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1.
Chinese Medical Journal ; (24): 1324-1328, 2021.
Article in English | WPRIM | ID: wpr-878163

ABSTRACT

BACKGROUND@#There have been few real-life dose-comparing studies on the efficacy and safety of secukinumab in Chinese patients with plaque psoriasis. We conducted a real-life cohort study to investigate the efficacy and safety of secukinumab 150 and 300 mg in Chinese patients with moderate-to-severe plaque psoriasis.@*METHODS@#A total of 106 patients with moderate-to-severe plaque psoriasis were included in this study. Patients received either secukinumab 150 mg or secukinumab 300 mg according to patients' weights and severity of psoriasis. The treatment continued for at least 24 weeks. The efficacy was evaluated by improvement in the psoriasis area and severity index (PASI) scores. The safety was also analyzed.@*RESULTS@#Fifty-nine patients (55.7%) were treated with secukinumab 300 mg and 47 patients (44.3%) were treated with secukinumab 150 mg. After 12-week treatment, PASI75/90/100 responses were achieved in 100%, 97.8%, and 95.7% of patients, respectively, in secukinumab 150 mg group, and the efficacy was maintained to week 24. In secukinumab 300 mg group, PASI75/90/100 responses were achieved in 93.2%, 81.4%, and 76.3% of patients, respectively, at week 12. In this group, PASI75/90/100 responses reached 91.5%, 86.4%, and 79.9%, respectively, at week 24. Biologic-experienced patients had lower responses than biologic-naïve patients. Secukinumab 150 and 300 mg were well tolerated. Five patients discontinued treatment due to poor response, adverse event, or economic reasons.@*CONCLUSIONS@#This real-life study demonstrated that high PASI 90 and PASI 100 responses were achieved in Chinese psoriasis patients receiving secukinumab 150 or 300 mg. Biologic-naïve was associated with better clinical efficacy.


Subject(s)
Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal, Humanized , China , Cohort Studies , Humans , Psoriasis/drug therapy , Severity of Illness Index , Treatment Outcome
3.
Medwave ; 20(10): e8064, 30-11-2020.
Article in English, Spanish | LILACS | ID: biblio-1145807

ABSTRACT

Introducción La psoriasis es una enfermedad crónica que compromete la piel, padecida por cerca de 125 millones de personas en todo el mundo. En un grupo determinado de pacientes, también puede afectar el sistema articular. Para el control y seguimiento de los pacientes con psoriasis se estableció la aplicación de los índices de severidad del área de psoriasis y de calidad de vida dermatológica. Ambos parámetros son necesarios para el inicio de terapia biológica, según lo establecido en la guía de manejo de psoriasis (2015) del comité nacional de enfermedades reumatológicas, inmunológicas y de metabolismo óseo del Instituto Venezolano de los Seguros Sociales. Objetivo Caracterizar las variables clínicas, epidemiológicas y la prescripción de terapia biológica en los pacientes con psoriasis que acceden al programa de dispensación de alto costo de la farmacia del Instituto Venezolano de los Seguros Sociales. Método Es un estudio descriptivo, transversal. Resultados Se evaluaron 374 expedientes, donde el sexo masculino fue más frecuente con 56,1% (p < 0,001), provenientes en su mayoría de la ciudad de Caracas, en la comparación de los grupos de edad con el sexo, se observó que existía una diferencia entre estos (p < 0,05). El 57,5% usó previamente metotrexato; 6,68% biológicos; 3,2% esteroides tópicos y 31% no reportó qué tipo de terapia previa recibía. Dentro de las presentaciones clínicas, 70% correspondió a la psoriasis en placa. El 79% de los pacientes presentaba actividad moderada según el índice de la severidad del área de psoriasis, y al 11% se les realizó el índice de calidad de vida dermatológica, de los cuales 39% presentaban un efecto extremadamente importante. El rango anérgico de la prueba de Mantoux representó 70,9% de los casos, donde al 0,3% le fue realizado la prueba de Booster, y la radiografía de tórax se reportó normal en 95%. El medicamento biológico más demandado fue el etanercept con 52% de los casos. Conclusiones El sexo masculino y su relación con la psoriasis fue un hallazgo de importancia, como también se evidenció la necesidad de mejorar los componentes administrativos en la gestión de los formatos de solicitud de medicamentos y fortalecer la aplicación de la clinimetría con elemento de buena práctica médica.


Introduction Psoriasis is a chronic disease that affects the skin. One hundred twenty-five million people around the world suffer from this condition. In specific groups of patients, the joints may also be involved. To control and follow-up patients with psoriasis, psoriasis area severity and dermatological quality of life measurements were established. Both parameters are necessary for the initiation of biological therapy, as specified in the psoriasis management guide (2015) of the national committee of rheumatological, immunological, and bone metabolism diseases of the Venezuelan Institute of Social Security. Objective To characterize the clinical and epidemiological variables and the prescription of biological therapy in patients with psoriasis who access the high-cost dispensing program of the Venezuelan Institute Social Security (IVSS) pharmacy. Methods This is a descriptive, cross-sectional study. Results A total of 374 patient records were assessed. The male gender was more frequent, with 56.1% (p <0.001), mostly from Caracas city. In comparing age groups with sex, a difference among these was observed (p <0.05). 57.5% previously used methotrexate, 6.68% biological, 3.2% topical steroids, and 31% did not report which type of previous therapy they had received. Amongst the clinical presentations, 70% corresponded to plaque psoriasis. 79% of the patients presented moderate activity according to the Psoriasis Area and Severity Index (PASI): Eleven percent were assessed with the Dermatology Life Quality Index (DLQI); 39% of them reported an extremely important effect. The anergic range of the Mantoux test represented 70.9% of the cases, and 0.3% took the booster evaluation. Chest X-ray was reported normal in 95% of the cases. The most demanded biological medicine was etanercept, in 52% of the cases. Conclusions Male gender and its association with psoriasis was an important finding. The need to improve the administrative components in completing the medication request formats and strengthen clinical measurements and good medical practice was also found.


Subject(s)
Humans , Male , Psoriasis/drug therapy , Psoriasis/epidemiology , Quality of Life , Biological Therapy , Venezuela/epidemiology , Severity of Illness Index , Cross-Sectional Studies , Prescriptions
4.
Chinese Medical Journal ; (24): 2905-2909, 2020.
Article in English | WPRIM | ID: wpr-877912

ABSTRACT

BACKGROUND@#Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis.@*METHODS@#We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12.@*RESULTS@#The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported.@*CONCLUSION@#During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis.@*TRIAL REGISTRATION@#Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300.


Subject(s)
Double-Blind Method , Follow-Up Studies , Humans , Ointments , Psoriasis/drug therapy , Resorcinols , Severity of Illness Index , Stilbenes , Treatment Outcome
5.
Chinese Medical Journal ; (24): 2665-2673, 2020.
Article in English | WPRIM | ID: wpr-877883

ABSTRACT

BACKGROUND@#Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis.@*METHODS@#This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12.@*RESULTS@#A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.@*CONCLUSION@#Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis.@*TRIAL REGISTRATION@#ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized , China , Double-Blind Method , Humans , Psoriasis/drug therapy , Severity of Illness Index , Treatment Outcome
6.
Braz. j. med. biol. res ; 53(12): e10109, 2020. graf
Article in English | LILACS, ColecionaSUS | ID: biblio-1132504

ABSTRACT

Psoriasis is a chronic inflammatory skin disorder in humans, and the inflammatory reaction plays an important role in development and onset of psoriasis. 4'-O-β-D-glucosyl-5-O-methylvisamminol (4GMV) is one of the major active chromones isolated from Saposhnikoviae divaricata (Turcz.) Schischk, which has been reported to exhibit excellent anti-inflammatory activities. However, the possible therapeutic effect on psoriasis and underlying mechanism has not been reported. Thus, the aim of this study was to investigate the protective effect of 4GMV on the imiquimod (IMQ)-induced psoriasis-like lesions in BALB/c mice and the anti-inflammatory effect on the lipopolysaccharide (LPS)-induced inflammation in RAW264.7 macrophages. The results demonstrated that 4GMV decreased IMQ-induced keratinocyte proliferation and inflammatory cell infiltration. Moreover, 4GMV treatment significantly inhibited the production of NO, PEG 2, and cytokines such as interleukin (IL)-1β, IL-6, interferon (IFN)-γ, and IL-22 in LPS-stimulated RAW264.7 macrophages. 4GMV also suppressed the LPS-upregulated protein expressions of iNOS and COX-2 in a dose-dependent manner. Furthermore, qRT-PCR analysis showed that 4GMV down-regulated the mRNA level of IL-1β and IL-6 expression. Further studies by western blot indicated that 4GMV inhibited the activation of upstream mediator NF-κB by suppressing the expression of TLR4 and the phosphorylation of IκBα and p65. The phosphorylation of JNK, p38, and ERK were also markedly reversed by 4GMV in LPS-treated RAW264.7 macrophages. Taken together, these results demonstrated that 4GMV showed a protective effect in IMQ-induced psoriasis-like mice and inhibited inflammation through the NF-κB and MAPK signaling pathways, indicating that 4GMV might be a potential therapeutic drug for psoriasis.


Subject(s)
Animals , Rabbits , Psoriasis/chemically induced , Psoriasis/drug therapy , Dermatitis , Lipopolysaccharides , Cytokines , NF-kappa B , Chromones , MAP Kinase Signaling System , Imiquimod , Glucosides , Inflammation , Mice, Inbred BALB C
7.
Biol. Res ; 53: 48, 2020. graf
Article in English | LILACS | ID: biblio-1142415

ABSTRACT

BACKGROUND: Psoriasis is a common chronic inflammatory skin disease. Keratinocytes hyperproliferation and excessive inflammatory response contribute to psoriasis pathogenesis. The agents able to attenuate keratinocytes hyper-proliferation and excessive inflammatory response are considered to be potentially useful for psoriasis treatment. Daphnetin exhibits broad bioactivities including anti-proliferation and anti-inflammatory. This study aims to evaluate the anti-psoriatic potential of daphnetin in vitro and in vivo, and explore underlying mechanisms. METHODS: HaCaT keratinocytes was stimulated with the mixture of IL-17A, IL-22, oncostatin M, IL-1α, and TNF-α (M5) to establish psoriatic keratinocyte model in vitro. Cell viability was measured using Cell Counting Kit-8 (CCK-8). Quantitative Real-Time PCR (qRT-PCR) was performed to measure the mRNA levels of hyperproliferative marker gene keratin 6 (KRT6), differentiation marker gene keratin 1 (KRT1) and inflammatory factors IL-1ß, IL-6, IL-8, TNF-α, IL-23A and MCP-1. Western blotting was used to detect the protein levels of p65 and p-p65. Indirect immunofluorescence assay (IFA) was carried out to detect p65 nuclear translocation. Imiquimod (IMQ) was used to construct psoriasis-like mouse model. Psoriasis severity (erythema, scaling) was scored based on Psoriasis Area Severity Index (PASI). Hematoxylin and eosin (H&E) staining was performed to examine histological change in skin lesion. The expression of inflammatory factors including IL-6, TNF-α, IL-23A and IL-17A in skin lesion was measured by qRT-PCR. RESULTS: Daphnetin attenuated M5-induced hyperproliferation in HaCaT keratinocytes. M5 stimulation significantly upregulated mRNA levels of IL-1ß, IL-6, IL-8, TNF-α, IL-23A and MCP-1. However, daphnetin treatment partially attenuated the upregulation of those inflammatory cytokines. Daphnetin was found to be able to inhibit p65 phosphorylation and nuclear translocation in HaCaT keratinocytes. In addition, daphnetin significantly ameliorate the severity of skin lesion (erythema, scaling and epidermal thickness, inflammatory cell infiltration) in IMQ-induced psoriasis-like mouse model. Daphnetin treatment attenuated IMQ-induced upregulation of inflammatory cytokines including IL-6, IL-23A and IL-17A in skin lesion of mice. CONCLUSIONS: Daphnetin was able to attenuate proliferation and inflammatory response induced by M5 in HaCaT keratinocytes through suppression of NF-κB signaling pathway. Daphnetin could ameliorate the severity of skin lesion and improve inflammation status in IMQ-induced psoriasis-like mouse model. Daphnetin could be an attractive candidate for future development as an anti-psoriatic agent.


Subject(s)
Humans , Animals , Mice , Rabbits , Psoriasis/chemically induced , Psoriasis/drug therapy , Umbelliferones/pharmacology , Adjuvants, Immunologic/adverse effects , Imiquimod/adverse effects , Inflammation/drug therapy , Anti-Inflammatory Agents/pharmacology , Keratinocytes , Cell Proliferation , Mice, Inbred BALB C
8.
Rev. cuba. estomatol ; 56(4): e2010, oct.-dez. 2019. graf
Article in Portuguese | LILACS | ID: biblio-1093257

ABSTRACT

RESUMO Introdução: a psoríase é uma doença inflamatória crônica e recorrente da pele que raramente ocorre apenas e primariamente na mucosa bucal. Objetivo: A descrever um caso de psoríase primária na mucosa bucal. Apresentação do caso: Um paciente de 16 anos de idade relatou uma "mancha que fez com que se sentisse desconfortável". O paciente apresentava uma placa leucoplásica, exofítica e uma úlcera. Na histopatologia e com as características clínicas, a suspeita de mucosite psoriasiforme foi confirmada. O tratamento escolhido para as lesões da psoríase foi a aplicação tópica de valerato de betametasona 1 mg/g por três semanas. Após duas semanas de tratamento, o paciente retornou para reavaliação clínica e foi observado sucesso na terapêutica. Conclusões: A presença de psoríase exclusiva na cavidade bucal é uma entidade rara. A apresentação clínica variada e a ausência de alterações locais ou sistêmicas associadas foram elementos-chave na suspeição diagnóstica. A abordagem por meio de cirurgia para remoção da lesão exofítica e o uso de betametasona tópica permitiram o controle locorregional(AU)


RESUMEN Introducción: La psoriasis es una enfermedad inflamatoria crónica y recurrente de la piel y que en rara ocasión ocurre única y por primaria vez en mucosa bucal. Objetivo: Describir un caso de psoriasis primaria en mucosa bucal. Presentación de caso: Paciente de 16 años de edad consultada que refirió una "mancha que incomodaba al comer". La paciente presentaba una placa leucoplásica, exofítica y una úlcera. En la histopatología y con las características clínicas, se confirmó la sospechosa de mucositis psoriasiforme. El tratamiento elegido para las lesiones de psoriasis fue la aplicación tópica de valerato de betametasona 1 mg/g durante tres semanas. Después de dos semanas de tratamiento la paciente retornó para reevaluación clínica y se constató éxito en la terapéutica escogida. Conclusiones: la presencia de psoriasis exclusiva en la cavidad bucal es una entidad poco frecuente. La presentación clínica variada y la ausencia de alteraciones locales o sistémicas asociadas fueron elementos clave en la sospecha diagnóstica. El abordaje por medio de cirugía para remoción de la lesión exofítica y utilización de betametasona tópica posibilitó el control locorregional(AU)


ABSTRACT Introduction: Psoriasis is a chronic inflammatory and recurrent skin disease that rarely occurs solely and primarily in the oral mucosa. Objective: Describe a case of primary psoriasis of the oral mucosa. Case presentation: A 16-year-old female patient attends consultation and reports "a spot that hurts when eating." Clinical observation revealed the presence of leukoplastic, exophytic plaque and an ulcer. Histopathological examination confirmed the suspicion of psoriasiform mucositis. The treatment chosen for the psoriatic lesions was topical application of betamethasone valerate 1 mg/g for three weeks. After two weeks of treatment, the patient returned for clinical reassessment and the treatment applied was found to have been successful. Conclusions: Exclusively oral psoriasis is an uncommon condition. Multi-faceted clinical presentation and the absence of local or systemic associated alterations were key elements in the diagnostic suspicion. Surgical removal of the exophytic lesion and application of topical betamethasone led to locoregional control(AU)


Subject(s)
Humans , Female , Adolescent , Psoriasis/drug therapy , Stomatitis/diagnosis , Betamethasone/therapeutic use , Mouth/injuries
9.
Arq. gastroenterol ; 56(3): 261-263, July-Sept. 2019. tab, graf
Article in English | LILACS | ID: biblio-1038723

ABSTRACT

ABSTRACT BACKGROUND: Psoriasis is an inflammatory skin disease that affects 1%-3% of Caucasian populations and may be persistent, disfiguring and stigmatising. Proton pump inhibitors (PPI) are potent blockers of gastric acid secretion. They are widely regarded as the agents of choice for the treatment of acid-peptic disorders. In addition to anti-secretory effects PPI have been found to have anti-oxidant properties and direct effects on neutrophils, monocytes, endothelial, and epithelial cells that might prevent inflammation. OBJECTIVE: This study evaluated the treatment of psoriasis with esomeprazole. METHODS: Ten patients were selected and psoriasis was evaluated according to Psoriasis Area and Severity Index (PASI). Exclusion criteria included concomitant use of any treatment for Psoriasis, organic diseases, use of other PPI than esomeprazole. Patients were medicated with esomeprazole 40 mg B.I.D. for 90 days. At the 90th day the patients were evaluated according PASI score. RESULTS: Statistically significant results were seen when compared PASI before and at 90th day of treatment (P=0.0002). CONCLUSION: The use of esomeprazole for psoriasis resulted in excellent clinical results with a significant reduction of PASI score.


RESUMO CONTEXTO: A psoríase é uma doença inflamatória da pele que afeta 1%-3% das populações caucasianas e pode ser persistente, desfigurante e estigmatizante. Inibidores da bomba de prótons (IBP) são potentes bloqueadores da secreção de ácido no estômago. Eles são considerados como os agentes de escolha para o tratamento de doenças ácido-pépticas. No entanto, além dos efeitos anti-secretores, IBP apresentam propriedades anti-oxidantes e efeitos diretos sobre os neutrófilos, monócitos, células epiteliais e endoteliais que podem impedir a inflamação. OBJETIVO: Avaliar o tratamento da psoríase com esomeprazol. MÉTODOS: Foram selecionados pacientes adultos (18 anos ou mais) com psoríase. Os critérios de exclusão foram o uso concomitante de qualquer tratamento para a psoríase, doenças orgânicas e uso de outro IBP. Foram selecionados 10 pacientes e a psoríase foi avaliada pelo índice de gravidade e área da psoríase (Psoriasis Area and Severity Index - PASI). Os pacientes foram medicados com esomeprazol 40 mg BID por 90 dias. No nonagésimo dia os pacientes foram novamente avaliados por meio do PASI. RESULTADOS: Dados estatisticamente significativos foram vistos quando comparado PASI antes do tratamento e no nonagésimo dia de tratamento, P=0,0002. CONCLUSÃO: O uso do esomeprazol para psoríase apresentou excelentes resultados clínicos com redução importante do PASI. Este estudo piloto é a primeira publicação na literatura inglesa sobre o tratamento da psoríase com esomeprazol.


Subject(s)
Humans , Male , Female , Adult , Aged , Psoriasis/drug therapy , Proton Pump Inhibitors/therapeutic use , Esomeprazole/therapeutic use , Pilot Projects , Middle Aged
12.
An. bras. dermatol ; 94(2): 224-226, Mar.-Apr. 2019. graf
Article in English | LILACS | ID: biblio-1001141

ABSTRACT

Abstract Psoriasis has been associated with various autoimmune diseases, however, its relation to bullous diseases is infrequent. Of these, bullous pemphigoid appears as the main associated entity, even though both conditions differ considerably in demographic and clinical aspects. We report the case of a 42-year-old female patient, with long-standing psoriasis who consulted due to the exacerbation of psoriatic plaques associated with generalized bullous lesions on the skin and oral mucosa, with one-week duration. With clinical signs and histopathological findings compatible with bullous pemphigoid associated with psoriasis, we decided to treat her with methotrexate 10mg a week. The patient had an excellent response after two months of treatment.


Subject(s)
Humans , Adult , Psoriasis/drug therapy , Methotrexate/therapeutic use , Pemphigoid, Bullous/drug therapy , Dermatologic Agents/therapeutic use , Psoriasis/complications , Psoriasis/diagnosis , Pemphigoid, Bullous/complications , Pemphigoid, Bullous/diagnosis , Treatment Outcome , Fluorescent Antibody Technique, Direct
13.
Rev. Assoc. Med. Bras. (1992) ; 65(4): 530-534, Apr. 2019.
Article in English | LILACS | ID: biblio-1003055

ABSTRACT

The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.


Subject(s)
Humans , Psoriasis/drug therapy , Dermatologic Agents/administration & dosage , Immunosuppressive Agents/administration & dosage , Antibodies, Monoclonal/administration & dosage , Psoriasis/pathology , Time Factors , Severity of Illness Index , Brazil , Methotrexate/administration & dosage , Methotrexate/adverse effects , Treatment Outcome , Cyclosporine/administration & dosage , Cyclosporine/adverse effects , Acitretin/administration & dosage , Acitretin/adverse effects , Dermatologic Agents/adverse effects , Clinical Decision-Making , Immunosuppressive Agents/adverse effects , Antibodies, Monoclonal/adverse effects
14.
Rev. Assoc. Med. Bras. (1992) ; 65(4): 493-508, Apr. 2019. tab
Article in English | LILACS | ID: biblio-1003057

ABSTRACT

The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.


Subject(s)
Humans , Psoriasis/drug therapy , Etanercept/administration & dosage , Immunologic Factors/administration & dosage , Antibodies, Monoclonal/administration & dosage , Psoriasis/pathology , Time Factors , Severity of Illness Index , Brazil , Risk Factors , Treatment Outcome , Etanercept/adverse effects , Clinical Decision-Making , Immunologic Factors/adverse effects , Antibodies, Monoclonal/adverse effects
15.
Medicina (B.Aires) ; 78(4): 272-281, ago. 2018. ilus, tab
Article in Spanish | LILACS | ID: biblio-954994

ABSTRACT

Con la aparición de los tratamientos biológicos, se ha modificado la terapéutica de muchas enfermedades, en especial las reumatológicas, dermatológicas y oncológicas. Debido al alto costo de estos productos y el vencimiento de las patentes, la industria farmacológica desarrolla los biosimilares, fármacos que son una versión (copia) de la sustancia de un medicamento biológico original, y que pueden facilitar el acceso a estos tratamientos. Son elaborados de acuerdo a exigencias específicas de organismos reguladores en cuanto a calidad, eficacia y seguridad, y debe demostrarse que son comparables al medicamento de referencia. Este trabajo revisa las normativas regulatorias internacionales y nacionales, las controversias que rodean a los biosimilares y presenta la posición de un grupo de expertos con respecto al uso de biosimilares.


With the appearance of biological treatments, therapeutics has changed in many rheumatological, dermatological and oncological diseases. Due to the high cost of these biological medicaments and the expiration of patents, the pharmacological industry develops biosimilars, drugs that are a version (copy) of the substance of the original biological medicine, with the aim of facilitating access to these treatments. These biosimilars are prepared according to the specific requirements of regulatory bodies in terms of quality, efficacy and safety, and must be shown they are comparable to the reference product. This paper reviews the international and national regulatory framework, the controversies surrounding biosimilars, and presents the position of a group of experts regarding the use of biosimilars.


Subject(s)
Humans , Psoriasis/drug therapy , Dermatologic Agents/administration & dosage , Biosimilar Pharmaceuticals/administration & dosage , Legislation, Drug , Argentina , Societies, Medical , Consensus
16.
Rev. Assoc. Med. Bras. (1992) ; 64(7): 643-648, July 2018. tab, graf
Article in English | LILACS | ID: biblio-976834

ABSTRACT

SUMMARY Objective: The objective of this study was to analyse the existing bibliographic production on clinical trials related to the use of vitamin D for oral treatment of psoriasis. Method: A literature review of clinical trials related to the use of vitamin D for oral treatment of psoriasis, published in the LILACS, Scielo, Medline, PubMed and Cochrane Library from 1986 to 2013. The search included the following terms: "Psoriasis and oral Vitamin D"; "psoríase e vitamina D oral". Results: After analysing the titles and summaries, 10 articles met the eligibility criteria. Discussion: According to the literature, most tests were made in moderate psoriasis with doses ranging from 0.25 to 2μg, demonstrating improvement with this treatment modality. Some studies suggest the use of high doses, but the biggest concern is hypercalciuria as a side effect. Conclusion: The use of active metabolites of vitamin D orally for the treatment of psoriasis showed efficacy and safety.


RESUMO OBJETIVO: O objetivo deste estudo foi analisar a produção bibliográfica existente sobre os ensaios clínicos relacionados ao uso da vitamina D para tratamento por via oral da psoríase. MÉTODOS: Revisão de literatura de ensaios clínicos relacionados ao uso de vitamina D para tratamento por via oral da psoríase publicados no Lilacs, SciELO, MedLine, PubMed e Biblioteca Cochrane no período de 1986 a 2013. A pesquisa incluiu os seguintes termos: "Psoriasis and oral Vitamin D"; "psoríase e vitamina D oral". RESULTADOS: Depois de analisar os títulos e resumos, dez artigos preencheram os critérios de elegibilidade. DISCUSSÃO: Segundo a literatura, a maioria dos ensaios foi realizada na psoríase moderada, com dose que varia de 0,25 a 2 μg, demonstrando melhora com esta modalidade terapêutica. Alguns estudos sugerem o uso de doses elevadas, porém a maior preocupação é a hipercalciúria como efeito colateral. CONCLUSÃO: O uso de metabólitos ativos de vitamina D por via oral para o tratamento da psoríase demonstrou eficácia e segurança com relação aos efeitos colaterais.


Subject(s)
Humans , Female , Psoriasis/drug therapy , Vitamin D/therapeutic use , Vitamins/therapeutic use , Psoriasis/etiology , Vitamin D/adverse effects , Vitamin D Deficiency/complications , Vitamins/adverse effects , Administration, Oral , Clinical Trials as Topic
17.
An. bras. dermatol ; 93(3): 438-440, May-June 2018. graf
Article in English | LILACS | ID: biblio-949870

ABSTRACT

Abstract: Erythrodermic psoriasis is a rare but severe type of psoriasis that may be triggered by human immunodeficiency virus infection. We describe the case of a 65-year-old male patient with chronic psoriasis who presents an exacerbation of his condition over a period of two weeks. Because of the severity of his case and subsequent need for systemic therapy, human immunodeficiency virus enzyme immunoassay was performed and tested positive. He thus began antiretroviral therapy combined with acitretin, showing good clinical response after 8 weeks of treatment. There is little evidence regarding the management of erythrodermic psoriasis associated with HIV infection, so antiretroviral therapy and systemic retinoid remain as the first-line treatment.


Subject(s)
Humans , Male , Aged , Psoriasis/virology , HIV Infections/complications , Dermatitis, Exfoliative/virology , Psoriasis/drug therapy , HIV Infections/drug therapy , Acitretin/therapeutic use , Anti-Retroviral Agents/therapeutic use , Keratolytic Agents/therapeutic use
18.
An. bras. dermatol ; 93(3): 385-390, May-June 2018. tab, graf
Article in English | LILACS | ID: biblio-949872

ABSTRACT

Abstract: BACKGROUND: Narrow-band UVB (NB-UVB) has been shown to be one of the most effective treatment modalities for psoriasis. Tazarotene, a known effective anti-psoriatic modality, when combined with NB-UVB may enhance the therapeutic success. OBJECTIVE: To study clinical efficacy and safety of combination of NB-UVB with topical tazarotene 0.05% gel in psoriasis. METHOD: Thirty patients with plaque psoriasis having symmetrical lesions were enrolled for 12 weeks. All patients were instructed to apply tazarotene gel on target plaque on left side of body once daily. In addition, the whole body was irradiated with NB-UVB twice weekly. Efficacy was assessed by target plaque scoring and number of treatment sessions for clearance. RESULT: Our study resulted in 3 key findings: Firstly, therapeutic efficacy of NB-UVB was enhanced by addition of tazarotene. This enhanced efficacy was more apparent in decreasing scaling and thickness as compared to decrease in erythema. Secondly, combination therapy showed faster clearance of target plaques, with reduction in mean number of treatment sessions. Thirdly, mean cumulative NB-UVB dose needed to achieve clearance of target plaques was significantly reduced with combination therapy. STUDY LIMITATIONS: The study was not randomized or controlled, but an open-label trial. The study period was relatively short, i.e., 12 weeks, without any follow-up period. CONCLUSION: Tazarotene gel significantly enhances the therapeutic efficacy of NB-UVB irradiation with faster clearance and without serious side effects.


Subject(s)
Humans , Male , Female , Adolescent , Adult , Middle Aged , Young Adult , Psoriasis/radiotherapy , Ultraviolet Therapy/methods , Follow-Up Studies , Dermatologic Agents/administration & dosage , Psoriasis/drug therapy , Time Factors , Prospective Studies , Treatment Outcome , Combined Modality Therapy/methods , Nicotinic Acids/administration & dosage
19.
Rev. medica electron ; 40(2): 471-479, mar.-abr. 2018. ilus
Article in Spanish | LILACS, CUMED | ID: biblio-902300

ABSTRACT

RESUMEN El síndrome de Sézary constituye la fase leucémica de la micosis fungoide caracterizado por eritrodermia, adenopatías superficiales y células atípicas en sangre. Predomina en los hombres con una proporción 2/1 respecto a las mujeres, y en las edades entre los 60 y 70 años de edad. La enfermedad es de difícil tratamiento, con un pronóstico reservado por su baja supervivencia. Por ser infrecuente y su posible similitud con otras dermatosis, se presenta un caso con antecedentes de psoriasis vulgar con 5 años de evolución, que hacía aproximadamente 6 meses, se encontraba sin mejoría en brote de agudización a pesar de los tratamientos indicados (AU).


ABSTRACT Sezary syndrome is the leukemic part of the fungoid mycosis, characterized by erythroderma, surface adenopathies and atypical cells in blood. It predominates in men with a 2/1 proportion in respect to women, and in ages ranging from 60 to 70 years. It is a difficult treated disease, with a reserved prognosis because of the low survival. Due to its infrequency and possible similarity to other dermatosis, it is presented a case with antecedents of vulgar psoriasis of 5 years evolution, without improvement for around 6 months, in acute outbreak in spite of the indicated treatments (AU).


Subject(s)
Humans , Male , Aged , Psoriasis/complications , Psoriasis/drug therapy , Skin Neoplasms , Sezary Syndrome/complications , Sezary Syndrome/diagnosis , Sezary Syndrome/etiology , Sezary Syndrome/mortality , Sezary Syndrome/pathology , Sezary Syndrome/epidemiology , Physical Examination , Skin Diseases , Therapeutics , Secondary Care , Biopsy/methods , Mycosis Fungoides/complications , Mycosis Fungoides/epidemiology , Oncology Service, Hospital , Diagnostic Tests, Routine
20.
Brasília; CONITEC; jan. 2018. graf, ilus.
Non-conventional in Portuguese | LILACS, BRISA | ID: biblio-905593

ABSTRACT

CONTEXTO: A artrite psoriásica (AP) é uma artrite inflamatória crônica que afeta ligamentos, tendões, fáscias, articulações axiais e periféricas e está associada à psoríase cutânea. No Brasil, o Protocolo Clínico e Diretriz Terapêutica (PCDT) do Ministério da Saúde de 2017 estabelece o tratamento não medicamentoso e medicamentoso para a AP. O tratamento medicamentoso inclui anti-inflamatórios não esteroidais (AINE), glicocorticoides e medicamentos modificadores do curso da doença (MMCD) sintéticos e biológicos (medicamentos anti-TNF). Os medicamentos biológicos são indicados em caso de falha ao tratamento prévio com os AINES e MMCD sintéticos (AP periférica) ou AINES (AP axial), constituindo a última linha de tratamento da doença. TECNOLOGIA: Ustequinumabe (STELARA®). INDICAÇÃO: Artrite Psoriásica ativa. PERGUNTA: O uso de ustequinumabe é eficaz e seguro em pacientes com AP ativa que apresentaram resposta inadequada a MMCDs quando comparado às opções disponíveis atualmente no SUS? Evidências científicas: Dados de dois ensaios clínicos randomizados controlados por placebo demonstram que ustequinumabe é eficaz para os desfechos de AP periféricos (ACR20, ACR50, DAS28 e entesite), de AP axial (BASDAI20 e BASDAI70, somente em pacientes sem uso prévio de medicamentos anti-TNF) e de pele (PASI75). Os dados demonstram que ustequinumabe é menos eficaz em pacientes que já realizaram uso de medicamentos anti-TNF (PSUMMIT II). Dados de comparação direta entre ustequinumabe e os medicamentos anti-TNF não estão disponíveis. Estudo de comparação indireta, com baixa qualidade, demonstrou eficácia inferior de ustequinumabe comparado aos medicamentos anti-TNF disponíveis no SUS. Dados de segurança são limitados a 108 semanas de acompanhamento, e não apresentam grupo comparador ou controle. Cerca de 71% dos pacientes que usaram ustequinumabe apresentaram algum evento adverso, sendo 43% infecções. Mais de um evento adverso grave ocorreu em 9,7% dos pacientes, sendo os mais frequentes infarto agudo do miocárdio, neoplasia maligna, osteoartrite e colecistite. AVALIAÇÃO ECONÔMICA: A análise de custo minização sugere que ustequinumabe é mais caro em comparação aos medicamentos anti-TNF subcutâneos disponíveis no SUS (adalimumabe, etanercepte e golimumabe), mesmo com a proposta de fornecimento da fase de indução pelo demandante. A análise de custo minimização não é adequada para o contexto, uma vez que há evidência de que a eficácia de ustequinumabe não é equivalente a dos medicamentos antiTNF. AVALIAÇÃO DE IMPACTO ORÇAMENTÁRIO: A análise de impacto orçamentário apresentada pelo demandante sugere economia de R$ 2 a 7 milhões de reais com a incorporação de ustequinumabe em cinco anos, considerando o fornecimento da fase de indução. Uma limitação da análise é não apresentar um cenário alternativo sem considerar o fornecimento da fase de indução de tratamento, uma vez que o horizonte temporal considera o prazo de fornecimento da fase de indução proposto pelo demandante, de cinco anos. Em reanálise dos dados, observa-se que ustequinumabe pode gerar impacto substancial no orçamento sem o fornecimento da indução, que pode variar de R$ 19 a R$ 46 milhões em cinco anos. Este valor é bem superior a economia sugerida com o fornecimento da fase de indução. Portanto, a análise restrita ao horizonte temporal de cinco anos (sem considerar um cenário alternativo onde a fase de indução não será fornecida) não é adequada, considerando o potencial impacto orçamentário ao SUS. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: Alguns medicamentos estão em fase de estudo clínico para o tratamento da artrite psoriásica (abatacepte, apremilaste, brodalumabe, guselkumabe, ixequizumabe, tofacitinibe e upadacitinibe). Essas novas tecnologias ainda não tiveram seu registro aprovado pela Anvisa para a AP. DISCUSSÃO: A evidência disponível sobre eficácia e segurança de ustequinumabe é baseada em dois ensaios clínicos randomizados controlados por placebo em 24 semanas. Comparado a placebo, ustequinumabe apresenta melhor eficácia para os desfechos articulares e de pele em pacientes com artrite psoriásica, com dados de segurança a curto prazo em um ano. Entretanto, não há estudos de comparação direta com os medicamentos anti-TNF disponibilizados pelo SUS. Nesse contexto, há evidência de baixa qualidade, de inferioridade de eficácia do ustequinumabe em comparação aos anti-TNF disponíveis no SUS. O custo do medicamento por paciente na análise de custo minimização demonstrou ser maior em dois e cinco anos, mesmo com o fornecimento da fase de indução pelo demandante. O impacto orçamentário da incorporação do medicamento poderá ser substancial, principalmente após o período de fornecimento da fase de indução pelo demandante. Outras agências de ATS já recusaram o reembolso de ustequinumabe considerando-o menos custo-efetivo comparado aos medicamentos anti-TNF mais antigos, como adalimumabe. Portanto, os dados do presente relatório sugerem que ustequinumabe é menos eficaz e mais caro em comparação com os medicamentos subcutâneos já disponíveis no SUS. RECOMENDAÇÃO PRELIMINAR DA CONITEC: O plenário da CONITEC, em sua 58ª reunião ordinária, recomendou preliminarmente a não incorporação do ustequinumabe para o tratamento de pacientes adultos com artrite psoriásica ativa moderada a grave. A matéria será disponibilizada em Consulta Pública. CONSULTA PÚBLICA: Foram recebidas 101 contribuições de experiência ou opinião e 10 contribuições de cunho técnico-científico, onde 96% e 70% discordaram da recomendação preliminar da CONITEC, respectivamente. O principal motivo de discordância foi a necessidade de se oferecer uma nova alternativa terapêutica. Novas evidências foram apresentadas e analisadas, com sustentação da evidência de inferioridade de ustequinumabe em relação a anti-TNF-α disponíveis no SUS. DELIBERAÇÃO FINAL DA CONITEC: Os membros da CONITEC presentes na 62ª reunião ordinária da plenária, realizada no dia 07/12/2017, deliberaram por unanimidade recomendar a não incorporação de ustequinumabe para o tratamento de artrite psoriásica ativa moderada a grave. Foi assinado o Registro de Deliberação nº 318/2017. DECISÃO: Não incorporar o ustequinumabe para o tratamento de pacientes adultos com artrite psoriásica ativa que apresentaram resposta inadequada aos medicamentos modificadores do curso da doença, no âmbito do Sistema Único de Saúde ­ SUS, dada pela Portaria nº 6, publicada no DOU nº 18, do dia 25 de janeiro de 2018, seção 1, pág. 123.(AU)


Subject(s)
Immunoglobulin G/therapeutic use , Immunosuppressive Agents/therapeutic use , Psoriasis/drug therapy , Brazil , Cost-Benefit Analysis/economics , Technology Assessment, Biomedical , Unified Health System
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