Use of Dupilumab in 543 Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Retrospective Study.

BACKGROUND: Dupilumab has proven to be an effective treatment for patients with moderate-to-severe atopic dermatitis (AD) in clinical trials. However, real-world experience with dupilumab in a broader population is limited. METHODS: The study population comprised adult patients with moderate-to-severe AD, defined as an Eczema Area Severity Index (EASI) score of 24 or higher, treated with dupilumab at 10 Italian teaching hospitals. We analyzed physician-reported outcome measures (EASI), patient-reported outcome measures (pruritus and sleep score, Dermatology Life Quality Index [DLQI]), and serological markers (IgE and eosinophil count) after 16 weeks. RESULTS: We enrolled 543 patients with moderate-to-severe AD. Two patients (0.4%) discontinued treatment. The median (IQR) change from baseline to 16 weeks of treatment in the EASI score was -87.5 (22.0) (P<.001). The EASI-50, EASI-75, and EASI-90 response rates were 98.1%, 81.5%, and 50.8% after 16 weeks. At 16 weeks, 93.0% of the patients had achieved a 4-point or higher improvement in DLQI from baseline. During treatment with dupilumab, 12.2% of the patients developed conjunctivitis, and total IgE decreased significantly (P<.001). Interestingly, in the multivariate logistic regression model, the risk of developing dupilumab-related conjunctivitis was associated with early onset of AD (OR, 2.25; 95%CI, 1.07-4.70; P=.03) and presence of eosinophilia (OR, 1.91; 95%CI, 1.05-3.39; P=.03). CONCLUSION: This is the broadest real-life study in AD patients treated with dupilumab to date. We observed more significant improvements induced by dupilumab in adult patients with moderate-to-severe AD than those reported in clinical trials.

Moderate-to-severe atopic dermatitis in adolescents treated with dupilumab: A multicentre Italian real-world experience.

BACKGROUND: Moderate-to-severe atopic dermatitis (AD) in the adolescence is a high burden disease, and its treatment can be very challenging due to paucity of approved systemic drugs for this age and their side-effects. Dupilumab was recently approved for treatment of adolescent AD. OBJECTIVES: A multicentre, prospective, real-world study on the effectiveness and safety of dupilumab in adolescents (aged from ≥12 to <18 years) with moderate-to-severe AD was conducted. The main AD clinical phenotypes were also examined. METHODS: Data of adolescents with moderate-to-severe AD treated with dupilumab at label dosage for 16 weeks were collected. Treatment outcome was assessed by EASI, NRS itch, NRS sleep loss and CDLQI scores at baseline and after 16 weeks of treatment. The clinical scores were also evaluated according to clinical phenotypes. RESULTS: One hundred and thirty-nine adolescents were enrolled in the study. Flexural eczema and head and neck eczema were the most frequent clinical phenotypes, followed by hand eczema and portrait-like dermatitis. Coexistence of more than 1 phenotype was documented in 126/139 (88.5%) adolescents. Three patients (2.1%) contracted asymptomatic SARS-CoV-2 infection and 1 of the discontinued dupilumab treatment before the target treatment period. A significant improvement in EASI, NRS itch, NRS sleep loss and CDLQI was observed after 16 weeks of treatment with dupilumab. This outcome was better than that observed in clinical trials. Dupilumab resulted effective in all AD phenotypes, especially in diffuse eczema. Twenty-eight (20.1%) patients reported adverse events, conjunctivitis and flushing being the most frequent. None of patients discontinued dupilumab due to adverse event. CONCLUSIONS: Dupilumab in adolescent AD showed excellent effectiveness at week 16 with consistent improvement of all clinical scores. Moreover, dupilumab showed a good safety profile also in this COVID-19 pandemic era.

Dupilumab therapy of atopic dermatitis of the elderly: a multicentre, real-life study.

BACKGROUND: Treatment of moderate-to-severe atopic dermatitis (AD) in the elderly may be challenging, due to side-effects of traditional anti-inflammatory drugs and to comorbidities often found in this age group. Furthermore, efficacy and safety of innovative drugs such as dupilumab are not yet well known. OBJECTIVES: A multicentre retrospective, observational, real-life study on the efficacy and safety of dupilumab was conducted in a group of patients aged ≥65 years and affected by severe AD. Their main clinical features were also examined. METHODS: Data of elderly patients with severe (EASI ≥24) AD treated with dupilumab at label dosage for 16 weeks were retrospectively collected. Treatment outcome was assessed by comparing objective (EASI) and subjective (P-NRS, S-NRS and DLQI) scores at baseline and after 16 weeks of treatment. RESULTS: Two hundred and seventy-six patients were enrolled in the study. They represented 11.37% of all patients with severe AD. Flexural eczema was the most frequent clinical phenotype, followed by prurigo nodularis. The coexistence of more than one phenotype was found in 63/276 (22.82%) subjects. Data on the 16-week treatment with dupilumab were available for 253 (91.67%) patients. Efficacy of dupilumab was demonstrated by a significant reduction of all the scores. No statistically significant difference regarding efficacy was found in elderly patients when compared to the group of our AD patients aged 18-64 years, treated with dupilumab over the same period. Furthermore, only 18 (6.52%) patients discontinued the drug due to inefficacy. Sixty-one (22.51%) patients reported adverse events, conjunctivitis and flushing being the most frequent. One (0.36%) patient only discontinued dupilumab due to an adverse event. CONCLUSIONS: Therapy with dupilumab led to a significant improvement of AD over a 16-week treatment period, with a good safety profile. Therefore, dupilumab could be considered as an efficacious and safe treatment for AD also in the elderly.

Efficacy and safety of dupilumab in atopic dermatitis in elderly patients: a retrospective study.

Atopic dermatitis (AD) is a common inflammatory skin disease with high prevalence in both children (15-30%) and adults (2-10%), but limited data are available for older people. Elderly patients form a challenging group, as multiple comorbidities, associated polypharmacy and failures with previous treatments are common. We performed a retrospective observational study on elderly (≥ 65 years) patients treated with dupilumab, monoclonal antibody to the shared alpha subunit of the interleukin-4 and -13 receptor approved for the treatment of moderate-to-severe AD in adults.

Rational ideation and empiric validation of an innovative digital dermographic tester.

BACKGROUND: Dermographism is a condition characterized by a weal response to a combination of pressure and traction on skin surface, and its diagnosis is based on medical history, clinical criteria and provocation test. The Dermographic Tester® , a pen-sized tool containing a spring-loaded blunt tip, is the most widely used instrument for the provocation test, and it exerts increasing pressures on the skin surface according to an arbitrary units (AU) scale. Analysing the mechanism of function and trying to convert the AUs to SI units (g/mm2 ), we found that this instrument had some defects and limits that would compromise a true and repeatable quantification of the weal response threshold. Consequently, we decided to develop a new instrument, the Digital Dermographic Tester (DDT), which is engineered with an inside force sensor to implement features lacking in the current tools, in the hope of enhancing the precision of the provocation test. AIM: To validate the effectiveness and accuracy of the DDT. METHODS: We tested the DDT on 213 participants purposely sampled to obtain three groups, each with a different pattern of reaction to mechanical stimuli. Based on anamnestic, diagnostic and symptomatic criteria, patients were divided into dermographic urticaria (DU), spontaneous urticaria (SU) and healthy control (HC) groups. The DDT was used to apply 12 levels of pressure to the skin surface, and a frequency distribution of positive reactions was displayed for each group. RESULTS: A force of 36-40 g/mm2 appropriately differentiated physiological from pathological conditions with high sensitivity and specificity. CONCLUSIONS: The DDT was found to be capable of differentiating patients with DU patients from those with SU and from HCs, and was able to precisely identify the weal elicitation threshold.

The effect of smartphone addiction on hand joints in psoriatic patients: an ultrasound-based study.

BACKGROUND: Distal interphalangeal (DIP) arthritis is a frequent form of psoriatic arthritis being often linked to nail psoriasis. Modern society is characterized by overuse of smartphones. Indeed, literature has recently focalized on research into smartphone addiction and health-related problems. OBJECTIVES: As smartphone addiction is able to determine overuse and repeated movements of DIP joints and nails, the aim of this study was to evaluate the impact of smartphone use on hand joints of young psoriatic patients. METHODS: An observational study involving four different groups such as non-smartphone-addicted (SA) psoriatic patients, SA psoriatic patients, non-SA controls and SA controls was performed. Each subject underwent an ultrasound examination of both hands by three independent and blinded to group assignment radiologists. A specific score was used to evaluate the inflammatory state of the analysed joints. RESULTS: The total ultrasound score was statistically significantly higher in SA controls respect to non-SA controls (3.4 vs. 1.4; P < 0.05) as well as in SA psoriasis patients compared to non-SA psoriatic subjects (15.2 vs. 6.7; P < 0.01). Higher mean of ultrasound score was found for left hand in controls (both SA or not) and for right hand in psoriatic subjects (both SA or not), however without reaching statistical significance. CONCLUSIONS: Smartphone overuse was found to be linked with higher signs of inflammation of musculoskeletal structures of hands joints in both psoriasis and controls through ultrasound examination. Therefore, smartphone overuse may be a factor which facilitate or speed up the possible development of psoriatic arthritis.

Psoriasis and sport: a new ally?

BACKGROUND: Psoriasis is a common chronic multifactorial disease which can result in restrictions to social and recreational activities. Psoriasis subjects are at high risk to develop metabolic and cardiovascular diseases. Physical activity, a vital component in prevention and management of these diseases, is reported to be potentially associated in a negative way with psoriasis. OBJECTIVE: To investigate the relationship between psoriasis and physical activity. MATERIALS AND METHODS: Anamnestic and physical examination as well as a specific doctor-administered questionnaire was performed to a group of 416 consecutive sportive subjects and 489 sex and age-matched controls. Moreover, similar investigations were executed on 400 consecutive psoriatic patients without psoriatic arthritis. RESULTS: Psoriasis was significantly more common in controls respect to sportive group (n = 27, 5.4% vs. n = 7, 1.7%, P < 0.01) whereas a positive familial history of psoriasis was observed in similar percentages in both groups (n = 51, 10.2% vs. n = 40, 9.6%). The number of subjects performing sports activities was significantly lower in psoriasis group compared to controls (n = 44, 11% vs. n = 106, 21.3%; P < 0.001). Of these psoriatic patients, 35/44 referred that sporting activities showed a positive influence on the natural course of their disease, whereas the remaining 11 patients did not highlight positive or negative influences on their illness. Interestingly, 23.75% of psoriatic patients (n = 95) related that they had regularly carried out sporting activities before the onset of the dermatosis referring that psoriasis represented a huge obstacle to continue practicing physical activities. CONCLUSION: Our survey showed that regular physical activity may lower the risk of psoriasis and have a beneficial effect on the natural course of the disease, positively influencing not only the severity as well as the incidence of metabolic comorbidities, but also, through possible epigenomic, metabolic, anti-inflammatory and psycho-emotional effects, the onset of the dermatosis. However, larger birth cohort studies are needed to confirm these results.