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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Gait and balance impairment is common in multiple sclerosis (MS), often leading to walking aids need. Rehabilitation is the most common and effective approach to tackle the burden of these symptoms, but less attention is given to the correct use of an assistive device for ambulation. Here, we aimed to maximise the effect of a rehabilitation program including walking aid training with a sensorized crutch in people with MS (PwMS). 24 PwMS (15 females, age=57.8±9.8 years, all EDSS=6) underwent a 20-session rehabilitation program focusing on gait, balance, and proper assistive device use. The experimental group (FB_group, N=12) used a crutch with real-time feedback based on user support load, whilst the control group (NOFB_group, N=12) used a standard crutch. Assessment included Timed 25 Foot Walk (T25FW), Timed Up and Go (TUG) and Modified Fatigue Impact Scale (MFIS). Moreover, functional Near-Infrared Spectroscopy (fNIRS) was used to investigate cortical activity during linear and curvilinear walking tasks. At baseline, no differences were found between groups concerning either clinical or neural evaluations. Following rehabilitation, we observed a reduction in fatigue perception in both groups (p=0.038). Moreover, FB_group performed better than NOFB_group in T25FW and TUG (p=0.028 and p=0.038, respectively). Further, after treatment, FB_group showed increased neural activity in areas involved in cognitive functions (Brodmann Areas-BA 9,10, p<0.01), multisensory integration and body representation (BA39, p=0.01) during both linear and curvilinear walking. Instead, NOFB_group showed increased activity in motor planning areas (BA 6,8, p<0.05). A significant difference was also found between groups in BA9 after treatment (FB_group>NOFBgroup, p=0.04). A 20-session rehabilitation period effectively reduces fatigue among PwMS. Moreover, a real-time feedback crutch seems to have a positive impact on walking ability. This might be due to a feedback-induced increased attention focusing on the assistive device, as suggested by the fNIRS results. [ABSTRACT FROM AUTHOR]