Age affects drug survival rates of interleukin (IL)-17 and IL-23 inhibitors in patients with plaque psoriasis: Results from a retrospective, multicentric, multi-country, cohort study.

BACKGROUND: Scarce data related to the drug survival of biologic agents in psoriasis patients aged ≥65 years is available. OBJECTIVES: To evaluate the drug survival of interleukin (IL)-23 or the IL-17 inhibitors approved for the treatment of moderate-to-severe psoriasis in elderly patients (aged ≥65 years), compared with younger adult patients (aged <65 years), and to identify clinical predictors that can influence the drug survival. METHODS: This retrospective multicentric cohort study included adult patients with moderate-to-severe psoriasis, dissecting two-patient subcohorts based on age: elderly versus younger adults. Kaplan-Meier estimator and proportional hazard Cox regression models were used for drug survival analysis. RESULTS: We included 4178 patients and 4866 treatment courses; 934 were elderly (1072 treatment courses), and 3244 were younger patients (3794 treatment courses). Drug survival, considering all causes of interruption, was higher in patients aged <65 years than in elderly patients overall (log-rank p < 0.006). This difference was significant for treatment courses involving IL-23 inhibitors (p < 0.001) but not for those with IL-17 inhibitors (p = 0.2). According to both uni- and multi-variable models, elder age was associated with an increased risk of treatment discontinuation (univariable analysis: HR: 1.229, 95% CI 1.062-1.422; p < 0.006; multivariable analysis: HR: 1.199, 95% CI 1.010-1.422; p = 0.0377). Anti-IL-23 agents were associated with a reduced likelihood of treatment discontinuation after adjusting for other variables (HR: 0.520, 95% CI 0.368-0.735; p < 0.001). Being previously treated with IL-17 inhibitors increased the probability of discontinuation. CONCLUSION: Elderly patients with psoriasis have an increased risk of biologic treatment discontinuation compared with younger adult patients, particularly, if being treated with IL-23 inhibitors. However, in stratified analyses conducted in elderly patients, IL-23 inhibitors showed higher drug survival rates than IL-17 inhibitors.

Real-World Clinical, Psychosocial, and Economic Burden of Atopic Dermatitis: Results From the ESSENTIAL AD Multicountry Study.

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.

Patients with atopic dermatitis often suffer from debilitating symptoms that impact their everyday lives. Although several treatment options are available, many patients continue to experience symptoms of disease. The ESSENTIAL AD study assessed burden of atopic dermatitis in patients receiving systemic and/or non-systemic therapies in real-life clinical practices across 15 countries in Eastern Europe, the Middle East, and Africa. The results of the study demonstrated that adult patients with atopic dermatitis continue to have substantial disease burden regardless of treatment with systemic therapy or non-systemic therapy. The findings suggest that optimal management of atopic dermatitis needs to be reassessed in Eastern Europe, the Middle East, and Africa, especially as new, more effective treatment options become available to patients.

Management of Moderate to Severe Plaque Psoriasis with Brodalumab in Daily Practice: Real-World Evidence from the LIBERO Study in the Czech Republic.

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.

A severe case of pemphigoid gestationis persisting after labour - case report and review of the literature.

BACKGROUND AND AIM: Pemphigoid gestationis (PG) is a rare skin disease of pregnancy. Given its incidence in pregnant women, physicians and especially obstetricians may not encounter this diagnosis in their entire career. We find this to be a major problem and there is an obligation to report it in as much detail as possible along with recommended treatments with proven efficacy. CASE REPORT: We describe the case of a 27 year old patient who was referred to the dermatology department with severe dissemination of blisters in the 9th week of pregnancy. She was diagnosed with pemphigoid gestationis in her first pregnancy. High doses of corticosteroids were initiated but due to inadequate effect cyclosporine was added. The pregnancy was complicated with gestational diabetes. The patient gave birth in her 33rd week by caesarian section due to premature rupture of the membrane. Vesicles were seen on the newborn immediately after birth which diminished spontaneously over 2 weeks. Blisters were still seen on the patient 1 month after labor even with the combination of systemic corticosteroids with cyclosporine. CONCLUSION: PG is a rare dermatosis of pregnancy. The course of the disease can be severe, necessitating systemic therapy. As described in this patient, systemic corticosteroids may not be sufficient and adding another immunosuppressive treatment may be needed. If pemphigoid gestationis has occurred during a previous pregnancy it is advised to reconsider another pregnancy.

Treatment of Severe Atopic Dermatitis with Dupilumab in Patients with Advanced Cancer.

Atopic dermatitis is a chronic inflammatory intensively pruritic skin disease. Patients with moderate-to-severe atopic dermatitis or with difficult-to-treat areas are candidates for systemic therapy, especially when topical therapy is inadequate. Currently, we have available not only conventional immunosuppressive systemic therapy, but also targeted biological therapy, which has shown a remarkable reduction in clinical severity with a good safety profile. Dupilumab has been approved to treat moderate-to-severe atopic dermatitis. Even though the therapy has been available for more than 3 years, there are still limited data regarding the treatment of patients with concomitant cancer. Previous immunosuppressive treatment for atopic dermatitis, such as cyclosporine or azathioprine, poses a safety risk for patients with malignant disease. We present a case series of three patients with advanced cancer and severe atopic dermatitis treated with dupilumab for an average of 17 months with a great response toward atopic dermatitis without cancer recurrence. One patient had colorectal cancer' the second and the third both had cancer duplicity-colorectal and kidney cancer and penile squamous cell carcinoma with prostate cancer. Our cases suggest that dupilumab can safely control atopic dermatitis in patients with advanced cancer.

Long-Term Efficacy, Safety, and Drug Survival of Guselkumab in Patients with Psoriasis: Real-World Data from the Czech Republic BIOREP Registry.

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.

Reproductive Healthcare in Women with Rheumatoid Arthritis and Psoriatic Diseases in Routine Clinical Practice: Survey Results of Rheumatologists and Dermatologists.

INTRODUCTION: The proportion of women being treated with biologics is growing. However, data on treatment recommendation awareness among treating physicians and women who are considering pregnancy and family planning are limited. In this study, we used a questionnaire survey to learn how rheumatologists and dermatologists address women's needs for family planning, pregnancy, and breastfeeding, as well as their possible concerns with concurrent inflammatory rheumatic disease or psoriasis. METHODS: A 55-question (in English) survey aimed at identifying surveyed physicians' current practices regarding the reproductive health needs of women with rheumatoid arthritis, psoriasis, or psoriatic arthritis. This survey included 82 rheumatologists and 38 dermatologists from the Czech Republic, Hungary, and Slovakia. RESULTS: The proportion of female patients of reproductive age with the moderate-to-severe disease was 10-30% of all patients treated by the respondents. At the time of diagnosis, approximately two-thirds of the respondents discussed family planning with their patients. Rheumatologists collaborated with other specialists more frequently than dermatologists and gynecologist-obstetricians. Half of the rheumatologists revised systemic treatment 6 months before the patient planned to become pregnant, whereas dermatologists appear to act much sooner. Rheumatologists chose systemic glucocorticoids as the first-line treatment for pregnancy flares, whereas dermatologists chose topical corticosteroids. Congresses and interdisciplinary forums were rated the most valuable sources of information by physicians. CONCLUSIONS: There is a need for more holistic, multidisciplinary, collaborative, and integrated communication between clinicians and women of childbearing age. Physicians should consider the implications of these conditions and medical treatment for women of childbearing age and family planning for those with rheumatoid arthritis and psoriatic disease. Patient-centered care that includes patients' reproductive choices should be a routine clinical practice.

Efficacy of switches within the class of IL-17 inhibitors: An analysis of data from the Czech nationwide registry of psoriatic patients receiving biological/targeted therapy (BIOREP).

The IL-17 cytokine family encompasses six different homodimers and heterodimers referred to as IL-17A-F. Due to some differences in the mechanism of IL-17 inhibition, aninsufficient effect of one IL-17 inhibitor does not necessarily imply lack of efficacy of the other agent of the same class. Aim of study was analysis of the success rate of switches among IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab) in patients treated in the Czech Republic. Data were obtained from the Czech nationwide registry of psoriatic patients receiving biological/targeted therapy (BIOREP). Our analysis involved data of a total of 90 patients with severe chronic plaque psoriasis and baseline PASI scores >10 both prior to first-line biological therapy initiation and after switch to another agent of the class of IL-17 inhibitors. The most effective switch was that from secukinumab to brodalumab, with PASI 90 reached by 64.7% and 73.3% of patients at weeks 12 and 24. Among patients switched from secukinumab to ixekizumab target PASI 90 responses were achieved (at weeks 12 and 24) by 41.2% and 55.2% of patients. Among patients switched from ixekizumab to brodalumab target PASI 90 responses were achieved, at the above time points, by 30.8% and 38.5% of patients. Our analysis showed a high success rate of switches from secukinumab to ixekizumab and brodalumab, followed by the ixekizumab-to-brodalumab switch. Importantly, the therapeutic response and success rates of individual switches are independent of the patient's body weight and presence of psoriatis arthritis.

Drug Survival of Interleukin (IL)­17 and IL­23 Inhibitors for the Treatment of Psoriasis: A Retrospective Multi­country, Multicentric Cohort Study.

BACKGROUND: Drug survival, defined as the length of time from initiation to discontinuation of a given therapy, allows comparisons between drugs, helps to predict patient's likelihood of remaining on a specific treatment, and achieving the best decision for each patient in daily clinical practice. OBJECTIVE: The aim of this study was to provide data on drug survival of secukinumab, ixekizumab, brodalumab, guselkumab, tildrakizumab, and risankizumab in a large international cohort, and to identify clinical predictors that might have an impact on the drug survival of these drugs. METHODS: This was a retrospective, multicentric, multi-country study that provides data of adult patients with moderate to severe psoriasis who started treatment with an interleukin (IL)-17 or IL-23 inhibitor between 1 February 2015 and 31 October 2021. Data were collected from 19 distinct hospital and non-hospital-based dermatology centers from Canada, Czech Republic, Italy, Greece, Portugal, Spain, and Switzerland. Kaplan-Meier estimator and proportional hazard Cox regression models were used for drug survival analysis. RESULTS: A total of 4866 treatment courses (4178 patients)-overall time of exposure of 9500 patient-years-were included in this study, with 3164 corresponding to an IL-17 inhibitor (secukinumab, ixekizumab, brodalumab) and 1702 corresponding to an IL-23 inhibitor (guselkumab, risankizumab, tildrakizumab). IL-23 inhibitors had the highest drug survival rates during the entire study period. After 24 months of treatment, the cumulative probabilities of drug survival were 0.92 (95% confidence interval [CI] 0.89-0.95) for risankizumab, 0.90 (95% CI 0.88-0.92) for guselkumab, 0.80 (95% CI 0.76-0.84) for brodalumab, 0.79 (95% CI 0.76-0.82) for ixekizumab, and 0.75 (95% CI 0.73-0.77) for secukinumab. At 36 months, only guselkumab [0.88 (95% CI 0.85-0.91)], ixekizumab [0.73 (95% CI 0.70-0.76)], and secukinumab [0.67 (95% CI 0.65-0.70)] had more than 40 patients at risk of drug discontinuation. Only two drugs had more than 40 patients at risk of drug discontinuation at 48 months, with ixekizumab demonstrating to have a higher cumulative probability of drug survival [0.71 (95% CI 0.68-0.75)] when compared with secukinumab [0.63 (95% CI 0.60-0.66)]. Secondary failure was the main cause for drug discontinuation. According to the final multivariable model, patients receiving risankizumab, guselkumab, and ixekizumab were significantly less likely to discontinue treatment than those receiving secukinumab. Previous exposure to biologic agents, absent family history of psoriasis, higher baseline body mass index (BMI), and higher baseline Psoriasis Area and Severity Index (PASI) were identified as predictors of drug discontinuation. CONCLUSION: The cumulative probability of drug survival of both IL-17 and IL-23 inhibitors was higher than 75% at 24 months, with risankizumab and guselkumab demonstrating to have overall cumulative probabilities ≥ 90%. Biological agent chosen, prior exposure to biologic agents, higher baseline BMI and PASI values, and absence of family history of psoriasis were identified as predictors for drug discontinuation. Risankizumab, guselkumab, and ixekizumab were less likely to be discontinued than secukinumab.

Prevalence of genital and oral human papillomavirus infection among psoriasis patients on biologic therapy.

Current knowledge about human papillomavirus (HPV) infection in psoriasis patients treated with biologics is limited. In this study we evaluated the prevalence of oral and genital HPV infection in psoriasis patients treated with biologics or topical therapy for at least 6 months. The presence of HPV DNA in oral rinse and genital smears was evaluated. In total, 267 patients who met the inclusion criteria and agreed to participate were enrolled: 110 (41.2%) on topical therapy, 84 (31.5%) on anti-TNF-alpha therapy, 31 (11.6%) on anti-IL-12/23 therapy and 42 (15.7%) on anti-IL-17 therapy. The presence of genital HPV infection was detected in 34.6% of men receiving anti-TNF-α treatment, in 25.0% of patients on anti-IL-12/23 and 18.8% of patients on anti-IL-17 therapy. The difference in prevalence was not statistically different from men on topical treatment (26.3%). Prevalence of oral HPV infection was higher across all of the biologic groups (11.9% for anti-TNF-α, 12.9% for anti-IL-12/23 and 19.0% for anti-IL-17) compared to patients on topical therapy (7.3%), but statistically significant only for anti-IL-17 (p < 0.05). The presence of oral HPV infection in patients treated with biologics was significantly higher (44.0%) in patients on long-term biologic treatment (>8 years) compared to patients taking biologics for a shorter period (9.1%; p < 0.01). Our results suggest that patients on biologics for psoriasis have a higher prevalence of oral HPV infection compared to patients on topical treatment. Long-term treatment with biologics seems to be associated with a higher prevalence of oral HPV infection, independent of previous conventional immunosuppressive therapy.

Leg Ulcer Therapy by Local Injection of Autologous Growth Factors: Results of a Pilot Study.

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.

Efficacy, safety, and drug survival of patients with psoriasis treated with IL-17 inhibitors - brodalumab, ixekizumab, and secukinumab: real-world data from the Czech Republic BIOREP registry.

BACKGROUND: Real-world data on the use of interleukin-17 (IL-17) inhibitors for the treatment of psoriasis are limited. OBJECTIVE: To evaluate and compare the efficacy, safety, and drug survival of IL-17 inhibitors. METHODS: This retrospective study analyzed the BIOREP registry data of patients treated with at least one IL-17 inhibitor (secukinumab, ixekizumab, and brodalumab). RESULTS: In total, 949 patients were included. The improvement in PASI score was significant for all drugs, and the proportion of patients achieving PASI 75, 90, and 100 after both 3 and 24 months of therapy was highest for brodalumab, followed by ixekizumab and secukinumab. The Dermatology Life Quality Index score decreased to ˂3 after 3 months and to ˂2 after 24 months of therapy for all inhibitors. Loss of effectiveness was the major reason for discontinuation in 17.2% of patients, followed by adverse events in 3.2% of patients. The drug survival probability was the highest for brodalumab, followed by ixekizumab and secukinumab. Negative predictors for treatment discontinuation were obesity and the number of treatment lines, whereas a positive predictor was the presence of concomitant psoriatic arthritis; sex had no influence. CONCLUSION: This real-life study demonstrated the effectiveness and good safety profile of all currently available IL-17 inhibitors.

Real-life experience in the effectiveness, impact on quality of life and safety of dupilumab treatment in patients with moderate to severe atopic dermatitis in the Czech Republic.

OBJECTIVES: The aim of the study was to assess the effectiveness and safety of dupilumab therapy in patients with moderate-to-severe atopic dermatitis (AD) in a real-life Czech bicentric cohort. METHODS: We retrospectively analysed 50 patients with moderate-to-severe AD treated with dupilumab in two centres in the Czech Republic. Baseline characteristics, the Eczema Area and Severity Index (EASI) score and Dermatology Life Quality Index (DLQI) were collected at baseline and each 3 following months. The proportion of patients achieving EASI50, EASI75, EASI90 and EASI100 were analysed. Levels of immunoglobulin E (IgE) were collected before and after 6 and 12 months of therapy. Adverse events were recorded as well. RESULTS: Thirty-two men and 18 women with mean body mass index (BMI) of 25.7 were enrolled in our analysis. The mean age of the patients was 37.6 years and the mean time from diagnosis until the initiation of dupilumab therapy was 35.0 years. After 4 months, EASI75 was achieved by 75.7%, out of which 40.5% achieved EASI90 and 10.8% achieved complete clearance. Improvement continued with time, and the proportion of patients with EASI90 increased to 71.4% at the 6th month and at the 12th month of therapy the EASI90 was 65.2%. EASI100 was achieved by 14.3% and 13.0% at the 6th and 12th month, respectively. A marked reduction was observed in the DLQI and also in IgE levels. EASI responses were independent of BMI. No new safety issues were identified. Adverse events were experienced by 44% (22/50) of the patients and they were all mild in intensity. Conjunctivitis and herpes simplex virus infection were the most common adverse events. CONCLUSION: Our results confirmed the effectiveness and safety of dupilumab in a real-life setting in adult patients with moderate-to-severe AD in the Czech Republic. Dupilumab was well-tolerated and resulted in a significant clinical improvement in combination with improvement of quality of life.

Dupilumab for the treatment of atopic dermatitis: real-world data from the Czech Republic BIOREP registry.

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.

Adalimumab Biosimilar-Induced Severe Paradoxical Palmoplantar Pustulosis in a Patient with Psoriasis and Psoriatic Arthritis Successfully Treated with Ixekizumab.

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.

Risankizumab for the Treatment of Moderate-to-Severe Psoriasis: Real-Life Multicenter Experience from the Czech Republic.

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.