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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
2.
Rev. Hosp. Ital. B. Aires (2004) ; 39(4): 146-148, dic. 2019. ilus
Article in Spanish | LILACS | ID: biblio-1099838

ABSTRACT

Los anticuerpos monoclonales que inhiben los puntos de control PD-1 y CTLA-4 se usan actualmente en el tratamiento del melanoma y cáncer metastásico de pulmón de células no pequeñas, entre otros. Se refiere el caso de una paciente con cáncer de pulmón en tratamiento con pembrolizumab. La paciente se presentó con edema facial y parálisis facial periférica. En el laboratorio se observó la hormona tirotrofina (TSH) elevada y se llegó al diagnóstico de hipotiroidismo por pembrolizumab. Inició tratamiento con levotiroxina con mejoría clínica. Se presenta este caso por el importante papel del dermatólogo en el manejo multidisciplinario del paciente oncológico. (AU)


Monoclonal antibodies that inhibit PD-1 and CTLA-4 control points are currently used in the treatment of melanoma and metastatic non-small cell lung cancer, among others. The case of a patient, with lung cancer being treated with Pembrolizumab. The patient was presented with facial edema and peripheral facial paralysis and in the laboratory the elevated hormone Tyrotrophin (TSH) was observed, the diagnosis of pembrolizumab hypothyroidism was reached. She started treatment with levothyroxine with clinical improvement. This case is presented by the important role of the dermatologist in the multidisciplinary management of the cancer patient. (AU)


Subject(s)
Humans , Female , Middle Aged , M Phase Cell Cycle Checkpoints/drug effects , Immunotherapy/adverse effects , Antibodies, Monoclonal/adverse effects , Thyroxine/therapeutic use , Brain Neoplasms/complications , Brain Neoplasms/drug therapy , Thyrotropin/analysis , Carboplatin/administration & dosage , Carcinoma, Non-Small-Cell Lung/complications , Carcinoma, Non-Small-Cell Lung/drug therapy , Tumor Suppressor Proteins/drug effects , Dermatology , Facial Injuries , Facial Paralysis , CTLA-4 Antigen/drug effects , CTLA-4 Antigen/physiology , Programmed Cell Death 1 Receptor/drug effects , Programmed Cell Death 1 Receptor/physiology , Pemetrexed/administration & dosage , Melanoma/complications , Melanoma/drug therapy , Antibodies, Monoclonal/administration & dosage , Antibodies, Monoclonal/therapeutic use , Neoplasm Metastasis/drug therapy
3.
Rev. chil. infectol ; 36(5): 608-615, oct. 2019. tab
Article in Spanish | LILACS | ID: biblio-1058087

ABSTRACT

Resumen La incorporación de terapias biológicas ha significado un gran avance en el manejo de diversas patologías de origen autoinmune, neoplásico u otros. Si bien su uso ha implicado mejoras significativas en el pronóstico de estas enfermedades, no está exento de complicaciones, entre estas, las infecciosas. El objetivo de este consenso fue evaluar el perfil de seguridad, desde la mirada infectológica, de las terapias biológicas de uso más frecuente y dar recomendaciones para la prevención de infecciones en pacientes tratados con ellas, basándose en la evidencia de mayor calidad disponible para los biológicos seleccionados. El consenso cuenta de dos manuscritos. Esta primera parte detalla los riesgos de desarrollar complicaciones infecciosas dependiendo del tipo de biológico utilizado para determinada patología. La revisión incluyó búsqueda amplia en MEDLINE y Epistemonikos de revisiones sistemáticas y meta-análisis de estudios clínicos controlados y caso/control que examinaban infecciones posteriores al tratamiento con anti-TNF alfa, anti-CD20, anti-CD52, CTLA4-Ig y anti-integrinas. Esta búsqueda se complementó con revisión de cohortes multicéntricas de usuarios de biológicos, del MMWR del CDC, Atlanta, E.U.A. y de registros nacionales y/o de sociedades científicas en la que se hiciera mención a complicaciones infecciosas derivadas del uso de biológicos.


The use of biological therapies has meant a great improvement in the management of several conditions like autoimmune, neoplastic or others diseases. Although its use has implied significant improvements in the prognosis of these diseases, it is not exempt from complications: infectious diseases as one of them. The objective of this consensus was to evaluate, from an infectious viewpoint, the safeness of the most frequently used biological therapies and give recommendations for the prevention of infections in patients treated with these drugs. These recommendations were based on the highest quality evidence available for the selected biologics. The consensus counts of two manuscripts. This first part details the risks of developing infectious complications depending on the type of biological used for a certain pathology. This evaluation included a broad search in MEDLINE and Epistemonikos of systematic reviews and meta-analyzes of controlled clinical trials and casecontrol examining post-treatment infections with anti-TNF alpha, anti-CD20, anti-CD52, CTLA4-Ig and anti-integrins. The research was complemented by a review of: multicentre cohorts of biological users, the MMWR of the CDC, Atlanta, U.S.A., and national registers and scientific societies in which infectious complications derived from the use of biological therapies were mentioned.


Subject(s)
Humans , Biological Therapy/adverse effects , Communicable Diseases/chemically induced , Consensus , Antibodies, Monoclonal/adverse effects , Biological Therapy/standards , Opportunistic Infections/chemically induced , Opportunistic Infections/prevention & control , Chile , Risk Factors , Risk Assessment
4.
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
5.
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
7.
Medwave ; 18(7): e7363, 2018.
Article in English, Spanish | LILACS | ID: biblio-966478

ABSTRACT

INTRODUCCIÓN: Los tratamientos biológicos han aparecido como principal alternativa para el manejo de los pacientes con psoriasis en placa que no responden a tratamiento convencional, resultando necesario evaluar su real efectividad y seguridad. MÉTODOS: Realizamos una búsqueda en Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante el cribado de múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, analizamos 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 21 revisiones sistemáticas que en conjunto incluyeron diez estudios primarios, todos correspondientes a ensayos aleatorizados. Concluimos que secukinumab logra mejoría clínica en pacientes con psoriasis en placa, aunque probablemente se asocia a efectos adversos graves.


INTRODUCTION: Biological treatments have appeared as the main alternative for the management of patients with plaque psoriasis that do not respond to conventional treatment. So, evaluating its actual efficacy and safety is needed. METHODS: We searched in 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 21 systematic reviews including ten studies overall, of which all were randomized trials. We concluded secukinumab achieves clinical improvement in patients with plaque psoriasis, although it is probably associated with serious adverse effects.


Subject(s)
Humans , Psoriasis/drug therapy , Dermatologic Agents/therapeutic use , Antibodies, Monoclonal/therapeutic use , Psoriasis/pathology , Randomized Controlled Trials as Topic , Databases, Factual , Treatment Outcome , Dermatologic Agents/adverse effects , Antibodies, Monoclonal, Humanized , Antibodies, Monoclonal/adverse effects
8.
Einstein (Säo Paulo) ; 16(2): eRC4030, 2018. tab, graf
Article in English | LILACS | ID: biblio-953153

ABSTRACT

ABSTRACT Immunotherapy-induced pneumonitis is a rare complication with incidence estimated around 3%. This disease is difficult to diagnose and has great morbidity. For this reason, it became a challenge for oncologists and emergencists. We reviewed the case of five patients who used anti-PD1 (program cell death receptor antagonist 1) for antineoplastic treatment and developed treatment-induced pneumonitis. All patients had respiratory problems because of immunotherapy and presence of ground-glass radiologic change. Among all patients, only one had grade 5 pneumonitis, and delaying to begin corticosteroid therapy and worsening in clinical picture led to patient death. Other four patients with symptomatic grade 2 pneumonitis underwent corticosteroid therapy and had improvement in clinical and radiologic picture. Two patients were treated after an episode of pneumonitis, and no new pulmonary complications were observed until the end of this study. Immunotherapy-induced pneumonitis, although uncommon, can be potentially fatal. Medical team has the responsibility to pay attention for most common symptoms of the disease such as cough and dyspnea and conduct an early diagnosis and effective early treatment with corticosteroids.


RESUMO A pneumonite secundária à imunoterapia é uma complicação rara, com incidência estimada em cerca de 3%. No entanto, trata-se de uma intercorrência de difícil diagnóstico e com grande morbidade, que tem se tornado um desafio para oncologistas e emergencistas. Foram revisados os casos de cinco pacientes que fizeram uso de anti-PD1 (program cell death receptor antagonist 1) para tratamento antineoplásico e que evoluíram com quadro de pneumonite induzida pelo tratamento. Todos os pacientes apresentaram sintomas respiratórios em vigência de tratamento, com imunoterapia e presença de alteração radiológica em vidro fosco. Dentre estes pacientes, apenas um apresentou pneumonite grau 5, com atraso na introdução de corticoidoterapia, indo a óbito em decorrência do quadro. Os outros quatro pacientes apresentaram pneumonite grau 2, sintomática, sendo tratados com corticoidoterapia e evoluindo com melhora clínica e radiológica. Dois pacientes mantiveram o tratamento após o episódio de pneumonite, sem novas complicações pulmonares posteriores, até o momento. A pneumonite induzida por imunoterapia, apesar de ser um evento pouco frequente, pode acarretar grande morbidade, além de ser potencialmente fatal, cabendo à equipe médica ter atenção aos sintomas mais comuns, como tosse e dispneia, para diagnóstico precoce e tratamento efetivo, com uso precoce de corticoide.


Subject(s)
Humans , Male , Aged , Aged, 80 and over , Pneumonia/chemically induced , Antibodies, Monoclonal, Humanized/adverse effects , Immunotherapy/adverse effects , Antibodies, Monoclonal/adverse effects , Antineoplastic Agents/adverse effects , Pneumonia/drug therapy , Pneumonia/diagnostic imaging , Carcinoma/therapy , Adrenal Cortex Hormones/therapeutic use , Fatal Outcome , Antibodies, Monoclonal, Humanized/therapeutic use , Nivolumab , Lung Neoplasms/therapy , Middle Aged , Antibodies, Monoclonal/therapeutic use , Antineoplastic Agents/therapeutic use
10.
Rev. bras. reumatol ; 56(6): 478-482, Nov.-Dec. 2016. tab
Article in English | LILACS | ID: biblio-830068

ABSTRACT

ABSTRACT Objective: To evaluate the prevalence of systemic and localized infection by Candida species and its possible association with demographic, clinical and laboratory manifestations and therapy in patients with rheumatic diseases taking TNF blockers. Methods: Consecutive patients with rheumatic diseases receiving anti-TNF agents were included. The following risk factors up to four weeks prior to the study were analyzed: use of antibiotics, immunosuppressant drugs, hospitalization and invasive procedures. All subjects were evaluated for clinical complaints; specific blood cultures were obtained for fungi and blood samples were collected for Candida spp. detection by polymerase chain reaction. Results: 194 patients [67 with rheumatoid arthritis (RA), 47 with ankylosing spondylitis (AS), 36 with juvenile idiopathic arthritis (JIA), 28 with psoriatic arthritis and 16 with other conditions] were included. The average age of patients was 42 ± 16 years, with 68 (35%) male and mean disease duration of 15 ± 10 years. Sixty-four (33%) patients were receiving adalimumab, 59 (30%) etanercept and 71 (36%) infliximab. Eighty-one percent of patients were concomitantly taking immunosuppressant drugs. At the time of the study, only one (0.5%) patient had localized fungal infection (vaginal candidiasis). None of the patients included had systemic candidiasis with positive blood cultures for fungi or PCR positive for Candida spp. in peripheral blood sample. Conclusions: This was the first study to assess the prevalence of invasive and localized fungal disease by Candida in a significant number of patients with rheumatic diseases on anti-TNF therapy, and demonstrated low risk of candidiasis, despite the high prevalence of immunosuppressive drug use.


RESUMO Objetivo: Avaliar a prevalência de infecção sistêmica e localizada por Candida spp. e sua possível associação com dados demográficos, manifestações clínicas e laboratoriais e terapêutica em pacientes com doenças reumatológicas em uso de anti-TNF. Métodos: Foram incluídos pacientes consecutivos com doenças reumatológicas em uso de agentes anti-TNF. Foram analisados os seguintes fatores de risco até quatro semanas antes do estudo: uso de antibioticoterapia, imunossupressores, hospitalização e procedimentos invasivos. Todos foram avaliados para queixas clinicas, coletaram hemocultura específica para fungos e amostras de sangue para pesquisa de Candida spp. por reação em cadeia de polimerase. Resultados: Foram incluídos 194 pacientes [67 com artrite reumatoide (AR), 47 espondilite anquilosante (EA), 36 artrite idiopática juvenil (AIJ), 28 artrite psoriásica e 16 outros]. A média de idade era de 42 ± 16 anos, com 68 (35%) do sexo masculino e média de duração de doença de 15 ± 10 anos; 64 (33%) pacientes usavam adalimumabe, 59 (36%) etanercepte e 71 (36%) infliximabe; 81% faziam uso concomitante de imunossupressores. No momento do estudo, apenas um (0,5%) paciente apresentou infecção fúngica localizada (candidíase vaginal). Nenhum dos pacientes incluídos apresentou candidíase sistêmica com hemocultura positiva para fungos ou PCR positiva para Candida spp. em amostra de sangue periférico. Conclusões: Este foi o primeiro estudo que avaliou prevalência de doença fúngica invasiva e localizada por Candida em um expressivo número de pacientes reumatológicos em terapia anti-TNF e demonstrou baixo risco de candidíase, apesar da alta prevalência de uso de imunossupressores.


Subject(s)
Humans , Male , Female , Adult , Candidiasis/epidemiology , Rheumatic Diseases/immunology , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Antirheumatic Agents/adverse effects , Antibodies, Monoclonal/adverse effects , Candida/isolation & purification , Candidiasis/immunology , Rheumatic Diseases/drug therapy , Prevalence , Immunocompromised Host , Antirheumatic Agents/therapeutic use , Middle Aged , Antibodies, Monoclonal/therapeutic use
11.
Rev. Méd. Clín. Condes ; 26(5): 649-662, sept. 2015. tab
Article in Spanish | LILACS | ID: biblio-1128566

ABSTRACT

Las Enfermedades Inflamatorias Intestinales (EII) son entidades crónicas del tracto digestivo, que afectan frecuentemente a pacientes en edad reproductiva. Debido a las características de estas enfermedades y su tratamiento, existen múltiples desafíos. En este artículo, revisamos la evidencia más reciente con respecto a fertilidad y embarazo en pacientes con EII. En general, existe evidencia de que pacientes con EII tienen una mayor tasa de complicaciones durante el embarazo con respecto a pacientes sin EII. Sin embargo, esta diferencia está directamente asociada al grado de actividad de la enfermedad. La mayor parte de los fármacos hoy usados en el tratamiento de EII son considerados seguros durante el embarazo y se recomienda continuarlos, sobre todo considerando que el mayor riesgo de complicaciones está asociado a una enfermedad activa. Sin embargo es importante considerar las opciones caso a caso. Las dos grandes excepciones son metotrexato y talidomida que están completamente contraindicadas. La recomendación más importante es educar a toda paciente con EII en edad reproductiva, explicando que el embarazo debe llevarse a cabo cuando la enfermedad esté controlada y que la probabilidad de complicaciones está relacionada con el grado de actividad y severidad de la EII. Los médicos tratantes deben educar a las pacientes, enfatizando el seguimiento de los controles y tratamiento


Inflammatory bowel diseases (IBD) are chronic conditions of the gastrointestinal tract that can affect patients during their childbearing years. Considering the characteristics of disease and the medications used to treat it, several issues arise in the care of these patients when they attempt or achieve conception. We review the most current evidence concerning fertility and pregnancy outcomes in patients with IBD. With the exception of those women who undergo pelvic surgery, patients with IBD have no decreased fertility. Overall, when looking at obstetrical outcomes, patients with IBD have worse outcomes when compared to controls, but this is usually driven by disease activity at conception. While most medications used to treat IBD are low risk, some precautions need to be taken and the risk-to-benefit ratio needs to be considered on a case-to-case basis. In general, aminosalicylates and thiopurines should be continued, but methotrexate and thalidomide are contraindicated. Anti-tumor necrosis factor agents are considered safe to continue but full monoclonal antibodies do cross the placenta. As a general rule, it is important to counsel women that conception is optimal when disease is in remission, as adverse obstetrical outcomes are directly associated with disease activity. Clinicians need to educate patients before, during and after conception, emphasizing treatment compliance.


Subject(s)
Humans , Female , Pregnancy , Pregnancy Complications , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/drug therapy , Colitis, Ulcerative/complications , Colitis, Ulcerative/drug therapy , Crohn Disease/complications , Crohn Disease/drug therapy , Adrenal Cortex Hormones/adverse effects , Fertility , Immunologic Factors/adverse effects , Anti-Bacterial Agents/adverse effects , Antibodies, Monoclonal/adverse effects
12.
An. bras. dermatol ; 90(2): 232-235, Mar-Apr/2015. graf
Article in English | LILACS | ID: lil-741064

ABSTRACT

Biologic drugs represent a substantial progress in the treatment of chronic inflammatory immunologic diseases. However, its crescent use has revealed seldom reported or unknown adverse reactions, mainly associated with anti-tumor necrosis factor (anti-TNF). Psoriasiform cutaneous reactions and few cases of alopecia can occur in some patients while taking these drugs. Two cases of alopecia were reported after anti-TNF therapy. Both also developed psoriasiform lesions on the body. This is the second report about a new entity described as 'anti-TNF therapy-related alopecia', which combines clinical and histopathological features of both alopecia areata and psoriatic alopecia. The recognition of these effects by specialists is essential for the proper management and guidance of these patients.


Subject(s)
Adolescent , Adult , Female , Humans , Male , Alopecia/chemically induced , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Antibodies, Monoclonal/adverse effects , Crohn Disease/drug therapy , Psoriasis/chemically induced , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Alopecia/pathology , Dermoscopy , Drug Eruptions , Infliximab , Psoriasis/pathology , Scalp/pathology
14.
Article in English | WPRIM | ID: wpr-141155

ABSTRACT

The aims of this study were to assess the risk of tuberculosis (TB) and the status of latent tuberculosis infection (LTBI) in Korean patients with inflammatory bowel disease (IBD) receiving tumor necrosis factor (TNF)-alpha blockers. We reviewed medical records of 525 Korean IBD patients (365 TNF-alpha blocker naive and 160 TNF-alpha blocker exposed) between January 2001 and December 2013. The crude incidence of TB was significantly higher in IBD patients receiving TNF-alpha blockers compared to TNF-alpha-blocker-naive patients (3.1% vs. 0.3%, P=0.011). The mean incidence of TB per 1,000 patient-years was 1.84 for the overall IBD population, 4.89 for TNF-alpha blocker users, and 0.45 for TNF-alpha-blocker-naive patients. The adjusted risk ratio of TB in IBD patients receiving TNF-alpha blocker was 11.7 (95% confidence interval, 1.36-101.3). Pulmonary TB was prevalent in patients treated with TNF-alpha blockers (80.0%, 4/5). LTBI was diagnosed in 17 (10.6%) patients, and none of the 17 LTBI patients experienced reactivation of TB during treatment with TNF-alpha blockers. Treatment with TNF-alpha blockers significantly increased the risk of TB in IBD patients in Korea. De novo pulmonary TB infection was more prevalent than reactivation of LTBI, suggesting an urgent need for specific recommendations regarding TB monitoring during TNF-alpha blocker therapy.


Subject(s)
Mercaptopurine/adverse effects , Adult , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Antibodies, Monoclonal/adverse effects , Cohort Studies , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Female , Humans , Latent Tuberculosis/chemically induced , Male , Mycobacterium tuberculosis/isolation & purification , Republic of Korea , Retrospective Studies , Tuberculosis, Pulmonary/chemically induced , Tumor Necrosis Factor-alpha/antagonists & inhibitors
15.
Article in English | WPRIM | ID: wpr-141154

ABSTRACT

The aims of this study were to assess the risk of tuberculosis (TB) and the status of latent tuberculosis infection (LTBI) in Korean patients with inflammatory bowel disease (IBD) receiving tumor necrosis factor (TNF)-alpha blockers. We reviewed medical records of 525 Korean IBD patients (365 TNF-alpha blocker naive and 160 TNF-alpha blocker exposed) between January 2001 and December 2013. The crude incidence of TB was significantly higher in IBD patients receiving TNF-alpha blockers compared to TNF-alpha-blocker-naive patients (3.1% vs. 0.3%, P=0.011). The mean incidence of TB per 1,000 patient-years was 1.84 for the overall IBD population, 4.89 for TNF-alpha blocker users, and 0.45 for TNF-alpha-blocker-naive patients. The adjusted risk ratio of TB in IBD patients receiving TNF-alpha blocker was 11.7 (95% confidence interval, 1.36-101.3). Pulmonary TB was prevalent in patients treated with TNF-alpha blockers (80.0%, 4/5). LTBI was diagnosed in 17 (10.6%) patients, and none of the 17 LTBI patients experienced reactivation of TB during treatment with TNF-alpha blockers. Treatment with TNF-alpha blockers significantly increased the risk of TB in IBD patients in Korea. De novo pulmonary TB infection was more prevalent than reactivation of LTBI, suggesting an urgent need for specific recommendations regarding TB monitoring during TNF-alpha blocker therapy.


Subject(s)
Mercaptopurine/adverse effects , Adult , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Antibodies, Monoclonal/adverse effects , Cohort Studies , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Female , Humans , Latent Tuberculosis/chemically induced , Male , Mycobacterium tuberculosis/isolation & purification , Republic of Korea , Retrospective Studies , Tuberculosis, Pulmonary/chemically induced , Tumor Necrosis Factor-alpha/antagonists & inhibitors
16.
An. bras. dermatol ; 89(6): 1017-1018, Nov-Dec/2014.
Article in English | LILACS | ID: lil-727640

ABSTRACT

Immunobiologic therapy is indicated for severe forms of psoriasis, resistant to conventional therapy. There is growing concern about their safety profile and possible association with cancer development. This article documents two cases of renal cell cancer during treatment with biologic therapy, reviewing what is described in the literature . The risk of solid tumors as a complication of using TNF-alpha inhibitors is controversial. No conclusion can be drawn from the data in the literature, however, we believe that special attention should be given to those with known risk factors for a specific neoplasm.


Subject(s)
Adult , Aged , Humans , Male , Middle Aged , Carcinoma, Renal Cell/chemically induced , Immunologic Factors/adverse effects , Kidney Neoplasms/chemically induced , Psoriasis/drug therapy , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Antibodies, Monoclonal/adverse effects , Dermatologic Agents/adverse effects , Immunoglobulin G/adverse effects , Receptors, Tumor Necrosis Factor , Risk Factors , Treatment Outcome
17.
Rev. bras. reumatol ; 54(2): 102-109, Mar-Apr/2014. tab, graf
Article in Portuguese | LILACS | ID: lil-710219

ABSTRACT

Introdução: Com o crescimento do uso de drogas imunobiológicas (IBD) ampliamos o conhecimento sobre sua eficácia e segurança. Objetivo: Analisar as reações infusionais imediatas (RII) às IBD endovenosas - infliximabe (IFX), rituximabe (RTX), abatacepte (ABT) e tocilizumabe (TCZ) - no tratamento de doenças autoimunes. Método: Avaliamos 2.126 infusões feitas no CID (Centro de Infusão) em 268 pacientes. A droga usada, a indicação clínica, o tempo de infusão e o uso de pré-medicação foram determinados pelo médico prescritor. Foram consideradas RII todas as intercorrências apresentadas durante a infusão e/ou período observacional de 30 minutos. A conduta adotada nas RII seguiu os protocolos do CID. Resultados: Em relação ao tipo de IBD, as infusões foram distribuídas em: IFX (1.584; 74,5%), TCZ (226; 10,63%), RTX (185; 8,7%) e ABT (131; 6,16%). As RII foram descritas em 87 procedimentos (4,09%): 77 no grupo IFX e 10 no grupo RTX. Não foram descritas RII nos grupos de ABT e TCZ. A maioria foi considerada leve (n = 5; 41,17%) ou moderada (n = 50; 58,81%) e não houve reações graves. Das infusões interrompidas, 79 (92,9%) foram reiniciadas e concluídas com êxito. Apenas seis (0,28%) não foram concluídas por causa das RII. Conclusão: Apesar da diferença entre o número de procedimentos por droga, trata-se de uma análise de "vida real", na qual a incidência de RII foi semelhante à descrita na literatura. A baixa incidência de RII corrobora os dados de segurança tanto de forma quantitativa como qualitativa e ressalta a importância do acompanhamento médico especializado durante a infusão. .


Introduction: With the increasing use of immunobiological drugs (IBD), the knowledge about their effectiveness and safety has increased. Objective: To analyze the immediate infusional reactions (IIR) to intravenous IBD: infliximab (IFX), rituximab (RTX), abatacept (ABT) and tocilizumab (TCZ) on the treatment of autoimmune diseases. Method: 2126 infusions performed in the Infusion Centre - CID in 268 patients were analyzed. The used drug, its clinical indication, infusion time, and use of premedication were determined by the prescribing physician. All intercurrences presented during infusion and/or during a thirty minutes observation period were considered as IIR. The approach adopted in IIR followed the protocols of the Infusion Centre - CID. Results: Regarding the type of IBD, the infused drugs given were: IFX (1584, 74.5%), TCZ (226, 10.63%), RTX (185, 8.7%) and ABT (131, 6,16%). IIR were described in 87 procedures (9.4%): 77 - IFX group and 10 - RTX group. IIR were not described in ABT and TCZ groups. Most were considered as mild (n = 5; 41.17%) or moderate (n = 50, 58.81%) reactions; there were no serious reactions. Regarding to discontinue infusions, 79 (92.9%) were resumed and completed successfully. Only six (0.28% of infusions) were not completed because of IIR. Conclusion: Despite the differences between the number of procedures per drug, ours is a "real life" analysis, where the incidence of IIR was similar to that described in the literature. The low incidence of IIR corroborates the safety data, both quantitatively and qualitatively, and underscores the importance of specialized medical support during infusion. .


Subject(s)
Humans , Autoimmune Diseases/drug therapy , Immunologic Factors/adverse effects , Abatacept , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/adverse effects , Antibodies, Monoclonal, Murine-Derived/administration & dosage , Antibodies, Monoclonal, Murine-Derived/adverse effects , Antibodies, Monoclonal/administration & dosage , Antibodies, Monoclonal/adverse effects , Autoimmune Diseases/epidemiology , Infliximab , Infusions, Intravenous , Immunoconjugates/administration & dosage , Immunoconjugates/adverse effects , Immunologic Factors/administration & dosage , Prevalence , Retrospective Studies , Rituximab , Severity of Illness Index , Time Factors
18.
An. bras. dermatol ; 89(1): 154-156, Jan-Feb/2014. graf
Article in English | LILACS | ID: lil-703547

ABSTRACT

The tumor necrosis factor alpha is a cytokine related to immune and inflammatory processes by acting on different parts of the body. It is secreted by several cell types including macrophages, lymphocytes, monocytes, neutrophils, dendritic cells, among others. Infliximab is a chimeric monoclonal antibody that specifically binds to soluble and transmembrane tumor necrosis factor alpha form blocking its action. In rheumatoid arthritis it is used because the cytokines that cause inflammation in this disease are regulated by tumor necrosis factor alpha and IL-1. We report the case of a 46-year-old patient with rheumatoid arthritis who developed segmental vitiligo after two months using infliximab. The event aims to alert to the existence of this adverse effect that can be induced with the use of this medication.


Subject(s)
Female , Humans , Middle Aged , Antibodies, Monoclonal/adverse effects , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/drug therapy , Vitiligo/chemically induced , Tumor Necrosis Factor-alpha/antagonists & inhibitors
19.
Article in English | WPRIM | ID: wpr-208223

ABSTRACT

We evaluated the utility of follow-up interferon-gamma release assays (IGRAs) for the diagnosis of reactivation of latent tuberculosis infection (LTBI) or new tuberculosis in ankylosing spondylitis (AS) patients receiving anti-tumor necrosis factor alpha (anti-TNFalpha). The study participants (n=127) had a negative IGRA screening before receiving anti-TNFalpha and were evaluated by follow-up IGRA. We retrospectively examined data of the subjects according to age, gender, tuberculosis prophylaxis, concomitant medications, IGRA conversion and anti-TNFalpha, including type and treatment duration. The median duration of anti-TNFalpha was 21.5 months, and the median age was 35.3 yr. Of the 127 patients, IGRA conversion was found in 10 patients (7.9%). There was no significant variation between IGRA conversion rate and any risk factors except for age. IGRA conversion rate was not significantly different between AS and rheumatoid arthritis (P=0.12). IGRA conversion was observed in AS patients receiving anti-TNFalpha in Korea. A follow-up IGRA test can be helpful for identifying LTBI or new tuberculosis in AS patients receiving anti-TNFalpha.


Subject(s)
Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal/adverse effects , Antirheumatic Agents/adverse effects , Female , Follow-Up Studies , Humans , Interferon-gamma/blood , Latent Tuberculosis/blood , Longitudinal Studies , Male , Middle Aged , Prognosis , Reproducibility of Results , Sensitivity and Specificity , Spondylitis, Ankylosing/blood , Treatment Outcome , Tumor Necrosis Factor-alpha/antagonists & inhibitors
20.
Article in English | WPRIM | ID: wpr-53759

ABSTRACT

There is no consensus on whether it is safe to re-administer tumor necrosis factor-alpha (TNFalpha) inhibitors in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS) flared after withdrawal of TNFalpha inhibitors due to active tuberculosis (TB). We evaluated the safety of restarting anti-TNFalpha therapy in patients with TNFalpha-associated TB. We used data of 1,012 patients with RA or AS treated with TNFalpha inhibitors at Seoul St. Mary's Hospital between January 2003 and July 2013 to identify patients who developed active TB. Demographic and clinical data including the results of tuberculin skin tests (TST) and interferon-gamma releasing assays (IGRA) were collected. Fifteen patients developed active TB. Five cases were occurred in RA and 10 cases in AS. Nine of 15 patients had a negative TST or IGRA and 6 TST-positive patients had received prophylaxis prior to initiating anti-TNFalpha therapy. All patients discontinued TNFalpha inhibitors with starting the treatment of TB. Eight patients were re-administered TNFalpha inhibitors due to disease flares and promptly improved without recurrence of TB. TNFalpha inhibitors could be safely resumed after starting anti-TB regimen in patients with RA or AS.


Subject(s)
Adult , Aged , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal, Humanized/adverse effects , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/drug therapy , Enzyme Inhibitors/adverse effects , Female , Humans , Hydroxychloroquine/adverse effects , Immunoglobulin G/adverse effects , Immunosuppressive Agents/adverse effects , Interferon-gamma Release Tests , Male , Methotrexate/adverse effects , Middle Aged , Mycobacterium tuberculosis/isolation & purification , Receptors, Tumor Necrosis Factor/therapeutic use , Retrospective Studies , Spondylitis, Ankylosing/drug therapy , Tuberculin Test , Tuberculosis/chemically induced , Tumor Necrosis Factor-alpha/antagonists & inhibitors
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