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1.
Pharm Res ; 37(2): 29, 2020 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-31915934

RESUMO

PURPOSE: To speed up the drug development process in the biopharmaceutical industry, high throughput methods are indispensable for assessing drug candidates and potential lead formulations, in particular during late stages of discovery and early phases of development. This study aimed to establish a bio-layer-interferometry based high throughput assay for assessing formulation dependent mAb self-interaction (SI-BLI) and to compare the results with kD values obtained by dynamic light scattering (DLS). METHODS: Self-interaction of proprietary and commercially available mAbs was analyzed by SI-BLI and dynamic light scattering (DLS). RESULTS: We found significant correlations of the SI-BLI results and kD-values obtained by DLS for both, different mAbs in one platform formulation and for mAbs formulated in several buffer compositions. In total, we assessed self-interaction propensity of different mAbs in 58 formulations and found significant Pearson correlation (p < 0.05) between kD and results of SI-BLI. CONCLUSIONS: The SI-BLI results correlate with kD and enable fast ranking of both different drug candidates and potential lead formulations. Thus, SI-BLI might decrease the risk to lose potent mAb candidates during transition from discovery to development, and help to accelerate the development of high concentration liquid formulations.


Assuntos
Adalimumab/química , Omalizumab/química , Composição de Medicamentos , Ensaios de Triagem em Larga Escala , Humanos , Interferometria/métodos , Cinética , Ligação Proteica , Conformação Proteica , Multimerização Proteica
4.
Expert Opin Drug Saf ; 19(1): 93-97, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31615274

RESUMO

Objectives: The objective of this study was to calculate adherence, persistence and 10-year switches in patients with PsA, by comparing adalimumab and etanercept in real life.Methods: The authors conducted a retrospective, observational, pharmacological and non-interventional study taking into consideration the dispensations of the study drugs at the Hospital Pharmacy, from 1 January 2007 to 31 December 2018. In the study, the authors considered adalimumab and etanercept. The authors calculated adherence to treatment through the relationship between received daily dose (RDD) and prescribed daily dose (PDD), and calculated persistence to treatment as the difference in days between the first and last dispensation.Results: The authors enrolled 113 patients, 60 treated with adalimumab and 53 with etanercept. Adherence levels were 0.83 for adalimumab and 0.84 for etanercept. Switches occurred in 42% of adalimumab and in 47% of etanercept prescriptions.Conclusion: In the treatment of PsA, persistence and switches are a problem for patients who cannot follow a consistent therapy over time, for clinicians who have to manage therapy suspension and changes, and for the National Health System that must procure and pay for a high number of drugs without information on their real value in terms of efficacy and safety of use.


Assuntos
Adalimumab/administração & dosagem , Artrite Psoriásica/tratamento farmacológico , Etanercepte/administração & dosagem , Adesão à Medicação/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antirreumáticos/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto Jovem
5.
Gastroenterology ; 158(1): 189-199, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31600487

RESUMO

BACKGROUND & AIMS: Anti-tumor necrosis factor (anti-TNF) therapies are the most widely used biologic drugs for treating immune-mediated diseases, but repeated administration can induce the formation of anti-drug antibodies. The ability to identify patients at increased risk for development of anti-drug antibodies would facilitate selection of therapy and use of preventative strategies. METHODS: We performed a genome-wide association study to identify variants associated with time to development of anti-drug antibodies in a discovery cohort of 1240 biologic-naïve patients with Crohn's disease starting infliximab or adalimumab therapy. Immunogenicity was defined as an anti-drug antibody titer ≥10 AU/mL using a drug-tolerant enzyme-linked immunosorbent assay. Significant association signals were confirmed in a replication cohort of 178 patients with inflammatory bowel disease. RESULTS: The HLA-DQA1*05 allele, carried by approximately 40% of Europeans, significantly increased the rate of immunogenicity (hazard ratio [HR], 1.90; 95% confidence interval [CI], 1.60-2.25; P = 5.88 × 10-13). The highest rates of immunogenicity, 92% at 1 year, were observed in patients treated with infliximab monotherapy who carried HLA-DQA1*05; conversely the lowest rates of immunogenicity, 10% at 1 year, were observed in patients treated with adalimumab combination therapy who did not carry HLA-DQA1*05. We confirmed this finding in the replication cohort (HR, 2.00; 95% CI, 1.35-2.98; P = 6.60 × 10-4). This association was consistent for patients treated with adalimumab (HR, 1.89; 95% CI, 1.32-2.70) or infliximab (HR, 1.92; 95% CI, 1.57-2.33), and for patients treated with anti-TNF therapy alone (HR, 1.75; 95% CI, 1.37-2.22) or in combination with an immunomodulator (HR, 2.01; 95% CI, 1.57-2.58). CONCLUSIONS: In an observational study, we found a genome-wide significant association between HLA-DQA1*05 and the development of antibodies against anti-TNF agents. A randomized controlled biomarker trial is required to determine whether pretreatment testing for HLA-DQA1*05 improves patient outcomes by helping physicians select anti-TNF and combination therapies. ClinicalTrials.gov ID: NCT03088449.


Assuntos
Adalimumab/imunologia , Doença de Crohn/terapia , Cadeias alfa de HLA-DQ/genética , Infliximab/imunologia , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adalimumab/uso terapêutico , Adulto , Alelos , Doença de Crohn/sangue , Feminino , Estudo de Associação Genômica Ampla , Heterozigoto , Humanos , Infliximab/uso terapêutico , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Fator de Necrose Tumoral alfa/imunologia , Adulto Jovem
10.
An Bras Dermatol ; 94(6): 751-753, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31789263

RESUMO

Lobular capillary hemangioma or pyogenic granuloma is a benign vascular tumor of the skin or mucous membranes. Most patients present a single lesion. It manifests clinically as an erythematous, friable, and fast-growing tumor. This report details a case with exuberant presentation in a patient with ankylosing spondylitis, using adalimumab. Factors triggering pyogenic granuloma are not well known. They may spontaneously regress, but most require treatment.


Assuntos
Adalimumab/uso terapêutico , Antirreumáticos/uso terapêutico , Granuloma Piogênico/patologia , Dermatopatias/patologia , Espondilite Anquilosante/tratamento farmacológico , Granuloma Piogênico/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Dermatopatias/etiologia , Espondilite Anquilosante/complicações , Fator de Necrose Tumoral alfa/antagonistas & inibidores
12.
Expert Opin Drug Saf ; 18(12): 1219-1235, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31801415

RESUMO

Introduction: The treatment strategies for noninfectious uveitis (NIU) aim to achieve disease remission, prevention of recurrences, and preserving vision, while minimizing the side effects associated with the therapies used.Areas covered: The index review aims to provide a detailed overview of the adverse events and safety parameters associated with the systemic therapies for the management of the NIU.Expert opinion: Despite being the cornerstone of management of acute cases of NIU, long-term corticosteroid use is associated with multi-system side effects, requiring the use of steroid-sparing agents. Adalimumab was recently approved by the FDA for the management of NIU based on the results of VISUAL studies. Similarly, newer drugs targeting various aspects of the inflammatory cascade are being developed. However, until we completely understand the molecular pathways of the inflammatory diseases, the therapeutic profile of these newer agents needs to be broad enough to suppress inflammatory cascade and narrow enough to spare normal cellular processes. Another strategy that has shown some potential in decreasing the systemic side effects is to provide local drug delivery. Therefore, the future of management of NIU is very bright with many novel therapeutic agents and strategies of drug delivery on the horizon.


Assuntos
Sistemas de Liberação de Medicamentos , Desenvolvimento de Medicamentos , Uveíte/tratamento farmacológico , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Corticosteroides/administração & dosagem , Corticosteroides/efeitos adversos , Humanos
13.
Clin Exp Rheumatol ; 37 Suppl 121(6): 3-17, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31856939

RESUMO

Several epidemiologic studies report on the prevalence of Behçet's syndrome (BS) and demographic and clinical findings in patients from different countries and ethnicities. Although these studies point out geographic differences in disease course, methodologic differences make it difficult to compare the results of these studies. Recent data suggest that neutrophil extracellular trap levels are elevated in patients with BS, and that it may be a potential therapeutic target for the reduction or prevention of BS-associated thrombotic risk. Details on the mode of functioning of ERAP have been delineated and further epigenetic data reported. Wall thickness of lower extremity veins is increased among BS patients without any apparent clinical involvement. Magnetic resonance (MR) venography and Doppler ultrasonography (USG) were comparable in the diagnosis of chronic deep vein thrombosis, while MR venography is more effective in detecting collateral formations. Results were also collected on some dietary and non-dietary factors in triggering oral ulcers, while smoking seems to have a protective role. With regards to the therapy, it has been demonstrated that endovascular interventions carry the risk of inducing pathergy phenomenon. Apremilast has been convincingly shown to be useful for oral ulcers of BS and classical immunosuppressives are effective as first line therapy in more than half of patients with uveitis. While infliximab and adalimumab seem to be equally effective in the treatment of refractory uveitis of BS, the combination of adalimumab and immunosuppressives appears to be superior to immunosuppressives alone for venous thrombosis of the extremities. In addition, tocilizumab might be an alternative to anti-TNF agents for patients with arterial involvement refractory to immunosuppressives. On the other hand, the place of IL-17 inhibition in the treatment of BS still remains questionable.


Assuntos
Síndrome de Behçet , Imunossupressores/uso terapêutico , Adalimumab , Síndrome de Behçet/complicações , Síndrome de Behçet/diagnóstico , Síndrome de Behçet/tratamento farmacológico , Predisposição Genética para Doença , Humanos , Úlceras Orais/etiologia , Prevalência , Fator de Necrose Tumoral alfa/uso terapêutico , Uveíte/etiologia , Trombose Venosa/etiologia
14.
Croat Med J ; 60(5): 431-438, 2019 Oct 31.
Artigo em Inglês | MEDLINE | ID: mdl-31686457

RESUMO

AIM: To investigate the efficacy of adalimumab treatment in an experimental rat sclerosing encapsulated peritonitis (SEP) model. METHODS: The study involved 40 Wistar albino rats divided into four groups: chlorhexidine (CH) group, control group, CH + adalimumab group, and CH + resting group. The control group received normal saline intraperitoneally (i.p.). Other groups received 0.1% CH gluconate, 15% ethanol, and normal saline mixture i.p. for three weeks in order to induce SEP. CH + adalimumab group received 5 mg/kg adalimumab i.p. at the beginning of week 4 and week 6, while CH + resting group was followed-up for three weeks without applying any procedure after the onset of SEP. Rats in groups CH and control group were sacrificed on day 21, and rats in group CH + adalimumab and CH + resting were sacrificed on day 42. All groups were evaluated for peritoneal thickness, inflammation, vascularization, and fibrosis. RESULTS: CH + adalimumab group showed a significant decrease in peritoneal thickness, fibrosis score, and vascular score compared with CH group and CH + resting group. CONCLUSION: Adalimumab can prevent SEP development.


Assuntos
Adalimumab/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Fibrose Peritoneal/tratamento farmacológico , Animais , Modelos Animais de Doenças , Fibrose Peritoneal/patologia , Fibrose Peritoneal/fisiopatologia , Ratos , Ratos Wistar
15.
Orv Hetil ; 160(44): 1744-1750, 2019 Nov.
Artigo em Húngaro | MEDLINE | ID: mdl-31657252

RESUMO

We present herewith cases of non-infectious uveitis with biological treatment where the ocular complaints were the initial symptoms indicating a multi-organ autoimmune disease. The first case was a patient with panuveitis and Vogt-Koyanagi-Harada disease, the second case was also a panuveitic patient with sarcoidosis and the third case was a patient with intermediate uveitis and inflammatory bowel disease. In all cases, emerging new, biological therapy (adalimumab) was necessary to achieve permanent inactive period of uveitis and the autoimmune disease. Introducing systemic biological treatment (adalimumab) in ophthalmology is crucial in the therapy of immune-mediated, non-infectious uveitis in order to preserve visual acuity. Orv Hetil. 2019; 160(44): 1744-1750.


Assuntos
Adalimumab/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Oftalmologia , Pan-Uveíte/tratamento farmacológico , Uveíte/tratamento farmacológico , Humanos , Doenças Inflamatórias Intestinais/diagnóstico , Pan-Uveíte/diagnóstico , Sarcoidose/diagnóstico , Resultado do Tratamento , Uveíte/diagnóstico , Síndrome Uveomeningoencefálica/diagnóstico , Acuidade Visual
16.
Z Gastroenterol ; 57(10): 1218-1225, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31610585

RESUMO

INTRODUCTION: Response to anti-TNF therapy is crucial for life expectancy and life quality in patients with severe Crohn's disease. We investigated if a previously reported gene expression profile predictive for infliximab response could be also applied to adalimumab response in an independent cohort. METHODS: Forty-seven Slovene Crohn's disease patients indicated for adalimumab therapy were enrolled in the study. Inflamed and non-inflamed colon biopsy samples were obtained during routine colonoscopy prior to adalimumab treatment. Response to adalimumab was measured with IBDQ. Gene expression in inflamed and non-inflamed colon biopsy samples was measured with RT-qPCR. Genotypes were extracted from previously available genotype data. Statistical analysis was performed with SPSS software. The R package e1071 was used to train bootstrap aggregated support vector machines (SVM). RESULTS: SVM prediction model analysis was used to analyze pooled, non-inflamed, and inflamed colon tissue datasets using IBDQ response after 4, 12, 20 and 30 weeks of adalimumab treatment. The bagging approach was used in an endeavor to obtain 100 % accuracy using 10 × 100 or 100 × 100 iterations. Average adalimumab response prediction accuracy is 75.5 % for pooled samples, 90.5 % for inflamed samples, and 100 % for non-inflamed samples. Moreover, models trained on selected SNPs from analyzed genes had an average accuracy of 92.8 %, confirming the involvement of genetic regions mapping the reported genes. Finally, using combined gene expression and SNP data we observed 100 % adalimumab response prediction accuracy for pooled, inflamed, and non-inflamed datasets. DISCUSSION: Our study supports the reported genetic anti-TNF response profile and extends it for adalimumab prediction.


Assuntos
Adalimumab , Doença de Crohn , Marcadores Genéticos , Adalimumab/uso terapêutico , Adulto , Anti-Inflamatórios/uso terapêutico , Doença de Crohn/tratamento farmacológico , Doença de Crohn/genética , Feminino , Perfilação da Expressão Gênica , Humanos , Masculino , Pessoa de Meia-Idade , Farmacogenética , Eslovênia
17.
Medicine (Baltimore) ; 98(38): e17208, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31567972

RESUMO

Ulcerative colitis (UC) and Crohn disease (CD) are the most common forms of inflammatory bowel disease (IBD). Because these subtypes of IBD are characterized by periods of activity and remission, an understanding of the modulation of biochemical markers with the clinical features of IBD or its treatment, may be useful for determining the correct treatment protocol.This study aimed to evaluate the serum levels of 27 protein biomarkers to determine their association with IBD, correlation with clinical findings of disease, and modulation according to the pharmacologic therapy.A case-control study was carried out in Zacatecas, Mexico. The 27 protein profiles of serum from 53 participants (23 UC, 11 CD, and 19 controls) were evaluated using the Pro Human Cytokine 27-Plex immunoassay (Bio-Rad).Considering the controls as a reference, the group with IBD endoscopic activity showed higher serum levels of granulocyte colony-stimulating factor (G-CSF), interleukin 1 receptor antagonist (IL-1Ra), and platelet-derived growth factor BB (PDGF-BB) (P < .05). Interferon-induced protein 10 (IP-10) was associated with extraintestinal symptoms of disease (P = .041). Both PDGF-BB and interleukin 6 (IL-6) showed the strongest correlations with clinical features of IBD. Levels of IL-6, IL-7, and monocyte chemoattractant protein 1 were higher with 5-aminosalicylic acid (5-ASA) + Azathioprine therapy than controls (P < .05). Combined therapy with 5-ASA + Adalimumab led to the strongest changes in marker modulation: IL-4, IL-5, IL-15, and PDGF-BB, were upregulated (P < .05).Elevated serum levels of G-CSF, IL-1Ra, and PDGF-BB were associated with IBD endoscopic activity, and of IP-10 with extraintestinal manifestations of IBD. Combined therapy of 5-ASA + Adalimumab produced significant upregulation of IL-4, IL-5, IL-15, and PDGF-BB. This information may be useful for deciding on the course of pharmacologic therapy for patients with IBD and for generating new therapy alternatives to improve the outcome of patients with IBD.


Assuntos
Quimiocinas/sangue , Citocinas/sangue , Doenças Inflamatórias Intestinais/sangue , Peptídeos e Proteínas de Sinalização Intercelular/sangue , Adalimumab/uso terapêutico , Adulto , Idoso , Anti-Inflamatórios/uso terapêutico , Azatioprina/uso terapêutico , Becaplermina/sangue , Biomarcadores/sangue , Estudos de Casos e Controles , Quimiocina CXCL10/sangue , Feminino , Fator Estimulador de Colônias de Granulócitos/sangue , Humanos , Doenças Inflamatórias Intestinais/tratamento farmacológico , Interleucina-6/sangue , Masculino , Mesalamina/uso terapêutico , Pessoa de Meia-Idade , Receptores de Interleucina-1/sangue
18.
Expert Opin Pharmacother ; 20(17): 2161-2168, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31574236

RESUMO

Introduction: Crohn's disease (CD) is a chronic inflammatory condition that can occur throughout the gastrointestinal tract. The aims of treatment of children with CD are to induce and maintain clinical remission of disease, optimize nutrition and growth, minimize adverse effects of therapies, and if possible, achieve mucosal healing.Areas covered: This review summarizes evidence for the various therapeutic options in the treatment of children with CD. Exclusive enteral nutrition, corticosteroids, and biologics may be used for induction of remission. Immunomodulators (thiopurines, methotrexate) and biologics (infliximab, adalimumab) may be employed for maintenance of remission to prevent flares of disease and avoid chronic steroid use. In cases of fibrotic disease, intestinal perforations, or medically refractory, surgery may be the best therapeutic option.Expert opinion: Exclusive enteral nutrition, corticosteroids, and biologics (including anti-TNF inhibitors) may be used for induction of remission in patients with active flare of their disease. Immunomodulators and TNF inhibitors may be used for maintenance of remission. Early use of anti-TNF inhibitors in patients with moderate to severe CD may improve efficacy and prevent penetrating complications of disease. While pediatric data is limited, newer biologics, such as vedolizumab and ustekinumab, are used off-label in anti-TNF refractory disease.


Assuntos
Adalimumab/uso terapêutico , Doença de Crohn/tratamento farmacológico , Fatores Imunológicos/uso terapêutico , Infliximab/uso terapêutico , Adalimumab/efeitos adversos , Corticosteroides/efeitos adversos , Corticosteroides/uso terapêutico , Criança , Ensaios Clínicos como Assunto , Humanos , Fatores Imunológicos/efeitos adversos , Infliximab/efeitos adversos , Indução de Remissão
20.
Brasília; CONITEC; out. 2019. ilus, tab.
Não convencional em Português | BRISA/RedTESA | ID: biblio-1024749

RESUMO

INTRODUÇÃO: A colite ulcerativa (RCU) é uma doença inflamatória intestinal (DII) crônica caracterizada por inflamação difusa da mucosa cólica e pela evolução recidivante e remitente. Os sinais e sintomas da RCU dependem da localização, significância e gravidade da doença. A incidência de colite ulcerativa é semelhante entre homens e mulheres. A idade do início da doença é entre 30 anos e 40 anos. No Brasil, estudo epidemiológico encontrou uma incidência média anual de 7,16 novos casos/100.000 habitantes/ano e uma prevalência de 28,3/100.000. O tratamento da RCU depende da gravidade e localização da doença. Os princípios gerais para tratar a colite ulcerativa ativa são considerar a atividade, distribuição (proctite, lado esquerdo, colite extensa) e padrão de doença (frequência de recaída, curso da doença, resposta a medicamentos anteriores, perfil de efeitos colaterais de medicação, manifestação intestinal). TECNOLOGIA: adalimumabe (Humira®), infliximabe (Remicade®, Bio-Manguinhos Infliximabe), golimumabe (Simponi®), vedolizumabe (Entyvio®). PERGUNTA: O adalimumabe, infliximabe, golimumabe e vedolizumabe são eficazes, seguros e custo-efetivos para tratamento da colite ulcerativa moderada a grave? EVIDÊNCIAS CIENTÍFICAS: a evidência disponível sobre eficácia e segurança comparativa entre biológicos para RCU moderada a grave é oriunda de metanálises indiretas. As evidências indiretas mostraram que, em pacientes que não fizeram uso prévio de biológicos, o infliximabe e o vedolizumabe são os mais bem classificados para induzir a remissão clínica e a cicatrização da mucosa. As evidências sugerem que o infliximabe apresenta um desempenho melhor do que o adalimumabe e o golimumabe. Todos os tratamentos avaliados (com exceção do infliximabe) não aumentaram as taxas de eventos adversos, enquanto o vedolizumabe foi estatisticamente inferior ao placebo em relação à ocorrência de eventos adversos graves. AVALIAÇÃO ECONÔMICA: Em comparação com a terapia com adalimumabe (menor custo e menor efetividade), o golimumabe apresentou uma relação de custo-efetividade incremental (RCEI) de R$ 27.849,62 por QALY ganho e o infliximabe, mostrou uma RCEI de R$ 39.358,70 por QALY, ao passo que o vedolizumabe, mostrou uma RCEI de R$ 58.624,33. O infliximabe quando comparado com golimumabe mostrou uma RCEI de R$ 44.936,40 por QALY ganho. Já o vedolizumabe quando comparado ao infliximabe resultaria em uma RCEI de R R$76.227,79 por QALY ganho. AVALIAÇÃO DE IMPACTO ORÇAMENTÁRIO: O impacto orçamentário com a inserção dos quatro biológicos para RCU moderada a grave após falha da terapia convencional, seria cerca de R$ 89,04 milhões no primeiro ano, totalizando cerca de R$ 393,5 milhões em cinco anos. Caso fosse incorporado apenas o golimumabe, o infliximabe e vedolizumabe nas proporções 20%, 40% e 40%, respectivamente, o impacto no orçamento no primeiro ano seria de R$ 96 milhões com total de R$ 425,8 milhões em cinco anos. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: O horizonte tecnológico aponta que há terapias doze terapias com diferentes mecanismos de ação e com via de administração oral em desenvolvimento. CONSIDERAÇÕES: A evidência disponível sobre eficácia e segurança entre biológicos para RCU moderada a grave é oriunda de evidências indiretas que sugerem que o infliximabe e vedolizumabe apresentaram um desempenho melhor nas fases de indução e remissão. O infliximabe parece ser o biológico mais custo-efetivo comparado ao adalimumabe. A sociedade identificou uma necessidade em saúde ainda não atendida pelo PCDT para retocolite ulcerativa vigente, caracterizada pelos pacientes que não respondem, que perdem a resposta ou apresentam intolerância aos medicamentos convencionais. RECOMENDAÇÃO PRELIMINAR DA CONITEC: Os membros do Plenário reconheceram que há uma população não contemplada no PCDT de RCU vigente que poderiam se beneficiar com o uso de biológico. Os medicamentos infliximabe e vedolizumabe apresentaram como candidatos potenciais para esta lacuna, desde que atendidos os requisitos de eficácia, segurança, custoefetividade e impacto orçamentário para o SUS. Neste sentido, a Conitec, em sua 79ª reunião ordinária, recomendou que a matéria fosse disponibilizada em consulta pública com recomendação preliminar pela incorporação no SUS do vedolizumabe e infliximabe para RCU moderada a grave. CONSULTA PÚBLICA: Foram recebidas 1525 contribuições, sendo 121 técnico-científicas e 1404 contribuições de experiência ou opinião. A maioria discordou parcialmente da recomendação da Conitec sendo o principal argumento a necessidade de incorporação de todos os biológicos avaliados. As evidências apresentadas já haviam sido incluídas ou não estavam de acordo com os critérios de inclusão estabelecidos neste relatório. O tratamento da população pediátrica foi abordado, sendo o infliximabe, o único biológico com indicação em bula para esta população. A CONITEC entendeu que não houve argumentação suficiente para alterar sua recomendação inicial. RECOMENDAÇÃO FINAL: Os membros da Conitec presentes na 81ª reunião ordinária, deliberaram por recomendar a incorporação do infliximabe e do vedolizumabe para tratamento da retocolite ulcerativa moderada a grave, conforme Protocolo Clínico e Diretrizes Terapêuticas e não recomendar adalimumabe e golimumabe. Foram assinados os Registros de Deliberação nº 469/2019 e n° 473/2019. DECISÃO: Incorporar o infliximabe e o vedolizumabe para o tratamento da retocolite ulcerativa moderada a grave, limitados ao custo do tratamento com infliximabe conforme Protocolo Clínico e Diretrizes Terapêuticas do Ministério da Saúde e não incorporar o adalimumabe e o golimumabe para tratamento de retocolite ulcerativa moderada a grave, no âmbito do Sistema Único de Saúde ­ SUS. Dada pela Portaria n° 49, publicada no Diário Oficial da União n° 206, seção 1, página 45, em 23 de outubro de 2019.


Assuntos
Humanos , Adalimumab/uso terapêutico , Infliximab/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Avaliação da Tecnologia Biomédica , Sistema Único de Saúde , Brasil , Análise Custo-Benefício/economia
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