Search Results (20)

Background: Tildrakizumab, an anti-IL-23p19 monoclonal antibody, has demonstrated efficacy in clinical trials, but real-world evidence remains crucial for confirming its profile in diverse populations. Methods: We have conducted a multicenter, retrospective observational study within the Spanish Psoriasis Group (GPS). This study updates previous findings with a larger sample size (n = 372) and longer follow-up. We assessed absolute Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), and the Dermatology Life Quality Index (DLQI) improvements, as well as safety, in patients with moderate-to-severe plaque psoriasis. Results: The cohort included a large population of patients with a high prevalence of comorbidities and prior biologic exposure. Effectiveness was high, with a significant proportion of patients achieving PASI < 1. Compared to recent real-world data, our cohort demonstrates superior complete clearance rates (PASI < 1) and includes a comprehensive DLQI assessment. Notably, 79 patients were aged ≥65 years, confirming the drug’s utility in the elderly. Safety was consistent with previous reports, with no new signals detected. Conclusions: Tildrakizumab shows robust effectiveness and safety in a complex, bio-experienced real-world population. The lack of clinical predictors of response suggests a need for future pharmacogenetic exploration. Full article

Psoriasis is a chronic, inflammatory skin disease occurring worldwide that significantly affects patients’ quality of life. This common skin condition is characterized by abnormal hyperplasia of keratinocytes, which leads to the formation of raised, scaly plaques, typically located on the head, elbows, knees, and lumbar region. Psoriasis usually requires long-term drug therapy, which aims not only to combat skin symptoms but also to improve quality of life. Although topical treatments, systemic treatments (methotrexate, cyclosporine, acitretin), and phototherapy play a role, biologic agents have improved the efficacy of treatment of moderate-to-severe psoriasis. The purpose of this article is to comprehensively review the clinical trial data and evaluate and compare the key features of the currently approved biologic drugs for the treatment of psoriasis. Full article

Background: Psoriasis involving difficult-to-treat anatomical areas, such as the scalp, genitalia, fingernails, and palmoplantar regions, carries a disproportionate disease burden and often requires systemic therapy. In this context, real-life data comparing the long-term effectiveness of tildrakizumab 100 mg versus 200 mg in patients with difficult-to-treat psoriasis remain limited. Methods: This multicenter retrospective observational study included adult patients in three Italian dermatology centers. Global efficacy endpoints included PASI75, PASI90, PASI100, and absolute PASI ≤ 2 at weeks 16, 32, 52, and 104. Site-specific effectiveness was assessed as complete clearance (PGA = 0) in patients with baseline involvement (PGA ≥ 2) of difficult-to-treat areas. Outcomes were described by dose. Results: 183 patients were included (100 mg: n = 89; 200 mg: n = 94). Patients receiving 200 mg had higher baseline BMI and were more frequently biologic-experienced. At week 104, PASI75 was achieved by 94.2% of patients receiving 100 mg and 94.7% receiving 200 mg, while PASI90 and PASI100 were achieved by 82.7% vs. 57.9% and 48.1% vs. 47.4%, respectively. Clearance of difficult-to-treat areas improved progressively across all sites. Scalp and genital psoriasis showed higher and earlier clearance rates, whereas nail and palmoplantar psoriasis showed slower and more heterogeneous responses. No consistent dose-dependent advantage emerged, despite less favorable baseline characteristics in the 200 mg group. Conclusions: Over 104 weeks, tildrakizumab showed sustained long-term effectiveness in both global disease control and difficult-to-treat areas. The 200 mg dose, used in a more difficult-to-treat population, achieved comparable long-term outcomes, supporting dose optimization in clinical practice. Full article

Introduction: Super responders (SRs)—patients achieving complete skin clearance (PASI = 0) soon after biologic initiation—represent a clinically relevant but underexplored phenotype. This study is one of the first real-world, multi-agent analyses comparing SR likelihood across biologic classes in plaque psoriasis. We assessed whether biologic choice predicts SR in routine clinical practice. Methods: We performed a retrospective, single-center study of 116 adults with moderate-to-severe plaque psoriasis initiating their first biologic (adalimumab, tildrakizumab, guselkumab, risankizumab, bimekizumab, or secukinumab). SR was defined as PASI = 0 at week 12. SR proportions (exact 95% CIs) were compared using Fisher’s exact tests and odds ratios (ORs). Multivariable logistic regression estimated adjusted associations between biologic and SR, controlling for age, sex, disease duration, BMI, baseline PASI, and prior cyclosporine/acitretin. Sensitivity analyses included Firth bias-reduced regression, the exclusion of sparse drug strata, and an alternative endpoint (PASI ≤ 1 at week 12). Results: Overall, 26/116 patients (22.4%) achieved SR. SR proportions differed by agent, highest with bimekizumab (11/17; 64.7%); Fisher’s p < 0.001 vs. others; OR = 12.83 (95% CI 4.17–39.50). In adjusted models, bimekizumab remained independently associated with SR (adjusted OR = 17.30; 95% CI 4.62–64.82; p = 2.35 × 10⁻⁵), while other covariates were not significant. Conclusions: In this real-world cohort, biologic selection—particularly bimekizumab—was the main determinant of early complete clearance. These findings highlight mechanistic class as a key driver of rapid, deep responses and support prospective validation with harmonized SR definitions and extended follow-up. Full article

Background/Objectives: The treatment landscape of psoriasis has changed dramatically with the emergence of novel biological agents such as those targeting interleukin (IL)-23. Despite their high efficacy, evidence regarding their effectiveness and tolerability in elderly patients is currently limited. The number of older adults living with psoriasis is constantly increasing, highlighting the need for evidence-based guidance focused on this population. The aim of this study was to summarize our center’s experience with the IL-23 inhibitors guselkumab and risankizumab for the treatment of moderate-to-severe psoriasis in patients aged ≥65 years. Methods: We retrospectively reviewed all charts of moderate-to-severe psoriasis patients who received at least one dose of guselkumab or risankizumab (tildrakizumab is not available for use in Greece as of this date) and included those aged ≥65 years at the time of drug initiation. Disease severity was assessed using the Psoriasis Area and Severity Index (PASI), which was calculated at baseline and each subsequent visit up to 156 weeks of treatment. Treatment responses were evaluated with the percentages of patients achieving PASI75/90/100 (reductions from baseline PASI by 75, 90, and 100%, respectively) and absolute PASI ≤ 1 and PASI ≤ 3. All adverse events (AEs) were assessed and documented. The drug survival was estimated using the Kaplan–Meier estimate. Results: In total, 93 elderly patients (64 risankizumab and 29 guselkumab) were included. Regarding risankizumab’s effectiveness, PASI75 response rates increased from 77.4% at week 12 to 90.9% at week 52 and remained stable at 90.5% by week 156. Corresponding PASI100 responses were 67.7%, 81.8%, and 80.9%, respectively. Guselkumab-treated patients exhibited PASI75 response rates of 71.4% at week 12, which improved to 91.3% at week 52 and 100% for those evaluated at week 156, with PASI100 responses of 57.1%, 73.9%, and 83.3%. During observation, 6 (9.4%) risankizumab and 2 (6.9%) guselkumab patients discontinued medication. No statistically significant differences were observed regarding drug survival between patients aged ≥65 vs. <65 years. No serious AEs occurred, and no patient discontinued medication due to AEs. Conclusions: Both guselkumab and risankizumab demonstrated sustained efficacy and persistence along with a favorable safety profile in elderly patients with psoriasis over a three-year period. While our study is limited by its retrospective nature, our findings support the use of IL-23 inhibitors in this growing patient population. Full article

Background/Objectives: Psoriasis is a chronic immune-mediated skin disease with an estimated global prevalence of 3%. Real-world studies have demonstrated that biologic therapies have transformed the management of moderate-to-severe psoriasis by providing optimal disease control and a favorable safety profile. However, a new challenge lies in identifying those most likely to achieve an early and sustained response, defined as ‘super-responders’ (SRs). This is particularly relevant given recent evidence suggesting that IL-23 inhibitors may have long-term disease-modifying effects by acting on tissue-resident memory T cells. Identifying positive and negative baseline predictors associated with achieving SR status in patients treated with anti-IL-23 agents. Methods: This retrospective observational study analyzed data from the electronic medical records of IRCCS Humanitas Research Hospital between June 2021 and June 2025. A total of 611 patients with moderate-to-severe psoriasis who were treated with risankizumab, guselkumab or tildrakizumab were included in the study. Clinical assessments were conducted at baseline and weeks 16, 28 and 52. SR status was defined as achieving a PASI score of ≤1 at week 16, with this score being maintained through weeks 28 and 52. Results: Of the 611 enrolled patients, 390 (63.8 %) achieved SR status. In multivariate logistic regression, disease duration ≤ 2 years was the strongest independent predictor (Odds Ratio [OR] 2.47, p = 0.025), followed by bio-naïve status (OR 1.53, p = 0.019). Obesity (OR 0.71, 95 % CI 0.45–1.13) and cardiometabolic comorbidities (OR 0.93, 95 % CI 0.63–1.38) were not significantly associated with response after adjustments. No serious adverse events or treatment discontinuations occurred during 52 weeks of follow-up. Conclusions: Shorter disease duration (≤2 years) and bio-naïve status were identified as independent predictors of SR status. Identifying these patients could inform the development of personalized treatment strategies, including dose optimization and extended dosing intervals. Full article

In routine clinical settings, identifying the factors that influence the persistence of biologic therapies is crucial for tailoring psoriasis management to individual patient profiles. This study aimed to evaluate the real-world drug survival of tildrakizumab in patients diagnosed with plaque psoriasis at the Dermatology Department of HUCA and to explore the clinical predictors of treatment discontinuation. We conducted a retrospective, hospital-based analysis involving 100 patients treated with tildrakizumab (Ilumetri^®) between 1 January 2021 and 30 April 2024. Kaplan–Meier estimates were used to construct survival curves, and multivariate analyses were performed using Cox proportional hazards regression models. Both crude and adjusted hazard ratios (HRs) were calculated to assess potential differences across patient subgroups. The multivariate analysis identified statistically significant associations between reduced drug survival and the presence of psoriatic arthritis (p = 0.02), previous biologic exposure (p = 0.02), and arterial hypertension (p = 0.012). Other comorbidities did not demonstrate significant effects. The most common reasons for treatment discontinuation were primary inefficacy and suboptimal response in patients with arthritis. Overall, tildrakizumab demonstrated robust survival outcomes in this patient population, though diminished persistence was observed in those with prior biologic use, comorbid arthritis, and hypertension. Full article

Background: Alopecia areata (AA) is an autoimmune disease affecting 2% of the global population, often causing localized scalp hair loss that can progress to alopecia totalis or universalis. While corticosteroids and JAK inhibitors are effective, their significant side effects highlight the need for safer, more targeted treatments. Recently, biologics have gained attention as potential treatments for AA. Methods: A review of clinical trials, case series, and case reports published on PubMed was conducted to assess the efficacy of cytokine-targeting biologics for the treatment of AA. Data on the mechanism of action, treatment outcomes, and safety were extracted and analyzed. Results: Cytokine-targeting biologics identified included Dupilumab, Secukinumab, Tralokinumab, Etanercept, Ustekinumab, Infliximab, Adalimumab, and Tildrakizumab. Dupilumab and ustekinumab demonstrated strong efficacy, with dupilumab showing significant regrowth in 89% of cases and ustekinumab in all patients. Tralokinumab demonstrated a 33.75% improvement, with no patients achieving SALT₅₀. Limited efficacy was observed with secukinumab, tildrakizumab, and adalimumab, with 71.4%, 77.8%, and 50% of patients, respectively, showing no response. Disease worsening was observed in patients who received etanercept (29%) and infliximab (50%). Conclusions: Further research is necessary to optimize treatment protocols, identify predictive biomarkers, and, crucially, discover novel and more effective cytokine targets to advance biologics as a cornerstone therapy for AA. Full article

Background/Objectives: Psoriasis is a chronic inflammatory skin disease that may have a significant impact on patients’ quality of life. Alongside clinical scores, treatment goals include improvements in patients’ quality of life, divided into its social, working and psychosocial life aspects. Indeed, psychological impairment should always be considered in the management of moderate-to-severe psoriasis. Tildrakizumab, an anti-IL-23, is approved for the management of moderate-to-severe psoriasis. Both clinical trials and real-life studies show its efficacy and safety; however, no studies have evaluated how tildrakizumab may improve different domains of quality of life, including physical, psychological, and social aspects of patients’ quality of life. The objective was to evaluate the effectiveness of tildrakizumab in the management of moderate-to-severe psoriasis, focusing on the impact on all domains of patients’ quality of life. Methods: A 28-week multicenter, real-life, retrospective study was performed enrolling patients affected by moderate-to-severe psoriasis undergoing treatment with tildrakizumab. PASI and DLQI were evaluated at each follow-up (W16, W28). A sub-analysis of each DLQI question evaluated different domains of quality of life, including physical, psychological, and social aspects of patients’ quality-of-life. Results: A total of 62 patients were enrolled. At week 28, 97.1%, 85.7%, and 54.3% of patients achieved PASI75, PASI90, and PASI100, respectively. DLQI showed a significant reduction from baseline (20.3 ± 5.5) to week 28 (0.9 ± 2.2, p < 0.0001), with up to 82.9% achieving DLQI < 1. Sub-analysis of each question (Q1–Q10) showed a reduction in the value of each answer from baseline to week 28. Conclusions: The results confirm tildrakizumab as an effective and safe treatment in real life, positively affecting all domains of quality of life, with significant impact already appreciable at week 16 of follow-up. Full article

Objectives: This study is a retrospective analysis of patients with plaque psoriasis treated with biological drugs at a single center in Poland. We sought to evaluate patient demographics, disease characteristics, comorbidity burden, and treatment patterns in this cohort. Methods: Data were collected from the medical records of patients with plaque psoriasis who received biological treatments. In total, data from 1 January 2013 to 2 August 2024 were analyzed, encompassing 159 patients. The variables analyzed included age, disease duration, affected areas, prior treatments, and treatment outcomes. Results: The mean age at the start of biological treatment was 48 years (range: 10–73 years), with an average psoriasis duration of 18.2 years (range: 1–51 years). Obesity was noted in 39% of patients. Psoriasis lesions commonly affected the scalp (74.66%) and nails (64.38%). Methotrexate was the most commonly used systemic therapy prior to biologics (86.30%). Risankizumab and adalimumab were the most frequently prescribed biologics. Secondary treatment failure led to the highest discontinuation rates with tildrakizumab, whereas bimekizumab, guselkumab, risankizumab, and secukinumab showed the lowest rates. Conclusions: Biological drugs play a pivotal role in managing plaque psoriasis, particularly for patients with comorbidities and in treating challenging areas such as the scalp and nails. Risankizumab and adalimumab were prominent in prescription patterns. Future research involving larger cohorts and prospective designs is needed to deepen understanding and optimize treatment strategies for plaque psoriasis in Poland. Full article

Background: The treatment of psoriasis has made considerable progress with biologicals, including tumor necrosis factor inhibitors, and recently, monoclonal antibodies inhibiting directly interleukin (IL) 17, IL-23, or both IL-12/23. Newer biologicals are directed to the interleukin pathway and appear to improve complete or near-complete clearance. The newer biologicals have also been shown to have an excellent safety profile. However, despite experience with patients having confirmed the results obtained in clinical trials, there are still few data on using the newer biologicals. Methods: The present active study aimed to prospectively evaluate safety profiles and persistence of some biologicals in a multicenter pharmacovigilance study, that enrolled 733 patients treated with a biologic drug in five Calabrian hospital units. Informative and treatment persistence evaluations with predictors for suspension and occurrence of adverse events (AEs) were executed. In particular, reasons for treatment discontinuation in our program take account of primary/secondary failure or development of an AE. Results: AEs occurred in 187/733 patients and serious AEs (SAEs) were identified in 5/733 patients. An number of 182/733 patients showed a primary/secondary inefficacy. The AEs and SAEs were described with adalimumab, infliximab, and etanercept but not with abatacept, brodalumab, tildrakizumab, golinumab, ixekizumab, guselkumab, risankizumab, secukinumab, and ustekinumab. Conclusions: Our analysis, although limited by a small sample size and a short-term follow-up period, offers suitable data on commonly used biological agents and their safety, interruption rate, and the attendance of SAEs. Real-world studies should be carried out to evaluate other safety interests. Full article

Background/Objectives: Psoriasis (PsO) is a chronic inflammatory skin disease that severely impacts patients’ quality of life (QoL). Its global prevalence is about 2%, with significant regional variations. PsO manifests in the form of erythematous and scaly plaques, causing intense pruritus and discomfort and limiting daily activities. The condition often includes comorbidities such as psoriatic arthritis, cardiovascular diseases, and metabolic syndrome, further deteriorating QoL. Psychological well-being is notably affected, with high levels of depression and anxiety due to the visible lesions, leading to social stigma and isolation. QoL indexes like WHO-QoL and SF-36 assess various well-being aspects, while patient-reported outcomes (PROs) provide a comprehensive understanding of PsO’s impact. However, there are no universally shared PROs in outpatient practice to fully understand the impact of the disease and associated therapies. This study aims to evaluate differences between DLQI and WHO-5 in adult patients with moderate-to-severe PsO treated with tildrakizumab 100 mg or 200 mg. Methods: The study was conducted at the University Hospital of Siena, Italy, from May 2023 to April 2024. Data from 15 patients treated with tildrakizumab 200 mg and 15 patients treated with tildrakizumab 100 mg, observed for at least 28 weeks, were recorded. Demographic data, PASI, DLQI, and WHO-5 scores were analyzed. Patients in the 100 mg group (G100) were selected to match the demographic characteristics of the 200 mg group (G200). Reduction rates of DLQI and WHO-5 were assessed at baseline values and after 4, 16, and 28 weeks. Results: Both groups experienced improvements in QoL. The group treated with 200 mg showed more pronounced and rapid reductions in DLQI and WHO-5 scores compared to the 100 mg group. WHO-5 demonstrated faster improvements in overall well-being than DLQI, indicating its greater sensitivity to changes in mental well-being and overall QoL. No differences in adverse events were observed between the two groups, with no major adverse events reported. Conclusions: In our study, WHO-5 proved more sensitive than DLQI in capturing well-being changes in PsO patients treated with tildrakizumab. However, a combined use of both WHO-5 and DLQI questionnaires should be encouraged in clinical practice. Furthermore, this study confirmed the superior QoL improvement associated with tildrakizumab 200 mg compared to 100 mg. Future research should explore the long-term impact on QoL and comparative effectiveness among other biologic therapies in diverse patient populations. Full article

Background: The management of pediatric dermatological conditions such as alopecia areata (AA), psoriasis, atopic dermatitis (AD), and hidradenitis suppurativa (HS) has significantly evolved with the introduction of biologics and small molecule targeted therapies. The advancement in understanding the immunopathogenesis of these chronic skin conditions has led to the development and approval of novel biologics and small molecule therapies. Initially approved by the United States Food and Drug Administration (FDA) for adults, most of these therapies are now being evaluated in clinical trials for safety and efficacy in adolescents and children, expanding new treatment options for pediatric patients. The role of the FDA in drug approval is multifaceted from drug inception, ensuring that research, data, and evidence show that the proposed drug is effective and safe for the intended use. Objective: The goal of this review article is to provide an overview of the recently FDA-approved and potential biologic and oral small molecule therapies in clinical trials for AA, psoriasis, AD, and HS in pediatric patients. Methods: The search for this review included keywords in ClinicalTrials.gov, PubMed, and Google Scholar for the latest research and clinical trials relevant to these conditions and treatments without the PRISMA methodology. Results: For pediatric AA, ritlecitinib is FDA-approved, while baricitinib and updacitinib are in phase 3 clinical trials for pediatric approval. The FDA-approved drugs for pediatric psoriasis include secukinumab, ustekinumab, ixekizumab, etanercept, and apremilast. Other phase 3 clinical trials for pediatric psoriasis include risankizumab, guselkumab, tildrakizumab, brodalumab, and deucravacitinib. For pediatric AD, the FDA-approved drugs are dupilumab, tralokinumab, abrocitinib, and upadacitinib, with many other drugs in phase 3 trials. Adalimumab is an FDA-approved biologic for pediatric HS, with various clinical trials ongoing for adults. The approved biologics and small molecule therapies had higher efficacy and improved safety profiles compared to traditional medications. Conclusions: With numerous ongoing trials, the success of these clinical trials could lead to their inclusion in treatment guidelines for these chronic skin conditions. Biologics and small molecule therapies offer new avenues for effective disease management, enabling personalized therapeutic interventions and improving pediatric health outcomes. Full article

Background: Interleukin 23 (IL-23) inhibitors, such as guselkumab, risankziumab, and tildrakizumab, have proved to be highly effective and safe for psoriasis treatment either in bio-naïve or bio-experienced patients. A substantial proportion of patients show a primary or secondary inefficacy to IL-17 inhibitors and can benefit from an alternative line of treatment, like IL-23 inhibitors. To date, no sufficient data are available on the effectiveness of IL-23 inhibitors after an anti-IL-17 agent. Methods: Our study includes 48 patients with moderate to severe psoriasis undergoing a switch from IL-17 to IL-23 inhibitors. This trial is registered with SS_DERMO_20. Results: The mean PASI (Psoriasis Area Severity Index) decreases from 11.6 to 3.3 at week 16, with responses maintained at weeks 28 and 52 (2 and 1.4, respectively), and a PASI100 achievement in more than 24% of patients at 16 weeks and 61.9 at 48 weeks, with no occurrence of serious adverse events. However, almost one in six patients interrupted the IL-23 inhibitors mainly due to primary ineffectivenss. Conclusions: Our data support the evidence that an interclass switch among IL-17 inhibitors is a safe and effective therapeutic option for these patients. Full article

Tildrakizumab is a humanized IgG1κ monoclonal antibody that selectively targets the p19 subunit of interleukin IL-23, thereby inhibiting the IL-23/IL-17 axis, which is primarily implicated in the immunopathogenesis of psoriasis. Tildrakizumab is approved for the treatment of moderate-to-severe plaque-type psoriasis in adults based on the evidence of two randomized and controlled phase-III clinical trials (reSURFACE 1 and reSURFACE 2). Here, we report our real-life experience treating 53 psoriatic patients (19 female and 34 male) who were administered tildrakizumab every 12 weeks and received follow-ups over 52 weeks. Descriptive and inferential statistical analyses were performed, in particular the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI) and, if applicable, the Nail Psoriasis Severity Index (NAPSI) and Palmoplantar Psoriasis Physician Global Assessment (PPPGA). These were assessed at baseline and after different timepoints (weeks) during the follow-up period. We described and evaluated demographical and epidemiological characteristics in our cohort group, focusing on comorbidities. In this group, 35.9% of patients were female and 64.1% were male, with 47.1% being smokers and with a mean age of 51.2 years. A total of 37.7% of these patients was affected by scalp psoriasis; regarding comorbidities, hypertension was the most frequent (32.5%), followed by psoriatic arthritis (PsA) (18.60%) and diabetes (13.9%). At week 52, 93%, 90.2% and 77% of patients achieved a PASI reduction ≥75% (PASI 75), PASI 90 and PASI 100, respectively. In addition, NAPSI, PPPGA and DLQI scores were significantly reduced by week 52. In our cohort of complex psoriasis patients, disease remission began at the end of the fourth week of treatment and remained constant from week 16 to week 52. Full article