with dirty sputum, drowsy consciousness, intermittent chills, as well as multiple firm erythematous subcutaneous nodules on both legs was presented to the hospital. The initial impression was erythema nodosum as judged by the manifestation of tender nodules on both her shins and calves. The pathological findings including a lobular panniculitis with granulomatous inflammation, an occluded large vein infiltrated by lymphocytes and multinucleated giant cells, septal fibrosis, thickened vessels with mononuclear cell infiltration, and fat necrosis in the lobules were all consistent with the diagnosis of EI. Follow-up confirmatory studies consisted of acid-fast stain of the sputum specimens, sputum culture, and Mycobacterium kansasii infection as isolated and identified by the polymerase chain reaction (PCR) technique. The pulmonary M kansasii infection was confirmed and considered the etiology of EI. The skin lesions regressed rapidly after the administration of a triple anti-mycobacterial therapy combining rifampicin, isoniazid and ethambutol and showed no recurrence in the 6month follow-up. The relation between EI and NTM infection was never identified. In this case, the clinical presentation and histopathology is consistent with EI. Pulmonary M kansasii infection is diagnosed by clinical symptoms, image findings, negative MTB PCR results in sputum samples, positive results in sputum culture, and PCR identification. The clinical findings and positive response to treatment suggest a causative relationship between pulmonary M kansasii infection and EI. Therefore, in addition to tuberculosis, NTM infection could be a trigger for erythema induratum. A high clinical suspicion, early diagnosis by clinicopathologic correlation, identification of the pathogen, and specific antimycobacterial treatment are all essential in the management of EI relating to NTM infection.
Commercial support: None identified.
Commercial support: None identified.
Introduction: During pregnancy a woman’s body undergoes profound hormonal and mechanical modification, the skin also pass through this process. Even this changes been physiological, they can be cause of distress for many pregnant women and need to be carefully studied. Objective: The aim of this study was to determine the prevalence of major skin changes during pregnancy among women cared for at Hospital S~ao Jose, Crici uma, SC - Brazil.
MAY 2016
J AM ACAD DERMATOL
AB53