RESUMEN
BACKGROUND: Dupilumab is the first biologic available to treat atopic dermatitis (AD). Its effectiveness and safety were demonstrated in clinical trials. OBJECTIVE: We sought to assess the effectiveness and safety of dupilumab in adults with AD in a real-life French multicenter retrospective cohort. METHODS: We included patients treated during March 2017-April 2018. Efficacy outcomes, including Scoring Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI) scores, were collected at baseline and 3 months when available. Adverse events (AEs) were recorded at follow-up. RESULTS: We included 241 patients. The median ± interquartile range (IQR) follow-up time was 3.8 ± 3.7 months. A ≥75% improvement in SCORAD was achieved in 27 of 163 (16.6%) patients, and a ≥75% improvement in EASI was achieved in 40 of 82 (48.8%) patients. The median SCORAD and EASI scores at 3 months were significantly lower than those at baseline (SCORAD ± IQR, 25 ± 21 vs 56 ± 27.4, P < 10-9 and EASI ± IQR, 4.1 ± 6.8 vs 17.9 ± 15.4, P < 10-9, respectively). Conjunctivitis was reported in 84 of 241 (38.2%) patients. The proportion with eosinophilia (>500 cells/mm3) during follow-up (57%) was higher than that at baseline (33.7%) (n = 172, P < 10-6). Dupilumab was stopped in 42 cases; 27 patients stopped because of AEs. LIMITATIONS: No control group, missing data. CONCLUSION: This real-life study demonstrated a similar dupilumab effectiveness as that seen in clinical trials, but it also revealed a higher frequency of conjunctivitis and eosinophilia.
Asunto(s)
Anticuerpos Monoclonales/uso terapéutico , Conjuntivitis/inducido químicamente , Dermatitis Atópica/tratamiento farmacológico , Eosinofilia/inducido químicamente , Seguridad del Paciente/estadística & datos numéricos , Adulto , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales Humanizados , Estudios de Cohortes , Conjuntivitis/epidemiología , Dermatitis Atópica/diagnóstico , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Eosinofilia/epidemiología , Femenino , Francia , Humanos , Inyecciones Subcutáneas , Estimación de Kaplan-Meier , Masculino , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Medición de Riesgo , Índice de Severidad de la EnfermedadAsunto(s)
Inhibidores de Puntos de Control Inmunológico/efectos adversos , Inmunoterapia/efectos adversos , Linfohistiocitosis Hemofagocítica/inducido químicamente , Adulto , Anticuerpos Monoclonales Humanizados/efectos adversos , Anticuerpos Monoclonales Humanizados/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Terapia Combinada , Resultado Fatal , Femenino , Francia/epidemiología , Humanos , Inhibidores de Puntos de Control Inmunológico/uso terapéutico , Ipilimumab/efectos adversos , Ipilimumab/uso terapéutico , Linfohistiocitosis Hemofagocítica/epidemiología , Masculino , Persona de Mediana Edad , Neoplasias/tratamiento farmacológico , Nivolumab/efectos adversos , Nivolumab/uso terapéuticoRESUMEN
BACKGROUND: Dupilumab is the first human monoclonal antibody approved for the treatment of atopic dermatitis (AD). Clinical trials have reported an increase of ocular side effects in patients who receive dupilumab, with a prevalence of 5-37%. OBJECTIVE: To compare the prevalence of ocular disease between AD patients receiving dupilumab treatment and AD reference group and to study the profile of the patients who developed ocular disease secondary to dupilumab treatment. METHODS: Efficacy outcomes were collected both at baseline and at month 4 (M4). Presence of ocular disease was recorded at M4. RESULTS: Data from 100 patients were examined. At M4, ocular disease was significantly more frequent in the dupilumab group (36% vs. 10%, P = 0.002). Severe allergic conjunctivitis and blepharitis were significantly more frequent in the dupilumab group (30% vs. 4%, P < 0.001, and 22% vs. 2%, P = 0.004, respectively). Six of 18 patients permanently discontinued therapy. CONCLUSION: This study observed a prevalence of 36% of ocular disease in AD patients treated with dupilumab. Additional studies are required to confirm the risk factors we found for dupilumab-associated ocular disease and to identify new ones. Consultation with an ophthalmologist before the introduction of dupilumab might limit the occurrence of complications.
Asunto(s)
Dermatitis Atópica , Oftalmopatías , Anticuerpos Monoclonales Humanizados , Estudios de Cohortes , Dermatitis Atópica/tratamiento farmacológico , Dermatitis Atópica/epidemiología , Humanos , Prevalencia , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: Biotherapies or targeted therapies are fairly new treatments indicated for moderate to severe psoriasis. The side effects appear to be mainly infectious or cancerous. The role of biotherapies in the development of a pre-cancerous condition, monoclonal gammopathy of undetermined significance (MGUS), has recently been debated in the literature. OBJECTIVES: To evaluate the incidence of MGUS in psoriasis patients treated with biotherapy. MATERIALS AND METHODS: This study was a French multicenter retrospective study carried out through the French multicenter study group RESOPSO. Data on the results of serum protein electrophoreses performed before and within at least six months after the start of the biotherapy were collected. Demographic data, medical history, and psoriasis treatment history were specified. RESULTS: Four hundred and forty three patients were eligible for inclusion. Of these, three presented with monoclonal gammopathy for which the assessment was in favor of MGUS. The average treatment period was 19.7 months. Six patients presented with MGUS prior to the treatment. These patients' immunoglobulin levels remained stable, with an average remission of 24 months. Only psoriatic rheumatism appeared to be statistically linked to MGUS. CONCLUSION: The incidence and frequency of MGUS in psoriasis patients treated with biotherapy do not appear to increase relative to the general population.