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1.
Healthcare (Basel) ; 12(6)2024 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-38540616

RESUMO

Head and neck cancer, the seventh most common cancer worldwide, often affects the larynx, with a higher incidence in men. Total laryngectomy, a common treatment, results in the loss of phonation, and tracheoesophageal voice rehabilitation is the current rehabilitation method of choice. Despite ongoing debates regarding the timing of tracheoesophageal puncture (TEP), a crucial procedure for voice prosthesis placement, the secondary puncture continues to be the preferred choice in the majority of cases. This underscores the persistent controversy and the absence of consensus in this field. The aim of this manuscript was to define evidence-based recommendations regarding the procedure of primary TEP with voice prosthesis placement, establish the conditions and requirements for performing primary TEP, determine the indications and contraindications of primary TEP, as well as to define the complications and management of primary TEP. A total of 19 statements were formulated, with 78.95% of them having a Level of Evidence 4 and a Grade of Recommendation C. There is not sufficient evidence comparing the outcomes of primary TEP versus secondary TEP. Future studies with robust methodologies are needed to clarify the role of primary and secondary TEP in the rehabilitation of patients undergoing total laryngectomy.

2.
Int J Dermatol ; 63(4): 503-511, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38168847

RESUMO

BACKGROUND: Biological therapy dose modification is a common practice in the long-term treatment of plaque psoriasis. OBJECTIVE: The objective of the study was to determine prevalence, characteristics of patients, effectiveness, treatment survival of secukinumab dose reduction (SEC-DR) strategy and assess its safety and cost implications. METHODS: A retrospective, observational, multicenter cohort study was conducted in patients with plaque psoriasis treated with secukinumab and up to 2 years of follow-up. RESULTS: In 63/347 patients with an initial standard dose regimen, SEC-DR was tried at any moment in 18.2% of them after sustained response. In 51 patients, the interval between administrations was increased while in 12 patients, monthly dose was reduced to 150 mg. Successful SEC-DR was achieved in 77.8% of the patients, with sustained PASI response to the end of the study. Survival of secukinumab treatment and safety profile were not compromised by DR. The use of DR saved 33% of the cost, including failures in which standard treatment was resumed. LIMITATIONS: The proper of the study designed and the arbitrary definition of "DR success." CONCLUSION: Off-label SEC-DR strategy was used in patients with sustained response to standard dose regimen; this strategy showed long-term efficacy without compromising treatment survival or worsening the safety profile while also being cost saving.


Assuntos
Anticorpos Monoclonais Humanizados , Anticorpos Monoclonais , Psoríase , Humanos , Anticorpos Monoclonais/efeitos adversos , Estudos de Coortes , Redução da Medicação , Psoríase/tratamento farmacológico , Psoríase/induzido quimicamente , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
4.
Contraception ; 120: 109950, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36641098

RESUMO

OBJECTIVE: To examine challenges accessing contraception in the past year and their association with interest in using an over the counter (OTC) oral contraceptive pill (OCP) among Black, Indigenous, and people of color (BIPOC) in the United States. STUDY DESIGN: From May 2021 to March 2022, a collaborative research team conducted a cross-sectional online survey using convenience sampling to recruit people who identify as Asian American, Native Hawaiian, or Pacific Islander, Black or African American, Indigenous, or Latina/Latinx and used or wanted to use a contraceptive method in the past year. Respondents were recruited through reproductive justice and community-based organizations. RESULTS: Among 727 respondents, 45% reported experiencing at least one challenge accessing contraception in the past year of which 37% reported a logistical challenge, and 20% reported an interpersonal challenge. Sixty-seven percent of respondents said they were likely to use an OTC OCP. Respondents who reported experiencing at least one challenge accessing contraception in the past year were more likely to say they would use an OTC OCP. Fifty-seven percent of respondents who were not using a contraceptive method in the past year reported they were likely to use an OTC OCP. CONCLUSION: Among people in this study, interest in an OTC OCP is high, particularly among those who have faced challenges accessing contraception, and among those who are not currently using a contraceptive method. IMPLICATIONS: Availability of an OCP OTC has the potential to address challenges accessing contraceptive care among BIPOC in the United States, who are often impacted by structural inequities and racism. Findings from this study can inform future OTC implementation strategies to ensure OTC access addresses logistical and interpersonal challenges.


Assuntos
Anticoncepção , Pigmentação da Pele , Feminino , Estados Unidos , Humanos , Estudos Transversais , Anticoncepcionais Orais , Dispositivos Anticoncepcionais
5.
Dermatol Ther ; 35(10): e15757, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-36190008

RESUMO

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.


Assuntos
Anticorpos Monoclonais Humanizados , Psoríase , Ustekinumab , Anticorpos Monoclonais Humanizados/uso terapêutico , Ensaios Clínicos como Assunto , Humanos , Psoríase/tratamento farmacológico , Resultado do Tratamento , Ustekinumab/uso terapêutico
6.
Dermatol Ther ; 35(8): e15653, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35731640

RESUMO

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.


Assuntos
Psoríase , Qualidade de Vida , Anticorpos Monoclonais Humanizados , Estudos de Coortes , Humanos , Medidas de Resultados Relatados pelo Paciente , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
7.
Dermatol Ther ; 35(2): e15231, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34820971

RESUMO

Data 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.


Assuntos
Psoríase , Adulto , Anticorpos Monoclonais Humanizados , Humanos , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
8.
J Dermatolog Treat ; 33(3): 1329-1338, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-32900254

RESUMO

BACKGROUND: Methotrexate (MTX) is frequently used in the treatment of moderate-to-severe psoriasis, however, there is limited data on health-related quality-of-life (HRQoL), psoriasis clinical outcomes and hepatic fibrosis in MTX-treated patients in routine clinical practice. OBJECTIVES: To investigate the impact of moderate-to-severe psoriasis in MTX-treated patients in Spain regarding to HRQoL, psoriasis clinical data and risk of hepatic fibrosis. METHODS: Observational, non-interventional, cross-sectional, retrospective, multicentre study, performed in Spain in moderate-to-severe plaque psoriasis patients treated with MTX > 16 weeks prior to inclusion. RESULTS: Despite ongoing treatment, 17.1% of 457 evaluable patients reported moderate-to-extreme impact on HRQoL (DLQI > 5); 21.4% BSA > 5 and 35.2% moderate-to-severe pruritus (VAS ≥ 4). Persistent severe psoriasis (PASI ≥ 10 and/or DLQI ≥ 10) was observed in 10.7%. Hepatic steatosis was identified in 64.1% of patients (HSI ≥ 36) and 37.2% of the patients were at-risk of advanced fibrosis which was associated to the MTX treatment duration. CONCLUSIONS: The study identified unmet needs in moderate-to-severe plaque psoriasis patients treated with MTX, revealing a significant proportion of sub-optimally controlled patients in terms of HRQoL and different domains of the disease. This study also found patients at-risk of advanced fibrosis, with evidence suggesting a correlation between longer exposures to MTX and higher risk of advanced fibrosis.


Assuntos
Fármacos Dermatológicos , Psoríase , Estudos Transversais , Fármacos Dermatológicos/efeitos adversos , Humanos , Cirrose Hepática , Metotrexato/uso terapêutico , Psoríase/induzido quimicamente , Psoríase/tratamento farmacológico , Qualidade de Vida , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
9.
J Dermatolog Treat ; 33(4): 2110-2117, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33913796

RESUMO

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.


Assuntos
Hepatopatia Gordurosa não Alcoólica , Psoríase , Humanos , Hepatopatia Gordurosa não Alcoólica/induzido quimicamente , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Estudos Prospectivos , Psoríase/tratamento farmacológico , Sistema de Registros , Inibidores do Fator de Necrose Tumoral
10.
World J Gastroenterol ; 27(41): 7113-7124, 2021 Nov 07.
Artigo em Inglês | MEDLINE | ID: mdl-34887631

RESUMO

Non-alcoholic fatty liver disease (NAFLD) is currently considered the most common cause of liver disease. Its prevalence is increasing in parallel with the obesity and type 2 diabetes mellitus (DM2) epidemics in developed countries. Several recent studies have suggested that NAFLD may be the hepatic manifestation of a systemic inflammatory metabolic disease that also affects other organs, such as intestine, lungs, skin and vascular endothelium. It appears that local and systemic proinflammatory/anti-inflammatory cytokine imbalance, together with insulin resistance and changes in the intestinal microbiota, are pathogenic mechanisms shared by NAFLD and other comorbidities. NAFLD is more common in patients with extrahepatic diseases such as inflammatory bowel disease (IBD), obstructive syndrome apnea (OSA) and psoriasis than in the general population. Furthermore, there is evidence that this association has a negative impact on the severity of liver lesions. Specific risk characteristics for NAFLD have been identified in populations with IBD (i.e. age, obesity, DM2, previous bowel surgery, IBD evolution time, methotrexate treatment), OSA (i.e. obesity, DM2, OSA severity, increased transaminases) and psoriasis (i.e. age, metabolic factors, severe psoriasis, arthropathy, elevated transaminases, methotrexate treatment). These specific phenotypes might be used by gastroenterologists, pneumologists and dermatologists to create screening algorithms for NAFLD. Such algorithms should include non-invasive markers of fibrosis used in NAFLD to select subjects for referral to the hepatologist. Prospective, controlled studies in NAFLD patients with extrahepatic comorbidities are required to demonstrate a causal relationship and also that appropriate multidisciplinary management improves these patients' prognosis and survival.


Assuntos
Diabetes Mellitus Tipo 2 , Hepatopatia Gordurosa não Alcoólica , Psoríase , Humanos , Intestinos , Pulmão , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Hepatopatia Gordurosa não Alcoólica/terapia , Estudos Prospectivos , Fatores de Risco
11.
Dermatol Ther (Heidelb) ; 11(6): 2207-2215, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34561788

RESUMO

INTRODUCTION: There is limited and conflicting evidence over the real-world drug survival of secukinumab (SEC) in patients with psoriasis, especially in the long term. Our objective was to analyze the short- and long-term survival of SEC (S-SEC) and its predictive factors for the treatment of psoriasis. METHODS:  Patients clinically diagnosed with plaque psoriasis and under treatment with secukinumab (n = 384) in a daily practice setting were analyzed in a retrospective, multicenter study performed in a nationwide cohort and followed up for a period of 2 years. Kaplan-Meier curve was plotted to analyze drug survival time, and log-rank test was performed to compare several groups. Factors related to speed of treatment discontinuation were studied with a Cox regression model. RESULTS: The overall cumulative secukinumab drug survival rates observed at 6, 12, 18, and 24 months were 97.1%, 89.0%, 81.1%, and 74.3%, respectively. Obesity [hazard ratio (HR), 1.809, CI 95% 1.114-2.962; p = 0.004] and previous experience with biological therapies, particularly those who had been treated with ≥ 2 biologicals with different mechanisms of action (HR 3.476, CI 95% 1.875-6.444; p = 0.017) were associated with an early discontinuation, whereas psoriatic arthritis was associated with delayed discontinuation, (HR 0.493, CI 95% 0.265-0.917; p = 0.025). CONCLUSIONS: In our study, we found that cumulative secukinumab drug survival for psoriasis patients for the period 6-18 months was in the range of real-world evidence studies. Additionally, we observed a relatively high long-term survival rate at 24 months (74.3%).

12.
J Allergy Clin Immunol ; 147(1): 60-71, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33075408

RESUMO

BACKGROUND: The multimorbid burden and use of systemic immunosuppressants in people with psoriasis may confer greater risk of adverse outcomes of coronavirus disease 2019 (COVID-19), but the data are limited. OBJECTIVE: Our aim was to characterize the course of COVID-19 in patients with psoriasis and identify factors associated with hospitalization. METHODS: Clinicians reported patients with psoriasis with confirmed/suspected COVID-19 via an international registry, Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection. Multiple logistic regression was used to assess the association between clinical and/or demographic characteristics and hospitalization. A separate patient-facing registry characterized risk-mitigating behaviors. RESULTS: Of 374 clinician-reported patients from 25 countries, 71% were receiving a biologic, 18% were receiving a nonbiologic, and 10% were not receiving any systemic treatment for psoriasis. In all, 348 patients (93%) were fully recovered from COVID-19, 77 (21%) were hospitalized, and 9 (2%) died. Increased hospitalization risk was associated with older age (multivariable-adjusted odds ratio [OR] = 1.59 per 10 years; 95% CI = 1.19-2.13), male sex (OR = 2.51; 95% CI = 1.23-5.12), nonwhite ethnicity (OR = 3.15; 95% CI = 1.24-8.03), and comorbid chronic lung disease (OR = 3.87; 95% CI = 1.52-9.83). Hospitalization was more frequent in patients using nonbiologic systemic therapy than in those using biologics (OR = 2.84; 95% CI = 1.31-6.18). No significant differences were found between classes of biologics. Independent patient-reported data (n = 1626 across 48 countries) suggested lower levels of social isolation in individuals receiving nonbiologic systemic therapy than in those receiving biologics (OR = 0.68; 95% CI = 0.50-0.94). CONCLUSION: In this international case series of patients with moderate-to-severe psoriasis, biologic use was associated with lower risk of COVID-19-related hospitalization than with use of nonbiologic systemic therapies; however, further investigation is warranted on account of potential selection bias and unmeasured confounding. Established risk factors (being older, being male, being of nonwhite ethnicity, and having comorbidities) were associated with higher hospitalization rates.


Assuntos
COVID-19 , Hospitalização , Psoríase , Sistema de Registros , SARS-CoV-2 , Adulto , Fatores Etários , COVID-19/mortalidade , COVID-19/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psoríase/mortalidade , Psoríase/terapia , Fatores de Risco , Fatores Sexuais
13.
Acta Derm Venereol ; 101(1): adv00354, 2021 01 04.
Artigo em Inglês | MEDLINE | ID: mdl-33269405

RESUMO

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.


Assuntos
Produtos Biológicos , Psoríase , Produtos Biológicos/efeitos adversos , Feminino , Humanos , Masculino , Prescrições , Estudos Prospectivos , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Sistema de Registros
15.
Dermatol Ther ; 33(6): e14066, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32713119

RESUMO

The objective of the study was to evaluate efficacy and safety of ixekizumab in psoriasis patients under clinical practice conditions. Observational, retrospective, multicentre study that included patients with ixekizumab from March 2017 to March 2019. ≥ 90% reduction in the Psoriasis Area and Severity Index (PASI 90) and absolute PASI <2 were the parameters used to assess treatment response. Adverse events (AEs) were collected. Of the 301 patients included, 111 were women (36.9%), mean age was 48.5 (±13.5) years. Mean baseline PASI score was 13.5 (±7.7). More than half of the patients (68.5%) had received at least one biological drug before. At 3 months, 208 (76.5%) patients achieved PASI <2 and 156 (57.3%) PASI 90. At 12 months, 130 (73.4%) patients achieved absolute PASI <2 and 104 (58.7%) PASI 90. Multivariate analysis revealed that prior use of biologics was influential in achieving PASI <2 at both 3 and 12 months (OR 2.82, P = .006; OR 9.51, P < .001, respectively). Sixty-five patients (21.59%) exhibited at least one AE, injection site reaction was the most common (39; 36.8%). Likewise in trials, ixekizumab displayed an excellent profile of safety and efficacy also in real-life. Effectiveness appears superior in biologic-naive patients.


Assuntos
Fármacos Dermatológicos , Psoríase , Anticorpos Monoclonais Humanizados/efeitos adversos , Fármacos Dermatológicos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
16.
Dermatol Ther ; 33(4): e13678, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32447810

RESUMO

A change of pricing policy in Spain have made both doses of ustekinumab (UST), 45 and 90 mg, recently available at the same price. Our primary objective was to evaluate effectiveness of UST 90 mg at 52 and 104 weeks in psoriasis patients in clinical practice; secondary objectives were to study the reasons for using this dose and to delineate its efficacy in patients previously treated with anti-IL17 drugs. 91.8% of the 141 patients treated with UST 90 started with 45 mg and later increased their dose. Clinicians changed dose due to weight over 100 kg in 20.6% of the cases and all the other dose changes were off-label to improve partial cutaneous or articular response or due to a previous failure of anti-IL17 therapy. After 12 months of UST 90 treatment, absolute PASI was lower than 3 in 87.5% of patients and lower than 1 in 72.2%. Efficacy data were even better for patients with body mass index (BMI) <25. UST 90 can be effective in patients with previous use of anti-IL17 drugs. It appears to be an alternative treatment option not only for high BMI patients, but also to increase the cutaneous or articular efficacy of the drug in patients with normal BMI.


Assuntos
Fármacos Dermatológicos , Psoríase , Índice de Massa Corporal , Fármacos Dermatológicos/efeitos adversos , Humanos , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Estudos Retrospectivos , Espanha , Resultado do Tratamento , Ustekinumab/efeitos adversos
17.
J Am Acad Dermatol ; 83(1): 139-150, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32213306

RESUMO

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.


Assuntos
Psoríase/tratamento farmacológico , Adulto , Idoso , Terapia Biológica/efeitos adversos , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Espanha , Fatores de Tempo
18.
Reumatol. clín. (Barc.) ; 16(1): 24-31, ene.-feb. 2020. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-194256

RESUMO

OBJETIVO: 1) Analizar la implementación de los modelos de atención multidisciplinar en pacientes con artritis psoriásica (APs), y 2) definir estándares de calidad de mínimos y de excelencia. MÉTODOS: Se envió una encuesta a profesionales que ya realizan atención multidisciplinar o están en vías preguntando por: 1) tipo de modelo de abordaje multidisciplinar, y 2) grado, prioridad y facilidad de la implementación de los estándares de calidad de estructura, proceso y resultado. En 6 reuniones regionales se presentaron y discutieron los resultados de la encuesta, tanto a nivel nacional como regional, y se definió la prioridad definitiva de los estándares de calidad. En una reunión de grupo nominal, 11 expertos (reumatólogos y dermatólogos) analizaron los resultados de la encuesta y las reuniones regionales. Con ello definieron qué estándares de calidad son actualmente de mínimos y cuáles de excelencia. RESULTADOS: Los modelos de atención multidisciplinar conjunto y paralelo son los más implementados, y los de los estándares de calidad es muy variable: en los de estructura varía del 22 al 74%, en los de proceso del 17 al 54% y en los de resultado del 2 al 28%. De los 25 estándares de calidad originales, 9 se consideran solo de mínimos, 4 de excelencia y 12 tienen definidos unos criterios para ser de mínimos y otros para la excelencia. CONCLUSIONES: La definición de estándares de calidad de mínimos y de excelencia ayudará en la consecución del objetivo de la atención multidisciplinar para pacientes con APs, que es la mejor asistencia sanitaria posible


OBJECTIVE: 1) To analyze the implementation of multidisciplinary care models in psoriatic arthritis (PsA) patients, 2) To define minimum and excellent standards of care. METHODS: A survey was sent to clinicians who already performed multidisciplinary care or were in the process of undertaking it, asking: 1) Type of multidisciplinary care model implemented; 2) Degree, priority and feasibility of the implementation of quality standards in the structure, process and result for care. In 6 regional meetings the results of the survey were presented and discussed, and the ultimate priority of quality standards for care was defined. At a nominal meeting group, 11 experts (rheumatologists and dermatologists) analyzed the results of the survey and the regional meetings. With this information, they defined which standards of care are currently considered as minimum and which are excellent. RESULTS: The simultaneous and parallel models of multidisciplinary care are those most widely implemented, but the implementation of quality standards is highly variable. In terms of structure it ranges from 22% to 74%, in those related to process from 17% to 54% and in the results from 2% to 28%. Of the 25 original quality standards for care, 9 were considered only minimum, 4 were excellent and 12 defined criteria for minimum level and others for excellence. CONCLUSIONS: The definition of minimum and excellent quality standards for care will help achieve the goal of multidisciplinary care for patients with PAs, which is the best healthcare possible


Assuntos
Humanos , Artrite Psoriásica/epidemiologia , Comunicação Interdisciplinar , Projetos , Padrão de Cuidado , Indicadores de Qualidade em Assistência à Saúde , Inquéritos e Questionários , Qualidade da Assistência à Saúde , Espanha
20.
Reumatol Clin (Engl Ed) ; 16(1): 24-31, 2020.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-29496420

RESUMO

OBJECTIVE: 1) To analyze the implementation of multidisciplinary care models in psoriatic arthritis (PsA) patients, 2) To define minimum and excellent standards of care. METHODS: A survey was sent to clinicians who already performed multidisciplinary care or were in the process of undertaking it, asking: 1) Type of multidisciplinary care model implemented; 2) Degree, priority and feasibility of the implementation of quality standards in the structure, process and result for care. In 6 regional meetings the results of the survey were presented and discussed, and the ultimate priority of quality standards for care was defined. At a nominal meeting group, 11 experts (rheumatologists and dermatologists) analyzed the results of the survey and the regional meetings. With this information, they defined which standards of care are currently considered as minimum and which are excellent. RESULTS: The simultaneous and parallel models of multidisciplinary care are those most widely implemented, but the implementation of quality standards is highly variable. In terms of structure it ranges from 22% to 74%, in those related to process from 17% to 54% and in the results from 2% to 28%. Of the 25 original quality standards for care, 9 were considered only minimum, 4 were excellent and 12 defined criteria for minimum level and others for excellence. CONCLUSIONS: The definition of minimum and excellent quality standards for care will help achieve the goal of multidisciplinary care for patients with PAs, which is the best healthcare possible.


Assuntos
Artrite Psoriásica/terapia , Dermatologistas , Equipe de Assistência ao Paciente , Desenvolvimento de Programas , Qualidade da Assistência à Saúde/normas , Reumatologistas , Pesquisas sobre Atenção à Saúde , Implementação de Plano de Saúde/normas , Humanos , Espanha , Padrão de Cuidado , Resultado do Tratamento
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