RESUMEN
BACKGROUND: Safety is an important consideration in decisions on treatment for patients with moderate-to-severe psoriasis and the study of drug safety is the main purpose of the BIOBADADERM registry. The combination of a biologic agent and a conventional systemic drug [generally methotrexate (MTX)] is a common treatment in clinical practice. However, there is a paucity of evidence from real-world practice on the safety of such combination regimens in the treatment of psoriasis. OBJECTIVES: The primary objective of this study was to ascertain whether the use of regimens combining biologic drugs with MTX in the management of moderate-to-severe psoriasis increases the risk of adverse events (AEs) or serious AEs (SAEs). We compared monotherapy using tumour necrosis factor (TNF), interleukin (IL)-17 and IL-23 inhibitors with the use of the same drugs in combination with MTX. METHODS: Using data from the BIOBADADERM registry, we compared biologic monotherapies with therapies that were combined with MTX. We estimated adjusted incidence rate ratios (aIRR) using a random effects Poisson regression with 95% confidence intervals for all AEs, SAEs, infections and serious infections and other AEs by system organ class. RESULTS: We analysed data from 2829 patients and 5441 treatment cycles, a total of 12 853 patient-years. The combination of a biologic with MTX was not associated with statistically significant increases in overall risk of AEs or SAEs in any treatment group. No increase in the total number of infections or serious infections in patients receiving combined therapy was observed for any group. However, treatment with a TNF inhibitor combined with MTX was associated with an increase in the incidence of gastrointestinal AEs (aIRR 2.50, 95% CI 1.57-3.98; P < 0.002). CONCLUSIONS: The risk of AEs and SAEs was not significantly increased in patients with moderate-to-severe psoriasis receiving different classes of biologic drugs combined with MTX compared with those on biologic monotherapy.
Asunto(s)
Productos Biológicos , Psoriasis , Humanos , Metotrexato , Estudios de Cohortes , Psoriasis/patología , Sistema de Registros , Terapia Biológica , Productos Biológicos/efectos adversosRESUMEN
OBJECTIVES: Interleukin-17 (IL-17) contributes to the pathogenesis of psoriasis. Secukinumab, ixekizumab, and brodalumab are monoclonal antibodies anti-IL-17 antibodies, approved for the treatment of moderate/severe plaque psoriasis.The aim of the study was to describe the effectiveness and safety of anti-IL-17 agents in moderate/severe plaque psoriasis in clinical practice. We also analysed anti-IL-17 therapies' survival, dose adjustment, and clinical patients' factors associated with their effectiveness and safety. METHODS: A retrospective, longitudinal study was conducted at a tertiary hospital. We included patients with moderate/severe psoriasis treated with anti-IL-17 agents. The effectiveness was evaluated with Psoriasis Area and Severity Index (PASI) score and safety through the adverse drug reactions (ADRs) collected. RESULTS: 38 patients were studied (median age=47.4 years, 71.0% male). The mean number of biological therapies that patients received was 2.6, and anti-IL-17 therapy was the first biological therapy for 36.8% of patients. The median years in treatment were 2.5 (95% CI 1.95 to 2.98) for secukinumab, 1.2 (95% CI 0.36 to 1.47) for ixekizumab, and 0.7 (IQR 0.71) for brodalumab. The median PASI score after 6 months of treatment was 0 (IQR 0) and 85.3% of patients achieved a PASI of 90 (84.0% with secukinumab, 87.5% with ixekizumab, and 100% with brodalumab). Dose adjustment was associated with the line of treatment (p=0.034 for naïve patients), age (p=0.044 for younger patients), and concomitant pathologies (p=0.015 without more diseases).24 patients suffered from ADRs, mainly infections of the upper respiratory tract, and there were no statistically significant differences between the three therapies. CONCLUSIONS: Anti-IL-17 agents constitute an effective treatment for patients with moderate/severe plaque psoriasis and for longer. Dose reductions were associated with fewer lines of treatment, younger patients and absence of concomitant pathologies. ADR were minor and similar among the anti-IL-17.
RESUMEN
The aim of the study was to assess the long-term effectiveness and safety of secukinumab in Spanish patients with moderate-to-severe psoriasis in a daily practice setting. Nationwide multicenter, observational, retrospective, non-interventional, single-cohort study including patients who initiated treatment with secukinumab in daily clinical practice conditions. Subjects were followed for a minimum of 3 months and a maximum of 24 months. Psoriasis Area Severity Index (PASI), Body Surface Area and Physician's Global Assessments were collected at baseline and months 3, 6, 12, 18 and 24 during treatment. Adverse events and reasons for secukinumab withdrawal were collected and classified for analyses. A total of 384 patients were enrolled in the study. Median PASI declined rapidly from 14.3 at baseline to 2.7 at month 3, 2.1 at month 12, and remained low (2.8) at month 24. Within the group of patients with PASI ≥10 at baseline (n = 278), 58.3%, 60.4% and 56.5% achieved a PASI90 response at months 3, 12 and 24, respectively. As for absolute PASI, 86.5%, 69.5%, 42.7% and 37% achieved PASI <5, < 3, < 1 and 0, respectively, at month 3. Secukinumab was more effective in biologic-naïve patients and in those with lower Body Mass Index. Secukinumab presented a good long-term safety profile. Secukinumab was effective and safe in a routine clinical setting, in a large cohort of patients with moderate-to-severe plaque psoriasis, in the short-, medium- and long-term (up to 24 months).
Asunto(s)
Anticuerpos Monoclonales , Psoriasis , Humanos , Estudios Retrospectivos , Estudios de Cohortes , Anticuerpos Monoclonales/efectos adversos , Resultado del Tratamiento , Psoriasis/diagnóstico , Psoriasis/tratamiento farmacológico , Psoriasis/inducido químicamente , Índice de Severidad de la EnfermedadRESUMEN
Psoriasis is a chronic dermatological disease with great impact on patients' quality of life (QoL). The main objective of this study was to assess the impact of secukinumab treatment on different patient-reported outcomes (PROs) during a long-term follow-up in Spanish patients with moderate-to-severe psoriasis under real-world conditions. Retrospective, observational, open-label, nationwide multicenter cohort study that included patients who initiated treatment with secukinumab in daily clinical practice conditions. PROs assessing disease impact and QoL included Dermatology Life Quality Index (DLQI), Patient's Global Psoriasis Assessment, Itch Numerical Rating Scale and EuroQoL Thermometer Visual Analogue Scale. Outcomes, including PROs and Psoriasis Area and Severity Index (PASI), were assessed at months 3, 6, 12, 18, and 24 during treatment. A total of 238 patients were enrolled in the study. Patients had a mean DLQI score of 14.9 at baseline; 78.3%, 73.7%, and 71.7% of them achieved a DLQI 0/1 response at months 6, 12, and 24, respectively. DLQI score was lower in the long term for naïve patients. A sharp decrease in mean DLQI was observed during the first 3 months, reaching a plateau that was maintained until the end of follow-up. Similar findings were observed for the rest of QoL assessments. There was a close association between improvement in QoL and skin clearance (PASI), which progressively increased during follow-up. In this study, secukinumab sustainably improved patient's QoL during a 24-month follow-up, with strongest effects in patients naïve to biological therapies and with a direct correlation with PASI improvement.
Asunto(s)
Psoriasis , Calidad de Vida , Anticuerpos Monoclonales Humanizados , Estudios de Cohortes , Humanos , Medición de Resultados Informados por el Paciente , Psoriasis/diagnóstico , Psoriasis/tratamiento farmacológico , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: Limited information is available regarding the risk of incident liver disease in patients with psoriasis receiving systemic therapies. OBJECTIVES: To describe the liver safety findings of conventional and modern systemic therapies for moderate-to-severe psoriasis, and to compare the relative incidence rates of hepatic adverse events (AEs) for each drug. METHODS: All the patients on the BIOBADADERM registry were included. Crude and adjusted incidence rate ratios (cIRR and aIRR, respectively) of hepatic AEs, using anti-TNF drugs as reference, were determined. Outcomes of interest were hypertransaminasemia, nonalcoholic fatty liver disease (NADFLD) and a group of other, less represented, hepatic AEs. RESULTS: Our study included 3,171 patients exposed to systemic drugs (6279 treatment cycles). Incident hypertransaminasemia was the most frequent hepatic AE (incidence rate of 21 per 1000 patients-years [CI 95% 18-23]), followed by NAFLD (8 cases per 1000 patients-years [95% CI 6-10]). Methotrexate (aIRR 3.06 [2.31-4.4]; p = 0.000) and cyclosporine (aIRR 2.37 [1.05-5.35]; p = .0378) were associated with an increased risk for hypertransaminasemia when compared to anti-TNF-α agents. No differences were observed between different groups of biologics. Conventional therapies were not associated with new incident NAFLD. CONCLUSIONS: Comparative information of the incidence of hepatic AEs could facilitate drug selection in moderate-to-severe psoriasis.
Asunto(s)
Enfermedad del Hígado Graso no Alcohólico , Psoriasis , Humanos , Enfermedad del Hígado Graso no Alcohólico/inducido químicamente , Enfermedad del Hígado Graso no Alcohólico/epidemiología , Estudios Prospectivos , Psoriasis/tratamiento farmacológico , Sistema de Registros , Inhibidores del Factor de Necrosis TumoralRESUMEN
An increasing number of publications have brought attention to COVID-19-associated cutaneous lesions. Histopathological descriptions and clinical correlation of the histopathological findings of COVID-19 skin lesions are lacking. In this manuscript, we reviewed and described the histopathological characteristics of COVID-19 infection cutaneous patterns reported in the literature.
Asunto(s)
Prueba de COVID-19 , COVID-19/complicaciones , SARS-CoV-2/aislamiento & purificación , Enfermedades Cutáneas Virales/patología , Biopsia , COVID-19/diagnóstico , COVID-19/patología , Humanos , Enfermedades Cutáneas Virales/diagnósticoRESUMEN
The effect of sex on systemic therapy for psoriasis has not been well studied. The aim of this study was to analyse a large multicentre Spanish cohort of 2,881 patients with psoriasis (58.3% males), followed from January 2008 to November 2018, to determine whether sex influences prescription, effectiveness of therapy, and the risk of adverse events. The results show that women are more likely than men to be prescribed biologics. There were no differences between men and women in effectiveness of therapy, measured in terms of drug survival. Women were more likely to develop adverse events, but the difference in risk was small and does not justify different management. Study limitations include residual confounding and the use of drug survival as a proxy for effectiveness.
Asunto(s)
Productos Biológicos , Psoriasis , Productos Biológicos/efectos adversos , Femenino , Humanos , Masculino , Prescripciones , Estudios Prospectivos , Psoriasis/diagnóstico , Psoriasis/tratamiento farmacológico , Sistema de RegistrosAsunto(s)
COVID-19/epidemiología , Psoriasis/tratamiento farmacológico , Adulto , Anciano , COVID-19/complicaciones , Estudios de Cohortes , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Psoriasis/complicaciones , Sistema de Registros , Índice de Severidad de la Enfermedad , EspañaRESUMEN
BACKGROUND: Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. OBJECTIVE: To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. METHODS: The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort. RESULTS: Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5). LIMITATIONS: Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered. CONCLUSION: Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.
Asunto(s)
Psoriasis/tratamiento farmacológico , Adulto , Anciano , Terapia Biológica/efectos adversos , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sistema de Registros , España , Factores de TiempoAsunto(s)
Anticuerpos Monoclonales Humanizados/efectos adversos , Fármacos Dermatológicos/efectos adversos , Psoriasis/tratamiento farmacológico , Aplasia Pura de Células Rojas/inducido químicamente , Enfermedad Crónica/tratamiento farmacológico , Transfusión de Eritrocitos , Hemoglobinas/análisis , Humanos , Masculino , Persona de Mediana Edad , Psoriasis/sangre , Psoriasis/diagnóstico , Aplasia Pura de Células Rojas/sangre , Aplasia Pura de Células Rojas/diagnóstico , Aplasia Pura de Células Rojas/terapia , Recuento de Reticulocitos , Índice de Severidad de la EnfermedadRESUMEN
To assess the discriminative utility of nail features detected by B-mode (BM) and color Doppler (CD) ultrasound (US) between patients with psoriasis (PsO) and psoriatic arthritis (PsA) and healthy controls. Sixty patients with PsA, 21 patients with PsO, and 20 healthy controls were prospectively included. All patients underwent a dermatologic assessment and PsA patients also a rheumatologic assessment. All patients and controls underwent a US assessment of the finger nails that included a BM score for nail plate integrity and four different CD scores based on the amount and location of CD signals in the nail bed/matrix. In addition, we measured the thickness of the nail bed (TNB) and nail plate (TNP). The BM score and the CD score based on the amount of signals in the nail bed in contact with the ventral plate discriminated between the control group (median, range 0.0, 0-4 and 2.0, 0-9, respectively) and the PsO/PsA group (median, range: 7.0, 0-31 and 5.14, 0-13, respectively) (p < 0.05) with or without clinical nail involvement. The CD scores based on the percentage of the nail bed/matrix occupied by Doppler signals did not discriminate between controls and PsO/PsA patients. TNB and TNP were significantly higher in psoriatic nails with or without clinical involvement than in control nails. In PsO/PsA patients, the BM score, TNB and TNP were significantly higher in clinically involved nail than in clinically non-involved nails. Our results showed discriminative utility of BM US and some CD US features for PsO/PsA nails.
Asunto(s)
Artritis Psoriásica/diagnóstico por imagen , Uñas/diagnóstico por imagen , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Casos y Controles , Femenino , Voluntarios Sanos , Humanos , Masculino , Persona de Mediana Edad , Psoriasis/diagnóstico por imagen , Ultrasonografía , Ultrasonografía Doppler en ColorRESUMEN
PURPOSE: The aim of this study was to identify clinical factors associated with dose reduction and dose escalation in the treatment with ustekinumab in patients with moderate-to-severe plaque psoriasis. MATERIALS AND METHODS: An observational, longitudinal and retrospective study was conducted using patients with moderate-to-severe plaque psoriasis. We reviewed clinical histories and variables were recorded on a database (patients' characteristics, pharmacotherapeutics, effectiveness and safety). We evaluated correlation between dose reduction, dose escalation and used dose with other variables. RESULTS: Of the study's 62 patients, Ustekinumab dose was adjusted in 45.2% (22.6% with reduced doses and 22.6% with increased doses). We found a statistically significant correlation between extending the dosing interval and the absence of psoriatic arthritis, no concomitant systemic therapies, treatment time with ustekinumab, lower PASI at week 28 and achieving PASI75 at week 28. There was also a statistically significant correlation between dose escalation and diabetes mellitus, psoriatic arthritis, prior biological treatments, concomitant systemic therapies, concomitant phototherapy and not achieving PASI75 at week 28. CONCLUSIONS: Dose-reduction strategies would increase ustekinumab efficiency in patients that achieve PASI 75 without psoriatic arthritis, diabetes mellitus, previous BT and concomitant treatment with conventional systemic drugs.
Asunto(s)
Fármacos Dermatológicos/administración & dosificación , Psoriasis/tratamiento farmacológico , Ustekinumab/administración & dosificación , Adulto , Anciano , Relación Dosis-Respuesta a Droga , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
Martorell hypertensive ischemic ulcer can be a real clinical and therapeutic challenge. Controversy exists regarding both the underlying triggers of the disease and the type of treatment that should be established. Early skin grafting has been suggested as an effective treatment to enhance pain reduction and wound healing in these patients. The authors present the case of a 68-year-old woman with well-controlled hypertension and diabetes who developed extremely painful, rapidly progressing bilateral ulcers on the distal aspect of her legs. Without previous surgical debridement, the lesions were covered with punch grafts. Pain and necrotic progression were immediately controlled and complete epithelialization was achieved in 7 weeks.
Asunto(s)
Hipertensión/complicaciones , Isquemia/complicaciones , Isquemia/patología , Úlcera de la Pierna/complicaciones , Úlcera de la Pierna/cirugía , Necrosis/terapia , Trasplante de Piel/métodos , Anciano , Terapia Combinada , Comorbilidad , Desbridamiento/métodos , Femenino , Humanos , Hipertensión/fisiopatología , Isquemia/terapia , Úlcera de la Pierna/patología , Necrosis/patología , Resultado del Tratamiento , Cicatrización de Heridas/fisiologíaAsunto(s)
Acitretina/uso terapéutico , Carcinoma Basocelular/diagnóstico , Hipotricosis/diagnóstico , Queratolíticos/uso terapéutico , Linfoma Folicular/diagnóstico , Neoplasias Cutáneas/diagnóstico , Acitretina/administración & dosificación , Carcinoma Basocelular/complicaciones , Carcinoma Basocelular/tratamiento farmacológico , Carcinoma Basocelular/patología , Diagnóstico Diferencial , Femenino , Pie , Mano , Humanos , Hipotricosis/complicaciones , Hipotricosis/tratamiento farmacológico , Hipotricosis/patología , Queratolíticos/administración & dosificación , Linfoma Folicular/complicaciones , Linfoma Folicular/tratamiento farmacológico , Linfoma Folicular/patología , Persona de Mediana Edad , Neoplasias Cutáneas/complicaciones , Neoplasias Cutáneas/tratamiento farmacológico , Neoplasias Cutáneas/patologíaAsunto(s)
Antimetabolitos Antineoplásicos/efectos adversos , Erupciones por Medicamentos/etiología , Fluorouracilo/efectos adversos , Lupus Eritematoso Cutáneo/inducido químicamente , Adenocarcinoma/terapia , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Exantema , Humanos , Masculino , Neoplasias del Recto/terapiaAsunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Hiperpigmentación/inducido químicamente , Adenocarcinoma/tratamiento farmacológico , Adulto , Anticuerpos Monoclonales de Origen Murino/efectos adversos , Bevacizumab/efectos adversos , Neoplasias del Colon/tratamiento farmacológico , Ciclofosfamida/efectos adversos , Doxorrubicina/efectos adversos , Fluorouracilo/efectos adversos , Humanos , Hiperpigmentación/patología , Leucovorina/efectos adversos , Linfoma de Células B Grandes Difuso/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Compuestos Organoplatinos/efectos adversos , Prednisona/efectos adversos , Rituximab , Vincristina/efectos adversosRESUMEN
BACKGROUND: It is not clear how to best use biologics in the treatment of psoriasis. Our objective was to assess use of a protocol for biological therapies (BT) in psoriasis. METHODS: A consensus protocol was established that included the indications for BT and dose optimization. Patient's characteristics, effectiveness, and cost of BT were analyzed before and after the implementation with two cross-sectional studies to assess its impact. RESULTS: About 106 were treated before the protocol and 118 patients were treated after. After implementing the protocol, the dose was reduced in 43.4% of the patients receiving adalimumab, in 37.5% for etanercept, in 28.6% for infliximab, and in 14.7% for ustekinumab. No statistically significant differences were found in PASI score after the implementation of the protocol, except for the percentage of patients that achieved PASI 75 with ustekinumab, which was slightly higher. The global yearly savings achieved with the protocol implementation were 115,969 . CONCLUSIONS: The protocol helped to increase the efficiency of BT, with decreasing doses of BT without affecting treatment effectiveness.