Investigator's Global Assessment Research Articles

Effectiveness of Dupilumab for Chronic Prurigo in Chinese Patients: A Real-World Case Series Study.

Treatment of chronic prurigo (CPG) is challenging. As an antagonist of IL-4R, dupilumab has shown effectiveness in treating CPG in several clinical studies. Recently, the US Food and Drug Administration (FDA) approved dupilumab for the treatment of prurigo nodularis (PN). The purpose of this study was to examine the efficacy of dupilumab in Chinese patients with CPG, and to analyze the difference in response between subtypes of CPG. This retrospective study included 18 patients with CPG who were treated with dupilumab for at least 16 weeks from March 2022 to October 2022. Disease severity and patient self-assessment questionnaires were assessed at baseline and each visit, including the peak Pruritus Visual Analogue Scale (PP-VAS), Prurigo Activity and Severity Score (PAS), Investigator Global Assessment (IGA), Dermatology Life Quality Index (DLQI), Hospital Anxiety and Depression Scale (HADS) and Itchy-specific Quality of Life questionnaire (ItchyQoL). After 2 weeks of dupilumab treatment, pruritus scores were significantly reduced as measured by PP-VAS scores. Prurigo Activity and Severity scores decreased significantly at Week 2, whereas IGA improved significantly at Week 8. The DLQI, HADS, and ItchyQoL scores at Week 16 also showed significant improvement from baseline. Patients in all subtypes showed improvement in pruritus and lesion severity. Dupilumab was effective in improving pruritus and lesions in patients with various subtypes of CPG.

Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis.

The aim of this study was to evaluate guselkumab efficacy on regional psoriasis in a subset of psoriasis patients with a self-reported psoriatic arthritis (PsA) diagnosis. In the phase 3 VOYAGE-1 and -2 studies, at week (W)0, patients with moderate-to-severe psoriasis were randomized to guselkumab 100mg, placebo → guselkumab 100mg at W16 through W44, or adalimumab 80mg then 40mg at W1 through W48 (VOYAGE-1) or W24 (VOYAGE-2). Pooled efficacy outcomes, including scalp-specific Investigator's Global Assessment (ss-IGA), hands and/or feet Physician's Global Assessment (hf-PGA), fingernail PGA (f-PGA), Nail Psoriasis Area and Severity Index (NAPSI), and Dermatology Life Quality Index (DLQI), were compared (nominal p-values) through W24 in patients with self-reported PsA diagnosis. Response rates/percentage improvement from baseline were determined, employing treatment failure rules and non-response/no improvement data imputation. A total of 76, 153, and 106 psoriasis patients with self-reported PsA were randomized to the placebo, guselkumab, or adalimumab groups, respectively; the baseline characteristics of patients in all three arms were comparable. At W16, a greater proportion of guselkumab- versus placebo-treated patients achieved ss-IGA 0/1 (80.6% vs. 22.7%, p < 0.001), hf-PGA 0/1 (68.9% vs. 14.8%, p < 0.001), f-PGA 0/1 (47.6% vs. 17.0%, p < 0.001), and DLQI 0/1 (45.6% vs. 2.7%, p < 0.001) responses; mean percentage NAPSI improvement was also greater with guselkumab (39.5% vs. 6.5%, p < 0.001). At W24, patients receiving guselkumab had higher ss-IGA 0/1 (77.5% vs. 58.5%, p = 0.003) and DLQI 0/1 (47.7% vs. 34.3%, p = 0.024) response rates versus those receiving adalimumab. Response rates/mean percentageimprovements at W48 (VOYAGE-1) were numerically greater with guselkumab than adalimumab (e.g., NAPSI improvement: 75.6% vs. 60.9%). Guselkumab-treated patients with psoriasis and self-reported PsA showed meaningful improvements in nail, scalp, and palmoplantar psoriasis. VOYAGE-1 (ClinicalTrials.gov Identifier: NCT02207231) and VOYAGE-2 (ClinicalTrials.gov Identifier: NCT02207244).

Tralokinumab Efficacy Over 1Year in Adults with Moderate-to-Severe Atopic Dermatitis: Pooled Data from Two Phase III Trials.

Two phase III trials, ECZTRA 1 and 2, confirmed the efficacy and safety of tralokinumab versus placebo in adults with moderate-to-severe atopic dermatitis (AD). To further explore the long-term efficacy of tralokinumab for AD, a pooled analysis of these trials was conducted. ECZTRA 1 and 2 patients (n = 1596 total) were randomized to tralokinumab 300mg or placebo every 2weeks (q2w) over 16weeks. Patients achieving Investigator's Global Assessment of clear/almost clear skin (IGA 0/1) and/or 75% improvement in the Eczema Area and Severity Index (EASI-75) at Week 16, were re-randomized to tralokinumab q2w, every 4weeks (q4w), or placebo (tralokinumab withdrawal) for another 36weeks. Patients not achieving the response criteria at Week 16 received open-label tralokinumab q2w plus optional topical corticosteroids (TCS). A pooled, prespecified analysis assessed the proportions of Week 16 responders that maintained IGA 0/1 and/or EASI-75 at Week 52. Pooled data from all patients initiated with tralokinumab, regardless of the response at Week 16 or dosing regimen received thereafter, were analyzed post hoc. In patients who achieved the primary endpoints at Week 16, IGA 0/1 responses were maintained at Week 52 without rescue treatment (including TCS) by 55.9%, 42.4%, and 34.0% of patients re-randomized to tralokinumab q2w, q4w, or placebo (tralokinumab withdrawal), respectively, while EASI-75 responses were maintained by 57.3%, 50.4%, and 26.4%, respectively (prespecified analysis). In a post hoc analysis of all patients initiated with tralokinumab, response rates improved over time with continued tralokinumab treatment beyond Week 16 to Week 52 for EASI-50 (63.1-82.7%), EASI-75 (37.6-61.8%), EASI-90 (20.4-37.3%), and IGA 0/1 (23.0-36.2%). Tralokinumab treatment provides progressive and sustained improvement over 1 year in the extent and severity of AD in patients with moderate-to-severe AD. NCT03131648 (ECZTRA 1); study start date: 30 May 2017; primary completion date: 7 August 2018; study completion date: 10 October 2019. NCT03160885 (ECZTRA 2); study start date: 12 June 2017; primary completion date: 4 September 2019; study completion date: 14 August 2019. INFOGRAPHIC.

Safety, Pharmacokinetics and Preliminary Efficacy of IL4-Rα Monoclonal Antibody AK120 in Both Healthy and Atopic Dermatitis Subjects: A Phase I, Randomized, Two-Part, Double-Blind, Placebo-Controlled, Dose-Escalation, First-In-Human Clinical Study.

Interleukin-4 (IL-4) and interleukin-13 (IL-13) are two essential cytokines involved in the T helper 2 (Th2)-mediated inflammatory response to diseases, such as atopic dermatitis (AD). AK120 is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) directed against the IL-4 receptor alpha (IL-4Rα) subunit shared by the IL-4 and IL-13 receptor complexes. This mAb inhibits the signaling of the IL-4 and IL-13 cytokines. The study consisted of two parts. Part 1 was a single ascending dose (SAD) study with five cohorts (receiving 15, 50, 150, 300 or 600mg of AK120, respectively) of healthy subjects; part 2 was a multiple ascending dose (MAD) study with four cohorts (receiving AK120 at doses of 300mg once every 2 weeks [Q2W], 300mg once weekly [QW], 150 mg QW or 75mg QW) of subjects with AD. A total of 81 subjects (40 in part 1, 41 in part 2) were enrolled in the study. The compound was safe and well tolerated in both a SAD up to 600mg in healthy subjects and in a MAD from 75 to 600mg in subjects with AD. The exposure of AK120 increased in an approximately dose-dependent manner upon subcutaneous dosing. The levels of the biomarkers serum thymus and activation-regulated chemokine ligand 17 (TARC/CCL17) and immunoglobulinE decreased from baseline after AK120 administration, indicating the inhibitionoftheIL-4/IL-13 signaling pathways. AK120 showed improved Eczema Area and Severity Index (EASI) scores, and the proportion of subjects with Investigator Global Assessment (IGA) score 0/1 increased after AK120 treatment. AK120 exhibited an acceptable safety profile in healthy and AD subjects, and showed preliminary efficacy. These findings support the continued investigation of AK120 for treating AD. ClinicalTrials.gov identification number: NCT04256174.

Psychosocial Consequences of Hand Eczema-A Prospective Cross-Sectional Study.

Hand eczema (HE) is a chronic inflammatory disease with a high prevalence, negatively influencing patients' quality of life (QoL). It may also affect patients' psychological status. The aim of this study was to assess and characterize the psychological burden of HE, its influence on patients' QoL, and the presence and severity of anxiety and depressive disorders in HE patients. The study group consisted of 100 adult HE individuals. To assess the severity of the disease, two instruments were used: the Investigator Global Assessment for Chronic Hand Eczema (IGA-CHE) scale and the Hand Eczema Severity Index (HECSI). Assessment of patients' quality of life (QoL) was obtained with the use of the DLQI tool. Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) questionnaires were employed to assess depression and anxiety, respectively, as well as a modified version of the Hospital Anxiety and Depression Scale (HADS-M). The mean DLQI value for the whole group reached 11.62 ± 6.35 points (13.27 ± 6.67 points in females and 9.15 ± 4.95 points in males; p = 0.023). A decrease in QoL correlated positively with the severity of the disease and the severity of itch and pain. In 17 patients (17%), a possible diagnosis of depressive disorder was found. Patients scoring higher results on the PHQ-9 and HADS-M depression (D) questionnaires reported greater intensity of the itch (r = 0.363, p < 0.001, and r = 0.237, p = 0.017, respectively) and the pain (r = 0.445, p < 0.001, and r = 0.287, p = 0.004, respectively). The anxiety disorder might possibly be diagnosed in 25% of patients (n = 25). This study revealed a positive correlation between the severity of the anxiety symptoms, measured with the use of both GAD-7 and HADS-M anxiety (A) tools, and the intensity of the pain (r = 0.248, p = 0.013, and r = 0.342, p = 0.001, respectively). The severity of depressive and anxiety symptoms correlated positively with the severity of the disease. The psychosocial burden of HE is an undeniable phenomenon. The disorder influences patients' QoL and may cause mental disturbances such as depression and anxiety disorders.

Roflumilast (Zoryve)

&#x0D; CADTH recommends that Zoryve be reimbursed by public drug plans for the treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients 12 years of age and older if certain conditions are met.&#x0D; Zoryve should only be covered to treat patients who have a clinical diagnosis of plaque psoriasis with an Investigator Global Assessment (IGA) score of at least 2 (mild) and an area of plaque psoriasis appropriate for topical treatment covering a body surface area of 2% to 20% (inclusive).&#x0D; Zoryve should be discontinued if a response has not been demonstrated by 8 weeks. A response to treatment is defined as at least a 2-grade improvement from baseline in IGA score or an IGA score of “clear” or “almost clear” (0 or 1). The cost of Zoryve should not exceed the drug program cost of treatment with the least costly topical therapy reimbursed for the treatment of plaque psoriasis.&#x0D;

44232 Investigator Global assessment (IGA) of Acne Vulgaris and IGA Success among patients with moderate to severe non-nodular Acne Vulgaris (AV) administered sarecycline in community practices across the U.S: Analysis of PROSES,by race and baseline AV severity

44232 Investigator Global assessment (IGA) of Acne Vulgaris and IGA Success among patients with moderate to severe non-nodular Acne Vulgaris (AV) administered sarecycline in community practices across the U.S: Analysis of PROSES,by race and baseline AV severity

Clinical Trial of Alpha and Beta Defensin Skin Care Regimen for Improvement of Periocular Wrinkles.

Defensins recruit leucine-rich repeat-containing G protein-coupled receptor 6 positive (Lgr6+) stem cells which ultimately regenerate new basal stem cells, healthy keratinocytes, and nascent hair follicles. Thus, defensins are an exciting, novel therapy for the reversal of skin aging. This is a multicenter, prospective, open-label clinical trial. Twenty healthy subjects, aged 45-80, with Fitzpatrick skin types II-IV were enrolled in the study. A skin care regimen containing alpha-defensin 5 and beta-defensin 3 were applied to the face twice daily for 12 weeks. This skin care regimen contains a greater percentage of defensins than that already studied.7 All participants underwent imaging at baseline, day 30, day 60, and day 90. Primary endpoints included investigator scoring on the Fitzpatrick-Goldman wrinkle scale and percent improvement in periorbital wrinkles, laxity, pigmentation, erythema, texture, and radiance. Secondary endpoints were investigator Global Aesthetic Improvement Score (GAIS), subject GAIS, and investigator assessment of tolerability. A final subject questionnaire was completed on day 90.&nbsp; Results: Based on the Fitzpatrick-Goldman wrinkle scale, a statistically significant improvement was noted in both wrinkling and elastosis from baseline to day 90. 30% of subjects were rated as much improved and 50% of subjects were rated as improved on the physician GAIS at the 90 day follow up. Improvements were noted in all aspects of skin quality including wrinkles, laxity, dyschromia, erythema, texture, and radiance.&nbsp; Conclusion: The enhanced formula containing increased concentrations of alpha-defensin 5 and beta-defensin 3 is a safe and efficacious topical therapy for the treatment of periorbital rhytids. Hartman N, Loyal J, Taub A, et al. Clinical trial of alpha and beta defensin skin care regimen for improvement of periocular wrinkles. J Drugs Dermatol. 2023;22(9):874-880. doi:10.36849/JDD.7184.

The Effectiveness of Using CO2 Fractional Laser and Mebo Burn Ointment Together in Treating Scars on the Face after Surgery.

This study aimed to investigate the efficacy and safety of CO2 fractional laser combined with Mebo burn ointment in treating facial postoperative scars. Sixty patients with facial postoperative scars in the department of plastic surgery of Sun Yat-sen Memorial Hospital from January 2020 to June 2022 were divided into a control group (30 cases) and a study group (30 cases). Both groups received CO2 fractional laser treatment, but the study group also received Mebo burn ointment application. The study found that both methods resulted in a significant decrease in Sawada score and a significant increase in Investigator Global Assessment score after treatment (P < 0.05), with the study group showing a more significant improvement and higher patient satisfaction (P < 0.05). All patients experienced varying degrees of bleeding, swelling, and erythema immediately after treatment, with two cases of pigmentation and two cases of persistent erythema in the control group, and one case of pigmentation and one case of persistent erythema in the study group. Adverse reactions were minimal, with the study group showing better tolerance. The study suggests that CO2 fractional laser combined with Mebo burn ointment is an effective and safe treatment for facial postoperative scars.

Treatment outcomes of secukinumab in adult patients with moderate-to-severe plaque psoriasis in China: A real-world multicenter retrospective study.

Secukinumab is effective in treating patients with moderate-to-severe plaque psoriasis. However, most studies assessing its effectiveness in routine clinical settings in China are mostly single-center studies with a limited sample size. The objective of this study was to assess secukinumab's efficacy, treatment patterns, and characteristics in patients with moderate-to-severe plaque psoriasis. This 24-week, multicenter (n = 5) retrospective study analyzed the data of Chinese adult patients with moderate-to-severe plaque psoriasis who initiated secukinumab treatment between May 2019 and March 2020. The Psoriasis Area and Severity Index (PASI), body surface area (BSA), Investigator's Global Assessment Modified 2011 (IGA mod 2011), and Dermatology Life Quality Index (DLQI) were assessed. Dermatologists documented the treatment dosage and modification reasons. Of the 244 secukinumab-naïve patients, most were men (73.4%, 179/244) and weighed 60-90 kg (72.8%, 177/243). The mean (SD) age at secukinumab initiation was 38.1 (11.6) years, and the disease duration was 13.5 (7.9) years. Most patients (97.1%, 237/244) received secukinumab 300 mg. At weeks 4, 12, 16, and 24, the proportion of patients achieving PASI 75 (≥75% reduction from baseline) was 40.0%, 92.1%, 88.4%, and 88.9%, respectively; PASI 90 was 15.0%, 73.7%, 81.4%, and 68.3%, respectively; and PASI 100 was 8.7%, 40.8%, 58.1%, and 41.3%, respectively. During the same periods, BSA and IGA mod 2011 showed similar improvement trends. An increasing proportion of patients achieved DLQI of 0-1 (21.6%, 65.7%, 75.0%, and 80.3%, respectively). Treatment modification was highest at week 12. The average interval between two administrations after week 4 was 62.95 days. Secukinumab was highly effective in improving the PASI, IGA, BSA, and DLQI in Chinese patients with moderate-to-severe plaque psoriasis throughout the first 24 weeks. The treatment pattern for Chinese patients differs from that in the clinical guidelines.

Fractional carbon dioxide laser combined with subcision for the treatment of three subtypes of atrophic acne scars: a retrospective analysis.

Fractional carbon dioxide (CO2) laser combined with subcision has been widely used for the clinical treatment, but the efficacy of the combined therapy on three types of atrophic acne scars remains unreported. This retrospective study analyzed the clinical data of 413 patients with atrophic acne scars, treated with fractional CO2 laser combined with subcision in the combined group and with fractional CO2 laser in the control group. The treatment efficacy was evaluated by the Investigator's Global Assessment (IGA) and the Échelle d'évaluation clinique des cicatrices d'acné (ECCA). We reported adverse reactions such as erythema, lump, skin sensitivity, acne recurrence, and hyperpigmentation that occurred in both treatment groups. The treatment efficiency of the combined group was significantly higher than that of the control group (P < 0.001). Among the three subtypes of atrophic acne scars, the ECCA scores in the combined group of boxcar-type and rolling-type scars after treatment were lower than those in the control group (P = 0.041, P < 0.001, respectively), and no statistical difference in scores between the two groups for icepick-type scars was seen (P = 0.062). There was no statistical difference in adverse reactions between the two groups (P = 0.361). Fractional CO2 laser combined with subcision is more effective than fractional CO2 laser in thetreatment of boxcar-type and rolling-type scars, but there is no significant difference in the treatment of icepick-type scars.

Persistence and effectiveness of guselkumab treatment in patients with moderate-to-severe plaque psoriasis in a non-interventional real-world setting: The SPRING study.

Guselkumab is a monoclonal antibody that blocks the IL-23 pathway with proven efficacy and tolerability in the treatment of moderate-to-severe plaque psoriasis. To assess the persistence, effectiveness and safety of guselkumab in patients with moderate-to-severe psoriasis in real clinical practice in Spain. SPRING was a Phase IV, retrospective and non-interventional study analysing patients with moderate-to-severe plaque psoriasis who had initiated guselkumab under clinical practice conditions at least 12 months before inclusion in the study. The primary endpoint was persistence (non-persistence: discontinuation or interruption ≥90 days). Effectiveness was assessed using the Psoriasis Area Severity Index (PASI) and Investigator Global Assessment (IGA). Dermatology Life Quality Index (DLQI) and safety were also evaluated. A total of 284 patients were included between September 2020 and June 2021. The 1-year probability of persistence was 89.6% (86.1%-93.3%). The 1-year probability of persistence was also calculated according to prior biologic treatment, being 90.3% for biologic-naïve patients and 89.5% for patients who received one or more biologic therapies before guselkumab. Additionally, patients were also classified based on the frequency of the administration of guselkumab treatment; the 1-year probability of persistence was 91.9% in patients receiving guselkumab according to the Summary of Product Characteristics and 89.3% in patients with lengthened intervals of administration. After 1 year, PASI 90 was achieved by 56.4% of patients, IGA 0/1 response and BSA <3% were achieved by 65.5% and 77.8% of patients, respectively, and 65.8% achieved a minimal clinically significant difference (>4-point reduction) in the DLQI score at 1 year. Twenty-six adverse reactions (4 of them serious) were reported in 16 patients. This study suggests that guselkumab has high persistence in real clinical practice in Spain, independently of the previous biologic treatments and changes in the frequency of treatment. Effectiveness and safety are consistent with previously published data.

Treatment with Methotrexate in Infants and Toddlers with Atopic Dermatitis: A Retrospective Multi-Center Study.

Atopic dermatitis (AD) is a chronic inflammatory skin disease affecting up to 20% of children. Methotrexate (MTX) is used off-label as a systemic treatment for AD patients unresponsive to topical therapies, but limited data exist regarding its safety and efficacy in children, especially in those < 4 years old. To further investigate MTX in younger patients, we screened the medical records of three referral centers between 2016 and 2022 and identified 28 infants and toddlers < 4 years old with AD treated with MTX. Mean age upon MTX initiation was 2.7 ± 1.2 years and mean investigator global assessment (IGA) score was 3.78 ± 0.4. Median duration of MTX treatment was five months. Following 12 and 24 weeks of MTX treatment, the response rate was 50% and IGA 0/1 was achieved in 14.2% and 21.4% of patients, respectively. Most treatment cessations were attributed to a lack of efficacy or parental concern. Although adverse events were reported in 57.1% of patients, MTX was discontinued due to such adverse events only in two patients (7.1%). Taken together, MTX demonstrated a high safety profile in AD patients <4 years old. MTX efficacy was moderate and presumably underestimated by parents who opted for premature treatment cessation due to concerns associated with an immunomodulatory drug.

Noncorticosteroid Topical Therapies for the Treatment of Plaque Psoriasis: A Narrative Review.

Objective: The objective was to compare the safety and efficacy of noncorticosteroid topical treatments for plaque psoriasis. Data Sources: A literature search of the PubMed database was performed (January 1978 to May 2023) using the keywords plaque psoriasis, tapinarof, benvitimod, Vtama, roflumilast, Zoryve, pimecrolimus, tacrolimus, tazarotene, tacalcitol, calcitriol, Vectical, calcipotriene, Dovonex, tacalcitol, vitamin D analogs, salicylic acid, non-corticosteroid topical, Investigator's Global Assessment, and Physician's Global Assessment. Study Selection and Data Extraction: Relevant English-language articles and clinical trial data were considered. Data Synthesis: Six noncorticosteroid topical classes for the treatment of plaque psoriasis were selected. The percentage of patients with plaque psoriasis who achieved Investigator's Global Assessment (IGA) success after 8 weeks of treatment with tacalcitol, calcipotriene/betamethasone dipropionate compound, tazarotene/halobetasol propionate, and roflumilast was 17.9%, 39.9%, 40.7%, and 42.4%, respectively. For 12-week trials of tapinarof and coal tar, 37.4% and 58.2% of patients achieved IGA success, respectively. There were 48% and 71.4% reductions in IGA scores with salicylic acid (12 weeks) and pimecrolimus (4 weeks), respectively. Finally, 66.7% of patients achieved Physician's Global Assessment success with 8 weeks of tacrolimus. There were no serious adverse events for the noncorticosteroid topicals. Conclusion: Noncorticosteroid topicals are suitable options for patients with plaque psoriasis who would like to avoid topical corticosteroids or have experienced adverse effects from chronic corticosteroid use. Due to treatment duration differences and varied outcome measures, it is unclear which noncorticosteroid topical is most efficacious; however, calcineurin inhibitors appear to exhibit the greatest efficacy. Each topical was efficacious in treating plaque psoriasis and had an adequate safety profile. Despite several treatment options for plaque psoriasis, medication adherence is a limiting factor.

Psychological Burden and Willingness to Pay Among Korean Rosacea Patients and Their Association With Rosacea Phenotype and Severity: A Multi-Center Cross-Sectional Study.

Rosacea is a chronic inflammatory disorder that can adversely affect the patient's quality of life (QOL). However, few studies have examined the association between the psychological burden and willingness to pay (WTP) with rosacea features and severity. The study aimed to determine the overall psychological burden and WTP among Korean rosacea patients and identify factors that may contribute, such as patient demographics, clinical features, and rosacea severity. This prospective cross-sectional study recruited Koreans with rosacea. All were asked to complete a questionnaire on their demographics, rosacea-related symptoms, self-rated severity, dermatology life quality index (DLQI), and WTP. The clinical features were assessed by a board-certified dermatologist. The investigator's global assessment and global flushing severity score (GFSS) were used to determine the clinical severity of rosacea. Multiple regression analysis was conducted to identify factors contributing to the psychological burden and WTP. Out of 201 rosacea patients, 147 (73.1%) were female, and 54 (26.9%) males, with a median age of 50.1 years. Their median DLQI score was 8 (interquartile range [IQR]): 4.0-13.0). The median WTP per month for the control of rosacea was $100, with relative WTP (WTP/household income per month x 100) being 3.3%. According to the multiple regression model, phymatous change (β = .153, p = .030), DLQI score (β = .152, P = .045), and GFSS (β = .154, P = .041) contributed most to the WTP. Rosacea patients experience substantial psychological and economic burdens. More vigorous treatment should be performed for those with phyma and severe flushing whose QOL is most severely affected.

Evaluation of the effectiveness and safety of combined oral and topical photoprotection with a standardized extract of Polypodium leucotomos (Fernblock®) in a Moroccan population with xeroderma pigmentosum.

Xeroderma pigmentosum (XP) is a rare autosomal-recessive genodermatosis resulting from a DNA-repair defect syndrome. The purpose was to evaluate the prevention on new malignant lesions in patients taking a supplement with Fernblock® (Polypodium leucotomos extract [PLE]) and secondarily correlation with the photoprotective behavior. A prospective, single-center and open cohort study was conducted over a 12-month period. The study was performed in Morocco. Optimal photoprotection behavior was recommended. Patients were instructed to take one capsule containing 480 mg of Fernblock® and 5 mcg vitamin D and to apply sunscreen with a SPF50+ and Fernblock® every 2 h during sun exposure. The demographic, clinical, and dermatoscopic patient data were collected at baseline (T0) and following visits at 3 months (T3), 6 months (T6), and 12 months (T12) when it was assessed: Investigator Global Assessment (IGA), Patient/Guardian Global Assessment (PGA), Patient/Guardian Satisfaction Questionnaire, and Photographic and Adverse Events Registration. Pertinent statistical study was performed. Eighteen patients completed the study. Eleven patients (61%) finished the study without new lesions. Seven patients developed new lesions by the end of the study. Among them, only 30% showed an ideal photoprotective behavior. The lack of an optimal photoprotective behavior increased the probability of developing lesions by 2.5 times with 95% confidence interval. In our study, more than 60% of patients taking a supplement with Fernblock® did not develop new lesions, and furthermore, we detected that patients following almost ideal photoprotection were 2.5 times less likely to develop NMSC lesions.

Fixed-combination halobetasol propionate and tazarotene topical lotion decreases TNF-α and IL-17A levels in psoriatic lesions

ObjectiveFixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) is approved for the treatment of plaque psoriasis in adults, with a demonstrated efficacy and safety profile in phase 3 trials. This study examined the effect of HP/TAZ on the reduction of tumor necrosis factor alpha (TNF-α) and interleukin 17 A (IL-17A) and its correlation to psoriasis improvement.Materials and methodsTen adults with mild-to-moderate plaque psoriasis and 2 symmetrical plaques self-applied HP/TAZ (treated plaque) or vehicle lotion (untreated plaque) for 12 weeks. At baseline and each study visit (weeks 2, 4, 8, and 12), Investigator’s Global Assessment (IGA) score and erythema, scaling, and induration were assessed. Additionally, D-squame tape strips were utilized to quantify TNF-α and IL-17A in target lesions by enzyme-linked immunosorbent assay.ResultsSignificant improvements in mean IGA score in HP/TAZ–treated compared with untreated plaques were evident at week 2 and maintained through week 12 (p < 0.003). HP/TAZ significantly reduced TNF-α levels at weeks 4 through 12 (p < 0.03) and IL-17A levels at weeks 2 through 8 (p < 0.05) in treated compared with untreated plaques.ConclusionsHP/TAZ was highly effective in treating psoriasis plaques and, although HP/TAZ is not a biologic, effectively reduced cytokine-associated inflammatory markers that drive psoriatic disease.

Dupilumab improve acquired reactive perforating collagenosis characterized by type 2 inflammation.

Acquired reactive perforating collagenosis (ARPC) is a clinically challenging disease with an unclear pathogenesis. To evaluate the efficacy and safety of dupilumab for the treatment of ARPC, and analyze the expression of type 2 inflammation-related molecules in ARPC lesions. This retrospective cohort study included 20 patients with ARPC; 10 received dupilumab and 10 received conventional therapy. The efficacy and safety of dupilumab were evaluated at 12 weeks. Immunohistochemical and immunofluorescence analyses of T- and B-cell markers, and type 2 inflammation-related cytokines, were performed on skin samples from ARPC patients, atopic dermatitis (AD) patients, and healthy controls. Significantly more patients showed improvements in the Investigator Global Assessment score (100% vs. 0%; p < 0.0001) and itching (90%/8.33%, P =.001) in the dupilumab group compared to the conventional group at 12 weeks. There were no adverse effects in the dupilumab group. The ARPC lesions showed enhanced dermal infiltration of CD3+ T-cells, with a predominance of Th2 cells, similar to AD lesions. IL-4 and IL-13 were co-localized with GATA3 in ARPC lesions. Dupilumab improved ARPC charaterized with type 2 inflammation.

Efficacy and safety of tralokinumab in the treatment of atopic dermatitis: A systematic review and meta-analysis of randomized controlled trials.

To assess the efficacy and safety of Tralokinumab in the treatment of moderate-to-severe atopic dermatitis (AD). PubMed, Embase, Clinical Trials Website, and Cochrane Library were systematically searched for eligible randomized controlled trials which assessed the effects of Tralokinumab on AD. Primary outcomes included Scoring Atopic Dermatitis score, EASI-75%, and Investigator's Global Assessment score of 0 or 1 in 12 to 16 weeks. Secondary outcomes included the Eczema area and severity index score, the Numeric Rating Scales score, the dermatology life quality index score, and the overall incidence of adverse events. The quality of included studies was evaluated using the Cochrane System and the modified Jadad scale. Analysis was performed using Stata 16 software. Eight randomized controlled trials involving 2878 patients were included in this meta-analysis. Compared to placebo, Tralokinumab treatment exhibited a significantly higher Scoring Atopic Dermatitis score [SMD = -0.53, 95% confidence intervals [CI]: -0.62 to -0.44, P < .00001], an increased number of patients with EASI-75% [odds ratio (OR) = 2.44, 95% CI: 2.00-2.97, P < .00001] and Investigator's Global Assessment score of 0 or 1 in 12 to 16 weeks [OR = 2.12, 95% CI: 1.71-2.63, P < .00001]. No significant difference was observed in the incidence of overall adverse events [OR = 1.00, 95% CI: 0.85-1.18, P = 1.00] between the 2 groups. Tralokinumab is effective and safe in treatment of moderate-to-severe AD.

Efficacy and safety profile of dupilumab for the treatment of atopic dermatitis in children and adolescents: A systematic review and meta-analysis.

Dupilumab is the first biologic approved for the treatment of moderate-to-severe atopic dermatitis (AD) in children and adolescents. Previous systematic reviews explored the effectiveness and safety of dupilumab in adults with AD. However, the underlying mechanisms of AD can vary among different age groups, emphasizing the need for separate investigation into the use of dupilumab in children and adolescents with AD. To evaluate the efficacy and safety of dupilumab in children and adolescents with AD based on evidence from clinical trials and observational studies. The process of meta-analysis was conducted according to preferred reporting items for systematic reviews and meta-analyses guidelines. Seven clinical trials and 11 observational studies involving 1275 children and adolescents with AD were eligible for quantitative analysis. Overall, the pooled percentages of eczema area and severity index (EASI) 50, EASI 75, EASI 90, EASI 100, and investigator's global assessment (IGA) 0/1 were 72.9% (95% CI: 61.6%-81.9%), 57.4% (48.1%-66.2%), 31.3% (24.0%-39.7%), 29.7% (23.3%-37.0%), and 35.2% (29.3%-41.5%). With prolonged treatment time, an increase was seen in the pooled rate of EASI response, indicating that dupilumab may provide sustained benefits for children and adolescents over the long term. The reported adverse events were primarily mild and manageable, with an overall incidence rate of 7.2% across clinical trials and 7.6% across observational studies. Dupilumab was an effective and safe treatment option for children and adolescents with AD, with positive results observed from long-term use and an acceptable safety profile. More long-term, high-quality, controlled studies in different regions are needed for further verification.