Safety of omalizumab in chronic urticaria during pregnancy: a real-life study.

BACKGROUND: Managing a pregnant patient with chronic spontaneous urticaria (CSU) is often challenging. Recent data have shown that most CSU treatments in pregnant patients are second-generation H1 antihistamines (sgAHs), while data on the safety of omalizumab are scant. OBJECTIVES: To evaluate, in a routine clinical practice setting, the efficacy and safety of omalizumab in patients with severe CSU refractory to sgAHs who either became pregnant during treatment or who started the drug during pregnancy. METHODS: We conducted a retrospective study of women aged ≥ 18 years who were pregnant, who received one or more doses of omalizumab at any time during their pregnancy or who were taking omalizumab at the time of, or in the 8 weeks before, conception. RESULTS: Twenty-nine pregnant patients were evaluated: 23 (79%) conceived a child while taking omalizumab (group A), while 6 (21%) started omalizumab treatment during pregnancy (group B). Among patients in group A, we observed 23 births (21 liveborn singletons and 1 liveborn twin pair) and 1 miscarriage. Fifteen (65%) patients discontinued omalizumab after confirming their pregnancy, while eight (35%) were exposed to omalizumab during their entire pregnancy. In group B, omalizumab was introduced at a mean (SD) 10.83 (3.60) weeks' gestation and all patients were exposed to it until the end of pregnancy. In this group, there were seven liveborn infants (five singletons and one twin pair). No adverse events, pregnancy complications or congenital anomalies in newborns were recorded in either group. CONCLUSIONS: Omalizumab for CSU treatment before and during pregnancy does not appear to have negative effects on maternal or fetal outcomes.

Association between maternal dupilumab exposure and pregnancy outcomes in patients with moderate-to-severe atopic dermatitis: A nationwide retrospective cohort study.

BACKGROUND: There is limited epidemiological evidence on outcomes associated with dupilumab exposure during pregnancy; monitoring pregnancy outcomes in large populations is required. OBJECTIVE: To investigate the potential association between exposure to dupilumab in pregnant women with atopic dermatitis and any adverse pregnancy, neonatal, congenital and post-partum outcomes. METHODS: We performed a multicentre retrospective cohort study across 19 Italian tertiary referral hospital. Childbearing women were eligible if aged 18-49 years and carried out the pregnancy between 1 October 2018 and 1 September 2022. RESULTS: We retrospectively screened records of 5062 patients receiving dupilumab regardless of age and gender, identifying 951 female atopic dermatitis patients of childbearing age, 29 of whom had been exposed to the drug during pregnancy (3%). The median duration of dupilumab treatment prior to conception was 22.5 weeks (range: 3-118). The median time of exposure to the drug during pregnancy was 6 weeks (range: 2-24). All the documented pregnancies were unplanned, and the drug was discontinued in all cases once pregnancy status was reported. The comparison of the study cohort and the control group found no significant drug-associated risk for adverse pregnancy, congenital, neonatal or post-partum outcomes. The absence of a statistically significant effect of exposure on the event was confirmed by bivariate analysis and multivariate analysis adjusted for other confounding factors. CONCLUSIONS: This cohort of pregnant patients exposed to dupilumab adds to the existing evidence concerning the safety of biologic agents in pregnancy. No safety issues were identified regarding the primary outcome assessed. In clinical practice, these data provide reassurance in case of dupilumab exposure during the first trimester. However, the continuous use of dupilumab throughout pregnancy warrants further research.

Analysis of clinical factors as possible predictors of response to omalizumab and relapse after treatment discontinuation in chronic spontaneous urticaria.

Omalizumab is a monoclonal anti-IgE antibody which is effective in chronic spontaneous urticaria (CSU), although clinical response appears to be variable in the real-life setting. The aim of this study was to evaluate whether the response of CSU to omalizumab and disease relapse are associated with individual and/or clinical characteristics of patients. We retrospectively evaluated the clinical records of 124 patients treated with omalizumab for moderate to severe CSU refractory to antihistamines. Disease activity was assessed using the urticaria activity score over the last 7 days (UAS7). After 24 weeks of treatment, 91% of patients showed complete remission (UAS7 = 0) or good control (UAS7 < 7) of CSU. Omalizumab was re-administered in 45 patients because of recurrence of moderate to severe symptoms at week 8 after treatment discontinuation or later, and clinical results achieved with retreatment were similar to those observed in the first course. Among the parameters included in our analysis (age and sex of patients, documented history of atopy or autoimmune thyroid disease, CSU duration and baseline severity, concurrent angioedema, and association with chronic inducible urticaria), none was associated with response to omalizumab in our study population. Similarly, these parameters did not significantly differ between patients who experienced CSU relapse and those without relapse. Predictors of response to omalizumab treatment in CSU patients are still unclear, and further studies are needed to evaluate the presence of baseline factors that can influence treatment outcome.

Contact allergy in children with and without atopic dermatitis: An Italian multicentre study.

BACKGROUND: Contact allergy and atopic dermatitis (AD) are both common inflammatory T cell-mediated diseases and many factors may influence the prevalence of contact allergy in AD patients. In children, their possible correlation was debated with conflicting results. OBJECTIVES: The present study aimed to assess the prevalence of contact sensitivity in children and to investigate the association with AD. MATERIALS AND METHODS: A retrospective multicentre study on children aged from 0 to 14 years patch tested between January 2017 and December 2018 was performed. Children were consecutively patch tested with the SIDAPA (Società Italiana Dermatologia Allergologica Professionale Ambientale) baseline series. RESULTS: Among the 432 children investigated for contact allergy, 125 (28.9%) showed a positive reaction to at least one of the allergens tested, with a higher prevalence of positive patch test reactions in girls (32.3%) than in boys (25.0%). The most frequent contact allergens were nickel sulphate (10.2%), cobalt chloride (6.7%), methylisothiazolinone (3.7%), fragrance mix-2 (3.2%), potassium dichromate (2.8%), fragrance mix-1 (2.1%) and methylchloroisothiazolinone/methylisothiazolinone (2.1%). One-hundred-three children (23.8%) suffered from AD showing a higher prevalence of positive patch test (36.9%) compared to children without AD (26.4%). CONCLUSIONS: Despite the topic being still controversial, the present study suggests a consistent prevalence of contact allergy among children with higher sensitivity rate among children with AD than without AD.

Spreading Allergic Contact Dermatitis to Tea Tree Oil in an Over-the-Counter Product Applied on a Wart.

Tea tree oil is an essential oil obtained by distillation from the leaves and terminal branchlets of Melaleuca alternifolia and is now present in numerous products for body care and self-medication. We report a case of allergic contact dermatitis to tea tree oil in a young man who was applying a lotion containing tea tree oil on a wart localized on the plantar aspect of the right big toe, which had previously been treated with cryotherapy. He developed a severe eczematous eruption on the right foot and the right leg, with subsequent id reactions affecting the right thigh, the contralateral lower limb, the trunk and the upper limbs. The lotion was discontinued, and the dermatitis resolved after topical corticosteroid therapy. Patch testing with the aforementioned lotion 10% pet. and oxidized tea tree oil 5% pet. identified tea tree oil as the culprit agent of the dermatitis. This case report confirms that products made of natural ingredients, often perceived to be harmless, can cause allergic reactions.

Topical dermocosmetics and acne vulgaris.

Acne is a highly common skin disease especially among teenagers. Modern acne treatments are based also on the use of moisturizers, cleansers and sunscreens. In choosing the right cleanser, it is important to consider some aspects: the interaction between skin type and the cleanser, the optimal time and method of cleaning and the cosmetic perception of the patient. The aim of our review is to highlight the importance of choosing the most suitable topical dermocosmetics for the different skin types, as well as the most effective timing and method to combine dermocosmetics with the standard acne treatment. A search in literature for selected key words was performed using PubMed. Additional papers were identified based on author expertise. Treatment of acne patients should include education for proper daily skin hygiene, including protection from environmental damage. However, given the low number of clinical studies on cleansers, it is difficult to make reliable recommendations. The correct choice and use of topical dermocosmetics are fundamental in the management of acne patients. Daily use of moisturizers, cleansers and sunscreens can reduce both inflammatory and non-inflammatory acne lesion counts and may be helpful for acne treatment if combined with specific drugs.

DECISA Project (DErmatology Clinics in Italy: Survey on Alitretinoin): A real-life retrospective cohort multicenter study on 438 subjects with chronic hand eczema.

Alitretinoin is the only systemic agent approved to treat moderate-severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids. No nationwide Italian data regarding real-life efficacy, safety, and tolerability of treatment are available. The DECISA project (DErmatology Clinics in Italy: Survey on Alitretinoin) retrospectively examined data from a registry including 15 Dermatology Clinics authorized to prescription of alitretinoin for CHE patients. Disease severity was assessed at baseline, and after 3 and 6 months of treatment, using the 5-point Physician Global Assessment (PGA) and the modified Total Lesion-Symptoms-Severity (mTLSS) scores. Between November 2010 and July 2018, data of 248 male and 190 female patients (mean age 49.71 ± 13.20 years) treated with alitretinoin were collected. Of them, 43.2% had irritant contact dermatitis, 22.2% allergic contact dermatitis, 18.0% atopic dermatitis, 16.7% mixed (irritant/allergic) type of eczema. At 3 months, the 420 re-evaluated patients showed significantly reduced mTLSS and PGA (P < .0000001 vs baseline for both); PGA was clear/almost clear in 35.6% of cases. At 6 months, the 341 re-evaluated patients showed significant (P < .0000001) improvement of mTLSS and PGA vs baseline and 3 months (PGA clear/almost clear: 41.4%). Relapses occurred in 125 patients; 58 underwent an additional course of alitretinoin, with similarly good results. No relevant safety issues were reported; 86 patients experienced adverse effects, which forced 40 to prematurely stop treatment. The DECISA project results confirm the real-life efficacy, safety and tolerability of alitretinoin in the treatment of moderate to severe CHE refractory to standard topical therapies.

Myroxylon pereirae (balsam of Peru): Still worth testing?

BACKGROUND: Because Myroxylon pereirae (MP), or balsam of Peru, is nowadays almost not used "as such," and fragrance mix 1 (FM1) apparently is more sensitive in detecting fragrance allergy, the usefulness of testing MP in baseline series was recently questioned. OBJECTIVES: Identification of the number of clinically relevant patch test reactions to MP not detected by FM1. METHODS: Retrospective analysis of 12 030 patients patch tested with MP and FM1 for contact dermatitis between January 2018 and December 2019 in 13 Italian dermatology clinics. RESULTS: Four hundred thirty-nine patients (3.6%) had a positive patch test reaction to MP; 437 (3.6%) had a positive patch test reaction to FM1. Positive reactions to both MP and FM1 were observed in 119 subjects (1.0%), 310 (2.6%) reacted to MP only, 304 (2.5%) to FM1 only, 5 to MP and sorbitan sesquioleate (SSO), 9 to FM1 and SSO, and 5 to MP, FM1, and SSO. Single sensitizations were clinically relevant in 75.2% of cases for MP (62.9% current, 12.3% past) and 76.3% for FM1 (70.1% current, 6.2% past). CONCLUSIONS: Based on our results, MP appears to be still worth testing along with FM1 in baseline series, because it allows detection of a remarkable number of fragrance allergies, often relevant, which would be otherwise missed.

Patch testing of budesonide in Italy: The SIDAPA baseline series experience, 2018-2019.

BACKGROUND: Budesonide was included in the European Baseline Series in 2000 as the most suitable marker forcorticosteroid hypersensitivity. In the last two decades, a decreasing trend of budesonide allergy has been observed. OBJECTIVES: To estimate the prevalence of positive patch test reactions to budesonide in a large, Italian patch test population, characterizing patients according to MOAHLFA index and evaluating the benefit with extended readings of budesonide patch test. METHODS: Retrospective analysis of patient demographics and patch test results over a 2-year period (2018-2019) was performed at 14 patch test clinics in Italy. RESULTS: Ninety out of 14 544 (0.6%) patients reacted to budesonide 0.01% pet.. Positive reactions were mild in 54.4% and late readings at day 7 showed new positive reactions in 37.8% of patients. The MOAHLFA index showed a significant positive association with male gender, atopic dermatitis, and age >40 years and a significant negative association with hand and face dermatitis. CONCLUSIONS: We documented a low prevalence of budesonide allergy in Italy, confirming its decreasing trend recently reported in the literature. Nevertheless, budesonide needs to be maintained in the baseline series for its good ability to detect corticosteroid sensitization.

Topical antibiotics in the dermatological clinical practice: Indications, efficacy, and adverse effects.

Topical antibiotic therapy is a central component of patient management for several skin conditions, including acne, hidradenitis suppurativa, rosacea, impetigo or other superinfected dermatitis, and prevention of wound infections. Moreover, particular situations, such as skin diseases of bacterial origin in pregnancy and infants often warrant topical therapy. However, the occurrence of local delayed hypersensitivity reactions and the rising rate of antibiotic resistance are becoming great challenges faced by many dermatologists today. This narrative review provides an overview of the main topical antibiotics used in dermatology, focusing on their clinical role in the most common dermatological indications. For this purpose, a review of MEDLINE and PubMed for pertinent, scientific, and clinical publications until March 2020 was performed. Only articles published in the English language were included.

Urticaria: recommendations from the Italian Society of Allergology, Asthma and Clinical Immunology and the Italian Society of Allergological, Occupational and Environmental Dermatology.

BACKGROUND: Urticaria is a disorder affecting skin and mucosal tissues characterized by the occurrence of wheals, angioedema or both, the latter defining the urticaria-angioedema syndrome. It is estimated that 12-22% of the general population has suffered at least one subtype of urticaria during life, but only a small percentage (estimated at 7.6-16%) has acute urticaria, because it is usually self-limited and resolves spontaneously without requiring medical attention. This makes likely that its incidence is underestimated. The epidemiological data currently available on chronic urticaria in many cases are deeply discordant and not univocal, but a recent Italian study, based on the consultation of a national registry, reports a prevalence of chronic spontaneous urticaria of 0.02% to 0.4% and an incidence of 0.1-1.5 cases/1000 inhabitants/year. METHODS: We reviewed the recent international guidelines about urticaria and we described a methodologic approach based on classification, pathophysiology, impact on quality of life, diagnosis and prognosis, differential diagnosis and management of all the types of urticaria. CONCLUSIONS: The aim of the present document from the Italian Society of Allergology, Asthma and Clinical Immunology (SIAAIC) and the Italian Society of Allergological, Occupational and Environmental Dermatology (SIDAPA) is to provide updated information to all physicians involved in diagnosis and management of urticaria and angioedema.