Optimising the Therapeutic Interval for Biologics in Patients with Psoriasis

In our clinical experience, more than half of patients do not present a complete response to biologic drugs, or drug loses its efficacy over time. Plasma determinations of drug and antidrug antibodies levels are an objective tool for optimisation in these patients; however, established therapeutic ranges are not suitable, so the objective of this study was to study these patients and optimise their healthcare. We have made a retrospective, observational study, using data of plasma levels of drugs and anti-drugs antibodies of infliximab, adalimumab or Etanercept, we summarise all data and make a study of sensitivity, specificity, positive and negative predictive value on current therapeutic ranges. We have found a statistically significant association between subtherapeutic levels and therapeutic failure in psoriasis treated with infliximab and adalimumab. New ranges were found with higher sensitivity than the established ones, we propose 2–10 g/mL therapeutic range for infliximab, 3–11 g/mL for adalimumab, and 1–7 g/mL for etanercept. In conclusion, levels of drug and anti-drug antibodies are a decisive tool for predicting therapeutic response. The current therapeutic ranges may have minimum values that are excessively high, owing to which lowering them significantly increases the sensitivity of the test in all cases, and negative predictive value in the case of etanercept. Further prospective studies are needed to prove the usefulness of these new ranges.9 página

Análisis de seguridad de dupilumab en práctica clínica real. Experiencia a 52 semanas de cinco centros de referencia en Andalucía

Dupilumab es un fármaco biológico que bloquea el receptor de las interleucinas IL-4 e IL-13, y que ha demostrado su eficacia en el tratamiento de la dermatitis atópica (DA) grave1, 2, 3. Si bien los resultados de dupilumab en la práctica clínica real son limitados, nuestra propia experiencia ha demostrado un comportamiento semejante al obtenido en los ensayos clínicos previos4, 5. Por el contrario, otros investigadores han observado una incidencia mayor de efectos adversos (EA), principalmente alteraciones oculares y una eosinofilia transitoria6. Debido a esta discordancia y al tratarse de un mecanismo de acción totalmente novedoso, creemos conveniente profundizar en el perfil de seguridad resultante del bloqueo de esta vía inmunológica

104-week safety and effectiveness of dupilumab in the treatment of severe atopic dermatitis. The experience of 5 reference dermatology units in Spain

Atopic Dermatitis (AD) is a multifactorial disease resulting from the interaction of genetic predisposition, environmental triggers, disruption of skin barrier function, and type 2 immune dysregulation. Management of mild forms of AD includes the use of emollients, topical corticosteroids or calcineurin inhibitors, and phototherapy, while systemic immunosuppressive agents such as oral corticosteroids and Cyclosporine A (CsA) are reserved for severe refractory cases.1 Nevertheless, severe cases are usually not adequately controlled with any of these therapies, requiring a further step to reach clinical control.2 Recently, FDA and EMA have authorized Dupilumab, a treatment targeting Th2 cytokines Il-4 and Il-13 which has shown to be effective to control the signs and symptoms of AD. Real-world experience with Dupilumab shows a similar effectivity as compared to randomized clinical trials, but it is yet to know how this drug will perform in the long term in routine medical practic

Omalizumab: what benefits should we expect?

Chronic spontaneous urticaria (CSU) is a skin disease characterised by wheal appearance, swelling, itching, and painful skin. Omalizumab has been used for CSU treatment demonstrating good efficacy. To investigate the efficacy and safety of omalizumab treatment in CSU patients in real-life practice. A retrospective analysis was performed on 38 patients suffering from CSU who received 300 mg of omalizumab every four weeks. After omalizumab treatment, 68.4% of patients showed a complete response (UAS7 = 0). All the patients were able to stop treatment with corticosteroids, cyclosporine, and anti-leukotrienes, and only 39.5% of patients remained on anti-histamines. Omalizumab treatment led to a 96% and 65% decrease in emergency room and primary health care visits, respectively, as well as a reduction in the direct costs associated with the disease. No omalizumab-related adverse events were reported. Omalizumab exhibits good efficacy in alleviating the symptoms of CSU, leads to a decrease in concomitant medication use, restores patients' quality of life, and has economic benefits by reducing disease-related health care costs

Fifty-two week follow-up safety and effectiveness results of dupilumab treatment of moderate-to-severe atopic dermatitis from a retrospective, multicentric series

Atopic dermatitis (AD) is a chronic, systemic disease that has a multifactorial etiology, where immune system disorders and epidermal barrier dysfunction are added to the influence of genetic and environmental factors. Dupilumab has been approved by United States and the European Union regulatory agencies in 2017 for the treatment of moderate‐to‐severe AD in adult patients who are candidates for systemic treatment. In this short report, we present a retrospective, multicentric study, in which five hospitals in Andalusia, Spain, have taken part. Our objective is to evaluate the safety and effectiveness of dupilumab in patients with moderate‐to‐severe AD treated with dupilumab with at least 52 weeks of follow‐up

Atopic Dermatitis: Background, Objectives and Future Perspectives (Superresponders).

In this Special Issue entitled Atopic Dermatitis: New Perspectives, we have tried to collect research of special interest related mainly to the incorporation of pathophysiological aspects and therapeutic novelties in this regard [...]

Guselkumab as a switching strategy after anti-TNFα, anti-IL17, or anti-IL12/23 therapies in moderate-to-severe psoriasis.

The IL23/Th17 axis plays a strategic role in psoriasis (PSO). Guselkumab (GUS) is a selective inhibitor of the IL23p19 subunit. Its introduction has managed to increase the levels of efficacy, safety and survival in PSO. In real clinical practice, patients can loss effectiveness or suffered adverse events that forces a change in their treatments. There is scarce evidence of the effectiveness, safety, and survival of GUS in real clinical practice after anti-TNFα, anti-IL17, and/or anti-IL12/23. This is multicenter, observational and retrospective study of real clinical practice includes patients with moderate-to-severe plaque PSO in treatment with GUS. The objective of the study was to evaluate the effectiveness of GUS after anti-TNFα, anti-IL17, and anti-IL12/23. The study includes clinical information from February 2019 to February 2022. PASI, BSA, Pruritus, DLQI, survival, and safety were evaluated up to 76 weeks. Analyses were performed "as observed" using GraphPad Prism version 8.3.0 for Windows. A total of 103 patients were included in the analysis. At baseline there were significant differences between the anti-TNF, anti-IL17, and anti-IL12/23 groups for (1) dyslipidemia; (2) number of previous biological treatments and (3) PASI, BSA, VAS Pruritus, and DLQI scores. The effectiveness of GUS in terms of PASI, BSA, Pruritus, and DLQI was not impacted by previous biological alternatives. Treatment survival including discontinuations due to lack of effectiveness or safety reasons was 100%, 92.7%, and 92.1% for anti-TNFα, anti-IL17, and anti-IL12/23, respectively, at 130 weeks. No differences were found between groups. One adverse event was reported in the anti-LI12/23 group. The mid-term effectiveness, safety and survival of GUS if not impacted by previous biological therapy as anti-TNFα, anti-IL17, and/or anti-IL12/23. Our results indicate that GUS could be a switching strategy in patients who fail or present AE to other biological alternatives in moderate-to-severe PSO

Determining the Value of Two Biologic Drugs for Chronic Inflammatory Skin Diseases: Results of a Multi-Criteria Decision Analysis.

Multi-criteria decision analysis (MCDA) is a tool that systematically considers multiple factors relevant to health decision-making. The aim of this study was to use an MCDA to assess the value of dupilumab for severe atopic dermatitis compared with secukinumab for moderate to severe plaque psoriasis in Spain. Following the EVIDEM (Evidence and Value: Impact on DEcision Making) methodology, the estimated value of both interventions was obtained by means of an additive linear model that combined the individual weighting (between 1 and 5) of each criterion with the individual scoring of each intervention in each criterion. Dupilumab was evaluated against placebo, while secukinumab was evaluated against placebo, etanercept and ustekinumab. A retest was performed to assess the reproducibility of weights, scores and value estimates. The overall MCDA value estimate for dupilumab versus placebo was 0.51 ± 0.14. This value was higher than those obtained for secukinumab: 0.48 ± 0.15 versus placebo, 0.45 ± 0.15 versus etanercept and 0.39 ± 0.18 versus ustekinumab. The highest-value contribution was reported by the patients' group, followed by the clinical professionals and the decision makers. A fundamental element that explained the difference in the scoring between pathologies was the availability of therapeutic alternatives. The retest confirmed the consistency and replicability of the analysis. Under this methodology, and assuming similar economic costs per patient for both treatments, the results indicated that the overall value estimated of dupilumab for severe atopic dermatitis was similar to, or slightly higher than, that of secukinumab for moderate to severe plaque psoriasis

Drug survival of systemic and biological treatments for moderate-to-severe atopic dermatitis in adults: a multicentre retrospective observational study

Drug survival is a real-life reflection of drug per-formance in routine medical practice and measures thepatient’s persistence under a given treatment. Survival of sys-temic treatment of atopic dermatitis (AD) in routine clinicalpractice has been evaluated in previous analyses.1–3Recently,dupilumab, a fully human monoclonal antibody that targetsthe interleukin-4 receptor a, has been approved for the treat-ment of moderate-to-severe AD. Although its efficacy andeffectiveness have been reported in previous clinical trials4andreal-world evidence publications,5,6the drug survival analysesof dupilumab have, to date, been limite

Revisión de las últimas novedades en el manejo del paciente con urticaria crónica: Consenso multidisciplinar de la comunidad autónoma de Andalucía

[EN]: Chronic urticaria is a difficult-to-treat skin disorder that has a major impact on patient quality of life. The latest update of the European guideline on the management of urticaria was published in 2018. In this consensus statement, produced in the autonomous community of Andalusia, Spain, we describe a multidisciplinary approach for applying the new treatment algorithm proposed by the European guideline in our region.[ES]: La urticaria crónica es una enfermedad de la piel difícil de tratar que presenta un alto impacto negativo en la calidad de vida de los pacientes. La última actualización de la guía europea para el manejo del paciente con urticaria se publicó en 2018. Con el actual contexto, presentamos un enfoque multidisciplinar para la aplicación del nuevo algoritmo de tratamiento propuesto por la guía en el territorio español, más concretamente, en la comunidad autónoma de Andalucía