RESUMO
BACKGROUND: The efficacy and safety of dupilumab in atopic dermatitis (AD) have been defined in clinical trials but limited real-world evidence on long term treatment outcomes are currently available to inform clinical decisions. OBJECTIVES: to describe long-term effectiveness and safety of dupilumab up to 48 months in patients with moderate-to-severe AD. METHODS: a multicenter, retrospective, dynamic cohort study was conducted to assess long term effectiveness and safety of dupilumab in patients with moderate to severe AD in a real-world setting. Predictors of minimal disease activity (MDA) optimal treatment target criteria (defined as the simultaneous achievement of EASI90, itch NRS score ≤1, sleep NRS score ≤1 and DLQI ≤1) were investigated. RESULTS: 2576 patients were enrolled from June 2018 to July 2022. MDA optimal treatment target criteria were achieved by 506 (21.91%), 769 (40.63%), 628 (50.36%), 330 (55.37%) and 58 (54.72%) of those that reached 4, 12, 24, 36 and 48 months of follow-up, respectively. Logistic regression revealed a negative effect on MDA achievement for conjunctivitis and food allergy at all timepoints. Adverse events (AE) were mild and were observed in 373 (15.78%), 166 (7.02%), 83 (6.43%), 27 (4.50%) and 5 (4.55%) of those that reached 4, 12, 24, 36 and 48 months of follow-up. Conjunctivitis was the most frequently reported AE during the available follow-up. AE led to treatment discontinuation in <1% of patients during the evaluated time periods. CONCLUSION: High long-term effectiveness and safety of dupilumab were confirmed in this dynamic cohort of patients with moderate to severe AD, regardless of clinical phenotype and course at baseline. Further research will be needed to investigate the effect of Th2 comorbidities and disease duration on the response to dupilumab and other newer therapeutics for AD.
RESUMO
Health care spending in Italy is high and continues to increase; assessing the long-term health and economic outcomes of new therapies is essential. Atopic dermatitis (AD) is a chronic, pruritic, immune-mediated inflammatory dermatosis, a clinical condition that significantly affects patients' quality of life at a high cost and requires continuous care. This retrospective study aimed to assess the direct cost and adverse drug reactions (ADRs) of Dupilumab and patients' clinical outcomes. All AD patients treated with Dupilumab at the Sassari University Hospital, Italy, between January 2019 and December 2021 were included. Eczema Area Severity Index, Dermatology Life Quality Index, and Itch Numeric Rating Scale scores were measured. ADRs and drug expenses were analyzed. A statistically significant posttreatment improvement was observed for all the indices measured: EASI (P < 0.0001), DLQI (P < 0.0001), NRS (P < 0.0001). The total expenditure for Dupilumab, in the observed period, amounted to 589.748,66 for 1358 doses, and a positive correlation was shown between annual expenditure and delta percentage of variation pre- and posttreatment for the clinical parameters evaluated.
RESUMO
Derived inflammatory indexes from routine hematological parameters might be useful for predicting early-response vs. late/non-response to dupilumab, the first biological agent approved for moderate-to-severe atopic dermatitis (AD). We tested this hypothesis by retrospectively investigating the association between pre-specified baseline inflammatory indexes and dupilumab response (≥50% reduction in the Eczema Area and Severity Index, EASI 50) at 4 and 16 weeks in a consecutive series of 66 AD patients (38 males and 28 females). Forty-six patients (69.7%) were early-responders at 4 weeks, whereas the remaining twenty (30.3%) were late/non-responders at 16 weeks. In logistic regression, the platelet-to-lymphocyte ratio (PLR) was independently associated with early-response (OR = 1.0159, 95% CI 1.0005 to 1.0315, p = 0.0426). The predictive performance of PLR and other derived indexes towards early-response was further improved by their combination with serum IgE concentrations, with a maximum AUC value for the combined systemic immune inflammation index (SII)-IgE of 0.797 (95% CI = 0.677 to 0.884, p < 0.0001). Derived inflammatory indexes, particularly SII-IgE, might be useful to identify early-responders to dupilumab and develop alternative treatment protocols for late/non-responders.
RESUMO
BACKGROUND: Acne is a frequent adolescent disease characterized by inflammatory and non-inflammatory lesions whose topical treatment very often presents adverse phenomena such as irritation or resistance to antibiotics that reduce the patient's compliance. The purpose of this study is to compare a commercial product (Acnatac gel) based on clindamycin-tretinoin (CTG) with a galenic compound containing 2 essential oils (Myrtus communisL. and Origanum vulgare) and tretinoin (MOTC) to evaluate its anti-acne effectiveness and action on the microclimate of the skin. METHODS: Sixty volunteers were randomly divided into an A group using MOTC and a B group, as a positive control, using CTG. The effectiveness was assessed with non-invasive skin analysis (Sebumeter, pH meter, Tewameter and Mexameter) and the counts of the number of lesions, after 15 and 30 days. RESULTS: In both groups, there is a worsening of transepidermal water loss (TEWL) due to tretinoin. MOTC has improved, starting from 15 days of treatment, the papular erythema (p = 0.0329 vs CTG) and has reduced at all times even the rashes of retinoids present in the healthy perilesional skin (p = 0.0329 and p = 0.0017, respectively, at 15 and 30 days). CONCLUSION: MOTC has shown, compared to Acnatac, to have anti-acne efficacy and to possess an anti-inflammatory activity, due to essential oils, able to reduce in vivo erythematous lesions and those induced by retinoids.