Introduction: Psoriasis is a chronic, immune-mediated disease that significantly impacts patients’ quality of life. Deucravacitinib, an oral selective TYK2 inhibitor, has shown promising efficacy and safety in phase 3 trials, but real-world evidence remains limited. Objective: To evaluate the effectiveness and safety of deucravacitinib in moderate-to-severe psoriasis in an Italian real-life multicenter cohort. Methods: A retrospective multicenter study was conducted across nine dermatology units in the Lazio region, including 49 adult patients treated with deucravacitinib. Clinical outcomes were assessed using the Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Disease Activity index for Psoriatic Arthritis (DAPSA), and Dermatology Life Quality Index (DLQI) at baseline, week 8, and week 16. Results: Mean PASI scores significantly improved, from 11.4 at baseline to 4 at week 8 and to 1.7 at week 16. PASI 75 and PASI 90 responses were achieved by 31 and 13 patients, respectively. DLQI improved from 12 to 1 at week 16, indicating substantial quality-of-life gains. Clinical improvement was consistent in difficult-to-treat areas (scalp, nails, palmoplantar regions) and among patients with psoriatic arthritis. No significant difference emerged between biologic-naïve and biologic-experienced groups. Treatment was well tolerated, with only mild adverse events reported. Conclusion: This real-world study confirms deucravacitinib as an effective and safe oral treatment for moderate-to-severe psoriasis, providing rapid and sustained clinical improvement and enhanced patient quality of life.

INTRODUCTION:Up to 30% of patients with psoriasis develop psoriatic arthritis (PsA) during their lifetime, which can result in irreversible joint damage. Early identification and interception of PsA could potentially decrease inflammation and progression of structural damage. This review summarizes the state of the art on psoriasis-to-PsA transition and discusses the challenges to prevent and early manage PsA. AREAS COVERED:One primary hurdle clinicians face is their inability to establish an early PsA diagnosis because of the poor specificity of symptoms. Arthralgia, severe psoriasis, a history of uveitis, nail psoriasis, scalp psoriasis, having a first-degree relative with PsA, familial aggregation, genetic factors, specific skin phenotypes, mechanical stress, and obesity confer an increased risk of PsA transition. However, underlying molecular and cellular mechanisms remain poorly defined. EXPERT OPINION:The evolution from cutaneous to synovio-entheseal inflammation in patients with psoriasis presents an opportunity to investigate the critical events linked to arthritis development. Further efforts should be made to clearly define early PsA and identify patients with psoriasis at increased PsA risk. Machine learning and artificial intelligence may analyze and integrate different factors to more objectively estimate the possible risk of psoriasis to PsA transition for each patient.

BACKGROUND:Interleukin (IL)-23 inhibitors are highly effective therapies for psoriasis, but some patients may need to discontinue the treatment. Intraclass switching is a potential strategy, although data on its effectiveness remain limited. OBJECTIVES:To evaluate the patterns and effectiveness of intraclass switching among IL-23 inhibitors in a real-world setting. METHODS:This retrospective, multicentre study included adult patients with plaque psoriasis who switched between IL-23 inhibitors. Clinical and demographic data were analysed, and univariable and multivariable analyses identified predictors of treatment response. RESULTS:We analysed 116 patients (120 switches). Switching occurred from guselkumab (45.0%), tildrakizumab (44.2%) and risankizumab (10.8%), mainly due to secondary ineffectiveness (82.5%). Risankizumab was the most common post-switch agent (70.0%), followed by guselkumab (23.3%) and tildrakizumab (6.7%). Psoriasis Area and Severity Index 90% improvement (PASI 90) rates were 28.5% at week 16, 49.5% at week 36 and 60.7% at week 52. Fifteen patients (12.5%) withdrew from treatment, mainly due to lack of efficacy (10 patients, 67%) or adverse events (4 patients, 27%). Univariate analysis showed lower PASI 90 achievement in patients with psoriatic arthritis at weeks 16 after the switch (P = 0.02) and 36 (P = 0.02) and in those with body mass index (BMI) ≥ 25 kg m-2 at week 52 (P = 0.01). Patients switching from risankizumab had lower PASI 90 rates at weeks 16 (P = 0.04) and 36 (P = 0.03), while those switching to risankizumab had higher PASI 90 rates at week 16 (P = 0.02). Multivariate analysis confirmed BMI ≥ 25 kg m-2 was associated with reduced PASI 90 at weeks 36 (P = 0.04) and 52 (P = 0.04). CONCLUSIONS:Intraclass switching among IL-23 inhibitors is an effective strategy, with risankizumab emerging as the most favourable option.

Atopic dermatitis (AD) is a chronic inflammatory skin condition commonly associated with other dermatologic comorbidities, which can complicate management and affect treatment outcomes. This review aims to analyse the dermatologic comorbidities of AD, their underlying mechanisms, and therapeutic implications, with a focus on their management in clinical practice. A narrative review was conducted by searching PubMed, Embase, Cochrane and ClinicalTrials.gov, using terms related to AD and its comorbidities, including allergic contact dermatitis, alopecia areata, prurigo nodularis, psoriasis, hidradenitis suppurativa and chronic spontaneous urticaria. The literature highlights a strong association between AD and several dermatologic comorbidities, including allergic contact dermatitis, alopecia areata, chronic spontaneous urticaria, hidradenitis suppurativa, psoriasis, prurigo nodularis and vitiligo. Promising therapeutic effects were observed with JAK inhibitors, dupilumab and other biologics across multiple comorbid condition. Recognizing comorbidities in AD is critical for effective management. Tailored therapies targeting both AD and its comorbidities, based on shared immunological mechanisms, may improve outcomes. Further research is needed to optimize treatment strategies and explore combination therapies for patients with both AD and comorbid dermatological conditions.

BACKGROUND:Bimekizumab, a monoclonal antibody targeting interleukin (IL)-17A and IL-17F, has shown efficacy in psoriatic arthritis (PsA) clinical trials, but real-world data on its effectiveness are limited. This study aimed to evaluate its real-world effectiveness in PsA patients treated in dermatologic settings. METHODS:We conducted a multicenter, prospective, observational study in dermatology units across Lazio, Italy, including 20 patients with psoriasis and PsA treated with bimekizumab. Rheumatologic assessments were performed at baseline and after 16 weeks, evaluating tender and swollen joint counts, the Visual Analog Scale (VAS) pain score, the Disease Activity in Psoriatic Arthritis (DAPSA) score, and the Leeds Enthesitis Index (LEI). Ultrasound evaluations (US) of joints and entheses were conducted at baseline and Week 16. RESULTS:Twenty patients were enrolled, including 10 bio-experienced patients. At 16 weeks, significant improvements were observed in tender joint count (3.65 to 2.15, p = 0.004), swollen joint count (1.35 to 0.55, p = 0.028), VAS pain score (6.35 to 3.35, p < 0.001), DAPSA (22.71 to 8.67, p < 0.001), and LEI (0.85 to 0.25, p = 0.004). US revealed a decrease in the number of patients with power Doppler (PD) positive joints (45% to 25%) and a reduction in synovial PD score (2.26 to 0.81, p = 0.002). The number of patients with US-positive enthesitis decreased (50% to 30%), with a significant reduction in the enthesis PD score (1.00 to 0.25, p = 0.047). Four patients (20%) developed mild candidiasis, with no treatment discontinuation. CONCLUSIONS:Bimekizumab demonstrated significant, rapid improvements in real-world PsA patients, including those with prior biologic failures. Its favorable safety profile and effectiveness highlight its potential as a valuable treatment option for PsA.

INTRODUCTION:Dimethyl fumarate (DMF) is an approved conventional systemic treatment for psoriasis that does not exhibit any drug-drug interactions or cumulative organ toxicities. AIM:This retrospective real-world study aimed to analyze the long-term efficacy, safety, and tolerability of DMF in patients with moderate psoriasis. METHODS:Data on safety and efficacy were collected from medical charts. The effect on disease severity was assessed using the Psoriasis Area Severity Index. RESULTS:Our study included 148 patients over a 48-week treatment period, confirming DMF as an effective option in the treatment of moderate psoriasis. Adverse events were only mild or moderate, principally flushing, epigastralgia, and diarrhea. However, DMF exhibited a delayed onset of action, and the dropout rate was high. These aspects highlight the importance of educating patients about the activity profile of DMF, the potential occurrence of side effects, and their management. However, side effects are self-limiting with discontinuation of treatment and generally occur early, allowing patients to be promptly switched to other therapies if DMF is not tolerated. CONCLUSIONS:Our results confirm that DMF may be offered as a first-line treatment for moderate psoriasis as it demonstrated efficacy even in the long-term, when treatment is tolerated, especially in patients with a disease duration of less than five years. DMF may also be proposed when the patient presents comorbidities, when immunosuppression is undesired, and/or before the initiation of biological therapies.

Several studies have demonstrated that psoriasis severity is generally greater in male patients, but it is unclear whether this gender difference may affect short-term therapeutic response. Notably, no studies have specifically investigated bimekizumab, a humanized, full-length IgG1 monoclonal antibody that acts as a dual inhibitor of interleukin (IL)-17A and IL-17F. This was a cross-sectional, observational, retrospective, multicenter analysis. A cohort of 318 patients with moderate to severe psoriasis, 229 male patients (median [IQR] age 35 [23–67] years) and 89 female patients (median [IQR] age 33 [20–68] years), were retrospectively evaluated for short-term response (16 weeks) to bimekizumab according to standard dosage (320 mg at weeks 0, 4, 8, 12, and 16, and every 8 weeks thereafter). Patients were assessed to evaluate whether gender differences in demographic and clinical characteristics can affect treatment response to standard dose of bimekizumab, during the first 16 weeks of treatment. Therapeutic outcomes were evaluated by analyzing Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores recorded in each patient at three consecutive time points: baseline (T0), after 4 weeks (T4), and after 16 weeks of treatment (T16). Male patients showed more severe disease at baseline, compared to female patients (p = 0.01). A significant reduction in disease severity was observed in both male and female patients after 16 weeks of treatment, but male patients showed a faster decrease in PASI score between baseline and week 4 of treatment compared to female patients (p < 0.001). Nevertheless, by week 16, difference in PASI response and DLQI reduction between genders became less pronounced. Although male patients exhibit greater disease severity at baseline compared to female patients, this does not result in a differential response to bimekizumab over the short term. Both male and female patients had equal probability of achieving complete or near-complete disease remission within the first 4 weeks of treatment, and both maintain this response status through week 16. The therapeutic benefit of bimekizumab may be due to the rapid dual inhibition of IL-17A and IL-17F, which may lead to consistent and robust clinical response across genders, regardless of baseline disease severity. Our results suggest a “gender severity-invariant effect” of bimekizumab, highlighting the treatment as rapidly effective in both genders, despite initial differences in disease severity.

Introduction: Genital involvement is observed in approximately 60% of patients with psoriasis, presenting clinicians with formidable challenges in treatment. While new biologic drugs have emerged as safe and effective options for managing psoriasis, their efficacy in challenging-to-treat areas remains inadequately explored. Intriguingly, studies have shown that interleukin (IL)-17 inhibitors exhibit effectiveness in addressing genital psoriasis. Objectives: We aimed to determine the effectiveness profile of bimekizumab in patients affected by moderate-to-severe plaque psoriasis with involvement of genitalia. Methods: Bimekizumab, a dual inhibitor of both IL-17A and IL-17F, was the focus of our 16-week study, demonstrating highly favorable outcomes for patients with genital psoriasis. The effectiveness of bimekizumab was evaluated in terms of improvement in Static Physician's Global Assessment of Genitalia (sPGA-G) and Psoriasis Area and Severity Index. Results: Sixty-five adult patients were enrolled. Remarkably, 98.4% of our participants achieved a clear sPGA-G score (s-PGA-g=0) within 16 weeks. Moreover, consistent improvements were observed in PASI scores, accompanied by a significant reduction in the mean Dermatology Life Quality Index (DLQI), signifying enhanced quality of life. Notably, none of the patients reported a severe impairment in their quality of life after 16 weeks of treatment. In our cohort of 65 patients, subgroup analyses unveiled that the effectiveness of bimekizumab remained unaffected by prior exposure to other biologics or by obesity. Conclusions: Our initial findings suggest that bimekizumab may serve as a valuable treatment option for genital psoriasis. Nevertheless, further research with larger sample sizes and longer-term follow-up is imperative to conclusively validate these results.

(1) Background/Objectives: Nail psoriasis (NP) is a chronic and difficult-to-treat disease, which causes significant social stigma and impairs the patients’ quality of life. Moreover, nail psoriasis is a true therapeutic challenge for clinicians. The presence of nail psoriasis can be part of a severe form of psoriasis and can have predictive value for the development of psoriatic arthritis. Our real-world-evidence multicenter study aims to evaluate the efficacy of bimekizumab in nail psoriasis. (2) Methods: A retrospective analysis of a multicenter observational study included 834 patients affected by moderate-to-severe psoriasis, in 33 Dermatologic Units in Italy, treated with bimekizumab from December 2022 to September 2023. Clinimetric assessments were based on Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and Physician’s Global Assessment of Fingernail Psoriasis (PGA-F) for the severity of nail psoriasis at 0, 12, 24, and 36 weeks. (3) Results: Psoriatic nail involvement was present in 27.95% of patients. The percentage of patients who achieved a complete clearance of NP in terms of PGA-F 0 was 31.7%, 57%, and 88.5% at week 4, 16, and 36, respectively. PASI 100 was achieved by 32.03% of patients at week 4, by 61.8% at week 16, and by 78.92% of patients at week 36. The mean baseline PASI was 16.24. The mean DLQI values for the entire group of patients at baseline, at week 4, at week 16, and at week 36 were 14.62, 3.02, 0.83, and 0.5, respectively. (4) Conclusions: Therapies that promote the healing of both the skin and nails in a short time can also ensure a lower risk of subsequently developing arthritis which is disabling over time. Bimekizumab proved to be particularly effective to treat NP, with a fast response in terms of complete clearance, with over 88.5% of patients free from NP after 36 weeks. The findings of our real-world study showed that patients with moderate-to-severe PsO and concomitant NP had significantly faster and more substantial improvements in NP up to 36 weeks with respect to previous research findings. Considering the rapid healing of the nail, the dual inhibition of IL17 A and F might have a great value in re-establishing the dysregulation of keratin 17 at the nail level.

Introduction: This was an observational, retrospective, multicenter study, enrolling elderly patients (>65 years old) treated with ixekizumab with a diagnosis of psoriasis (PsO) and/or psoriatic arthritis (PsA) during the period 2020 to 2023. Objectives: We sought to investigate the efficacy of ixekizumab in elderly patients in the treatment of moderate to severe psoriasis. Methods: We included 73 patients with psoriasis (32.9%), psoriatic arthritis (1.4%) and both of them (PsO-PsA 65.8%), attending the outpatient clinics of seven Italian referral center for psoriasis in Lazio region: Policlinico Umberto I Università Roma La Sapienza, Sant’Andrea Università di Roma La Sapienza, Polo Pontino Università Roma La Sapienza, Fondazione Policlinico Universitario A. Gemelli, Università Campus Biomedico Roma, Istituto Dermopatico dell’Immacolata, and Policlinico Tor Vergata. We collected data related to the characteristics of the patients (age, sex, body mass index) and of the disease (age at onset, duration of psoriasis, previous treatments). The severity of psoriasis was measured with the Psoriasis Area and Severity Index (PASI) score at baseline and after 16, 24, 52, 104 and 156 weeks of treatment. Results: PASI90 was achieved by all the patients in week 16 and remained stable until the end of the study. PASI100 has been achieved by 55.1% of patients at weeks 16 and by 81.3% at week 104. A statistically significant difference has been highlighted between baseline and all the other time points (p<0.0001) for PASI score. A similar trend was observed for VAS score and DLQI score. Conclusions: Ixekizumab was effective and with a good safety profile in psoriatic patients over 65 years. No significant adverse events were reported.

Background and Objectives Psoriasis (PsO) and psoriatic arthritis (PsA) are often undertreated and require a multidisciplinary approach. In recent years, patent expiration has allowed the introduction of tumor necrosis factor inhibitor (anti-TNF) biosimilars, which have stimulated a significant increase in the use of biological therapies. This article reports the findings of a multidisciplinary approach to achieve a consensus on the use of adalimumab in patients with PsO or PsA.Methods A voting panel of 36 Italian dermatologists and rheumatologists were chosen by eight Italian clinicians (the Board), to provide a consensus on the real-world management of PsO and PsA with adalimumab using the Delphi Method, comprising three survey rounds. Twelve statements were defined by the Board and submitted to the panel (rating scale 1-7).Results Clinicians reached a wide consensus on the effectiveness (score 6-7: 67%) and long-term efficacy (6-7: 100%) of adalimumab in all clinical forms of PsO and PsA, including pediatric patients (6-7: 85%). Considering cost-effectiveness and safety, adalimumab is suggested as a first-line treatment in patients with enthesitis, predominant peripheral arthritis, axial involvement or associated inflammatory bowel disease (IBD) or uveitis. Adalimumab can be also considered after failure of etanercept (6-7: 94%).Conclusion Results from this Delphi study clearly show an overall consensus on the use of adalimumab in the management of PsO and PsA, particularly as first-choice for specific subpopulations (uveitis, IBD, hidradenitis suppurativa). Considering the cost-effectiveness of biosimilars within Italy, adalimumab may represent an effective and safe first-line treatment for patients with moderate-to-severe PsO or PsA, and a valid choice for switching after failure.

Purpose of the article: The aim of this multicenter observational study is to report data from real world on the use of bimekizumab in patients aged >= 65 years with moderate-to-severe plaque psoriasis. Elderly patients are poorly represented in clinical trials on bimekizumab for plaque psoriasis, and real-world studies are important to guide clinical choices. Materials and methods: A retrospective multicenter study was conducted in 33 dermatological outpatient clinics in Italy. Patients aged >= 65 years, with moderate-to-severe plaque psoriasis and treated with bimekizumab were enrolled. No exclusion criteria were applied. Bimekizumab was administered following the Italian Guidelines for the management of plaque psoriasis and according to the summary of product characteristics, in adult patients who were candidates for systemic treatments. Overall, 98 subjects were included, and received bimekizumab up to week 36. Clinical and demographic data were collected before the initiation of treatment with bimekizumab. At baseline and each dermatological examination (4, 16, and 36 weeks), clinical outcomes were measured by the following parameters: (1) PASI score; (2) site-specific (scalp, palmoplantar, genital, nail) Psoriasis Global Assessment (PGA). At each visit, the occurrence of any adverse events (AEs) was recorded, including serious AEs and AEs leading to bimekizumab discontinuation. Results: The mean PASI score was 16.6 +/- 9.4 at baseline and significantly decreased to 4.3 +/- 5.2 after 4 weeks (p < 0.001), and 1.1 +/- 1.7 after 16 week (p < 0.001). This level of improvement was maintained after 36 weeks (p < 0.001). PASI <= 2 was recorded in 36 (36.7%) at week 4, 68% and 69.4% at week 16 and 36, respectively. By week 16, 86/98 (87.8%) patients reached PASI75, 71/98 (72.4%) obtained PASI90, and 52/98 (53.1%) PASI100. Binary logistic regression tests showed a significant association of PASI100 by week 4 with lower PASI at baseline. PASI 100 at 16 or 36 weeks was not associated with baseline PASI, obesity, age, gender, previously naive state, and presence of psoriatic arthritis. Patients naive to biologics at baseline had similar response to bimekizumab as non-naive subjects. Conclusions: Bimekizumab is a suitable option for elder patients as it is effective, tolerated and has a convenient schedule.

Purpose Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A approved for the treatment of moderate-to-severe plaque psoriasis. The objective of this study was to describe the real-world long-term effectiveness of ixekizumab in patients with plaque psoriasis in Italy. Materials and Methods A retrospective study was conducted in patients affected by moderate-to-severe plaque psoriasis who were continuously treated with ixekizumab for at least 12 months. Patient data was obtained at 4-weeks, 12-weeks and 6-, 12-, 18- and 24-months after baseline (June 2017 and September 2019) from 10 sites. Results were analyzed by complete case approach, with sensitivity analysis performed to evaluate the impact of missing data. Results A total of 198 patients were enrolled in the study. At Month 24, 94.3% of patients achieved PASI75 response, while 85.1 and 71.8% achieved PASI90 and PASI100, respectively; and 91.1% of the patients achieved absolute PASI score ≤2. Patients experienced psoriasis improvement at 4 weeks after starting treatment, and improvement was maintained with continued ixekizumab use. The quality of life of patients also improved significantly starting at Week 12, with sustained effect in the long term. Conclusion This 24-month observational cohort study confirmed that ixekizumab is effective in the long-term management of patients with moderate-to-severe plaque psoriasis.

Introduction: Bimekizumab is a monoclonal antibody that targets Interleukin-17 A and F, approved for the treatment of moderate-to-severe plaque psoriasis. While bimekizumab has been evaluated in several phase-III clinical trials, real-world evidence is still very limited. Method: This multicenter retrospective study included patients affected by plaque psoriasis treated with bimekizumab from May 1, 2022 to April 30, 2023, at 19 Italian referral hospitals. Patients affected by moderate-to-severe plaque psoriasis eligible for systemic treatments were included. The effectiveness of bimekizumab was evaluated in terms of reduction in psoriasis area and severity index (PASI) compared with baseline at weeks 4 and 16. The main outcomes were the percentages of patients achieving an improvement of at least 75% (PASI75), 90% (PASI90) and 100% (PASI100) in PASI score. Results: The study included 237 patients who received at least one injection of bimekizumab. One hundred and seventy-one patients and 114 reached four and 16 weeks of follow-up, respectively. Complete skin clearance was achieved by 43.3% and 75.4% of patients at weeks 4 and 16, respectively. At week 16, 86.8% of patients reported no impact on their quality of life. At week 16, there were no significant differences between bio-naïve and bio-experienced patients in terms of PASI75, PASI90 and PASI100. The most commonly reported adverse events (AEs) were oral candidiasis (10.1%). No severe AEs or AEs leading to discontinuation were observed throughout the study. Conclusion: Our experience supports the effectiveness and tolerability of bimekizumab in a real-world setting with similar results compared with phase-III clinical trials.

Journal of the European Academy of Dermatology and VenereologyEarly View LETTER TO THE EDITOR PsoBioVax: A multicentric Italian case–control study of the immunological response to anti-SARS-CoV-2 vaccine among psoriatic patients under biological therapy L. Sacchelli, Corresponding Author L. Sacchelli [email protected] orcid.org/0000-0003-4388-4523 Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy Correspondence M. A. Chessa and L. Sacchelli, Via G. Massarenti, 1, 40138 Bologna, Italy. Email: [email protected]; [email protected]Search for more papers by this authorF. Filippi, F. Filippi orcid.org/0000-0001-8173-4257 Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, ItalySearch for more papers by this authorA. Balato, A. Balato orcid.org/0000-0001-5485-0172 Unit of Dermatology, University of Campania Luigi Vanvitelli, Naples, ItalySearch for more papers by this authorR. Balestri, R. Balestri orcid.org/0000-0002-0885-054X Division of Dermatology, Psoriasis Outpatient Service, APSS, Trento, ItalySearch for more papers by this authorF. Bellinato, F. Bellinato orcid.org/0000-0002-6163-6921 Dipartimento di Medicina Sezione Di Dermatologia Università di Verona, Verona, ItalySearch for more papers by this authorN. Bernardini, N. Bernardini orcid.org/0000-0002-6295-3574 Department of Medico-Surgical Sciences and Biotechnologies Faculty of Pharmacy and Medicine Sapienza University of Rome – Polo Pontino (ASL Latina), Latina, ItalySearch for more papers by this authorL. Bianchi, L. Bianchi Dermatology, University of Rome Tor Vergata, Rome, ItalySearch for more papers by this authorM. Burlando, M. Burlando orcid.org/0000-0002-4381-6718 Department of Dermatology, DISSAL University of Genoa, IRCCS Ospedale Policlinico San Martino, Genova, ItalySearch for more papers by this authorA. Campanati, A. Campanati orcid.org/0000-0002-3740-0839 Dermatological Clinic, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Ancona, ItalySearch for more papers by this authorM. A. Chessa, Corresponding Author M. A. Chessa [email protected] orcid.org/0000-0002-0149-8870 Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy Correspondence M. A. Chessa and L. Sacchelli, Via G. Massarenti, 1, 40138 Bologna, Italy. Email: [email protected]; [email protected]Search for more papers by this authorM. Corazza, M. Corazza Department of Medical Sciences, Section of Dermatology and Infectious Diseases, University of Ferrara, Ferrara, ItalySearch for more papers by this authorA. Di Cesare, A. Di Cesare orcid.org/0000-0002-1001-4604 Department of Health Sciences, Section of Dermatology, University of Florence, Florence, ItalySearch for more papers by this authorV. Di Lernia, V. Di Lernia Dermatology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, ItalySearch for more papers by this authorF. Diotallevi, F. Diotallevi Dermatological Clinic, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Ancona, ItalySearch for more papers by this authorM. Esposito, M. Esposito orcid.org/0000-0002-4773-6993 Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy Dermatology Unit, Ospedale San Salvatore, L'Aquila, ItalySearch for more papers by this authorM. C. Fargnoli, M. C. Fargnoli orcid.org/0000-0002-7249-2556 Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy Dermatology Unit, Ospedale San Salvatore, L'Aquila, ItalySearch for more papers by this authorP. Gisondi, P. Gisondi orcid.org/0000-0002-1777-9001 Dipartimento di Medicina Sezione Di Dermatologia Università di Verona, Verona, ItalySearch for more papers by this authorA. Giunta, A. Giunta orcid.org/0000-0003-3589-9346 Dermatology, Fondazione PTV Policlinico Tor Vergata, Rome, ItalySearch for more papers by this authorK. Hansel, K. Hansel orcid.org/0000-0002-6674-4278 Dermatology Section, Department of Medicine and Surgery, University of Perugia, Perugia, ItalySearch for more papers by this authorM. Magnano, M. Magnano orcid.org/0000-0001-9429-9004 Division of Dermatology, Psoriasis Outpatient Service, APSS, Trento, ItalySearch for more papers by this authorM. Megna, M. Megna orcid.org/0000-0003-1803-2046 Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, ItalySearch for more papers by this authorG. Odorici, G. Odorici orcid.org/0000-0002-5910-8994 Department of Medical Sciences, Section of Dermatology and Infectious Diseases, University of Ferrara, Ferrara, ItalySearch for more papers by this authorF. Prignano, F. Prignano orcid.org/0000-0002-5997-2045 Department of Health Sciences, Section of Dermatology, University of Florence, Florence, ItalySearch for more papers by this authorC. Potenza, C. Potenza Department of Medico-Surgical Sciences and Biotechnologies Faculty of Pharmacy and Medicine Sapienza University of Rome – Polo Pontino (ASL Latina), Latina, ItalySearch for more papers by this authorG. Rech, G. Rech Division of Dermatology, Psoriasis Outpatient Service, APSS, Trento, ItalySearch for more papers by this authorM. Rovesti, M. Rovesti Dermatologic Unit, Ospedale “Guglielmo da Saliceto”, Piacenza, PC, ItalySearch for more papers by this authorA. Ruggiero, A. Ruggiero orcid.org/0000-0002-4658-7391 Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, ItalySearch for more papers by this authorF. Satolli, F. Satolli UOC Dermatologia, University of Parma, Parma, ItalySearch for more papers by this authorL. Stingeni, L. Stingeni orcid.org/0000-0001-7919-8141 Dermatology Section, Department of Medicine and Surgery, University of Perugia, Perugia, ItalySearch for more papers by this authorD. Gibertoni, D. Gibertoni orcid.org/0000-0002-1722-3724 Research and Innovation Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, ItalySearch for more papers by this authorF. Bardazzi, F. Bardazzi Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, ItalySearch for more papers by this author L. Sacchelli, Corresponding Author L. Sacchelli [email protected] orcid.org/0000-0003-4388-4523 Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy Correspondence M. A. Chessa and L. Sacchelli, Via G. Massarenti, 1, 40138 Bologna, Italy. Email: [email protected]; [email protected]Search for more papers by this authorF. Filippi, F. Filippi orcid.org/0000-0001-8173-4257 Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, ItalySearch for more papers by this authorA. Balato, A. Balato orcid.org/0000-0001-5485-0172 Unit of Dermatology, University of Campania Luigi Vanvitelli, Naples, ItalySearch for more papers by this authorR. Balestri, R. Balestri orcid.org/0000-0002-0885-054X Division of Dermatology, Psoriasis Outpatient Service, APSS, Trento, ItalySearch for more papers by this authorF. Bellinato, F. Bellinato orcid.org/0000-0002-6163-6921 Dipartimento di Medicina Sezione Di Dermatologia Università di Verona, Verona, ItalySearch for more papers by this authorN. Bernardini, N. Bernardini orcid.org/0000-0002-6295-3574 Department of Medico-Surgical Sciences and Biotechnologies Faculty of Pharmacy and Medicine Sapienza University of Rome – Polo Pontino (ASL Latina), Latina, ItalySearch for more papers by this authorL. Bianchi, L. Bianchi Dermatology, University of Rome Tor Vergata, Rome, ItalySearch for more papers by this authorM. Burlando, M. Burlando orcid.org/0000-0002-4381-6718 Department of Dermatology, DISSAL University of Genoa, IRCCS Ospedale Policlinico San Martino, Genova, ItalySearch for more papers by this authorA. Campanati, A. Campanati orcid.org/0000-0002-3740-0839 Dermatological Clinic, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Ancona, ItalySearch for more papers by this authorM. A. Chessa, Corresponding Author M. A. Chessa [email protected] orcid.org/0000-0002-0149-8870 Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy Correspondence M. A. Chessa and L. Sacchelli, Via G. Massarenti, 1, 40138 Bologna, Italy. Email: [email protected]; [email protected]Search for more papers by this authorM. Corazza, M. Corazza Department of Medical Sciences, Section of Dermatology and Infectious Diseases, University of Ferrara, Ferrara, ItalySearch for more papers by this authorA. Di Cesare, A. Di Cesare orcid.org/0000-0002-1001-4604 Department of Health Sciences, Section of Dermatology, University of Florence, Florence, ItalySearch for more papers by this authorV. Di Lernia, V. Di Lernia Dermatology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, ItalySearch for more papers by this authorF. Diotallevi, F. Diotallevi Dermatological Clinic, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Ancona, ItalySearch for more papers by this authorM. Esposito, M. Esposito orcid.org/0000-0002-4773-6993 Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy Dermatology Unit, Ospedale San Salvatore, L'Aquila, ItalySearch for more papers by this authorM. C. Fargnoli, M. C. Fargnoli orcid.org/0000-0002-7249-2556 Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy Dermatology Unit, Ospedale San Salvatore, L'Aquila, ItalySearch for more papers by this authorP. Gisondi, P. Gisondi orcid.org/0000-0002-1777-9001 Dipartimento di Medicina Sezione Di Dermatologia Università di Verona, Verona, ItalySearch for more papers by this authorA. Giunta, A. Giunta orcid.org/0000-0003-3589-9346 Dermatology, Fondazione PTV Policlinico Tor Vergata, Rome, ItalySearch for more papers by this authorK. Hansel, K. Hansel orcid.org/0000-0002-6674-4278 Dermatology Section, Department of Medicine and Surgery, University of Perugia, Perugia, ItalySearch for more papers by this authorM. Magnano, M. Magnano orcid.org/0000-0001-9429-9004 Division of Dermatology, Psoriasis Outpatient Service, APSS, Trento, ItalySearch for more papers by this authorM. Megna, M. Megna orcid.org/0000-0003-1803-2046 Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, ItalySearch for more papers by this authorG. Odorici, G. Odorici orcid.org/0000-0002-5910-8994 Department of Medical Sciences, Section of Dermatology and Infectious Diseases, University of Ferrara, Ferrara, ItalySearch for more papers by this authorF. Prignano, F. Prignano orcid.org/0000-0002-5997-2045 Department of Health Sciences, Section of Dermatology, University of Florence, Florence, ItalySearch for more papers by this authorC. Potenza, C. Potenza Department of Medico-Surgical Sciences and Biotechnologies Faculty of Pharmacy and Medicine Sapienza University of Rome – Polo Pontino (ASL Latina), Latina, ItalySearch for more papers by this authorG. Rech, G. Rech Division of Dermatology, Psoriasis Outpatient Service, APSS, Trento, ItalySearch for more papers by this authorM. Rovesti, M. Rovesti Dermatologic Unit, Ospedale “Guglielmo da Saliceto”, Piacenza, PC, ItalySearch for more papers by this authorA. Ruggiero, A. Ruggiero orcid.org/0000-0002-4658-7391 Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, ItalySearch for more papers by this authorF. Satolli, F. Satolli UOC Dermatologia, University of Parma, Parma, ItalySearch for more papers by this authorL. Stingeni, L. Stingeni orcid.org/0000-0001-7919-8141 Dermatology Section, Department of Medicine and Surgery, University of Perugia, Perugia, ItalySearch for more papers by this authorD. Gibertoni, D. Gibertoni orcid.org/0000-0002-1722-3724 Research and Innovation Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, ItalySearch for more papers by this authorF. Bardazzi, F. Bardazzi Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, ItalySearch for more papers by this author First published: 07 December 2023 https://doi.org/10.1111/jdv.19662 L. Sacchelli and F. Filippi contributed equally. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat Open Research DATA AVAILABILITY STATEMENT The data that support the findings of this study are available on request from the corresponding author, MAC. The data are not publicly available due to their containing information that could compromise the privacy of research participants. REFERENCES 1Hansun S, Charles V, Gherman T. The role of the mass vaccination programme in combating the COVID-19 pandemic: an LSTM-based analysis of COVID-19 confirmed cases. Heliyon. 2023; 9(3):e14397. https://doi.org/10.1016/j.heliyon.2023.e14397 10.1016/j.heliyon.2023.e14397 PubMedWeb of Science®Google Scholar 2Wack S, Patton T, Ferris LK. COVID-19 vaccine safety and efficacy in patients with immune-mediated inflammatory disease: review of available evidence. J Am Acad Dermatol. 2021; 85(5): 1274–1284. https://doi.org/10.1016/j.jaad.2021.07.054 10.1016/j.jaad.2021.07.054 CASPubMedWeb of Science®Google Scholar 3Cristaudo A, Graceffa D, Pimpinelli F, Sperati F, Spoletini G, Bonifati C, et al. Immunogenicity and safety of anti-SARS-CoV-2 BNT162b2 vaccine in psoriasis patients treated with biologic drugs. J Eur Acad Dermatol Venereol. 2022; 36(4): e266–e268. https://doi.org/10.1111/jdv.17861 10.1111/jdv.17861 CASPubMedWeb of Science®Google Scholar 4Al-Janabi A, Littlewood Z, Griffiths CEM, Hunter HJA, Chinoy H, Moriarty C, et al. Antibody responses to single-dose SARS-CoV-2 vaccination in patients receiving immunomodulators for immune-mediated inflammatory disease. Br J Dermatol. 2021; 185(3): 646–648. https://doi.org/10.1111/bjd.20479 10.1111/bjd.20479 CASPubMedWeb of Science®Google Scholar 5Nah EH, Cho S, Park H, Kim S, Noh D, Kwon E, et al. SARS-CoV-2 antibody response and sustainability after a third dose of BNT162b2 in Healthcare Workers at Health Promotion Centers. Viruses. 2023; 15: 751. 10.3390/v15030751 CASPubMedGoogle Scholar 6Chiricozzi A, Gisondi P, Bellinato F, Girolomoni G. Immune response to vaccination in patients with psoriasis treated with systemic therapies. Vaccines. 2020; 8(4):769. https://doi.org/10.3390/vaccines8040769 10.3390/vaccines8040769 CASWeb of Science®Google Scholar 7Talamonti M, Galluzzo M. Safety of COVID-19 vaccines in patients with psoriasis undergoing therapy with anti-interleukin agents. Expert Opin Biol Ther. 2021; 21(11): 1535–1537. https://doi.org/10.1080/14712598.2021.1965985 10.1080/14712598.2021.1965985 CASPubMedWeb of Science®Google Scholar 8Musumeci ML, Caruso G, Trecarichi AC, Micali G. Safety of SARS-CoV-2 vaccines in psoriatic patients treated with biologics: a real life experience. Dermatol Ther. 2022; 35:e15177. https://doi.org/10.1111/dth.15177 10.1111/dth.15177 CASPubMedWeb of Science®Google Scholar 9Valencia López M, Meineke A, Stephan B, et al. SARS-CoV-2 vaccination status and adverse events among patients with psoriasis – data from the German registries PsoBest and CoronaBest. J Eur Acad Dermatol Venereol. 2023; 37: e831–e833. https://doi.org/10.1111/jdv.19039 10.1111/jdv.19039 PubMedWeb of Science®Google Scholar Early ViewOnline Version of Record before inclusion in an issue ReferencesRelatedInformation

BACKGROUND:Confirmatory data on the long-term effectiveness and safety of ixekizumab in psoriatic patients from real-world studies are needed. OBJECTIVES:The primary aim was to evaluate the 3-year drug survival of ixekizumab in the treatment of patients with moderate-to-severe plaque psoriasis, in a multicenter real-world setting. The secondary aim was to assess the influence of predictive factors on the drug survival of ixekizumab. METHODS:A retrospective analysis was performed on a cohort of patients with chronic plaque psoriasis, who received at least one dose of ixekizumab before December 2018. The drug survival analysis was performed and descriptively analyzed using Kaplan-Meier survival curves. Multivariable Cox regression analyses were carried out including variables considered to be of clinical importance. RESULTS:A total of 306 patients were enrolled. The overall drug survival at 12, 24, and 36 months of treatment with ixekizumab was 92.11%, 83.85%, and 80.19%, respectively. A higher probability (HR 2.34) of drug withdrawal was found among patients who had already received an anti-IL-17 agent compared with bio-naive patients (p 0.017). CONCLUSIONS:We found that ixekizumab is a biological agent characterized by long-term effectiveness, not influenced by several clinical factors and associated with a good safety profile.

Introduction Dimethyl fumarate (DMF) is approved as oral systemic treatment for moderate-to-severe psoriasis. Scarce evidence is available for DMF treatment in psoriatic patients at the time of COVID-19 pandemic. The objective of this study was to assess the long-term effectiveness and safety of DMF monotherapy in moderate-to-severe psoriasis during the COVID-19 pandemic period. Methods This multicenter, retrospective study included patients with moderate-to-severe psoriasis who had received a 48-week DMF treatment during the COVID-19 pandemic. Selected outcomes were: variation of mean PASI, proportion of patients achieving PASI50 and PASI75, variation of mean PGA and face PGA, genital PGA, scalp PGA, mean itch VAS and mean DLQI. Results Forty-four patients were enrolled, and four patients became COVID-19 positive during the observation period but did not discontinue DMF therapy. DMF produced a significant improvement of signs and symptoms of psoriasis as expressed by mean PASI variation from 13.07 at baseline to 6.11 at week 48 (p < 0.0001), itch VAS from 3.22 at baseline to 1.18 at week 48 (p < 0.001), PGA from 2.84 at baseline to 1.30 at week 48 (p < 0.0001) and DLQI from 13.09 at baseline to 6.07 at week 48 (p < 0.0001). The percentage of patients who achieved PASI50 and PASI75 was 4.55% at week 4 and 59.09% at week 48 and 0% at week 4 and 22.73% at week 48, respectively. A clinical important decrease of mean PGA score was observed in all subgroups, face psoriasis, genital psoriasis and scalp psoriasis. Adverse events were predictable and manageable. Conclusions DMF monotherapy is an effective and safe treatment option in moderate-to-severe psoriasis also in patients who develop SARS-CoV-2 infection.

Introduction: Psoriasis (PsO), a chronic inflammatory, multisystemic, and multifactorial disease can cause endothelial dysfunction, artery calcification, and atherosclerotic disease. A higher incidence of vascular occlusive events has been observed in psoriatic patients compared to healthy controls, and multiple studies confirm the association between moderate-severe PsO and atherosclerosis, coronary artery calcification, and higher cardiovascular risk. Objective: We sought to analyze atherosclerotic disease prevalence in epiaortic vessels of psoriatic and non-psoriatic patients to understand if PsO could represent an independent risk factor predisposing to atherosclerotic disease. Methods: We evaluated 47 psoriatic patients without cardiovascular risk factors with color Doppler ultrasound (CDUS). If atheromatous plaques were detected, a computed tomography angiography (CTA) was performed. We evaluated 47 non-psoriatic patients without cardiovascular risk factors with CDUS. Atherosclerosis prevalence in both groups were statistically analyzed. CDUS performance was compared to CTA. Results: In the psoriatic group (mean age 50.9 years), 6 had atheromatous plaques and 12 had an intima-media thickness (IMT) > 1 mm (overall prevalence of atherosclerotic disease: 38.2%). All plaques detected with CDUS were confirmed at CTA. In the control group (mean age 51.3 years), CDUS revealed atheromatous plaques in 4 patients and IMT > 1 mm in 4 ones (overall prevalence of 17%). The difference of atherosclerotic disease prevalence between the groups was statistically significant (P < 0.05). Conclusion: Our results highlight that PsO could be considered a predisposing factor for atherosclerotic disease development in epiaortic vessels, as it causes an increased IMT, that is also considered an independent cardiovascular risk factor.

Background: Dupilumab, a fully human monoclonal antibody targeting the alpha subunit of IL-4 was recently approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients. Objective: To assess dupilumab effectiveness and safety in adults with moderate-to-severe AD in a real-life Italian multicentre retrospective cohort. Methods: Adult moderate-to-severe AD patients, referring to 39 Italian centers, received dupilumab in the context of a national patient access program. Disease assessment was performed at baseline, after 4 and 16 weeks of treatment using Eczema-Area-and-Severity-Index (EASI) score, itch and sleep numerical-rating-score (itch-NRS, sleep-NRS) and Dermatology-Life-Quality-Index (DLQI). Results: A total of 109 (71 M/38F) patients was studied. There was a significant reduction in EASI score, itch-NRS, sleep-NRS and DLQI from baseline to week 4 and a further significant decline to week 16. EASI 50, EASI75 and EASI90 were achieved by 59.6%, 28.4% and 9.3% of patients at 4 weeks and by 87.2%, 60.6% and 32.4% of them at 16 weeks, respectively. Adverse events were experienced by 19.2% (21/109) of the patients and they were all mild in intensity, being conjunctivitis the most common side effect. Conclusions: Dupilumab significantly improved disease severity, pruritus, sleep loss and quality of life with an acceptable safety profile.