Paolo Calzari

Dr. Paolo Calzari


Research Focus & Metrics

Academic Career Length

6Years (2021-Present)

(Calculated once Scilit publication data is synced: current year − year of first publication + 1)

Representative Publications

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7 November 2024 in Pharmaceuticals
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RARiccardo Asero
Riccardo Asero
PCPaolo Calzari
Paolo Calzari
SVSilvia Vaienti
Silvia Vaienti
MCMassimo Cugno
Massimo Cugno
Chronic spontaneous urticaria (CSU) is a complex dermatological condition characterized by recurrent wheals and/or angioedema lasting for more than six weeks, significantly impairing patients’ quality of life. According to European guidelines, the first step in treatment involves second-generation H1-antihistamines (sgAHs), which block peripheral H1 receptors to alleviate symptoms. In cases with inadequate responses, the dose of antihistamines can be increased by up to fourfold. If symptoms persist despite this adjustment, the next step involves the use of omalizumab, a monoclonal anti-IgE antibody, which has shown efficacy in the majority of cases. However, a subset of patients remains refractory, necessitating alternative treatments such as immunosuppressive agents like cyclosporine or azathioprine. To address these unmet needs, several new therapeutic targets are being explored. Among them, significant attention is being given to drugs that block Bruton’s tyrosine kinase (BTK), such as remibrutinib, which reduces mast cell activation. Therapies like dupilumab, which target the interleukin-4 (IL-4) and IL-13 pathways, are also under investigation. Additionally, molecules targeting the Mas-related G protein-coupled receptor X2 (MRGPRX2), and those inhibiting the tyrosine kinase receptor Kit, such as barzolvolimab, show promise in clinical studies. These emerging treatments offer new options for patients with difficult-to-treat CSU and have the potential to modify the natural course of the disease by targeting key immune pathways, helping to achieve longer-term remission. Further research is essential to better elucidate the pathophysiology of CSU and optimize treatment protocols to achieve long-term benefits in managing this condition. Altogether, the future of CSU treatments that target pathogenetic mechanisms seems promising.

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Journal Article
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RARiccardo Asero
Riccardo Asero
Silvia Mariel FerrucciSilvia Mariel Ferrucci
Silvia Mariel Ferrucci
PCPaolo Calzari
Paolo Calzari
Dario ConsonniDario Consonni
Dario Consonni
MCMassimo Cugno
Massimo Cugno
The response of severe chronic spontaneous urticaria (CSU) to omalizumab largely depends on the autoimmune or autoallergic endotype of the disease. Whether thyroid autoimmunity may predict omalizumab response along with total IgE in CSU is still unclear. Three hundred and eighty-five patients (M/F 123/262; mean age 49.5 years; range 12–87 years) with severe CSU were studied. Total IgE levels and thyroid autoimmunity (levels of anti-thyroid peroxidase [TPO] IgG) were measured before omalizumab treatment. Based on the clinical response, patients were divided into early (ER), late (LR), partial (PR) and non (NR) responders to omalizumab. Thyroid autoimmunity was detected in 92/385 (24%) patients. Altogether, 52%, 22%, 16% and 10% of patients were ER, LR, PR and NR to omalizumab, respectively. Response to omalizumab was not associated with thyroid autoimmunity (p = 0.77). Conversely, we found a strongly positive association between IgE levels and omalizumab response (p < 0.0001); this association was largely driven by early response (OR = 5.46; 95% CI: 2.23–13.3). Moreover, the predicted probabilities of early response strongly increased with increasing IgE levels. Thyroid autoimmunity alone cannot be used as a clinical predictor of omalizumab response. Total IgE levels remain the only and most reliable prognostic marker for omalizumab response in patients with severe CSU.

10 October 2025 in Dermatology and Therapy
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GAGianluca Avallone
Gianluca Avallone
ABAndrea Bombelli
Andrea Bombelli
Luigi GargiuloLuigi Gargiulo
Luigi Gargiulo
CFCATERINA FOTI
CATERINA FOTI
ITIlaria Trave
Ilaria Trave
Silvia Mariel FerrucciSilvia Mariel Ferrucci
Silvia Mariel Ferrucci
Introduction Atopic dermatitis (AD) is a chronic inflammatory skin condition that significantly affects the quality of life (QoL). Lebrikizumab, a biologic drug targeting interleukin-13, demonstrated efficacy and safety in clinical trials. However, real-world data remain limited, largely restricted to Asian populations. Methods This 16-week retrospective multicenter study included 78 adults from a predominantly white cohort with moderate-to-severe AD treated with lebrikizumab throughout 2024. Patients were both naïve and experienced with biologics or Janus kinase inhibitors (bio/JAKi-naïve or -experienced). The primary outcome for disease severity and therapeutic response was measured using the Eczema Area and Severity Index (EASI). Secondary outcomes included the Dermatology Life Quality Index (DLQI), itch- and sleep-numerical rating scales (NRS), body surface area (BSA), Investigator Global Assessment (IGA), SCORing Atopic Dermatitis (SCORAD), and Patient-Oriented Eczema Measure (POEM). Atopic Dermatitis Control Tool (ADCT) and minimal disease activity (MDA) were used to estimate disease control, and Hospital Anxiety and Depression Scales to monitor mental health status. Results At week 16, benefits in disease severity were observed for EASI (− 15.8 ± 9.4, p < 0.0001) and EASI head and neck (− 2.0 ± 1.7, p < 0.0001). QoL significantly improved in 70% of patients (DLQI reduction of − 12.6 ± 9.3, p < 0.0001), accompanied by decreased pruritus (Itch-NRS reduction of − 4.6 ± 3.2, p < 0.0001) and better sleep quality (sleep-NRS reduction of − 4.1 ± 3.4, p < 0.0001). A 76% reduction in BSA score was recorded, 85% of subjects improved their IGA index, with 62% achieving a score of 0–1, and SCORAD and POEM assessments significantly improved (p < 0.0001). Patients perceived a better control of the disease (ADCT, − 10.9 ± 7.1, p < 0.0001), and 14% of patients achieved MDA. Anxiety and depression levels decreased. Four mild adverse events were registered. Conclusions This is one of the first real-world multicenter studies in a predominantly adult white population showing that lebrikizumab is effective, safe and improves symptoms, QoL, and mental health in moderate-to-severe AD bio/JAKi-naïve and -experienced patients.

21 September 2024 in Journal of Clinical Medicine
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PCPaolo Calzari
Paolo Calzari
AGAlessandra Chiei Gallo
Alessandra Chiei Gallo
FBFrancesca Barei
Francesca Barei
EBEleonora Bono
Eleonora Bono
MCMassimo Cugno
Massimo Cugno
Silvia Mariel FerrucciSilvia Mariel Ferrucci
Silvia Mariel Ferrucci
Background: Omalizumab, an anti-IgE monoclonal antibody, is an effective treatment for patients with chronic spontaneous urticaria (CSU) resistant to antihistamines, but about 10% are unresponsive. Our aim was to assess the effectiveness, safety, and drug survival (DS) of omalizumab by considering clinical and laboratory characteristics. Methods: We conducted a retrospective study on 296 patients with severe CSU treated with omalizumab. Disease activity, comorbidities, and serum levels of total IgE and anti-thyroid autoantibodies were evaluated over a period of up to 8 years. DS was analyzed using unadjusted Kaplan–Meier survival curves. When applicable, the risk of discontinuation was assessed using Cox regression analysis. Results: Out of 296 patients, 118 (40.4%) were early responders, 72 (25.0%) were late responders, 76 (26.0%) were partial responders, and 25 (8.6%) were non-responders. Early responders were more likely to be patients without associated inducible urticaria (p = 0.021, χ2 = 9.692), without autoimmune thyroiditis (p = 0.007, χ2 = 12.037), and those with higher IgE levels (p = 0.039, χ2 = 8.385). Overall, DS was 53.5% at 8 years, primarily due to clinical remission. DS due to inefficacy and clinical remission were 83.9% and 62.1%, respectively, at 8 years. No patients discontinued omalizumab due to adverse events. Patients with normal IgE levels (p = 0.012, HR = 4.639, CI: 1.393–15.445) and those with autoimmune thyroiditis (p = 0.028, HR = 3.316, CI: 1.128–8.718) had a higher risk of discontinuing omalizumab due to inefficacy. Conclusions: This study confirms the long-term effectiveness and safety of omalizumab in the treatment of CSU over a period of up to 8 years. Most patients discontinued omalizumab due to clinical remission, while only 5.1% discontinued it due to ineffectiveness.

14 January 2023 in Journal of Clinical Medicine
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PCPaolo Calzari
Paolo Calzari
SVSilvia Vaienti
Silvia Vaienti
Gianluca NazzaroGianluca Nazzaro
Gianluca Nazzaro
The effects of UV radiation on the skin and its damage mechanisms are well known. New modalities of exogenous photoprotection have been studied. It was demonstrated that Polypodium leucotomos extract acts as an antioxidant, photoprotectant, antimutagenic, anti-inflammatory, and immunoregulator. It is effective when taken orally and/or applied topically to support the prevention of skin cancers. It also has an important role in preventing photoaging. This review aims to report the mechanisms through which Polypodium leucotomos acts and to analyze its uses in oncodermatology with references to in vitro and in vivo studies. Additionally, alternative uses in non-neoplastic diseases, such as pigmentary disorders, photosensitivity, and atopic dermatitis, have been considered.

16 January 2024 in Pharmaceuticals
Verified
Journal Article
Open access
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FBFrancesca Barei
Francesca Barei
MZMartina Zussino
Martina Zussino
STSimona Tavecchio
Simona Tavecchio
LALuisa Angileri
Luisa Angileri
ARArianna Rizzo
Arianna Rizzo
Silvia Mariel FerrucciSilvia Mariel Ferrucci
Silvia Mariel Ferrucci
Background: The main objective was to analyze patient-reported outcomes (PRO) trends over a four-year period in severe atopic dermatitis (AD) patients treated with dupilumab. Methods: data from 126 severe patients receiving dupilumab for at least 48 months were collected. The clinical scores assessed included the Eczema Area and Severity Index (EASI), Pruritus Numerical Rating Scale (NRS), Sleep NRS, Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), and Atopic Dermatitis Control Tool (ADCT). Results: the study compellingly demonstrates dupilumab’s effectiveness in reducing EASI and improving PROs, with sustained enhancements observed beyond the initial twelve months of treatment. Univariate and multivariate regression analyses show that baseline factors do not significantly increase the risk of adverse outcomes related to Pruritus NRS, POEM, or ADCT at T48. The robust correlation between ADCT and other PROs suggests closely aligned changes. Conclusion: Dupilumab’s benefits endure beyond the first year, emphasizing its long-term efficacy, and consistently improves AD outcomes regardless of individual characteristics or clinical variables. ADCT appears to be a practical and versatile tool for the streamlined assessment of AD treatment outcomes.