Efficacy and safety of ustekinumab in the treatment of moderate to severe plaque psoriasis in Singapore

INTRODUCTION@#Ustekinumab is a human monoclonal antibody that binds to the p40 subunit of both interleukin (IL)-12 and IL-23, and it is approved for the treatment of moderate to severe plaque psoriasis. In this study, we assessed the efficacy and safety of patients receiving ustekinumab for psoriasis.@*METHODS@#This retrospective study included all adults with chronic plaque psoriasis who were prescribed ustekinumab in a tertiary dermatologic centre between December 2009 and December 2015. Efficacy end points included a proportion of patients achieving at least 50% and 75% improvement from baseline psoriasis area and severity index (PASI) and body surface area (BSA) at Weeks 4 and 16.@*RESULTS@#A total of 99 patients were prescribed ustekinumab; 69% of these were Chinese, followed by 15% Indians and 9% Malays. 31 patients had documented PASI scores and 55 patients had documented BSA improvements. In patients with recorded PASI scores, 29 (93.5%) of 31 patients achieved PASI 50, and 21 (67.7%) of 31 achieved PASI 75 at week 16. In patients with recorded BSA, 43 (78.2%) of 55 had at least 50% BSA improvement, and 31 (56.4%) of 55 achieved 75% BSA improvement at 16 weeks. Regarding safety, no patient experienced tuberculosis reactivation. A total of 11 (11%) of 99 patients had latent tuberculosis infection and were treated with prophylactic isoniazid. No patient experienced serious adverse events. No cardiovascular events, cutaneous malignancies or deaths were reported over six years.@*CONCLUSION@#Ustekinumab is safe and efficacious in the treatment of patients with moderate to severe plaque psoriasis in a multiethnic Asian population.

Safety and efficacy of ustekinumab in the treatment of Crohn Disease: a systematic review and meta-analysis

ABSTRACT Background and Aims The present systematic review and meta-analysis was designed to estimate the safety and effectiveness of ustekinumab in the treatment of Crohn disease (CD) in clinical trials and observational studies. Methods We retrieved all the related publications from the PubMed, Cochrane, EBSCO, Google Scholar and EMBASE databases using a systematic search strategy. We only included clinical trials and observational studies that were published in English. Results Only 31 studies that met the eligibility criteria out of the 733 identified studies were included. The overall clinical response rate in the cohort studies was of 0.539 (95% confidence interval [95%CI]: 0.419-0.659), and in the clinical trials it was of 0.428 (95%CI: 0.356-0.501). The pooled clinical remission rate was of 0.399 (95%CI: 0.295-0.503) in randomized control trials (RCTs,) and of 0.440 (95%CI: 0.339-0.542) in cohort studies. The rate of adverse effects was of 0.158 (95%CI: 0.109-0.207) in cohort studies and of 0.690 (95%CI: 0.633-0.748) in RCTs. Conclusion Ustekinumab is effective in the treatment of CD. However, more research is required on the safety profiles because there was considerable variation among the included studies. (AU)

Psoriasis paradójica palmoplantar secundaria al tratamiento de la colitis ulcerosa con adalimumab / Paradoxical psoriasis of the palms and soles due to treatment of ulcerative colitis with adalimumab

Los anticuerpos anti-TNF-a (tumor necrosis factor alpha) se utilizan para tratar tanto la psoriasis como la enfermedad inflamatoria intestinal (EII). Sin embargo, estos fármacos han sido implicados en la ocurrencia de la psoriasis paradójica en los pacientes sin antecedentes de psoriasis que reciben tratamiento por una colitis ulcerosa (CU) y otras enfermedades autoinmunes. Se presenta el caso de un paciente de 29 años, sin antecedentes de dermatosis, que desarrolló una psoriasis palmoplantar paradójica por el uso del adalimumab que recibía por un diagnóstico de CU. El cuadro remitió al suspender el medicamento y recurrió al reiniciarlo, motivo por el cual se rotó al ustekinumab. La CU respondió satisfactoriamente, sin nuevas lesiones dermatológicas.

Anti TNF-a (tumor necrosis factor alpha) antibodies are used to treat both psoriasis and inflammatory bowel disease (IBD). However, these drugs have been implicated in the occurrence of the so-called paradoxical psoriasis in patients with no previous history of psoriasis, who receive treatment for ulcerative colitis and other autoimmune diseases. We present a 29-year-old male patient, with no previous history of dermatosis, who developed paradoxical palmar-plantar psoriasis due to the use of adalimumab that he was receiving for a diagnosis of ulcerative colitis. The condition remitted when the drug was suspended and recurred when it was restarted, and for that reason, treatment was rotated to ustekinumab. Ulcerative colitis responded satisfactorily, with no new dermatological lesions.

Crohn's disease - treatment with biological medication

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.

Recalcitrant Pityriasis Rubra Pilaris Treated with Ustekinumab / 대한피부과학회지

No abstract available.

Recent medical therapy for psoriasis

Psoriasis is a chronic inflammatory disease. Medical therapy is the mainstay of the management of psoriasis, and the main target of psoriasis treatment is immunological dysregulation. Cyclosporine and methotrexate, the main conventional psoriasis treatments, usually lead to a Psoriasis Area and Severity Index (PASI) 75 response in 50% to 60% of patients, but show some organ toxicity. Biologics for psoriasis have recently become the main therapeutic agents for moderate to severe psoriasis unresponsive to conventional treatment. Tumor necrosis factor-α inhibitors were the first anti-psoriatic biologics to be developed, and also show good efficacy for psoriatic arthritis. Ustekinumab, the sole biologic designed for the inhibition of interleukin (IL)-12/23, has been most widely used for psoriasis in Korea. The main strength of ustekinumab is its relatively long treatment interval. IL-17 inhibitors have recently been introduced in Korea for psoriasis treatment. Secukinumab and ixekizumab are currently available IL-17 inhibitors that block the development of psoriasis lesions in the downstream events of psoriasis pathogenesis. They have excellent therapeutic efficacy, with a PASI 90 response in up to 60%–70% of patients. Selective IL-23 inhibitors have been more recently introduced in our country. They have an excellent PASI 90 response, and a longer injection interval than IL-17 inhibitors. New immunological modulators such as phosphodiesterase inhibitors, tyrosine kinase 2 inhibitors, and janus kinase inhibitors are planned to be introduced for psoriasis treatment. These are small molecules that can be administered orally, and some patients who are reluctant to receive injection therapy are expected to favor these therapeutic agents.

Ustekinumab is effective in biological refractory Crohn's disease patients–regardless of approval study selection criteria

BACKGROUND/AIMS: Ustekinumab is effective in active Crohn's disease. In a retrospective study, we assessed the clinical outcome in nonresponders to anti-tumor necrosis factor therapy, and/or conventional therapy and/or the α4β7-integrin inhibitor vedolizumab. As approval study populations do not always reflect the average “real world” patient cohort, we assessed weather patients who would not have qualified for approval studies show similar outcomes. METHODS: Forty-one patients with mild to severe active Crohn's disease were treated with ustekinumab (intravenous 6 mg per kg/body weight) followed by subcutaneous ustekinumab (90 mg) at week 8. Depending on the clinical response maintenance therapy was chosen every 8 or 12 weeks. Clinical response was defined by Crohn's Disease Activity Index (CDAI) decline, decline of stool frequency or clinical improvement. Inclusion criteria for approval studies were assessed. RESULTS: The 58.5% (24/41) showed clinical response to ustekinumab. The 58.3% of this group (14/24) achieved clinical remission. Clinical response correlated significantly with drop of stool frequency and improvement of CDAI score. The 39 out of 41 patients had no side effects and we observed no serious infections. About a third of our patients would not have met ustekinumab approval study criteria. However, patients who did not meet study criteria showed clinical improvement numerically in the same range compared to patients who would have qualified for approval studies. CONCLUSIONS: Ustekinumab is effective, safe and well tolerated in a highly therapy refractory patient cohort. Even though a reasonable number of patients did not meet ustekinumab approval study criteria, approval study results seem to be representative to the overall patient cohort.

The Effects of Systemic Psoriasis Therapies on the C-Reactive Protein and the Neutrophil-Lymphocyte Ratio

BACKGROUND: Currently, no generally accepted laboratory marker for monitorizing the disease activity and therapy response of psoriasis is known. OBJECTIVE: The aim of the study is to evaluate the effects of systemic therapies on C-reactive protein (CRP) and the neutrophil-lymphocyte ratio (NLR) in psoriasis. METHODS: One hundred patients with psoriasis treated with narrow band ultraviolet B, acitretin, cyclosporine, methotrexate, adalimumab, etanercept, and ustekinumab were prospectively evaluated. At baseline and at week 12, CRP, NLR, and Psoriasis Area and Severity Index (PASI) were evaluated. RESULTS: A statistically significant decrease was observed in PASI scores, CRP, and NLR values from the baseline to the 12-week visit (p=0.001, p=0.001, p=0.001, respectively). The reduction in PASI scores and NLR values was positively correlated (r=0.460, p=0.001). The comparisons between treatment groups revealed that the median decrease in NLR values was statistically higher in the adalimumab group than in the methotrexate group (p=0.007). And the median decrease in PASI scores was significantly higher in the adalimumab group compared with the methotrexate and acitretin therapy group (p=0.007, p=0.042, respectively). CONCLUSION: In the present study, systemic therapy of psoriasis was demonstrated to decrease the levels of CRP and NLR, which are known to be indicators of systemic inflammation and cardiovascular comorbidities.

Treatment Outcomes and Response Pattern of Ustekinumab in Korean Patients with Psoriasis: A Retrospective Single-center Study / 대한피부과학회지

BACKGROUND: Psoriasis is a chronic immune-mediated inflammatory skin disease affecting 2~3% of the worldwide population. Ustekinumab, an IL-12/23p40 inhibitor, is a biologic reported to be effective and safe in treating psoriasis. However, there are limited data on the treatment outcomes of ustekinumab in patients with psoriasis in Korea. OBJECTIVE: To evaluate the treatment outcomes and response pattern of ustekinumab in patients with psoriasis in Korea. METHODS: This was a retrospective single-center study. Eighty-four patients with psoriasis treated with ustekinumab were analyzed. Each patient's medical records, psoriasis area and severity index (PASI) score, and body surface area were reviewed at baseline and up to week 52. RESULTS: A total of 84 patients were included (male:female=1.8:1). The mean age was 44.5 years. At week 16, 86.7% achieved PASI75, 59.0% achieved PASI90, and 20.5% achieved PASI100. By week 16, 84.8% of subjects had attained PASI75 for the head region, whereas 79.0% had attained it for the lower extremities, indicating a relatively slower treatment response of psoriatic lesions on the lower extremities. Four patients discontinued treatment due to lack of effect. No severe adverse events occurred during the follow-up period. CONCLUSION: Ustekinumab demonstrated highly effective and safe treatment profiles in Korean psoriatic patients, consistent with the previous reports from mainly Western countries. Psoriasis severity and treatment responsiveness may vary with body region.

Economic Factors as Major Determinants of Ustekinumab Drug Survival of Patients with Chronic Plaque Psoriasis in Korea

BACKGROUND: Drug survival, defined as the time until discontinuation, is a parameter reflecting real-world therapeutic effectiveness. Few studies have examined the influence of economic factors on the drug survival of biologic agents for psoriasis, particularly in Asian countries. OBJECTIVE: To determine the drug survival for ustekinumab in real-life settings and investigate the factors affecting drug survival for psoriasis patients in Korea. METHODS: We evaluated 98 psoriasis patients who were treated with ustekinumab at a single center. We analyzed the efficacy and drug survival of ustekinumab. Cox proportional hazard analysis and competing risk regression analysis were performed to reveal the factors affecting the drug survival of ustekinumab. RESULTS: The overall mean drug survival was 1,596 days (95% confidence interval [CI], 904~2,288). Among the 39 cessations of ustekinumab treatment, 9 (23.1%) patients discontinued treatment after experiencing satisfactory results. Multivariate Cox proportional hazard analysis revealed that paying on patients' own expense was the major predictor for the discontinuation of ustekinumab (hazard ratio [HR], 9.696; 95% CI, 4.088~22.998). Competing risk regression analysis modeling of discontinuation because of factors other than satisfaction of an event also revealed that ustekinumab treatment at the patient's expense (HR, 4.138; 95% CI, 1.684~10.168) was a predictor of discontinuation rather than satisfaction. CONCLUSION: The results of our study revealed that the cost of biologics treatment affects the drug survival of ustekinumab and suggested that economic factors affect the drug survival of ustekinumab treatment in Korea.

A Case of Paradoxical Flare of Pustular Psoriasis after Ustekinumab Therapy / 대한피부과학회지

Biologics are the most advanced treatment for psoriasis. Ustekinumab, one of the biologics for psoriasis, is a human monoclonal antibody that binds to the p40 subunit of interleukin-12 and interleukin-23. A 41-year-old woman with a 17-year history of plaque psoriasis and psoriatic arthritis presented with worsening lesions. The patient had previously been treated with a number of topical and systemic medications and narrow band ultraviolet B. However, none of the treatments consistently controlled her disease. Thus, treatment with ustekinumab 45 mg via subcutaneous injection was initiated. Approximately 7 days after the first treatment, she experienced a flare with generalized pustules in her whole body. The condition was controlled with systemic steroid treatment. The patient was subsequently treated with adalimumab, and improvement in her plaque and pustular lesions was noted. Herein, we report a case of psoriasis that flared up after ustekinumab therapy, which was accompanied by a morphological change from plaque to pustular lesions.

A New Medical Therapy for Axial Spondyloarthritis / 대한내과학회지

Nonsteroidal anti-inflammatory drugs (NSAIDs) have been the first choice of treatment for axial spondyloarthritis (axSpA); cyclooxygenase (COX)-2 inhibitors reduce both inflammation and bone formation. When NSAID treatment fails, tumor necrosis factor inhibitors (TNFis) can be used to treat active axSpA, but, presently, TNFis cannot completely prevent radiographic progression. Theoretically, as TNF is a strong pro-inflammatory cytokine triggering bone resorption, TNFis should stimulate bone formation. Recently, it was discovered that the IL-23/-17 axis is associated with enthesitis development and bone formation in a mouse model. The anti-IL-23 monoclonal antibody ustekinumab has been approved as treatment for moderate-to-severe plaque psoriasis and psoriatic arthritis. However, in axSpA patients, ustekinumab effectiveness was low and a phase 3 clinical trial was terminated. The anti-IL-17A monoclonal antibody secukinumab has been approved as treatment for moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. In a 3-year extension of the MEASURE 1 observational study, the mean change in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) from baseline to week 104 was 0.30 ± 2.53 among patients with evaluable X-rays originally randomized to secukinumab (n = 168). Such patients exhibited less radiographic progression compared to other TNFi studies. Several new drugs are in clinical trials exploring their effects on axSpA; these include ixekizumab (an anti-IL-17A monoclonal antibody), brodalumab (an anti-IL-17 receptor monoclonal antibody), and the Janus kinase (JAK) inhibitors tofacitinib and upadacitinib. The IL-23/-17 axis is important in terms of axSpA inflammation and bone formation. However, to date, no drug has completely prevented radiographic progression in axSpA patients.

Ustekinumab treats psoriasis by suppressing RORC and T-box but its suppression of GATA restrains its efficacy

Psoriasis is a T-cell mediated disease that involves IL-23/Th17 and IL-12/Th1 axes. Ustekinumab, a fully human monoclonal antibody targeting the p40 subunit of both IL-12 and IL-23, has proven to be efficient and safe for treating patients with psoriasis. Yet, there have been no reports with human skin/blood samples that would elucidate the molecular mechanisms by which ustekinumab calms psoriasis skin lesions. To investigate the efficacy and molecular pathway (RORC, t-BOX and GATA) of ustekinumab in treating patients with psoriasis skin lesions. A total of 30 patients with psoriasis were randomized into placebo group and treatment group. PASI of each patient was calculated at 0, 12 and 24 weeks post-treatment. The mRNA levels of RORC, t-BOX and GATA in peripheral blood mononuclear cells separated from patients' whole blood were analyzed using qPCR. Decreased mRNA of RORC, t-BOX and GATA were observed after continuous injections, indicating that ustekinumab exerts its effect by interacting with these molecules; while no significant difference in foxp3 mRNA levels were found between placebo group and treatment group.

¿Es efectivo el ustekinumab para la artritis psoriásica que no responde a tratamiento inicial? / Is ustekinumab effective for psoriatic arthritis with insufficient response to initial treatment?

INTRODUCCIÓN: La artritis psoriásica es una artritis inflamatoria sin una clara etiología, con el tratamiento biológico como un pilar fundamental en pacientes más complejos. Existen varias alternativas para tratamiento biológico, debido a su alto costo, es importante evaluar la real efectividad de estos para un buen tratamiento. MÉTODOS: Para responder esta pregunta utilizamos Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud a nivel mundial, la cual es mantenida mediante búsquedas en múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, reanalizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. RESULTADOS Y CONCLUSIONES: Identificamos 12 revisiones sistemáticas que en conjunto incluyen tres ensayos aleatorizados. Concluimos que el ustekinumab logra una mejoría clínica en pacientes con psoriasis, y probablemente no se asocia a efectos adversos graves.

INTRODUCTION: Psoriatic arthritis is an inflammatory arthritis without a clear etiology. Biological therapy is key for its treatment, especially in more complex patients. There are several alternatives for biological treatment, but due to its high cost, it is important to evaluate their real effectiveness. METHODS: To answer this question we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS: We identified 12 systematic reviews including three randomized trials overall. We concluded ustekinumab leads to clinical improvement in psoriatic arthritis, and probably is not associated to severe adverse effects.

Economic Burden Can Be the Major Determining Factor Resulting in Short-Term Intermittent and Repetitive Ustekinumab Treatment for Moderate-to-Severe Psoriasis

BACKGROUND: The continuous use of biologic agents in the treatment of psoriasis has been reported to result in successful and sustained therapeutic effects and safety. However, some patients choose intermittent and repetitive treatment. OBJECTIVE: To determine the factors for selecting intermittent and repetitive ustekinumab treatment for the management of psoriasis. METHODS: From January 2011 to October 2016, we enrolled 30 psoriasis patients who discontinued ustekinumab treatment and were followed up for psoriasis treatment. We reviewed data regarding patients' clinical characteristics and the treatment they received, and investigated the factors for selecting intermittent treatment. RESULTS: A total of 52 ustekinumab treatment periods were administered to the 30 patients. Of the 52 treatment periods, 34.6% were covered by insurance and 82.4% were discontinued after sufficient improvement had been made or at the patient's request. Further analysis comparing the first and second ustekinumab treatments revealed that the patients who used ustekinumab in second treatment were more likely to be insured. In addition, the rate of patients reaching psoriasis area and severity index (PASI)75 and PASI90 was similar between the first and subsequent ustekinumab treatments. CONCLUSION: We found that the patients who used ustekinumab intermittently were those who were satisfied with the outcome of ustekinumab treatment but could not afford the treatment. These results suggested that economic burden can be a factor for the patients' choice of short-term intermittent treatment. The expansion of insurance coverage can increase the effectiveness of, and patients' satisfaction with, the management of psoriasis.

Emerging Therapies: What Are Promising in the Near Future? / 대한소화기학회지

The treatment of inflammatory bowel disease has evolved with the development of anti-TNF agents. In spite of long-term effectiveness, many patients do not respond or no longer responds to these drugs. Therefore, the development of new drugs that act on different inflammatory pathways has become necessary. Vedolizumab, a gut-specific biological agent, inhibits interaction α4β7 integrin with mucosal addressin cell adhesion molecule-1 without inhibiting systemic immune responses. Long-term vedolizumab therapy in patients with Crohn's disease and ulcerative colitis was safe and effective. Additionally, vedolizumab can be used in patients already failed an anti-TNF therapy. Ustekinumab is a fully human immunoglobulin G1 kappa monoclonal antibody that blocks the p40 subunit of IL-12 and IL-23. Ustekinumab will be a clinically effective agent to use in medically-refractory Crohn's disease especially as a second line drug. Tofacitinib is an oral, small molecule that inhibits JAK1, JAK3 and in a lesser extent, JAK2. Perhaps the most attractive things of these JAK inhibitors is that they are given orally instead of parenterally. Early results showed that patients with moderately to severely active ulcerative colitis receiving tofacitinib were more likely to achieve remission at 8 weeks than those receiving placebo. However, these results have not been as robust in Crohn's disease. Much of the positioning will depend on the safety profile such as opportunistic infection and atherogenic risk. The challenges for the future are to determine the therapeutic drug monitoring-guided dose optimization, optimal timing and drug combinations to produce the most effective, and safest outcomes for IBD patients.

Multiple Lentigines Arising in Sites of Resolving Psoriatic Plaques after Treatment with Ustekinumab

No abstract available.

Informe de evaluación científica basada en la evidencia disponible: artritis psoriásica / Scientific evaluation report based on available evidence: psoriatic arthritis

INTRODUCCIÓN: Artritis psoriásica en un tipo de artritis inflamatoria que causa dolor en las articulaciones, inflamación y rigidez en personas con psoriasis (1). Psoriasis es una condición crónica, en la cual gruesas áreas de la piel se inflaman tomando un color rojizo que usualmente van acompañados de descamación. La mayoría de las personas que desarrollan artritis psoriásica primero presentan síntomas en la piel y luego desarrollan los síntomas de la artritis. Los principales síntomas de las artritis psoriásica incluye dolor y sensibilidad en las articulaciones, movilidad reducida o rigidez en las articulaciones o en la espalda, y en algunos casos rigidez matutina por más de 30 minutos, descamación de la piel y uñas descoloradas, quebradizas y picadas. TECNOLOGÍAS SANITARIAS ANALIZADAS: Golimumab, adalimumab, secukinumab, certolizumab, infliximab y ustekinumab. EFICACIA DE LOS TRATAMENTOS: Las conclusiones con respecto a la efectividad de los tratamientos considerados es que, en cuanto a: -Ustekinumab: El uso de ustekinumab lleva a una mejora en las escalas ACR 20, PASI 75, DAS-28 y HAQ-DI Ustekinumab probablemente no se asocia a eventos adversos graves. -Certolizumab: El uso de certolizumab lleva a una mejora en las escalas ACR 20, PASI 75 y HAQ-DI Probablemente el uso de certolizumab se asocia a una mayor tasa de eventos adversos serios. -Secukinumab: El uso de secukinumab en artritis psoriásica lleva a una mejora en diferentes escalas relacionadas con la actividad de la enfermedad y los síntomas. El uso de secukinumab en artritis psoriásica probablemente no se asocia a eventos adversos graves. La certeza de la evidencia es moderada. -Golimumab: El uso de golimumab lleva a una mejora en las escalas ACR 20, PASI 75 y HAQ-DI Probablemente el uso de golimumab se asocia a una mayor tasa de eventos adversos serios. -Infliximab: El uso de infliximab probablemente lleva a una mejora en las escalas ACR 20, PASI 75 y HAQDI. El uso de infliximab podría asociarse a eventos adversos graves, pero la certeza de la evidencia es baja. Adalimumab: El uso de adalimumab lleva a una mejora en las escalas ACR 20, PASI 75, y HAQ-DI. El uso de adalimumab podría no asociarse a eventos adversos graves, pero la certeza de la evidencia es baja. EVALUACIÓN ECONÓMICA: En referencia a los estudios de costo-efectividad encontrados, a pesar de que hacen uso de diferentes comparadores, se aprecia que tienden a concluir que las diversas terapias con biológicos serían costo-efectivas. Sobre la base de las recomendaciones de los diferentes países, se podría concluir que no existe una fuerte diferenciación de los tratamientos en base a su efectividad y seguridad, y el costo de los mismos sería la razón más influyente para financiar uno u otro. Las herramientas más usadas para llevar esto a cabo parecen ser los acuerdos de precios, pero también se encontraron acuerdos sobre umbrales máximos de costo anual del tratamiento, que sobrepasado, el proveedor debería reembolsar en un porcentaje. Se aprecia, además, que se han tendido a aprobar todos los tratamientos, con algunas variaciones en las restricciones clínicas establecidas (ej. período de discontinuación ante la no respuesta), con el objetivo de dar mayor libertad a pacientes y médicos a elegir el tratamiento a seguir. Se recomienda explorar acuerdos de riesgo compartido: tanto de topes máximos de gasto anual por paciente como de dosis gratuitas (para mejor certidumbre de efectividad en el paciente) y rebajas de precio para que los tratamientos no difieran sustancialmente en el costo anual por paciente. REPERCUSIONES ÉTICAS, JURÍDICAS Y SOCIALES: Repercusiones éticas: Respecto de la presencia de conflictos de interés en los estudios considerados en el análisis de la eficacia de las intervenciones contenidas en este informe, en relación a Ustekinumab un estudio recibió financiamiento de Janssen Research & Development. En relación a Certolizumab, el estudio fue financiado por UCB Pharma, en relación a Secukinumab todos los ensayos fueron financiados por Novartis Pharmaceuticals. Sobre Golimumab, el ensayo incluido fue financiado por Centocor Inc (40), En relación a Infliximab, ambos ensayos fueron financiados por Centocor Inc. Finalmente, los 2 estudios relacionados con Adalimumab fueron financiados por Abbott . Respecto a la presencia de conflictos de interés en los estudios considerados en la evaluación económica de las intervenciones contenidas en este informe, 3 estudios no refieren si recibieron o no financiamiento. Un estudio refiere haber sido financiado por Pfizer y otro estudio fue financiado por el National Institute for Health Research (NIHR). Repercusiones sociales: Las personas con artritis psoriática son en general adultos de edad media entre 30 y 50 años, no existiendo diferencias de prevalencia e incidencia dependiendo del género. Esta enfermedad compromete la calidad de vida de las personas en diferentes intensidades variando por patrón de presentación como por las articulaciones comprometidas. Tanto en formas leves como severas afecta la dinámica familiar y la capacidad laboral de las personas que presentan esta patología. Quiénes son tratados con los fármacos evaluados y contenidos en este informe, presentan una disminución de su sintomatología, mejorando su calidad de vida, sin sufrir mayores efectos adversos, favoreciendo de esta forma su reingreso a la actividad laboral o escolar. Para estos pacientes actualmente no existe ninguna cobertura en el régimen GES. Repercusiones jurídicas: a) Golimumab Conforme a la información recibida por este Ministerio de Salud (excluye a ISAPRE ex Mas Vida, que no entregó información), el medicamento no ha sido objeto de recursos o de acuerdos extracontractuales. b) Adalimumab: Al respecto, corresponde señalar que conforme a la información recibida (excluye a ISAPRE ex Mas Vida, que no entregó información), es posible indicar que para el medicamento Adalimumab, desde el año 2012 a abril de 2017, existen seis requerimientos; un acuerdo extracontractual que otorga cobertura en sistema ISAPRE y cinco recursos rechazados, también en el sistema ISAPRE. Sin embargo, del total de requerimientos, tres fueron solicitados para la patología Artritis Reumatoide (uno de los cuales se solucionó vía transacción), dos para Espondilitis Anquilosante y una para enfermedad de Crohn. c) Secukinumab: Conforme a la información recibida por este Ministerio de Salud (excluye a ISAPRE ex Mas Vida, que no entregó información), el medicamento no ha sido objeto de recursos o de acuerdos extracontractuales. d) Certolizumab: Conforme a la información recibida por este Ministerio de Salud (excluye a ISAPRE ex Mas Vida, que no entregó información), es posible indicar que para el medicamento certolizumab, desde el año 2012 a abril de 2017, no se registran acuerdos extracontractuales, ni litigios. e) Infliximab: Conforme a la información recibida por este Ministerio de Salud (excluye a ISAPRE ex Mas Vida, que no entregó información), es posible indicar que para el medicamento Infliximab, desde el año. 2012 a abril de 2017, existe un acuerdo extracontractual que otorga cobertura en sistema ISAPRE. Sin embargo, en este acuerdo se indica el medicamento para la patología Artritis Reumatoidea. f) Ustekinumab: Conforme a la información recibida por este Ministerio de Salud (excluye a ISAPRE ex Mas Vida, que no entregó información), el medicamento no ha sido objeto de recursos o de acuerdos extracontractuales.

Paradoxical Flare of Psoriasis after Ustekinumab Therapy

No abstract available.