Background
Little has been published on the real‐world effectiveness and safety of apremilast in psoriasis.
Objectives
To evaluate the effectiveness, safety and drug survival of apremilast at ...52 weeks in patients with moderate to severe plaque psoriasis or palmoplantar psoriasis in routine clinical practice.
Methods
Retrospective, multicentre study of adult patients with moderate to severe plaque psoriasis or palmoplantar psoriasis treated with apremilast from March 2016 to March 2018.
Results
We studied 292 patients with plaque psoriasis and 85 patients with palmoplantar psoriasis. The mean (SD) Psoriasis Area and Severity Index (PASI) score was 10.7 (7.0) at baseline and 3.0 (4.2) at 52 weeks. After 12 months of treatment, 73.6% of patients had a PASI score of 3 or less. In terms of relative improvement by week 52, 49.7% of patients achieved PASI‐75 (≥75% reduction in PASI score) and 26.5% achieved PASI‐90. The mean physician global assessment score for palmoplantar psoriasis fell from 4.2 (5.2) at baseline to 1.3 (1.3) at week 52. Overall drug survival after 1 year of treatment with apremilast was 54.9 %. The main reasons for treatment discontinuation were loss of efficacy (23.9%) and adverse events (15.9%). Almost half of the patients in our series (47%) experienced at least one adverse event. The most common events were gastrointestinal problems.
Conclusions
Apremilast may be a suitable alternative for the treatment of moderate to severe psoriasis and palmoplantar psoriasis. Although the drug has a good safety profile, adverse gastrointestinal effects are common.
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PRP is a rare entity of unknown etiopathogenesis. Lack of management guidelines makes it a challenge for clinicians.
To add our experience to increase evidence about PRP.
We performed ...a retrospective, descriptive and multicentric study of 65 patients with PRP, being the largest European case series of patients with PRP.
PRP was more frequent in male patients with an average age of 51 years, but erythrodermic forms presented in older patients (average age 61 years).
Six (75%) paediatric patients and ten (60%) non-erythrodermic adults controlled their disease with topical corticosteroids. On the contrary, 26 (68%) erythrodermic patients required biologic therapy as last and effective therapy line requiring an average of 6.5 months to achieve complete response.
Our study showed a statistical difference in terms of outcome and response to treatment between children or patients with limited disease and patients who develop erythroderma.
La pitiriasis rubra pilaris (PRP) es una entidad rara de etiopatogenia desconocida. La falta de guías clínicas la convierte en un desafío para los clínicos.
Contribuir con nuestra experiencia a aumentar la evidencia disponible sobre esta entidad.
Realizamos un estudio retrospectivo, descriptivo y multicéntrico de 65 pacientes con PRP, siendo la serie de casos europea más grande de pacientes con PRP.
La PRP fue más frecuente en los varones con una edad promedio de 51 años, pero las formas eritrodérmicas se presentaron en pacientes de mayor edad, en torno a los 61 años.
Seis (75%) de los pacientes pediátricos y 10 (60%) de los adultos no eritrodérmicos controlaron su enfermedad con corticoides tópicos. Por el contrario, 26 (68%) de los pacientes eritrodérmicos necesitaron terapia biológica como última línea terapéutica eficaz; requiriendo un promedio de 6,5 meses para lograr una respuesta completa.
Nuestro estudio mostró una diferencia estadística en términos de resultado y respuesta al tratamiento entre niños o pacientes con enfermedad limitada y pacientes que desarrollan eritrodermia.
Risankizumab – a humanized monoclonal antibody that targets the p19 subunit of IL-23 – has been recently approved to treat moderate-to-severe plaque psoriasis. Real-world data based on a ...representative pool of patients are currently lacking.
To assess the mid- and long-term safety and efficacy profile of risankizumab in patients with moderate-to-severe psoriasis in the routine clinical practice.
This was a retrospective and multicenter study of consecutive psoriatic patients on risankizumab from April 2020 through November 2022. The primary endpoint was the number of patients who achieved a 100% improvement in their Psoriasis Area and Severity Index (PASI) (PASI100) on week 52.
A total of 510 patients, 198 (38.8%) women and 312 (61.2%) men were included in the study. The mean age was 51.7±14.4 years. A total of 227 (44.5%) study participants were obese (body mass index BMI >30kg/m2). The mean baseline PASI score was 11.4±7.2, and the rate of patients who achieved PASI100 on week 52, 67.0%. Throughout the study follow-up, 21%, 50.0%, 59.0%, and 66% of the patients achieved PASI100 on weeks 4, 16, 24, and 40, respectively. The number of patients who achieved a PASI ≤2 was greater in the group with a BMI ≤30kg/m2 on weeks 4 (P=.04), 16 (P=.001), and 52 (P=.002). A statistically significantly greater number of patients achieved PASI100 in the treatment-naïve group on weeks 16 and 52 (P=.001 each, respectively). On week 16 a significantly lower number of participants achieved PASI100 in the group with psoriatic arthropathy (P=.04). Among the overall study sample, 22 (4.3%) patients reported some type of adverse event and 20 (3.9%) discontinued treatment.
Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice.
Risankizumab es un anticuerpo monoclonal humanizado que se dirige a la subunidad p19 de IL-23, recientemente aprobado para el tratamiento de la psoriasis en placas moderada a grave. Actualmente faltan datos del mundo real basados en una muestra representativa de pacientes.
Evaluar la eficacia y la seguridad a medio y a largo plazo del risankizumab en pacientes con psoriasis moderada a grave en la práctica clínica habitual.
Estudio retrospectivo y multicéntrico realizado en pacientes consecutivos con psoriasis que recibieron tratamiento con risankizumab desde abril de 2020 hasta noviembre de 2022. El criterio de valoración principal fue la proporción de pacientes que alcanzaron una mejora en el Índice de Área y Severidad de la Psoriasis (Psoriasis Area and Severity Index PASI) del 100% (PASI100) en la semana 52.
Se incluyeron en el estudio un total de 510 pacientes, 198 (38,8%) mujeres y 312 (61,2%) hombres. La edad media fue de 51,7±14,4 años, y 227 (44,5%) sujetos eran obesos (índice de masa corporal IMC>30kg/m2). La puntuación media del PASI basal fue de 11,4±7,2. La proporción de pacientes que alcanzaron PASI100 en la semana 52 fue del 67,0%. A lo largo del seguimiento del estudio, el 21%, el 50,0%, el 59,0% y el 66% de los pacientes alcanzaron un PASI100 en las semanas 4, 16, 24 y 40, respectivamente. La proporción de pacientes que alcanzaron un PASI≤2 fue mayor en el grupo con un IMC≤30kg/m2 en la semana 4 (p=0,04), la semana 16 (p=0,001) y la semana 52 (p=0,002). Una proporción estadísticamente significativa mayor de pacientes alcanzó un PASI100 en el grupo sin tratamiento previo en la semana 16 y a la semana 52 (p=0,001 en cada una, respectivamente). En la semana 16, una proporción significativamente menor de sujetos alcanzó un PASI100 en el grupo con artropatía psoriásica (p=0,04). Entre la muestra total del estudio, 22 (4,3%) pacientes reportaron algún tipo de evento adverso y 20 (3,9%) abandonaron o se retiraron del tratamiento.
Risankizumab fue un tratamiento efectivo y seguro para pacientes con psoriasis moderada a grave en la práctica clínica.
BACKGROUND AND OBJECTIVESIt is necessary to expand the knowledge in the use of apremilast in clinical practice. The APPRECIATE study (NCT02740218) aims to describe the characteristics of patients ...with psoriasis treated with apremilast, to evaluate their perspectives and those of dermatologists, as well as the outcomes obtained in clinical practice in Spain. METHODSObservational, retrospective, cross-sectional, multicenter study of patients with chronic plaque psoriasis who could be contacted 6 (±1) months after apremilast initiation. The data were obtained from medical records and questionnaires from patients and physicians. RESULTSA total of 80 patients were evaluated; at apremilast onset, they showed mean (standard deviation, SD) Psoriasis Area and Severity Index (PASI) = 8.3 (5.3), mean (SD) Dermatology Life Quality Index (DLQI) = 8.9 (6.6). At six months, 58.8% (n=47) of patients continued apremilast treatment (discontinuations due to lack of efficacy 16.3%, safety/tolerability 20.0%). In patients continuing treatment, PASI75 was achieved by 36.7% of patients; mean (95% CI) DLQI score was 2.2 (0.7-3.6) and mean (SD) Patient Benefit Index score was 2.8 (0.8). Compliance with physicians' expectations was correlated with benefits reported by patients (r=0.636). Adverse events were reported by 56.3% of patients (the most common were diarrhoea and nausea). CONCLUSIONSPatients receiving apremilast for 6 months in Spanish clinical practice, reported substantial improvements in their quality of life (mean DLQI reduced by more than 6 points) and disease severity (PASI75 achieved by over one-third of patients), despite less skin involvement than patients who enrolled in clinical trials.
INTRODUCTION AND OBJECTIVESA 5% risk of reactivation of hepatitis B virus (HBV) infection has been reported in patients with diseases other than psoriasis treated with tumor necrosis factor ...inhibitors. The aim of this study was to investigate the risk of HBV reactivation in patients with a past history of HBV infection who were receiving biologic therapy for psoriasis.MATERIAL AND METHODSThis was a multicenter study of 20 patients with psoriasis who were treated with at least 1 biologic agent. All the patients had serologic evidence of past HBV infection (positive total hepatitis B core antibody and negative hepatitis B surface antibody). We analyzed the clinical, serological, and liver function variables recorded before, during, and at the end of follow-up. The viral load at the end of follow-up was also analyzed for all patients.RESULTSNone of the patients fulfilled the criteria for HBV reactivation at the end of a median follow-up period of 40 months. Combining our data with data from other studies of psoriasis patients with a past history of HBV infection who were treated with a biologic, we calculated a maximum estimated risk of HBV reactivation for a mean follow-up period of 30 months of 2.7 reactivations per 100 patients.CONCLUSIONSBiologic therapy did not cause HBV reactivation in our series of patients. Nonetheless, because of the potentially serious complications associated with HBV reactivation, it is important to measure viral load in patients with a history of HBV infection prior to initiation of biologic therapy to rule out occult carriage. These patients should also be monitored regularly in conjunction with a hepatologist.
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