Efectividad, seguridad, calidad de vida y satisfacción de pacientes con psoriasis palmo-plantar tratados con espuma de calcipotriol y betametasona / Effectiveness, safety, quality of life and satisfaction of patients with palmo-plantar psoriasis treated with calcipotriol and betametasone foam

Objetivo: Evaluar la efectividad, la seguridad, la calidad de vida y la satisfacción de pacientes con psoriasis palmo-plantar (PP) no pustulosa tratados con espuma de calcipotriol y betametasona dipropionato (Cal/BD).Material y métodos: Estudio observacional, prospectivo. Se incluyeron pacientes adultos con diagnóstico de psoriasis no controlada con afectación PP para los que estuviera indicado iniciar tratamiento tópico con Cal/BD. Las variables recogidas fueron: demográficas (sexo y edad), antropométricas (índice de masa corporal (IMC)), relacionadas con la patología (Body Surface Area (BSA) categorizado como <10% o bien ≥10%) y relacionadas con el tratamiento (tratamientos farmacológicos previos).Para evaluar la efectividad y la seguridad del tratamiento se empleó el Palmoplantar Psoriasis Area Severity Index (PPASI) y el Physician’s Global Assessment (PGA), y se recogió la incidencia y gravedad de los efectos adversos. Para valorar la calidad de vida se utilizó el Dermatology Life Quality Index (DLQI), así como el Treatment Satisfaction Questionnaire for Medication (TSQM-14) para valorar la satisfacción del paciente con el tratamiento a las 4 semanas. Las variables de efectividad y de calidad de vida se evaluaron al inicio y a las 4 semanas de tratamiento, calculándose la diferencia en términos absolutos entre ambas.Resultados: Se incluyeron 19 pacientes (11 mujeres) con una edad de 59 (RIQ 11,4) años y un IMC de 25,9 (RIQ 6,0) kg/m2, todos ellos con un BSA <10%, previamente pretratados con tratamientos tópicos (74%; 14/19), acitretino (48%; 9/19) e inmunosupresores (26%; 5/19), entre otros. (AU)

Objective: To evaluate effectiveness, safety, quality of life and satisfaction of patients with non-pustular palmo-plantar (PP) psoriasis treated with calcipotriol and betamethasone (Cal/BD) foam.Material and methods: Observational, prospective study. We included adult patients with a diagnosis of uncontrolled PP psoriasis in which topical treatment was indicated. Demographic (sex and age), anthropometric (body mass index (BMI)), related to the pathology (Body Surface Area (BSA) categorized as <10% or ≥10%) and related to the treatment (previous pharmacological treatments) variables were studied. To evaluate effectiveness and safety of the treatment, Palmoplantar Psoriasis Area Severity Index (PPASI) and Physician’s Global Assessment (PGA) were used, and the incidence and severity of the adverse effects were collected. To assess quality of life, Dermatology Life Quality Index (DLQI) was used, as well as Treatment Satisfaction Questionnaire for Medication (TSQM-14) to assess patient satisfaction with treatment at the 4th week. The variables of effectiveness and quality of life were evaluated at the beginning and at 4th week of treatment, calculating the difference in absolute terms between them.Results: We included 19 patients (11 women) with a median of 59 (IQR 11.4) years old and a BMI of 25.9 (IQR 6.0) kg/m2. All the patients showed a BSA <10% and were previously treated with topical treatments (74%; 14/19), acitretin (48%; 9/19) and immunosuppressants (26%; 5/19), among others. (AU)

Persistencia de tratamiento con antagonistas del factor de necrosis tumoral frente a antagonistas de interleucinas en psoriasis moderada-grave / Persistence of treatment with tumor necrosis factor antagonists versus interleukin antagonists in moderate-severe psoriasis

Objetivo: Evaluar y comparar el tiempo de persistencia y analizar los motivos de suspensión con fármacos antagonistas del factor de necrosis tumoral (anti-TNF) frente a antagonistas de interleucinas (anti-IL) en primera línea de tratamiento biológico en pacientes con psoriasis.Material y métodos: Estudio retrospectivo observacional realizado entre 01/2010 y 05/2019. Se incluyeron pacientes adultos diagnosticados de psoriasis moderada-grave en tratamiento con anti-TNF o anti-IL en primera línea de tratamiento biológico. Se estudiaron variables demográficas y relacionadas con el tratamiento, calculándose el tiempo de persistencia con el fármaco de estudio, así como las suspensiones de tratamiento. Resultados: Se incluyeron 94 pacientes (39 mujeres) con una media de 49 años (desviación estándar 13,0), 46 (48,9%) pacientes tratados con anti-TNF (35/46 adalimumab y 11/46 etanercept) y 48 (51,1%) pacientes tratados con anti-IL (26/48 secukinumab, 15/48 ustekinumab y 7/48 ixekizumab). El tiempo de persistencia en primera línea de tratamiento biológico fue de 18,4 (rango intercuartílico (RIQ) 22,2) meses, siendo 9,3 (RIQ 21,7) meses superior en los pacientes tratados con anti-IL (24,7 vs. 15,4 meses; p=0,002). A la finalización del seguimiento el 38,3% (36/94) de la población había interrumpido el tratamiento, debido a: falta de efectividad (34,8% (16/46) anti-TNF vs. 14,6% (7/48) anti-IL; p=0,003), eventos adversos (2,2% (1/46) anti-TNF) y otros motivos (17,4% (8/46) anti-TNF vs. 8,3% (4/48) con anti-IL; p>0,05). Conclusiones: El tiempo de persistencia en primera línea de tratamiento biológico fue de 18,4 meses, siendo significativamente superior en los pacientes tratados con anti-IL. El principal motivo de suspensión fue la falta de efectividad en ambos grupos de tratamiento. (AU)

Objective: To evaluate and compare the time of persistence and to analyse the discontinuation reasons with tumor necrosis factor antagonists (anti-TNF) vs. interleukin antagonists (anti-IL) as first line with biological treatments in patients with psoriasis. Material and methods: Retrospective observational study carried out between 01/2010 and 05/2019. Adult patients diagnosed with moderate to severe psoriasis in treatment with anti-TNF or anti-IL as first line with biological treatments were included. Demographic and treatment-related variables were studied, calculating the time of persistence with the study drug, as well as treatment discontinuations. Results: We included 94 patients (39 women) with a mean of 49 years (standard deviation 13.0), 46 (48.9%) patients treated with anti-TNF (35/46 adalimumab and 11/46 etanercept) and 48 (51.1%) patients treated with anti-IL (26/48 secukinumab, 15/48 ustekinumab and 7/48 ixekizumab). Persistence time with biological treatment in first line was 18.4 (interquartile range (IQR) 22.2) months, being 9.3 (IQR 21.7) months higher in patients treated with anti-IL (24.7 vs. 15.4 months; p=0.002). At the end of the follow-up, 38.3% (36/94) of the population had discontinued their treatments. The reasons for discontinuation were: lack of effectiveness (34.8% (16/46) anti-TNF vs. 14.6% (7/48) anti-IL; p=0.003), side effects (2.2% (1/46) anti-TNF) and other reasons (17.4% (8/46) anti-TNF vs. 8.3% (4/48) anti-IL; p>0.05). Conclusion: The persistence time with biological treatment in first line was 18.4 months, being significantly higher in the anti-IL group. The main reason of discontinuation was lack of effectiveness in both groups of treatment. (AU)

[Effectiveness and safety of Very Low Calory Diets in obese patients]. / Evaluación de la efectividad y seguridad de Dietas de Muy Bajo Contenido Calórico en pacientes obesos.

PURPOSE: To evaluate effectiveness, safety and adherence of Very Low Calory Diet (VLCD) in patients with obesity. METHODS: Observational prospective descriptive study. Patients with BMI >30 kg/m2 who started VLCD were included. We arranged 3 pharmacotherapeutical consultations, picking up the variables: age, sex, BMI, side effects and number of VLCD cycles. We defined effectiveness as weight loss in absolute and relative terms and weight loss rate (kg/week); safety as incidence and severity of side effects by the Pharmacovigilance Spanish System (SEFV); and adherence by a SMAQ adapted questionnaire. RESULTS: 29 women and 15 men were included, with a mean of 42 years. 5 patients did not complete the follow-up. Effectiveness: weight loss average was 7kg (IQR 9,5 a 5,3) and relative of 6,7%, (p < 0.0005). The weight loss rate was 1,2kg per week (IQR 1,6 a 0,9). SAFETY: 33% of the patients described side effects. All of them were mild (37% constipation, 16% dizziness, 12% anxiety, 5% headache, 2% gases y 2% epigastrical pain). ADHERENCE: 84% of the patients were adherent by the SMAQ adapted questionnaire: 74% in the first cycle and 92% in the following ones. The relation between the number of cycles and the adherence did not get statistical differences (p = 0,1127). CONCLUSIONS: Effectiveness and adherence to the treatment could improve in obese patients by setting interdisciplinary measures in the daily clinical practice.

Evaluación de la efectividad y seguridad de Dietas de Muy Bajo Contenido Calórico en pacientes obesos / Efectiveness and safety of very low calory diets in obese patients

Objetivos: Evaluar efectividad, seguridad y adherencia de Dietas de Muy Bajo contenido Calórico (DMBC) en pacientes con obesidad. Método: Estudio descriptivo prospectivo observacional. Se incluyeron pacientes con IMC >30 kg/m2 que inician tratamiento con DMBC. Se realizaron tres consultas farmacéuticas, recogiéndose las variables: edad, sexo, IMC, efectos adversos y número de ciclos de DMBC. Se definió efectividad como la pérdida de peso en términos absolutos y relativos, y la tasa de pérdida de peso kg/semana; seguridad como incidencia y gravedad de efectos adversos según el Sistema Español de Farmaco vigilancia (SEFV); y adherencia a través de un cuestionario SMAQ adaptado. Resultados: Se incluyeron 29 mujeres y 15 hombres; media de 42 años. 5 pacientes no completaron el seguimiento. Efectividad: la mediana de pérdida de peso fue de 7 kg (RIQ 9,5a 5,3) y relativa de 6,7%, (p < 0,0005). La tasa de pérdida de peso kg/semana fue de 1,2 kg (RIQ 1,6 a 0,9). Seguridad: el 33% de los pacientes refirieron efectos adversos. Todos fueron leves (37% estreñimiento, 16% mareos, 12% ansiedad, 5% cefaleas, 2% gases y 2% dolor epigástrico). Adherencia: el 84% de los pacientes fueron adherentes segúnel cuestionario SMAQ adaptado, en 1er ciclo un 74% y un 92%en sucesivos. La relación entre el número de ciclos y la adherencia, no alcanzó diferencias significativas (p = 0,1127). Conclusiones: La efectividad y la adherencia al tratamiento son mejorables a través de la implantación de medidas interdisciplinares de seguimiento activo al paciente obeso en la práctica clínica diaria

Purpose: To evaluate effectiveness, safety and adherence of Very Low Calory Diet (VLCD) in patients with obesity. Methods: Observational prospective descriptive study. Patients with BMI>30 kg/m2 who started VLCD were included. We arranged 3 pharmaco therapeutical consultations, picking up the variables: age, sex, BMI, side effects and number of VLCD cycles. We defined effectiveness as weight loss in absolute and relative terms and weight loss rate (kg/week); safety as incidence and severity of side effects by the Farmaco vigilance Spanish System (SEFV); and adherence by a SMAQ adapted questionnaire. Results: 29 women and 15 men were included, with a mean of 42years. 5 patients did not complete the follow-up. Effectiveness: weight loss average was 7kg (IQR 9,5 a 5,3) and relative of6,7%, (p < 0.0005). The weight loss rate was 1,2kg per week (IQR 1,6 a 0,9).Safety: 33% of the patients described side effects. All of them were mild (37% constipation, 16% dizziness, 12% anxiety, 5% headache,2% gases y 2% epigastrical pain).Adherence: 84% of the patients were adherent by the SMAQ adapted questionnaire: 74% in the first cycle and 92% in the following ones. The relation between the number of cycles and the adherence did not get statistical differences (p = 0,1127). Conclusions: Effectiveness and adherence to the treatment could improve in obese patients by setting interdisciplinary measures in the daily clinical practice (AU)