Publications by authors named "Francesca Prignano"

95 Publications

Guselkumab: an anti-IL-23 antibody for the treatment of moderate-to-severe plaque psoriasis.

Eur J Dermatol 2021 Mar 1. Epub 2021 Mar 1.

Dermatology Unit "Daniele Innocenzi", Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Polo Pontino, Corso della Repubblica, 7904100 Latina, Rome, Italy.

Guselkumab, a subcutaneously administered fully human IgG1λ monoclonal antibody that selectively inhibits the p19 subunit of interleukin 23, is approved in both the USA and the EU for the treatment of adult patients with moderate-to-severe plaque psoriasis. The efficacy and safety of guselkumab were demonstrated in four randomized, double-blind, Phase III trials (VOYAGE 1 and 2, NAVIGATE, and ECLIPSE), which demonstrated high levels of clinical response over three years of continuous treatment, regardless of sex, age, body weight, and race, maintaining a favourable safety profile and long-term tolerability. Guselkumab was shown to be efficacious in patients with prior failure of other biologics, including adalimumab and ustekinumab, and was superior to both adalimumab and secukinumab in head-to-head trials. Guselkumab efficacy was also observed in the treatment of psoriasis localized in difficult-to-treat body regions including the scalp, palms and/or soles, and fingernails. Treatment with guselkumab improved health-related quality of life and patient-reported signs and symptoms. Guselkumab has a consistently favourable safety profile and is well tolerated over the long-term. Clinical development of guselkumab as a treatment is ongoing for other immune-mediated inflammatory diseases, including psoriatic arthritis, Crohn's disease, and ulcerative colitis. In the overall management of patients with plaque psoriasis, guselkumab is a robust treatment option with durable maintenance of response over time.
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http://dx.doi.org/10.1684/ejd.2021.3965DOI Listing
March 2021

Treat-to-Target Approach for the Management of Patients with Moderate-to-Severe Plaque Psoriasis: Consensus Recommendations.

Dermatol Ther (Heidelb) 2021 Feb 11;11(1):235-252. Epub 2021 Jan 11.

Institute of Dermatology, Catholic University, Largo Francesco Vito, 1, 00168, Rome, Italy.

Introduction: Treat-to-target strategies are used in several chronic diseases to improve outcomes. Treatment goals have also been suggested for psoriasis, but there is currently no consensus on targets, and guidance is needed to implement this strategy in clinical practice. The project 'Treat to Target Italia' was launched by a scientific board (SB) of 10 psoriasis experts to generate expert consensus recommendations.

Methods: On the basis of the published literature, their clinical experience, and the results of a survey among Italian dermatologists, the SB identified four relevant topics: (1) clinical remission; (2) quality of life; (3) abrogation of systemic inflammation; (4) safety. They drafted 20 statements addressing these four topics and submitted them to a panel of 28 dermatologists, in a Delphi process, to achieve consensus (greater than 80% agreement).

Results: Consensus was reached on all statements. Treatment goals defining clinical remission should include a 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI90 response) or an absolute PASI score of less than or equal to 3. Patient's quality of life and satisfaction are important targets. If PASI targets are achieved, there should be no or very low impact of psoriasis on quality of life [Dermatology Life Quality Index (DLQI) score less than or equal to 3]. If PASI or DLQI goals are not achieved within 3-4 months, treatment should be changed. Abrogation of systemic inflammation may be crucial for preventing or delaying inflammatory comorbidities. Safety is an equally important target as efficacy.

Conclusion: These 20 consensus statements define the parameters of a treat-to-target strategy for psoriasis in Italy. It is hoped that use of these in the management of patients with psoriasis will improve treatment outcomes and patient health-related quality of life.
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http://dx.doi.org/10.1007/s13555-020-00475-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7859133PMC
February 2021

Secukinumab Improves Patient Perception of Anxiety and Depression in Patients with Moderate to Severe Psoriasis: A Post hoc Analysis of the SUPREME Study.

Acta Derm Venereol 2020 12 3. Epub 2020 Dec 3.

Dermatology Unit, Policlinico Tor Vergata, 00133 Rome, Italy.

This study evaluated whether secukinumab treatment for patients with moderate to severe plaque psoriasis correlates with improvements in symptoms of anxiety and depression. SUPREME was a 24-week, phase IIIb, multicentre, prospective study conducted across 50 centres in Italy with an extension period of up to 72 weeks. Assessments used were: Psoriasis Area Sever­ity Index (PASI), Hospital Anxiety and Depression Scale (HADS) – Anxiety (HADS-A), and HADS – Depression (HADS-D) scores and Dermatology Quality Life Index (DLQI). Compared with baseline, a significantly greater proportion of patients who reported moderate to severe clinical symptoms of anxiety or depression (HADS-A or HADS-D ≥ 11) were free of moderate to severe symptoms at weeks 16 and 48. The PASI and DLQI scores reduced over time with secukinumab treatment. Psoriasis treatment with secukinumab for 48 weeks resulted in significantly improved skin clearance and a parallel improvement in symptoms of anxiety and depression, assessed by HADS.
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http://dx.doi.org/10.2340/00015555-3712DOI Listing
December 2020

Characteristic of chronic plaque psoriasis patients treated with biologics in Italy during the COVID-19 Pandemic: Risk analysis from the PSO-BIO-COVID observational study.

Expert Opin Biol Ther 2021 02 13;21(2):271-277. Epub 2021 Jan 13.

Fondazione Policlinico Universitario A. Gemelli IRCCS, Dermatologia, Dipartimento Scienze Mediche e Chirurgiche , Rome, Italy.

: The susceptibility of patients with chronic plaque psoriasis and the risks or benefits related to the use of biological therapies for COVID-19 are unknown. Few data about prevalence, clinical course and outcomes of COVID-19 among psoriatic patients were reported. The aims of this study were 1) to assess the prevalence and severity of COVID-19 in psoriatic patients treated with biologic agents during the first phase of the emergency (22 February to 22 April 2020) in Italy, and 2) to report the clinical outcomes of patients who have been exposed to individuals with confirmed SARS-CoV-2 infection. : Patients with moderate-to-severe chronic plaque psoriasis, aged ≥18 years and undergoing treatment with biologic agents as of 22 February 2020, were eligible to be included in PSO-BIO-COVID study. Demographic and clinical characteristics of patients using any biologic for psoriasis treatment between 22 February and 22 April 2020 were registered. : A total of 12,807 psoriatic patients were included in the PSO-BIO-COVID study. In this cohort 26 patients (0.2%) had a swab confirmation of SARS-CoV-2 infection. Eleven patients required hospitalization and two died. : The incidence of COVID-19 observed in our cohort of psoriatic patients (0.2%) is similar to that seen in the general population (0.31%) in Italy. However, the course of the disease was mild in most patients. Biological therapies may likely lessen 'cytokine storm' of COVID-19, which sometimes lead to multiple organ failure, ARDS, and death.
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http://dx.doi.org/10.1080/14712598.2021.1853698DOI Listing
February 2021

Understanding and Minimising Injection-Site Pain Following Subcutaneous Administration of Biologics: A Narrative Review.

Rheumatol Ther 2020 Dec 18;7(4):741-757. Epub 2020 Nov 18.

Department and Hiller Research Unit of Rheumatology, University Clinic Düsseldorf (UKD), Heinrich Heine University, Düsseldorf, Germany.

Injection-site pain (ISP) is a subjective side effect that is commonly reported with the subcutaneous administration of biological agents, yet it may only be a concern to some. Multiple factors related to the product formulation, such as pH, volume and excipients, and/or to the injection process have the potential to contribute to ISP, while patient-related factors, such as low body weight, gender and age, can make an individual more susceptible to experiencing ISP. While total elimination of ISP remains unlikely with any subcutaneously administered agent, it can be minimised by helping the patient to develop a confident and competent injection technique via robust and effective training. Careful management of patient expectations along with open discussion regarding the potential risk of ISP may serve to minimise treatment-related anxieties and, importantly, allow the patient to remain in control of his/her treatment. Other interventions to help minimise ISP include psychological interventions, allowing biologics to reach room temperature prior to injection, using the most suitable injection device for the individual patient and selecting an alternative drug formulation, when available. Productive patient-physician communication remains important in order to support and optimise treatment experience and adherence, while also providing the opportunity for patients to discuss any ISP-related issues.
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http://dx.doi.org/10.1007/s40744-020-00245-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7672413PMC
December 2020

Management of psoriatic arthritis in rheumatology and dermatology settings: sub-analysis of the Italian population from the international LOOP study.

Clin Rheumatol 2020 Nov 6. Epub 2020 Nov 6.

UOC di Dermatologia, AO San Pio di Benevento, Benevento, Italy.

Psoriatic arthritis (PsA) patients are often treated by dermatology and rheumatology specialities and may receive different treatments. To evaluate the impact of dermatology/rheumatology specialist settings on diagnosis and therapeutic approach in PsA patients. This cross-sectional multicounty study in Italy involved twenty-eight rheumatology or dermatology clinics. Patients with suspected or confirmed PsA were examined by both a dermatologist and a rheumatologist. A total of 413 patients were enrolled and 347 (84%) were diagnosed with PsA. The majority of patients were enrolled from a rheumatology setting (N = 224, 64.6%). Patients with PsA in the dermatology settings had significantly higher disease activity, including skin involvement and musculoskeletal symptoms. Time from PsA onset to diagnosis was 22.3 ± 53.8 vs. 39.4 ± 77.5 months (p = 0.63) in rheumatology and dermatology settings; time from diagnosis to initiation of csDMARD was 7.3 ± 27.5 vs. 19.5 ± 50.6 months, respectively (p < 0.001). In contrast, time from diagnosis to bDMARD use was shorter in dermatology settings (54.9 ± 69 vs. 44.2 ± 65.6 months, p = 0.09, rheumatology vs. dermatology), similar to the time taken from first csDMARDs and bDMARDs (48.7 ± 67.9 vs. 35.3 ± 51.9 months, p = 0.34). The choice to visit a rheumatologist over a dermatologist was positively associated with female gender and swollen joints and negatively associated with delay in time from musculoskeletal symptom onset to PsA diagnosis. This study highlights a diagnostic delay emerging from both settings with significantly different therapeutic approaches. Our data reinforce the importance of implementing efficient strategies to improve early identification of PsA that can benefit from the integrated management of PsA patients. Key Points • A diagnostic delay was observed from both dermatology and rheumatology settings with significantly different therapeutic approaches. • Shared dermatology and rheumatology clinics offer the combined expertise to improve in the early identification and management of PsA.
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http://dx.doi.org/10.1007/s10067-020-05482-wDOI Listing
November 2020

Effectiveness and Safety of Anti-interleukin-17 Therapies in Elderly Patients with Psoriasis.

Acta Derm Venereol 2020 11 4;100(18):adv00316. Epub 2020 Nov 4.

Department of Dermatology, CH Victor Dupouy, FR-95100 Argenteuil, France. E-mail:

Anti-interleukin-17 agents have recently been developed for the treatment of psoriasis. This study evaluated the tolerance and effectiveness of anti-interleukin-17 agents for psoriasis in elderly patients in daily practice. A multicentre, retrospective study was performed, involving psoriatic patients aged ≥65 years who had received an anti-interleukin-17 agent, including secukinumab, ixekizumab or brodalumab. A total of 114 patients were included: 72 received secukinumab, 35 ixekizumab, and 7 brodalumab. Treatment was stopped in 32 patients (28.9%), because of relapses in 14 patients (41.2%), primary failures in 11 patients (32.4%), or adverse events in 7 patients (20.6%). The 3 most frequently reported adverse events were injection site reactions (n = 4), oral candidiasis (n = 3), and influenza-like illness (n = 3). Regarding effectiveness, 80 patients (70%) reached a Physician Global Assessment score of 0/1, 6 months after treatment initiation. In conclusion, anti-interleukin-17 therapy appears to be an effective and safe therapeutic option for psoriasis treatment in patients aged ≥ 65 years.
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http://dx.doi.org/10.2340/00015555-3678DOI Listing
November 2020

Psoriasis and its management in women of childbearing age: tools to increase awareness in dermatologists and patients.

G Ital Dermatol Venereol 2020 Aug;155(4):434-440

Section of Dermatology, Department of Health Sciences, University of Florence, Florence, Italy.

Psoriasis is a common, chronic inflammatory disease with a multifactorial pathogenesis. Mean age at presentation of psoriasis is 28 years in women, which is almost the height of fertility age. Since women of childbearing potential represent a significant proportion of psoriatic patients, the impact of psoriasis and its treatment on fertility, pregnancy, and breastfeeding should be highlighted for a proper management. Therefore, when approaching to a psoriatic woman of childbearing age, Healthcare Providers should be adequately informed and ready to provide the patients with answers to the most frequently asked questions. The Italian Society of Dermatology and Venereology (SIDeMaST) has fostered a Task Force named "Psoriasis in Women of Childbearing Age" which is composed by a group of Italian female dermatologists with a high expertise in psoriasis treatment. The aims of the Task Force are to increase awareness of the disease and its treatment in patients of childbearing age among both dermatologists and women affected by psoriasis and to encourage counselling on family planning. With the aim of providing a real support for the proper management of the delicate journey to motherhood, the Italian Task Force has published two different informative booklets addressed to patients and dermatologists which focus on the main issues regarding psoriasis in women of childbearing age.
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http://dx.doi.org/10.23736/S0392-0488.20.06748-6DOI Listing
August 2020

Intellectual Disability and Hidradenitis Suppurativa.

Dermatology 2020 Oct 9:1-3. Epub 2020 Oct 9.

Section of Dermatology, Department of Health Sciences, University of Florence, Florence, Italy,

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http://dx.doi.org/10.1159/000510655DOI Listing
October 2020

Clinical experience with adalimumab biosimilar imraldi in hidradenitis suppurativa.

Dermatol Ther 2020 11 19;33(6):e14387. Epub 2020 Oct 19.

Department of Health Sciences, Section of Dermatology, University of Florence, Florence, Italy.

Adalimumab is the only biologic therapy approved for the treatment of patients with hidradenitis suppurativa, a chronic and disabling skin condition. To date, there are no studies in the literature about the effectiveness of adalimumab biosimilar SB5 in hidradenitis suppurativa. The aim of this study was to evaluate its efficacy and safety. A retrospective observational study was performed in hidradenitis suppurativa adalimumab naive patients and in patients who were switched from the adalimumab originator. Eleven patients were included in the study. Our results support adalimumab SB5 as an effective and well tolerated drug, with a good interchangeability with its originator also for the treatment of hidradenitis suppurativa.
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http://dx.doi.org/10.1111/dth.14387DOI Listing
November 2020

Anti-tumor necrosis factor agents in psoriasis: addressing key challenges using biosimilars.

Expert Opin Biol Ther 2021 Jan 4;21(1):75-80. Epub 2020 Sep 4.

Department of Dermatology, Aarhus University Hospital , Aarhus, Denmark.

Introduction: Anti-tumor necrosis factor agents are key treatment options in moderate-severe psoriasis. The advent of multiple biosimilars of these drugs provides a major opportunity to address this particular factor by helping to reduce costs. Reduced cost can help improve undertreatment, which is one of the challenges in treating moderate-severe psoriasis. There is now a wealth of real-world evidence demonstrating that patients with psoriasis can be initiated on - or transitioned to - an anti-TNF biosimilar without detrimental effects on overall safety and efficacy. Furthermore, recent results suggest that patients can be switched between different biosimilar versions of the same anti-TNF agent without any compromise in outcomes.

Areas Covered: In this review, we summarized the role of anti-TNFs in psoriasis, health economic aspects of anti-TNF biosimilars, and their real-world data in clinical practice and registries.

Expert Opinion: The introduction and competition of anti-TNF biosimilars reduced the cost of biologics and accumulated real-world data support efficacy and safety of anti-TNF biosimilars for psoriasis treatment. Although IL-17 and IL-23 inhibitors show better efficacy in psoriasis patients, long-term efficacy and safety data of anti-TNF and cost-effectiveness of anti-TNF biosimilars may play an important role to increase patient access to biologics through greater adoption of biosimilars.
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http://dx.doi.org/10.1080/14712598.2020.1812576DOI Listing
January 2021

Patients' demographic and socioeconomic characteristics influence the therapeutic decision-making process in psoriasis.

PLoS One 2020 12;15(8):e0237267. Epub 2020 Aug 12.

Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.

Background: Knowledge regarding differences in care for psoriatic patients is limited. The aim of this study was to investigate factors influencing prescription of systemic treatments for patients with psoriasis with a special focus on socioeconomic factors.

Methods And Findings: This was a non-interventional, cross-sectional study, conducted in 18 Italian University and/or hospital centers with psoriasis-specialized units. Questionnaires evaluating demographic and socioeconomic characteristics were administered to participants. Overall, 1880 consecutive patients affected by mild-to-severe psoriasis were recruited. Univariate and multivariable logistic regression analyses of systemic therapy prescription, with a special focus on biologics, accounting for the above mentioned characteristics were performed. Our analysis showed that all analyzed patients' characteristics were significantly associated with biological therapy compared to non-biological systemic one. Particularly, women were less likely to receive biologics than men (OR = 0.66; 95% CI, 0.57-0.77). Elderly patients (≥65 years) and subjects with a BMI ≥30 had lower odds to receive biologics respect to adults (≥35-64 years) (OR = 0.33; 95% CI, 0.25-0.40), and subjects with BMI≥25<30 (OR = 0.64; 95% CI, 0.53-0.77), respectively. Northern and Southern patients were both less likely to receive biologics than Central patients (OR = 0.75; 95% CI, 0.63-0.89, and OR = 0.56; 95% CI,0.47-0.68, respectively). Lower economic profile and never reading books were both associated with decreased odds of receiving biological therapy.

Conclusions: This study shows that sex, age, comorbidities, and socioeconomic characteristics influence the prescription of systemic treatments in psoriasis, highlighting that there are still unmet needs influencing the therapeutic decision-making process that have to be addressed.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0237267PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7423114PMC
October 2020

Real-World Effectiveness and Safety of Apremilast in Older Patients with Psoriasis.

Drugs Aging 2020 09;37(9):657-663

Service de Dermatologie, Hôpital Victor Dupouy, 69 rue du Lieutenant-Colonel Prud'hon, 95100, Argenteuil, France.

Introduction: Apremilast is a drug recently developed for psoriasis. Few data are available on its use in the elderly. We evaluated the tolerance and effectiveness of apremilast used in daily practice for psoriasis treatment in older patients.

Methods: We performed a multicenter, retrospective study involving patients aged ≥ 65 years who had received apremilast as a psoriasis treatment. Demographic data and details regarding psoriasis and adverse events (AEs) were collected from patient medical records.

Results: 135 patients were included (mean age: 73.5 years). Treatment was stopped in 74 patients (54.8%) for AEs (n = 43, 56.6%), primary failures (n = 18, 23.4%), and relapses (n = 7, 9.2%). When patients were stratified by age at treatment initiation, the main cause of discontinuation in patients ≥ 75 years was AEs, whereas in patients aged 65-74 years it was primary failures (28.3%). Sixty-one patients reported AEs, mainly digestive (n = 49). Regarding effectiveness, 45.2% of patients reached PGA 0/1 between 3 and 6 months after treatment initiation. One-year apremilast continuation rates were better in the 65-74 and 75-84 years subgroups than in the > 85 years subgroup (p = 0.01).

Conclusion: Apremilast seems to be an effective and safe therapeutic option for psoriasis in the elderly. The main AEs reported by patients did not seem to differ from those reported previously in younger populations. However, AEs were more frequent in patients > 75 years old leading to more frequent discontinuation of apremilast compared with younger patients, suggesting a higher level of vigilance is needed in the elderly.
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http://dx.doi.org/10.1007/s40266-020-00781-yDOI Listing
September 2020

Novel Therapeutic Approaches and Targets for the Treatment of Atopic Dermatitis.

Curr Pharm Biotechnol 2021 ;22(1):73-84

Dermatology Unit, Department of Health Sciences, University of Florence, Florence, Italy.

Background: Atopic Dermatitis is one of the most common inflammatory skin diseases, with an estimated prevalence of 2.1-4.9% in adults. Recently, advances in Atopic Dermatitis understanding have highlighted the role of inappropriate Th2 cell activation as principally involved in its pathogenesis. Other immune pathways seem to play a key role in the complex Atopic Dermatitis pathophysiology. The anti-IL-4/IL-13 was the first monoclonal antibody approved for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is resistant to other therapies. Following its interesting results in terms of efficacy and safety, new therapies are in development.

Methods: Monoclonal antibodies targeting IL-5, IL-13, IL-17, IL-22, IL-23, IL-31 and TSLP are currently under investigation on patients with moderate to severe Atopic Dermatitis patients. Moreover, small molecules like anti-PDE4 and JAK inhibitors may also represent other treatment possibilities.

Results: In this section, we present data available on the efficacy and safety of newer molecules for the treatment of Atopic Dermatitis.

Conclusion: The extreme clinical heterogeneity and the chronic progression of Atopic Dermatitis need for newer, safer and more effective treatments, able to control the disease and to improve the quality of life of affected patients. Dupilumab, and the other monoclonal antibodies and small molecules currently under investigation aim to improve the clinical management of Atopic Dermatitis.
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http://dx.doi.org/10.2174/1389201021666200611112755DOI Listing
February 2021

Is biologic treatment of hidradenitis suppurativa during the COVID-19 pandemic different from psoriasis biologic treatment?

J Dermatolog Treat 2020 Jun 19. Epub 2020 Jun 19.

Department of Health Sciences, Section of Dermatology, University of Florence, Florence, Italy.

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http://dx.doi.org/10.1080/09546634.2020.1771256DOI Listing
June 2020

Molluscum contagiosum in pediatric patients: to treat or not to treat? Could a personalized imiquimod regimen be the answer to the dilemma?

J Dermatolog Treat 2020 Jun 22:1-6. Epub 2020 Jun 22.

Department of Dermatology, The Princess Alexandra Hospital NHS Trust, Harlow, UK.

Although molluscum contagiosum virus (MCV) infection is a common disease widespread among children and young adults, there is no shared opinion on treatment that can be divided into physical, chemical, medical (immunomodulating or anti-viral). According to some authors, MCV is best left to clear by itself. To assess the clearance of MCV lesions in a sample of pediatric patients. It compares outcomes in treated with Imiquimod cream, compared with non-treated patients. The sample consits of 48 pediatric patients affected by MVC clinically diagnosed. It was divided into two groups: Group I, treated with Imiquimod 5% cream once/day until the onset of a visible inflammatory reaction. Once the reaction was illicited, application was suspended until the irritation resolved. If the lesion was still present, drug was administered again using the same regimen. The cycle was repeated until complete clinical resolution. Group II, control, comprises non-treated patients. Follow up visits were carried out 12, 16, 20, 48, and 52 weeks from the beginning of treatment. At week 20, all patients except one in the treated group were lesion free. Persistence of MCV lesions was documented in one patient only until week 48. In the control group all patients were still affected by MCV lesions during the follow-up period. Spontaneous clinical resolution of the infection was observed in only 2 patients at week 52. The results of the study show Imiquimod's significant efficacy. Our study is one of the few case-control studies in pediatric population carried out with such long-term follow-up. Efficacy of this personalized treatment, scarce recurrence, absence of cicatricial sequelae and lack of necessity for deep sedation, in the case of children with disseminated lesions, makes the use of Imiquimod the first line of treatment compared with other destructive treatments or with no-treatment at all.
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http://dx.doi.org/10.1080/09546634.2020.1762840DOI Listing
June 2020

COVID-19 and psoriasis: Should we fear for patients treated with biologics?

Dermatol Ther 2020 Jul 5;33(4):e13434. Epub 2020 May 5.

Clinic of Dermatology, Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti, Italy.

The new coronavirus pandemic poses question and challenges for dermatologists. One of question is if psoriasis patients treated with immunomodulating and immunosuppressive drugs have to discontinue their treatment in the midst of fears for the infection and its consequences. One of the challenges is how can we support our patients in this critical time. Previous coronaviruses outbreaks reports, current published evidences on pathogenesis and on clinical reports of COVID infection in immunosuppressed patients are used to make a scientifically based decision.
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http://dx.doi.org/10.1111/dth.13434DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7235531PMC
July 2020

The psoriatic shift induced by interleukin 17 is promptly reverted by a specific anti-IL-17A agent in a three-dimensional organotypic model of normal human skin culture.

Eur J Histochem 2020 Apr 16;64(2). Epub 2020 Apr 16.

Department of Biomedical Sciences for Health, University of Milan.

Interleukin 17A (IL-17A), mainly produced by the T helper subclass Th17, plays a key role in the psoriatic plaque formation and progression. The clinical effectiveness of anti-IL-17A agents is documented, but the early and specific mechanisms of their protection are not identified yet. The challenge of the present study is to investigate the possible reversal exerted by a specific anti-IL-17A agent on the psoriatic events induced by IL-17A in a three-dimensional organotypic model of normal human skin. Bioptic skin fragments obtained after aesthetic surgery of healthy women (n=5) were incubated with i) IL-17A biological inhibitor (anti-IL-17A), ii) IL-17A, iii) a combination of IL-17A and its specific IL-17A biological inhibitor (COMBO). A Control group was in parallel cultured and incubation lasted for 24 and 48 h epidermal-side-up at the air-liquid interface. All subjects were represented in all experimental groups at all considered time-points. Keratinocyte proliferation and the presence of epidermal Langerhans cells were quantitatively estimated. In parallel with transmission electron microscopy analysis, immunofluorescence studies for the epidermal distribution of keratin (K)10, K14, K16, K17, filaggrin/occludin, Toll-like Receptor 4, and Nuclear Factor kB were performed. IL-17A inhibited cell proliferation and induced K17 expression, while samples incubated with the anti-IL-17A agent were comparable to controls. In the COMBO group the IL-17A-induced effects were almost completely reverted. Our study, for the first time, elucidates the most specific psoriatic cellular events that can be partially affected or completely reverted by a specific anti-IL-17A agent during the early phases of the plaque onset and progression. On the whole, this work contributes to expand the knowledge of the psoriatic tableau.
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http://dx.doi.org/10.4081/ejh.2020.3115DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7171424PMC
April 2020

SB5 adalimumab biosimilar in the treatment of psoriasis and psoriatic arthritis.

Dermatol Ther 2020 05 11;33(3):e13435. Epub 2020 May 11.

Department of Health Sciences, Section of Dermatology, University of Florence, Florence, Italy.

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http://dx.doi.org/10.1111/dth.13435DOI Listing
May 2020

Optimizing a clinical guidance for diagnosis of atopic dermatitis in adults: joint recommendations of the Italian Society of Dermatology and Venereology (SIDeMaST), Italian Association of Hospital Dermatologists (ADOI), and Italian Society of Allergological, Occupational and Environmental Dermatology (SIDAPA).

G Ital Dermatol Venereol 2020 Feb 16;155(1):1-7. Epub 2019 Dec 16.

Department of Dermatology, ASST-Spedali Civili, University of Brescia, Brescia, Italy.

Atopic dermatitis (AD) places significant burden not only on quality of life, but is also associated with considerable costs to healthcare systems. Diagnosis of AD may be challenging when it starts in adolescence or adulthood, and is further complicated as its manifestations are different from those generally seen in children. Accordingly, better definition of diagnostic criteria for adult onset AD is needed to avoid misdiagnosis and undertreatment in adult patients. To provide practical guidance for clinicians to reliably diagnose AD in adult patients, representatives from three Italian dermatology scientific societies (Italian Society of Dermatology and Venereology [SIDeMaST], Italian Association of Hospital Dermatologists [ADOI], Italian Society of Allergological, Occupational and Environmental Dermatology [SIDAPA]) carried out a joint consensus meeting to develop useful indications for improving diagnosis of moderate to severe AD in adult patients in routine clinical practice. The most representative criteria for morphological criteria, localization, clinical history, and differential diagnosis were identified by the experts. The most frequent clinical presentations are those on the flexural areas, hands, face/neck, and trunk, with itch and eczema as key manifestations. The diagnostic path defined herein can form a sort of "check list" for physicians to adopt when evaluating patients with suspected AD, which can help in refining a diagnosis and refer the patient for specialist dermatological care. It is hoped that the practical guidance developed by the consensus group will help to improve outcomes, lower overall costs of care, and ameliorate the patient's quality of life, even though validation in a large cohort of patients is still needed.
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http://dx.doi.org/10.23736/S0392-0488.19.06522-2DOI Listing
February 2020

Fibroblasts to Keratinocytes Redox Signaling: The Possible Role of ROS in Psoriatic Plaque Formation.

Antioxidants (Basel) 2019 Nov 18;8(11). Epub 2019 Nov 18.

Department of Biomedical, Experimental and Clinical Sciences "Mario Serio", University of Florence, viale Morgagni 50, 50134 Florence, Italy.

Although the role of reactive oxygen species-mediated (ROS-mediated) signalling in physiologic and pathologic skin conditions has been proven, no data exist on the skin cells ROS-mediated communication. Primary fibroblasts were obtained from lesional and non-lesional skin of psoriatic patients. ROS, superoxide anion, calcium and nitric oxide levels and lipoperoxidation markers and total antioxidant content were measured in fibroblasts. NADPH oxidase activity and NOX1, 2 and 4 expressions were assayed and NOX4 silencing was performed. Fibroblasts and healthy keratinocytes co-culture was performed. MAPK pathways activation was studied in fibroblasts and in co-cultured healthy keratinocytes. Increased intracellular calcium, •NO and ROS levels as well as an enhanced NADPH oxidase 4 (NOX4)-mediated extracellular ROS release was shown in lesional psoriatic vs. control fibroblasts. Upon co-culture with lesional fibroblasts, keratinocytes showed p38 and ERK MAPKs pathways activation, ROS, Ca and •NO increase and cell cycle acceleration. Notably, NOX4 knockdown significantly reduced the observed effects of lesional fibroblasts on keratinocyte cell cycle progression. Co-culture with non-lesional psoriatic and control fibroblasts induced slight cell cycle acceleration, but notable intracellular ROS accumulation and ERK MAPK activation in keratinocytes. Collectively, our data demonstrate that NOX4 expressed in dermal fibroblasts is essential for the redox paracrine regulation of epidermal keratinocytes proliferation.
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http://dx.doi.org/10.3390/antiox8110566DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6912201PMC
November 2019

Secukinumab demonstrates improvements in absolute and relative psoriasis area severity indices in moderate-to-severe plaque psoriasis: results from a European, multicentric, retrospective, real-world study.

J Dermatolog Treat 2020 Aug 2;31(5):476-483. Epub 2019 Oct 2.

Dermatology, Ctr Hosp Porto, Porto, Portugal.

This European, multicentric, retrospective study aimed to collect data on secukinumab effectiveness in a real-world setting. All psoriatic patients starting secukinumab between January 2016 and February 2017 in 11 European centers were followed until February 2018 and retrospectively evaluated. Secukinumab effectiveness was assessed by relative improvement from baseline of the Psoriasis Area Severity Index (PASI) and absolute PASI score modifications throughout 52 weeks of therapy. Additionally measures assessing effectiveness were used, including improvements of body surface area (BSA) and Dermatology Life Quality Index (DLQI). Out of the 330 patients with potentially 52-week treatment duration, naïve to biologics patients showed greater probability to achieve PASI score of ≤1, ≤2, ≤3, and ≤5 at week 12, compared to bio-experienced patients (45.86% vs. 27.17%, 62.42% vs. 42.42%, 73.89% vs. 57.80%, and 84.08% vs. 74.57%, respectively). The greater effectiveness of secukinumab treatment in bio-naïve patients was confirmed at week 24 and 52. In this real-world experience, secukinumab was proven effective in treating psoriasis patients throughout a 52-weeks observation period, with higher response in bio-naïve patients. This study may contribute to defining the clinical profile of secukinumab best-responders.
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http://dx.doi.org/10.1080/09546634.2019.1671577DOI Listing
August 2020

Moderate-to-severe psoriasis and pregnancy: impact on fertility, pregnancy outcome and treatment perspectives.

G Ital Dermatol Venereol 2019 Jun;154(3):305-314

Unit of Dermatology, Department of Surgery and Translational Medicine, University of Florence, Florence, Italy.

Psoriasis affects 2-4% of the world's population, with no difference between men and women and 70% of patients experiencing disease onset before the age of 40, which coincides with the reproductive years. Few data are available from literature on impact of psoriasis on fertility, course and outcome of pregnancy and risk associated with treatments. Recent studies on other immune-mediated inflammatory diseases, among which psoriasis is also included, indicate that rheumatoid arthritis and inflammatory bowel diseases can impact female fertility and pregnancy outcomes especially during active disease episodes. In psoriasis hormonal and metabolic comorbidities, unhealthy lifestyles and systemic inflammation could also influence the ability to conceive, pregnancy course and birth outcomes. In this article we review current knowledge on reproductive function, course and outcome of pregnancy in women affected by moderate-to-severe psoriasis. Systemic treatments are also considered with a special focus on TNF-alpha blocking agents and implication of molecular structure on placental transportation and fetal exposure.
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http://dx.doi.org/10.23736/S0392-0488.18.06255-7DOI Listing
June 2019

Comment on "Oral lichenoid reaction in a psoriatic patient treated with secukinumab: A drug-related rather than a class-related adverse event?"

JAAD Case Rep 2019 Feb 25;5(2):138-139. Epub 2019 Jan 25.

Division of Dermatology, Department of Surgery and Translational Medicine, University of Florence, Florence, Italy.

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http://dx.doi.org/10.1016/j.jdcr.2018.10.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6355511PMC
February 2019

Clindamycin as unique antibiotic choice in Hidradenitis Suppurativa.

Dermatol Ther 2019 03 21;32(2):e12792. Epub 2018 Dec 21.

Department of Surgery and Translational Medicine, Section of Dermatology, University of Florence, Florence, Italy.

The rifampicin (RF)-clindamycin (CL) combination is recommended as first line therapy in moderate to severe Hidradenitis Suppurativa (HS) by European S1 guidelines. Although prolonged use of RF should be discouraged, there are currently few alternatives to this combination therapy. The aim of the present study was to assess retrospectively the efficacy of oral CL monotherapy in patients diagnosed with HS. In the period January 2017-May 2018, 31 HS patients who received a 300 mg b.i.d. oral dose of CL were studied retrospectively. Efficacy of the treatment was evaluated by comparing the main HS severity scores (Sartorius score modified by Revuz, Hidradenitis Suppurativa Physician Global Assessment [HS-PGA] and International Hidradenitis Suppurativa Severity Score System [IHS4]) before (W0) and after (W12) CL oral therapy. CL efficacy was demonstrated by the extreme and significant reduction of all three disease severity parameters during the 12-week period (p ≤ .01). There was also a statistically significant change in the mean visual analogue scale for pain. The present study demonstrates the efficacy of oral CL monotherapy as RF-sparing regimen alternative to RF-CL combination in a selected group of patients.
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http://dx.doi.org/10.1111/dth.12792DOI Listing
March 2019

Hidradenitis suppurativa and associated diseases.

G Ital Dermatol Venereol 2018 Jun;153(3 Suppl 2):8-17

Unit of Dermatology, Department of Surgery and Translational Medicine, University of Florence, Florence, Italy -

Hidradenitis suppurativa is a chronic, inflammatory, recurrent, debilitating skin disease characterized by recurrent abscesses, draining sinuses, and scarring, affecting principally areas of body friction. Although the disease pathogenesis is not fully understood, recent advances suggest that hidradenitis suppurativa should be viewed as a systemic inflammatory disease. Moreover, recent studies have defined hidradenitis suppurativa as a systemic disease linked to several comorbidities. Metabolic disorders including obesity and metabolic syndrome are the most common associated conditions observed in patients with hidradenitis suppurativa. Autoimmune diseases, like inflammatory bowel diseases, autoinflammatory diseases, spondyloarthritis, some genetic keratin disorders and also the risk of skin tumor seems to occur more frequently in these patients. This disease can also have severe effects on self-esteem and quality of life and can be associated with psychiatric diseases. The link between hidradenitis suppurativa and systemic associations may be attributed to common genetic or environmental factors or shared inflammatory pathways. Due to these reasons it is mandatory that clinical intervention for hidradenitis suppurativa must include consideration and attention to these comorbidities and complications. In this article we have reviewed current available literature on diseases that can occur together with hidradenitis suppurativa.
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http://dx.doi.org/10.23736/S0392-0488.17.05772-8DOI Listing
June 2018

Tuscan consensus on the use of UVBnb phototherapy in the treatment of psoriasis.

G Ital Dermatol Venereol 2019 Apr 29;154(2):99-105. Epub 2018 Oct 29.

Section of Dermatology, Department of Clinical Medicine and Immunological Science, University of Siena, Siena, Italy.

Psoriasis (PSO) is traditionally defined as an immune-mediated, inflammatory dermatological disease characterized by a chronic-relapsing course and associated with multifactorial inheritance (genetic predisposition and influence of various environmental factors). Considered until recently a dermatological disease only, today PSO is correctly known as a systemic one because of the involvement of multiple organs with important impact on social life and relationships. PSO is found in the 0.3-4.6% of the world's population, while its prevalence in the Italian population is estimated at 2.8%. Therefore, if we consider that in Tuscany more than 100,000 people out of 3,672,202 suffer of psoriasis, it is of paramount importance to focus on a shared clinical and therapeutic protocol to manage the disease. With the aim of ensuring diagnostic-therapeutic suitability, high levels of care and standardization of treatment, a unique clinical-therapeutic management model has been developed and validated in Tuscany, involving all accredited regional dermatological centers. Among the possible alternatives to be implemented in the treatment of patients with mild, moderate-severe psoriasis, UVBnb phototherapy is widely used alone or in association with other systemic and non-systemic devices. Despite this, there is still no universally shared therapeutic protocol. In this context the CO.FO.TO working group (Consensus Fototerapia Toscana) is born with the aim of defining and validating the main guidelines in the use of phototherapy with UVBnb in psoriasis; the guidelines are based both on the real-life experience of the different centers of reference in the region and on the revision of the recent literature.
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http://dx.doi.org/10.23736/S0392-0488.18.06223-5DOI Listing
April 2019

Efficacy and safety of adalimumab after failure of other anti-TNFα agents for plaque-type psoriasis: clinician behavior in real life clinical practice.

J Dermatolog Treat 2019 Aug 6;30(5):441-445. Epub 2018 Nov 6.

d Department of Medicine, Section of Clinical, Allergological and Venereological Dermatology , University of Perugia , Perugia , Italy.

During treatment with biologic agents for psoriasis (Pso) in a number of patients a failure may occur and discontinuation with transitioning to another drug or an optimization strategy, consisting in a dose-adjustment or a co-medication with a traditional systemic agent, represent two possible alternatives. The SAFARI study objective was a retrospective observation of adalimumab efficacy and safety profile after switching from other anti-TNFα agents related to clinician behavior after the failure of the first-line agent. The retrospective multicenter observation demonstrated that after a first-line anti-TNFα failure adalimumab efficacy was consistent at week-12 and 24 with a further significant improvement at week-48 with a proportion of patients achieving PASI75/PASI90/PASI100 of 83.3, 71.6, and 56.9.%, respectively. Clinician strategies to extend drug-survival after first-line anti-TNFα failure, such as co-medication or dose-adjustment, were irrelevant to future drug effectiveness. Adalimumab profile was excellent in this 5-year retrospective observation, showing the clinical validity of interclass transitioning among anti-TNFα options.
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http://dx.doi.org/10.1080/09546634.2018.1529382DOI Listing
August 2019