Mo1208 Effect of Adalimumab on Clinical Laboratory Parameters in Pediatric Crohn's Disease Patients From IMAgINE 1

2015 ◽  
Vol 148 (4) ◽  
pp. S-638-S-639 ◽  
Author(s):  
Jeffrey S. Hyams ◽  
Joel R. Rosh ◽  
James Markowitz ◽  
Jaroslaw Kierkus ◽  
Marla Dubinsky ◽  
...  
2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S232-S232
Author(s):  
B Morão ◽  
C Nascimento ◽  
C Frias Gomes ◽  
T Gonçalves ◽  
F Castro ◽  
...  

Abstract Background Bowel wall thickness (BWT) is an accurate sonographic parameter to assess disease activity in Crohn’s disease (CD). International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) was developed to allow a reproducible assessment of intestinal inflammation in CD using bowel ultrasound (IUS). Aim to assess BWT and IBUS-SAS variation after induction therapy with infliximab (IFX) and their correlation with clinical and laboratory parameters. Methods Prospective multicentre study including patients with active CD starting IFX. Harvey-Bradshaw index (HBI), C-reactive protein (CRP), faecal calprotectin (FC) and IUS were performed at week 0 (W0) and 14 (W14). IUS response and remission were defined as a reduction in BWT ≥25% and its normalization(≤3mm) in the most affected segment, respectively. IBUS-SAS was calculated using BWT, Doppler signal, bowel wall stratification (BWS) and inflammatory fat. Results We included 37 patients (62% males; median age 30 years, range 16–73). According to Montreal classification, most patients were A2 (70%), had ileocolonic disease (L3 57%) and an inflammatory phenotype (B1 60%); 41% had perianal disease. Most were anti-TNF therapy naive(84%), and combination therapy was used in 62%. Terminal ileum was the most affected segment identified by IUS (60%). Table 1 shows clinical, laboratory and sonographic parameters [median (IQR)]. At W14, 81% were in clinical remission, 43% in laboratorial remission (normal CRP and FC), 24% had IUS response and 11% had IUS remission. There was a significant reduction in HBI, CRP, FC and sonographic parameters (except for BWS) between W0 and W14. We found a fair to good correlation between BWT and HBI(r=0.363, p=0.03), CRP(r=0.391, p=0.02) and FC(r=0.373, p=0.03) at W14. IBUS-SAS had also a fair to good correlation with CRP(r=0.340, p=0.04) and FC(r=0.527, p=0.001) at W14. The area under the curve of IBUS-SAS for predicting clinical and laboratorial remission was 0.60; best-cut off 64.65 (sens. 57%; specif. 63%). Conclusion There was a significant reduction in sonographic parameters after 14 weeks of IFX and one quarter of our patients had an IUS response, suggesting that reduction in BWT could be an early marker of response to therapy. We found a good correlation between IUS and clinical and laboratory parameters at W14. IUS evaluation after induction therapy can be a helpful tool to monitor disease activity and guide CD patient management in our daily practice.


1984 ◽  
Vol 29 (12) ◽  
pp. 1093-1097 ◽  
Author(s):  
Cosimo Prantera ◽  
Carlo Luzi ◽  
Piero Olivotto ◽  
Susan Levenstein ◽  
Paola Cerro ◽  
...  

Author(s):  
João Eugênio Loureiro Lopes ◽  
Helena Demuner Vallandro ◽  
Marina Dadalto Scarpati ◽  
Bruna Barcellos Chaia ◽  
Vitor Lorencini Belloti ◽  
...  

Introdução: A doença de Crohn é uma doença inflamatória intestinal (DII) que inicia um processo inflamatório crônico idiopático intestinal, levando a um quadro clínico variávelcujo principal sintoma é a diarreia crônica. O diagnóstico é feito a partir da combinação de dados clínicos, laboratoriais e exames endoscópicos. Após confirmado o diagnóstico, otratamento pode envolver classes medicamentosas como imunobiológicos. Em relação ao uso de imunobiológicos, como o adalimumabe, deve-se ter cautela pelo seu efeitoimunossupressor, que pode, em indivíduos susceptíveis, ativar focos latentes de infecção, como os de tuberculose (TB). Objetivo: Relatar um caso de tuberculose miliar como reação adversa ao uso de adalimumabe e conscientizar a comunidade médica quanto aos riscos da administração de terapia imunobiológica. Relato de caso: Paciente do sexo masculino, 31 anos, com diagnóstico de Doença de Crohn em acompanhamento ambulatorial com terapia imunobiológica com adalimumab, é admitido na emergência com quadro agudo de sintomas respiratórios e sistêmicos. Durante a investigação hospitalar, apesar de pesquisa do bacilo álcool- -ácido resistente (BAAR) no escarro ter apresentado três amostras negativas, a tomografia computadorizada (TC) de tórax apresentava padrão sugestivo de tuberculose miliar, além de um lavado broncoalveolar com pesquisa positiva para Mycobacterium tuberculosis. Confirmado o diagnóstico de TB miliar, o tratamento foi iniciado com  rifampicina, isoniazida, pirazinamida e etambutol. Conclusão: Levando em consideração a alta mortalidade e os impactos negativos da tuberculose miliar, é imprescindível que todos os pacientes com DII em uso de imunobiológicos sejam rastreados para infecção latente, através da radiografia de tórax e teste tuberculínico (PPD). Entretanto, mesmo com o rastreio regular e registro de vacinação prévia, a possibilidade de tuberculose miliar ainda não pode ser descartada em quadros clínicos inespecíficos neste perfil de pacientes.Palavras chave: Adalimumab, Tuberculose, Efeitos colaterais e reações adversas relacionados a medicamentosABSTRACTIntroduction: Crohn’s disease is an inflammatory bowel disease (IBD) that initiates a chronic idiopathic intestinal inflammatory process, leading to a variety of clinical symptoms with chronic diarrhea as the main one. Diagnosis is built from a combination of clinical, laboratory and endoscopic data. The treatment involves immunobiological drugs, such as adalimumab and due to its immunosuppressive effect, it must be administered with caution, because it isable to activate latent foci of infection, such as tuberculosis (TB), in susceptible individuals. Objective: To report a miliary tuberculosis case originated as an adverse reaction to the use of adalimumab and to make the medical community aware of the risks of administering immunobiological therapy. Case report: A 31-year-old male, diagnosed with Crohn’s Disease, undergoing immunobiological treatment with adalimumab, is admitted in the emergency department with acute respiratory and systemic symptoms. During hospitalization, despite the investigation of alcohol-acid resistant bacillus (BAAR) in sputum showing three different samples with negative results, the computerized tomography (CT) of the chest showed a pattern suggestive of miliary tuberculosis, in addition to a bronchoalveolar lavage with a positive test for Mycobacterium tuberculosis. After the diagnosis of miliary TB was confirmed, treatment with rifampicin, isoniazid, pyrazinamide and ethambutol was started. Conclusion: Considering the high mortality and negative impacts of miliary tuberculosis, it is essentialthat all patients with IBD on immunobiological treatment are screened for latent infection through chest radiograph and PPD. However, even with regular screening and registration of previous vaccinations, the possibility of miliary tuberculosis cannot be ruled out in this profile of patients with unspecific clinical conditions.Keywords: Adalimumab, Tuberculosis, Drug-related side effects and adverse reactions 


1994 ◽  
Vol 8 (3) ◽  
pp. 193-198 ◽  
Author(s):  
Hanna Binder ◽  
Hugh J Freeman

This study examined potential risk factors for recurrent small intestinal resection in a ‘reagent-grade’ group of 94 consecutive patients with prior removal of histologically defined Crohn’s disease localized to the distal ileum seen by one gastroenterologist at a single teaching hospital. There were 38 males and 56 females ranging in age from 15 to 58 years, with an average length of follow-up of 8.7 years. Of these, 26% required a second resection for recurrent small intestinal disease. Cumulative reoperation rates in these 25 patients were 18% at five years and 24% at 10 years. Univariate and multivariate analyses of multiple demographic, clinical, laboratory and pathological variables revealed two apparent statistically significant independent risk factors for a second intestinal resection: steroid treatment, likely an indirect indication of more severe disease activity; and the presence of an internal fistula, consistent with the emerging concept of a relatively more aggressive clinical form of Crohn’s disease.


2006 ◽  
Vol 63 (9) ◽  
pp. 787-792 ◽  
Author(s):  
Leposava Lukic-Kostic ◽  
Jasna Jovic ◽  
Slobodan Sekulovic

Background/aim: Crohn's disease (CD) is a chronic granulomatous inflammatory disease of unknown etiology, involving any part of the gastrointestinal tract, and frequently followed by extra intestinal manifestations. The use of ultrasonography plays a significant role in diagnosing this disease, as well as in monitoring the effects of the therapy. The aim of this study was to assess the use of ultrasonographic diagnostics in the patients with moderate serious and the mild form of CD. Methods. The study involved 30 patients both sexes with CD of moderate form determined using the standard diagnostics, according to the Crohn's Disease Activity Index - CDAI ranging from 220?400. The patients were divided into two groups with CDAI > 320 (Ia), and CDAI between 220 and 320 (Ib), respectively. The Control group was made of 19 patients with the mildly active stage of the disease and the CDAI values in the range from 100?220. The patients were submitted to an ultrasonographic examination of the terminal ileum affected with CD in order to determine the length of the affected segment of intestine, the thickness of the wall, the changes of the structure of the wall, the changes of the surrounding mesenterium with the enlarged lymph nodes. CD complications, abscesses, and enteroenteral fistulas were investigated, too. Results. The comparison of the ultrasonographic findings of the three groups revealed that more serious clinical laboratory image of CD significantly correlated with the higher length of the affected segment (p < 0.001), higher thickness of the wall (p < 0.001), the higher number and the larger lymph nodes of the mesenterium (p < 0.001). Only the most serious patients were found to have abscess of the ileocecal area (Ia ? 40%). There was no difference found between the groups regarding the occurrence of enteroenteral fistulas. Conclusion. Considering the obtained results and data from the literature, it could be concluded that an ultrasonographic examination of the ileocecal area plays an important role in the diagnostic procedure in the management of a patient with CD. Of particular significance is the possibility to use this examination in monitoring the effects of the therapy in patients with CD.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S634-S635
Author(s):  
G Kokkotis ◽  
D Bekiari ◽  
M Bletsa ◽  
M Gizis ◽  
N Perlepe ◽  
...  

Abstract Background Fatigue is common in IBD patients, even in clinical remission and adversely affects the quality of life. For this reason, it has been suggested to use fatigue questionnaires as PROS (patient reported outcomes). We aimed to study the degree of fatigue in IBD patients and identify factors that are positively or negatively related to its presence. Methods Patients with IBD (men: 51.6%, Crohn’s Disease: 65.2%, age: 36.7 years median, 18.1–72 yrs range), with a regular f-up in our Department completed the Fatigue Severity Scale, IBD Fatigue self assessment 1 & 2, short IBDQ and Short Health Scale upon consensus. Two groups of patients were studied: Group A, patients attended the IBD outpatient clinic (121 patients / 144 questionnaires) and Group B, patients attended the infusion centre for biological therapy (55 patients / 414 questionnaires). The SPSS-23 statistical programme was used to identify correlations between fatigue and various clinical-laboratory parameters of patients. Results Problematic fatigue (FSS&gt; 36) was reported by 46.5% of patients. No difference was observed between Crohn’s disease and Ulcerative Colitis or between the two groups of patients. There were statistically significant correlations between fatigue and disease activity (R = 0.428, P &lt;0.001) and HGB (R = −0.177, p &lt; 0.001). Fatigue was significantly associated with quality of life based on the short IBDQ and SHS questionnaires (R = −0.655, p &lt; 0.001 and R = 0.485, p &lt; 0.001 respectively). There was also a statistically significant relationship of both fatigue and quality of life with parameters such as female sex (p &lt; 0.01), arthralgia (p &lt; 0.05) and biological agent treatment (p &lt; 0.05), while quality of life was statistically significant related with the disease type (P =0.01) too. Sequential measurements showed that the quality of life and fatigue rate were consistently maintained in patients with remission under biological therapy. Conclusion In the group of IBD patients we studied, a significant correlation with various clinical characteristics was observed. The presence of fatigue is a factor associated with poor quality of life for patients.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S292-S292
Author(s):  
C Flores ◽  
R Petry ◽  
C Bortolin Fonseca ◽  
L Dos Santos Harlacher

Abstract Background Biological therapy has revolutionized treatment of Crohn’s Disease (CD), increasing the rate of disease remission. Despite this, a significant percentage of patients present partial response or loss of response over time. These patients need optimization of therapy, whether by increasing the dosage or reducing the interval between infusions. The main objective of this study was to identify possible factors related to the need to optimize the dose of infliximab (IFX) in patients with CD. This finding can facilitate the early identification of the need for therapeutic optimization, reducing the risks of unfavorable evolution and decreasing costs related to the disease. Methods Retrospective and prospective maintained database of CD patients under IFX treatment being followed up in the Infusion Center at the Day Hospital of the Hospital de Clínicas de Porto Alegre, Brazil, from 2009 to 2018. Epidemiological, clinical, laboratory and endoscopic characteristics that correlate with worse prognosis of CD were evaluated. The main goal of the study was to identify possible factors related to the need for (IFX) optimization. Results 121 patients were evaluated. Of these, 58 (47,93%) needed the optimization of the IFX dosage. The only variables that had significant statistical difference between the groups with or without need for optimization were anemia (p=0.019) and C reactive protein (CRP) which were persistently elevated in week 14 (p=0.039). After the adjustment with the multivariate model, only the elevated CRP during week 14 was still statistically significant, with a 119% greater risk of optimizing treatment when compared to those of normal CRP. Conclusion Among the factors studied, only the maintenance of higher CRP during week 14 was associated to the need for optimization of the IFX dose. This finding agrees with the literature that describes week 14 as an ideal moment for evaluating the serum levels of immunobiologics as a predictor of sustained response. Thus, in the absence of therapeutic drug monitoring, we could look at persistently high CRP as a marker of the need for therapeutic optimization. This finding needs to be confirmed in prospective studies.


Sign in / Sign up

Export Citation Format

Share Document