Effectiveness of tildrakizumab 200 mg: an Italian multicenter study
Psoriasis is a chronic immune-mediated disease that can be challenging to treat, especially in patients with severe disease or high body weight. Tildrakizumab is a monoclonal antibody which inhibits IL-23, approved for moderate-to-severe psoriasis with a standard 100 mg dose. A 200 mg dose may provide greater efficacy for patients over 90 kg or with high disease burden. This multicenter, prospective study evaluated the effectiveness and safety of tildrakizumab 200 mg in patients with moderate-to-severe psoriasis, focusing on those with specific challenges: body weight over 90 kg, baseline PASI ≥20, and difficult-to-treat areas. The study also compared bio-naive versus bio-experienced and male versus female patients. Adults received tildrakizumab 200 mg subcutaneously at weeks 0 and 4, then every 12 weeks. Clinical improvements were assessed using PASI, DLQI, genital PASI, and NAPSI scores. After 24 weeks, the mean PASI score dropped from 14.6 to 0.4, with PASI 90 and PASI 100 scores exceeding 80% (100.0% and 80.3%, respectively). DLQI scores improved from 14.2 to 1.8, and significant improvements were seen in genital PASI and NAPSI scores. No significant adverse events occurred. Tildrakizumab 200 has been shown to be an effective therapeutic option, particularly for patients with high body weight, significant disease burden, and involvement of sensitive areas with no new safety signals.
Real-world burden of atopic dermatitis: Austrian and Swiss data from the MEASURE-AD study
Atopic dermatitis (AD) is characterized by flares of eczematous lesions accompanied by intense pruritus, which can tremendously impact quality of life (QoL). Despite continuous therapeutic progress, there are still unmet needs regarding AD management.
Long-term safety and efficacy of MBA-P01 for the treatment of glabellar lines: results from a multicenter, repeated-dose, open-label extension study
Purpose Following the introduction of new type of botulinum toxin (MBA-P01), a recent phase 3 study demonstrated that MBA-P01 showed comparable efficacy and safety to onabotulinumtoxin A for reducing glabellar lines. The primary objective of this study was to evaluate the long-term safety of repeated MBA-P01 administration for the treatment of glabellar lines.Materials and methods This multicenter, single-group, repeated-dose, long-term open-label extension study evaluated repeated treatment with MBA-P01 (20 U, five treatments over 16 months), with posttreatment evaluation performed up to 52 weeks.Results Based on the safety assessment results, no specific irreversible adverse reactions were associated with the safety profile of MBA-P01. Repeated treatment with MBA-P01 was effective for a treatment duration of 3-5 months.Conclusion In conclusion, multiple cycles of treatment of glabellar lines with MBA-P01 at a dose of 20 U were well tolerated. Clinical trial registration information: This study is registered in ClincalTrials.gov (NCT05321979).
Biologics and oral systemic treatment preferences in patients and physicians for moderate-to-severe atopic dermatitis: a discrete choice experiment in the United Kingdom and Germany
As the available treatments for moderate-to-severe atopic dermatitis (AD) expand, understanding patient and physician preferences becomes crucial for informed decision-making. To quantify patient and physician preferences for biologics and oral systemic AD treatment attributes. We conducted a cross-sectional, online discrete choice experiment (DCE) involving 306 AD patients and 206 physicians throughout the United Kingdom and Germany. Qualitative interviews identified the key attributes for inclusion in the DCE. Each choice task comprised two hypothetical patient profiles. Data were analyzed using a random-parameters logit model. Results indicated a significant emphasis on efficacy, with reducing sleep disturbance and itch ranking first and second among patients, and the reverse for physicians. Time to itch relief was the third most important efficacy attribute for both groups, but relatively more important for patients than for physicians. For both groups, the risk of eye problems was the most important safety concern of those included. Mode of administration was not of great importance compared to efficacy and safety attributes. Our findings suggest patients prioritize sleep disturbance, an attribute not captured in prior preference studies in AD, time to itch relief and itch. These findings emphasize the importance of addressing sleep-related issues, whilst also targeting fast itch control, to enhance patients' well-being.
Noninvasive high-intensity focused ultrasound for skin brightening efficacy using a topical agent containing glutathione and hyaluronic acid
High-intensity focused ultrasound (HIFU) is well-documented for skin rejuvenation, lifting, and tightening. However, its synergistic effects with topical agents, enhanced by HIFU-induced vibration and heat, remain underexplored.
Systemic treatment of recessive dystrophic epidermolysis bullosa with mesenchymal stromal cells: a scoping review of the literature and conclusions for future clinical research
The ability of mesenchymal stromal cells (MSCs) to facilitate regenerative responses in inflamed and injured tissues, coupled with preclinical data suggesting potential to restore defective collagen VII at the dermo-epidermal junction, has raised the hope that MSCs may provide an effective disease-modifying therapy for patients suffering from recessive dystrophic epidermolysis bullosa (RDEB). We present a descriptive analysis of the clinical research on systemic MSC administration to RDEB patients available in PubMed, including six early-phase studies and one case report, involving 59 patients who received 1-3 intravenous infusions of MSCs from various sources. Based on 133 MSC infusions, a total of 44 mostly mild adverse events were reported as definitely, possibly or likely related to the study treatment, only two of which led to treatment discontinuation. Improvements were seen in skin manifestations, disease activity, pain, pruritus and quality of life, with considerable heterogeneity in reported outcome variables and measurement tools between studies, and large inter-patient variability within studies. Although the current evidence base is limited, reflecting the typical challenges of clinical research in rare diseases, the reported results suggest potential treatment benefits for patients and provide a rationale for continuing to pursue this therapeutic approach.
Plain language summary of the pivotal study of calcium hydroxylapatite with lidocaine for improvement of jawline contour
Summary A study (ClinicalTrials.gov identifier: NCT03583359) that tested whether an injectable filler treatment called calcium hydroxylapatite with lidocaine, or CaHA (+), could improve the shape of the jawline. Loss of jawline shape is a change to jawline appearance, like sagging or deflating, that occurs as people get older. A total of 123 participants received CaHA (+) injections on day 1 of the study (immediate treatment). Fifty-seven participants did not receive CaHA (+) until week 12 (delayed treatment). Jawline shape at week 12 was rated on a five-point scale (0 = no loss of shape or volume; 4 = extreme loss). Researchers also looked at participants' satisfaction and self-reported improvement, ratings of how old participants thought they looked, and side effects. In the immediate treatment group, 76% of participants had improvement in jawline shape at week 12 (compared with 9% of participants in the delayed treatment group), which typically lasted approximately 8 months, and 94% self-reported improvement in jawline appearance. The participants were more satisfied with their jawlines and reported looking approximately 3 years younger at week 12 compared with before treatment. Regardless of sex or skin tone, side effects were categorized as mostly mild or moderate reactions, like lumps or bruising, at the site where CaHA (+) was injected. The results showed that CaHA (+) injections improved jawline shape in most participants and caused only mild or moderate side effects regardless of sex or skin tone, suggesting that CaHA (+) is safe and works well for diverse groups of patients. This summary is for patients and others interested in learning about how CaHA (+) works, its safety, and its ability to improve jawline shape. The study was sponsored by Merz North America, Inc.
A systematic review of recent randomized controlled trials for palmoplantar pustulosis
Palmoplantar pustulosis (PPP) is a chronic inflammatory condition, that leads to significant functional impairment and reduced quality of life. Despite its low incidence, treatment options are diverse and often ineffective, necessitating a review of recent therapeutic advances. This review aims to evaluate the efficacy and safety of recent therapeutic options for the treatment of PPP, focusing on phototherapy, systemic therapies, and biologics. A systematic literature search identified 13 studies evaluating phototherapy and systemic therapies, including biologics. Inclusion criteria focused on randomized controlled trials with participants diagnosed with PPP. Phototherapy showed success: excimer laser demonstrated high efficacy for severe disease [PPP Area and Severity Index (PPPASI)-75 of 95.0%], while psoralen plus ultraviolet A therapy with retinoids or fumaric acid esters worked well in milder disease (PPPASI-90 of 90.0 and 81.8%, respectively). Evidence supports the efficacy and safety of guselkumab, brodalumab, and apremilast over a range of disease severity (PPPASI-50 ranged from 57.4 to 78.3% at week 16). Agents including anakinra, secukinumab, spesolimab, and RIST4721 (primary outcomes not achieved) may not be first-line treatments. By targeting multiple inflammatory pathways in PPP, JAK inhibitors may be more effective than biologics in treating PPP; however, more research is needed to confirm their safety and appropriate use. Multiple new treatments exist for PPP with promising results, however longer-term studies with standardized outcome reporting are needed to determine optimal treatment strategies and their comparative efficacy.
Successful treatment of cutaneous polyarteritis nodosa with baricitinib
Polyarteritis nodosa (PAN) is a rare systemic necrotizing vasculitis preferentially targeting medium-sized arteries. PAN has two clinical entities: systemic PAN (sPAN) and cutaneous PAN (cPAN). cPAN is a skin-limited vasculitis, while ulcerative cPAN often predicts a higher risk of recurrence and a worse prognosis. However, there is still little experience and no consensus on cPAN treatment. Janus kinase-signal transducer and activator of transcription (JAK-STAT) inhibition with baricitinib (JAK1/JAK2) inhibitor in patients with inflammatory skin diseases has demonstrated good therapeutic outcomes in several clinical studies. However, the use of baricitinib in patients with cPAN has not been reported to date. We report the first case of cPAN successfully treated with baricitinib. The patient had previously undergone various treatments, including corticosteroids and immunosuppressants, but these were continually switched due to inadequate efficacy or significant side effects. Following treatment with baricitinib, the patient's ulcers healed, subcutaneous nodules resolved, and livedo reticularis alleviated, resulting in a marked improvement in quality of life. No severe adverse reactions were observed during the treatment period. Over 1 year of follow-up, there was no recurrence of the rash. Our results support the evidence that baricitinib is a promising therapy for cPAN.
Long-term effectiveness and safety of risankizumab in patients with moderate-to-severe psoriasis with and without cardiometabolic comorbidities: a single-center retrospective study
Psoriasis is a chronic skin disease driven by immune system dysfunction and associated with increased cardiovascular risk and metabolic disorders. Risankizumab is an anti-interleukin-23 humanized monoclonal antibody approved for the treatment of moderate-to-severe plaque psoriasis. We conducted a 3-year retrospective study to evaluate the effectiveness and the safety of risankizumab in patients with moderate-to-severe psoriasis, comparing those with and without the presence of at least one cardiometabolic comorbidity (CMD). Our study included 333 patients treated with risankizumab for at least one year. One hundred and sixty-two patients had at least one CMD. After one year of treatment, a reduction of at least 90% and 100% in Psoriasis Area and Severity Index (PASI) score compared with baseline (PASI90 and PASI100, respectively) was observed in 80.3% and 63% of patients with CMDs compared to 83% and 63.2% of patients without CMDs. No statistically significant differences were observed between the two cohorts of patients in terms of effectiveness and rates of adverse events. No significant safety findings were observed throughout the study period. Our study supports data from clinical trials and real-world studies, even in patients with concomitant cardiometabolic comorbidities.
Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 years
Baricitinib, an oral selective Janus kinase inhibitor, improved clinical signs and symptoms of moderate-to-severe atopic dermatitis (AD) at week 16 in the phase 3 pediatric study BREEZE-AD-PEDS.
Ixekizumab-induced interstitial lung disease: a case report confirmed by transbronchial lung cryobiopsy
Ixekizumab, an interleukin-17A (IL-17A) inhibitor used in psoriasis treatment, has been linked to drug-induced interstitial lung disease (DI-ILD). The pathophysiological mechanisms and histopathological features of this adverse effect remain poorly documented. A 69-year-old male with familial psoriasis developed respiratory symptoms after 18 months of ixekizumab therapy. His medical history included mild smoking-related interstitial pneumonia and chronic obstructive pulmonary disease. One month after treatment, he presented with cough and dyspnea. High-resolution chest CT showed bilateral ground-glass opacities, accompanied by elevated Krebs von den Lungen-6 and surfactant protein-D levels. Transbronchial lung cryobiopsy (TBLC) revealed a fibrotic non-specific interstitial pneumonia pattern with granulomatous changes. Immunohistochemical analysis demonstrated a predominance of CD4-positive cells and IL-17A-positive lymphocytes, suggesting Th17 cell involvement in the pathogenesis. The patient's condition improved following ixekizumab discontinuation. This case identifies distinct histopathological features in ixekizumab-induced DI-ILD, particularly the presence of granulomatous changes and Th17 cell involvement. The findings suggest that IL-17A inhibition may trigger pulmonary inflammation through Th17 cell function dysregulation. This observation supports the importance of careful pulmonary monitoring in patients receiving biologic therapies for psoriasis, particularly those with pre-existing lung conditions. TBLC may contribute to understanding the pathogenesis of this drug-induced complication.
Five-year real-world drug survival of dupilumab in severe atopic dermatitis and associate predictors
Atopic dermatitis (AD) profoundly impacts patients' lives, necessitating long-term systemic treatments.
Comparison of safety profile in patients with atopic dermatitis treated with dupilumab or conventional systemic treatment: real world data from the US network
Safety of dupilumab in atopic dermatitis (AD) was investigated in randomized controlled trials (RCT). However, head-to-head trials comparing with conventional systemic drugs are lacking and large real-world data on the long-term safety profile as compared are scarce.
Short-term effectiveness and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis: results from a 16-week real-world multicenter retrospective study - il AD (Italian landscape atopic dermatitis)
Abrocitinib is a JAK-1 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis (AD). We conducted a 16-week multicenter retrospective study to assess the short-term effectiveness and safety of abrocitinib in patients with moderate-to-severe AD. Our retrospective study included 85 adult patients from 14 Italian Dermatology Units affected by moderate-to-severe AD treated with abrocitinib 100/200 mg. Effectiveness of abrocitinib at weeks 4 and 16 was assessed by using the Eczema Area and Severity Index (EASI), the Investigator Global Assessment (IGA), the peak pruritus and sleep- Numerical Rating Scale (PP-NRS and S-NRS, respectively). At week 16, improvement of at least 90% in EASI (EASI90) and IGA 0/1 was observed in 49.4% and 61.2% of patients, respectively. A reduction of at least 4 points in PP-NRS and S-NRS compared with baseline was achieved by 70.6% of patients for both endpoints. No significant safety reports were observed during the study period. Naïve patients had better rates of EASI 90 compared to patients who previously failed dupilumab. Our data confirm the effectiveness of abrocitinib in a real-world setting with better clinical responses at weeks 4 and 16, compared with Phase-III clinical trials. Longer analyses are required to further establish the safety profile of abrocitinib.
Complete responses and SALT zero scores in alopecia areata: not the same
Superior effect of adalimumab versus secukinumab on ultrasound-confirmed synovitis in psoriatic arthritis: comprehensive evidence from musculoskeletal ultrasound and clinical assessments
Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disorder affecting 30% of psoriatic patients. Effective treatment, especially with biologics like IL-17 and TNF inhibitors, is vital for improving patient outcomes. This study aimed to compare the efficacy of secukinumab and adalimumab in PsA patients through clinical and ultrasonographic evaluations. We enrolled 116 PsA patients, with 58 patients receiving secukinumab and 58 receiving adalimumab. Regular follow-ups were conducted at weeks 4, 12, 24, and 52. The primary outcome was the proportion of patients achieving at least a 20% improvement in the ACR response (ACR20) at week 12, with additional evaluations for axial arthritis, enthesitis, skin involvement, minimal disease activity, health assessment questionnaire, and ultrasound changes. There was no significant difference in ACR20 response between the two groups at week 12 (OR: 0.59, 95% CI: 0.26-1.37, = 0.22). However, secukinumab demonstrated superior efficacy in achieving Psoriasis Area and Severity Index (PASI)90 (OR: 2.25, 95%CI: 1.07-4.74, = 0.03), while adalimumab showed better improvement in ultrasound synovitis count (β: 0.94, 95%CI: 0.09-1.79, = 0.03) and synovitis PD signal (β: 0.20, 95%CI: 0.03-0.36, = 0.02). In conclusion, both treatments were highly effective for PsA, with secukinumab being more suitable for severe skin involvement and adalimumab for significant ultrasound-confirmed synovitis.
Anatomical consideration and techniques in thread nose augmentation with mesh scaffold implant
Non-surgical rhinoplasty has evolved with the introduction of volumizing threads, which offer a less invasive alternative to traditional methods by enhancing nasal contours while minimizing filler use. This technique is gaining popularity, particularly in Southeast Asia, due to its shorter recovery time, reduced risk profile, and ability to prevent the 'Avatar nose' effect. However, there is limited anatomical guidance available for its application, especially in the Asian population.
Disease burden and patient characteristics associated with systemic therapy utilization among adults with atopic dermatitis: data from CorEvitas Atopic Dermatitis Registry
The decision to initiate advanced systemics in patients with atopic dermatitis (AD) is complex.
Polynucleotide-based treatments for various facial scars including combat injuries
This study examines the therapeutic efficacy of polynucleotide-based therapies, specifically REJURAN, for managing scars and burns. Scars and burns present significant challenges in dermatology, often affecting patients' quality of life. Traditional treatments can be limited in effectiveness, prompting the exploration of innovative approaches like polynucleotide therapy, which utilizes salmon DNA to stimulate tissue repair, modulate inflammation, and enhance collagen production.