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Congenital Syphilis: A case report
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4895
Congenital Syphilis: A case report Isabelle Wu, MD, Hospital das Clınicas da Faculdade de Medicina of S~ao Paulo University; Maria Cecılia Rivitti-Machado, MD, Hospital das Clınicas da Faculdade de Medicina of S~ao Paulo University; Renata Orlandi, MD, Hospital das Clınicas da Faculdade de Medicina of S~ao Paulo University; Abes Mahmed Amed Filho, MD, Hospital das Clınicas da Faculdade de Medicina of S~ao Paulo University; Marcello Menta Simonsen Nico, MD, Hospital das Clınicas da Faculdade de Medicina of S~ao Paulo University
Consistency of response across subgroups of patients with psoriasis treated with guselkumab: Results from the VOYAGE 1 and 2 trials Andrew Blauvelt, MD, Oregon Medical Research Center; Kristian Reich, MD, Dermatologikum Hamburg; Kim A. Papp, MD, K Papp Clinical Research and Probity Research, Inc.; Christopher E.M. Griffiths, MD, Dermatology Centre, Salford Royal Hospital, U of Manchester, Manchester Academic Health Science Cntr; April W. Armstrong, MD, University of Southern California; Peter Foley, MD, The University of Melbourne, St. Vincent’s Hospital, Melbourne and Skin & Cancer Foundation Inc.; Yaung-Kaung Shen, PhD, Janssen Research & Development, LLC; Alexa B. Kimball, MD, Depart of Dermatology, Harvard Medical School; Kenneth B. Gordon, MD, Northwestern University, Feinberg School of Medicine Objective: To evaluate the consistency of response of guselkumab (GUS) across predetermined subgroups of psoriasis patients.
Introduction: Congenital syphilis (CS) is still a public health problem in the world, particularly in the developing countries. In Brazil, the incidence of CS is approximately 2.4:1000 live births. Syphilis is a bacterial infection caused by Treponema pallidum, which can be transmitted transplacentally to the fetus. The infection in pregnant women who is not diagnosed or not effectively treated can lead to serious adverse outcomes such as fetal death, stillbirth, low birth weight, neonatal death, and congenital infection in infants. Proper prenatal care should be performed, to aim at an early diagnosis and treatment of the pregnant women infected with syphilis, in order to prevent disabilities due to CS. Methods: We describe a case report of a one month old male infant presented to our clinic with a history of lesions that started one week after birth on the palms and soles, progressing to the legs, superior limbs, neck and face. The mother said to have a negative serology to infectious diseases in the third trimester, but did not bring the results of the prenatal laboratory examinations. Results: Infant presented desquamation of palms and soles, multiple slightly hyperchromic lesions surrounded by scaling (Biett colarette) localized on soles/feet, palms/hands, legs, arms, cervical and chin regions. Congenital syphilis was suspected and laboratory exams were carried out: serum VDRL titers 1:128; serum fluorescent treponemal antibody absorption (FTA-Abs) reactive; cerebral spinal fluid’s (CSF) VDRL titers 1:1; T. pallidum hemagglutination (TPHA) titer 1:32 in the CSF, being diagnosed with neurosyphilis. The infant was treated with IV crystalline penicillin 50,000 IU/Kg/dose, every 8 hours for 10 days, with complete remission of the skin lesions, and still is being followed by our group, with a continuous decrease of VDRL titers. Retrospective revision of the mother prenatal laboratory exams showed positive conversion of VDRL 1:64 in the third trimester and was not adequately treated for syphilis at that time. Conclusion: CS is a preventable infection; therefore, an adequate screening of pregnant women is essential. Despite the existent efforts, CS remains an important public health problem, attributable to the lack of a proper prenatal follow-up. CS should be considered when a neonate presents with blistering or desquamation on the palms and soles, and when the obstetric history is unclear, regarding screening or treatment. Commercial support: None identified.
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Materials/Methods: In VOYAGE 1 (n ¼ 837) and VOYAGE 2 (n ¼ 992), patients (pts) were randomized to GUS 100 mg at weeks 0/4/12, and q8wk; placebo (PBO) at weeks 0/4/12 followed by GUS 100 mg at weeks 16/20 and q8 Wk; or ADA 80 mg at week 0, 40 mg at week 1, and 40 mg q2wk through Wk 47 (VOYAGE 1) or Wk 23 (VOYAGE 2). The coprimary endpoints were the proportions of GUS vs PBO patients achieving $90% improvement in PASI score (PASI 90) and cleared/minimal disease (IGA 0/1) responses at week 16. Response rates across endpoints were evaluated for predetermined sub-groups. Results: At week 16, significantly (P \.001) higher proportions of pts in the GUS vs PBO group achieved PASI 90 in VOYAGE 1 (73.3% vs 2.9%) and VOYAGE 2 (70.0% vs. 2.4%), and IGA 0/1 in VOYAGE 1 (85.1% vs 6.9%) and VOYAGE 2 (84.1% vs. 8.5%). In both studies, a substantially higher proportion of GUS-treated pts demonstrated PASI 90 and IGA 0/1 responses than PBO pts at week 16, across all subgroups defined by baseline demographics (gender, race, age [\45 yrs, $45 to \65 yrs, $65 yrs]), geographic region (North America, non-North America), disease characteristics (age at psoriasis diagnosis [\25 yrs, $25 yrs]); duration of psoriasis since diagnosis [\15 yrs, $15 yrs]; baseline PASI [\20, $20], IGA [\4, 4], DLQI score [\10, $10], and BSA [\20%, $20%]; presence of psoriatic arthritis); and previous biologic and nonbiologic medication history. In both studies, GUS treatment resulted in greater benefit at Week 24 compared to ADA treatment across all subgroups (nearly all 95% CIs on the difference excluding 0). GUS treatment resulted in consistent responses across all subgroups analyzed with reasonable sample sizes. As observed in the overall study population, GUS was well-tolerated among pts in each of the subgroups analyzed. Conclusions: The efficacy of GUS across predefined subgroups of psoriasis pts was consistent with that observed in the overall study population, with excellent responses in pts with long-standing psoriasis, severe disease at baseline, prior biologic use, and psoriatic arthritis. Commercial support: Janssen Research & Development, LLC. sponsored this study 100%.
Congenital syphilis: A menace that will not go away Silvana Castillo Loaiza, MD, Universidad del Valle; Adriana R. Cruz A., MD, Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDEIM); Natalia Vargas-Navia, MD, Universidad del Valle; Juan Carlos Salazar, MD, UConn Health Introduction: Syphilis is a sexually transmitted disease caused by the spirochete Treponema pallidum. In pregnant women, syphilis can lead to deleterious consequences to the mother, fetus and newborn. Although there are strategies to prevent congenital syphilis (CS) through antenatal syphilis screening and treatment of the mother, disease burden remains high. In 2012, WHO has estimated 350,000 adverse pregnancy outcomes worldwide, as a consequence of syphilis. Colombia currently notifies 1.4 CS/1000 live births per year, with the Pacific Coast region as one of the most affected. Despite the increases in the number of CS cases, few clinicians have seen florid cases of the disease in the newborn child. With this in mind, we provide a case which depicts prototypical clinical manifestations of the disease. Case report: A 34-week old newborn born was admitted to a hospital in Cali, Colombia. He weighed 2.200 grams; skin examination evidenced a bullous rash with several 1-2 cm tense blisters and ulcers on face, trunk and extremities. Irritability was noticed during infant manipulation. Rapid plasma reagin (RPR) was reported 1:128. Spinal fluid analysis was normal, with nonreactive VDRL. Long-bone radiographs revealed metaphyseal lucencies and periostitis. Cerebral ultrasound depicted residual calcifications and ventriculomegalia. His mother attended three prenatal visits, where RPR was ordered but not performed. Mother’s RPR at delivery was 1:32 and was HIV negative. Mother’s partner had an episode of venereal syphilis a year prior to the infant’s birth, unfortunately only the partner received penicillin treatment. Discussion: This case reveals how infants can be severely affected by CS. Effective prevention of CS depends on the identification of syphilis in pregnant women through routine serologic screening during the first antenatal care visit. Although 90% of cases are diagnosed in developing countries, increased rates reported by US surveillance systems raise alerts (rate increased 27.5% during 2013-14). Point-of-care tests and treating within the same visit with at least one dose of penicillin has demonstrated effectiveness in the prevention of mother-to-child transmission of infection. Partner treatment should be encouraged always. Ensuring skills in syphilis prevention, diagnosis and treatment among dermatologists is key in order to improve multidisciplinary teams that can better approach solutions to this public health problem. References will be provided. Commercial support: None identified.
JUNE 2017
5753 Consumer perception and clinical efficacy evaluation of a topical acne regimen containing a prebiotic Sheree Wiener, RN, Arbonne International; Peter Matravers, PharmD, Arbonne International; Robert Bianchini, PhD, Arbonne International Objective: To determine if the use of an acne regimen reduced acne lesions, improved skin clarity and blotchiness, increased skin hydration and improved barrier function. Methods: 32 male and female subjects between the ages of 18 to 40 with mild to moderate acne completed the study. Test articles, acne cleanser, acne toner pads, acne treatment lotion, all contain prebiotic. During the course of the study, subjects applied the test articles as a regimen twice a day, in the morning and evening. Assessments, including clinical grading, bio-instrumentation, photographs and subject self-assessment questionnaires, were conducted at visit 1 (baseline), visit 2 (3 days), visit 3 (1 week), visit 4 (4 weeks) and visit 5 (6 weeks). Conclusion: Overall results indicated that the acne regimen with prebiotic (acne cleanser, acne toner pads, and acne lotion), when used twice a day for 6 weeks, helped reduce acne lesions, improve skin clarity and blotchiness, skin barrier function and increase skin hydration. Commercial Support: Funded by Arbonne International LLC, Irvine, CA and conducted at Essex Testing Clinic, Inc., Verona, NJ.
J AM ACAD DERMATOL
AB83
4895
Congenital Syphilis: A case report Isabelle Wu, MD, Hospital das Clınicas da Faculdade de Medicina of S~ao Paulo University; Maria Cecılia Rivitti-Machado, MD, Hospital das Clınicas da Faculdade de Medicina of S~ao Paulo University; Renata Orlandi, MD, Hospital das Clınicas da Faculdade de Medicina of S~ao Paulo University; Abes Mahmed Amed Filho, MD, Hospital das Clınicas da Faculdade de Medicina of S~ao Paulo University; Marcello Menta Simonsen Nico, MD, Hospital das Clınicas da Faculdade de Medicina of S~ao Paulo University
Consistency of response across subgroups of patients with psoriasis treated with guselkumab: Results from the VOYAGE 1 and 2 trials Andrew Blauvelt, MD, Oregon Medical Research Center; Kristian Reich, MD, Dermatologikum Hamburg; Kim A. Papp, MD, K Papp Clinical Research and Probity Research, Inc.; Christopher E.M. Griffiths, MD, Dermatology Centre, Salford Royal Hospital, U of Manchester, Manchester Academic Health Science Cntr; April W. Armstrong, MD, University of Southern California; Peter Foley, MD, The University of Melbourne, St. Vincent’s Hospital, Melbourne and Skin & Cancer Foundation Inc.; Yaung-Kaung Shen, PhD, Janssen Research & Development, LLC; Alexa B. Kimball, MD, Depart of Dermatology, Harvard Medical School; Kenneth B. Gordon, MD, Northwestern University, Feinberg School of Medicine Objective: To evaluate the consistency of response of guselkumab (GUS) across predetermined subgroups of psoriasis patients.
Introduction: Congenital syphilis (CS) is still a public health problem in the world, particularly in the developing countries. In Brazil, the incidence of CS is approximately 2.4:1000 live births. Syphilis is a bacterial infection caused by Treponema pallidum, which can be transmitted transplacentally to the fetus. The infection in pregnant women who is not diagnosed or not effectively treated can lead to serious adverse outcomes such as fetal death, stillbirth, low birth weight, neonatal death, and congenital infection in infants. Proper prenatal care should be performed, to aim at an early diagnosis and treatment of the pregnant women infected with syphilis, in order to prevent disabilities due to CS. Methods: We describe a case report of a one month old male infant presented to our clinic with a history of lesions that started one week after birth on the palms and soles, progressing to the legs, superior limbs, neck and face. The mother said to have a negative serology to infectious diseases in the third trimester, but did not bring the results of the prenatal laboratory examinations. Results: Infant presented desquamation of palms and soles, multiple slightly hyperchromic lesions surrounded by scaling (Biett colarette) localized on soles/feet, palms/hands, legs, arms, cervical and chin regions. Congenital syphilis was suspected and laboratory exams were carried out: serum VDRL titers 1:128; serum fluorescent treponemal antibody absorption (FTA-Abs) reactive; cerebral spinal fluid’s (CSF) VDRL titers 1:1; T. pallidum hemagglutination (TPHA) titer 1:32 in the CSF, being diagnosed with neurosyphilis. The infant was treated with IV crystalline penicillin 50,000 IU/Kg/dose, every 8 hours for 10 days, with complete remission of the skin lesions, and still is being followed by our group, with a continuous decrease of VDRL titers. Retrospective revision of the mother prenatal laboratory exams showed positive conversion of VDRL 1:64 in the third trimester and was not adequately treated for syphilis at that time. Conclusion: CS is a preventable infection; therefore, an adequate screening of pregnant women is essential. Despite the existent efforts, CS remains an important public health problem, attributable to the lack of a proper prenatal follow-up. CS should be considered when a neonate presents with blistering or desquamation on the palms and soles, and when the obstetric history is unclear, regarding screening or treatment. Commercial support: None identified.
4983
Materials/Methods: In VOYAGE 1 (n ¼ 837) and VOYAGE 2 (n ¼ 992), patients (pts) were randomized to GUS 100 mg at weeks 0/4/12, and q8wk; placebo (PBO) at weeks 0/4/12 followed by GUS 100 mg at weeks 16/20 and q8 Wk; or ADA 80 mg at week 0, 40 mg at week 1, and 40 mg q2wk through Wk 47 (VOYAGE 1) or Wk 23 (VOYAGE 2). The coprimary endpoints were the proportions of GUS vs PBO patients achieving $90% improvement in PASI score (PASI 90) and cleared/minimal disease (IGA 0/1) responses at week 16. Response rates across endpoints were evaluated for predetermined sub-groups. Results: At week 16, significantly (P \.001) higher proportions of pts in the GUS vs PBO group achieved PASI 90 in VOYAGE 1 (73.3% vs 2.9%) and VOYAGE 2 (70.0% vs. 2.4%), and IGA 0/1 in VOYAGE 1 (85.1% vs 6.9%) and VOYAGE 2 (84.1% vs. 8.5%). In both studies, a substantially higher proportion of GUS-treated pts demonstrated PASI 90 and IGA 0/1 responses than PBO pts at week 16, across all subgroups defined by baseline demographics (gender, race, age [\45 yrs, $45 to \65 yrs, $65 yrs]), geographic region (North America, non-North America), disease characteristics (age at psoriasis diagnosis [\25 yrs, $25 yrs]); duration of psoriasis since diagnosis [\15 yrs, $15 yrs]; baseline PASI [\20, $20], IGA [\4, 4], DLQI score [\10, $10], and BSA [\20%, $20%]; presence of psoriatic arthritis); and previous biologic and nonbiologic medication history. In both studies, GUS treatment resulted in greater benefit at Week 24 compared to ADA treatment across all subgroups (nearly all 95% CIs on the difference excluding 0). GUS treatment resulted in consistent responses across all subgroups analyzed with reasonable sample sizes. As observed in the overall study population, GUS was well-tolerated among pts in each of the subgroups analyzed. Conclusions: The efficacy of GUS across predefined subgroups of psoriasis pts was consistent with that observed in the overall study population, with excellent responses in pts with long-standing psoriasis, severe disease at baseline, prior biologic use, and psoriatic arthritis. Commercial support: Janssen Research & Development, LLC. sponsored this study 100%.
Congenital syphilis: A menace that will not go away Silvana Castillo Loaiza, MD, Universidad del Valle; Adriana R. Cruz A., MD, Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDEIM); Natalia Vargas-Navia, MD, Universidad del Valle; Juan Carlos Salazar, MD, UConn Health Introduction: Syphilis is a sexually transmitted disease caused by the spirochete Treponema pallidum. In pregnant women, syphilis can lead to deleterious consequences to the mother, fetus and newborn. Although there are strategies to prevent congenital syphilis (CS) through antenatal syphilis screening and treatment of the mother, disease burden remains high. In 2012, WHO has estimated 350,000 adverse pregnancy outcomes worldwide, as a consequence of syphilis. Colombia currently notifies 1.4 CS/1000 live births per year, with the Pacific Coast region as one of the most affected. Despite the increases in the number of CS cases, few clinicians have seen florid cases of the disease in the newborn child. With this in mind, we provide a case which depicts prototypical clinical manifestations of the disease. Case report: A 34-week old newborn born was admitted to a hospital in Cali, Colombia. He weighed 2.200 grams; skin examination evidenced a bullous rash with several 1-2 cm tense blisters and ulcers on face, trunk and extremities. Irritability was noticed during infant manipulation. Rapid plasma reagin (RPR) was reported 1:128. Spinal fluid analysis was normal, with nonreactive VDRL. Long-bone radiographs revealed metaphyseal lucencies and periostitis. Cerebral ultrasound depicted residual calcifications and ventriculomegalia. His mother attended three prenatal visits, where RPR was ordered but not performed. Mother’s RPR at delivery was 1:32 and was HIV negative. Mother’s partner had an episode of venereal syphilis a year prior to the infant’s birth, unfortunately only the partner received penicillin treatment. Discussion: This case reveals how infants can be severely affected by CS. Effective prevention of CS depends on the identification of syphilis in pregnant women through routine serologic screening during the first antenatal care visit. Although 90% of cases are diagnosed in developing countries, increased rates reported by US surveillance systems raise alerts (rate increased 27.5% during 2013-14). Point-of-care tests and treating within the same visit with at least one dose of penicillin has demonstrated effectiveness in the prevention of mother-to-child transmission of infection. Partner treatment should be encouraged always. Ensuring skills in syphilis prevention, diagnosis and treatment among dermatologists is key in order to improve multidisciplinary teams that can better approach solutions to this public health problem. References will be provided. Commercial support: None identified.
JUNE 2017
5753 Consumer perception and clinical efficacy evaluation of a topical acne regimen containing a prebiotic Sheree Wiener, RN, Arbonne International; Peter Matravers, PharmD, Arbonne International; Robert Bianchini, PhD, Arbonne International Objective: To determine if the use of an acne regimen reduced acne lesions, improved skin clarity and blotchiness, increased skin hydration and improved barrier function. Methods: 32 male and female subjects between the ages of 18 to 40 with mild to moderate acne completed the study. Test articles, acne cleanser, acne toner pads, acne treatment lotion, all contain prebiotic. During the course of the study, subjects applied the test articles as a regimen twice a day, in the morning and evening. Assessments, including clinical grading, bio-instrumentation, photographs and subject self-assessment questionnaires, were conducted at visit 1 (baseline), visit 2 (3 days), visit 3 (1 week), visit 4 (4 weeks) and visit 5 (6 weeks). Conclusion: Overall results indicated that the acne regimen with prebiotic (acne cleanser, acne toner pads, and acne lotion), when used twice a day for 6 weeks, helped reduce acne lesions, improve skin clarity and blotchiness, skin barrier function and increase skin hydration. Commercial Support: Funded by Arbonne International LLC, Irvine, CA and conducted at Essex Testing Clinic, Inc., Verona, NJ.
J AM ACAD DERMATOL
AB83