Search

Introduction: Limited real-world evidence exists about the burden of atopic dermatitis (AD) in patients receiving systemic or non-systemic therapies in clinical practices. ESSENTIAL AD was an observational study that aimed to fill this information gap., Methods: ESSENTIAL AD enrolled (September 2021-June 2022) adult patients with physician-confirmed AD that was routinely managed with systemic and non-systemic treatment in a real-world setting from 15 countries in Eastern Europe, the Middle East, and Africa. Primary outcome variables were Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and Dermatology Life Quality Index (DLQI) assessed during one office visit., Results: A total of 799 enrolled patients fulfilled selection criteria and were included in the study. Patients mean (standard deviation [SD]) age was 36.3 (14.4) years, 457 (57.2%) were female, and the majority of patients were white (647 [81.0%]). Mean (SD) time since AD diagnosis was 17.6 (15.2) years (median 16.5; interquartile range [IQR] 3.3-26.8). The mean (SD) EASI, SCORAD, and DLQI total scores were 11.3 (11.3 [median 8.1; IQR 3.6-15.8]), 37.8 (17.9 [median 35.5; IQR 24.2-49.0]), and 10.6 (7.2 [median 10.0; IQR 5.0-15.0]), respectively. Patients receiving systemic treatment had significantly higher disease burden (mean [SD] EASI 13.3 [13.0]; median [IQR] 9.6 [3.9-17.9]) versus non-systemic treatment (mean [SD] 9.3 [8.7]; median [IQR] 6.8 [3.0-13.2]; P < 0.0001). Results were similar for SCORAD (39.9 [19.6] vs 35.6 [15.7]; median [IQR] 38.6 [24.7-53.1] vs 32.6 [23.9-44.6]; P = 0.0017), and DLQI total scores (11.4 [7.4] vs 9.9 [6.9]; median [IQR] 11.0 [5.0-16.0] vs 9.0 [5.0-14.0]; P = 0.0033, respectively)., Conclusion: Patients with AD continue to have substantial disease burden despite treatment with systemic therapy, suggesting that a need for effective disease management remains, including effective therapies that improve psychological outcomes and reduce economic burden of AD, in Eastern Europe, the Middle East, and Africa., (© 2024. The Author(s).)

Introduction: Psoriasis is a chronic, immune-mediated inflammatory skin disease. Despite the availability of several therapies, many patients affected by this disease remain untreated, do not have adequate response, or suffer from treatment-related toxic effects. It has been shown that the interleukin (IL)-17 pathway plays a key role in the immunopathogenesis of psoriasis. Brodalumab, the first human monoclonal IgG2 antibody that selectively binds to subunit A of the human IL-17 receptor, blocking interactions with a number of cytokines of the IL-17 family, has confirmed fast onset of action, high complete clearance rates, and sustained efficacy. Nevertheless, there is only a limited amount of published real-world evidence (RWE) data., Methods: This was an open-label, multicenter, real-world, prospective, non-interventional, non-controlled (single-arm) observational study (LIBERO-CZ) assessing the management of moderate to severe psoriasis with brodalumab in daily practice for up to 52 weeks of treatment., Results: Fifty-four patients (70.4% male, mean age 46.9 ± 13.4 years, weight 95.6 ± 22.7 kg, disease duration 18.6 ± 12.7 years) were enrolled and included in the final analysis. Forty-nine of the patients completed the study and five discontinued prematurely; 51.8% of all the enrolled patients were biologic-naïve. At baseline, 28% patients were classified as severe (psoriasis area severity index (PASI) ≥ 20). Overall, the mean PASI decreased by 15.6 from 16.1 (± 5.0) at baseline to 0.5 (± 1.2) at the last visit. The primary endpoint of an absolute PASI ≤ 3 at week 12 (as observed analysis) was achieved by 95.9% of patients. The static Physician's Global Assessment (sPGA) success (defined as clear = 0 and almost clear = 1) at week 52 was achieved by 92.1% of patients. PASI 75, PASI 90, and PASI 100 were achieved by 98.0%, 87.8%, and 75.5% of patients, respectively, after approximately 52 weeks of treatment. The study also recorded very positive results concerning patient-reported outcomes., Conclusions: LIBERO-CZ confirms the fast onset and high clearance rates of brodalumab in real life in both biologic-naïve and biologic-experienced patients., (© 2023. The Author(s).)

Background: Real-world data on the long-term use of guselkumab for treatment of psoriasis are still limited., Objective: We aimed to evaluate long-term efficacy, safety, and drug survival of guselkumab in a real-world setting., Methods: This is a retrospective study analyzing Czech Republic registry (BIOREP) data of patients treated with guselkumab., Results: In total, 333 patients were included. Improvement in Psoriasis Area and Severity Index (PASI) score was significant. Mean PASI score decreased from 16 at baseline to 0.7, 0.9, and 0.8 after 12, 24, and 36 months, respectively. Absolute PASI scores of ≤ 3 and ≤ 1 were achieved in 93.9% and 77.9%, 94.2% and 71.0%, and 94.8% and 70.7% of patients after 12, 24, and 36 months, respectively. Response PASI 90 and PASI 100 were attained in 81.8% and 57.1%, 75.4% and 50.7%, and 75.9% and 55.2% of patients after 12, 24, and 36 months, respectively. The percentage of patients achieving PASI 90 and PASI 100 responses was higher throughout the study in bio-naive and in normal-weight patients, while presence of psoriatic arthritis had no influence. Improvement in Dermatology Life Quality Index (DLQI) score was also significant; mean DLQI score decreased from 14.2 at baseline to 0.9, 1.0, and 0.7 after 12, 24, and 36 months, respectively. Patients with PASI 100 had lower mean DLQI throughout the study compared with patients with PASI 90. Major reason for discontinuation was loss of effectiveness in 7.1% of patients, while only 0.6% were due to adverse events. Overall cumulative drug survival was high, with only a minimal decline over time, reaching 91.6%, 87.0%, and 85.5% after 12, 24, and 36 months, respectively. Drug survival was not affected by previous biological treatment, patient weight, or presence of psoriatic arthritis., Conclusions: This real-world study demonstrated the long-term effectiveness, good safety profile, and high drug survival of guselkumab treatment over a period of 36 months., (© 2023. The Author(s).)

Introduction: Population ageing has led to an increase in the prevalence of many chronic diseases that occur in elderly patients including chronic wounds of various aetiologies, especially leg ulcers. The treatment of these wounds is lengthy and associated with health, economic and social problems. The aim of our study was to compare the outcomes of local injections of autologous growth factors with standard dressings for leg ulcer treatment., Methods: The study included 25 patients with leg ulcers treated with autologous growth factors, and 15 patients treated with standard wet dressings only. The area and depth of ulcers were measured on days 0, 5, 28, 84 and 168, and statistically processed using the chi-square test, the Fischer exact test, the Wilcoxon two-sample test, the non-parametric paired Wilcoxon test and the Friedman analysis of variance (ANOVA) test at a significance level of 5%., Results: Area and depth did not significantly differ between the two groups before initiation of the treatment (p = 0.472 and p = 0.242, respectively). During the study period, the average leg ulcer area decreased in both the study and control groups by 72% and 40%, respectively. The paired Wilcoxon test showed that this decrease was significant in the study group (p < 0.001), but not in the control group (p = 0.075)., Conclusion: Leg ulcers heal better when treated with autologous growth factor injections than when treated with standard dressings alone. A further study with a larger number of patients is needed to confirm the presented results. However, this method seems to be a promising way to treat ulcers of the lower extremities., (© 2022. The Author(s).)

Psoriasis vulgaris is a chronic immune-mediated inflammatory disease of the skin. Biologic therapy has been available for more than 10 years and has become one of the standard treatments for patients with moderate to severe psoriasis. Initially, only biologics against tumour necrosis factor alpha (TNF-α) were used, and only later did drugs against different interleukins (ILs), including IL-17 or IL-23, became available. The side effects of biologic therapy include paradoxical adverse events (PAEs), such as palmoplantar pustular reaction, especially with anti-TNF-α drugs. We present the case of a 49-year-old female patient with diabetes and psoriasis and psoriatic arthritis treated with an adalimumab biosimilar who developed a severe PAE of the palmoplantar pustular type. Treatment with adalimumab was stopped and the patient switched to ixekizumab which was successful. When a paradoxical reaction develops during biologic therapy, especially when it is severe as in our patient, switching to another class of biologics is advised., (© 2021. The Author(s).)

Introduction: Risankizumab has been approved for the treatment of moderate-to-severe plaque psoriasis; however, real-life data are limited. Our objectives were to evaluate the effectiveness and safety of risankizumab and its impact on the quality of life of patients with psoriasis in a real-world setting., Methods: We retrospectively analyzed 154 patients from 18 centers in the Czech Republic who had undergone biologic therapy with risankizumab for moderate-to-severe plaque psoriasis. Baseline characteristics included data on comorbidities, demographics, previous therapies, Dermatology Life Quality Index (DLQI) score, and Psoriasis Area and Severity Index (PASI) score. The proportion of patients achieving a 90% improvement in their PASI score from baseline (PASI 90) and complete resolution (PASI 100) after 16, 28, and 52 weeks was analyzed., Results: A total of 95 men and 59 women with mean body mass index (BMI) of 29.6 were enrolled in our analysis. The mean age of the patients was 48.5 years and the mean time from diagnosis until initiation of risankizumab therapy was 22.5 years. After 16 weeks, 63.8 and 44.7% patients achieved PASI 90 and PASI 100 responses, respectively. Improvement continued with time, and the proportion of patients with PASI 90 and PASI 100 responses increased to 82.4 and 67.6%, respectively, at week 52. A significant reduction was observed over time in the DLQI. Patients achieving PASI 100 response at week 16 had a higher reduction in the DLQI score than those with PASI 90 response (- 15.9 vs. - 11.8). PASI 90 and PASI 100 responses were independent of the BMI and previous biologic therapy. No new safety issues were identified., Conclusions: In this patient population, risankizumab was effective and safe in a real-world setting, and a high number of patients achieved PASI 90 and PASI 100 responses. A higher reduction in the DLQI was seen in patients with PASI 100 response, which supports the evidence that this value should be the new therapeutic goal., (© 2021. The Author(s).)

Introduction: The study aimed to evaluate the real-world effectiveness of adalimumab as well as investigate the persistence of treatment and identify factors, which may affect it., Methods: More than 1150 patients (4363.1 patient-years) with psoriasis who had been treated with adalimumab since the start of the BIOREP registry in the Czech Republic were included in this analysis. Treatment effectiveness was defined as improvement in Psoriasis Area and Severity Index (PASI). The analysis was performed during the years 2005 and 2018. Patients were on on-label dose., Results: After 12 and 96 months of therapy, 84% and 88% of patients had a 75% reduction in PASI score from baseline, respectively. Drug survival was analyzed according to the number of previous biological therapies, and results showed 75% and 58.1% survival rate for biologically naïve patients in the 20th and 80th month of treatment, respectively. The negative predictors of adalimumab survival were the female gender, obesity, baseline PASI score and the number of previous biological therapies., Conclusions: Baseline factors including PASI, number of previous biological therapies, and sex were associated with shorter adalimumab survival. This long-term study shows that adalimumab is effective and has high treatment persistence.