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Vaccines against SARS-CoV-2 are important for protection from COVID-19; however, patients with immune-mediated conditions and patients taking immunosuppressive medications, including patients with inflammatory bowel disease (IBD), were excluded from studies demonstrating the safety and efficacy of these vaccines. This article provides an overview of the research and recommendations currently published on vaccines against COVID-19 in adult populations with IBD, including studies evaluating effects of commonly used medications. COVID-19 vaccines are strongly recommended for patients with IBD. Messenger RNA (mRNA) and adenovirus vector vaccines are safe in patients with IBD, and reports of severe reactions or IBD flares are rare. Studies assessing antibody response, T-cell immunity, and real-world experience demonstrate positive outcomes for mRNA and adenovirus vector vaccines in patients with IBD, although mRNA vaccines may have a slight advantage. Studies assessing inactive COVID-19 vaccines are still needed. Immunosuppressive therapies used in IBD, especially tumor necrosis factor antagonists, combination therapy, and corticosteroids, may reduce antibody responses and durability, but the impact on infection, hospitalizations, and death requires further evaluation. Educating patients with this evidence-based information will likely help to reduce concerns and vaccine hesitancy.
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BACKGROUND & AIMS: The effect of pregnancy on inflammatory bowel disease (IBD) remains poorly understood. We aimed to monitor intestinal inflammation using fecal calprotectin (FC) in pregnant women and their babies during early life. METHODS: Pregnant women with or without IBD and their infants were prospectively enrolled. FC levels were measured at each trimester of pregnancy and in babies throughout the first 3 years of life. Repeated-measures analysis was applied to investigate changes in FC levels while adjusting for confounders. The FC levels were correlated with the bacterial abundance in both mothers and babies. RESULTS: Six hundred and fourteen fecal samples from 358 mothers (98 with IBD) and 1005 fecal samples from 289 infants (76 born to IBD mothers) were analyzed. Pregnant Patients with IBD maintained higher FC levels through pregnancy compared with controls (P = 7.5 × 10-54). FC gradually increased in controls and declined in Patients with IBD throughout pregnancy (P for interaction = 5.8 × 10-7). Babies born to mothers with IBD presented with significantly higher FC levels than those born to controls up to 3 years of age, after adjusting for sex, delivery mode, feeding behavior, and antibiotics exposure (2 weeks to 3 months of age, P = .015; 12-36 months of age, P = .00003). Subdoligranulum, Roseburia, Fusicatenibacter, and Alistipes negatively correlated, and Streptococcus, Prevotella, Escherichia-Shigella, and Bifidobacterium positively correlated with maternal FC levels at T3. Faecalibacterium, Bifidobacterium, and Alistipes showed negative correlations, and Streptococcus were positively correlated with FC levels within 3 months of birth. CONCLUSIONS: Pregnancy is associated with decreased inflammatory activity in mothers with IBD. Higher FC levels in babies born to mothers with IBD suggest subclinical inflammation in early life, the long-term consequences of which are uncertain.
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Colite Ulcerativa/diagnóstico , Doença de Crohn/diagnóstico , Complexo Antígeno L1 Leucocitário/análise , Complicações na Gravidez/diagnóstico , Efeitos Tardios da Exposição Pré-Natal/diagnóstico , Adulto , Antibacterianos/administração & dosagem , Bactérias/efeitos dos fármacos , Bactérias/imunologia , Bactérias/isolamento & purificação , Estudos de Casos e Controles , Pré-Escolar , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/imunologia , Colonoscopia , Doença de Crohn/tratamento farmacológico , Doença de Crohn/imunologia , Fezes/química , Feminino , Microbioma Gastrointestinal/efeitos dos fármacos , Microbioma Gastrointestinal/imunologia , Humanos , Lactente , Recém-Nascido , Mucosa Intestinal/imunologia , Mucosa Intestinal/microbiologia , Estudos Longitudinais , Masculino , Gravidez , Complicações na Gravidez/tratamento farmacológico , Complicações na Gravidez/imunologia , Efeitos Tardios da Exposição Pré-Natal/imunologia , Estudos Prospectivos , Índice de Gravidade de DoençaRESUMO
Patients with inflammatory bowel diseases [IBD] are frequently treated with immunosuppressant medications. During the coronavirus disease 2019 [COVID-19] pandemic, recommendations for IBD management have included that patients should stay on their immunosuppressant medications if they are not infected with the severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], but to temporarily hold these medications if symptomatic with COVID-19 or asymptomatic but have tested positive for SARS-CoV-2. As more IBD patients are infected globally, it is important to also understand how to manage IBD medications during convalescence while an individual with IBD is recovering from COVID-19. In this review, we address the differences between a test-based versus a symptoms-based strategy as related to COVID-19, and offer recommendations on when it is appropriate to consider restarting IBD therapy in patients testing positive for SARS-CoV-2 or with clinical symptoms consistent with COVID-19. In general, we recommend a symptoms-based approach, due to the current lack of confidence in the accuracy of available testing and the clinical significance of prolonged detection of virus via molecular testing.
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Betacoronavirus , Técnicas de Laboratório Clínico , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/prevenção & controle , Hospedeiro Imunocomprometido , Imunossupressores/administração & dosagem , Doenças Inflamatórias Intestinais/tratamento farmacológico , Pandemias/prevenção & controle , Pneumonia Viral/imunologia , Pneumonia Viral/prevenção & controle , Infecções Assintomáticas , Betacoronavirus/isolamento & purificação , COVID-19 , Teste para COVID-19 , Infecções por Coronavirus/diagnóstico , Esquema de Medicação , Humanos , Imunossupressores/uso terapêutico , Doenças Inflamatórias Intestinais/complicações , Doenças Inflamatórias Intestinais/imunologia , Pneumonia Viral/diagnóstico , Medição de Risco , SARS-CoV-2Assuntos
Controle de Doenças Transmissíveis , Infecções por Coronavirus , Doenças Inflamatórias Intestinais , Pandemias , Administração dos Cuidados ao Paciente , Pneumonia Viral , Adulto , Assistência ao Convalescente/métodos , Assistência ao Convalescente/organização & administração , Betacoronavirus/isolamento & purificação , COVID-19 , Teste para COVID-19 , Técnicas de Laboratório Clínico/métodos , Estudos de Coortes , Controle de Doenças Transmissíveis/métodos , Controle de Doenças Transmissíveis/organização & administração , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Infecções por Coronavirus/transmissão , Transmissão de Doença Infecciosa/prevenção & controle , Feminino , Humanos , Doenças Inflamatórias Intestinais/diagnóstico , Doenças Inflamatórias Intestinais/epidemiologia , Doenças Inflamatórias Intestinais/terapia , Masculino , Mortalidade , Cidade de Nova Iorque/epidemiologia , Inovação Organizacional , Avaliação de Processos e Resultados em Cuidados de Saúde , Administração dos Cuidados ao Paciente/métodos , Administração dos Cuidados ao Paciente/organização & administração , Administração dos Cuidados ao Paciente/tendências , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Pneumonia Viral/transmissão , SARS-CoV-2 , Telemedicina/métodos , Tratamento Farmacológico da COVID-19Assuntos
Colite Ulcerativa/patologia , Avaliação de Resultados em Cuidados de Saúde/métodos , Colite Ulcerativa/terapia , Monitoramento de Medicamentos/efeitos adversos , Monitoramento de Medicamentos/métodos , Endoscopia Gastrointestinal , Humanos , Mucosa Intestinal/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão , Resultado do Tratamento , CicatrizaçãoRESUMO
BACKGROUND AND AIMS: Prenatal and early life bacterial colonisation is thought to play a major role in shaping the immune system. Furthermore, accumulating evidence links early life exposures to the risk of developing IBD later in life. We aimed to assess the effect of maternal IBD on the composition of the microbiome during pregnancy and on the offspring's microbiome. METHODS: We prospectively examined the diversity and taxonomy of the microbiome of pregnant women with and without IBD and their babies at multiple time points. We evaluated the role of maternal IBD diagnosis, the mode of delivery, antibiotic use and feeding behaviour on the microbiome composition during early life. To assess the effects of IBD-associated maternal and infant microbiota on the enteric immune system, we inoculated germ-free mice (GFM) with the respective stool and profiled adaptive and innate immune cell populations in the murine intestines. RESULTS: Pregnant women with IBD and their offspring presented with lower bacterial diversity and altered bacterial composition compared with control women and their babies. Maternal IBD was the main predictor of the microbiota diversity in the infant gut at 7, 14, 30, 60 and 90 days of life. Babies born to mothers with IBD demonstrated enrichment in Gammaproteobacteria and depletion in Bifidobacteria. Finally, GFM inoculated with third trimester IBD mother and 90-day infant stools showed significantly reduced microbial diversity and fewer class-switched memory B cells and regulatory T cells in the colon. CONCLUSION: Aberrant gut microbiota composition persists during pregnancy with IBD and alters the bacterial diversity and abundance in the infant stool. The dysbiotic microbiota triggered abnormal imprinting of the intestinal immune system in GFM.
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Microbioma Gastrointestinal/imunologia , Doenças Inflamatórias Intestinais/microbiologia , Complicações na Gravidez/microbiologia , Efeitos Tardios da Exposição Pré-Natal/microbiologia , Imunidade Adaptativa , Adulto , Animais , Bactérias/classificação , Bactérias/isolamento & purificação , Disbiose/imunologia , Disbiose/microbiologia , Transplante de Microbiota Fecal/métodos , Fezes/microbiologia , Feminino , Seguimentos , Trato Gastrointestinal/imunologia , Trato Gastrointestinal/microbiologia , Vida Livre de Germes , Humanos , Recém-Nascido , Doenças Inflamatórias Intestinais/imunologia , Masculino , Troca Materno-Fetal , Gravidez , Complicações na Gravidez/imunologia , Efeitos Tardios da Exposição Pré-Natal/imunologia , Estudos ProspectivosRESUMO
The Spanish IBD Registry (ENEIDA) is reporting in this issue of the Journal on a retrospective assessment of outcomes of cyclosporine use and infliximab use to treat steroid refractory acute severe ulcerative colitis (SR-ASUC) between 1989 and 2013. Overall, they found similar outcomes in terms of 3 month and 1 year colectomy rates. Serious adverse events were lower in cyclosporine users. While this study does not meet the standard of a prospective randomized controlled trial, it does remind us that cyclosporine can be effective in (SR-ASUC) and should be considered in those who have already failed antibody to tumor necrosis factor therapy or as a bridge to immunomodulators that have a slower onset of action.
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Colite Ulcerativa/cirurgia , Ciclosporina , Colectomia , Humanos , Imunossupressores , Infliximab , Estudos Prospectivos , Sistema de Registros , Estudos RetrospectivosRESUMO
In a patient presenting with suspected inflammatory bowel disease, the initial endoscopic evaluation is a valuable tool for determining the correct disease diagnosis and the extent and severity of disease. A full colonoscopy and ileoscopy should be performed when possible, with systematic biopsies from each segment. When a diagnosis of inflammatory bowel disease is established, it is possible to distinguish between Crohn disease and ulcerative colitis, and specific endoscopic features may assist in this categorization. Because patchy healing can occur with treatment, it is important to obtain a thorough and accurate assessment of disease characteristics and distribution before initiating therapy.
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Colite Ulcerativa/diagnóstico , Colonoscopia/métodos , Doença de Crohn/diagnóstico , Endoscopia Gastrointestinal/métodos , Biópsia , Diagnóstico Diferencial , Humanos , Intestinos/patologiaRESUMO
On February 9, 2016, the Food and Drug Administration Arthritis Advisory Committee recommended by a vote of 21 to 3, that the biosimilar to infliximab, CT-P13, be approved for rheumatoid arthritis and ankylosing spondylitis and, by extrapolation, for all the indications for which infliximab is currently approved, including adult and pediatric ulcerative colitis and Crohn's disease. On April 5, 2016, the Food and Drug Administration concurred with this recommendation and approved CT-P13 (Inflectra; Pfizer Inc.) for all diseases for which infliximab had previously been approved, including adult and pediatric moderate to severe ulcerative colitis and pediatric and adult moderate to severe and fistulizing Crohn's disease. This was despite the absence of any randomized controlled trials studying the infliximab biosimilar in any inflammatory bowel disease. This highly controversial approach has been criticized by various rheumatology and gastroenterology professional societies around the world. This review will cover the stepwise approach to biosimilar development, issues of extrapolation and interchangeability, and conclude with a discussion of the regulatory, intellectual property issues, and financial implications, which will all intersect in the decision and ability to prescribe a biosimilar or reference anti-tumor necrosis factor drug.
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Medicamentos Biossimilares/uso terapêutico , Aprovação de Drogas/métodos , Fármacos Gastrointestinais/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Anticorpos Monoclonais/uso terapêutico , Humanos , Infliximab/uso terapêutico , Estados Unidos , United States Food and Drug AdministrationRESUMO
BACKGROUND: Consensus on what constitutes a quality colonoscopy report for patients with inflammatory bowel disease (IBD) is lacking. We developed a template for quality colonoscopy reporting that can be used broadly by endoscopists. METHODS: After a literature review of topics relevant to colonoscopy reporting, members of the Building Research in Inflammatory Bowel Disease Globally (BRIDGe) group and 2 external experts proposed candidate reporting elements. The RAND/University of California, Los Angeles appropriateness method was applied to rate the importance and feasibility of elements for inclusion in colonoscopy reports for patients with IBD. Panelists used the modified Delphi method to anonymously rate the importance and feasibility of candidate elements on a 1-to-9 scale (1-3: not important/feasible, 4-6: moderately important/feasible, 7-9: very important/feasible). Disagreement was assessed using a validated index. The panelists then met in person for discussion followed by a second round of voting. Elements rated a median of 7 or higher on importance after rerating were retained. RESULTS: One hundred two reporting elements were proposed. A total of 48 elements were retained across the four themes of "disease background," "findings and interventions," "Crohn's disease with an ileocolonic anastomosis," and "pouchoscopy." CONCLUSIONS: A comprehensive list of recommended elements for quality IBD colonoscopy reporting stratified by clinical scenario has been described, using a rigorous and evidence-based approach. These elements can be incorporated into endoscopy reporting software platforms. Standardized endoscopy reporting may improve the quality of care in IBD.
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Colite Ulcerativa/diagnóstico por imagem , Colo/cirurgia , Colonoscopia , Doença de Crohn/diagnóstico por imagem , Documentação/normas , Íleo/cirurgia , Anastomose Cirúrgica , Bolsas Cólicas , Consenso , Doença de Crohn/cirurgia , Técnica Delphi , Humanos , Proctocolectomia Restauradora , Literatura de Revisão como AssuntoRESUMO
Ulcerative colitis (UC) is a chronic inflammatory condition of the colon, characterized by diffuse mucosal inflammation, bloody diarrhea, and urgency. The mainstay of treatment has been mesalamine agents, steroids, thiopurines, and anti-tumor necrosis factor alpha (TNF-α) antibodies. Over the past several years, new therapies have emerged which have provided clinicians new treatment options as well as new challenges in deciding which treatment is best for their patient at given points in their disease course. These agents include budesonide-Multi-Matrix System (MMX), adalimumab, golimumab, and vedolizumab. In addition, randomized controlled trials have investigated a combination therapy of infliximab and azathioprine and a controlled trial of infliximab versus cyclosporine for intravenous steroid refractory UC. This review will focus on where these agents may be optimally positioned in treatment algorithms for UC.
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Anti-Inflamatórios/uso terapêutico , Colite Ulcerativa/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Adalimumab/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Budesonida/uso terapêutico , Glucocorticoides/uso terapêutico , Humanos , Índice de Gravidade de Doença , Fator de Necrose Tumoral alfa/antagonistas & inibidoresRESUMO
The anti-tumor necrosis factor-α (TNF) antibodies have revolutionized the management of ulcerative colitis and Crohn's disease. The development of assays to allow for the measurements of serum drug levels and anti-drug antibodies have provided a more objective means of therapeutic decision making, particularly among patients losing response to treatment. Additionally, more evidence is emerging that indicates the relationship between drug levels and response to therapy including clinical response, mucosal healing and sustained remission. The use of combination therapies of the anti-TNF agents and the thiopurine immunosuppressants may also decrease immunogenicity to the anti-TNF agents and potentiate response to therapy. With more evidence emerging evidence of the importance of therapeutic drug levels and anti-drug antibodies, clinicians may be able to better optimize the current arsenal of inflammatory bowel disease therapeutics to achieve greater rates of durable remission and improved quality of life.
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Anticorpos/uso terapêutico , Colite Ulcerativa/tratamento farmacológico , Doença de Crohn/tratamento farmacológico , Imunossupressores/uso terapêutico , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Animais , Anticorpos/efeitos adversos , Anticorpos/sangue , Colite Ulcerativa/sangue , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/imunologia , Doença de Crohn/sangue , Doença de Crohn/diagnóstico , Doença de Crohn/imunologia , Monitoramento de Medicamentos/métodos , Humanos , Imunossupressores/efeitos adversos , Imunossupressores/sangue , Valor Preditivo dos Testes , Indução de Remissão , Fatores de Tempo , Resultado do Tratamento , Fator de Necrose Tumoral alfa/imunologiaRESUMO
BACKGROUND: The adequacy of exposure of purine analogs as measured by 6-thioguanine nucleotides concentrations in the setting of combination therapy remains poorly understood. The aim of this study was to investigate the relationship between the mean corpuscular volume (MCV) value (as a surrogate marker of 6-thioguanine nucleotides concentration) and Crohn's disease outcomes in the setting of combination therapy with infliximab. METHODS: The SONIC trial was a randomized controlled trial comparing infliximab to azathioprine and to infliximab plus azathioprine in 508 Crohn's disease patients. An increase of at least 7 femtoliter (fL) of the MCV (ΔMCV) was used for statistical analysis. RESULTS: At week 26, the mean increase of MCV was similar among patients treated with azathioprine alone (mean of 7.9 fL) or in combination with infliximab (mean of 8.5 fL). In the azathioprine group, 63.6% of patients with ΔMCV >7 were in steroid-free clinical remission at week 26 as compared with 33.3% of patients without ΔMCV >7 (P = 0.0046). In the combination therapy group, ΔMCV above 7 was associated with mucosal healing (75.0% for ΔMCV >7 versus 47.1% for ΔMCV <7, P = 0.0172) but not with steroid-free clinical remission. Patients with a ΔMCV above 7 were more likely to have infliximab trough level above 3 µg/mL at week 30 (68.4% versus 38.8% for ΔMCV <7, P = 0.0032). CONCLUSIONS: These results suggest that ΔMCV above 7 (which is a surrogate for a higher 6-thioguanine nucleotides concentration) leads to improved Crohn's disease outcomes, even when combined with infliximab. It also suggests the possibility that a lower azathioprine exposure might be less effective in combination therapy.
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Azatioprina/uso terapêutico , Doença de Crohn/tratamento farmacológico , Índices de Eritrócitos/efeitos dos fármacos , Eritrócitos/efeitos dos fármacos , Infliximab/uso terapêutico , Mucosa/efeitos dos fármacos , Cicatrização/efeitos dos fármacos , Adulto , Biomarcadores/análise , Doença de Crohn/patologia , Método Duplo-Cego , Quimioterapia Combinada , Eritrócitos/patologia , Feminino , Fármacos Gastrointestinais/uso terapêutico , Humanos , Imunossupressores/uso terapêutico , Masculino , Mucosa/patologia , PrognósticoRESUMO
BACKGROUND & AIMS: Our post hoc analysis assessed the association of early (at weeks 26-30) clinical, endoscopic, biologic, and pharmacokinetic outcomes with corticosteroid-free remission at week 50 (CSFR50); CSFR50 was observed in 55.2% and 65.4% of patients treated with infliximab, alone or in combination with azathioprine, respectively. METHODS: We analyzed data from 203 patients: 96 received infliximab monotherapy and 107 received combination therapy. Receiver operating characteristic analysis was used to set cut-off points for the week 30 trough serum infliximab concentration (SIC30) and percentage change, from baseline, in the C-reactive protein (CRP) level at week 26, to predict CSFR50. Univariate and multivariate procedures analyzed predictive parameters of CSFR50 (odds ratio [OR] and 95% confidence interval [CI]). Mucosal healing (MH, zero ulcers) and CRP normalization (<8.0 mg/L) also were assessed. RESULTS: Trough SIC30 was higher in patients with than without CSFR50. Patients given combination therapy had higher trough SIC30s than those given monotherapy. Median trough SIC30 was significantly higher in patients with than without CSFR50 among those on infliximab monotherapy (2.14 vs 0.80 µg/mL; P = .006), but not for those on combination therapy (3.56 vs 3.54 µg/mL; P=.31). In patients with increased baseline levels of CRP (n = 120), corticosteroid-free remission at week 26 (CSFR26) (OR, 4.09; 95% CI, 1.65-10.11), and trough SIC30s of 3.0 µg/mL or greater (OR, 3.20; 95% CI, 1.38-7.42) were associated significantly with CSFR50. In patients evaluable for MH (n = 123), trough SIC30s of 3.0 µg/mL or greater (OR, 3.34; 95% CI, 1.53-7.28) and CRP normalization (OR, 2.69; 95% CI, 1.10-6.54) were associated significantly with MH at week 26 (MH26). Furthermore, CSFR26 (OR, 4.43; 95% CI, 1.81-10.82) and MH26 (OR, 3.01; 95% CI, 1.33-6.81) were associated significantly with CSFR50. CONCLUSIONS: Trough SIC30 is associated positively with MH26; CSFR26 and MH26 are independent predictors of CSFR50. Trough SIC30 of 3.0 µg/mL or greater early during maintenance treatment is an important determinant of clinical and endoscopic Crohn's disease outcomes. ClinicalTrials.gov number, NCT00094458.
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Anticorpos Monoclonais/uso terapêutico , Azatioprina/uso terapêutico , Doença de Crohn/tratamento farmacológico , Fatores Imunológicos/uso terapêutico , Adulto , Anticorpos Monoclonais/farmacocinética , Proteína C-Reativa/análise , Doença de Crohn/patologia , Quimioterapia Combinada/métodos , Feminino , Humanos , Fatores Imunológicos/farmacocinética , Infliximab , Mucosa Intestinal/patologia , Masculino , Pessoa de Meia-Idade , Prognóstico , Soro/química , Resultado do TratamentoRESUMO
BACKGROUND AND AIMS: The Crohn's Disease Activity Index (CDAI) has been criticised due to heavy weighting on subjective clinical symptoms. C-reactive protein (CRP) and endoscopic lesions are objective measures of inflammation. We investigated the relationships between clinical disease activity, CRP normalisation and mucosal healing in Crohn's disease (CD). METHODS: The Study of Biologic and Immunomodulator Naive Patients in CD trial compared infliximab to azathioprine and to infliximab plus azathioprine in 508 CD patients. Mucosal healing was defined as the absence of mucosal ulceration at the week 26 ileocolonoscopy in a patient who had evidence of ulceration at the baseline ileocolonoscopy. RESULTS: 188 patients who had evaluable ileocolonoscopy with evidence of mucosal ulceration at baseline, CDAI scores and CRP values at baseline and week 26 were analysed. Seventy-two of 136 patients (53%) who had a CDAI<150 at week 26 achieved mucosal healing, and 38 of 90 patients (42%) achieved both CRP normalisation (CRP<0.8 mg/dL) and mucosal healing while in clinical remission. The positive predictive value (PPV) and negative predictive value (NPV) of CDAI to detect mucosal healing using 150 as a cut-off for CDAI were 65% and 53%, respectively. The PPV and NPV of CDAI to detect mucosal healing and CRP normalisation using 150 as a cut-off for CDAI were 79% and 42%, respectively. CONCLUSIONS: Half the patients under azathioprine and/or infliximab in clinical remission have endoscopic and/or CRP evidence of residual active CD, whereas other patients with endoscopic and CRP normalisation have persistent clinical symptoms. Clinical symptoms as scored by CDAI are not a reliable measure of the underlying inflammation.
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Proteína C-Reativa/metabolismo , Colo/patologia , Doença de Crohn/tratamento farmacológico , Monitoramento de Medicamentos/métodos , Íleo/patologia , Mucosa Intestinal/patologia , Índice de Gravidade de Doença , Adulto , Anti-Inflamatórios/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Azatioprina/uso terapêutico , Biomarcadores/sangue , Colonoscopia , Doença de Crohn/sangue , Doença de Crohn/diagnóstico , Doença de Crohn/patologia , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Quimioterapia de Indução , Infliximab , Masculino , Valor Preditivo dos Testes , Sensibilidade e Especificidade , Resultado do TratamentoRESUMO
The management of Crohn's disease and ulcerative colitis has become increasingly complex. With the current utilization of immunosuppressive therapies earlier in the disease course for patients presenting with moderate to severe disease, there is a great need for additional biologic agents targeting inflammatory mediators other than anti-tumor necrosis factor-α (anti-TNF) agents. Although anti-TNF agents have positively impacted the treatment of inflammatory bowel disease, many patients can lose their response or develop intolerance to these agents over time through the formation of antidrug antibodies. Furthermore, a sizeable percentage of patients are primary nonresponders to anti-TNF drugs. Vedolizumab (Entyvio, Takeda Pharmaceuticals), a monoclonal antibody to the α4ß7 integrin, inhibits gut lymphocyte trafficking and has been demonstrated to be an effective and safe agent for the treatment of both Crohn's disease and ulcerative colitis. This article reviews the clinical trial evidence and rationale for the use of vedolizumab in moderate to severe Crohn's disease and ulcerative colitis.