scholarly journals P562 5-ASA in ulcerative colitis: Are they really needed in the biological therapy era?

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S474-S474
Author(s):  
C Arieira ◽  
F Dias de Castro ◽  
T Cúrdia Gonçalves ◽  
M J Moreira ◽  
J Cotter
Keyword(s):  
Colorectal Cancer ◽  
Ulcerative Colitis ◽  
Biologic Therapy ◽  
Fecal Calprotectin ◽  
Inflammatory Biomarkers ◽  
Faecal Calprotectin ◽  
Reactive Protein ◽  
Maintenance Of Remission ◽  
Treatment Escalation

Abstract Background Biologic therapy has demonstrated efficacy for induction and maintenance of remission in ulcerative colitis (UC). However, it remains unclear whether oral aminosalicylates (5-ASA) should be continued or stopped after treatment escalation to biologics. The aim of the study was to evaluate differences in inflammatory biomarkers or the occurrence of complications in UC patients being treated with a combination of 5-ASA and biologics vs. biologics alone. Methods Retrospective study, including patients with UC and on biologic therapy with a minimum follow-up of 6 months. Collected inflammatory biomarkers were faecal calprotectin, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). The occurrence of complications was defined as the need of hospitalisation, need of corticosteroids or other top-up therapy, surgery and the occurrence of dysplasia or colorectal cancer. Results We included 65 patients with UC, 56.9% female with a mean age of 32.8 (±12.8) years. The median follow-up was 30 (6–132) months. Regarding extension, 61.5% were E3, 35.4% E2 and 3.1% E1. While 44 patients (67.7%) were on 5-ASA and biologics (infliximab = 32, adalimumab = 6, vedolizumab = 6), 21 (32.3%) were on biologics alone (infliximab = 13, adalimumab = 3, vedolizumab = 5). The median duration of biologic therapy was 30 (6–126) months. Regarding baseline characteristics, including age, gender, duration of the disease or biologic therapy and age at UC diagnosis, there were no differences between groups. No differences regarding inflammatory biomarkers were observed – fecal calprotectin (p = 0.39), CRP (p = 0.9) and ESR (p = 0.61). No differences were found regarding complications, namely the need of hospitalisation (p = 0.06) or need of corticosteroids (p = 0.89). Only one patient developed dysplasia (under infliximab and 5-ASA). Any of the included patients needed surgery or developed colorectal cancer. Conclusion About two-thirds of the UC patients under biologics are co-treated with 5-ASA. No differences between UC patients under combination biologics+5-ASA vs. biologics alone were found regarding inflammatory biomarkers or the occurrence of complications. These results raise the question if continuing 5-ASA in UC patients under biologics is really necessary.

scholarly journals P466 Acute Severe Ulcerative Colitis in the modern era: biologic therapy-exposed patients and salvage therapy with intensified infliximab

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S457-S457
Author(s):  
K Fasoulas ◽  
K Soufleris ◽  
N Kafalis ◽  
P Kevrekidou ◽  
S Bouzoukas ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Medical Therapy ◽  
Salvage Therapy ◽  
Biologic Therapy ◽  
Rescue Therapy ◽  
Fecal Calprotectin ◽  
Disease Extent ◽  
Severe Ulcerative Colitis ◽  
Modern Era

Abstract Background Acute Severe Ulcerative Colitis (ASUC) is still associated with significant morbidity and risk of colectomy, almost 70 years since the landmark study of Truelove-Witts established steroid efficacy and 15 years since the Järnerot study introduced infliximab as an effective rescue therapy. It remains unclear if management of ASUC in the modern era (biologic-exposed patients and intensified infliximab regimens) leads to different outcomes. Methods A retrospective review of all recently hospitalized ASUC patients was performed. We aimed to compare rates of colectomy, response to steroids, and response to salvage infliximab in bio-naive and bio-exposed patients. Intensified infliximab was used as salvage therapy: 10 mg/kg infusions, aiming a trough level of at least 10 μg/ml at Week 10. We also tried to identify disease and patient related characteristics predictive of colectomy or response to medical therapy. Results 50 patients were included (male 66%, mean age: 47.4 years) and followed up for a mean of 24.2 months. 24 patients (48%) experienced ASUC while on biologic therapy: 11 on infliximab, 6 on vedolizumab, 5 on adalimumab, 2 on golimumab. Endoscopy showed deep ulcers at 23 patients (47%). Fecal calprotectin was > 1800 ng/ml in all patients. Half the patients (25) received rescue therapy with Infliximab due to steroid refractoriness. Eleven patients (22%) underwent colectomy, 2 (4%) of which during the index hospitalization. Although colectomy rates were similar among bio-naïve and bio-exposed (20% vs 25%, p:0.675), bio-exposed patients were more refractory to steroids (0dds Ratio:3.6 ;95% CI:1.01–13.2, p:0.047). Response to rescue infliximab was similar (Odds Ratio:0.45 ;95% CI:0.13–1.5, p:0.215), even in patients failing standard dosed infliximab. High CRP levels (4.89 mg/dl vs 2.64 mg/dl, p:0.014) and low albumin levels (3.4 g/dl vs 3.9 g/dl, p:0.013) were predictive of colectomy in contrast to endoscopic severity and disease extent. Conclusion ASUC remains a therapeutic challenge in the modern era, with considerable refractoriness to medical therapy and colectomy risk: 50% of our group of ASUC patients responded to steroids and 22% underwent colectomy within two years of follow-up. High inflammatory burden, depicted by high CRP values and hypoalbuminemia can predict need for colectomy. Bio-exposed patients were more refractory to steroids but they showed comparable response to intensified infliximab, so they can be managed in the same way, at least until therapy with small molecules proves more efficient by future studies.

Effectiveness and Safety of Golimumab in Treating Outpatient Ulcerative Colitis: A Real-Life Prospective, Multicentre, Observational Study in Primary Inflammatory Bowel Diseases Centers

2017 ◽  
Vol 26 (3) ◽  
pp. 239-244 ◽  
Author(s):  
Antonio Tursi ◽  
Leonardo Allegretta ◽  
Nello Buccianti ◽  
Nicola Della Valle ◽  
Walter Elisei ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Diseases ◽  
Real Life ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Background & Aims: Golimumab (GOL) has been recently approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments. Our aims were to assess the real-life efficacy and safety of GOL in managing UC outpatients in Italian primary Inflammatory Bowel Diseases (IBD) centres.Methods: Consecutive UC outpatients with at least 3-months follow-up were enrolled. Primary end-point was the induction and maintenance of remission in UC, defined as Mayo score ≤2, at 6-month follow-up.Results: Ninety-three patients were enrolled. At 6-month follow-up, remission was obtained in 34 (36.5%) patients. Shorter duration of disease was the only significant predictive factor of remission. Clinical response was achieved in 60 (64.5%) patients, while mucosal healing (MH) was obtained in 18 (19.3%) patients. Sixteen (47.0%) patients under remission were still under therapy with steroids. C-reactive protein and fecal calprotectin significantly dropped during the follow-up (p<0.001 for both proteins). Adverse events occurred in 4 (4.3%) patients and 3 of them stopped treatment. Colectomy was performed in only one patient (1.1%).Conclusions: Golimumab seems to be safe and effective in inducing and maintaining remission in real life UC outpatients.Abbreviations: ADA: Adalimumab; CRP: C-reactive Protein; GOL: Golimumab; FC: Fecal calprotectin; IBD: Inflammatory Bowel Diseases; IFX: Infliximab; IQR: Interquartile range; MH: Mucosal Healing; SC: Subcutaneously; TBC: Tuberculosis; TNFα: Tumor necrosis factor α; UC: Ulcerative Colitis.    

scholarly journals Fecal Calprotectin, CRP and Leucocytes in IBD Patients: Comparison of Biomarkers With Biopsy Results

2020 ◽  
Author(s):  
Barry D Kyle ◽  
Terence A Agbor ◽  
Shajib Sharif ◽  
Usha Chauhan ◽  
John Marshall ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Fecal Calprotectin ◽  
Dependent Manner ◽  
Ascending Colon ◽  
C Reactive Protein ◽  
Concentration Dependent Manner ◽  
Reactive Protein ◽  
Inflammatory Bowel ◽  
Descending Colon ◽  
Active Inflammation

Abstract Background This study aimed to compare fecal calprotectin (FC) levels with other commonly used parameters as part of patient care during evaluation for inflammatory bowel disease (IBD). Methods We recruited adult IBD patients with ulcerative colitis (UC) and Crohn’s disease (CD) and compared the results of the patient’s biopsy results (i.e., inflamed versus noninflamed) for six sites (i.e., ileum, ascending colon, transverse colon, descending colon, sigmoid colon, rectum) with concentrations of C-reactive protein (CRP), total leucocytes and fecal calprotectin (FC). Results We found that FC was significantly elevated in a concentration-dependent manner that correlated with the number of active inflammation sites reported in biopsy. Although CRP and leucocyte measurements trended upwards in line with inflammation reported from biopsy, the results were highly variable and highlighted poor reliability of these biomarkers for indicating IBD inflammation. Conclusions These results strongly suggest that FC correlates best with biopsy reports and is a superior marker than CRP and leucocytes.

scholarly journals Synchronous cytomegalovirus infection in a newly diagnosed ulcerative colitis patient

2017 ◽  
Vol 8 (1) ◽  
Author(s):  
Jin Yu Chieng ◽  
Yasotha Sugumaran ◽  
Sellymiah Adzman ◽  
Pan Yan
Keyword(s):  
Ulcerative Colitis ◽  
Medical Illness ◽  
C Reactive Protein ◽  
Colitis Patient ◽  
Intravenous Ganciclovir ◽  
Reactive Protein ◽  
Chronic Medical Illness ◽  
History Of ◽  
Cmv Colitis

A 61-year-old Punjabi female patient presented with six months history of mild abdominal discomfort with bloody diarrhea. She did not have underlying chronic medical illness; she neither took steroid nor immunosuppressant. She was found anemic, thrombocytosis, and elevated C-reactive protein. Colonoscopy showed moderate left sided colitis, with histopathology evidence of ulcerative colitis (UC) with cytomegalovirus (CMV) infection. Her serum anti-CMV IgM antibody was detected. She was treated with intravenous ganciclovir, together with 5-ASA and tapering dose of steroid. Anemia was corrected. Subsequent clinic reviews and follow up endoscopies showed dramatically improvement. CMV colitis should be considered for the patients presenting with moderate to severe UC. Early prescription of antiviral would be beneficial in the treatment of flare of UC.

scholarly journals Evaluation of efficacy and comparative frequency of adverse events in patients with ulcerative colitis receiving the original infliximab and its biosimilar. One year of observation

2019 ◽  
Vol 91 (8) ◽  
pp. 41-46
Author(s):  
O V Knyazev ◽  
T V Shkurko ◽  
A V Kagramanova ◽  
A A Lishchinskaya ◽  
M Yu Zvyaglova ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Real Life ◽  
Fecal Calprotectin ◽  
Biologic Drugs ◽  
Real Life Data ◽  
Bowel Diseases ◽  
Significant Clinical Improvement ◽  
One Year

Real - life data on the effectiveness and safety of biosimilar and biologic drugs licensed for treatment of inflammatory bowel diseases (IBD) is lacking. Aim. To investigate efficacy of original Infliximab (IFX) and its biosimilar in treating patients with ulcerative colitis (UC) and determine the frequency of adverse events during 1 year follow - up period. Materials and methods. Our cohort consisted of 98 ulcerative colitis patients, treated with original IFX and its biosimilar since December 2017 till December 2018 years. Original Infliximab was prescribed in 56 UC patients (57.1%) during 5 years and longer; 16 patients (16.3%) were switched to IFX biosimilar; 13 UC bio - naïve patients (13.3%) received original IFX, 29 (29.6%) patients - biosimilar IFX. In 14 patients (14.3%) original infliximab was rotated with biosimilar. We picked out 42 patients to assess efficacy of original IFX and biosimilar. Results and discussion. Twelve patients, received original IFX and 28 patients, treated with its biosimilar, showed significant clinical improvement by decreasing Mayo index from 9.7±0.4 and 10.2±0.2 points to 1.9±0.09 and 2.1±0.1 points, accordingly. Also we noticed positive change in laboratory markers - CRP decrease from 89.6±8.7 mg/l and 77.5±8.0 mg/l to 6.5±0.8 mg/l and 6.9±0.8 mg/l (p>0.05), albumin increase from 30.1±4.7 g/l and 29.6±3.6 g/l to 34.1±6.3 g/l and 32.8±5.9 g/l (p>0.05), increase of serum iron levels from 6.4±0.5 mcg/l and 7.1±0.65 mcg/l to 14.6±4.4 mcg/l and 15.9±5.1 mcg/l (p>0.05), hemoglobin increase from 104.7±9.8 g/l and 102.2±8.8 g/l till 124±11.3 g/l and 121±10.9 g/l (p>0.05), and fecal calprotectin decrease from 1680±134 mcg/g and 1720±126 mcg/g till 245.5±33.4 mcg/g and 230.5±29.8 mcg/g (p>0.05). During 1 year follow - up 12 UC patients, treated with original IFX and its biosimilar, developed adverse events. The majority of adverse events (n=8) were registered in patients, rotating administration of original IFX and its biosimilar. Conclusion. IFX biosimilar is effective as well as original IFX. Frequency of adverse events, occurred in patients, treated with original IFX, was comparable with adverse events frequency in patients, received biosimilar IFX. Frequency of adverse events was significantly higher in UC patients, rotating original IFX and its biosimilar.

scholarly journals P737 Ustekinumab induction effectiveness in Crohn’s disease in a real-life cohort

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S590-S591
Author(s):  
E Sánchez Rodríguez ◽  
F Mesonero Gismero ◽  
A López sanroman
Keyword(s):  
Biological Therapy ◽  
Treatment Time ◽  
Real Life ◽  
Delayed Response ◽  
Faecal Calprotectin ◽  
Tract Involvement ◽  
Maintenance Of Remission ◽  
Term Maintenance

Abstract Background Evaluation of Ustekinumab induction therapy is generally performed at week 16. Our aim was to evaluate if a delayed response may be expected beyond that time. Methods Retrospective study including patients with CD who received Ustekinumab since 1 June 2017 to 1 May 2019. Iv induction dose was based on weight while maintenance was conducted with 90 mg subcutaneous every 8 weeks. Results Twenty-five patients (52% male) were enrolled, of whom 28% (7/25) had ileal, 28(7/25) colonic, 44% (11/25) ileocolonic and 8% (2/25) upper tract involvement. Sixty-eight per cent (17/25) presented an inflammatory, 16% (4/25) a stricturing and 16% (4/25) a penetrating behaviour. Perianal disease was diagnosed in 20% of patients (5/25). All patients 100% (25/25) had previously taken immunosuppressants and 96% (24/25) biological therapy (mean 1.8 ± 0.87 (0–3) per patient): 36% (9/25) one, 36% (9/25) two and 24% (6/25) three agents. Ustekinumab was prescribed for achieving remission in 92% (23/25) of the patients, fistulising disease in 4% (1/25) and for maintenance of remission in the same percentage. Follow-up was 373.16 ± 182.53(59–683) days. Discontinuation rate was 24% (6/25), due to primary failure in 100% (6/6). For those who stopped the drug, average treatment time was 137.17 ± 95.11(61–1320) days whereas that of those who continued was 346.84 ± 192.10(32–669) days. Clinical response was evaluated at week 8, week 14–16, week 22–24 and during long-term maintenance (Table 1). All comparisons were statistically significant (p &lt; 0.05). We recorded Harvey-Bradshaw index(H-B), CRP and faecal calprotectin (FC) before induction with ustekinumab, at weeks 14–16, at weeks 22–24 and during maintenance. Results are presented in Table 2. Conclusion Evaluation of induction effectiveness at week 22–24 may allow to rescue those patients who present a delayed response to UST. During a 373.16 days follow-up, loss of response to Ustekinumab is low.

scholarly journals Fecal calprotectin role in diagnosis of ulcerative colitis and treatment follow-up

2019 ◽  
Vol 39 (2) ◽  
pp. 115-120
Author(s):  
Mahsa Mahdipour ◽  
Afshin Shafaghi ◽  
Fariborz Mansour-Ghanaei ◽  
Amineh Hojati ◽  
Farahnaz Joukar ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Fecal Calprotectin

scholarly journals Rapid fecal calprotectin testing predicts mucosal healing better than C-reactive protein and serum tumor necrosis factor α in patients with ulcerative colitis

2015 ◽  
Vol 53 (3) ◽  
pp. 253-260
Author(s):  
T. Voiosu ◽  
Andreea Benguş ◽  
P. Bălănescu ◽  
Roxana Dinu ◽  
A. Voiosu ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Tumor Necrosis Factor ◽  
Tumor Necrosis ◽  
Tumor Necrosis Factor Α ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Factor Α ◽  
Necrosis Factor

AbstractBackground and Aims. Serum and fecal biomarkers have been used as noninvasive methods for assessing disease activity in ulcerative colitis. C-reactive protein, serum tumor necrosis factor-α and fecal calprotectin are among the most promising such biomarkers. However, their role in the management of ulcerative colitis patients remains to be clarified. We aimed to evaluate the accuracy of C-reactive protein, fecal calprotectin and tumor necrosis factor-α in detecting clinical and endoscopic activity and predicting disease outcome.Methods. A cohort of ulcerative colitis patients was prospectively evaluated for clinical and endoscopic disease activity using the Mayo score. Serum C-reactive protein and tumor necrosis factor-α levels were measured and a point-of-care method was used for determining Calprotectin levels.Results. Fifty-three patients with ulcerative colitis were followed for a median of 12 months. Fecal calprotectin and C-reactive protein levels were significantly higher in patients with clinically active disease at baseline, but only calprotectin levels correlated with endoscopic activity. Calprotectin values over 300 μg/g had 60% sensitivity and 90% specificity for detecting active endoscopic disease and 61% sensitivity and 89% specificity for predicting mucosal healing.Conclusion. Rapid calprotectin testing is a better predictor of mucosal healing than serum biomarkers and it could improve the management of ulcerative colitis patients by decreasing the need for invasive investigations.

scholarly journals P471 What is the appropriate cut-off value of CRP to predict endoscopic remission in ulcerative colitis patients with clinical remission?

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S415-S415
Author(s):  
J Shin ◽  
G Seong ◽  
J H Song ◽  
S M Kong ◽  
T J Kim ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Sensitivity And Specificity ◽  
Clinical Remission ◽  
Activity Index ◽  
Area Under The Curve ◽  
Endoscopic Evaluation ◽  
Faecal Calprotectin ◽  
Reactive Protein ◽  
Endoscopic Remission ◽  
Low Sensitivity

Abstract Background A noninvasive and reliable markers for predicting endoscopic remission (ER) in ulcerative colitis (UC) patients with clinical remission (CR) provide important information in predicting disease progression and in determining treatment. Faecal calprotectin test is known to be the most accurate to predict ER, but patients are reluctant to handle faecal materials. C-reactive protein (CRP) is one of the surrogate markers for assessing disease activity, but it is known to have low sensitivity and specificity of normal CRP value (&lt;0.3 mg/dl). The sensitivity of the CRP test has been improved, and even fine values within the normal range can be measured. The aim of this study was to determine appropriate CRP cut-off values for the prediction of ER in UC patients with CR even though within normal CRP range. Methods A total of 132 UC patients who underwent endoscopic evaluation in CR were retrospectively reviewed. Serum biomarkers including haemoglobin, leukocytes, platelets, erythrocyte sedimentation rate, and CRP were evaluated within 1 week period from endoscopic evaluation. The clinical and endoscopic activity was measured by simple clinical colitis activity index and endoscopic Mayo subscore. Results In UC patient with CR, CRP level was significantly lower in ER (median 0.05, 0.03–2.57) vs. non-ER (median 0.11 0.03-2.81). (p &lt; 0.005) The proportion of males in non-ER was slightly higher than in ER (24, 72.7% vs. 52, 52.5 %; p = 0.042), and only gender and CRP showed statistical differences in baseline clinical characteristics. CRP had predictive value of ER [Area under the curve (AUC = 0.760)] and the sensitivity was 71.4%, specificity was 71.7 % at cut-off value of 0.09mg/dl. In contrast, the sensitivity and specificity of normal CRP (0.3mg/dl) were low. (sensitivity 27.3%, specificity 90.9%). Conclusion Norma CRP cut-off values are not sufficient to reflect ER. It may be helpful to change the CRP cut-off value that predicts ER in CR to value other than 0.3 mg/dl.

Association of baseline c-reactive protein with incident cancer and survival in cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 11052-11052
Author(s):  
K. H. Allin ◽  
S. E. Bojesen ◽  
B. G. Nordestgaard
Keyword(s):  
Colorectal Cancer ◽  
Lung Cancer ◽  
General Population ◽  
Cancer Patients ◽  
Early Death ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Hazard Ratios ◽  
Incident Cancer

11052 Background: We tested the hypothesis that baseline plasma levels of C-reactive protein (CRP) associate with risk of incident cancer in the general population, and early death in cancer patients. Methods: 10,408 individuals from the Danish general population, who had CRP measured at baseline, were followed for up to 16 years; 1,624 developed cancer and of these, 998 died during follow-up. Follow-up was 100% complete. We excluded individuals with a cancer diagnosis at baseline. Results: Baseline CRP levels >3 vs. <1 mg/L were associated with multifactorially adjusted hazard ratios of 1.3 (95% CI, 1.0–1.6) for cancer of any type, of 2.2 (1.0–4.6) for lung cancer, of 1.9 (0.8–4.6) for colorectal cancer, and of 0.7 (0.4–1.4) for breast cancer. Corresponding hazard ratios for the highest vs. the lowest quintile of baseline CRP levels were 1.3 (1.0–1.6), 2.1 (1.2–3.8), 1.7 (0.8–3.2), and 0.9 (0.5–1.7), respectively. Multifactorially adjusted hazard ratios for early death in cancer patients were 1.8 (1.2–2.7) for CRP >3 vs. <1 mg/L and 1.4 (1.1–1.7) for the highest vs. the lowest quintile. Elevated CRP levels associated with early death in cancer patients with localized disease, but not in cancer patients with metastases (interaction; P=.03). Conclusions: Elevated levels of CRP in cancer-free individuals are associated with increased risk of cancer of any type, of lung cancer, and possibly of colorectal cancer. Moreover, elevated levels of baseline CRP associate with early death after a diagnosis of any cancer, particularly in patients without metastases. No significant financial relationships to disclose.

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