scholarly journals THE IMPACT OF INTERMEDIATE TITER ANTIBODIES TO ADALIMUMAB (ATA) AND INFLIXIMAB (ATI) ON CLINICAL OUTCOMES IN PATIENTS WITH CROHN’S DISEASE (CD) OR ULCERATIVE COLITIS (UC)

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S57-S57
Author(s):  
Chaoyang Wang ◽  
Mazen Tolaymat ◽  
Raymond Cross
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Outcomes ◽  
High Titer ◽  
Complete Response ◽  
Response To Therapy ◽  
Loss Of Response ◽  
Titer Group ◽  
The Impact

Abstract Background Anti-TNF drugs, adalimumab (ADA) and infliximab (IFX), are effective treatments for ulcerative colitis (UC) and Crohn’s disease (CD). However, 30% of patients do not respond to treatment (primary non-response) and 40% lose response over time (loss of response). Loss of response is often due to development of antibodies to ADA (ATA) and IFX (ATI). While it is known that undetectable or low ATA/ATI titers (<200 ng/mL) are associated with better outcomes and high ATA/ATI titers (>1000 ng/mL) are associated with poor outcomes, the significance of intermediate ATA/ATI titers (200–999 ng/mL) is not well understood. This study aims to investigate the impact of intermediate ATA/ATI titers on outcomes in CD and UC patients. Methods A retrospective chart review was conducted on CD and UC patients to determine associations between intermediate ATA/ATI titers and adverse clinical outcomes. The primary clinical outcome of interest is persistence on anti-TNF therapy 1 year after measurement of ATA/ATI titers. Secondary clinical outcomes of interest include clinical response to therapy 1 year after measurement of ATA/ATI titers. Participants consist of UC or CD patients treated with IFX or ADA at the University of Maryland IBD Program between October 2016 and October 2019 that had at least one measurement of ADA/ IFX and ATA/ATI during the study period. Results 376 patients were identified (ADA=157 and IFX=219). 271 of 322 low titer patients persisted on their original anti-TNF compared to 9 of 15 intermediate titer patients (p=0.026) and 1 of 10 high titer patients (p<0.0001) (Table 1). The odds ratio (OR) of persistence comparing intermediate titer to low was 0.26 (0.09 to 0.80) and comparing high titer to low was 0.02 (0.00 to 0.14). In the low titer group, 47, 33, and 251 of 331 patients had no, partial, or complete response to therapy, respectively. In the intermediate titer group: 6, 1, and 8 of 15 patients, had no, partial or complete response; in the high titer group: 3, 1, and 3 of 10 patients, had no, partial, or complete response (Table 2). The difference in distribution of patients who showed no, partial, and complete response was significantly different between low titer patients and intermediate titer patients (p=0.019), but not different between intermediate titer and high titer patients (p=0.440). Conclusion Patients with intermediate titers were more likely than patients with low titers to lose response to anti-TNF and require a change anti-TNF therapy. Although our sample size of patients with intermediate titers was small, providers should consider dose optimization of anti-TNF with or without addition of an immune suppressant when intermediate titers are present. An alternative approach would be to repeat drug and antidrug antibody levels to assess for worsening pharmacokinetics. Persistence on original anti-TNF 1 year after first measurement in low, intermediate, and high titer patients (Fisher’s test). Response to therapy 1 year after first measurement in low, intermediate, and high titer patients (Fisher’s test).

scholarly journals P237 Annual incidence and prevalence of ulcerative colitis and Crohn’s disease from 2010 to 2017 in four Nordic countries: Results from the TRINordic study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S261-S262
Author(s):  
M Lördal ◽  
J Burisch ◽  
E Langholz ◽  
T Knudsen ◽  
M Voutilainen ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Observational Study ◽  
Nordic Countries ◽  
Annual Incidence ◽  
University Hospital ◽  
Retrospective Observational Study ◽  
Western World ◽  
The Impact

Abstract Background Incidence and prevalence of inflammatory bowel diseases (IBD) have been increasing for the past decades in the western world, however with an emerging trend of incidence stabilisation in recent years. There is an indication of higher IBD incidence and prevalence in northern Europe, especially in the Nordic region, compared with southern Europe. Methods This retrospective observational study collected data from the National Patient Registries and National Prescription Registries (Sweden [SWE], Norway [NOR], Denmark [DEN]) and one university hospital database (Turku, Finland [FIN]) during 2010–2017 to investigate the annual incidence and prevalence of ulcerative colitis (UC) and Crohn’s disease (CD). Patients with ≥2 ICD-10 diagnosis codes for UC (K51) or CD (K50) from 2010 or later and no K51 or K50 codes prior to 2010 were included; patients were classified according to their last code. The look-back period for SWE was until 2000, for NOR until 2008, for DEN until 1995, and for FIN until 2004. Incidence proportions highlight results through 2016, as 2017 patients had less than 1-year follow-up. Results In total, 69,876 patients were included (SWE n = 27,902, NOR n = 20,761, FIN n = 2,118, DEN n = 19,095), of which 44 367 patients were diagnosed with UC and 25,509 with CD. In 2016, the annual incidence of UC was 28 patients per 100,000 persons in NOR, 32 patients per 100,000 persons in DEN, 25 patients per 100,000 persons in SWE, and 44 patients per 100,000 in FIN. The corresponding results for the annual incidence of CD per 100,000 persons were 22 in NOR, 16 in DEN, 16 in SWE, and 21 in FIN. The prevalence per 100,000 persons of both UC and CD was the highest in DEN, followed by SWE and NOR, and lowest in FIN. Prevalence estimates increased in all four Nordic countries during 2010–2017: for UC, from 409 to 488 patients in SWE, from 256 to 428 in NOR, from 129 to 375 in FIN, and from 577 to 798 in DEN. For CD, it increased from 261 to 313 patients in SWE, from 164 to 258 in NOR, from 54 to 164 in FIN, and from 280 to 400 in DEN. Conclusion This retrospective observational study showed that during 2016, the annual incidence of UC ranged from 25–44 patients per 100,000 persons across the evaluated Nordic countries, whereas the annual incidence of CD was 16–22 patients per 100,000 persons. Prevalence of both UC and CD increased during 2010–2017 in all four countries. Estimates of UC and CD incidence and prevalence in this analysis are greater than reported in the published literature. Additional analyses are underway to further explore the impact of methodological decisions on the estimates of UC and CD annual incidence and prevalence.

scholarly journals Hypoalbuminaemia and Postoperative Outcomes in Inflammatory Bowel Disease: the NSQIP Surgical Cohort

2019 ◽  
Vol 13 (11) ◽  
pp. 1433-1438 ◽  
Author(s):  
Geoffrey C Nguyen ◽  
Lillian Du ◽  
Rachel Y Chong ◽  
Timothy D Jackson
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Postoperative Outcomes ◽  
Improvement Program ◽  
Septic Complications ◽  
Bowel Surgery ◽  
Inflammatory Bowel ◽  
The Impact ◽  
Normal Albumin

Abstract Background The inflammatory bowel diseases [IBD], including Crohn’s disease [CD] and ulcerative colitis [UC], frequently lead to bowel surgery. Hypoalbuminaemia has been shown to be a prognostic factor for outcomes following surgery for other indications, and we sought to determine its role in predicting IBD-related postoperative outcomes. Methods We included patients who underwent IBD-related major abdominal surgery in the American College of Surgeons’ National Surgical Quality Improvement Program [ACS-NSQIP] between 2005 and 2012. We assessed the impact of indicators of protein-energy malnutrition [PEM] including hypoalbuminaemia, weight loss, and body mass index on postoperative outcomes. Results We identified 10 913 IBD patients [6082 Crohn’s disease and 4831 ulcerative colitis] who underwent bowel surgery. The prevalence of modest and severe hypoalbuminaemia was 17% and 24%, respectively; 30-day mortality was higher in Crohn’s patients with modest and severe hypoalbuminaemia compared with those with normal albumin levels preoperatively [0.7% vs 0.2%, p <0.05; 2.4% vs 0.2%, p <0.01]. The same was true for patients with UC with modest and severe hypoalbuminaemia [0.9% vs 0.1%, p <0.01; 5.6% vs 0.1%, p <0.01]. Overall infectious complications were more common in the presence of severe hypoalbuminaemia for CD [20% vs 13%, p <0.01]. and UC [28% vs 15%, p <0.01] patients. Last, there were higher rates of extra-intestinal, non-septic complications in both CD and UC patients with hypoalbuminaemia compared with those with normal albumin levels. Conclusions This study suggests that moderate-severe hypoalbuminaemia is associated with worse IBD-related postoperative outcomes and may have a role in preoperative risk stratification.

scholarly journals Levels of Biosimilar Infliximab during and after Induction Treatment in Crohn’s Disease and Ulcerative Colitis—A Prospective Polish Population Study

2021 ◽  
Vol 10 (22) ◽  
pp. 5311
Author(s):  
Anna Pękala ◽  
Rafał Filip
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Response To Therapy ◽  
Response To Treatment ◽  
Induction Treatment ◽  
Therapeutic Drug ◽  
Induction Phase ◽  
Drug Levels ◽  
Trough Levels

Background: Primary lack or secondary loss of response to therapy with infliximab is a significant problem. This study aimed to evaluate the response to treatment in patients with Crohn’s disease (CD) and ulcerative colitis (UC) achieving therapeutic and sub-therapeutic trough levels of biosimilar infliximab (CT-P13). Results: A total of 65 patients (32 with CD and 33 with UC) were recruited. The overall response rate in both CD and UC patients exceeded 80%. There were no significant differences in treatment response and CT-P13 levels for patients with CD or UC. We did not find significant differences in the percentage of patients achieving drug levels of 3 μg/mL at week 6, 10, or 12; a significant decrease was observed at week 14. Up to 55.5% of patients with CD and 64.3% of patients with UC with sub-therapeutic CT-P13 levels at week 14 primarily responded to treatment. Conclusions: Intermediate measurements of drug levels at weeks 10 and 12 did not capture any pronounced decrease in infliximab concentrations below therapeutic levels in either group, thus suggesting no clinical usefulness. A significant percentage of patients primarily responded to treatment despite sub-therapeutic drug levels after the induction phase.

scholarly journals Anti-TNFα-terápiában részesülő gyulladásos bélbetegek hosszú távú utánkövetése

2020 ◽  
Vol 161 (47) ◽  
pp. 1989-1994
Author(s):  
Péter Bacsur ◽  
Soma Skribanek ◽  
Ágnes Milassin ◽  
Klaudia Farkas ◽  
Renáta Bor ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Treatment Period ◽  
Efficacy And Safety ◽  
Loss Of Response ◽  
Term Efficacy ◽  
Steroid Dependent ◽  
Inflammatory Bowel

Összefoglaló. Bevezetés: A gyulladásos bélbetegségek kezelésében a tumornekrózisfaktor-alfa-ellenes (anti-TNFα) antitestek elsődleges választási lehetőséget jelentenek a kortikoszteroid- és immunmoduláns kezelésre refrakter páciensek kezelési stratégiájában. Ezek a hatóanyagok hatékonyak, ám hosszú távú hatásosságukkal kapcsolatban sok az ellentmondás. Célkitűzés: Vizsgálatunk célja megvizsgálni az anti-TNFα-terápia (infliximab [IFX], adalimumab [ADA]) hosszú távú hatékonyságát gyulladásos bélbetegek körében. Módszerek: Retrospektív, adatgyűjtéses vizsgálatunkba a Szegedi Tudományegyetem I. Sz. Belgyógyászati Klinikáján gondozott, 18–65 év közötti gyulladásos bélbetegeket vontunk be. Az adatgyűjtést a Klinika informatikai rendszeréből végeztük a betegek ambuláns megjelenéseinek kezelőlapjaiból, illetve a zárójelentésekből. Eredmények: 102 beteg adatait elemeztük (Crohn-beteg: 67 fő, colitis ulcerosás: 35 fő). A Crohn-betegség diagnózisát követően átlagosan 7,84 év, a colitis ulcerosa diagnózisát követően átlagosan 9,86 év telt el az első anti-TNFα-terápia elkezdéséig. Az első kezelési ciklus átlagosan 2,64 évig tartott, a ciklus végén az IFX-t kapó betegek 50%-ánál, az ADA-t kapó betegek 46%-ánál volt remisszióban a betegség. A második kezelési ciklus átlagosan 4,67 évig tartott, a ciklus végén az IFX-t kapó betegek 36%-a, az ADA-t kapó betegek 40%-a volt remisszióban. Az első, illetve a második kezelési ciklus alatt az allergiás reakciók gyakorisága IFX esetében 13% és 18%, ADA esetében 4% és 3% volt. A primer hatástalanság és a másodlagos hatásvesztés az első ciklusban IFX esetében 4% és 10,5%, ADA esetében 11,5% és 19% volt. A második kezelési ciklusban IFX esetében 9%-ban és 18%-ban, ADA esetében 23%-ban és 10%-ban jelentették a ciklus végét. Következtetés: Az anti-TNFα-terápiák eredményeink alapján hosszú távon is hatékonynak és biztonságosnak bizonyultak. Másodlagos hatásvesztés kisebb arányban fordult elő a vizsgált populációban az irodalmi adatokhoz képest. Orv Hetil. 2020; 161(47): 1989–1994. Summary. Introduction: Anti-tumor necrosis factor-alpha (anti-TNFα) treatment is reserved for steroid-dependent or steroid/immunomodulator-refractory inflammatory bowel diseases patients. These agents are effective, however, their long-term safety is still questionable. Objective: We aimed to assess the long-term efficacy and safety of two anti-TNFα therapies. Methods: In our retrospective study, we reviewed medical records via the administration system of the First Department of Medicine, University of Szeged. Female and male patients, aged between 18–65 years who received anti-TNFα therapy between 2010–2019 were enrolled. Results: 102 patients with inflammatory bowel disease were enrolled (Crohn’s disease: 67, ulcerative colitis: 35). The first anti-TNFα therapy was introduced after an average 7.84 and 9.86 years from diagnosis of Crohn’s disease and ulcerative colitis. The first treatment period lasted for 2.64 years; 50% of patients receiving IFX and 46% of patients receiving ADA were in remission at the end of the period. The second treatment period lasted for 4.67 years, 36% of IFX-treated patients and 40% of ADA-treated patients were in remission at the end of the period. 13% and 18% of patients treated by IFX and 4% and 3% of patients treated by ADA experienced infusion reaction during the first and the second treatment period. Primary non-response and loss of response rates were 4% and 10.5% (IFX) and 11.5% and 19% (ADA) during the first treatment period. These rates were 9% and 18% (IFX) and 23% and 10% (ADA) during the second treatment period. Conclusion: Our study confirmed the long-term efficacy and safety of the anti-TNFα therapies. Loss of response rate is lower in our population compared to the literature. Orv Hetil. 2020; 161(47): 1989–1994.

scholarly journals Inflammatory Bowel Disease, the Oral Contraceptive Pill and Pregnancy

1994 ◽  
Vol 8 (7) ◽  
pp. 430-432 ◽  
Author(s):  
Robert N Allan
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Oral Contraceptive ◽  
Crohn's Disease ◽  
Bowel Disease ◽  
Oral Contraceptive Pill ◽  
Contraceptive Pill ◽  
Inflammatory Bowel ◽  
The Impact

This paper summarizes our current knowledge of the role of the oral contraceptive pill in the pathogenesis of inflammatory bowel disease (IBO), followed by a review of fertility in women and men. IBD and pregnancy, including the impact on the fetus and the mother with ulcerative colitis or Crohn’s disease, is considered. The safety of drug treatment during pregnancy, the outcome of surgical treatment during pregnancy and the problems that may be encountered during pregnancy in patients with an ileostomy or ileo-anal pouch are discussed, followed by a review of the short and long term prognosis of ulcerative colitis and Crohn’s disease partition.

Swapping Versus Dose Optimization in Patients Losing Response to Adalimumab With Adequate Drug Levels

2021 ◽  
Author(s):  
Xavier Roblin ◽  
Capucine Genin ◽  
Stéphane Nancey ◽  
Nicolas Williet ◽  
Pauline Veyrard ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Maintenance Therapy ◽  
Group Treatment ◽  
Treatment Discontinuation ◽  
Dose Optimization ◽  
Secondary Loss ◽  
Loss Of Response ◽  
Trough Levels

Abstract Background In cases of loss of response due to mechanistic failure under antitumor necrosis factor agents, it is recommended to switch to another class of biologics. Two different strategies were compared in patients with inflammatory bowel disease (IBD) who were treated with nonoptimized adalimumab (ADA) and experienced a loss of response despite therapeutic trough levels of adalimuma—either ADA dose optimization or switching to vedolizumab or ustekinumab. Methods Patients under maintenance therapy with ADA monotherapy (40 mg every 14 days) and who experienced a secondary loss of response with trough levels &gt; 4.9 μg/mL were included prospectively in this nonrandomized study. The primary end point was the survival rate without therapeutic discontinuation after ADA dose optimization or switching to another class of biologics. Results Adalimumab was optimized (n = 61 patients, 42 Crohn’s disease, 19 ulcerative colitis) or swapped for vedolizumab (n = 40, 20 ulcerative colitis) or ustekinumab (n = 30, 30 Crohn’s disease). At 24 months, 11 out of 70 patients (14.8%) in the swap group discontinued treatment compared with 36 out of 61 (59.6%) patients in the optimization group (P &lt; 0.001). The median time without therapeutic discontinuation was significantly longer in the swap group (&gt;24 months) than in the optimization group (13.3 months, P &lt; 0.001). In the optimization group, treatment discontinuation was positively associated with baseline fecal calprotectin &gt;500 μg/g (HR, 3.53; 95% CI, 1.16–10.72; P = 0.026) and inversely associated with variation of trough levels of adalimumab (&gt;2 µg/mL from baseline to week 8 after optimization; HR, 0.51; 95% CI, 0.13–0.82; P = 0.03). In the swap group, no factor was associated with treatment discontinuation. Conclusion In IBD patients under ADA maintenance therapy who experience a secondary loss of response and in whom trough levels are &gt;4.9µg/mL, swapping to another class is better than optimizing ADA, which is, however, appropriate in a subgroup of patients.

Features of very early-onset inflammatory bowel disease: the experience of the Federal Pediatric Center

2021 ◽  
Vol 19 (3) ◽  
pp. 5-13
Author(s):  
P.V. Shumilov ◽  
◽  
A.E. Shchigoleva ◽  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Primary Immunodeficiency ◽  
Bowel Disease ◽  
Early Onset ◽  
Activity Index ◽  
Response To Therapy ◽  
Inflammatory Bowel

Objective. To clarify the incidence of monogenic IBD-like diseases and the features of clinical course and response to therapy of major types of inflammatory bowel diseases (IBD) among children under the age of 6 with manifestation of the disease. Patients and methods. The study included 135 children under the age of 6 with manifestation of IBD; in the comparison group, there were 128 children after the age of 6 with manifestation of IBD (97 children with ulcerative colitis (UC) and 31 children with Crohn’s disease (CD)) who were observed for at least 1 year. All children underwent a standard examination, including calprotectin and antineutrophil antibodies testing, determination of activity by the Pediatric Ulcerative Colitis Activity Index (PUCAI) or the Pediatric Crohn’s Disease Activity Index (PCDAI), depending on the nosology. Children with the onset of IBD under 6 years of age underwent a genetic testing using Primary Immunodeficiency Panel by next-generation sequencing. All children were analyzed for efficacy of therapy during catamnestic observation. Results. It was revealed that in the study group the incidence of monogenic IBD-like diseases was 6.7%, of UC – 71.1%, of CD – 22.2%. Major types of IBD with very early onset differed little in their clinical, endoscopic and laboratory features from the forms with manifestation at an older age. In most cases, both CD (57%) and UC (71%) were characterized by low activity. Very earlyonset CD was characterized by isolated localization of the colon (53%, p = 0.037) and a non-stenotic and non-penetrating behaviour of the disease (60% of cases). The leading clinical symptoms were diarrhea (67%) and blood in the stool (63%, p = 0.04). Very early-onset UC was characterized by total lesion of the colon (84%, p = 0.001) and the development of anemia (48%, p = 0.01). Among children with very early-onset UC, the percentage of glucocorticosteroid-dependence and glucocorticosteroid-resistance was high, but anti-TNFα therapy was prescribed late. Conclusion. It is advisable to observe children with very early-onset IBD in federal multidisciplinary clinics, where there is experience in managing patients with this pathology. Key words: inflammatory bowel disease, very early onset, Crohn’s disease, ulcerative colitis, primary immunodeficiency, treatment, children

scholarly journals Intestinal Ultrasound in Inflammatory Bowel Disease: A Valuable and Increasingly Important Tool

2021 ◽  
pp. 1-17
Author(s):  
Catarina Frias-Gomes ◽  
Joana Torres ◽  
Carolina Palmela
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Response To Therapy ◽  
Inflammatory Bowel

<b><i>Background:</i></b> Intestinal ultrasound is emerging as a non-invasive tool for monitoring disease activity in inflammatory bowel disease patients due to its low cost, excellent safety profile, and availability. Herein, we comprehensively review the role of intestinal ultrasound in the management of these patients. <b><i>Summary:</i></b> Intestinal ultrasound has a good accuracy in the diagnosis of Crohn’s disease, as well as in the assessment of disease activity, extent, and evaluating disease-related complications, namely strictures, fistulae, and abscesses. Even though not fully validated, several scores have been developed to assess disease activity using ultrasound. Importantly, intestinal ultrasound can also be used to assess response to treatment. Changes in ultrasonographic parameters are observed as early as 4 weeks after treatment initiation and persist during short- and long-term follow-up. Additionally, Crohn’s disease patients with no ultrasound improvement seem to be at a higher risk of therapy intensification, need for steroids, hospitalisation, or even surgery. Similarly to Crohn’s disease, intestinal ultrasound has a good performance in the diagnosis, activity, and disease extent assessment in ulcerative colitis patients. In fact, in patients with severe acute colitis, higher bowel wall thickness at admission is associated with the need for salvage therapy and the absence of a significant decrease in this parameter may predict the need for colectomy. Short-term data also evidence the role of intestinal ultrasound in evaluating therapy response, with ultrasound changes observed after 2 weeks of treatment and significant improvement after 12 weeks of follow-up in ulcerative colitis. <b><i>Key Messages:</i></b> Intestinal ultrasound is a valuable tool to assess disease activity and complications, and to monitor response to therapy. Even though longer prospective data are warranted, intestinal ultrasound may lead to a change in the paradigm of inflammatory bowel disease management as it can be used in a point-of-care setting, enabling earlier intervention if needed.

scholarly journals P024 Ulcerative colitis versus Crohn's disease: differences observed in the IMPACT survey

2013 ◽  
Vol 7 ◽  
pp. S19-S20
Author(s):  
S. Lönnfors ◽  
J.O. Lindsay ◽  
S. Vermeire ◽  
M. Greco ◽  
D. Hommes ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
The Impact
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