Effectiveness and safety of guselkumab for the treatment of psoriasis in real-world settings at 24 weeks : A retrospective, observational, multicentre study by the Spanish Psoriasis Group

Altres ajuts: Acord transformatiu CRUE-CSICData on the effectiveness and safety of a drug in real-world clinical practice complement the evidence from clinical trials, which are carried out in a different setting. Little has been published on the effectiveness and safety of guselkumab in the treatment of psoriasis in clinical practice. The ojective of this study was to assess the effectiveness and safety of guselkumab at 24 weeks in patients with moderate to severe plaque psoriasis in routine clinical practice. A retrospective, multicentre study of adult patients with moderate to severe plaque psoriasis treated with guselkumab for at least 24 weeks was carried out in Spain. We studied 343 patients, 249 of whom were followed for 24 weeks. By week 24, the mean (SD) psoriasis area severity index (PASI) had decreased from 11.1 (7.3) to 1.7 (2.8) (−9.3; [−10.2;-8.4]), 85.9% of the patients had achieved PASI score of 4 or less and 77.9% a PASI score of 2 or less. In terms of relative PASI response, 59.4% of the patients achieved a PASI-90 response and 49.0% a PASI-100 response. On multivariate analysis, two factors reduced the probability of a PASI of 2 or less at 24 weeks: a BMI ≥30 (OR, 0.44; 95% CI, 0.22-0.88) and a greater previous exposure to biologic therapy (OR, 0.69; 95% CI, [0.56-0.84]). Adverse events were rare (9.9%) and led to withdrawal from treatment in only nine patients (2.6%) by the end of the follow-up period. The results of this study confirm the high efficacy and safety of guselkumab indicated by the clinical trial data. In clinical practice, the absolute PASI score appears to be a better marker of response to treatment than the relative value

Drug Survival of Interleukin (IL)‑17 and IL‑23 Inhibitors for the Treatment of Psoriasis: A Retrospective Multi‑country, 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

Efectividad y seguridad de los nuevos tratamientos para la psoriasis moderada- grave en la práctica clínica real

Les dades d'efectivitat i seguretat d'un fàrmac a la vida real es consideren essencials per a ponderar els resultats dels assaigs pivotals per a la presa de decisions dels clínics. L'objectiu va ser el de avaluar l'efectivitat i seguretat de nous fàrmacs per al tractament de la psoriasi moderada-greu. Es van realitzar tres estudis multicèntrics, observacionals i retrospectius. El primer d'ells va avaluar l'efectivitat i seguretat d'ustekinumab 90mg en una cohort de pacients amb un pes ≤100kg a les 24 setmanes. Els altres dos van avaluar l'efectivitat i seguretat d'apremilast a les 52 setmanes i de guselkumab a les 24 setmanes. En el primer treball es van incloure 74 pacients. El PASI basal (DE) mig va ser de 7.9 (4.8), 3.3 (3.5) a la setmana 16 i 2.2 (2.4) a la setmana 24. En aquest punt temporal, el 69.7% dels pacients van aconseguir un PASI ≤3, el 56.1% el PASI 75 i el 31.8% el PASI 90. No es van observar diferències significatives segons l' IMC de sobrepès o obesitat (p=0.995). En el grup de pacients que havia estat tractat prèviament amb UST 45 mg amb resposta insuficient, el PASI mig (DE) va ser de 2.7 (2.6) a la setmana 24 i el 63% va aconseguir el PASI ≤3. Respecte a la seguretat, no es van informar esdeveniments adversos (EA) greus. La sèrie de guselkumab va incloure 343 pacients. A les 24 setmanes, el PASI mig va disminuir de 11.1 (7.3) a 1.7(2.8), un 85.9% de pacients va aconseguir el PASI ≤4 i un 77.9% el PASI ≤2. En paràmetres de milloria relativa, un 59.4% dels pacients van aconseguir el PASI 90 i el 49.0% el PASI 100. A l'anàlisi multivariant es va observar que un IMC ≥30 (OR 0.44;95% IC [0.22-0.88]) i una major exposició a teràpia biològica prèvia (OR 0.69; 95% IC [0.56-0.84]) disminueixen la probabilitat d'aconseguir el PASI ≤2 a les 24 setmanes: La presencia d'EA va ser infreqüent (9,9%), sent motiu de suspensió només en 9 pacients (2.6%). La cohort d' apremilast va incloure 292 pacients amb psoriasi en placa i 85 amb psoriasi palmoplantar. El PASI mig basal dels pacients amb psoriasi en placa va ser de 10.7 (7.0), disminuint a 3.0 (4.2) a les 52 setmanes. Als 12 mesos, un 73.6% dels pacients van aconseguir un PASI ≤3. En paràmetres de PASI relatiu, un 49.7 % va aconseguir el PASI 75 i un 26.5% el PASI 90 a la setmana 52. En el grup de psoriasi palmoplantar, el physician global assessment (PPPGA) mig inicial va ser de 4.2 (5.2) i es va reduir a 1.3 (1.3) a les 52 setmanes. La supervivència del fàrmac va ser del 54.9% als 12 mesos. Els principals motius de discontinuació van ser la pèrdua d'eficàcia (23.9%), seguida de la presencia d'EA (15.9%). A la nostra sèrie el 47% dels pacients va presentar algun EA, sent els més freqüents els de tipus gastrointestinal. Els treballs presentats en aquesta tesi representen un reflex encertat, contemporani i en temps real dels resultats de la revolució terapèutica en psoriasi i han estat les series més nombroses per a cadascun dels fàrmacs. Els estudis reflecteixen, per un costat, que l'objectiu terapèutic es diferent a la pràctica clínica dels assaigs clínics, destacant el PASI absolut com a paràmetre d'èxit terapèutic enfront a la millora relativa dels assaigs pivotals i, per un altre costat, que el perfil de pacient de la pràctica clínica diària real es més complex. Respecte a la seguretat dels fàrmacs, la pràctica clínica també reflexa la freqüència dels EA i la tolerabilitat dels diferents tractaments.Los datos de efectividad y seguridad de un fármaco en vida real se consideran esenciales para ponderar los resultados de los ensayos pivotales para la toma de decisiones de los clínicos. El objetivo fue evaluar la efectividad y seguridad de nuevos fármacos para el tratamiento de la psoriasis moderada-grave. Se realizaron tres estudios multicéntricos, observacionales y retrospectivos. El primero evaluó la efectividad y seguridad de ustekinumab (UST) 90mg en una cohorte de pacientes con un peso ≤100kg a las 24 semanas. Los otros dos evaluaron la efectividad y seguridad de apremilast a las 52 semanas y de guselkumab a las 24 semanas. En el primer trabajo se incluyeron 74 pacientes. El PASI basal (DE) medio fue de 7.9 (4.8), 3.3 (3.5) en la semana 16 y 2.2 (2.4) en la semana 24. En este punto temporal, el 69.7% de los pacientes alcanzaron un PASI ≤3, el 56.1% el PASI 75 y el 31.8% el PASI 90. No se observaron diferencias significativas según el IMC de sobrepeso u obesidad (p=0.995). En el grupo de pacientes que había sido tratado previamente con UST 45 mg con respuesta insuficiente, el PASI medio (DE) fue de 2.7 (2.6) en la semana 24 y el 63% alcanzó el PASI ≤3. Respecto a la seguridad, no se informaron acontecimientos adversos (AA) graves. La serie de guselkumab incluyó 343 pacientes. A las 24 semanas, el PASI medio descendió de 11.1 (7.3) a 1.7(2.8), un 85.9% de pacientes alcanzó el PASI ≤4 y un 77.9% el PASI ≤2. En términos de mejoría relativa, un 59.4% de los pacientes alcanzaron el PASI 90 y el 49.0% el PASI 100. En el análisis multivariante se observó que un IMC ≥30 (OR 0.44;95% IC [0.22-0.88]) y una mayor exposición a terapia biológica previa (OR 0.69; 95% IC [0.56-0.84]) disminuyen la probabilidad de alcanzar PASI ≤2 a las 24 semanas:. La presencia de AA fue infrecuente (9,9%), siendo motivo de suspensión únicamente en 9 pacientes (2.6%). La cohorte de apremilast incluyó un total de 292 pacientes con psoriasis en placa y 85 con psoriasis palmoplantar. El PASI medio basal de los pacientes con psoriasis en placa fue de 10.7 (7.0), descendiendo 3.0 (4.2) a las 52 semanas. A los 12 meses, un 73.6% de los pacientes alcanzaron un PASI ≤3. En términos de PASI relativo, un 49.7 % consiguió el PASI 75 y un 26.5% el PASI 90 a la semana 52. En el grupo de psoriasis palmoplantar, el physician global assessment (PPPGA) medio inicial fue de 4.2 (5.2) y se redujo a 1.3 (1.3) a las 52 semanas. La supervivencia del fármaco fue del 54.9% a los 12 meses. Los principales motivos de discontinuación fueron la pérdida de eficacia (23.9%), seguida de la presencia de AA (15.9%). En nuestra serie el 47% de los pacientes presentó algún AA, siendo los más frecuentes los de tipo gastrointestinal. Los trabajos presentados en esta tesis representan un reflejo certero, contemporáneo y en tiempo real de los resultados de la revolución terapéutica en psoriasis y han sido, las series más numerosas para cada uno de los fármacos. Los estudios reflejan, por un lado, que el objetivo de eficacia en la práctica clínica es distinto al de los ECA, destacando el PASI absoluto como parámetro de éxito terapéutico frente a la mejoría relativa de los ensayos pivotales y, por otro lado, que el perfil de paciente de la práctica clínica real es más complejo. Respecto a la seguridad de los fármacos, la práctica clínica también refleja la frecuencia de los AA y la tolerabilidad de los distintos tratamientos.Physicians must evaluate the results of pivotal trials together with real-world data on effectiveness and safety when making clinical decisions. The objective was to evaluate the safety and effectiveness of new drugs for the treatment of moderate to severe psoriasis in clinical practice. The research comprised three retrospective, observational, multicentre studies. The first evaluated the effectiveness and safety of ustekinumab 90 mg at week 24 in a group of patients weighing ≤100kg. The other two evaluated the effectiveness and safety of apremilast at 52 weeks and guselkumab at 24 weeks. The first study analysed data from 74 patients. Mean (SD) score on the Psoriasis Area and Severity Index (PASI) was 7.9 (4.8) at baseline, 3.3 (3.5) at week 16, and 2.2 (2.4) at week 24. By week 24, 69.7% of the patients had an absolute PASI score under 3, 56.1% presented a PASI 75 response (at least 75% reduction from baseline), and 31.8% a PASI 90 response. A body mass index corresponding to overweight or obesity was not associated with any significant differences (p = 0.995). In the group of patients who had presented an inadequate response to prior treatment with UST 45 mg, the mean PASI was 2.7 (2.6) at week 24, and 63% of the patients had a PASI score under 3. Analysis of the safety data did not reveal any serious adverse events (AE). The study of guselkumab analysed data from 343 patients. By week 24, the mean PASI score had fallen from 11.1 (7.3) to 1.7 (2.8); 85.9% of patients had a PASI of 4 or less and 77.9% a PASI of 2 or less. In terms of relative improvement, 59.4% of the patients studied achieved a PASI 90 response and 49.0% a PASI 100 response. On multivariate analysis, a BMI of 30 or less (OR, 0.44; 95% CI, 0.22-0.88) and greater prior exposure to biologic therapy (OR, 0.69; 95% CI, 0.56-0.84) reduced the moderate probability of the patient achieving a PASI score of 2 or less at 24 weeks. AE were rare (9.9%) and had led to withdrawal of treatment in only 9 patients (2.6%) The apremilast cohort included a total of 292 patients with plaque psoriasis and 85 with palmoplantar psoriasis. In the patients with plaque psoriasis, mean PASI was 10.7 (7.0) at baseline decreasing to 3.0 (4.2) at 52 weeks. After 12 months of treatment, 73.6% of the patients had a PASI score of 3 or less. In terms of relative improvement, 49.7% achieved PASI 75 and 26.5% PASI 90 at week 52. In the group with palmoplantar psoriasis, the mean physician global assessment (PGA) score fell from 4.2 (5.2) at baseline to 1.3 (1.3) at week 52. Drug survival was 54.9% at 12 months. The main reasons for discontinuing treatment were loss of efficacy (23.9%) and AE (15.9%). In this series, 47% of the patients experienced AE, with the most common being gastrointestinal effects. The studies reported in this thesis are an accurate, contemporary, and real-time reflection of the results of the revolution in the treatment of psoriasis and represent the largest published series for each of the drugs studied. These studies highlight two fundamental differences between pivotal trials and real-world practice. The first is the use of endpoints reflecting relative clinical improvement in RCTs as against the use of the absolute PASI score to measure treatment outcomes in clinical practice. The second difference is the greater complexity of the patient profile in real-world clinical practice. With respect to safety, analysis of the data from routine clinical practice evidences the frequency of AE and the tolerability of the different treatments

Efectividad y seguridad de los nuevos tratamientos para la psoriasis moderada- grave en la práctica clínica real

Les dades d’efectivitat i seguretat d’un fàrmac a la vida real es consideren essencials per a ponderar els resultats dels assaigs pivotals per a la presa de decisions dels clínics. L’objectiu va ser el de avaluar l’efectivitat i seguretat de nous fàrmacs per al tractament de la psoriasi moderada-greu. Es van realitzar tres estudis multicèntrics, observacionals i retrospectius. El primer d’ells va avaluar l’efectivitat i seguretat d’ustekinumab 90mg en una cohort de pacients amb un pes ≤100kg a les 24 setmanes. Els altres dos van avaluar l’efectivitat i seguretat d’apremilast a les 52 setmanes i de guselkumab a les 24 setmanes. En el primer treball es van incloure 74 pacients. El PASI basal (DE) mig va ser de 7.9 (4.8), 3.3 (3.5) a la setmana 16 i 2.2 (2.4) a la setmana 24. En aquest punt temporal, el 69.7% dels pacients van aconseguir un PASI ≤3, el 56.1% el PASI 75 i el 31.8% el PASI 90. No es van observar diferències significatives segons l’ IMC de sobrepès o obesitat (p=0.995). En el grup de pacients que havia estat tractat prèviament amb UST 45 mg amb resposta insuficient, el PASI mig (DE) va ser de 2.7 (2.6) a la setmana 24 i el 63% va aconseguir el PASI ≤3. Respecte a la seguretat, no es van informar esdeveniments adversos (EA) greus. La sèrie de guselkumab va incloure 343 pacients. A les 24 setmanes, el PASI mig va disminuir de 11.1 (7.3) a 1.7(2.8), un 85.9% de pacients va aconseguir el PASI ≤4 i un 77.9% el PASI ≤2. En paràmetres de milloria relativa, un 59.4% dels pacients van aconseguir el PASI 90 i el 49.0% el PASI 100. A l’anàlisi multivariant es va observar que un IMC ≥30 (OR 0.44;95% IC [0.22-0.88]) i una major exposició a teràpia biològica prèvia (OR 0.69; 95% IC [0.56-0.84]) disminueixen la probabilitat d’aconseguir el PASI ≤2 a les 24 setmanes: La presencia d’EA va ser infreqüent (9,9%), sent motiu de suspensió només en 9 pacients (2.6%). La cohort d’ apremilast va incloure 292 pacients amb psoriasi en placa i 85 amb psoriasi palmoplantar. El PASI mig basal dels pacients amb psoriasi en placa va ser de 10.7 (7.0), disminuint a 3.0 (4.2) a les 52 setmanes. Als 12 mesos, un 73.6% dels pacients van aconseguir un PASI ≤3. En paràmetres de PASI relatiu, un 49.7 % va aconseguir el PASI 75 i un 26.5% el PASI 90 a la setmana 52. En el grup de psoriasi palmoplantar, el physician global assessment (PPPGA) mig inicial va ser de 4.2 (5.2) i es va reduir a 1.3 (1.3) a les 52 setmanes. La supervivència del fàrmac va ser del 54.9% als 12 mesos. Els principals motius de discontinuació van ser la pèrdua d’eficàcia (23.9%), seguida de la presencia d’EA (15.9%). A la nostra sèrie el 47% dels pacients va presentar algun EA, sent els més freqüents els de tipus gastrointestinal. Els treballs presentats en aquesta tesi representen un reflex encertat, contemporani i en temps real dels resultats de la revolució terapèutica en psoriasi i han estat les series més nombroses per a cadascun dels fàrmacs. Els estudis reflecteixen, per un costat, que l’objectiu terapèutic es diferent a la pràctica clínica dels assaigs clínics, destacant el PASI absolut com a paràmetre d’èxit terapèutic enfront a la millora relativa dels assaigs pivotals i, per un altre costat, que el perfil de pacient de la pràctica clínica diària real es més complex. Respecte a la seguretat dels fàrmacs, la pràctica clínica també reflexa la freqüència dels EA i la tolerabilitat dels diferents tractaments.Los datos de efectividad y seguridad de un fármaco en vida real se consideran esenciales para ponderar los resultados de los ensayos pivotales para la toma de decisiones de los clínicos. El objetivo fue evaluar la efectividad y seguridad de nuevos fármacos para el tratamiento de la psoriasis moderada-grave. Se realizaron tres estudios multicéntricos, observacionales y retrospectivos. El primero evaluó la efectividad y seguridad de ustekinumab (UST) 90mg en una cohorte de pacientes con un peso ≤100kg a las 24 semanas. Los otros dos evaluaron la efectividad y seguridad de apremilast a las 52 semanas y de guselkumab a las 24 semanas. En el primer trabajo se incluyeron 74 pacientes. El PASI basal (DE) medio fue de 7.9 (4.8), 3.3 (3.5) en la semana 16 y 2.2 (2.4) en la semana 24. En este punto temporal, el 69.7% de los pacientes alcanzaron un PASI ≤3, el 56.1% el PASI 75 y el 31.8% el PASI 90. No se observaron diferencias significativas según el IMC de sobrepeso u obesidad (p=0.995). En el grupo de pacientes que había sido tratado previamente con UST 45 mg con respuesta insuficiente, el PASI medio (DE) fue de 2.7 (2.6) en la semana 24 y el 63% alcanzó el PASI ≤3. Respecto a la seguridad, no se informaron acontecimientos adversos (AA) graves. La serie de guselkumab incluyó 343 pacientes. A las 24 semanas, el PASI medio descendió de 11.1 (7.3) a 1.7(2.8), un 85.9% de pacientes alcanzó el PASI ≤4 y un 77.9% el PASI ≤2. En términos de mejoría relativa, un 59.4% de los pacientes alcanzaron el PASI 90 y el 49.0% el PASI 100. En el análisis multivariante se observó que un IMC ≥30 (OR 0.44;95% IC [0.22-0.88]) y una mayor exposición a terapia biológica previa (OR 0.69; 95% IC [0.56-0.84]) disminuyen la probabilidad de alcanzar PASI ≤2 a las 24 semanas:. La presencia de AA fue infrecuente (9,9%), siendo motivo de suspensión únicamente en 9 pacientes (2.6%). La cohorte de apremilast incluyó un total de 292 pacientes con psoriasis en placa y 85 con psoriasis palmoplantar. El PASI medio basal de los pacientes con psoriasis en placa fue de 10.7 (7.0), descendiendo 3.0 (4.2) a las 52 semanas. A los 12 meses, un 73.6% de los pacientes alcanzaron un PASI ≤3. En términos de PASI relativo, un 49.7 % consiguió el PASI 75 y un 26.5% el PASI 90 a la semana 52. En el grupo de psoriasis palmoplantar, el physician global assessment (PPPGA) medio inicial fue de 4.2 (5.2) y se redujo a 1.3 (1.3) a las 52 semanas. La supervivencia del fármaco fue del 54.9% a los 12 meses. Los principales motivos de discontinuación fueron la pérdida de eficacia (23.9%), seguida de la presencia de AA (15.9%). En nuestra serie el 47% de los pacientes presentó algún AA, siendo los más frecuentes los de tipo gastrointestinal. Los trabajos presentados en esta tesis representan un reflejo certero, contemporáneo y en tiempo real de los resultados de la revolución terapéutica en psoriasis y han sido, las series más numerosas para cada uno de los fármacos. Los estudios reflejan, por un lado, que el objetivo de eficacia en la práctica clínica es distinto al de los ECA, destacando el PASI absoluto como parámetro de éxito terapéutico frente a la mejoría relativa de los ensayos pivotales y, por otro lado, que el perfil de paciente de la práctica clínica real es más complejo. Respecto a la seguridad de los fármacos, la práctica clínica también refleja la frecuencia de los AA y la tolerabilidad de los distintos tratamientos.Physicians must evaluate the results of pivotal trials together with real-world data on effectiveness and safety when making clinical decisions. The objective was to evaluate the safety and effectiveness of new drugs for the treatment of moderate to severe psoriasis in clinical practice. The research comprised three retrospective, observational, multicentre studies. The first evaluated the effectiveness and safety of ustekinumab 90 mg at week 24 in a group of patients weighing ≤100kg. The other two evaluated the effectiveness and safety of apremilast at 52 weeks and guselkumab at 24 weeks. The first study analysed data from 74 patients. Mean (SD) score on the Psoriasis Area and Severity Index (PASI) was 7.9 (4.8) at baseline, 3.3 (3.5) at week 16, and 2.2 (2.4) at week 24. By week 24, 69.7% of the patients had an absolute PASI score under 3, 56.1% presented a PASI 75 response (at least 75% reduction from baseline), and 31.8% a PASI 90 response. A body mass index corresponding to overweight or obesity was not associated with any significant differences (p = 0.995). In the group of patients who had presented an inadequate response to prior treatment with UST 45 mg, the mean PASI was 2.7 (2.6) at week 24, and 63% of the patients had a PASI score under 3. Analysis of the safety data did not reveal any serious adverse events (AE). The study of guselkumab analysed data from 343 patients. By week 24, the mean PASI score had fallen from 11.1 (7.3) to 1.7 (2.8); 85.9% of patients had a PASI of 4 or less and 77.9% a PASI of 2 or less. In terms of relative improvement, 59.4% of the patients studied achieved a PASI 90 response and 49.0% a PASI 100 response. On multivariate analysis, a BMI of 30 or less (OR, 0.44; 95% CI, 0.22-0.88) and greater prior exposure to biologic therapy (OR, 0.69; 95% CI, 0.56-0.84) reduced the moderate probability of the patient achieving a PASI score of 2 or less at 24 weeks. AE were rare (9.9%) and had led to withdrawal of treatment in only 9 patients (2.6%) The apremilast cohort included a total of 292 patients with plaque psoriasis and 85 with palmoplantar psoriasis. In the patients with plaque psoriasis, mean PASI was 10.7 (7.0) at baseline decreasing to 3.0 (4.2) at 52 weeks. After 12 months of treatment, 73.6% of the patients had a PASI score of 3 or less. In terms of relative improvement, 49.7% achieved PASI 75 and 26.5% PASI 90 at week 52. In the group with palmoplantar psoriasis, the mean physician global assessment (PGA) score fell from 4.2 (5.2) at baseline to 1.3 (1.3) at week 52. Drug survival was 54.9% at 12 months. The main reasons for discontinuing treatment were loss of efficacy (23.9%) and AE (15.9%). In this series, 47% of the patients experienced AE, with the most common being gastrointestinal effects. The studies reported in this thesis are an accurate, contemporary, and real-time reflection of the results of the revolution in the treatment of psoriasis and represent the largest published series for each of the drugs studied. These studies highlight two fundamental differences between pivotal trials and real-world practice. The first is the use of endpoints reflecting relative clinical improvement in RCTs as against the use of the absolute PASI score to measure treatment outcomes in clinical practice. The second difference is the greater complexity of the patient profile in real-world clinical practice. With respect to safety, analysis of the data from routine clinical practice evidences the frequency of AE and the tolerability of the different treatments.Universitat Autònoma de Barcelona. Programa de Doctorat en Medicin

Erythematous asymptomatic nodule on the sole

A 75-year-old man presented to the dermatology clinic with an asymptomatic lesion on his right plantar surface. The lesion had progressively grown for two months. Physical examination revealed an erythematous and slightly scaly nodule measuring 10x10 mm. Dermoscopy examination showed central diffuse erythema with small red globules. A punch-biopsy revealed a proliferation of irregularly branched small vessels with collapsed lumen, extending in an infiltrative pattern in the superficial and deep dermis. Although this is a rare location, a diagnosis of microvenular hemangioma was made

Alopecic and aseptic nodules of the scalp with trichoscopic and ultrasonographic findings

Alopecic and aseptic nodules of the scalp (AANS) is a rare entity, etiology of which is already unknown. It consists of a few dome-shaped, skin-colored nodules associated with nonscarring alopecia. They are usually located in the upper part of the occiput and surrounded by normal scalp. Most of the times, a biopsy is performed to make an accurate diagnosis. AANS have a good prognosis and even can resolve spontaneously. We present a new case of this entity with the description of trichoscopic and ultrasonographic findings that have recently been reported. These noninvasive techniques are useful for the diagnosis and could replace histological examination in the near future

Practical Update of the Guidelines Published by the Psoriasis Group of the Spanish Academy of Dermatology and Venereology (GPs) on the Treatment of Psoriasis With Biologic Agents : Part 2 - Management of Special Populations, Patients With Comorbid Conditions, and Risk Actualización práctica de las recomendaciones del Grupo de Psoriasis de la Academia Española de Dermatología y Venereología (GPS) para el tratamiento de la psoriasis con terapia biológica. Parte 2 «Manejo de poblaciones especiales, pacientes con comorbilidad y gestión del riesgo»

Background and objectives: Since its inception, the Psoriasis Group (GPs) of the Spanish Academy of Dermatology and Venereology (AEDV) has worked to continuously update recommendations for the treatment of psoriasis based on the best available evidence and incorporating proposals arising from and aimed at clinical practice. An updated GPs consensus document on the treatment of moderate to severe psoriasis was needed because of changes in the treatment paradigm and the approval in recent years of a large number of new biologic agents. Methodology: The consensus document was developed using the nominal group technique complemented by a scoping review. First, a designated coordinator selected a group of GPs members for the panel based on their experience and knowledge of psoriasis. The coordinator defined the objectives and key points for the document and, with the help of a documentalist, conducted a scoping review of articles in Medline, Embase, and the Cochrane Library up to January 2021. The review included systematic reviews and meta-analyses as well as clinical trials not included in those studies and high-quality real-world studies. National and international clinical practice guidelines and consensus documents on the management of moderate to severe psoriasis were also reviewed. The coordinator then drew up a set of proposed recommendations, which were discussed and modified in a nominal group meeting. After several review processes, including external review by other GPs members, the final document was drafted. Results: The present guidelines include updated recommendations on assessing the severity of psoriasis and criteria for the indication of systemic treatment. They also include general principles for the treatment of patients with moderate to severe psoriasis and define treatment goals for these patients as well as criteria for the indication and selection of initial and subsequent therapies Practical issues, such as treatment failure and maintenance of response, are also addressed