scholarly journals Το εύρος κατανομής του μεγέθους των ερυθρών αιμοσφαιρίων με συντελεστή μεταβλητότητας ως δείκτης ενεργότητας και βαρύτητας στα ιδιοπαθή φλεγμονώδη νοσήματα του εντέρου

2020 ◽  
Author(s):  
Μάριος Κατσαρός
Keyword(s):  
Mayo Score ◽  
Rutgeerts Score

ΣΚΟΠΟΣ: Η φυσική ιστορία των ΙΦΝΕ περιλαμβάνει περιόδους υφέσεων και εξάρσεων κατά τις οποίες παρατηρείται σημαντική ελάττωση στην ποιότητα ζωής των ασθενών και αυξημένος κίνδυνος νοσηλείας, επιπλοκών και χειρουργικών επεμβάσεων. Η επιτήρηση των ασθενών αποσκοπεί στην έγκαιρη αναγνώριση και πρόληψη της υποτροπής τροποποιώντας ή/και κλιμακώνοντας πρώιμα την φαρμακευτική αγωγή. Η παρακολούθηση των ασθενών βασίζεται στη χρήση κλινικών, εργαστηριακών, ενδοσκοπικών, ιστολογικών και απεικονιστικών παραμέτρων οι οποίες, παρουσιάζουν επιμέρους μειονεκτήματα κατά την εφαρμογή τους, όπως όπως χαμηλή ευαισθησία, υψηλό κόστος, περιορισμένη προσβασιμότητα και επεμβατικότητα.. Το RDW-CV αποτελεί ένα εύχρηστο οικονομικό δείκτη ο οποίος υπολογίζεται αυτόματα από τους αιματολογικούς αναλυτές και έχει διαπιστωθεί ότι μπορεί να εκφράσει με επιτυχία την ενεργότητα και τη βαρύτητα σε πλήθος παθολογικών καταστάσεων. Περιορισμένα είναι τα δεδομένα στη διεθνή βιβλιογραφία αναφορικά με τη χρήση του ως δείκτη φλεγμονής στα ΙΦΝΕ. Πρωτεύων σκοπός της παρούσας μελέτης είναι η διερεύνηση της ακρίβειας του RDW-CV στη διάγνωση της ενδοσκοπικής και ιστολογικής ενεργότητας και βαρύτητας σε ασθενείς με ΙΦΝΕ. Ακολούθως διερευνήθηκε η επίδραση της αναιμίας στη διαγνωστική του ακρίβεια, συγκρίθηκε η διαγνωστική του ακρίβεια με της CRP και της ΤΚΕ και αξιολογήθηκε η συσχέτιση του με κλινικούς, εργαστηριακούς, ενδοσκοπικούς και ιστολογικούς δείκτες ενεργότητας στα ΙΦΝΕ. ΥΛΙΚΟ ΚΑΙ ΜΕΘΟΔΟΙ: Πρόκειτα για μια μελέτη χρονικής στιγμής στην οποία συμπεριλήφθηκαν 131 ασθενείς με τεκμηριωμένη διάγνωση ΙΦΝΕ, εκ των οποίων 75 ασθενείς με NC με μέση ηλικία 38,49 ± 14,5 έτη και διάμεση διάρκεια νόσου 4,91 (0-34,91) έτη και 56 ασθενείς με ΕΚ με μέση ηλικία 41,96 ±15,85 έτη και διάμεση διάρκεια νόσου 6,75 (0,08-34,83) έτη. Στους ασθενείς υπολογίστηκαν οι ακόλουθες παράμετροι: CDAI, partial Mayo score, γενική αίματος, CRP, TKE, φεριτίνη, σίδηρος, φυλλικό οξύ, Β12, SES-CD, endoscopic Mayo score, Rutgeerts score, GHAS και Nancy index. ΑΠΟΤΕΛΕΣΜΑΤΑ: Διαπιστώθηκε αξιοσημείωτη διαγνωστική ακρίβεια του RDW-CV στην ενδοσκοπική ενεργότητα στο σύνολο των ασθενών, με σχετική υπεροχή στους ασθενείς με ΝC. Παρατηρήθηκε σημαντική διαγνωστική ακρίβεια στην ενδοσκοπική μετεγχειρητική υποτροπή σε ασθενείς με ΝC, και υπεροχή της ακρίβειας του στη διάγνωση της ενδοσκοπικής ενεργότητα στους ασθενείς με ΝC με αναιμία. Η ακρίβεια του στη διάγνωση της ενδοσκοπικής βαρύτητας ήταν ικανοποιητική και στις δύο ομάδες ασθενών, ενώ η διαγνωστική ακρίβεια του RDW-CV ήταν συγκρίσιμη με της CRP και της TKE σε όλες τις περιπτώσεις. Διαπιστώθηκε ικανοποιητική διαγνωστική ακρίβεια του RDW-CV στην ιστολογική ενεργότητα στο σύνολο των ασθενών, με σχετική υπεροχή της ικανότητας του στους ασθενείς με NC. H ακρίβεια του στη διάγνωση της ιστολογικής ενεργότητα υπερείχε στους ασθενείς με ΝC με αναιμία, ενώ σημαντικότατη ήταν η διαγνωστική ακρίβεια του στη βαρεία νόσο και στις δύο ομάδες ασθενών. Η διαγνωστική του ακρίβεια του RDW-CV ήταν συγκρίσιμη με της CRP της TKE σε όλες τις υποαναλύσεις. Τέλος παρατηρήθηκε σημαντική συσχέτιση του με κλινικούς, εργαστηριακούς ενδοσκοπικούς και ιστολογικούς και δείκτες ενεργότητας. ΣΥΜΠΕΡΑΣΜΑ: Tο RDW-CV αποτελεί ένα εύχρηστο, οικονομικό δείκτη με αξιοσημείωτη ακρίβεια στη διάγνωση της ενδοσκοπικής και ιστολογικής ενεργότητας και βαρύτητας στα ΙΦΝΕ, συγκρίσιμη με ευρέως χρησιμοποιούμενους βιοδείκτες. Επιπρόσθετα το RDW-CV σχετίζεται σημαντικά με εργαστηριακούς, κλινικούς, ενδοσκοπικούς και ιστολογικούς δείκτες, ικανούς να εκφράσουν την ενεργότητα, τόσο στη NC όσο και στην ΕΚ.

scholarly journals Full, partial and modified permutations of the Mayo Score: Characterizing clinical and patient-reported outcomes in ulcerative colitis patients

2021 ◽  
Author(s):  
April N Naegeli ◽  
Theresa Hunter ◽  
Yan Dong ◽  
Ben Hoskin ◽  
Chloe Middleton-Dalby ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Patient Reported Outcomes ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Assessment Scores ◽  
Mayo Score ◽  
Patient Reported ◽  
Practice Trials ◽  
Highly Correlated

Abstract Background Understanding ulcerative colitis (UC) disease activity assessed via the full, modified or partial Mayo Score may help clinicians apply results from clinical trials to practice and facilitate interpretation of recent and older studies. Methods Mayo Score variables were assessed in a cross-sectional study of 2608 UC patients. Results Permutations of Mayo Scores were highly correlated, and models predicting the omitted variable from each permutation demonstrated significant agreement between predicted and observed values. Conclusions Partial/modified Mayo Scores may be used to predict endoscopic and Physician's Global Assessment scores, and serve as proxies for the full Mayo Score in clinical practice/trials.

scholarly journals Fecal calprotectin is a useful biomarker for predicting the clinical outcome of granulocyte and monocyte adsorptive apheresis in ulcerative colitis patients: a prospective observation study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nobuhiro Ueno ◽  
Yuya Sugiyama ◽  
Yu Kobayashi ◽  
Yuki Murakami ◽  
Takuya Iwama ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Outcome ◽  
Sensitivity And Specificity ◽  
Reduction Rate ◽  
Fecal Calprotectin ◽  
Remission Induction ◽  
Clinical Activity ◽  
Observation Study ◽  
Mayo Score ◽  
Adsorptive Apheresis

Abstract Background Granulocyte and monocyte adsorptive apheresis (GMA) is widely used as a remission induction therapy for active ulcerative colitis (UC) patients. However, there are no available biomarkers for predicting the clinical outcome of GMA. We investigated the utility of Fecal calprotectin (FC) as a biomarker for predicting the clinical outcome during GMA therapy in active UC patients. Methods In this multicenter prospective observation study, all patients received 10 sessions of GMA, twice a week, for 5 consecutive weeks. FC was measured at entry, one week, two weeks, and at the end of GMA. Colonoscopy was performed at entry and after GMA. The clinical activity was assessed based on the partial Mayo score when FC was measured. Clinical remission (CR) was defined as a partial Mayo score of ≤ 2 and endoscopic remission (ER) was defined as Mayo endoscopic subscore of either 0 or 1. We analyzed the relationships between the clinical outcome (CR and ER) and the change in FC concentration. Result Twenty-six patients were included in this study. The overall CR and ER rates were 50.0% and 19.2%, respectively. After GMA, the median FC concentration in patients with ER was significantly lower than that in patients without ER (469 mg/kg vs. 3107 mg/kg, p = 0.03). When the cut-off value of FC concentration was set at 1150 mg/kg for assessing ER after GMA, the sensitivity and specificity were 0.8 and 0.81, respectively. The FC concentration had significantly decreased by one week. An ROC analysis demonstrated that the reduction rate of FC (ΔFC) at 1 week was the most accurate predictor of CR at the end of GMA (AUC = 0.852, P = 0.002). When the cut-off value of ΔFC was set at ≤ 40% at 1 week for predicting CR at the end of GMA, the sensitivity and specificity were 76.9% and 84.6%, respectively. Conclusion We evaluated the utility of FC as a biomarker for assessing ER after GMA and predicting CR in the early phase during GMA in patients with active UC. Our findings will benefit patients with active UC by allowing them to avoid unnecessary invasive procedures and will help establish new strategies for GMA.

scholarly journals P106 Depressive symptoms and anxiety and their screening in IBD patients: performance of the distress thermometer in Italian IBD patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S188-S189
Author(s):  
C Canaletti ◽  
F Colombo ◽  
A Dessì ◽  
E Geccherle ◽  
A Tongiorgi ◽  
...  
Keyword(s):  
Psychological Distress ◽  
Emotional Distress ◽  
Screening Tool ◽  
Anxiety And Depression ◽  
Depression Symptoms ◽  
Cutoff Score ◽  
Distress Screening ◽  
Single Item ◽  
Mayo Score ◽  
Clinical Indices

Abstract Background Roughly 50% of patients with IBD have symptoms of psychological distress (Mikocka-Walus et al. 2019) but only 15.2% receive attention for their mental health although the effect on disease severity can be profound. It is necessary to have an easy-to-administer psychological distress screening tool. The distress thermometer (DT) is a single-item distress screening scale with 11-likert response widely used in oncological patients. The aim of study was to determine whether the single-item DT compared favourably with IBD clinical indices and time consuming measures currently used to screen for distress. Methods Two hundered and twenty IBD patients (51.43% male) who were recruited in eight Italian hospitals completed the DT and identified the presence or absence of 34 problems using standardised problem list (PL). They completed the 14-item Hospital Anxiety and Depression Scale (HADS) and the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ). Disease clinical indices have been collected for each patient (Mayo score, Harvey–Bradshaw Index–HBI, years of illness, and exacerbation in the last year). Using receiver operating characteristic (ROC) analyses validated the use of the DT in Italian IBD population. Results 47.6% reported anxiety and depression symptoms (HADS ≥15) and needs emotional care. Anxiety is much more associated (43.8%) than depressive problems (26.2%). Data are confirmed by responses to DT and PL: 44.5% of patients reported moderate–severe emotional distress (TD ≥ 5), 43.1% of patients report nervousness and worry, 27.1% reported depression. We observed a strong positive correlation between IBDQ and HADS (r = 0.74, p < 0.001) and DT (r = 0.58, p < 0.001), while there was a slightly smaller association with Mayo score (r = 0.46, p < 0.001) and HBI (r = 0.39, p < 0.001). There was not a statistical significant correlation between disease indices and the emotional distress as measured by HADS or DT. ROC analyses showed that a DT cutoff score of 5 or higher had optimal sensitivity (83%) and specificity (68%) relative to the HADS score as ‘gold’ standard. DT scores yielded area under the curve estimates relative to the HADS cutoff score indicative of good overall accuracy (AUC = 0.81–95% CI: 0.77–0.85). Conclusion Our study confirms that anxiety and depression symptoms are associated with IBD. This is the first study that demonstrated that DT is an easy-to-administer screening tool of psychosocial distress in IBD population. We propose that gastroenterologists use DT to identify patients with psychological distress: an early psychological support and a multidisclinar equipe can determinate a patient’s better disease course (Mawdsley et al. 2005). Our analyses indicated that using a DT’s cutoff of 5 to indicate high levels of distress.

Predictors of Surgical Intervention in Patients with Inflammatory Bowel Disease

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Khaled Hamdy Abd El Megeed ◽  
Shereen Abou Bakr Saleh ◽  
Christina Alphonse Anwar ◽  
Ahmed Elkattary Mohamed Elkattary
Keyword(s):  
Inflammatory Bowel Disease ◽  
Surgical Treatment ◽  
Bowel Disease ◽  
Surgical Intervention ◽  
High Sensitivity ◽  
Medical Patients ◽  
Mayo Score ◽  
Calprotectin Level ◽  
Inflammatory Bowel ◽  
The Mean

Abstract Background Inflammatory bowel disease (IBD) is comprised of two major disorders: Ulcerative Colitis and Crohn’s disease. Ulcerative Colitis affects the colon, where as Crohn’s disease can involve any component of the gastrointestinal tract from the mouth to the perianal area. These disorders have somewhat different pathologic and clinical characteristics, but with substantial overlap; their pathogenesis remains poorly understood. Objective To determine & detect different predictors that help us to characterize patients with high probability of undergoing surgical intervention for inflammatory bowel diseases. Patients and Methods The present study was designed to detect & identify possible factors that can be used to predict surgical intervention in patients with IBD. The present study was a case control study that was conducted on 80 patients with inflammatory bowel disease (either controlled by medical treatment or needed surgical intervention as a part of disease control) who were recruited form Ain-Shams university hospitals and El Quabbary general hospital in Alexandria. In the present study, the mean age of the included patients was 36.67 ±8.5 years old and 50% of the patients were males. The mean age at the onset of the disease was 25.81 ±6.8 years old. Results In the present study, there were statistically significant differences between surgical and medical patients in terms of CDAI for CD (p < 0.001) and Mayo score for UC (p < 0.001). Surgical patients were more likely to have higher scores. CDAI and Mayo score were negative predictors of surgical treatment. CDAI score > 287 and Mayo score > 8.5 achieved high sensitivity and specificity for the detection of surgical treatment. In the present study, we found that there was statistically significant differences between surgical and medical patients in terms of Stool Calprotectin level. Surgical patients were more likely to have higher Stool Calprotectin level. Stool Calprotectin level was negative predictor of surgical treatment at a level of > 341.5 microgm/gm with high sensitivity and specificity. Conclusion Surgical treatment is a common outcome in IBD. Certain clinical features and the extent of disease are risk factors for surgical intervention. Our study indicates that smoking, Chron’s disease, perianal disease, granulomas, higher severity scores, higher stool Calprotectin level, CRP, and ESR were associated with higher risks of surgical intervention. In addition, smoking, peri-anal disease, CDAI, Mayo score, Stool Calprotectin level, and CRP level were predictors of surgical treatment. The findings of our analysis have implications for practice, particularly in the promotion of preoperative individualized risk prediction. The ability to predict which patients will need surgery and target more intensive, early treatment to that group would be invaluable. Further research through large prospective cohort studies is needed to confirm our findings and conclusions.

Anti-Tumor Necrosis Factor-Alpha Withdrawal in Children With Inflammatory Bowel Disease in Endoscopic and Histologic Remission

2021 ◽  
Author(s):  
Luca Scarallo ◽  
Giulia Bolasco ◽  
Jacopo Barp ◽  
Martina Bianconi ◽  
Monica di Paola ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Treatment Withdrawal ◽  
Clinical Relapse ◽  
Necrosis Factor Alpha ◽  
Mayo Score ◽  
Endoscopic Score ◽  
Inflammatory Bowel ◽  
Factor Alpha

Abstract Background The aim of the present study was to investigate outcomes of anti-TNF-alpha (ATA) withdrawal in selected pediatric patients with inflammatory bowel disease who achieved clinical remission and mucosal and histological healing (MH and HH). Methods A retrospective analysis was performed on children and adolescents affected by Crohn disease (CD) and ulcerative colitis (UC) who were followed up at 2 tertiary referral centers from 2008 through 2018. The main outcome measure was clinical relapse rates after ATA withdrawal. Results One hundred seventy patients received scheduled ATA treatment; 78 patients with CD and 56 patients with UC underwent endoscopic reassessment. We found that MH was achieved by 32 patients with CD (41%) and 30 patients with UC (53.6%); 26 patients with CD (33.3%) and 22 patients with UC (39.3%) achieved HH. The ATA treatment was suspended in 45 patients, 24 affected by CD and 21 by UC, who all achieved concurrently complete MH (Simplified Endoscopic Score for CD, 0; Mayo score, 0, respectively) and HH. All the patients who suspended ATA shifted to an immunomodulatory agent or mesalazine. In contrast, 17 patients, 8 with CD and 9 with UC, continued ATA because of growth needs, the persistence of slight endoscopic lesions, and/or microscopic inflammation. Thirteen out of 24 patients with CD who suspended ATA experienced disease relapse after a median follow-up time of 29 months, whereas no recurrence was observed among the 9 patients with CD who continued treatment (P = 0.05). Among the patients with UC, there were no significant differences in relapse-free survival among those who discontinued ATA and those who did not suspend treatment (P = 0.718). Conclusions Despite the application of rigid selection criteria, ATA cessation remains inadvisable in CD. In contrast, in UC, the concurrent achievement of MH and HH may represent promising selection criteria to identify patients in whom treatment withdrawal is feasible.

scholarly journals P236 Evaluation of histological inflammation by a novel image enhanced endoscopy technique, dual red imaging, in patients with ulcerative colitis: Preliminary study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S261-S261
Author(s):  
K FUJIMOTO ◽  
K Watanabe ◽  
K Hori ◽  
K Kaku ◽  
N Kinoshita ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
White Light ◽  
Narrow Band ◽  
Narrow Band Imaging ◽  
Topical Steroid ◽  
Treatment Goal ◽  
Practical Approach ◽  
Mayo Score ◽  
White Light Imaging ◽  
Pathological Assessment

Abstract Background Endoscopic remission is the ideal treatment goal for patients with ulcerative colitis (UC) in clinical practice. However, several recent investigations tried to evaluate histological healing as a more optimal treatment goal. The assessment of histological healing, however, is usually inconvenient and time-consuming because of the requirement of a biopsy and pathological assessment. Dual red imaging (DRI; Olympus Corporation, Japan) is a novel image enhanced endoscopy technique that can visualise the inflammation, including that in the surface crypt, and vessel findings of the brownish surface or green-coloured deeper layer of the mucosa in contrast to narrow band imaging. We preliminarily evaluated the utility of DRI in the assessment of histological healing in UC as a practical approach. Methods We enrolled UC patients who provided consent from May 2018 to September 2019 in our hospital, and performed colonoscopy in the entire colon with white-light imaging and DRI, and then endoscopic pictures and biopsy samples were obtained. Central pathological assessment of histological inflammation based on the Nancy index with individual items was performed for each biopsy sample. We also assessed the clinical background, UC activity according to the Mayo score, white-light endoscopic activity according to the Mayo endoscopic subscore (MES), and DRI findings using a 5-point scale. Results We evaluated a total of 90 sets of DRI and pathological findings from 47 UC patients (20 females; median age, 42 [20–84] years; 25 with pancolitis, 17 left-sided colitis, 3 proctitis, and 2 others; median duration of disease, 83 [1–379] months; median Mayo score, 2 [0–11]). Participants were treated with 5-aminosalicylates (38 oral; 7 topical), steroid (4 systemic; 6 topical), immunomodulator (7), anti-TNF agents (5), tofacitinib (3), and tacrolimus (8). Both the MES (r = 0.70) and DRI scale (r = 0.65) correlated well with the Nancy index. Among individual pathological items with respect to inflammation, ulceration (r = 0.69), chronic inflammatory infiltrate (r = 0.66), neutrophils in the lamina propria (r = 0.65), and serrated architectural abnormalities (r = 0.60) correlated well with the Nancy index in contrast to other pathological items. DRI seemed to facilitate the visualisation of histological inflammation in deeper layers of the mucosa compared with white-light imaging or narrow-band imaging. Conclusion The novel DRI technique has potential in the evaluation of histological inflammation without the requirement of a biopsy in patients with UC as a practical approach. A further prospective multicenter study in this regard is needed.

scholarly journals Effectiveness of treatment of moderate ulcerative colitis with prolonged mesalazine in real clinical practice

2021 ◽  
pp. 144-151
Author(s):  
O. V. Knyazev ◽  
A. V. Kagramanova ◽  
A. A. Lishchinskaya
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Topical Therapy ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
Prolonged Release ◽  
Mayo Score ◽  
Endoscopic Remission ◽  
Oral Mesalazine ◽  
High Doses

Introduction. Ulcerative colitis (UC) is one of the severe therapeutic diseases. High doses of oral granular mesalazine are required to maintain clinical and endoscopic remission of UC, which may be sufficient and supposedly more acceptable for patients, as some studies showed that adherence to topical therapy is significantly lower than to oral 5-ASA drugs.Objective of the study. To evaluate the efficacy of therapy of patients with moderate left-sided ulcerative colitis (UC) and pancolitis receiving prolonged-release ethylcellulose-coated mesalazine.Materials and methods. The evaluation of the outcomes of treatment of UC patients who received prolonged-release mesalazine was carried out. We examined 87 patients with UC who received granular ethylcellulose-coated mesalazine, of those 38 (43.7%) men and 49 (56.3%) women. The average age of the enrolled patients was 38.3 ± 12.6 years.Results and discussion. After 2 weeks from the beginning of therapy with prolonged-release mesalazine, the majority of patients – 71 (81.6%) responded to the therapy. After 12 weeks, 71 (81.6%) of 87 UC patients, who responded to therapy with prolongedrelease mesalazine, remained in clinical remission. On average, the Mayo score in the group decreased from 7.6 ± 0.99 to 2.6 ± 0.25 points. There was a significant decrease in CRP, ESR, leukocytosis, and fecal calprotectin. After 26 weeks, Mayo score in the group of patients remained on average at the level of 2.2–2.3 points. The number of UC patients with colon mucosal healing was 32 (36.8%) patients. A year after the start of therapy with prolonged-release mesalazine, 69 (79.3%) UC patients who responded to therapy had a clinical remission, of those 32 (36.8%) patients had a clinical and endoscopic remission. During the year of observation, no case of surgical intervention or re-hospitalization due to exacerbation of the disease was recorded in patients with UC who achieved remission.Conclusions. Treatment of moderate active UC should begin with oral mesalazine ≥ 3 g per day in combination with topical mesalazine. The prolonged-release mesalazines are the most preferred

scholarly journals Predictive value of fibrinogen in identifying inflammatory bowel disease in active stage

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xiao-Fu Chen ◽  
Yuan Zhao ◽  
Yu Guo ◽  
Zhi-Ming Huang ◽  
Xie-Lin Huang
Keyword(s):  
Inflammatory Bowel Disease ◽  
Confidence Interval ◽  
Disease Activity ◽  
Bowel Disease ◽  
Odds Ratio ◽  
Activity Index ◽  
Characteristic Curve ◽  
Disease Activity Index ◽  
Mayo Score ◽  
Inflammatory Bowel

Abstract Background We aimed to externally validate for the first time the diagnostic ability of fibrinogen to identify active inflammatory bowel disease (IBD). Methods The research totally involved 788 patients with IBD, consisted of 245 ulcerative colitis (UC) and 543 Crohn’ s disease (CD). The Mayo score and Crohn disease activity index (CDAI) assessed disease activity of UC and CD respectively. The independent association between fibrinogen and disease activity of patients with UC or CD was investigated by multivariate logistic regression analyses. Area under the receiver operating characteristic curve (AUROC) assessed the performance of various biomarkers in discriminating disease states. Results The fibrinogen levels in active patients with IBD significantly increased compared with those in remission stage (P < 0.001). Fibrinogen was an independent predictor to distinguish disease activity of UC (odds ratio: 2.247, 95% confidence interval: 1.428–3.537, P < 0.001) and CD (odds ratio: 2.124, 95% confidence interval: 1.433–3.148, P < 0.001). Fibrinogen was positively correlated with the Mayo score (r = 0.529, P < 0.001) and CDAI (r = 0.625, P < 0.001). Fibrinogen had a high discriminative capacity for both active UC (AUROC: 0.806, 95% confidence interval: 0.751–0.861) and CD (AUROC: 0.869, 95% confidence interval: 0.839–0.899). The optimum cut-off values of fibrinogen 3.22 was 70% sensitive and 77% specific for active UC, and 3.87 was 77% sensitive and 81% specific for active CD respectively. Conclusions Fibrinogen is a convenient and practical biomarker to identify active IBD.

scholarly journals DOP59 Maintenance of remission with tofacitinib in patients with ulcerative colitis: Updated results of a subpopulation analysis from an open-label, long-term extension study, OCTAVE Open

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S098-S099
Author(s):  
J F Colombel ◽  
M T Osterman ◽  
P Ibanez ◽  
A J Thorpe ◽  
H Zhang ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Opportunistic Infections ◽  
Safety Data ◽  
Similar Efficacy ◽  
Major Adverse Cardiovascular Events ◽  
Open Label ◽  
Phase 3 ◽  
Vein Thrombosis ◽  
Mayo Score

Abstract Background Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Efficacy and safety were demonstrated in 3 Phase 3, randomised, placebo-controlled studies in patients with moderate to severe UC.1 An ongoing, Phase 3, open-label, long-term extension (OLE) study (OCTAVE Open, NCT01470612) included patients from OCTAVE Induction 1 and 2 and OCTAVE Sustain. Methods We present data (as of May 2019) from the ‘maintenance remission’ subpopulation in the OLE study who were in remission (total Mayo score ≤2, no individual subscore &gt;1, rectal bleeding subscore of 0) at Week 52 of OCTAVE Sustain (having received tofacitinib 5 or 10 mg twice daily [BID]). These patients received tofacitinib 5 mg BID as per protocol in the OLE study. Efficacy data up to Month 36 of the OLE study (as observed and with non-responder and last observation carried forward imputation [NRI-LOCF]) are presented for this subpopulation. Safety data are reported for all patients who received tofacitinib 5 mg BID in the OLE study. Results Of 944 patients receiving ≥1 dose of tofacitinib in the OLE study, 163 were in remission at Week 52 of OCTAVE Sustain (mean age 45 years; 46.0% female). Of these, 66 (40.5%) and 76 (46.6%) received tofacitinib 5 and 10 mg BID, respectively, in OCTAVE Sustain, and 21 (12.9%) received a placebo. In total, 67/163 (41.1%) patients discontinued the OLE study, 16 (9.8%) due to adverse events (AEs) excl. worsening UC and 15 (9.2%) due to insufficient clinical response. Among patients that continued, efficacy (Table) was maintained over 36 months and was similar irrespective of the dose received in OCTAVE Sustain. Of 175 patients who received tofacitinib 5 mg BID (incl. 163 from the maintenance remission subpopulation), 152 (86.9%), 33 (18.9%) and 20 (11.4%) had AEs, serious AEs and severe AEs, respectively. The most frequent treatment-emergent AEs (TEAEs) were worsening UC (41 patients, 23.4%) and nasopharyngitis (38 patients, 21.7%). Six (3.4%) patients receiving tofacitinib 5 mg BID had serious infections, 11 (6.3%) had herpes zoster (non-serious and serious), 4 (2.3%) had opportunistic infections, 2 (1.1%) had major adverse cardiovascular events and 5 (2.9%) had malignancy (excl. non-melanoma skin cancer). No deep vein thrombosis, pulmonary embolism or deaths were reported in patients receiving tofacitinib 5 mg BID. Conclusion Most patients in remission at Week 52 of OCTAVE Sustain maintained efficacy with tofacitinib 5 mg BID over 36 months in the OLE study. Similar efficacy was observed for patients whose dose was reduced from tofacitinib 10 mg BID in OCTAVE Sustain to 5 mg BID in the OLE study, vs. those who received 5 mg BID throughout both OCTAVE Sustain and the OLE study. No new safety risks were identified. Reference

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