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.

An update on the current and emerging pharmacotherapies for basal cell carcinomas.

INTRODUCTION: Despite surgical approach is still the mainstay for basal cell carcinoma (BCC) management, several issues may limit the use of this technique, leading to the need for new treatments to offer patients a personalized approach. AREAS COVERED: A comprehensive review of the available and emerging pharmacologic strategies for BCC management, including mechanisms of action, and potential adverse effects, has been performed to provide with an up-to-date manuscript on the current treatment scenario of BCC. Globally, targeting the Sonic-Hedgehog pathway is one of the main mechanisms of action of currently investigated drugs. Other alternatives are based on the concept of an enhancement of the immune response such as immune checkpoint inhibitors, or intra-tumor treatments. EXPERT OPINION: Although low-risk BCCs are often treated with destructive methods or topical treatments, surgery is the mainstay of treatment for the majority of BCCs. However, several factors may limit the use of surgery in BCC management. Recently, major knowledge on BCCs pathogenesis has led to the development of effective and selective drugs. In our opinion, soon many drugs will be licensed, allowing clinicians to offer patients with BCC the right treatment at the right moment. Certainly, further studies are needed.

Dupilumab for the treatment of adult atopic dermatitis in special populations.

BACKGROUND: Special populations (SPs) involve people who require additional consideration in clinical research. Effectiveness of treatment or occurrence of side effects may be different in SPs with respect to not-SPs. OBJECTIVES: To retrospectively compare the effectiveness and safety of dupilumab in AD treatment of SPs versus not-SPs. METHODS: A 52-weeks retrospective study was performed enrolling patients with a diagnosis of moderate-to-severe AD undergoing treatment with dupilumab at labeled dosage. Patients were divided in Group A (SPs patients) and Group B (not-SPs patients). Disease severity was assessed using Eczema Area Severity Index (EASI), Pruritus-Numerical Rating Scale (P-NRS), and Dermatology Life Quality Index (DLQI) score at baseline and after 4 weeks (W4), W16, W24, and W52. RESULTS: A total of 263 patients were enrolled and divided in Group A (25) and Group B (238). SPs included history of cancer, severe kidney failure, viral hepatitis, neurological diseases, acquired immunodeficiency syndrome, and transplanted patients. A statistically significant reduction of EASI, DLQI, and P-NRS was assessed in both groups at each follow-up visit (p < .0001), without significant differences between the groups. No differences were recorded for safety. CONCLUSIONS: There are not significant differences between SPs and not-SPs as regards effectiveness and safety of dupilumab in AD management.