Current treatment goals are achieved by the majority of patients with atopic dermatitis treated with tralokinumab: results from a multicentric, multinational, retrospective, cohort study

Background: Tralokinumab is a human monoclonal antibody targeting interleukin-13 that is approved for the treatment of moderate-severe atopic dermatitis. Studies analyzing the efficacy and safety of tralokinumab in a real-world setting are scarce. Research design and methods: A European, multicentric, real-world, retrospective cohort study was defined to assess the effectiveness and safeness profile of tralokinumab, investigating the achievement of pre-specified treatment goals; and to detect potential differences in terms of effectiveness and safeness across some selected patient subcohorts. Results: A total of 194 adult patients were included in this study. A significant improvement in physician-assessed disease severity was detected at each follow-up visit as compared with baseline and similar trend was observed for patient-reported outcomes and quality of life. No meaningful difference in effectiveness was found when considering patient age (<65 versus ≥65 years), neither dissecting patient cohort in dupilumab-naive vs dupilumab-treated subjects. Among tralokinumabtreated patients, 88% achieved at least one currently identified real-world therapeutic goal at week 16. Conclusions: This retrospective multicenter study confirmed the effectiveness and safeness of tralokinumab throughout 32 weeks of observation, showing the achievement of therapeutic goals identified in both trial and real-world settings in a large proportion of tralokinumab-treated patients

Drug Survival of IL-12/23, IL-17 and IL-23 Inhibitors for Psoriasis Treatment: A Retrospective Multi-Country, Multicentric Cohort Study

Background: Drug survival analysis of biologic agents in psoriasis is of extreme importance, as it allows not only the evaluation of objective clinical outcomes (such as effectiveness and safety) but also of factors that are associated with patients’ adherence to treatment. The aim of this study was to evaluate and compare the drug survival of the most recent biologic agents approved for the treatment of moderate-to-severe psoriasis—ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, and risankizumab—and to identify clinical predictors that can influence the drug survival of these drugs. Methods: This retrospective multicentric cohort study from 16 dermatology centers in Portugal, Spain, Italy, Switzerland, Czech Republic, Canada, and the United States included patients that started IL-12/23, IL-17 (IL-17A and IL-17R) and IL-23 inhibitors for the treatment of psoriasis between January 1, 2012 and December 31, 2019. Survival analysis was performed using a Kaplan-Meier estimator, to obtain descriptive survival curves, and proportional hazard Cox regression models. Results: A total of 3312 treatment courses (total patients: 3145) were included in the study; 1118 (33.8%) with an IL-12/23 inhibitor (ustekinumab), 1678 (50.7%) with an IL-17 inhibitor [911 (27.5%) on secukinumab, 651 (19.7%) on ixekizumab, 116 (3.5%) on brodalumab], and 516 (15.5%) with an IL-23 inhibitor [398 (12.0%) on guselkumab, 118 (3.5%) on risankizumab]. At 18 months, the cumulative probability of survival was 96.4% for risankizumab, 91.1% for guselkumab, 86.3% for brodalumab, 86.1% for ustekinumab, 82.0% for ixekizumab, and 79.9% for secukinumab. Using ustekinumab as reference, drug survival of guselkumab was higher (HR 0.609; 95% CI 0.418–0.887) and that of secukinumab was lower (HR 1.490; 95% CI 1.257–1.766). In the final multivariable model, secukinumab, female sex, higher BMI, and prior exposure to biologic agents significantly increased the risk of drug discontinuation, whereas risankizumab was protective. Conclusion: In this multinational cohort with 8439 patient-years of follow-up, the cumulative probability of drug survival for all drugs was >79% at 18 months. Prescribed biologic, female sex, higher BMI, and previous exposure to biologic agents were predictors of drug discontinuation. Drug survival of guselkumab and risankizumab was higher than that of ustekinumab, and secukinumab was lower

Klinische Ergebnisse zur Anwendung eines Hämoglobin-Sprays zur Förderung der Heilung chronischer Wunden

A new technological approach for supplying hypoxic chronic wounds with oxygen is a moist wound treatment with aqueous solutions containing tissue compatible oxygen binders. This facilitates diffusion of oxygen, necessary for the healing process, from the surroundings (room air through an open-porous wound padding) into the ulcerous tissue. A product that is still in development is a spray which contains hemoglobin obtained from domestic pigs. Clinical investigations (a clinical trial, treatment observations and single patient uses) are presented, which were performed to create clinical data regarding efficiency and safety of this product. All data have shown that the application of the hemoglobin spray promoted wound healing in all analyzed cases.Data from a clinical study in Mexico and subsequent therapy observations revealed that in 39 out of 42 patients (93%) the treated wounds were healed. 9 patients from a series of therapy observations in Monterrey (Mexico) showed similar observations. All treated wounds were closed. Single patient uses carried out in Witten (Germany; 6 wounds from 8 (75%)) and Prague (Czech Republic; 5 wounds from 5 (100%) were healed) further support these results: The application of hemoglobin spray can promote healing of chronic wounds. Within the framework of the clinical investigation, the treatment observations, and the individual healing experiments the hemoglobin spray was applied more than 2,000 times onto chronic wounds of 82 patients. In all cases, the spray was well tolerated and there were no adverse event that might have been an adverse reaction to the hemoglobin spray.Ein neuer technologischer Ansatz zur Versorgung hypoxischer chronischer Wunden mit dem zur Heilung benötigten Sauerstoff ist eine feuchte Wundbehandlung mit wässrigen Lösungen, in denen gut gewebeverträgliche Sauerstoff-Binder eine erleichterte Diffusion von Sauerstoff aus der Umgebung (Raumluft aus einer offenporigen Wundauflage) zum Ulcus-Gewebe ermöglichen. Ein Produkt in Entwicklung enthält als Sauerstoff-Binder Hämoglobin vom Hausschwein (Hämoglobin-Spray).Klinische Untersuchungen (eine klinische Studie, Therapiebeobachtungen und individuelle Heilversuche) werden präsentiert, aus denen sich klinische Daten zur Wirksamkeit und Unbedenklichkeit ergeben.Alle durchgeführten Anwendungen des Hämoglobin-Spray ergaben, dass die Wundheilung gefördert wurde. In einer klinischen Studie und einer unmittelbar nachfolgenden Serie von Therapiebeobachtungen konnten bei 39 von 42 Patienten (93%) die behandelten Wunden komplett geheilt werden. In gleicher Weise wurden die Wunden von 9 Patienten einer weiteren Serie von Therapiebeobachtungen in Monterrey (Mexiko) bis zur Abheilung behandelt. Individuelle Heilversuche in Witten (Deutschland; 6 von 8 Wunden (75%) abgeheilt) und in Prag (Tschechische Republik; 5 von 5 Wunden (100%) geheilt) bestätigen diese Ergebnisse: Anwendungen des Hämoglobin-Sprays können die Heilung chronischer Wunden fördern.Dabei wurden die Anwendungen des Hämoglobin-Spray ausnahmslos gut vertragen, sämtliche beobachteten unerwünschten Ereignisse während der Anwendungen hatten andere Ursachen. Im Rahmen der klinischen Studie, der Therapiebeobachtungen und der individuellen Heilversuche wurde das Hämoglobin-Spray über 2.000-mal in den chronischen Wunden von 82 Patienten angewendet. Es wurde durchgehend gut vertragen, und es gab keine unerwünschten Ereignisse, die verdächtig waren, möglicherweise unerwünschte Reaktionen auf das Hämoglobin-Spray zu sein

Klinische Ergebnisse zur Anwendung eines Hämoglobin-Sprays zur Förderung der Heilung chronischer Wunden

A new technological approach for supplying hypoxic chronic wounds with oxygen is a moist wound treatment with aqueous solutions containing tissue compatible oxygen binders. This facilitates diffusion of oxygen, necessary for the healing process, from the surroundings (room air through an open-porous wound padding) into the ulcerous tissue. A product that is still in development is a spray which contains hemoglobin obtained from domestic pigs. Clinical investigations (a clinical trial, treatment observations and single patient uses) are presented, which were performed to create clinical data regarding efficiency and safety of this product. All data have shown that the application of the hemoglobin spray promoted wound healing in all analyzed cases.Data from a clinical study in Mexico and subsequent therapy observations revealed that in 39 out of 42 patients (93%) the treated wounds were healed. 9 patients from a series of therapy observations in Monterrey (Mexico) showed similar observations. All treated wounds were closed. Single patient uses carried out in Witten (Germany; 6 wounds from 8 (75%)) and Prague (Czech Republic; 5 wounds from 5 (100%) were healed) further support these results: The application of hemoglobin spray can promote healing of chronic wounds. Within the framework of the clinical investigation, the treatment observations, and the individual healing experiments the hemoglobin spray was applied more than 2,000 times onto chronic wounds of 82 patients. In all cases, the spray was well tolerated and there were no adverse event that might have been an adverse reaction to the hemoglobin spray.Ein neuer technologischer Ansatz zur Versorgung hypoxischer chronischer Wunden mit dem zur Heilung benötigten Sauerstoff ist eine feuchte Wundbehandlung mit wässrigen Lösungen, in denen gut gewebeverträgliche Sauerstoff-Binder eine erleichterte Diffusion von Sauerstoff aus der Umgebung (Raumluft aus einer offenporigen Wundauflage) zum Ulcus-Gewebe ermöglichen. Ein Produkt in Entwicklung enthält als Sauerstoff-Binder Hämoglobin vom Hausschwein (Hämoglobin-Spray).Klinische Untersuchungen (eine klinische Studie, Therapiebeobachtungen und individuelle Heilversuche) werden präsentiert, aus denen sich klinische Daten zur Wirksamkeit und Unbedenklichkeit ergeben.Alle durchgeführten Anwendungen des Hämoglobin-Spray ergaben, dass die Wundheilung gefördert wurde. In einer klinischen Studie und einer unmittelbar nachfolgenden Serie von Therapiebeobachtungen konnten bei 39 von 42 Patienten (93%) die behandelten Wunden komplett geheilt werden. In gleicher Weise wurden die Wunden von 9 Patienten einer weiteren Serie von Therapiebeobachtungen in Monterrey (Mexiko) bis zur Abheilung behandelt. Individuelle Heilversuche in Witten (Deutschland; 6 von 8 Wunden (75%) abgeheilt) und in Prag (Tschechische Republik; 5 von 5 Wunden (100%) geheilt) bestätigen diese Ergebnisse: Anwendungen des Hämoglobin-Sprays können die Heilung chronischer Wunden fördern.Dabei wurden die Anwendungen des Hämoglobin-Spray ausnahmslos gut vertragen, sämtliche beobachteten unerwünschten Ereignisse während der Anwendungen hatten andere Ursachen. Im Rahmen der klinischen Studie, der Therapiebeobachtungen und der individuellen Heilversuche wurde das Hämoglobin-Spray über 2.000-mal in den chronischen Wunden von 82 Patienten angewendet. Es wurde durchgehend gut vertragen, und es gab keine unerwünschten Ereignisse, die verdächtig waren, möglicherweise unerwünschte Reaktionen auf das Hämoglobin-Spray zu sein

Biologics combined with conventional systemic agents or phototherapy for the treatment of psoriasis: real-life data from PSONET registries.

BACKGROUND Biologics have greatly improved psoriasis management. However, primary and secondary non-response to treatment requires innovative strategies to optimize outcomes. OBJECTIVE To describe the use of combined treatment of biologics with conventional systemic agents or phototherapy in daily clinical practice. METHODS We collected data on frequency of use, demographics, treatment characteristics and drug survival of biologics combined with conventional systemic agents or phototherapy in five PSONET registries. RESULTS Of 9922 biologic treatment cycles, 982 (9.9%) were identified as combination treatment. 72.9% of treatment cycles concerned concomitant use of methotrexate, 25.3% concerned concomitant UVB therapy, acitretin or cyclosporin and 1.8% concerned combined treatment with PUVA, fumaric acids or a second biologic. Substantial variation was detected in type and frequency of combination treatments prescribed across registries. Patients initiated on combined treatment had generally severe disease and were affected with psoriasis for many years. The extent to which patients had been priory treated with biologic monotherapy and the proportion of patients affected with psoriatic arthritis differed between registries. Survival rates for etanercept, adalimumab, infliximab and ustekinumab with methotrexate ranged between 43 and 92%, 28 and 83%, 65 and 87% and 53 and 77%, respectively, across registries after one year with no consistent superior survival for a particular biologic. Longest survival on a biologic combined with methotrexate, acitretin or cyclosporin was 103, 78 and 34 months, respectively. CONCLUSION Methotrexate was the most commonly used concomitant treatment for patients on a biologic. Wide geographical variations in treatment selection and persistence of combination treatment exist. Data derived from ongoing studies may help to determine whether combined treatment is superior to biologic monotherapy