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1.
Clin Exp Dermatol ; 2024 Jun 11.
Article in English | MEDLINE | ID: mdl-38860563

ABSTRACT

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.

2.
Contact Dermatitis ; 90(5): 479-485, 2024 May.
Article in English | MEDLINE | ID: mdl-38268123

ABSTRACT

BACKGROUND: Eyelid dermatitis is a frequent reason of dermatological consultation. Its aetiology is not univocal, being contact dermatitis, both allergic and irritant, the most frequent. The primary sources of allergen exposure include cosmetics, metals, and topical medications, from direct, indirect, or airborne contact. OBJECTIVES: To define the frequency of positive patch test reactions to SIDAPA baseline series allergens, to document positive allergens, and to precise the final diagnosis in patients with eyelid involvement. METHODS: A total of 8557 consecutive patients from 12 Italian Dermatology Clinics underwent patch testing with SIDAPA baseline series in 2018 and 2019. Patients were divided into two groups: (i) with eyelid involvement with or without other involved sites (E-Group) and (ii) without eyelid involvement (NE-Group). The final diagnosis and the frequency of positive relevant patch test reactions were evaluated. RESULTS: E-Group consisted of 688 patients (females 78.6%, mean age 45.3 years), 8.0% of 8557 consecutively patch-tested patients. The final diagnosis in E-Group was ADC in 42.4%, ICD in 34.2%, and AD in 30.5%. The highest reaction rates were elicited by nickel sulphate and methylchloroisothiazolinone/methylisothiazolinone in both E-Group and NE-Group, even if these allergens were significantly more frequently positive in NE-Group patients than in E-Group ones. Positive patch test reactions to fragrance Mix II, dimethylaminopropylamine, and sorbitan sesquiolate were significantly more frequent in E-Group patients than in NE-Group ones. CONCLUSIONS: Eyelid dermatitis is a frequent dermatological complaint. Allergic contact dermatitis is the most frequent diagnosis commonly caused by nickel sulphate, isothiazolinones, and fragrances. The surfactants dimethylaminopropylamine and sorbitan sesquioleate are emerging causes of eyelid allergic contact dermatitis.


Subject(s)
Blepharitis , Dermatitis, Allergic Contact , Nickel , Female , Humans , Middle Aged , Allergens/adverse effects , Dermatitis, Allergic Contact/diagnosis , Dermatitis, Allergic Contact/etiology , Eyelids , Italy/epidemiology , Patch Tests , Retrospective Studies , Male , Adult
3.
Clin Cosmet Investig Dermatol ; 16: 3561-3574, 2023.
Article in English | MEDLINE | ID: mdl-38107670

ABSTRACT

Purpose: SUPREME, a phase IIIb study conducted in Italy, demonstrated safety and high efficacy of secukinumab for up to 72 weeks in patients with moderate-to-severe plaque-type psoriasis. SUPREME 2.0 study aimed to provide real-world data on the long-term drug survival and effectiveness of secukinumab beyond 72 weeks. Patients and Methods: SUPREME 2.0 is a retrospective observational chart review study conducted in patients previously enrolled in SUPREME study. After the end of the SUPREME study, eligible patients continued treatment as per clinical practice, and their effectiveness and drug survival data were retrieved from medical charts. Results: Of the 415 patients enrolled in the SUPREME study, 297 were included in SUPREME 2.0; of which, 210 (70.7%) continued secukinumab treatment throughout the 42-month observation period. Patients in the biologic-naïve cohort had higher drug survival than those in the biologic-experienced cohort (74.9% vs 61.7%), while HLA-Cw6-positive and HLA-Cw6-negative patients showed similar drug survival (69.3% and 71.9%). After 42 months, Psoriasis Area and Severity Index (PASI) 90 was achieved by 79.6% of patients overall; with a similar proportion of biologic-naïve and biologic-experienced patients achieving PASI90 (79.8% and 79.1%). The mean absolute PASI score reduced from 21.94 to 1.38 in the overall population, 21.90 to 1.24 in biologic-naïve and 22.03 to 1.77 in biologic-experienced patients after 42 months. The decrease in the absolute PASI score was comparable between HLA-Cw6-positive and HLA-Cw6-negative patients. The baseline Dermatology Life Quality Index scores also decreased in the overall patients (10.5 to 2.32) and across all study sub-groups after 42 months. Safety was consistent with the known profile of secukinumab, with no new findings. Conclusion: In this real-world cohort study, secukinumab showed consistently high long-term drug survival and effectiveness with a favourable safety profile.

4.
Dermatol Pract Concept ; 13(4)2023 Oct 01.
Article in English | MEDLINE | ID: mdl-37992389

ABSTRACT

INTRODUCTION: Tildrakizumab is a humanized IgG1κ monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, approved in 2018 for the treatment of patients with moderate-to-severe chronic plaque psoriasis. OBJECTIVES: This study aimed to evaluate the effectiveness, safety and survival of tildrakizumab in the medium term (48 weeks) in psoriatic patients failure to previous biologic treatment in a real world setting. METHODS: This was a retrospective, multicenter observational study that included adult patients with moderate-to-severe plaque psoriasis, failure to previous biologic therapy, consecutively treated with tildrakizumab. Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA) values were recorded at baseline, at 12 and 48 weeks of treatment. Safety and tolerability of tildrakizumab were investigated by examining the presence of any adverse events. RESULTS: Overall 51 patients were enrolled. Baseline disease severity was moderate to severe with a mean PASI score of 19.2 ± 8.5, mean BSA of 16 ± 10.4, and mean Dermatology Life Quality Index (DLQI) of 18.2 ± 6.8. A significant reduction in the mean PASI score was detected at 12 weeks of tildrakizumab therapy (3.5 ± 2.7, P < 0.001), with a further improvement at week 48 (0.6 ± 1.5, P < 0.001). At week 12, there was a great improvement in BSA score for all groups (P <0.001) with further increase at week 48. The effectiveness was confirmed also by DLQI assessment, with a significant decrease at week 12 and even more at week 48 (P <0.001). CONCLUSIONS: This study confirms the effectiveness of tildrakizumab in daily clinical practice in patients with moderate-to-severe plaque psoriasis.

5.
J Clin Med ; 12(10)2023 May 18.
Article in English | MEDLINE | ID: mdl-37240650

ABSTRACT

Brodalumab is a recombinant, fully human immunoglobulin IgG2 monoclonal antibody specifically targeted against interleukin-17RA that has been approved for the treatment of moderate-to-severe psoriasis in Europe. We developed a Delphi consensus document focused on brodalumab for the treatment of moderate-to-severe psoriasis. Based on published literature and their clinical experience a steering committee drafted 17 statements covering 7 domains specific to the treatment of moderate-to-severe psoriasis with brodalumab. A panel of 32 Italian dermatologists indicated their level of agreement using a 5-point Likert scale (from 1 = "strongly disagree" to 5 = "strongly agree") using an online modified Delphi method. After the first round of voting (32 participants), positive consensus was reached for 15/17 (88.2%) of the proposed statements. Following a face-to-face virtual meeting, the steering committee decided that 5 statements would form "main principles" and 10 statements formed the final list. After a second round of voting, consensus was reached in 4/5 (80%) of the main principles and 8/10 (80%) for consensus statements. The final list of 5 main principles and 10 consensus statements identify key indications specific to the use of brodalumab in the treatment of moderate-to-severe psoriasis in Italy. These statements aid dermatologists in the management of patients with moderate-to-severe psoriasis.

6.
J Dermatolog Treat ; 34(1): 2200868, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37026590

ABSTRACT

BACKGROUND: Long-term real-life data on secukinumab use in psoriasis are limited. OBJECTIVES: Determine the long-term effectiveness of secukinumab in moderate-to-severe psoriasis in real-life. METHODS: Multicenter retrospective study analyzing data from adult patients treated with secukinumab for at least 192 weeks and up to 240 weeks in Southern Italy, between 2016 and 2021. Clinical data, including concurrent comorbidities and prior treatments were collected. Effectiveness was assessed by Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI) scores at the initiation of secukinumab and at weeks 4, 12, 24, 48, 96, 144, 192, and 240. RESULTS: Two hundred and seventy-five patients (174 males), mean age 50.80 ± 14.78 years, were included; 29.8% had an uncommon localization, 24.4% psoriatic arthritis, 71.6% comorbidities. PASI, BSA, and DLQI improved significantly from week 4 and continued to improve over time. Between weeks 24 and 240, PASI score was mild (≤10) in 97-100% of patients, 83-93% had mild affected BSA (BSA ≤ 3), and 62-90% reported no effect of psoriasis on their quality of life (DLQI 0-1). Only 2.6% of patients reported adverse events and no patient discontinued the treatment during the study period. CONCLUSIONS: Secukinumab effectiveness in the long-term treatment of psoriasis is confirmed in real-world.


Subject(s)
Antibodies, Monoclonal , Psoriasis , Adult , Male , Humans , Middle Aged , Aged , Antibodies, Monoclonal/adverse effects , Retrospective Studies , Quality of Life , Treatment Outcome , Severity of Illness Index , Psoriasis/drug therapy , Psoriasis/chemically induced , Italy
7.
Article in English | MEDLINE | ID: mdl-36636635

ABSTRACT

Purpose: Psoriasis, a common systemic inflammatory disorder, presents with gender-related differences in the quality of life (QoL) and treatment outcomes. This post hoc analysis from the Phase 3b SUPREME study explored gender-related differences in patient characteristics and efficacy of secukinumab 300 mg on Psoriasis Area and Severity Index (PASI) 75/90/100 and impact on QoL using the Dermatology Life Quality Index (DLQI) in patients with moderate to severe psoriasis through week 24. Patients and Methods: The proportion of patients achieving PASI 75/90/100 was computed using a nonresponder imputation approach. Differences between cohorts were analyzed using a logistic regression model. The mean change from baseline in DLQI was computed using the Wilcoxon test. Results: Among the 433 patients (males: 71.6%), females had a higher DLQI than males at baseline (13.1 vs 9.5; P<0.0001). Males had a slightly higher response for PASI 90 than females at week 16 (80.7% vs 78.1%; P=0.0779) and 24 (83.2% vs 79.7%; P=0.0319). No differences were observed between genders in PASI 100/75 responses at week 24. Both genders showed an improvement in DLQI with secukinumab at week 24 (-10.9 vs -8.1, respectively, in females vs males; P=0.0004). Conclusion: In summary, secukinumab was effective in the treatment of psoriasis, irrespective of gender.

9.
Dermatol Ther ; 35(12): e15956, 2022 12.
Article in English | MEDLINE | ID: mdl-36271708

ABSTRACT

Psoriasis is a chronic, immune-mediated inflammatory disease for which no definitive cure exists and patients difficult to treat with moderate to severe psoriasis often require life-long therapy. In general, the use of any biologic agent as monotherapy allows a long-term efficacy, however survival response may progressively decrease over time. We report real-world long lasting response data in psoriatic patients on treatment with anti-TNFα evaluating those on the same anti-TNFα agent (infliximab, etanercept, adalimumab) from January 2011 and December 2013 to December 31, 2021 as monotherapy. On 210 treated patients, 69 were found to maintain the same anti-TNFα agent. The median survival rate for etanercept, infliximab and adalimumab was 10, 9.6, and 9.5 years respectively and the efficacy rate was similar (mean PASI96). Our results demonstrate that anti-TNFα agents are a long-term effective and safe therapeutic option for a satisfying proportion (33%) of patients with moderate-to-severe chronic plaque psoriasis. Further long-term real life studies are needed to better understand which are the causes of drug failure or persistent response and why these may occur at different time intervals in patients on the same drug.


Subject(s)
Adalimumab , Etanercept , Infliximab , Psoriasis , Tumor Necrosis Factor Inhibitors , Humans , Adalimumab/therapeutic use , Etanercept/therapeutic use , Immunoglobulin G , Infliximab/therapeutic use , Necrosis/drug therapy , Psoriasis/diagnosis , Psoriasis/drug therapy , Receptors, Tumor Necrosis Factor/therapeutic use , Tumor Necrosis Factor Inhibitors/therapeutic use
10.
Dermatol Ther ; 35(1): e15177, 2022 01.
Article in English | MEDLINE | ID: mdl-34699117

ABSTRACT

Vaccination is the most effective method to prevent and control the SARS-CoV-2 infection and biologics are not considered a contraindication for vaccination. The burning question is that safety data are lacking since patients taking drugs affecting the immune system were excluded from clinical trials leading to vaccine approbation. Moreover, it seems that vaccination could worsen psoriasis. We conducted a survey to investigate the safety of SARS-CoV-2 vaccines in psoriatic patients treated with biologics. A total of 150 patients with stable plaque psoriasis treated with biologics for at least 2 months were evaluated in a 3 months period. Fifty patients (22 F/28 M; age: 33-83 years) only underwent the first and second doses of SARS-CoV-2 vaccines. All patients discontinued their biological agents 10 days before and 10 days after each dose of vaccine. Of these, 24 patients were treated with anti-TNF, 14 with anti-IL17, 7 with anti-IL12-23, and 5 with anti-IL23. After the vaccines, all patients were evaluated at day 2, 7, and 14 for local and/or systemic side effects and/or adverse drug reactions to SARS-CoV-2 vaccines. None of the patients experienced any side effects or a psoriatic flare. Only one patient treated with infliximab biosimilar referred an exacerbation of psoriasis after vaccine. The remaining 100 patients reported that they did not get the vaccine yet. Our preliminary data confirm that SARS-CoV-2 mRNA vaccines are safe for patients with chronic plaque psoriasis treated with biologics and did not trigger psoriasis, although these data should be validated in a larger population. We encourage an early SARS-CoV-2 vaccines administration in all psoriatic patients on immunosuppressant drugs.


Subject(s)
Biological Products , COVID-19 Vaccines , Psoriasis , Adult , Aged , Aged, 80 and over , Biological Products/therapeutic use , COVID-19 , COVID-19 Vaccines/adverse effects , Humans , Middle Aged , Psoriasis/drug therapy , Tumor Necrosis Factor Inhibitors
11.
Clin Dermatol ; 39(3): 418-423, 2021.
Article in English | MEDLINE | ID: mdl-34517999

ABSTRACT

Italy was among the world's earliest and most affected countries by coronavirus disease 2019 (COVID-19). We report the Italian experience with the pandemic. The dermatologic community immediately reduced any type of activities to 80% to 90% of outpatient consultations, both in public hospitals and in private offices. The Italian Society of Dermatology and Sexually Transmitted Diseases and the Italian Forensic Dermatologic Society supported the dermatologic community by reporting recommendations in newsletters (vademecum) regarding the routine management of dermatologic patients either in the hospital or private setting. We have provided an overview of the skin manifestations from the pandemic, including the consequences of the misuse of safety measures. We also have evaluated the recently developed research projects on patients treated with biologics for psoriasis, atopic dermatitis, and hidradenitis suppurativa, as well as on the registries regarding various skin diseases affected by COVID-19.


Subject(s)
COVID-19 , Hidradenitis Suppurativa , Hidradenitis Suppurativa/epidemiology , Humans , Italy/epidemiology , Pandemics , SARS-CoV-2
12.
J Cosmet Dermatol ; 20 Suppl 1: 1-4, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33934478

ABSTRACT

BACKGROUND: Diaper dermatitis (DD) is an acute inflammatory reaction, regardless of the cause, of the diaper-covered area. Topical skin barrier repair cosmetic products are the mainstay treatment to cure and/or prevent DD. AIMS: To assess the efficacy/tolerability of a zinc gluconate-taurine/zinc oxide and panthenol/ glycerin/ Butyrospermum parkii butter barrier cream using clinical evaluation. METHODS: In this prospective, open-label trial, 20 patients (10 infants/10 adults), with mild/moderate DD enrolled at the Dermatology University Clinic of Catania (Italy) were instructed to apply the cream twice daily for 30 days. Degree of erythema was performed clinically by a 5-point severity scale (from 0 = no erythema to 4 = severe erythema), at baseline, at 15 and 30 days. An Investigator Global Assessment (IGA) using a 6-point scale (from -1 = worsening to 4 = complete response/clear) along with product tolerability was also performed at 15 and 30 days. Statistical analysis was performed using SAS version 9. RESULTS: At 15 days, a reduction of clinical erythema assessment (CEA) from baseline was observed (mean from 3.2 ± 0.8 to 2.5 ± 0.3; p < 0.06), that although nonsignificant, showed a significant progressive improvement at 30 days (mean from 3.2 ± 0.8 to 1.1 ± 0.9; p < 0.0001) without any age differences. CONCLUSIONS: Our preliminary results indicate that the tested barrier cream may represent a promising approach in DD rash. It may be used in mild-to-moderate forms in monotherapy without significant side effects or, where required, in association with pharmacological agents. Its long-term use is likely safe.


Subject(s)
Diaper Rash , Zinc Oxide , Adult , Diaper Rash/drug therapy , Emollients , Humans , Infant , Prospective Studies , Skin , Treatment Outcome , Zinc Oxide/therapeutic use
13.
Contact Dermatitis ; 85(3): 317-323, 2021 Sep.
Article in English | MEDLINE | ID: mdl-33931866

ABSTRACT

BACKGROUND: Budesonide was included in the European Baseline Series in 2000 as the most suitable marker forcorticosteroid hypersensitivity. In the last two decades, a decreasing trend of budesonide allergy has been observed. OBJECTIVES: To estimate the prevalence of positive patch test reactions to budesonide in a large, Italian patch test population, characterizing patients according to MOAHLFA index and evaluating the benefit with extended readings of budesonide patch test. METHODS: Retrospective analysis of patient demographics and patch test results over a 2-year period (2018-2019) was performed at 14 patch test clinics in Italy. RESULTS: Ninety out of 14 544 (0.6%) patients reacted to budesonide 0.01% pet.. Positive reactions were mild in 54.4% and late readings at day 7 showed new positive reactions in 37.8% of patients. The MOAHLFA index showed a significant positive association with male gender, atopic dermatitis, and age >40 years and a significant negative association with hand and face dermatitis. CONCLUSIONS: We documented a low prevalence of budesonide allergy in Italy, confirming its decreasing trend recently reported in the literature. Nevertheless, budesonide needs to be maintained in the baseline series for its good ability to detect corticosteroid sensitization.


Subject(s)
Budesonide/adverse effects , Dermatitis, Allergic Contact/diagnosis , Dermatitis, Allergic Contact/epidemiology , Patch Tests/methods , Adult , Age Distribution , Aged , Budesonide/immunology , Cross Reactions , Dermatitis, Atopic/diagnosis , Dermatitis, Atopic/epidemiology , Dermatitis, Occupational/diagnosis , Dermatitis, Occupational/epidemiology , Female , Humans , Italy/epidemiology , Male , Middle Aged , Prevalence , Retrospective Studies , Sex Distribution
14.
Acta Derm Venereol ; 101(10): adv00576, 2021 Oct 21.
Article in English | MEDLINE | ID: mdl-33903916

ABSTRACT

Secukinumab, a fully human monoclonal antibody, neutralizes interleukin-17A, a cornerstone cytokine driving the multiple manifestations of psoriasis. This post-hoc analysis of the SUPREME study was performed to determine the sustainability of response to secukinumab in terms of Psoriasis Area and Severity Index (PASI) 90 in patients with moderate-to-severe plaque psoriasis. Based on PASI 90 response at week 16, patients were stratified as PASI 90 responders (PASI90R, n = 337) or non-responders (PASI90NR, n = 72). At week 20, 94.2% (n = 295/313) achieved PASI 90/100 response in PASI90R, with response maintained through week 48 (89.6%, n = 189/211). An increased proportion of patients achieved PASI 90/100 response in PASI90NR (week 20: 29.9%, n = 20/67; week 48: 57.1%, n = 20/35). Overall, 64.4% patients achieved absolute PASI score = 0 at week 24 with response sustained to week 48 (66.9%). Secukinumab showed sustained and stable efficacy in maintaining PASI 90 response in patients with moderate-to-severe plaque psoriasis up to week 48.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Psoriasis , Humans , Psoriasis/diagnosis , Psoriasis/drug therapy , Severity of Illness Index , Treatment Outcome
15.
PLoS One ; 16(3): e0247835, 2021.
Article in English | MEDLINE | ID: mdl-33690732

ABSTRACT

BACKGROUND: Dilated and tortuous vessels within elongated dermal papillae represent a histopathological clue of psoriasis. However, the number of dilated capillaries (capillary density) in psoriasis remains undefined as the results from the available studies differ significantly. OBJECTIVES: To evaluate the capillary density in psoriasis using dermoscopy and horizontal histopathological sections (HHS), two techniques that share the horizontal view of the skin, and to compare the results with the existing data. METHODS: Twenty adult patients with stable plaque psoriasis were enrolled and, in each patient, a target area of the examined plaque, previously engraved by gently rotating a 5-mm biopsy punch device, underwent dermoscopy and biopsy for HHS. In all examined fields, capillary density was evaluated in a centered 4-mm diameter area, counting the number of red dots at dermoscopy and of dermal papillae at HHS. RESULTS: A total of 20 target lesions located on the trunk, arms and tights were evaluated. The mean capillary density resulting from dermoscopy was 43.02±6.60/mm 2 whereas that from HHS was 50.30±9.05/mm 2. These data showed a statistically significant difference (p = 0.006), with a strong correlation at Pearson's test (r = 0.88). CONCLUSIONS: Our results when compared with those from the existing literature showed some differences. The peculiarity of our work is represented by the precise measurement and correlation of the capillary density using two different methods, as the preliminary skin engraving allowed a perfect match between the area undergoing dermoscopy and that of skin sampling for HHS. Compared to dermoscopy in which deep-located vessels might have gone undetected, HHS seems to reflect more precisely and reliably the real capillary density showing an average of 50 capillaries/mm 2 that in a common 5x5 cm psoriatic patch corresponds to an average of 125.000 capillaries. These results highlight the extraordinary potential of psoriatic skin to develop such a complex and intricate vascular network.


Subject(s)
Capillaries/metabolism , Psoriasis/blood , Skin/blood supply , Adult , Biopsy/methods , Female , Histological Techniques/methods , Humans , Male , Microsurgery/methods , Middle Aged , Psoriasis/metabolism , Specimen Handling/methods
16.
Eur J Dermatol ; 31(1): 3-16, 2021 Feb 01.
Article in English | MEDLINE | ID: mdl-33648915

ABSTRACT

Guselkumab, a subcutaneously administered fully human IgG1λ monoclonal antibody that selectively inhibits the p19 subunit of interleukin 23, is approved in both the USA and the EU for the treatment of adult patients with moderate-to-severe plaque psoriasis. The efficacy and safety of guselkumab were demonstrated in four randomized, double-blind, Phase III trials (VOYAGE 1 and 2, NAVIGATE, and ECLIPSE), which demonstrated high levels of clinical response over three years of continuous treatment, regardless of sex, age, body weight, and race, maintaining a favourable safety profile and long-term tolerability. Guselkumab was shown to be efficacious in patients with prior failure of other biologics, including adalimumab and ustekinumab, and was superior to both adalimumab and secukinumab in head-to-head trials. Guselkumab efficacy was also observed in the treatment of psoriasis localized in difficult-to-treat body regions including the scalp, palms and/or soles, and fingernails. Treatment with guselkumab improved health-related quality of life and patient-reported signs and symptoms. Guselkumab has a consistently favourable safety profile and is well tolerated over the long-term. Clinical development of guselkumab as a treatment is ongoing for other immune-mediated inflammatory diseases, including psoriatic arthritis, Crohn's disease, and ulcerative colitis. In the overall management of patients with plaque psoriasis, guselkumab is a robust treatment option with durable maintenance of response over time.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Psoriasis/drug therapy , Clinical Trials, Phase III as Topic , Humans , Interleukin-23/antagonists & inhibitors , Randomized Controlled Trials as Topic , Severity of Illness Index , Treatment Outcome
17.
Dermatol Ther ; 34(3): e14911, 2021 05.
Article in English | MEDLINE | ID: mdl-33619833

ABSTRACT

Alitretinoin is the only systemic agent approved to treat moderate-severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids. No nationwide Italian data regarding real-life efficacy, safety, and tolerability of treatment are available. The DECISA project (DErmatology Clinics in Italy: Survey on Alitretinoin) retrospectively examined data from a registry including 15 Dermatology Clinics authorized to prescription of alitretinoin for CHE patients. Disease severity was assessed at baseline, and after 3 and 6 months of treatment, using the 5-point Physician Global Assessment (PGA) and the modified Total Lesion-Symptoms-Severity (mTLSS) scores. Between November 2010 and July 2018, data of 248 male and 190 female patients (mean age 49.71 ± 13.20 years) treated with alitretinoin were collected. Of them, 43.2% had irritant contact dermatitis, 22.2% allergic contact dermatitis, 18.0% atopic dermatitis, 16.7% mixed (irritant/allergic) type of eczema. At 3 months, the 420 re-evaluated patients showed significantly reduced mTLSS and PGA (P < .0000001 vs baseline for both); PGA was clear/almost clear in 35.6% of cases. At 6 months, the 341 re-evaluated patients showed significant (P < .0000001) improvement of mTLSS and PGA vs baseline and 3 months (PGA clear/almost clear: 41.4%). Relapses occurred in 125 patients; 58 underwent an additional course of alitretinoin, with similarly good results. No relevant safety issues were reported; 86 patients experienced adverse effects, which forced 40 to prematurely stop treatment. The DECISA project results confirm the real-life efficacy, safety and tolerability of alitretinoin in the treatment of moderate to severe CHE refractory to standard topical therapies.


Subject(s)
Dermatologic Agents , Dermatology , Eczema , Hand Dermatoses , Adult , Alitretinoin , Chronic Disease , Dermatologic Agents/adverse effects , Eczema/diagnosis , Eczema/drug therapy , Female , Hand Dermatoses/diagnosis , Hand Dermatoses/drug therapy , Humans , Italy , Male , Middle Aged , Retrospective Studies , Treatment Outcome , Tretinoin/adverse effects
18.
Front Neurosci ; 15: 629401, 2021.
Article in English | MEDLINE | ID: mdl-33568971

ABSTRACT

PURPOSE: To investigate the vascular status of the macula in psoriasis patients without history of ocular inflammation by Optical Coherence Tomography Angiography (OCTA). METHODS: This prospective cross-sectional multicenter study included 55 psoriasis patients and 55 control healthy subjects. A complete eye examination and 6 mm × 6 mm OCTA imaging were performed. Retinal vascular status was evaluated by analyzing vascular density (VD) of superficial vascular plexus (superficial wVD) and deep vascular plexuses (deep wVD) in a 6 mm × 6 mm area and in foveal (superficial fVD and deep fVD) and parafoveal sectors (superficial pVD and deep pVD). In addition, foveal thickness (FT) and foveal avascular zone (FAZ) and clinical variables, including best corrected visual acuity (BCVA), intraocular pressure and refractive condition, were collected. RESULTS: BCVA, intraocular pressure and refractive condition were comparable between cases and controls. OCTA imaging showed that superficial wVD and superficial pVD were lower in the psoriasis group in comparison with controls (p = 0.009 and p = 0.01, respectively). Similarly, deep wVD and pVD were lower in the psoriasis group in comparison with control subjects (p = 0.03 and p = 0.01, respectively). In a sub-analysis of 47 patients affected by psoriasis without psoriatic arthritis, lower values of wVD and pVD in both superficial and deep capillary plexuses were registered. CONCLUSION: OCTA is a useful tool which provides data on vascular status of the retina in psoriasis with no ocular involvement. VD data may suggest that vascular changes may occur earlier than clinical onset of posterior inflammation.

19.
Indian J Dermatol ; 66(5): 540-542, 2021.
Article in English | MEDLINE | ID: mdl-35068510

ABSTRACT

Porokeratosis ptychotropica (PP) is a rare variant of porokeratosis characterized by pruritic, symmetrical, red-brown verrucous papules, and plaques most commonly localized within the gluteal fold. Herein, we report the clinical, dermoscopy, and reflectance confocal microscopy (RCM) aspects of a case of PP in a 63-year-old Caucasian woman along with histopathological correlation. Both dermoscopy and RCM were able to recognize the cornoid lamella, the histopathological clue shared by all clinical variants of porokeratosis. These non-invasive techniques may help in the differential diagnosis with other inflammatory/infectious and neoplastic disorders that may clinically resemble PP, but show distinct patterns.

20.
Int J Clin Pract ; 74 Suppl 187: e13621, 2020 Dec.
Article in English | MEDLINE | ID: mdl-33249707

ABSTRACT

Urea, also known as carbamide, is a polar, hygroscopic molecule produced by the human body that was first discovered in urine in 1773 by the French chemist Hilaire Rouelle and was artificially synthesised from inorganic precursors in 1828 by the German chemist Friedrich Wöhler. The importance of urea in dermatology is twofold: it primarily has a physiological key role for the maintenance of skin hydration, and it secondarily has been used for more than a century in different topical preparation and concentration in various skin conditions. One of the first uses of urea was the topical treatment of wounds because of its antibacterial and proteolytic properties. Since the second part of the 20th century, urea became one of the most common moisturisers and keratolytic agents, useful for the treatment of xerosis, atopic dermatitis, ichthyosis and psoriasis.


Subject(s)
Dermatitis, Atopic , Dermatologic Agents , Eczema , Ichthyosis , Dermatologic Agents/therapeutic use , Humans , Urea
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