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
BACKGROUND: Tildrakizumab is a humanized, IgG1/κ antibody that interacts with the p19 subunit of interleukin 23. It is approved for the treatment of moderate-to-severe plaque psoriasis. Real-world evidence on the effectiveness and safety of tildrakizumab is limited. OBJECTIVES: To assess the effectiveness and safety of tildrakizumab at 24 weeks in patients with moderate-to-severe plaque psoriasis in routine clinical practice. METHODS: Retrospective, observational, multicentre study including adult patients with moderate-to-severe plaque psoriasis treated with tildrakizumab under real-life conditions. Patient data were extracted from anonymized electronic medical records. Statistical analysis was performed using SPSS22. RESULTS: A total of 190 patients were included. About 53.9% were men with a mean age of 51.45 (SD 3.9) and a mean BMI of 29.13 (SD 6.21). About 79.8% (132 out of 190) of patients had previously received biological therapy (BT) and 17.3% (33 out of 191) had psoriatic arthritis. Baseline PASI was 10.7 (SD 6.53). Up to 109 patients reached Week 24 and at this point mean baseline PASI decreased to 1.7 (SD 4.8), representing an 88.79% mean PASI reduction. At 6 months, 87.1% and 40.3% of the treated patients achieved PASI ≤3 and ≤1, respectively. At Week 24 mean BSA decreased from 13.2 (SD 10.07) to 1.6 (SD 4.40) and mean DLQI went from 12.5 (SD 7.12) to 1.2 (SD 3.27). Multivariate analysis showed no differences when effectiveness was correlated with gender, obesity, psoriatic arthritis or prior exposure to BT. The rate of adverse events (AE) was 5.9% (11 out of 190), where infections were the most frequent AE (4 out of 11). One patient suffered a haemorrhagic ictus and one patient died due to causes unrelated to the study. CONCLUSION: Tildrakizumab was effective and safe in a large cohort of patients with moderate-to-severe plaque psoriasis treated in a routine clinical setting.
Asunto(s)
Artritis Psoriásica , Psoriasis , Femenino , Humanos , Masculino , Persona de Mediana Edad , Artritis Psoriásica/tratamiento farmacológico , Psoriasis/tratamiento farmacológico , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: Determining tumor necrosis factor-alpha inhibitors (anti-TNF-α) failure is still a challenge in the management of moderate-to-severe psoriasis. Thus, our comprehensive systematic literature review aimed to gather information on the criteria used to define anti-TNF-α failure. We also aimed to discover the main reasons for anti-TNF-α failure and define subsequently administered treatments. MATERIALS AND METHODS: We conducted a systematic review following review and reporting guidelines (Cochrane and PRISMA). International (Medline/PubMed and Cochrane Library) and Spanish databases (MEDES, IBECS), and gray literature were consulted to identify publications issued until April 2021 in English or Spanish. RESULTS: Our search yielded 58 publications. Of these, 37 (63.8%) described the criteria used to define anti-TNF-α primary or secondary failure. Criteria varied across studies, although around 60% considered Psoriasis Area and Severity Index (PASI)-50 criteria. Nineteen (32.8%) reported the reasons for treatment failure, including the lack or loss of efficacy and safety-related problems, mainly infections. Finally, 29 (50%) publications outlined the treatments administered after anti-TNF-α: 62.5% reported a switch to another anti-TNF-α and 37.5% to interleukin (IL)-inhibitors.Our findings suggest a need to standardize the management of anti-TNF-α failure and reflect the incorporation of new targets, such as IL-inhibitors, in the treatment sequence.KEY MESSAGESIn the treatment of psoriasis, the primary and secondary anti-TNF-α failure criteria differ widely in the scientific literature.The strictest efficacy criteria for defining anti-TNF-α failure, or those recommended by guidelines such as PASI75, were underused both in clinical trials and observational studies.Most studies failed to consider patient-reported outcomes in assessing psoriasis treatment efficacy, which contrasts with recent recommendations on the inclusion of patient-reported HRQoL as a supporting criterion when considering clinical outcomes.
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Anticuerpos Monoclonales , Psoriasis , Humanos , Anticuerpos Monoclonales/uso terapéutico , Factor de Necrosis Tumoral alfa/uso terapéutico , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Psoriasis/tratamiento farmacológico , Psoriasis/patología , Resultado del TratamientoRESUMEN
NAVIGATE clinical trial demonstrated a higher rate of Psoriasis Assesment Severity Index (PASI)90 response in patients treated with guselkumab when compared to ustekinumab and an improved response in those who switched from ustekinumab to guselkumab due to partial response. The objective of the study is to describe ustekinumab to guselkumab switching in clinical practice. Observational, multicentric, descriptive study including 54 psoriasis patients who switched to guselkumab after treatment with ustekinumab from March 2019 to February 2021. Mean basal PASI with ustekinumab (16.7) was higher than with guselkumab (7.2). Up to 49.01% of patients were able to reach PASI90 with ustekinumab and up to 21.56% had a less frequent dosage regime vs. summary of product characteristics. Main reason to start guselkumab was a loss of ustekinumab cutaneous or articular response (82.36%) but up to 17.64% were switched in order to increase dosage regime efficiency. Six months after starting guselkumab, the absolute PASI was lower than 2 in 72% of patients and 38.5% of them were treated with a reduced dosage regime. Guselkumab doses used by our cohort were 19.5% lower than the expected according to the summary of product characteristics. No adverse events reported. There is no real-world evidence regarding patients who switched from ustekinumab to guselkumab. A short paragraph in the article by Fougerousse et al, reported 63 patients with a mean basal PASI of 5.3 and similar efficacy rate at week 16 to NAVIGATE. Our study adds practical information regarding efficacy, safety and efficiency through dose optimization in a real-world cohort.
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Anticuerpos Monoclonales Humanizados , Psoriasis , Ustekinumab , Anticuerpos Monoclonales Humanizados/uso terapéutico , Ensayos Clínicos como Asunto , Humanos , Psoriasis/tratamiento farmacológico , Resultado del Tratamiento , Ustekinumab/uso terapéuticoRESUMEN
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.
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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
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.
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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
The aim of this study was to generate practical recommendations to assist rheumatologists and dermatologists in the management of cardiovascular (CV) comorbidities in patients with moderate-to-severe psoriasis (MS-PSO) and psoriatic arthritis (PsA). A two-round Delphi study was conducted. A panel of experts rated their agreement with a set of statements (n = 52) on a nine-point Likert scale (1 = totally disagree; 9 = totally agree). Statements were classified as inappropriate (median 1-3), irrelevant (median 4-6) or appropriate (median 7-9). Consensus was established when at least two-thirds of the panel responded with a score within any one range. A total of 25 experts, 60% rheumatologists and 40% dermatologists, participated in two consultation rounds. There was overall unanimity on the appropriateness of an initial assessment for CV risk factors in all patients with MS-PSO and PsA. Most panelists (88.0%) also supported the evaluation of patients' psychological and physical status. Additionally, most panelists (72.2%) agreed on a novel sequential approach for the management of CV comorbidities. This sequence starts with the assessment of hypertension, diabetes and dyslipidemia along with the identification of depression and anxiety disorders. Once these factors are under control, smoking cessation programs might be initiated. Finally, if patients have not met weight loss goals with lifestyle modifications, they should receive specialized treatment for obesity. This study has drawn up a set of practical recommendations that will facilitate the management of CV comorbidities in patients with MS-PSO and PsA.
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Artritis Psoriásica , Psoriasis , Humanos , Artritis Psoriásica/diagnóstico , Artritis Psoriásica/epidemiología , Artritis Psoriásica/terapia , Psoriasis/diagnóstico , Psoriasis/epidemiología , Psoriasis/terapia , Comorbilidad , Reumatólogos , ObesidadRESUMEN
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.
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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)
Acrilatos/efectos adversos , Materiales Biocompatibles/efectos adversos , Reacción a Cuerpo Extraño/patología , Ácido Hialurónico/efectos adversos , Hidrogeles/efectos adversos , Queratoacantoma/patología , Acrilatos/administración & dosificación , Adulto , Materiales Biocompatibles/administración & dosificación , Combinación de Medicamentos , Femenino , Reacción a Cuerpo Extraño/etiología , Reacción a Cuerpo Extraño/cirugía , Humanos , Ácido Hialurónico/administración & dosificación , Hidrogeles/administración & dosificación , Queratoacantoma/etiología , Queratoacantoma/cirugíaAsunto(s)
Anticuerpos Monoclonales/uso terapéutico , Factores Inmunológicos/uso terapéutico , Pitiriasis Rubra Pilaris/tratamiento farmacológico , Femenino , Humanos , Infliximab , Infusiones Intravenosas , Persona de Mediana Edad , Pitiriasis Rubra Pilaris/patología , Piel/patología , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
Chronic radiodermatitis after radiotherapy is a frequent sequela that may be worrying for the patient. Few cases have been published in the literature in which pulsed-dye laser has been used in the treatment of telangiectasias that appeared after radiotherapy for breast cancer. We present a female patient with radiodermatitis on the neck after radiotherapy for nasopharyngeal carcinoma. The patient received five sessions of pulsed-dye laser treatment (3 ms pulse duration, 7 mm spot size, fluence between 7 and 12 J/cm 2). Sequential histological studies were performed. The response to treatment was very good, with the lesions almost completely disappearing. The patient was very satisfied with the result. Pulsed-dye laser is a safe and effective treatment for chronic radiodermatitis of the neck after radiotherapy.
Asunto(s)
Terapia por Láser , Radiodermatitis/patología , Radiodermatitis/radioterapia , Telangiectasia/patología , Telangiectasia/radioterapia , Femenino , Humanos , Persona de Mediana Edad , CuelloAsunto(s)
Calcifilaxia/etiología , Nefropatías Diabéticas/complicaciones , Fallo Renal Crónico/complicaciones , Enfermedades del Sistema Nervioso Periférico/etiología , Anciano , Biopsia , Calcifilaxia/patología , Femenino , Humanos , Fallo Renal Crónico/etiología , Tejido Nervioso/patología , Enfermedades del Sistema Nervioso Periférico/patología , Piel/patologíaRESUMEN
BACKGROUND: Nephrogenic fibrosing dermopathy (NFD) is a new skin-fibrosing disorder associated with renal dysfunction. It is marked by the acute onset of induration involving the upper and lower limbs, and it is characterized by distinctive histopathologic findings. METHODS: We report the case of a patient on hemodialysis who presented initially with the characteristic clinical and pathological features of NFD. The patient progressively developed painful hyperkeratotic spicules on both thighs and bone metaplasia was confirmed. RESULTS: Histological studies were performed at different stages of the disease showing an evolution from the well-known initial phase of NFD, characterized by thickening of the dermis, increased number of fibroblast-like cells, and mucin deposits, to an end stage characterized by the presence of dermal ossification. CONCLUSIONS: We report the exceptional finding of bone metaplasia in the setting of a case of NFD.
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Fibrosis/patología , Osificación Heterotópica/patología , Enfermedades de la Piel/patología , Adulto , Enfermedades Óseas/etiología , Enfermedades Óseas/patología , Fibrosis/etiología , Humanos , Fallo Renal Crónico/complicaciones , Masculino , Metaplasia/etiología , Metaplasia/patología , Osificación Heterotópica/etiología , Diálisis Renal , Enfermedades de la Piel/etiologíaRESUMEN
Follicular mycosis fungoides is an infrequent variant of mycosis fungoides. It has classically been defined by the presence of an atypical lymphoid infiltrate around and in the follicular epithelium with little or no epidermotropism, and no follicular mucin deposits. The fact that there are cases with epidermal involvement and/or follicular mucinosis means that some uniform diagnostic criteria are necessary. We describe two cases of follicular mycosis fungoides with follicular mucinosis and with varying degrees of associated epidermotropism.