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Luca Potestio,1,&ast; Cataldo Patruno,2,&ast; Stefano Dastoli,2 Claudio Brescia,1 Maddalena Napolitano1 1Section of Dermatology Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 2Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy&ast;These authors contributed equally to this workCorrespondence: Luca Potestio, Section of Dermatology Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 081 7462457 ; Fax +39 081 7462442, Email potestioluca@gmail.comIntroduction: Even if mild forms of atopic dermatitis (AD) are usually well controlled with topical prescription drugs and emollients, the management of severe forms of the disease may be challenging, especially in special populations (SPs). These patients include groups of disadvantaged people (elderly, patients with disabilities and serious medical conditions) who are usually excluded from clinical trials. As a consequence, most of the data about the efficacy and safety of a drug in these patients derives from post-marketing experiences. In this context, the aim of our study was to retrospectively investigate the effectiveness and safety of tralokinumab in the management of AD in SPs.Methods: A 24-weeks retrospective, dual-center study was performed enrolling patients with a diagnosis of moderate-to-severe AD undergoing treatment with tralokinumab at labelled dosage. 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, and W24. Adverse events (AEs) were monitored at the same timepoints. Statistical significance of clinical improvement (EASI, P-NRS, DLQI) at week 4, week 16, and week 24 as compared with baseline was evaluated by using Student’s t-test, considering significant a p-value < 0.05.Results: Our study enrolling 27 SPs patients showed a significant improvement in EASI and P-NRS since week 4, continuing to improve up to week 24. Similarly, DLQI significantly decreases at each timepoint as compared with baseline. Finally, no AEs were reported during the study period. Of interest, our cohort included oncologic patients, a patient with a history of severe infection, as well as subjects affected by severe neurological, psychiatric, pulmonary, and/or cardiovascular disease.Discussion: Our experience showed that tralokinumab is effective and safe in elderly patients and subjects affected by severe comorbidities.Keywords: atopic dermatitis, special populations, treatment, tralokinumab, biologics

Fabrizio Martora,&ast; Maria Carmela Annunziata,&ast; Luca Potestio, Teresa Battista, Angelo Ruggiero, Matteo Megna Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy&ast;These authors contributed equally to this workCorrespondence: Fabrizio Martora, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, NA, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 - 7462442, Email fabriziomartora92@libero.itAbstract: This case study outlines the management of a 24-year-old male with a history of juvenile nephronophthisis who underwent renal transplantation at age 12 and later required dialysis at 18 due to chronic rejection and hypertension. Subsequently, the patient developed severe Hidradenitis Suppurativa (HS) affecting the axillary, groin, and gluteal regions. Despite undergoing various systemic and intravenous antibiotic therapies, as well as Adalimumab treatment, the HS remained refractory. Adalimumab was discontinued due to a detected ejection fraction of 45% during cardiologic follow-up, likely due to COVID-19 related myocarditis. Following this, the patient was initiated on secukinumab therapy, initially undergoing an induction phase followed by maintenance dosing. Significant improvements were observed in quality of life, pain scores, and HS activity after 5 weeks of secukinumab therapy, with sustained benefits at the 6-month follow-up. Secukinumab was well tolerated, with no reported adverse events. This case underscores the effectiveness and safety of secukinumab as a therapeutic option for refractory HS, particularly in patients with comorbidities such as renal transplant recipients.Keywords: hidradenitis suppurativa, Adalimumab, antibiotic, Secukinumab

Luca Potestio, Giuseppe Lauletta, Nello Tommasino, Antonio Portarapillo, Antonia Salsano, Teresa Battista, Fabrizio Martora, Matteo Megna Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, ItalyCorrespondence: Luca Potestio, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Naples, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 - 7462442, Email potestioluca@gmail.comAbstract: Psoriasis is a chronic inflammatory cutaneous disease with multifactorial pathogenesis involving both genetic and environmental factors as well as the innate and acquired immune response. Several triggering factors may exacerbate or worsen the disease. In this context, we performed a review manuscript with the aim of investigating current literature on psoriasis risk factors, also showing possible mechanisms by which they act on psoriasis. Globally, risk factors can be divided in classic risk factors (eg, mechanical stress, infections and dysbiosis of the skin, common drugs, environment and pollution, lifestyle, psychological stress, hormonal and metabolic alterations) which have long been known to be responsible for worsening and/or reoccurrence of psoriatic manifestations, and emerging risk factors (eg, biological drugs, immunotherapy for oncologic disease, Covid-19, and vaccines) defined as those newly identified risk factors. Accurate patient information and monitoring of risk factors as well as planned follow-ups may help to prevent and treat the worsening of psoriasis and consequently improve the quality of life of psoriatic patients.Keywords: psoriasis, flare, risk factors, pathogenesis

Matteo Megna,&ast; Angelo Ruggiero,&ast; Nello Tommasino, Claudio Brescia, Fabrizio Martora, Sara Cacciapuoti, Luca Potestio Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy&ast;These authors contributed equally to this workCorrespondence: Luca Potestio, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email potestioluca@gmail.comAbstract: Tildrakizumab is a humanised IgG1/k-type monoclonal antibody that targets the p19 protein subunit of IL23. Despite its effectiveness and safety have been widely reported by clinical trials and real-life experiences, data regarding its use on patients who previously failed anti-IL17 (brodalumab, ixekizumab, bimekizumab and/or secukinumab) are scant. Therefore, further studies on this topic would be beneficial for clinicians in guiding the selection of biologic shifting, considering that anti-IL23, − 12/23, and -IL17 partially share their therapeutic targets. In this context, we performed a 28-week, single-center, real-life, retrospective study, with the aim of assessing the efficacy and safety of tildrakizumab in patients who previously failed anti-IL17, also focusing the attention on psoriasis located in difficult-to-treat areas (scalp, palms or soles, fingernails, genitals). A total of 23 patients (12 male, 52.2%; mean age 52.8 ± 12.4 years) were enrolled. Of these, 11 (47.8%) failed secukinumab, 7 (30.4%) ixekizumab, 3 (13.0%) brodalumab, 1 (4.3%) both secukinumab and ixekizumab and 1 (4.3%) bimekizumab. At baseline, mean PASI and BSA were 12.8 ± 5.9 and 18.7 ± 9.6, respectively. At W16 PASI75 and PASI90 response were achieved by 15 (65.2%), and 9 (39.1%) patients, respectively, whereas 19 (82.6%) and 13 (56.6%) subjects reached these scores at W28. One (4.3%) case of primary inefficacy and 1 (4.3%) case of secondary inefficacy were assessed. Finally, no severe adverse events were collected. Tildrakizumab seems to be a valuable option in selected patients with psoriasis unresponsive to anti-IL17, suggesting that prior exposure to biological therapies seem not directly affect its effectiveness.Keywords: Tildrakizumab, psoriasis, real-life, anti-IL23

Luca Potestio,&ast; Fabrizio Martora,&ast; Giuseppe Lauletta, Ylenia Vallone, Teresa Battista, Matteo Megna Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy&ast;These authors contributed equally to this workCorrespondence: Luca Potestio, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 - 7462442, Email potestioluca@gmail.comAbstract: Psoriasis pathogenesis is influenced by genetic factors and characterized by a complex interplay between genetic predisposition and various environmental triggers. These triggers set off metabolic processes involving inflammation, cell signaling, immune response dysregulation, and antigen presentation. Several types of innate and adaptive immune cells are involved in psoriasis. Among the cytokine cascade which leads to psoriasis development, the interleukin (IL)-23/Th17 axis, especially IL-17 production, emerges as crucial. Recognizing the pivotal role of this axis has facilitated the development of selective and effective biological drugs, such as anti-IL17 and anti-IL23 monoclonal antibodies. These drugs aim to achieve the complete or near-complete disappearance of psoriatic lesions, as indicated by PASI100 and PASI90 responses, respectively. In this context, the aim of our review was to delve into the functioning of the IL-23/Th17 axis, its dysregulation in psoriasis pathogenesis, and the therapeutic potential of its inhibition. Currently, 4 anti-IL17 (secukinumab, ixekizumab, bimekizumab and brodalumab) and 3 anti-IL23 (guselkumab, risankizumab and tildrakizumab) have been approved. All these drugs showed high levels of effectiveness in both clinical trials and real-life experiences, with an excellent profile in terms of safety. Certainly, furthers studies will allow for better characterization of biologics’ profile, in order to administer the right drug for the right patients at the right moment.Keywords: psoriasis, management, clinical trial, IL-17/23 axis

Nello Tommasino, Matteo Megna, Sara Cacciapuoti, Alessia Villani, Fabrizio Martora, Angelo Ruggiero, Lucia Genco, Luca Potestio Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, ItalyCorrespondence: Luca Potestio, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email potestioluca@gmail.comAbstract: Teledermatology may be defined as the application of telemedicine to dermatology. According to published data, teledermatology is more widespread in Europe and North America, probably where resources for health care are greater than in other areas of the world. Indeed, teledermatology requires advanced technology to be efficient, as high image quality is necessary to allow the dermatologist to make correct diagnoses. Thanks to the recent advances in this field, teledermatology is become routinary in daily clinical practice. However, its use has been improved over time, overcoming several challenges. The aim of this narrative review is to retrace the almost 30-year history of teledermatology, to address the new challenges posed by advancing technologies such as artificial intelligence and the implications it may have on healthcare.Keywords: teledermatology, artificial intelligence, dermatology

Fabrizio Martora, Teresa Battista,&ast; Luca Potestio,&ast; Antonio Portarapillo, Nello Tommasino, Matteo Megna Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy&ast;These authors contributed equally to this workCorrespondence: Fabrizio Martora, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 081 7462457, Fax +39 081 7462442, Email fabriziomartora92@libero.itAbstract: Managing HS has long posed a significant challenge for dermatologists. Adalimumab stands as the sole biologic drug sanctioned for HS, receiving approval in 2015 as an anti-tumor necrosis factor (TNF)-α drug. Real-life evidence over the years has debated its efficacy, suggesting a success rate hovering around 70%. However, the variability in existing treatments and the chronic-recurrent nature of the condition make its treatment and management exceedingly challenging. Hence, identifying new therapeutic targets for HS in the future becomes imperative. Recently, on October 31, 2023, the FDA approved secukinumab for moderate-severe HS, marking a significant development. There has been substantial discourse on the potential of anti-interleukin-23 drugs as new therapeutic avenues for treating HS in recent years. Here, we report a case of 17-year-old man successfully treated with Guselkumab. The results were confirmed at week 52.Keywords: hidradenitis suppurativa, anti-IL23, guselkumab, adalimumab, secukinumab

Luca Potestio,&ast; Fabrizio Martora,&ast; Sara Cacciapuoti, Matteo Megna, Alessia Villani, Angelo Ruggiero Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy&ast;These authors contributed equally to this workCorrespondence: Angelo Ruggiero, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email angeloruggiero1993@libero.itAbstract: COVID-19 pandemic completely changed every aspect of human life. Several measures were adopted to limit the spreading of the infection. Among these, vaccination was the main one. Globally, vaccination campaign was a success, showing to be efficient in controlling and preventing the SARS-Cov2 infection, reducing the risk of disease progression, hospitalization, and mortality. However, with the increasing number of vaccines administered, several cutaneous reactions were described, making dermatologists key players in their recognition and treatment. Among these, also viral reactivations have been described. In particular, cases of Pityriasis Rosea (PR) and PR-like reactivations have been collected. An early diagnosis is mandatory to avoid mistreatments. In this context, we conducted a review of the current literature investigating cases of PR following COVID-19 vaccination with the aim of understanding the possible pathogenetic mechanisms and causal correlation as well as to investigate the risk of this cutaneous eruption, to offer clinicians a wide perspective on the linkage between PR and COVID-19 vaccines.Keywords: COVID-19, vaccination, pityriasis rosea, safety

Fabrizio Martora,1 Claudio Marasca,2 Sara Cacciapuoti,1 Federica Fariello,1 Luca Potestio,1 Teresa Battista,1 Massimiliano Scalvenzi,1 Matteo Megna1 1Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 2Dermatology Unit, Medical Department, “Antonio Cardarelli” National Hospital, Naples, ItalyCorrespondence: Fabrizio Martora, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Naples, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email fabriziomartora92@libero.itBackground: The treatment of hidradenitis suppurativa (HS) has always been a real challenge for dermatologists; to date, adalimumab the only biologic drug approved for HS is adalimumab, an anti-tumor necrosis factor (TNF)-α drug, the approval of this drug dates to 2015, data provided by real life show an effectiveness rate of about 60% percent. Recently (31 October 2023) FDA approves secukinumab for moderate-severe HS. The treatment and management of HS is very challenging as available treatments are very limited and show very variable outcomes.Methods: We conducted a prospective monocentric study designed to evaluate the efficacy and safety of secukinumab treatment in HS patients in a real-life setting.Results: The initial cohort of patients recruited included 21 HS patients including 12 females and 9 males. About 57.1% of patients achieved the primary endpoint and recorded significant decrease in all the severity assessment scales (IHS4, DLQI and VAS pain scale) at week 16 and 52, when HiSCR reached 71.4%.Conclusion: The results of our study highlight that treatment with secukinumab in patients with severe HS who failed adalimumab may be a safe and effective therapeutic weapon.Keywords: hidradenitis suppurativa, secukinumab, adalimumab, treatments

Matteo Megna,&ast; Angelo Ruggiero,&ast; Antonia Salsano, Giuseppe Lauletta, Antonio Portarapillo, Ginevra Torta, Fabrizio Martora, Luca Potestio Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy&ast;These authors contributed equally to this workCorrespondence: Luca Potestio, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini, 5, Naples, 80131, Italy, Tel +39 - 081 -7462457, Fax +39 - 081 - 7462442, Email potestioluca@gmail.comAbstract: Psoriasis is a chronic inflammatory cutaneous disease, affecting up to 3% of the worldwide population. Several clinical phenotypes can be distinguished. Among these, erythrodermic psoriasis (EP) is a rare and severe variant (less than 3% of cases), characterized by severe generalized erythema and scaling affecting at least 90% of the body surface area. EP is often a life-threatening condition, since several systemic symptoms (tachycardia, fever, fatigue, lymphadenopathy, dehydration, serum electrolyte disturbances) can be associated. Thus, a prompt and appropriate treatment is mandatory. Unfortunately, EP treatment is challenging. Indeed, the reduced prevalence of EP makes clinical trials feasibility difficult, leading to the absence of established guidelines. So, the treatment of EP is often derived from moderate-to-severe psoriasis management which relies on the use of conventional systemic drugs (cyclosporine, dimethyl fumarate, methotrexate, retinoids) and biologic agents. However, conventional systemic drugs are often contraindicated for patients’ comorbidities, or their use is characterized by reduced efficacy and various adverse events (AEs). The recent development of biologic drugs, which showed excellent results in terms of effectiveness and safety in plaque psoriasis, made these drugs an ideal weapon in EP management, despite their use in EP is still off-label. Among these, risankizumab, a humanized immunoglobulin G1 monoclonal antibody targeting the p19 subunit of the IL23, is one of the latest biologics approved for the management of moderate-to-severe psoriasis. Herein, we reported the first case of a caucasian patient affected by EP successfully treated with risankizumab, reaching PASI100 response after 16 weeks of treatment, without experiencing AEs.Keywords: erythrodermic psoriasis, treatment, risankizumab

Megna M, Ruggiero A, Salsano A, et al. Clin Cosmet Investig Dermatol. 2023;16:3503–3507. The authors have advised that the study did not receive any funding. The funding statement “Medical writing was funded through a donation by Abbvie Srl” on page 3506 should be removed. The authors apologize for this error.

Luca Potestio, Matteo Megna, Alessia Villani, Sara Cacciapuoti, Massimiliano Scalvenzi, Fabrizio Martora Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, ItalyCorrespondence: Luca Potestio, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email potestioluca@gmail.comAbstract: COVID-19 was a worldwide emergency, leading to a global health crisis, which completely revolutionized every aspect of human life. Several strategies were adopted to limit the spreading of the infection such as testing and contact tracing, quarantine and isolation, use of face mask, social distancing, lockdowns, travel restrictions, etc. Of these, vaccines were the most important measures to reduce the transmission of the virus and the severity of the infection, in order to overcome the pandemic. Fortunately, vaccination campaign was a success, showing to be efficient in controlling and preventing the COVID-19, reducing the risk of disease progression, hospitalization, and mortality. Monitoring and addressing vaccine-related adverse events have been essential for maintaining public confidence. Indeed, with the increasing number of vaccines administered, various cutaneous reactions have been reported, making dermatologists key players in their recognition and treatment. Particularly, several cutaneous diseases and cutaneous findings have been reported. Of note, also viral reactivations have been described following COVID-19 vaccination. Among these, varicella zoster virus (VZV) reactivation has been collected. Globally, an early diagnosis and an accurate treatment of herpes zoster (HZ) is mandatory to reduce possible complications. In this context, we conducted a review of the current literature investigating cases HZ following COVID-19 vaccination with the aim of understanding the possible causal correlation and underlying pathogenetic mechanisms to offer clinicians a wide perspective on VZV reactivation and COVID-19 vaccines.Keywords: COVID-19, vaccination, herpes zoster, safety

Matteo Megna,1 Luca Potestio,1 Angelo Ruggiero,1 Sara Cacciapuoti,1 Francesco Maione,2 Marco Tasso,3 Francesco Caso,3,&ast; Luisa Costa3,&ast; 1Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 2Immunopharmalab, Department of Pharmacy, School of Medicine and Surgery, University of Naples Federico II, Naples, Italy; 3Rheumatology Research Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy&ast;These authors contributed equally to this workCorrespondence: Angelo Ruggiero, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email angeloruggiero1993@libero.itAbstract: Psoriasis is now considered to be the cutaneous phenotype of a systemic inflammatory condition, recognized under the term Psoriatic Disease (PsD). PsD has several extracutaneous manifestations, such as inflammatory articular and entheseal involvement, leading to psoriatic arthritis (PsA), and the less frequent intestinal and ocular manifestations with colitis/inflammatory bowel disease and uveitis, respectively. There have also been several reports of an increased frequency of comorbidities such as hypertension, diabetes, dyslipidemia, obesity, metabolic syndrome and cardiovascular manifestations during the course of PsD. The link between psoriasis and related comorbidities is considered a long-term disease sequela, often characterized by an unhealthy lifestyle and a consequence of systemic inflammation; hence, psoriasis requires adequate and prompt treatment, with the aim of controlling not only cutaneous manifestations but also extracutaneous manifestations and systemic inflammation. Pharmacological strategies for PsD have significantly increased over recent years. Recently, the targeted synthetic DMARDs, Janus kinase (JAK) inhibitors, tofacitinib and upadacitinib, were added to the therapeutic armamentarium for treating PsA, and deucravacitinib for psoriasis. These oral agents act directly on inflammatory mechanisms underlining the disease, as antagonists of the intracellular JAK signal pathway and, by STAT phosphorylation, inhibit gene proinflammatory cytokine transcription. JAK inhibitors represent a recent additional treatment strategy for PsD management and, among these, tofacitinib and upadacitinib have recently been approved for PsA, and deucravacitinib for psoriasis. In this review we describe ongoing and recent phase II and III randomized controlled trials (RCTs) evaluating the efficacy and safety of investigational JAK inhibitors in psoriasis and PsA.Keywords: JAK inhibitors, plaque psoriasis, psoriatic arthritis, TYK2 inhibitors

Sara Cacciapuoti,&ast; Luca Potestio,&ast; Gianluca Guerrasio, Gabriella Fabbrocini ,† Massimiliano Scalvenzi, Angelo Ruggiero,&ast; Giuseppina Caiazzo,&ast; Matteo Megna&ast; Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy&ast;These authors contributed equally to this work†Professor Gabriella Fabbrocini passed away on 3rd March 2023Correspondence: Angelo Ruggiero, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email angeloruggiero1993@libero.itBackground: Recent knowledge of psoriasis pathogenesis has led to the development of selective drugs. Among these, brodalumab is a monoclonal antibody targeting the interleukin (IL)-17A receptor approved for the treatment of moderate-to-severe plaque psoriasis. Biologics may be considered in patients with milder diseases in case of active psoriatic arthritis, severe impact on patient’s quality of life, and involvement of sensitive and difficult-to-treat areas. These skin locations commonly require systemic drugs. Recently, psoriasis severity monitoring has also changed. Indeed, the clinical evaluation by means of specific efficacy scores was combined with serological evaluation by means of the assay of specific inflammatory biomarkers.Methods: An observational study enrolled patients affected by moderate-to-severe plaque psoriasis involving difficult-to-treat areas, undergoing treatment with brodalumab to evaluate the effectiveness and safety of brodalumab in patients with psoriasis affecting difficult-to-treat areas (scalp and palmoplantar regions). Secondary outcomes were the assessment of the development of serum markers of inflammation during the treatment period as well as the evaluation of the dermoscopic features of the affected sites to quantify disease activity and response to treatment.Results: Twenty-five patients were included in the study. A statistically significant reduction from baseline in PASI, PSSI, ppPASI and DLQI values as early as week 24 was observed, with further improvement up to week 52. Plasma levels of MMP-3, VEGF-A, and hs-PCR decreased during treatment from week 0 to week 52.Conclusion: Our real-life experience suggests brodalumab as a valuable option for the management of psoriasis located in difficult-to-treat areas. Moreover, our study highlights that the use of brodalumab reduces the plasmatic levels of inflammatory biomarkers (MMP-3, VEGF-A and hs-PCR), showing how the drug modulates the skin inflammatory response by reducing systemic inflammation.Keywords: brodalumab, psoriasis, difficult-to-treat areas, biologic drugs, efficacy

Fabrizio Martora, Massimiliano Scalvenzi, Teresa Battista, Luigi Fornaro, Luca Potestio, Angelo Ruggiero, Matteo Megna Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, ItalyCorrespondence: Fabrizio Martora, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39-081-7462457, Fax +39-081-7462442, Email fabriziomartora92@libero.itAbstract: The treatment of hidradenitis suppurativa (HS) has always been a real challenge for dermatologists; to date, the only biologic drugs approved for HS are adalimumab, an anti-tumor necrosis factor (TNF)-α drug, authorized in 2015, and secukinumab, recently licensed. The management of this condition is challenging as the available treatments show variable results, and the course of the condition is often chronic-recurrent; therefore, it will be necessary for the future to identify new therapeutic targets for HS. In recent years, studies have focused on the development towards new therapeutic targets. The purpose of our review was to perform a comprehensive literature review of real-life data on anti-IL23 (guselkumab, tildrakizumab, and risankizumab) in HS to summarize the existing evidence on the efficacy and safety of these drugs. We selected 64 articles, among which 32 had the characteristics that we were looking for in our review. To date, the positive data expressed in real-life experiences contrast with the three existing Phase 2 studies conducted so far, where it seems that these drugs may be useful only for a subgroup of patients with HS whose features need to be elucidated. Data from Phase 3 studies and other real-life experiences, perhaps more detailed and with higher numbers, will certainly be needed to fully understand the efficacy and safety of this class of drugs.Keywords: hidradenitis suppurativa, anti-IL23, guselkumab, tildrakizumab, risankizumab, real life evidence

Luca Potestio,1 Elisa Camela,2 Sara Cacciapuoti,1 Luigi Fornaro,1 Angelo Ruggiero,1 Fabrizio Martora,1 Teresa Battista,1 Matteo Megna1 1Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 2Dermatology Unit, Istituto Dermopatico dell’Immacolata - IRCCS, Rome, ItalyCorrespondence: Luca Potestio, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy, Tel +39 - 081 - 7462457, Fax +39 - 081 - 7462442, Email potestioluca@gmail.comAbstract: Erythrodermic psoriasis (EP) is a severe and rare variant of psoriasis (less than 3% of cases), characterized by generalized scaling and erythema affecting more than 90% of body surface area. Several systemic symptoms can be present in patients with EP such as lymphadenopathy, arthralgia, fever, fatigue, dehydration, serum electrolyte disturbances, and tachycardia making this condition a possible life-threatening disease, particularly if appropriate treatments are not performed. In this scenario, effective and safe therapies are required. Unfortunately, the rarity of EP makes head-to-head Phase III trials challenging, leading to the lack of established guidelines for its management. Globally, conventional systemic drugs such as cyclosporine, methotrexate, and retinoids often have contraindications linked to patients’ comorbidities and have not shown a high profile of efficacy and safety. Recently, the development of biologic drugs including anti-tumor necrosis factor-α and anti-interleukin 12– 23, 23, and 17 has revealed favorable results for the management of plaque psoriasis, making them also a possible therapeutic option for EP disease. However, their use in EP is still off-label. The aim of our study was to review current literature on the use of biologic drugs for the treatment of EPs in order to offer a wide perspective on their possible application in EP management.Keywords: erythrodermic psoriasis, treatment, biologic drugs

Teresa Battista, Massimiliano Scalvenzi,&ast; Fabrizio Martora,&ast; Luca Potestio, Matteo Megna Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy&ast;These authors contributed equally to this workCorrespondence: Fabrizio Martora, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 81 – 7462457, Fax +39 - 81 – 7462442, Email fabriziomartora92@libero.itBackground: Nail psoriasis (NP) has a prevalence that ranges from 10 to 82% among patients with psoriasis (PsO) and is one of the most common difficult to treat site of psoriasis. We performed a thorough review of the literature, exploring evidence regarding all available NP systemic treatments, describing also in detail NP dedicated clinical trials.Methods: A literature search was conducted in PubMed and Embase prior to February 2023 using a combination of the terms “nail” AND “psoriasis” AND “systemic therapy” AND/OR “systemic treatment”. A total of 47 original studies and case reports were reviewed in this article.Results: Systemic therapies should be considered when the disorder involves more than 3 nails, has extensive skin and joint involvement, and has a significant impact on QoL, due to their best long-term efficacy. In detail, conventional and biologic systemic drugs demonstrated efficacy in recent trials, including acitretin, methotrexate, cyclosporine, apremilast, adalimumab, infliximab, etanercept, certolizumab, golimumab, ustekinumab, secukinumab, ixekizumab, brodalumab, bimekizumab, guselkumab, risankizumab and tildrakizumab.Conclusion: Several therapies have demonstrated efficacy and safety in the treatment of NP; however, the choice of treatment depends not only on the severity of the nail involvement, but also on whether PsA is present, the patient’s comorbidities other than PsA, previous treatment history, and the patient’s drug preferences.Keywords: nail psoriasis, psoriasis, treatment, biologics

Matteo Megna,1 Elisa Camela,2 Angelo Ruggiero,1 Teresa Battista,1 Fabrizio Martora,1 Sara Cacciapuoti,1 Luca Potestio1 1Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 2Dermatology Unit, Istituto Dermopatico dell’Immacolata - IRCCS, Rome, ItalyCorrespondence: Luca Potestio, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy, Tel +39 – 081 – 7462457, Fax +39 – 081 – 7462442, Email potestioluca@gmail.comAbstract: Generalized pustular psoriasis (GPP) is a severe and rare form of psoriasis, being a potentially life-threatening condition, characterized by recurring episodes or flares of widespread cutaneous erythema with macroscopic sterile pustules. An irregular innate immune response is linked to GPP, which is considered an auto-inflammatory disorder, while innate and adaptive immunopathogenic responses are involved in psoriasis pathogenesis. In consequence, different cytokine cascades have been suggested to be mainly involved in the pathogenesis of each different psoriasis form, with the interleukin (IL)23/IL17 axis implied in plaque psoriasis, and the IL36 pathway in the GPP. As regards GPP treatment, conventional systemic drugs available for plaque psoriasis are usually used as the first-line treatment option. However, contraindications and adverse events often limit the use of these therapies. In this scenario, biologic drugs may represent a promising treatment option. To date, even if 12 different biologics have been approved for plaque psoriasis, none of these is approved for GPP where they are employed off-label. Recently, spesolimab, an anti-IL36 receptor monoclonal antibody, has been recently approved for GPP. The purpose of this article is to assess the current literature about the use of biological therapies for the treatment of GPP to establish the basis for a shared GPP management algorithm.Keywords: pustular psoriasis, treatment, biologic drugs

Luca Potestio,&ast; Angelo Ruggiero,&ast; Gabriella Fabbrocini, Fabrizio Martora, Matteo Megna Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy&ast;These authors contributed equally to this workCorrespondence: Luca Potestio, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy, Tel +39 - 81 -7462457, Fax +39 - 081 - 7462442, Email potestioluca@gmail.comAbstract: Psoriasis management may be challenging, particularly for moderate-to-severe forms of the disease. Indeed, conventional systemic treatments are often avoided for contraindications or the risk of adverse events as well as phototherapy is often limited by logistic concerns. Despite the development of biological drugs and small molecules revolutionized the treatment options showing promising results in terms of safety and effectiveness, some limitations remain. Thus, there is still a need for new therapies that are always welcome in order to tailor the treatment to the patient and to have a higher level of performance, especially in order to maintain long-term effectiveness. In this scenario, deucravacitinib, an oral small molecule which selectively inhibits Tyrosine Kinase 2, may represent a promising weapon in psoriasis management. The aim of our manuscript is to review the current knowledge on the efficacy and safety of deucravacitinib for the management of psoriasis.Keywords: deucravacitinib, psoriasis, JAK inhibitors, TYK2 inhibitors

Luca Potestio,&ast; Fabrizio Martora,&ast; Gabriella Fabbrocini, Teresa Battista, Matteo Megna Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy&ast;These authors contributed equally to this workCorrespondence: Fabrizio Martora, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy, Tel +39 081 7462457, Fax +39 081 7462442, Email fabriziomartora92@libero.itAbstract: The introduction of biologic drugs revolutionized the treatment of psoriasis, shifting treatment goals to higher treatment outcomes and less frequent safety issues. The outbreak of Coronavirus disease 2019 (COVID-19) represented a worldwide challenge, strongly affecting lifestyle, global economy, and overall health. Among the strategies adopted to contain the spreading of the infection, vaccination is the main one. In this context, the introduction of COVID-19 vaccines raised several doubts about their effectiveness and safety in patients undergoing therapy with biological for psoriasis. Even if molecular and cellular mechanisms by which COVID-19 vaccines lead to psoriasis development have not yet been fully elucidated, vaccination itself can trigger the release of interleukin (IL)-6, interferon (IFN) and tumor necrosis factor (TNF) α by T-helper (Th)1/Th17 cells. All these cytokines are involved in psoriasis pathogenesis. Thus, the aim of this manuscript is to review current literature on the safety and effectiveness of COVID-19 vaccination in psoriasis patients undergoing treatment with biologics, in order to clarify any concerns.Keywords: psoriasis, COVID-19 vaccinations, biologic therapies, efficacy, safety

Luca Potestio, Fabrizio Martora, Sara Cacciapuoti, Matteo Megna, Alessia Villani, Angelo Ruggiero Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, ItalyCorrespondence: Angelo Ruggiero, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 - 7462442, Email angeloruggiero1993@libero.it

Angelo Ruggiero, Gabriella Fabbrocicni, Sara Cacciapuoti, Luca Potestio, Lucia Gallo, Matteo Megna Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, ItalyCorrespondence: Angelo Ruggiero, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Naples, 80131, Italy, Tel +39-081-7462457, Fax +39-081-7462442, Email angeloruggiero1993@libero.itBackground: Tildrakizumab, an anti-IL-23, showed promising efficacy and safety profiles in two randomized clinical-trials (reSURFACE-1 and reSURFACE-2), comparing tildrakizumab superiority to placebo and etanercept. Due to its recent availability in clinical-practice, real-life data are still limited.Objective: To assess the efficacy and safety of tildrakizumab in a real-world-practice in patients suffering from moderate-to-severe psoriasis.Methods: A 52-week observational retrospective study enrolled patients suffering from moderate-to-severe plaque-psoriasis, starting tildrakizumab treatment.Results: A total of 42 patients were included in the study. Mean PASI showed a significant reduction at each follow-up (p< 0.001), reducing from 13.5± 5.9 at baseline, 2.8± 3.8 at week-28, resulting stable up to week-52. High rates of patients reached both PASI90 and PASI100 responses at both week 16 (PASI90: 52.4%, PASI100: 33.3%) and week 28 (PASI90: 76.1%, PASI100: 61.9%), maintaining these up to week 52 (PASI90: 73.8%, PASI100: 59.5%). The impact of treatment on patient’s quality of life has been evaluated with DLQI, which showed a significant reduction during follow-ups.Conclusion: Our data confirm tildrakizumab as an effective and generally safe treatment for the management of moderate-to-severe psoriasis, with high rates of both PASI90 and PASI100 responses, and very few reported adverse events, up to 52 weeks of follow-up.Keywords: guselkumab, risankizumab, tildrakizumab, real-world practice, psoriasis, anti-IL-23, biologics

Luca Potestio, Ilaria Piscitelli, Gabriella Fabbrocini, Fabrizio Martora, Angelo Ruggiero,&ast; Matteo Megna&ast; Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy&ast;These authors contributed equally to this workCorrespondence: Angelo Ruggiero, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini, 5, Naples, 80131, Italy, Tel +39 - 81 -7462457, Fax +39 - 81 – 7462442, Email Angeloruggiero1993@libero.itAbstract: The introduction of biologic drugs revolutionized the management of moderate-to-severe forms of psoriasis. However, safety concerns still remain, particularly on patient affected by opportunistic infections. In this scenario, the safety of biologic drugs in patient with HBV infection is debated. Globally, screening for hepatitis before starting biological treatment is mandatory as well as a referral to an infectivologist and eventual prophylactic management should be evaluated case by case, also considering risk factors. On the one hand, the use of anti-Tumor Necrosis Factor seems to increase the risk of HBV reactivation, conversely, the use of recently approved classes of biologics [anti-interleukin (IL) 17 and anti-IL23] seems to have a lower risk of HBV reactivation. However, the evidence on the safety of anti-IL23 drugs in patients affected by HBV is scant, particularly for patients undergoing treatment with tildrakizumab. Herein, we report the first case of a female patient affected by moderate-to-severe psoriasis and with chronic HBV infection undergoing prophylaxis, successfully treated with tildrakizumab without reporting hepatitis reactivation. Even if limited, our case seems to confirm available evidence about the safety of anti-IL23, particularly tildrakizumab, on patients with chronic HBV infection undergoing prophylaxis.Keywords: psoriasis, HBV infection, biologic therapy, anti-IL23, tildrakizumab

Fabrizio Martora, Matteo Megna,&ast; Teresa Battista,&ast; Luca Potestio,&ast; Maria Carmela Annunziata, Claudio Marasca, Alessia Villani, Gabriella Fabbrocini Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy&ast;These authors contributed equally to this workCorrespondence: Fabrizio Martora, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email fabriziomartora92@libero.itAbstract: To date, adalimumab (ADA) is the only biotechnology drug approved for the management of hidradenitis suppurativa (HS), an inflammatory skin condition. However, it quickly became apparent that the efficacy of adalimumab in daily practice was highly variable. In our review, we highlighted the current evidence from literature on the use of biologics in HS in a real-life setting, particularly adalimumab, secukinumab and ustekinumab. Data on the effectiveness and safety of biologic drugs in HS management have been analyzed. Even if the results are promising, more studies are needed. In our opinion, the armamentarium of drugs for HS management is increasing, and treatment will be based on a tailored-tail approach, minimizing the risk of adverse events. In this context, we want to point out the reported effectiveness and safety data concerning adalimumab, ustekinumab and secukinumab as well as ixekizumab.Keywords: hidradenitis suppurativa, adalimumab, ustekinumab, secukinumab, ixekizumab, guselkumab, real life evidence

Angelo Ruggiero,1 Fabrizio Martora,1 Gabriella Fabbrocini,1 Alessia Villani,1 Claudio Marasca,1 Matteo Megna,1 Luigi Fornaro,1 Rosita Comune,2 Luca Potestio1 1Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 2Department of Precision Medicine, University of Campania Luigi Vanvitelli, Naples, ItalyCorrespondence: Angelo Ruggiero, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini, 5, Naples, 80131, Italy, Tel +39 - 081 - 7462457, Fax +39 - 081 - 7462442, Email Angeloruggiero1993@libero.itAbstract: Teledermatology represented one of the most important and useful tools during the COVID-19 pandemic era. Indeed, due to the severe restriction, and to reduce the spread of the infection, different measures were applied among different countries and hospitals to ensure a continuity of care for patients. In this scenario, teledermatology played a central role, especially in the management of patients suffering from chronic inflammatory skin diseases. The aim of this narrative review is to describe the role of teledermatology during the COVID-19 pandemic to analyze main strengths and limitations of this tool, as well as to provide future perspectives in clinical applications.Keywords: teledermatology, telemedicine, COVID-19, psoriasis, atopic dermatitis, hidradenitis suppurativa

Fabrizio Martora, Teresa Battista, Claudio Marasca, Lucia Genco, Gabriella Fabbrocini, Luca Potestio Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, ItalyCorrespondence: Fabrizio Martora, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy, Tel +39 - 081- 7462457, Fax +39 - 081 - 7462442, Email fabriziomartora92@libero.itAbstract: The outbreak of coronavirus disease 2019 (COVID-19) represented a new worldwide challenge, strongly impacting on the global economy, overall health and lifestyle. Since then, several strategies have been adopted to contain the widespread of infection. Among these, vaccination is currently the most important measure to fight against the pandemic. However, several concerns such as slower-than-hoped-for rollout, the hurried approval with limited data, the mechanism of action (in particular mRNA-based), and the uncertain duration of protection they afforded were initially raised. Moreover, even if cutaneous reactions have been rarely reported in clinical trials, global mass vaccination showed several dermatologic reactions not initially recognized, leaving dermatologists to decide how to diagnose and treat them. In this scenario, dermatologists should be ready to promptly recognize these clinical manifestations. Thus, the aim of this manuscript is to review current literature on cutaneous reactions following COVID-19 vaccination, particularly inflammatory dermatological diseases, in order to help clinicians to better understand these dermatological conditions and to provide an extensive overview of all the vaccine-related skin manifestations.Keywords: cutaneous reactions, COVID-19 vaccinations, side effects

Elisa Camela,1 Luca Potestio,1 Angelo Ruggiero,1 Sonia Sofia Ocampo-Garza,2 Gabriella Fabbrocini,1 Matteo Megna1 1Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 2Dermatology Department, Universidad Autónoma de Nuevo León, University Hospital &die;Dr. José Eleuterio González&die;, Monterrey, Nuevo León, MéxicoCorrespondence: Elisa Camela, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy, Tel +39 - 081 - 7462457, Fax +39 - 081 - 7462442, Email elisacamela@gmail.comAbstract: Although innovative targeted therapies have positively revolutionized psoriasis treatment shifting treatment goals to complete or almost complete skin clearance, primary or secondary lack of efficacy is still possible. Hence, identifying robust biomarkers that reflect the various clinical psoriasis phenotypes would allow stratify patients in subgroups or endotypes, and tailor treatments according to the characteristics of each individual (precision medicine). To sum up the current progress in personalized medicine for psoriasis, we performed a review on the available evidence on biomarkers predictive of response to psoriasis treatments, with focus on phototherapy and systemic agents. Relevant literature published in English was searched for using the following databases from the last five years up to March 20, 2022: PubMed, Embase, Google Scholar, EBSCO, MEDLINE, and the Cochrane library. Currently, more evidence exists towards biologicals, as justified by the huge health care costs as compared to phototherapy or conventional systemic drugs. Among them, most of the studies focused on anti-TNF and IL12/23, with still few on IL17 (mainly secukinumab). The most discussed biomarker gene is the HLA-C&ast;02:06 status that has been shown to be associated with psoriasis, and also differential response to biologicals. Although its positivity is associated with great response to MTX, debatable results were retrieved concerning both anti-TNF and IL12/23 while it seems not to affect secukinumab response. Personalized treatment in psoriasis would provide excellent outcome minimizing the risk of side effects. To date, although several candidates were proposed and assessed, the scarcity and heterogeneity of the results do not allow the identification of the gold-standard biomarker per each treatment. Anyway, the creation of a more comprehensive panel would be more reliable for the treatment decision process.Keywords: precision medicine, stratification medicine, biomarkers, pharmacogenetics, pharmacogenomics, biologicals, small molecules, phototherapy, conventional systemic treatments, apremilast, acitretin, ciclosporin, methotrexate, dimethyl fumarate, MTX, DMF, SM

Matteo Megna, Luigi Fornaro, Luca Potestio, Maria Antonietta Luciano, Mariateresa Nocerino, Mario Delfino, Maria Guarino, Gabriella Fabbrocini, Elisa Camela Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, NA, ItalyCorrespondence: Elisa Camela, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Naples, NA, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email elisacamela@gmail.comPurpose: To determine the efficacy and safety of adalimumab (ADA) and etanercept (ETA) biosimilars in elderly and children with psoriasis.Methods: A real-life retrospective observational study was conducted on pediatric (< 18 years) and geriatric (≥ 65 years) psoriasis patients treated with anti-TNF biosimilar agents referring to the Psoriasis Unit of the University of Naples Federico II, Italy, from January 2018 to January 2022. At baseline, demographic characteristics (age and sex), data on psoriasis duration and severity (measured by Psoriasis Area Severity Index [PASI] and body surface area [BSA]), presence of psoriatic arthritis if applicable, comorbidities, and previous psoriasis treatments were recorded. Patients were monitored by regular follow-ups (week 12, 24, 48 and 72) through clinical and haematological assessments and adverse events (AEs) were registered.Results: A total of 11 children and 23 elderly psoriasis patients were enrolled. Concerning children, 6 (54.5%) were under ADA biosimilar and 5 (45.5%) under ETA biosimilar. ETA and ADA biosimilars were equally effective and safe for up to 72 weeks (mean PASI and BSA < 3). No significant AEs were reported, and none discontinued treatment. In the elderly, 15 (65.2%) were treated with ADA biosimilar and 8 (34.8%) with ETA biosimilar. ETA and ADA biosimilars were equally effective up to 72 weeks (mean PASI < 4 and mean BSA < 5%). AEs (mainly mild) were registered in 9 subjects (39.1%). Also, 4 (17.4%) patients discontinued biologicals for secondary lack of efficacy (3, 75%) or AEs (1, 25%).Conclusion: Our study found that ADA and ETA biosimilars are effective and safe for the treatment of moderate-to-severe psoriasis in children and the elderly. No statistically significant efficacy and safety differences were found between ADA and ETA biosimilars in both children and the elderly. Geriatric patients displayed a higher discontinuation rate and side effects than the pediatric counterpart even if without approaching statistical significance.Keywords: psoriasis, etanercept, adalimumab, biosimilar, treatment

Matteo Megna, Luca Potestio, Gabriella Fabbrocini, Angelo Ruggiero Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, 80131, ItalyCorrespondence: Angelo Ruggiero, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 081 7462457, Fax +39 081 7462442, Email angeloruggiero1993@libero.itIntroduction: Guselkumab safety and efficacy profiles in psoriasis have been showed by VOYAGE (1 and 2) trials. Although trial results have been already previously confirmed by real-life studies, long-term real-life data, and drug survival data about guselkumab are still poor.Patients and Methods: We performed a 3-year retrospective study, with the aim of assessing guselkumab efficacy and safety profile in the management of plaque psoriasis in a real-life setting.Results: Thirty-one patients completed the study. Both Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA) statistically improved since week 16, and up to week 144 [PASI reduction from 16.4 ± 6.2 to 0.6 ± 0.9 (p < 0.0001) at week 144 while BSA from 33.2 ± 14.6 to 1.9 ± 1.4 (p < 0.0001)]. At week 12 PASI90 and PASI100 were achieved by 19 (61.3%) and 11 (35.4%) patients, respectively, as well as 24 (77.4%) and 18 (58.1%) subjects reached PASI 90 and PASI 100 at week 144. As regards the safety, no cases of injection site reaction, candida, serious AEs, malignancy, or major cardiovascular events were reported. Of note, mild AEs were collected with pharyngitis as the main one (7, 22.6%), followed by headache (5, 16.1%) and flu-like illness (5, 16.1%), all without requiring treatment discontinuation.Conclusion: Our experience confirmed the efficacy and safety of guselkumab in daily clinical practice up to 3 years, suggesting this drug as an effective treatment option in psoriasis long-term management.Keywords: psoriasis, guselkumab, IL-23, anti-IL-23, real life, biologic, IL-23, IL-17A

Angelo Ruggiero, Luca Potestio, Elisa Camela Snr, Gabriella Fabbrocini, Matteo Megna Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, 80131, ItalyCorrespondence: Angelo Ruggiero, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39-0817462457, Fax +39-081-7462442, Email angeloruggiero1993@libero.itAbstract: Bimekizumab, a novel humanized monoclonal IgG1 antibody that neutralizes both IL-17A and IL-17F, was recently approved the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Bimekizumab represents the latest anti IL-17 treatment available for the management of moderate to severe psoriasis. Bimekizumab safety and efficacy profiles were evaluated in four Phase III clinical trials, which evaluated bimekizumab versus placebo and ustekinumab (BE VIVID), versus placebo (BE READY), versus adalimumab (BE SURE), and versus secukinumab (BE RADIANT). Overall, bimekizumab displayed promising results in terms of both efficacy and safety, allowing reach PASI90 and PASI100 in short time (as early as week 4) and maintain it in the long term (52 weeks), with acceptable safety profile. Also, bimekizumab showed a rapid onset of response and a higher efficacy when compared to adalimumab, ustekinumab and secukinumab, with comparable safety profile. Herein, we carried out a comprehensive literature review of the available literature data about bimekizumab in the treatment of moderate to severe psoriasis.Keywords: psoriasis, bimekizumab, IL-17, anti-IL-17, review, biologic, IL-23, IL-17A

However, our experience showed that psoriasis exacerbation after COVID-19 vaccination may also develop in patients undergoing biologic treatment, even if the risk is reduced and limited. The patients in this manuscript have given written informed consent to publication of their case details. Hence, patients undergoing topical treatment for psoriasis have a higher risk of psoriatic flares compared with patients treated with systemic drugs. [Extracted from the article]