pregnancy outcomes after maternal exposure to topical corticosteroids: a population-based cohort...

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P6751 Impact of acne treatment on inflammatory bowel disease Sarah Fenerty, Wake Forest School of Medicine, Winston-Salem, NC, United States; Cheryl Gustafson, MD, Wake Forest School of Medicine, Winston-Salem, NC, United States; Laura Sandoval, DO, Wake Forest School of Medicine, Winston-Salem, NC, United States; Steven Feldman, MD, Wake Forest School of Medicine, Winston-Salem, NC, United States Background: Oral antibiotics and vitamin A analog isotretinoin are routinely prescribed for the treatment of moderate to severe acne. Although cases of inflammatory bowel disease have been reported in patients who were prescribed these medications, there is conflicting evidence to support a causal relationship. Purpose: To evaluate the relationship between oral antibiotic and isotretinoin use for the management of acne vulgaris and the development of inflammatory bowel disease (IBD). Methods: The MarketScanÔ Medicaid dataset was queried to identify patients who received an acne diagnosis in 2003 and had no previous IBD diagnosis. Isotretinoin and oral antibiotic prescriptions were documented. Patients were followed at most 4 years—until diagnosis of IBD or censoring. Multivariable Cox proportional hazards models were built to assess associations between the medical treatments and IBD using STATA 12 software. Results: From 176,889 acne patients followed, 324 patients were diagnosed with Crohn’s disease and 194 with ulcerative colitis. The overall prevalence of IBD development was 0.28%. There was no association between the use of isotretinoin and the incidence of IBD (HR, 0.57; P ¼.12; 95% CI, 0.28-1.16). Oral antibiotic use was associated with a decreased risk of IBD development (HR, 0.45; P \.001; 95% CI, 0.32-0.51). This association was comparable for both ulcerative colitis and Crohn’s disease (HRs of 0.47 and 0.42, respectively). Higher cumulative doses of oral antibiotics were associated with lower incidence of IBD. Limitations: Because cases were identified by diagnosis codes rather than clinical records, there could be outcome misclassification. Data on patient adherence is not available; therefore, prescription records must be used as a proxy for medication usage. Conclusion: There is an inverse association between oral antibiotics and the development of IBD in acne patients with a doseeresponse relationship. Clinicians and prospective patients should be cognizant of the lack of a causal relationship between isotretinoin for acne and the development of IBD. The Center for Dermatology Research is supported by an unrestricted educational grant from Galderma Laboratories, L.P. P7109 N-acetylcysteine in urea and lamellar ichthyosis Paloma Nogueras Morillas, Servicio de Dermatologia, Hospital Virgen de las Nieves, Granada, Spain; Carmen Martinez Peinado, Servicio de Dermatologia, Hospital Virgen de las Nieves, Granada, Spain; Cristina Garrido Colmenero, Servicio de Dermatolog ıa, Hospital Virgen de las Nieves, Granada, Spain; Eliseo Martinez Garcia, Servicio de Dermatolog ıa, Hospital Virgen de las Nieves, Granada, Spain; Ignacio Valenzuela Salas, Servicio de Dermatologia, Hospital Virgen de las Nieves, Granada, Spain; Jesus Tercedor Sanchez, Servicio de Dermatologia, Hospital Virgen de las Nieves, Granada, Spain; Jorge Hernandez Magdaleno, Servicio Farmacia, Hospital Virgen de las Nieves, Granada, Spain Backgroud: Lamellar ichtyosis is a rare disease of the subgroup of nonsyndromic autosomal recessive congenital ichtyosis characterized by nonbullous hyperkerato- sis with facial and body surface involvement presenting with thick hyperkeratotic scales, severe dryness, and variable skin redness. Topical therapy of ichthyosis has classically included generous and frequent applications of emollient creams, keratolytic agents, ointments, and bath oils. Although a permanent cure for lamellar ichthyosis may not yet be possible, we describe herein a palliative treatment that is efficient and well tolerated for patients with this entity. Case report: A 1.5-year-old female with lamellar ichthyosis had been treated from birth with emollient and urea preparations. She presented with large and dark scales with a dirty appearance particularly on the trunk, limbs, scalp, and neck. We prepared a topical water-in-oil emulsion containing 10% NAC and 5% urea. Conservation conditions were complied using airtight bottles, which were protected from light and stored in a cool, dry place. The parents were instructed to apply this preparation twice daily on the skin of right thigh (face, trunk, and limbs). On the skin of left thigh they used a water-in-oil emulsion containing only urea 5% (placebo). After the first week of treatment, our patient experienced rapid and significant improvement with a water-in-oil emulsion containing 10% N- acetylcysteine plus 5% urea with minimal side effects. We could not see changes in placebo-treated areas (left thigh). Preparations were applied thoroughly 10 months later, there was outstanding improvement. Conclusion: NAC is a thiol derivative that has traditionally been used as a mucolytic, antioxidant, nephroprotective agent and as an antidote for acetaminophen over- dose. NAC can prevent skin irritation resulting from radiotherapy and protects from sun-induced erythema. NAC is an atoxic and hypoallergic amino acid derivative with successful therapeutic uses and rare side effects like mild pruritus, irritation, and burning sensation. Recent studies show that NAC suppresses proliferation of NIH3T3 fibroblast cells, and this antiproliferative effect is mediated by reversible blocking of cell-cycle progression in G1 phase, but not by its cytotoxic effect. Because NAC is an atoxic and hypoallergic aminoacid derivative with successful therapeutic uses and rare side-effects, it may be useful in the treatment of hyperproliferative skin disorders. Commercial support: None identified. P6979 Pregnancy outcomes after maternal exposure to topical corticosteroids: A population-based cohort study Shu-Hui Wang, MD, MS, Far Eastern Memorial Hospital, Department of Dermatology, New Taipei, Taiwan; Ching-Chi Chi, MD, PhD, Chang Gung Memorial Hospital, Department of Dermatology, Chang Gung University College of Medicine, Chiayi, Taiwan; Fenella Wojnarowska, MD, University of Oxford, Nuffield Department of Clinical Medicine, Oxford, United Kingdom; Richard Mayon-White, MBBS, University of Oxford, Department of Primary Health Care Sciences, Oxford, United Kingdom Objective: To investigate whether maternal exposure to topical corticosteroids results in adverse pregnancy outcomes. Methods: We used the UK Health Informatics Centre (HIC) datasets to conduct a population-based retrospective cohort study. We identified 2645 women who were given a topical corticosteroid during the period from last menstrual period (LMP) to delivery and 7212 unexposed women matched for maternal age and the calendar year of pregnancy. We examined if there was an increased risk of adverse pregnancy outcomes (including orofacial cleft, low birth weight, preterm delivery, and stillbirth) in the exposed group. Results: No significant increase in adverse pregnancy outcomes (including orofacial cleft, low birth weight, preterm delivery, and stillbirth) was found in relation to maternal exposure to topical corticosteroid [adjusted risk ratio (RR), 1.85 [95% confidence interval (CI), 0.22-15.20], 0.97 (95% CI, 0.78-1.19), 1.14 (95% CI, 0.70- 1.86), and 1.04 (95% CI, 0.55-1.98), respectively]. Stratified analyses based on the potency of topical corticosteroids did not substantially change the results. Neither did sensitivity analyses that included topical corticosteroids given up to 85 days before last menstrual period. Conclusion: Congruent with previous studies, the present study found no associ- ations of maternal exposure to topical corticosteroids with orofacial cleft, preterm delivery, and stillbirth. In contrast to 2 previous cohort studies, the present study did not find an association of low birth weight with maternal exposure to either potent or very potent topical corticosteroid. However, this may be related to the limited sample size and the risk being small. Commercial support: None identified. P7082 Propranolol therapy for infantile haemangiomas: A case series of 33 infants Meriam Bouras, Department of Dermatology, Ibn Rochd University Hospital, Casablanca, Morocco; Fatima Dehbi, Department of Pediatry, Abderrahim Harouchi University Hospital, Casablanca, Morocco; Fatima Zohra Elfatouaki, Department of Dermatology, Ibn Rochd University Hospital, Casablanca, Morocco; Hakima Benchikhi, Department of Dermatology, Ibn Rochd University, Casablanca, Morocco; Khadija Khadir, Department of Dermatology, Ibn Rochd University Hospital, Casablanca, Morocco; Lahcen Ouzidane, Department of Pediatric Radiology, Abderrahim Harouchi University Hospital, Casablanca, Morocco; Said Chraibi, Department of Pediatric Cardiology, Casablanca, Morocco Introduciton: Propranolol, a nonselective beta-blocker, has recently been intro- duced as a novel modality for the treatment of proliferating haemangiomas in spite of the absence of marketing authorization in this indication. We report 33 cases of infantile hemangiomas treated by propranolol, with a long term evaluation of the efficiency and the safety of this treatment. Methods: A prospective study was conducted. Data were collected from the medical charts of patients treated with propranolol for infantile heamangiomas from May 2009 to June 2011 in the Department of Dermatology of Ibn Rochd University Hospital. The criteria of inclusion were represented by periorificiel localization, ulceration, voluminous subcutaneous heamangiomas, the failure of corticosteroid therapy, Cyrano hemangioma, and numerous heamangiomas. Oral propranolol was applied to 33 infants with heamangiomas at a dose of 2 mg per kilogram of body weight per day after cardiovascular examination. Results: We listed 33 cases of hemangiomas with propranolol therapy among 74 infantile hemangiomas recruited during the same period (44.6%) with 4 males and 29 females and a mean age of 4 months. The eligibility criteria were represented by periorificiel localization (n ¼ 8), ulceration (n ¼ 9), segmental hemangioma (n ¼ 7), voluminous subcutaneous heamangiomas (n ¼ 4), the failure of corticosteroid therapy (n ¼ 1), Cyrano hemangioma (n ¼ 2), and numerous heamangiomas (n ¼ 2). At 48 hours postmedication, all tumors decreased in density, color, and size. The changes became conspicuous within 5 days, the beginning of the palpebral opening was noted at 3 days, and the median delay of healing of ulceration was 5.33 weeks, and of regression of the extracutaneous locations of 3 months. The treatment was stopped at 11 infants with total regression, without recurrence or side effects. The follow-up period was 2 to 19 months. Discussion: Oral propranolol treatment is an effective and safe regimen for infantile proliferating heamangiomas. It can be used as the first-line therapeutic modality with minimal side effects. Other studies are necessary to determine dosage and optimum length of the treatment. Commercial support: None identified. APRIL 2013 JAM ACAD DERMATOL AB5

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Page 1: Pregnancy outcomes after maternal exposure to topical corticosteroids: A population-based cohort study

P6751Impact of acne treatment on inflammatory bowel disease

Sarah Fenerty, Wake Forest School of Medicine, Winston-Salem, NC, UnitedStates; Cheryl Gustafson, MD, Wake Forest School of Medicine, Winston-Salem,NC, United States; Laura Sandoval, DO, Wake Forest School of Medicine,Winston-Salem, NC, United States; Steven Feldman, MD, Wake Forest School ofMedicine, Winston-Salem, NC, United States

Background: Oral antibiotics and vitamin A analog isotretinoin are routinelyprescribed for the treatment of moderate to severe acne. Although cases ofinflammatory bowel disease have been reported in patients who were prescribedthese medications, there is conflicting evidence to support a causal relationship.

Purpose: To evaluate the relationship between oral antibiotic and isotretinoin usefor the management of acne vulgaris and the development of inflammatory boweldisease (IBD).

Methods: The MarketScan� Medicaid dataset was queried to identify patients whoreceived an acne diagnosis in 2003 and had no previous IBD diagnosis. Isotretinoinand oral antibiotic prescriptionswere documented. Patientswere followed at most 4years—until diagnosis of IBD or censoring. Multivariable Cox proportional hazardsmodels were built to assess associations between the medical treatments and IBDusing STATA 12 software.

Results: From 176,889 acne patients followed, 324 patients were diagnosed withCrohn’s disease and 194 with ulcerative colitis. The overall prevalence of IBDdevelopment was 0.28%. There was no association between the use of isotretinoinand the incidence of IBD (HR, 0.57; P ¼ .12; 95% CI, 0.28-1.16). Oral antibiotic usewas associated with a decreased risk of IBD development (HR, 0.45; P\.001; 95%CI, 0.32-0.51). This association was comparable for both ulcerative colitis andCrohn’s disease (HRs of 0.47 and 0.42, respectively). Higher cumulative doses of oralantibiotics were associated with lower incidence of IBD.

Limitations: Because cases were identified by diagnosis codes rather than clinicalrecords, there could be outcome misclassification. Data on patient adherence is notavailable; therefore, prescription records must be used as a proxy for medicationusage.

Conclusion: There is an inverse association between oral antibiotics and thedevelopment of IBD in acne patients with a doseeresponse relationship. Cliniciansand prospective patients should be cognizant of the lack of a causal relationshipbetween isotretinoin for acne and the development of IBD.

APRIL 20

r for Dermatology Research is supported by an unrestricted edum Galderma Laboratories, L.P.

The Cente cationalgrant fro

P7109N-acetylcysteine in urea and lamellar ichthyosis

Paloma Nogueras Morillas, Servicio de Dermatologia, Hospital Virgen de lasNieves, Granada, Spain; Carmen Martinez Peinado, Servicio de Dermatologia,Hospital Virgen de las Nieves, Granada, Spain; Cristina Garrido Colmenero,Servicio de Dermatolog�ıa, Hospital Virgen de las Nieves, Granada, Spain; EliseoMartinez Garcia, Servicio de Dermatolog�ıa, Hospital Virgen de las Nieves,Granada, Spain; Ignacio Valenzuela Salas, Servicio de Dermatologia, HospitalVirgen de las Nieves, Granada, Spain; Jesus Tercedor Sanchez, Servicio deDermatologia, Hospital Virgen de las Nieves, Granada, Spain; Jorge HernandezMagdaleno, Servicio Farmacia, Hospital Virgen de las Nieves, Granada, Spain

Backgroud: Lamellar ichtyosis is a rare disease of the subgroup of nonsyndromicautosomal recessive congenital ichtyosis characterized by nonbullous hyperkerato-sis with facial and body surface involvement presenting with thick hyperkeratoticscales, severe dryness, and variable skin redness. Topical therapy of ichthyosis hasclassically included generous and frequent applications of emollient creams,keratolytic agents, ointments, and bath oils. Although a permanent cure for lamellarichthyosis may not yet be possible, we describe herein a palliative treatment that isefficient and well tolerated for patients with this entity.

Case report: A 1.5-year-old female with lamellar ichthyosis had been treated frombirth with emollient and urea preparations. She presented with large and dark scaleswith a dirty appearance particularly on the trunk, limbs, scalp, and neck. Weprepared a topical water-in-oil emulsion containing 10% NAC and 5% urea.Conservation conditions were complied using airtight bottles, which wereprotected from light and stored in a cool, dry place. The parents were instructedto apply this preparation twice daily on the skin of right thigh (face, trunk, andlimbs). On the skin of left thigh they used a water-in-oil emulsion containing onlyurea 5% (placebo). After the first week of treatment, our patient experienced rapidand significant improvement with a water-in-oil emulsion containing 10% N-acetylcysteine plus 5% urea with minimal side effects. We could not see changesin placebo-treated areas (left thigh). Preparations were applied thoroughly 10months later, there was outstanding improvement.

Conclusion: NAC is a thiol derivative that has traditionally been used as a mucolytic,antioxidant, nephroprotective agent and as an antidote for acetaminophen over-dose. NAC can prevent skin irritation resulting from radiotherapy and protects fromsun-induced erythema. NAC is an atoxic and hypoallergic amino acid derivative withsuccessful therapeutic uses and rare side effects like mild pruritus, irritation, andburning sensation. Recent studies show that NAC suppresses proliferation ofNIH3T3 fibroblast cells, and this antiproliferative effect is mediated by reversibleblocking of cell-cycle progression in G1 phase, but not by its cytotoxic effect.Because NAC is an atoxic and hypoallergic aminoacid derivative with successfultherapeutic uses and rare side-effects, it may be useful in the treatment ofhyperproliferative skin disorders.

cial support: None identified.

Commer

13

P6979Pregnancy outcomes after maternal exposure to topical corticosteroids: Apopulation-based cohort study

Shu-Hui Wang, MD, MS, Far Eastern Memorial Hospital, Department ofDermatology, New Taipei, Taiwan; Ching-Chi Chi, MD, PhD, Chang GungMemorial Hospital, Department of Dermatology, Chang Gung UniversityCollege of Medicine, Chiayi, Taiwan; Fenella Wojnarowska, MD, University ofOxford, Nuffield Department of Clinical Medicine, Oxford, United Kingdom;Richard Mayon-White, MBBS, University of Oxford, Department of PrimaryHealth Care Sciences, Oxford, United Kingdom

Objective: To investigate whether maternal exposure to topical corticosteroidsresults in adverse pregnancy outcomes.

Methods: We used the UK Health Informatics Centre (HIC) datasets to conduct apopulation-based retrospective cohort study. We identified 2645 women who weregiven a topical corticosteroid during the period from last menstrual period (LMP) todelivery and 7212 unexposed women matched for maternal age and the calendaryear of pregnancy. We examined if there was an increased risk of adverse pregnancyoutcomes (including orofacial cleft, low birth weight, preterm delivery, andstillbirth) in the exposed group.

Results: No significant increase in adverse pregnancy outcomes (including orofacialcleft, low birth weight, preterm delivery, and stillbirth) was found in relation tomaternal exposure to topical corticosteroid [adjusted risk ratio (RR), 1.85 [95%confidence interval (CI), 0.22-15.20], 0.97 (95% CI, 0.78-1.19), 1.14 (95% CI, 0.70-1.86), and 1.04 (95% CI, 0.55-1.98), respectively]. Stratified analyses based on thepotency of topical corticosteroids did not substantially change the results. Neitherdid sensitivity analyses that included topical corticosteroids given up to 85 daysbefore last menstrual period.

Conclusion: Congruent with previous studies, the present study found no associ-ations of maternal exposure to topical corticosteroids with orofacial cleft, pretermdelivery, and stillbirth. In contrast to 2 previous cohort studies, the present study didnot find an association of low birth weight with maternal exposure to either potentor very potent topical corticosteroid. However, this may be related to the limitedsample size and the risk being small.

cial support: None identified.

Commer

P7082Propranolol therapy for infantile haemangiomas: A case series of 33infants

Meriam Bouras, Department of Dermatology, Ibn Rochd University Hospital,Casablanca, Morocco; Fatima Dehbi, Department of Pediatry, AbderrahimHarouchi University Hospital, Casablanca, Morocco; Fatima Zohra Elfatouaki,Department of Dermatology, Ibn Rochd University Hospital, Casablanca,Morocco; Hakima Benchikhi, Department of Dermatology, Ibn RochdUniversity, Casablanca, Morocco; Khadija Khadir, Department of Dermatology,Ibn Rochd University Hospital, Casablanca, Morocco; Lahcen Ouzidane,Department of Pediatric Radiology, Abderrahim Harouchi University Hospital,Casablanca, Morocco; Said Chraibi, Department of Pediatric Cardiology,Casablanca, Morocco

Introduciton: Propranolol, a nonselective beta-blocker, has recently been intro-duced as a novelmodality for the treatment of proliferating haemangiomas in spite ofthe absence of marketing authorization in this indication. We report 33 cases ofinfantile hemangiomas treated by propranolol, with a long term evaluation of theefficiency and the safety of this treatment.

Methods: A prospective studywas conducted. Datawere collected from the medicalcharts of patients treated with propranolol for infantile heamangiomas from May2009 to June 2011 in the Department of Dermatology of Ibn Rochd UniversityHospital. The criteria of inclusion were represented by periorificiel localization,ulceration, voluminous subcutaneous heamangiomas, the failure of corticosteroidtherapy, Cyrano hemangioma, and numerous heamangiomas. Oral propranolol wasapplied to 33 infants with heamangiomas at a dose of 2 mg per kilogram of bodyweight per day after cardiovascular examination.

Results: We listed 33 cases of hemangiomas with propranolol therapy among 74infantile hemangiomas recruited during the same period (44.6%) with 4 males and29 females and a mean age of 4 months. The eligibility criteria were represented byperiorificiel localization (n¼ 8), ulceration (n¼ 9), segmental hemangioma (n¼ 7),voluminous subcutaneous heamangiomas (n ¼ 4), the failure of corticosteroidtherapy (n¼ 1), Cyrano hemangioma (n¼ 2), and numerous heamangiomas (n¼ 2).At 48 hours postmedication, all tumors decreased in density, color, and size. Thechanges became conspicuous within 5 days, the beginning of the palpebral openingwas noted at 3 days, and the median delay of healing of ulceration was 5.33 weeks,and of regression of the extracutaneous locations of 3 months. The treatment wasstopped at 11 infants with total regression, without recurrence or side effects. Thefollow-up period was 2 to 19 months.

Discussion: Oral propranolol treatment is an effective and safe regimen for infantileproliferating heamangiomas. It can be used as the first-line therapeutic modalitywith minimal side effects. Other studies are necessary to determine dosage andoptimum length of the treatment.

cial support: None identified.

Commer

J AM ACAD DERMATOL AB5