INTRODUCTION: The aim of this observational, multicenter study was to assess the real-world use of brodalumab for the treatment of moderate-to-severe plaque psoriasis in patients in the Czech Republic, using data from the BIOREP registry. METHODS: The study included 273 patients aged ≥ 18 years with moderate-to-severe psoriasis who received brodalumab. Endpoints were drug survival (time from treatment initiation to discontinuation), effectiveness [Psoriasis Area and Severity Index (PASI)], and health-related quality-of-life [Dermatology Life Quality Index (DLQI)]. RESULTS: Predicted drug survival probability was 92.4% [95% confidence interval (CI): 89.1, 95.7%] at 6 months and 84.2% (95% CI 79.5, 89.1%) at 12 months; this was maintained at 24 months [80.4% (95% CI 74.5, 86.8%)]. Younger age, higher body mass index, and no previous biologic treatment were significantly associated with longer drug survival. Absolute PASI ≤ 3 after 3 months was achieved by 89.8% of patients; 92.4%, 77.8%, and 59.1% reached PASI 75, PASI 90, and PASI 100, respectively. After 12 months, 96.5% of 141 patients had an absolute PASI ≤ 3. The proportion of patients achieving DLQI 0/1 was 87.3% at 12 months. CONCLUSION: This study demonstrated high and sustained drug survival with high rates of skin clearance and improved quality of life in patients with relatively severe disease treated with brodalumab. Improvements were observed as early as 3 months post-treatment initiation and were sustained for up to 24 months in a real-life setting.

• Klíčová slova
• Brodalumab, Dermatology Life Quality Index, Drug survival, Efficacy, Psoriasis, Psoriasis Area Severity Index,
• MeSH
• dermatologické látky terapeutické užití   MeSH
• dospělí MeSH
• humanizované monoklonální protilátky * terapeutické užití   MeSH
• kvalita života * MeSH
• lidé středního věku MeSH
• lidé MeSH
• psoriáza * farmakoterapie   MeSH
• registrace * MeSH
• senioři MeSH
• stupeň závažnosti nemoci * MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH
• Geografické názvy
• Česká republika MeSH
• Názvy látek
• brodalumab MeSH Prohlížeč
• dermatologické látky MeSH
• humanizované monoklonální protilátky * MeSH

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.

• Klíčová slova
• BIOREP, Biological therapy, Guselkumab, Psoriasis, Real world, Registries,
• Publikační typ
• časopisecké články MeSH

BACKGROUND: Dupilumab has been approved to treat moderate-to-severe atopic dermatitis; however, the data in a real-world setting are still limited. OBJECTIVE: To analyze the effectiveness and safety of dupilumab. METHODS: This was a real-life Czech multicenter retrospective study from patients treated with dupilumab for severe AD. RESULTS: A total of 360 patients were included. At 16 weeks, 66.6, 34.1, and 5.5% of patients achieved EASI75/90 and EASI100, respectively. Improvement continued with the time, and the proportion of patients with EASI75/90 and EASI100 increased to 89.5, 55.6, and 12.9% after one year of treatment and reached 95.8, 60.4, and 27.1% in the second year of therapy, respectively. A significant reduction was observed in the DLQI scores. The most common adverse events were infections in 5.8% of patients, followed by ocular complications in 2.5% of patients. Persistence rates were 98.2% at four months to 93.1% at month 24, and lack of effectiveness was the most common reason for discontinuation. CONCLUSION: This real-life study confirmed the effectiveness and safety of dupilumab in a real-life setting during the COVID-19 pandemic. Our study revealed a higher frequency of infections and a lower conjunctivitis frequency than other real-life studies and clinical trials.

• Klíčová slova
• Atopic dermatitis, BIOREP, biological therapy, dupilumab, real-world, registries,
• MeSH
• atopická dermatitida * farmakoterapie   MeSH
• COVID-19 * MeSH
• humanizované monoklonální protilátky MeSH
• lidé MeSH
• pandemie MeSH
• registrace MeSH
• retrospektivní studie MeSH
• stupeň závažnosti nemoci MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• Geografické názvy
• Česká republika MeSH
• Názvy látek
• dupilumab MeSH Prohlížeč
• humanizované monoklonální protilátky MeSH

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.

• Klíčová slova
• Adalimumab, BIOREP, Long-term effectiveness, Persistence of treatment, Psoriasis, Registries,
• Publikační typ
• časopisecké články MeSH

BIOREP is a Czech registry of patients with psoriasis undergoing biological treatment. The objective of the study was to compare differences in demographic data, previous therapy, comorbidities, severity of psoriasis, quality of life, drug survival rates, and reasons for discontinuation between men and women. We analyzed a cohort of patients from the registry treated between May 2005 and January 2020. The total study population of 2472 patients (4051 treatment series) included 913 females and 1559 males. Women were significantly older than men at the onset of the biological treatment (47.8 vs 45.4 years, P < .0012) and the mean durations of psoriasis and that from its diagnosis until initiation of biological therapy, were longer in women (29.6 vs 27.2 years and 23.2 vs 20.6 years, P < .0012). Women as compared with men were also more often diagnosed with psoriatic arthritis (43.5% vs 33.0%, P < .0012). The prevalence rate of comorbidities was equivalent for both sexes except for that of depression (11.4% females vs 3.7% males, P < .0012). Both the DLQI and PASI scores were significantly different at baseline (DLQI = 16.0 and PASI = 19.5 for men vs DLQI 17.6 = and PASI = 17.7 for women, P < .0012). The survival probability with biological therapy was significantly lower in women for both biologically naïve and non-naïve patients, and there was more evidence of adverse effects in women. Our research demonstrates significant differences relative to multiple factors associated with psoriasis between men and women.

• Klíčová slova
• biological treatment, gender, psoriasis, registry,
• MeSH
• biologická terapie MeSH
• kvalita života * MeSH
• lidé MeSH
• pravděpodobnost MeSH
• psoriáza * diagnóza   farmakoterapie   epidemiologie   MeSH
• stupeň závažnosti nemoci MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Česká republika epidemiologie   MeSH