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"Loconsole, Francesco"
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Upadacitinib for the management of refractory hidradenitis suppurativa, psoriasis, and pyoderma gangrenosum
by
Loconsole, Francesco
,
Mortato, Edoardo
,
Sbarra, Giorgia
in
hidradenitis suppurativa
,
Psoriasis
,
pyoderma gangrenosum
2026
Dear Editor, Hidradenitis suppurativa (HS) is a chronic immune-mediated skin disease presenting with recurrent inflammatory nodules, abscesses, draining tunnels, and scarring, most commonly in intertriginous sites. Its estimated global prevalence is approximately 1% and its pathogenesis is complex, involving dysregulation of several pro-inflammatory cytokines, including tumor necrosis factor (TNF)-α and interleukin (IL)-17. HS frequently coexists with systemic inflammatory conditions, such as axial spondyloarthropathies and inflammatory bowel diseases (IBD). Additional associations with dermatologic diseases have been described, particularly with pyoderma gangrenosum (PG). Emerging evidence also suggests a potential link between HS and psoriasis, possibly due to overlapping cytokine pathways. When these conditions occur together, management becomes particularly challenging and may require therapeutic strategies targeting broad inflammatory networks. [...]
Journal Article
Drug survival of IL-12/23, IL-17 and IL-23 inhibitors for moderate-to-severe plaque psoriasis: a retrospective multicenter real-world experience on 5932 treatment courses – IL PSO (Italian landscape psoriasis)
by
Bardazzi, Federico
,
Burlando, Martina
,
Guarneri, Claudio
in
Biological products
,
Body mass index
,
Clinical medicine
2024
The development of several effective biological drugs for moderate-to-severe plaque psoriasis has dramatically changed the lives of patients. Despite the wide use of interleukin (IL) inhibitors, limited data are available to date regarding long-term treatment persistence.
This multicenter retrospective real-world study evaluated 5932 treatment courses across 5300 patients, all treated with interleukin inhibitors. Drug survival was expressed by using the Kaplan-Meier estimator for each biological drug at 6, 12, 24, 36 and 48 months. We also stratified by discontinuation associated with primary or secondary ineffectiveness.
In our study, the most prescribed drugs were secukinumab (1412), ixekizumab (1183), and risankizumab (977). After four years of follow-up, risankizumab emerged as the treatment with the highest drug survival overall, as 91.6% of patients were still on treatment. The overall probability of drug survival at four years was comparable for tildrakizumab (83.5%), ixekizumab (82.6%), guselkumab (82.4%) and brodalumab (81.8%). When evaluating only patients who discontinued the treatment because of ineffectiveness, once again risankizumab was the molecule with the highest drug survival at 4 years (93.4%), this time followed by ixekizumab (87%). Our study, in which all IL inhibitors were adequately represented, confirmed a slightly better treatment persistence for IL-23 inhibitors, consistent with other real-world studies.
Our experience showed that IL-23 inhibitors, and risankizumab in particular, had a higher probability of drug survival overall during a 4-year follow-up. Risankizumab and ixekizumab were less likely to be discontinued because of ineffectiveness after four years.
Journal Article
Predictive Factors for Super Responder Status and Long-Term Effectiveness of Guselkumab in Psoriasis: A Multicenter Retrospective Study
by
Caldarola, Giacomo
,
Marcelli, Lorenzo
,
Lembo, Serena
in
Brief Report
,
Clinical decision making
,
Dermatology
2025
Introduction
Psoriasis is a chronic inflammatory skin disorder, affecting around 2–3% of the global population. The IL-23/Th17 signaling pathway plays a critical role in disease progression. Guselkumab, an IL-23p19 monoclonal antibody, has shown substantial efficacy in clinical trials for treating moderate-to-severe plaque psoriasis. However, preliminary identification of super responders (SRe: patients achieving PASI 100 at week 20) can help optimize treatment strategies. This study aims to identify predictive factors for SRe status in patients receiving guselkumab therapy for psoriasis and to evaluate long-term effectiveness in the entire cohort and both SRe and non-super-responder (nSRe) groups to understand whether SRe status is also a predictor of long-term response to guselkumab in a real-world setting.
Methods
A retrospective longitudinal study was conducted at ten Italian centers between January and October 2024. Data from 1008 patients treated with guselkumab for at least 20 weeks were analyzed. Patients were classified as SRe (PASI 100 at week 20) and nSRe. Baseline clinical and anthropometric profiles, comorbidities, and treatment history were collected. Efficacy was evaluated using PASI scores. Logistic regression analysis was performed to identify predictive factors for achieving SRe status.
Results
Of 1008 patients, 581 (57.6%) were classified as SRe, while 427 (42.4%) were nSRe. SRe patients were more likely to be bio-naïve and had lower baseline PASI scores and comorbidities such as obesity, hypertension, and diabetes. Multivariate logistic regression identified obesity, prior biologic therapy, and a higher baseline PASI as negative predictors for SRe status. Guselkumab demonstrated significant long-term efficacy, with SRe patients achieving sustained PASI 100 in 85% at year 4 and 83.4% at year 5 compared to 54% and 59.2% in nSRe patients, respectively.
Conclusions
Our study highlights the importance of identifying patients most likely to achieve PASI 100 early in treatment. Factors such as obesity, prior biologic experience, and baseline PASI contribute to predicting complete skin clearance, which can guide clinical decision-making and enable personalized treatment strategies.
Journal Article
Cost analysis in the management of moderate-to-severe psoriasis: comparison between conventional and biological systemic therapies
by
De Caro, Anna Paola
,
Rubino, Luca
,
Mortato, Edoardo
in
Antirheumatic agents
,
biological therapy
,
costs and cost analysis
2024
Background. Psoriasis is a chronic inflammatory skin disease with an important socio-economic burden. Available therapies include conventional systemic drugs and biological drugs, such as Tumor Necrosis Factor (TNF)-α inhibitors, that are characterized by high costs. Aim. Perform a cost-estimation analysis of conventional treatment vs therapy with biosimilar TNF-α inhibitor between January 2021 and January 2022, according to the Apulia regional cost list. Methods. The average annual expenditure per patient on conventional treatment (cyclosporine and methotrexate) vs therapy with biosimilar TNF-α inhibitor was compared. The 'cost per responder' was determined by analyzing the percentages of 'responders' (patients achieving PASI 75 and PASI 90) and 'non-responders' (PASI <75) after one year of treatment. Results. The annual per capita expenditure with cyclosporin was €3,515.35, with methotrexate was €1,048.87, while for treatment with TNF-α biosimilar inhibitor drug was €3,030.11. The \"cost per responder\" analysis showed a value of €8,573 for cyclosporine, €2,834 for methotrexate, and €3,564 for TNF-α biosimilar inhibitor. Conclusions. Conventional drugs have a greater impact on healthcare expenditure than TNF-α biosimilar inhibitors.
Journal Article
Cost per responder for risankizumab vs secukinumab in patients with moderate-to-severe plaque psoriasis in Italy
by
Raimondo, Paola
,
Loconsole, Francesco
,
Gisondi, Paolo
in
Cost per responder
,
Plaque psoriasis
,
Psoriasis
2021
Purpose: The objective of this analysis was to compare the cost per responder between risankizumab and secukinumab among patients with moderate-to-severe plaque psoriasis in Italy. Methods: The clinical efficacy was assessed based on IMMerge study of published efficacy data as measured by Psoriasis Area and Severity Index response (PASI 90 and PASI 100) for risankizumab and secukinumab. The treatment cost was based on the number of administrations dispensed in the first (induction plus maintenance period) and the second (maintenance period only) year of treatment and the ex-factory price of each treatment. The cost per responder was adopted as a cost-effectiveness indicator. Results: Independently of the PASI response (PASI 90 and PASI 100) used and the year of treatment considered, the cost per responder was consistently lower for risankizumab compared to secukinumab in all clinical measures. For example, considering the first-year costs and PASI 100, the cost per responder for risankizumab was € 24,506.83 compared to € 38,000.00 for secukinumab. The differences in the cost per responder between risankizumab and secukinumab increased when higher PASI response levels were considered. Conclusion: This economic evaluation suggested that the cost per responder is consistently lower for risankizumab compared to secukinumab from the perspective of the Italian National Health Service in the treatment of moderate-to-severe plaque psoriasis.
Journal Article
Brodalumab for the treatment of plaque psoriasis in a real-life setting: a 3 years multicenter retrospective study—IL PSO (Italian landscape psoriasis)
by
Argenziano, Giuseppe
,
Dapavo, Paolo
,
Dini, Valentina
in
Biological products
,
Body mass index
,
brodalumab
2023
Brodalumab is a monoclonal antibody that targets the subunit A of the interleukin-17A receptor (IL17RA), inhibiting the signaling of various isoforms of the IL-17 family. It has been approved for the treatment of moderate-to-severe plaque psoriasis after being evaluated in three Phase-3 trials. However, long-term data on brodalumab in a real-life setting are still limited.
The aim of this study was to evaluate the long-term effectiveness and safety of brodalumab in psoriasis. We also assessed the drug survival of brodalumab in a 3 years timespan. We conducted a retrospective multicenter study on 606 patients followed up at 14 Italian dermatology units, all treated with brodalumab according to Italian guidelines. Patients' demographics and disease characteristics were retrieved from electronic databases. At baseline and weeks 12, 24, 52, 104 and 156, we evaluated the psoriasis area and severity index (PASI) score and investigated for adverse events. The proportions of patients reaching 75, 90 and 100% (PASI 75, PASI 90 and PASI 100, respectively) improvement in PASI, compared with baseline, were also recorded.
At week 12, 63.53% of the patients reached PASI 90 and 49.17% PASI 100. After 3 years of treatment, 65.22% of patients maintained a complete skin clearance, and 91.30% had an absolute PASI of 2 or less. Patients naïve to biological therapies had better clinical responses at weeks 12, 24 and 52. However, after 2 years of treatment, no significant differences were observed. Body mass index did not interfere with the effectiveness of brodalumab throughout the study. No new safety findings were recorded. After 36 months, 85.64% of our patients were still on treatment with brodalumab.
Our data confirm the effectiveness and the safety of brodalumab in the largest real-life cohort to date, up to 156 weeks.
Journal Article
Long-Term Effectiveness and Safety of Ixekizumab for the Treatment of Moderate-to-Severe Plaque Psoriasis: A Five-Year Multicenter Retrospective Study—IL PSO (Italian Landscape Psoriasis)
by
Bardazzi, Federico
,
Burlando, Martina
,
Valenti, Mario
in
Anti-IL-17
,
Biological products
,
Body mass index
2024
Introduction
The introduction of biological therapies has revolutionized the treatment of moderate-to-severe plaque psoriasis. In particular, ixekizumab, an inhibitor of interleukin-17A, has shown great results in terms of efficacy and safety in both clinical trials and real-world experiences. However, there is a lack of long-term real-world data available for ixekizumab.
Methods
We conducted a multicenter real-life study to evaluate the effectiveness and safety of ixekizumab in patients with moderate-to-severe plaque psoriasis. Psoriasis Area and Severity Index score (PASI) was collected at baseline and after 1, 2, 3, 4, and 5 years. The occurrence of any adverse events was recorded at each time point.
Results
We enrolled 1096 patients treated with ixekizumab for at least 1 year. At week 52, the percentages of PASI 90 and PASI 100 were 85.04% and 69.07%, respectively. After 5 years of treatment with ixekizumab, out of 145 patients, a PASI 90 response was achieved by 86.90% of patients, while complete skin clearance was reached by 68.28% of patients. We did not observe any new significant safety findings throughout the study period.
Conclusion
This study supports the long-term effectiveness and safety of ixekizumab in a real-world setting.
Journal Article
Real-World Experience of Methotrexate in the Treatment of Skin Diseases: an Italian Delphi Consensus
2023
Background
After decades of use, methotrexate displays an established safety and efficacy profile in both in-hospital and outpatient settings. Despite its widespread use, there is surprisingly little clinical evidence to guide daily practice with methotrexate in dermatology.
Objectives
To provide guidance for clinicians in daily practice for areas in which there is limited guidance.
Methods
A Delphi consensus exercise on 23 statements was carried out on the use of methotrexate in dermatological routine settings.
Results
Consensus was reached on statements that cover six main areas: (1) pre-screening exams and monitoring of therapy; (2) dosing and administration in patients naïve to methotrexate; (3) optimal strategy for patients in remission; (4) use of folic acid; (5) safety; and (6) predictors of toxicity and efficacy. Specific recommendations are provided for all 23 statements.
Conclusions
In order to optimize methotrexate efficacy, it is essential to optimize treatment using appropriate dosages, carrying out a rapid drug-based step-up on a treat-to-target strategy and preferably using the subcutaneous formulation. To manage safety aspects appropriately, it is essential to evaluate patients’ risk factors and carry out proper monitoring during the course of treatment.
Journal Article
Efficacy of Bimekizumab on Palmoplantar Psoriasis: A 16-Week Multicenter Retrospective Study-IL PSO (Italian Landscape PSOriasis)
by
Caccavale, Stefano
,
Satolli, Francesca
,
Di Lernia, Vito
in
Body mass index
,
Care and treatment
,
Drug therapy
2026
: Palmoplantar psoriasis (PP) is a challenging variant of psoriasis that affects high-impact areas such as palms and soles and significantly impairs quality of life despite often limited body surface involvement. Conventional topical and systemic therapies may be insufficient, and evidence on biologic treatments for this specific phenotype remains limited. Bimekizumab (BKZ), a monoclonal antibody targeting IL-17A and IL-17F, has shown high efficacy in plaque psoriasis. This study aimed to evaluate the real-world effectiveness and rapidity of action of BKZ in patients with palmoplantar psoriasis compared with patients with psoriasis vulgaris (PV).
: We conducted a multicenter retrospective cohort study using data from 22 Italian dermatological units within the IL-PSO (Italian Landscape-Psoriasis) database. Adult patients treated with BKZ between November 2022 and October 2024 were included and categorized into three groups: isolated PP, PP associated with PV (PP + PV), and PV without palmoplantar involvement. Clinical outcomes included the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and pruritus Visual Analogue Scale (VAS). Outcomes were assessed at baseline, week 4, and week 16.
: A total of 47 patients were included. The baseline PASI was lower in the PP group compared with the PP + PV and PV groups, whereas the DLQI was highest in patients with isolated PP. Rapid clinical improvement was observed in all groups. The mean % PASI reduction at week 4 was 60.5%, 65.1%, and 77.0% in the PP, PP + PV, and PV groups, respectively, increasing to 94.8%, 90.4%, and 91.8% at week 16. The proportion of patients achieving complete clearance (PASI = 0) at week 16 was 73.3% (11/15), 68.2% (15/22), and 70.0% (7/10), respectively. Significant improvements were also observed in DLQI and pruritus scores over time. No significant safety concerns emerged.
: In this real-world multicenter cohort, bimekizumab demonstrated rapid and high efficacy in patients with palmoplantar psoriasis, both isolated and associated with psoriasis vulgaris. These findings support the use of BKZ as an effective therapeutic option for psoriasis involving high-impact areas, as the palmoplantar, although larger studies are needed to confirm these results.
Journal Article
OPT-In; Optimized Patient Treatment Outcomes in Plaque Psoriasis: A 3-Year State-Transition Treatment-Sequencing Model in the Italian Setting
2024
Introduction
There are several treatment options for plaque psoriasis (PsO), but uncertainty remains around the optimal sequencing of treatments. The aims of this study were to investigate how adopting a best-treatment-first treatment sequence impacts patient outcomes and healthcare systems and to quantify the cost of treatment failure to the healthcare system.
Methods
A 3-year state-transition treatment-sequencing model which identifies all possible treatment sequences in PsO was adapted to the Italian healthcare setting. Treatments considered in the model are those with European Medicines Agency marketing authorization and reimbursement in Italy as of December 2022. Italian market share data (2019–2021) and list prices (2022) informed the current prescribed sequences; these sequences were compared against all possible sequences to determine opportunities for improvement. Both the national perspective in Italy as well as the local perspective from seven regions were considered. The cost of treatment failure was informed through a questionnaire circulated to Italian dermatologists.
Results
Overall, 1284 possible treatment sequences are possible when four lines of treatment are considered for patients with moderate-to-severe PsO in Italy. Within the estimated range of treatment failures across those sequences (0.97–2.56 per patient over 3 years), current prescribing behavior from the national perspective suggests patients will face 1.44 failures on average; this highlights the potential for improvement. For every treatment failure, the cost borne by the Italian National Healthcare Service (NHS) is €676.80. Overall, prescribing more optimized treatment sequences results in a 22.95% reduction in failures with a 2.27% increase in costs. The regional analyses found similar trends.
Conclusions
Results suggest that selecting the most effective treatment sequences for incident patients provides the greatest opportunity to reduce treatment failures and maximize patient outcomes with a modest impact on costs. While regional variations exist, there is room for improvement across the board, which could translate to more efficient local healthcare systems.
Journal Article