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.

Efficacy of Dupilumab in two patients with severe and recalcitrant atopic dermatitis previously treated with extracorporeal photopheresis.

Atopic dermatitis (AD) is a complex disease and can often be a clinical challenge for dermatologists. When standard immunosuppressive therapies fail, extracorporeal phototherapy (ECP) can be considered as a therapeutic option. In recent years, better understanding of the pathogenesis of AD allowed to improve treatment strategies with many emerging therapeutic options. Currently, Dupilumab, a monoclonal antibody that selectively inhibits IL-4 and IL-13, is the only biological drug authorized for the treatment of severe adult atopic dermatitis, refractory to traditional firstline and secondline therapies. ECP, compared to biological therapy, is associated with some disadvantages: it is costly and time-consuming for patients and personnel to administer. Moreover, it should be noted that the completion of the entire procedure takes about 3 hr and must be done in a hospital, while the administration of Dupilumab can be carried out by patients themselves at home. For these reasons and on the basis of our experience, it would be necessary to evaluate whether all patients with refractory atopic dermatitis in treatment with ECP with unsatisfactory clinical response should be switched to recent available target therapies.

Psoriasis and Fibromyalgia: A Systematic Review.

Psoriasis is a chronic inflammatory cutaneous condition characterized by several comorbidities, including musculoskeletal disorders. While the association with psoriatic arthritis has been widely addressed in literature, the aim of the present systematic review was to identify all available evidence on the relationship between psoriasis and fibromyalgia, a musculoskeletal syndrome primarily characterized by chronic widespread pain. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and MedLine and Web of Science (WOS) databases were searched for literature up to March 2023. After the removal of duplicate records, a total of 11 articles were deemed eligible for inclusion in a qualitative synthesis. Our results suggested that psoriatic patients had a higher prevalence of fibromyalgia (8-30%), with a very high impact on symptoms of psoriasis. Moreover, fibromyalgic patients had a slightly increased prevalence of psoriasis (2.2-6.7%) compared to the control groups. Finally, several studies demonstrated the substantial impact of fibromyalgia on psoriatic outcome measures in patients with concomitant psoriatic arthritis. In conclusion, available data support a potential interplay between psoriasis and fibromyalgia, but further research is encouraged in this area.

Evaluating the Clinical Meaning of Dermatology Life Quality Index Scores Between Different Phenotypes of Atopic Dermatitis in Patients Before and After Biologic Therapy With Dupilumab.

Background and Objective: Atopic Dermatitis (AD) is the most prevalent inflammatory skin disorder resulting in an intense impact on patients quality of life. The aim of this study is to evaluate the clinical meaning of the DLQI scores documented between different phenotypes of AD patients under biologic therapy with Dupilumab. Method: We conducted a retrospective analysis of 209 patients with AD treated with Dupilumab for 2 years. These patients were categorized into different clinical phenotypes. Severity of the disease was assessed by using the Eczema Area and Severity Index (EASI), Numerical Scale Rating (NRS) for sleep (NRS sleep), pruritus (NRS pruritus) and Dermatology Life Quality Index (DLQI) at baseline and subsequently at 4,12 and 24 months. Results: Our results show that the higher DLQI scores (mean: 18.6, range:9-30) achieved at T0 are associated with a prurigo nodularis AD pattern, while after 24 months (T3) of therapy with Dupilumab, the worst quality of life index results were reported in Flexural and Head-Neck combined clinical phenotypes. Conclusions: Quality of life is probably what matters most as an overall endpoint in AD. Assessing the clinical meaning of DLQI scores across different AD phenotypes could be a further aid when considering decision making factors in patient management.

Long-Term Persistence Rate of Secukinumab in Psoriatic Patients: A Six-Year Multicenter, Real-World Experience, Retrospective Study.

Background: Psoriatic disease, a chronic immune-mediated systemic inflammatory condition, significantly impairs patients' quality of life. The advent of highly targeted biological therapies has transformed treatment strategies, emphasizing the importance of selecting the most effective and cost-efficient option. Secukinumab, an IL-17A inhibitor, has demonstrated efficacy and safety in treating moderate-to-severe plaque psoriasis (PsO). However, long-term real-world data on its effectiveness and persistence rate are limited. Methods: This retrospective study, conducted across eight Italian dermatology centers, aimed to evaluate the 6-year persistence rate and effectiveness of secukinumab in patients with PsO. Additionally, the study investigated the onset of psoriatic arthritis during treatment. Results: Overall, 166 adult patients were analyzed. Their median age was 53.9 years. The mean BMI was 26.5. Of the 166 patients, 64 were bio-experienced while 102 were bio-naïve. A progressive reduction in PsO severity measured by PASI scores over 6 years of treatment was revealed: the PASI score decreased from a baseline value of 18.1 (±9.1) to 0.7 (±1.6) after 6 years of follow-up. Adverse events, including mucocutaneous fungal infections and cardiovascular disturbances, were reported in 19.9% of patients. The persistence rate was 86.8% at 24 months, decreasing to 66.4% at 72 months. Psoriatic arthritis onset during treatment was observed in 15 (9.0%) of patients. Conclusions: This study highlights the sustained effectiveness and favorable safety profile of secukinumab over 6 years, providing valuable real-world evidence. Understanding the long-term persistence rate and predictors of discontinuation could help clinicians optimize treatment decisions and improve patient outcomes in PsO management. We found that the absence of scalp PsO, no involvement of the genital area and normal weight were the best factors of persistence in secukinumab treatment in the long term.

Exploring the Relationship Between Dermatology Life Quality Index, Eczema Area and Severity Index, and Sleep Numerical Rating Scale and Pruritus Numerical Rating Scale in Patients with Atopic Dermatitis Treated with Dupilumab.

Objective: Patients with atopic dermatitis (AD) experience decreased quality of life (QoL). Here we describe the relationship between severity and QoL-related scores in patients with moderate-to-severe AD treated with dupilumab. Patients and Methods: This was a real-life, retrospective, and observational study involving patients with AD treated with dupilumab. Treatment effectiveness was evaluated based on the changes in the eczema area and severity index (EASI), sleep quality numerical rating scale ,and pruritus numerical rating scale (PNRS), as well as the dermatology life quality index (DLQI). The relationship between each of them was analyzed. After the first data collection at baseline, patients were re-evaluated at 3 subsequent follow-ups (4, 8, and 12 months). Results: A total of 52 patients were enrolled in the study. At 4 months, the change in DLQI is more correlated with PNRSs (r = 0.643, P < 0.001) than the other scores considered. At 8 months, however, the change in DLQIs correlates similarly both with PNRSs (r = 0.644, P < 0.001) and with the change in EASIs (r = 0.633, P < 0.001). At 12 months of treatments, however, the trend reverses and the correlation with EASIs becomes higher (r = 0.735, P < 0.001) than PNRSs (r = 0.0.659, P < 0.001). Conclusions: The results of our study show that the reduction in the impact on QoL for AD patients in the first months of therapy with dupilumab correlates more with the control of pruritus than with the disappearance of skin lesions.

Teledermatology in 2020: past, present and future perspectives.

Born in 1995, teledermatology (TD) turns 25 years old today. Since then, TD evolved according to patients and physicians needs. The present review aimed to summarize all the efforts and experiences carried out in the field of TD and its subspecialties, the evolution and the future perspectives. A literature search was conducted in PubMed and Google Scholar. The state of the art of the "tele-dermo research" included TD and clinical trials, TD/TDS web platforms, TDS and artificial intelligence studies. Finally, the future perspective of TD/TDS in the era of social distancing was discussed. Using TD in specific situations adds several benefits including time-effectiveness of intervention and reduction in the waiting time for the first visit, reduced travel-costs, reduced sanitary costs, equalization of access from patient to specialistic consult. The communication technologies devices currently available can adequately support the growing needs of tele-assistance. A main limit is the current lack of a common clear European regulation for practicing TD, encompassing privacy issues and data management. The pandemic lockdown of 2020 has highlighted the importance of performing TD for all those patient, elderly and/or fragile, where the alternative would be no care at all. Many efforts are needed to develop efficient workflows and TD programs to facilitate the interplay among the different TD actors, along with practice guidelines or position statements.

Dupilumab in Elderly Patients With Severe Atopic Dermatitis.

BACKGROUND: Atopic dermatitis (AD) in the elderly has been poorly investigated, although its incidence is gradually increasing mainly in industrialized countries. Age-specific factors in older patients must be considered when selecting treatment options. OBJECTIVES: To evaluate the efficacy and tolerability of dupilumab in treating elderly patients with severe AD. METHODS: This was a retrospective, multicenter study involving 26 elderly patients (age, ≥65 years) with severe AD who were treated with dupilumab for at least 16 weeks. Absolute and percentage frequencies were used to evaluate qualitative variables and mean and SD for quantitative ones. For Eczema Area and Severity Index (EASI), Pruritus Numeric Rating Scale (NRS), and Dermatology Life Quality Index (DLQI), the median was also calculated. Wilcoxon test was used to evaluate the variations in EASI, Pruritus NRS, and DLQI observed between the 2 examinations. RESULTS: After 4 months of therapy, the majority of patients showed a significant improvement in EASI (64.4%), Pruritus NRS (58.2%), and DLQI (44.9%). Only 11% of patients reported mild or moderate conjunctivitis. CONCLUSIONS: To the best of our knowledge, this is the first study concerning the use of dupilumab in the elderly with severe AD. Our data show the effectiveness of dupilumab in this particular population with a lower percentage of conjunctivitis than observed in studies on adults and also excellent control of itching. Only larger, controlled case studies will be able to clarify whether the dosage or frequency of administration of dupilumab in these patients should be different from the protocol used for adults.