Certolizumab Pegol for the Treatment of Plaque Psoriasis in Routine Clinical Practice: One-Year Results from the CIMREAL Study.

INTRODUCTION: Certolizumab pegol (CZP) is an anti-tumor necrosis factor alpha (TNFα) approved for the treatment of moderate to severe plaque psoriasis (PSO). However, data on its real-world use is currently limited. The objective of this study was to describe the 1-year real-world effectiveness of CZP, its impact on health-related quality of life (HRQoL), and safety outcomes in patients with moderate to severe PSO in multi-country settings. METHODS: CIMREAL, a prospective, noninterventional study, was conducted across Europe and Canada from August 2019 to December 2022. Patients were followed for 1-year, receiving CZP 400 mg initial doses at weeks 0, 2, and 4, followed by CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg Q2W maintenance dosing. Effectiveness was assessed using the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety was also evaluated. RESULTS: Overall, 399 patients with moderate to severe PSO were included. Of these, 93.7% (374/399) and 77.9% (311/399) completed months 3 and 12, respectively. Mean age (± standard deviation) was 42.9 ± 13.5 years and body mass index was 28.5 ± 6.8 kg/m2, with the majority of patients being female (68.2%). At 12 months, CZP showed substantial effectiveness, achieving PASI 75 and PASI 90 response rates (≥ 75% and ≥ 90% improvement from baseline, respectively) of 77% and 56.5%, respectively. Patients with PASI score of ≤ 3 and ≤ 2 experienced improvement from 3 months (49.8% and 41.1%, respectively) to 12 months (82.0% and 75.3%, respectively). HRQoL considerably improved, with mean DLQI scores decreasing from 12.4 to 2.3 after 12 months of treatment, and the proportion of patients with DLQI 0/1 increased from 28.6% at 3 months to 59.4% at 12 months. The 1-year probability of persistence was approximately 85%. Overall, 30.6% of the patients experienced any adverse events and 9.3% had serious adverse events. CONCLUSION: In routine clinical practice, CZP exhibited consistent effectiveness, positively impacting both skin psoriasis activity and HRQoL. The 1-year persistence of CZP was high, and no new safety signals were identified. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04053881 https://www. CLINICALTRIALS: gov/study/NCT04053881 .

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.

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.

Efficacy of monopolar radiofrequency on skin collagen remodeling: a veterinary study.

The aesthetic market offers various radiofrequency treatments for the reduction of wrinkles and rhytids. Even though this not an uncommon aesthetic therapy, there is considerable lack of clinical evidence on the various energy delivery systems available (unipolar, bipolar, tripolar, multipolar, etc.). The purpose of this study was to demonstrate the efficacy of a monopolar radiofrequency device (Exilis Elite, BTL Industries Inc., Boston, MA, USA) on the skin collagen in an animal model. The study treatment was done on the abdominal area of the potbellied Vietnamese mini pigs in the Veterinary Research Institute facility. All pigs were treated once per week for 4 weeks. The treatment area was sized 20 × 10 cm. The surface temperature was kept in the therapeutic interval from 39 °C to 43 °C and the therapy lasted for 10 minutes after reaching the therapeutic temperature. Biopsy samples were taken before the therapy and at the 3-month follow-up. The histology samples were stained and magnified (×400) before computer processing. The collagen volume was calculated using the stereological analysis and the data were statistically processed (using the nonparametric two-sample t-test). The collagen content tissue increased from average of 9.0% before the therapy up to 25.9% after the 3-month follow-up period. The statistical comparison of 54 samples taken before and after the treatment acknowledged the significant difference (p = 0.018). The stereological analysis proved large-scale improvement of collagen in the treated area. We have observed that the monopolar radiofrequency therapy significantly increases collagen remodeling.

Selective radiofrequency therapy as a non-invasive approach for contactless body contouring and circumferential reduction.

In this study, the efficacy of non-contact, selective radiofrequency (RF) were evaluated for body contouring as non-invasive fat and circumferential reduction of the abdomen. 40 healthy (36 female, 4 male) subjects showing significant volume of subcutaneous fat tissue on the abdomen and waistline were included. Once a week for 30 minutes, 4 sessions were performed. The applicator was placed on a supplied spacer covering the treatment area. Maximum power was 200W, which induced heat in the fat and connective tissue layer. The homogeneity of heat distribution and temperature of the skin surface were controlled. The circumferential reduction was measured at the baseline and after the last treatment. The photographs and adverse effects were recorded. Participants completed the self-evaluation questionnaires and rated their level of satisfaction. All subjects tolerated the treatments well. The only side effect was mild to moderate erythema. 35 subjects finished the protocol as planned and 5 subjects dropped off due to events not related to the study. 32 subjects had a 1-13 cm decrease in abdominal circumference and 3 subjects did not show significant response (0-1 cm). Most likely, a very thin fat layer was the reason for lack of response (the non-responding group was the thinnest patient group). No significant differences were found between men and women. The average decrease of 4.93 cm was calculated as a result of circumferential reduction statistical evidence. This study demonstrates that the selective RF system designed for contactless deep tissue heating is a painless, safe, and effective treatment for non-surgical body contouring and circumferential fat reduction.

The frequency of contact allergy in children and adolescents in the Czech Republic.

The objective of our study was to determine the prevalence of contact hypersensitivity in asymptomatic Czech schoolchildren. We recruited 236 Prague asymptomatic schoolchildren for epicutaneous tests. The children were tested with European baseline series (25 allergens). A total of 218 children (114 boys and 104 girls) completed the study. Of these, 67 (30.7%) children had one or more positive reactions to tested allergens. Nickel, neomycin and potassium dichromate were the most prevalent allergens detected in our study. Our findings may support the notion that allergic contact sensitization in children is not so rare and children, especially those with chronic dermatitis, should be patch tested regularly.

Orofacial granulomatosis associated with hypersensitivity to dental amalgam.

Orofacial granulomatosis is a clinicopathologic entity characterized by chronic swelling of the lip and possible soft tissues in the orofacial region owing to granulomatous inflammation of unknown cause. We present 3 cases of orofacial granulomatosis associated with allergic contact dermatitis to dental materials. Previous treatment with corticosteroids did not have any therapeutic effect. Patch testing revealed a positive reaction to several allergens, including dental amalgam and mercury in 2 cases. A lymphocyte transformation test modified for metals was used to evaluate lymphocyte reactivity. After the removal of the suspected allergens, all patients experienced recovery within 1 month, with the exception of the lip swelling, which gradually subsided over several months.

Colophony, a hidden allergen on ECG electrodes in a boy after cardiovascular surgery.

We report on the first case identifying colophony as a hidden allergen in declared acrylate-based conductive and adhesive foam electrodes. This surgery was followed by continuous electrocardiogram monitoring. The patch tests showed strong positive reactions to colophony. The presence of colophony on the electrocardiogram electrodes was not declared, but it was used in the soldering process during manufacture, which deposited a small amount that was sufficient to induce sensitization.

Caustic ulcers caused by cement aqua: report of a case.

Chromium is widely used in various industries including construction sector. Skin contact with cement has been associated with allergic or irritant contact dermatitis. Contact dermatitis is one of the most frequently reported health problems among construction workers. Irritant contact dermatitis from cement ranges from cement burns to cumulative irritant contact dermatitis. Cement burns are rarely reported and are considered a severe form of acute irritant contact dermatitis. They are associated with amateur user working in a short ready-mix time-frame with poor protective measures. They usually result in significant morbidity and initially are associated with minimal discomfort. We report a typical case.