Dermatology and Therapy最新文献

Introduction: Psoriasis in high-impact areas, including the scalp, nails, palms, and soles, can disproportionately impair patient quality of life. Here, we evaluate the 2-year efficacy of bimekizumab treatment in patients with moderate to severe plaque psoriasis in post hoc analyses of five phase 3/3b trials.

Methods: High-impact area efficacy data were pooled through 2 years across five phase 3/3b trials: BE VIVID, BE READY, BE SURE, their ongoing open-label extension (OLE) BE BRIGHT, and BE RADIANT (including its double-blinded treatment period and the first year of its OLE). Complete clearance of psoriasis in high-impact areas is reported over 2 years using the scalp Investigator's Global Assessment (IGA), palmoplantar IGA, and modified Nail Psoriasis Severity Index (mNAPSI). Patients included in these analyses had baseline moderate to severe scalp or palmoplantar involvement (scalp or palmoplantar IGA score ≥ 3) or mNAPSI score > 10.

Results: A total of 1107 patients were randomized to bimekizumab and entered the OLEs. Subsets of 821 patients had scalp IGA ≥ 3 at baseline, 377 had mNAPSI > 10, and 193 had palmoplantar IGA ≥ 3. Complete scalp clearance in patients with baseline scalp IGA ≥ 3 randomized to bimekizumab was achieved rapidly, with high responses sustained from first (86.4%) to second year (85.9%). Nail clearance responses in patients with baseline mNAPSI > 10 increased from 63.4% to 68.5% from first to second year. Palmoplantar clearance in patients with baseline palmoplantar IGA ≥ 3 was sustained from first (88.3%) to second year (89.8%). Similar trends were seen in the 374 patients who received bimekizumab 320 mg every 4 weeks (Q4W)/every 8 weeks (Q8W) initial/maintenance dosing.

Conclusion: In these analyses pooled across 2 years, bimekizumab showed sustained efficacy in psoriasis in high-impact areas.

Clinicaltrials:

Gov trial registration numbers: NCT03370133, NCT03410992, NCT03412747, NCT03598790, NCT03536884.

Introduction: Data on generalized pustular psoriasis (GPP) in Poland are limited. Therefore, this study aimed to evaluate the demographic and clinical characteristics of Polish patients with GPP. In addition, the effect of the frequency of disease flares and the concomitant presence of psoriasis vulgaris (PV) on patient characteristics was evaluated.

Methods: In this retrospective study, medical records of patients hospitalized for GPP in dermatology departments of the Polish Generalized Pustular Psoriasis Group were analyzed.

Results: A total of 90 patients from 14 dermatology centers were included. The median age of patients was 59 (range, 5-85) years, and most patients were female (68.9%). The most common comorbidity was hypertension (43.3%), followed by cardiovascular diseases, diabetes, and hyperlipidemia. The median duration of GPP was 3 years, and the median number of flares was 2. Hospitalization was required in 67% of flares. The main triggering factors were drugs (20.5%) and infections (19.3%). Women and men with GPP differed in terms of age (p < 0.01), distribution of comorbidities, and selected triggering factors (stress: p < 0.05). Almost 25% of patients experienced more than one flare per year. Patients with different frequency of flares did not differ significantly in age, sex distribution, or comorbidities, but those with a higher frequency of flares had a shorter disease duration (median: 0.6 vs. 4.0 years; p < 0.01). In 59.1% of patients, GPP was accompanied by PV. Patients with GPP and PV were younger than those with GPP alone (median: 48.0 vs. 66.0 years; p < 0.01).

Conclusions: In this study, the general demographic and clinical characteristics of patients with GPP were consistent with those described in other studies. However, a high rate of flares requiring hospitalization and a significant percentage of patients experiencing more than one flare per year indicate the unmet need in the management of patients with GPP.

Introduction: Biologic treatments have made complete skin clearance in moderate to severe plaque psoriasis a real possibility. Although clinical trials demonstrated the superiority of bimekizumab over secukinumab, adalimumab, and ustekinumab, direct comparisons with other biologics are not available. This systematic literature review (SLR) and network meta-analysis (NMA) aimed to evaluate the 1-year efficacy and safety of bimekizumab versus other biologic systemic therapies for moderate to severe plaque psoriasis.

Methods: We conducted an SLR to retrieve published randomised controlled trials (RCTs) in patients with moderate to severe plaque psoriasis. We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews and PsycINFO on 13 January 2022. Two NMA types were used to analyse the long-term achievement of 100% improvement from baseline in Psoriasis Area and Severity Index (PASI 100): (1) NMA of cumulative clinical benefits, based on the area under the curve, from week 0 to 52; (2) multinomial NMA at weeks 44‒60. Binomial NMA was used to evaluate long-term serious adverse events (SAEs).

Results: The SLR identified 38 RCTs, of which 19 were included in the NMA. Bimekizumab 320 mg administered every 4 weeks to week 16 then every 8 weeks (Q4W/Q8W) showed a greater cumulative average number of days of PASI 100 response compared with all other biologics. These differences were statistically significant versus all biologics, except risankizumab 150 mg. The multinomial NMA demonstrated that interleukin (IL)-17 and IL-23 inhibitors were the most efficacious treatments. No significant differences were found in long-term occurrence of SAEs.

Conclusion: Bimekizumab 320 mg Q4W/Q8W was superior to most other treatments in maintaining complete skin clearance during the first year of treatment. It demonstrated a greater cumulative average number of days with completely clear skin while displaying a comparable safety profile compared with all other biologics.

Introduction: Melasma is a common acquired disorder of melanogenesis that predominately affects women and presents as hyperpigmented skin lesions mainly located on the face. The study aims to investigate the epidemiologic characteristics and hormonal profiles in melasma patients.

Methods: One hundred fifty patients were enrolled in this study in a tertiary care hospital. Clinical patterns, pigment depth, disease severity, underlying conditions, and heredity were recorded. Endocrinologic profile and vitamin D levels were assessed.

Results: On clinical examination, the condition indicated a centrofacial localization in 74% of the patients. Extra facial melasma was noticed in 10 patients who had centrofacial melasma to begin with. Wood's lamp examination showed the dermal type as the most common. A family history of melasma was noted in 38% of the patients. Melasma Area and Severity Index (MASI) score ranged from 0.3 to 10.8, with a mean score of 4.12 ± 2.06. Pregnancy-induced melasma was reported in 36.1% of the patients. In 17.4% of women, melasma was related to using oral contraceptives. In 22% of patients, mild vitamin D deficiency was detected, while 21% had thyroid disorders.

Conclusion: There is a strong correlation between family history and prevalence of melasma. Sun exposure is a major precipitating factor and should be carefully addressed in Mediterranean countries like Greece. However, other factors such as concomitant medication, multiple pregnancies, use of oral contraceptives, thyroid disorders and vitamin D deficiency might precipitate melasma.

Introduction: Acne is the most frequent chronic inflammatory skin condition in adolescence but occurs also in later age. Our study aimed to characterise the epidemiology, geographical distribution, comorbidity and healthcare of acne juvenilis (AJ) and acne tarda (AT).

Methods: Statutory health insurance (SHI) data from 2016 to 2020 were analysed. Prevalence rates, including geographical distribution, comorbidities and drug use by specialists group, were measured.

Results: In 2020, the prevalence of acne among adults was 1.50% (AT > 25 years) and among adolescents was 3.88% (AT ≤ 25 years). The highest prevalence (13.02%) was observed at the age of 17 years. Sex differences were higher in AT (73.80% in women) than in AJ (64.55% in women). Compared with non-affected persons, individuals with acne - in particular with AT - showed significantly higher rates of skin-related comorbidities, including folliculitis (rate ratio (RR) 8.89), pyoderma (RR 7.27) and rosacea (RR 5.53), and non-skin-related comorbidities, such as ovarian dysfunction (RR 2.36), rhinitis allergica (RR 1.84) and Crohn's disease (RR 1.79). Preferred systemic therapeutics prescribed were anti-infectives in AT (46.86%) and retinoids in AJ (52.35%). In the majority of cases, dermatologists were involved in the treatment of acne (AT 65.77%; AJ 76.27%). The most commonly prescribed topical agents were adapalene with benzoyl peroxide (AT 87.72%; AJ 85.75%), while systemic isotretinoin (AT 81.20%; AJ 90.06%) was also a frequently used drug. General practitioners were more likely to prescribe anti-infectives, especially topical antibiotics such as chlortetracycline (AT 52.38%; AJ 44.44%) and systemic antibiotics, especially tetracycline (AT 58.33%; AJ 67.50%).

Conclusion: Acne affects a relevant proportion of the German population not only in adolescence, and management of this inflammatory skin disease does not naturally follow medical guidelines or specialist recommendations. These findings emphasise the importance of specialised care and comprehensive therapeutic management that should also consider the exploration of comorbidities.

Introduction: Acne is a one of the most frequent skin conditions among teenagers and young adults. It is currently managed with topical retinoids and antibiotics, which can present numerous side effects, thus reducing treatment adherence and effectiveness. We evaluated the efficacy and tolerability of a novel dermo-cosmetic cream (α-AZ) in treating mild to moderate acne.

Methods: Subjects were randomized into three groups: group 1 received α-AZ cream, group 2 was treated with α-AZ combined with an oral acne treatment routine, and group 3 received a topical acne treatment, for 84 days. All treated patients underwent a 28-day maintenance period with α-AZ cream. Total acne and post-inflammatory hyperpigmentation (PIH) scoring, quality of life (QoL), and skin tolerance were all evaluated during the treatment and maintenance periods.

Results: Acne and PIH lesions significantly decreased in group 1 compared to group 3 (p < 0.001), with a reduction in acne of 66.52 ± 2.92% in group 1 versus 52.55 ± 3.90% in group 3. Patients in group 1 achieved nearly clear skin by the end of the treatment. α-AZ cream treatment was well tolerated and all participants experienced an enhanced QoL. Participants expressed high satisfaction. Additional enhancements in all groups were noted during the maintenance phase across all clinical parameters.

Conclusion: The novel dermo-cosmetic α-AZ cream could serve as a valuable new approach to current treatments for mild and moderate acne. It can be used alone, as a once-daily adjuvant to oral acne treatments, or as part of a maintenance regimen.

Trial registration: ISRCTN registry, ISRCTN70142596, registered retrospectively on 11/12/2023.

Introduction: There is an unmet need for effective topical therapies for patients with uremic xerosis and chronic kidney disease-associated pruritus (CKD-aP). The long-term efficacy and tolerability of an emollient containing glycerol 15% and paraffin 10% (V0034CR) was evaluated in a phase 3 study.

Methods: In this randomized, double-blind, two-parallel group, vehicle-controlled study, patients with moderate-to-severe uremic xerosis were randomized to once-daily application of V0034CR or vehicle control for 28 days (period I). This was followed by a treatment-free period of ≤ 21 days (period II), then all patients received open-label treatment with V0034CR for ≥ 84 days (period III). Outcomes included treatment response at the end of period I (El Gammal's xerosis severity score), instrumental measures of scaling (D-Squame technique), time to relapse during period II, rate of recurrence during period III, pruritus severity over time, patient acceptability, and adverse events (AEs).

Results: The intent-to-treat population comprised 235 patients randomized to V0034CR (n = 118) or vehicle control (n = 117) during period I. Treatment response at the end of period I was achieved by 71 patients (60.2%) in the V0034CR group versus 48 (41.0%) with vehicle control (p = 0.0041). This coincided with greater reductions in the total surface area of squames (p = 0.001 vs vehicle control). Xerosis relapsed progressively without treatment in period II; however, remission was durable under maintenance therapy in period III. Improvements in pruritus severity were comparable between V0034CR and vehicle control, suggesting that the antipruritic effect of V0034CR was mainly exerted by its oil-in-water emulsion base. V0034CR had high patient acceptability and was well tolerated; the most common treatment-related AEs were irritation or erythema (2.1%), exacerbated pruritus (1.3%), and vesicles at the application site (0.9%).

Conclusion: These data support the use of V0034CR, with its hydrating and occlusive properties, for the long-term management of patients with moderate-to-severe uremic xerosis and CKD-aP.

Trial registration: ClinicalTrials.gov identifier NCT01084148; EudraCT number 2006-002201-31.

Introduction: Chronic Hand Eczema (CHE) is an inflammatory skin disease that causes significant impact on health-related quality of life (HRQoL). The Hand Eczema Impact Scale (HEIS) is a new patient-reported outcome (PRO) measure designed to assess the impact of CHE on key domains of HRQoL. This study aimed to develop and evaluate content and psychometric validity of the HEIS.

Methods: The HEIS was initially developed on the basis of a literature review and concept elicitation interviews. Qualitative cognitive debriefing interviews (n = 20) were conducted with patients with CHE to assess relevance and understanding of items, response options, and recall period. Psychometric properties (item performance, dimensionality, reliability, validity, responsiveness, and estimation of meaningful change thresholds) were then assessed using data (n = 258) from a phase 2b trial (NCT03683719).

Results: Cognitive debriefing confirmed all items were understood and relevant to patients. Inter-item correlations (all > 0.50) and confirmatory factor analysis (factor loadings ≥ 0.80) supported unidimensionality of the HEIS score, and mostly provided support for the HEIS Proximal Daily Activity Limitations (PDAL) score, with only one item loading below the prespecified threshold. Item properties and previous qualitative work supported retaining this item in the total score but removed from the HEIS PDAL domain. Internal consistency (Cronbach's alpha ≥ 0.89) and test-retest reliability (intra-class correlation coefficient ≥ 0.79) results were very strong. Strong correlations with concurrent measures (0.66-0.87) and significant differences between severity groups (p < 0.001) supported construct validity. Large effect sizes for mean change scores in participants that improved and significant differences between groups indicated ability to detect change. Anchor-based analyses supported within-individual responder definitions of ≥ 1.3 points for improvements in both HEIS score and HEIS PDAL score (covering three items) and of ≥ 1.5 points for HEIS embarrassment with the appearance of hands (Emb) score (covering two items).

Conclusions: The 9-item HEIS is the first CHE-specific PRO measure developed and validated according to regulatory guidance for assessment of the impact of CHE on key domains of HRQoL. This article provides evidence of strong content and psychometric validity and shows improvements of ≥ 1.3 points in HEIS score and HEIS PDAL score, and improvements of ≥ 1.5 points in HEIS Emb score represent clinically meaningful, important changes.

Trial registration: NCT03683719.

Introduction: Despite advancements in the treatment of psoriasis (PsO), there are few head-to-head studies assessing comparative effectiveness of the newest therapies approved to treat PsO. Our objective was to assess the comparative clinical effectiveness of risankizumab and deucravacitinib in patients with moderate-to-severe PsO.

Methods: This placebo-anchored matching-adjusted indirect comparison (MAIC) analysis utilized data from UltIMMa-1/2 risankizumab and POETYK PSO-1/2 deucravacitinib trials. Individual patient data from UltiMMA-1/2 were weighted via propensity score to match POETYK PSO-1/2 published summary data. Rate differences between risankizumab and deucravacitinib were assessed for Psoriasis Area and Severity Index (PASI) 75/90/100, the Static Physician Global Assessment (sPGA = 0 or 0/1), and the Dermatology Life Quality Index (DLQI) 0/1.

Results: At 16 weeks, risankizumab-treated patients demonstrated statistically significantly higher rates of skin clearance and greater improvement in quality of life (QoL) compared to those treated with deucravacitinib. Across all outcomes, risankizumab demonstrated a lower number needed to treat compared to deucravacitinib. Limitations are potential bias due to unobserved/unmeasurable differences and limited generalizability of the results.

Conclusions: This indirect comparison demonstrates that risankizumab has higher rates of skin clearance and greater improvements in QoL than deucravacitinib. This study will help inform healthcare providers in their treatment and management strategy of PsO.