scholarly journals A157 REAL-WORLD TIGHT OBJECTIVE MONITORING WITH ADALIMUMAB LEADS TO EARLIER DOSE OPTIMIZATION AND HIGHER CLINICAL REMISSION RATES AT 12 MONTHS.

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 163-164
Author(s):  
Y Xiao ◽  
A Al Khoury ◽  
P Golovics ◽  
R Kohen ◽  
W Afif ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Clinical Remission ◽  
Clinical Symptoms ◽  
Fecal Calprotectin ◽  
Dose Optimization ◽  
Early Assessment ◽  
Objective Monitoring ◽  
Bowel Diseases ◽  
One Year

Abstract Background Data suggests that tight objective monitoring of inflammatory bowel diseases (IBD) may improve one-year clinical outcomes. Aims The goal of this study is to assess the adherence to serial tight objective monitoring, via clinical symptoms and biomarkers, and the effect of such tight monitoring on one year outcome in IBD patients at an academic and an university-affiliated center. Methods We retrospectively reviewed the chart of 428 consecutive IBD patients who started adalimumaby at the McGill University Health Center and Jewish General Hospital (Montreal, Canada) between January 1, 2015 and January 1, 2019 [338 Crohn’s disease(CD), 90 ulcerative colitis(UC)]. Clinical symptoms (assessed by Harvey-Bradshaw-Index and partial Mayo), C-Reactive Protein(CRP), and fecal calprotectin(FCAL) were captured at treatment initiation and at 3, 6, 9, and 12 months. Combined adherence was defined as the evaluation of ≥2 of 3 parameters(clinical, CRP, FCAL). Dose optimization and drug sustainability curves were plotted by Kaplan-Meier method. Results Clinical symptoms were assessed in nearly all patients at 3 (CD-UC:95-94%), 6 (90-83%), 9 (86-85%) and 12 (96-89%) months. CRP was also available for most patients but the frequency of assessment decreased in CD patients over the study period. In comparison, compliance to serial FCAL testing was low throughout the follow-up period. Clinical remission at one-year was significantly higher in patients who were adherent to early assessment visit at 3 months (p=0.001 both for CD and UC). Adherence to early follow-up also resulted in earlier dose optimisation in both CD and UC patients(pLogrank=0.026 for UC and p=0.09 for CD). However, the overall drug sustainability did not differ. Conclusions Clinical assessment and CRP, but not FCAL, were frequently assessed in patients starting adalimumab. Adherence to early objective combined follow-up visits resulted in earlier dose optimization and improved one-year clinical outcomes but did not change drug sustainability rates. Funding Agencies None

scholarly journals P552 Assessing adherence to objective disease monitoring and outcomes with adalimumab in a real-world IBD cohort

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S519-S519
Author(s):  
Y Xiao ◽  
A Al Khoury ◽  
P Golovics ◽  
R Kohen ◽  
W Afif ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Clinical Symptoms ◽  
Fecal Calprotectin ◽  
Dose Optimization ◽  
Early Assessment ◽  
Mayo Score ◽  
Objective Monitoring ◽  
Kaplan Meier ◽  
One Year

Abstract Background Data suggests that tight objective monitoring may improve clinical outcomes in IBD. Methods The aim of this study is to assess the adherence to serial tight objective monitoring(clinical and biomarkers) and its effect on clinical outcomes. We retrospectively reviewed the chart of 428 consecutive IBD patients started on adalimumab between January 1,2015–January 1,2019 [338 Crohn’s disease(CD), 90 ulcerative colitis(UC)]. Clinical symptoms (assessed by Harvey-Bradshaw-Index, partial Mayo score), C-Reactive Protein(CRP), and fecal calprotectin(FCAL) assessments were captured at treatment initiation and at 3, 6, 9, and 12 months. Dose optimization and drug sustainability curves were plotted by Kaplan-Meier method Results Clinical evaluation was available in nearly all patients at 3(CD-UC:95-94%), 6(90-83%), 9(86-85%) and 12(96-89%) months. CRP was also available in nearly all patients but testing frequency decreased in CD patients over time. Compliance to serial FCAL testing was low. Clinical remission at one-year was higher in patients adherent to early assessment visit at 3 months (p=0.001 for CD and UC). Adherence to early follow-up resulted in earlier dose optimisation in CD and UC patients (pLogrank=0.026 for UC & p=0.09 for CD). Overall drug sustainability did not differ. Conclusion Clinical and CRP, but not FCAL, were frequently assessed in patients starting adalimumab. Adherence to early objective combined follow-up visits resulted in earlier dose optimization, improved one-year clinical outcomes but did not change drug sustainability.

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 A székletkalprotektin meghatározásának szerepe a bélbetegségek diagnosztikájában és kezelésében

2019 ◽  
Vol 160 (9) ◽  
pp. 322-328
Author(s):  
Ákos Iliás ◽  
Fióna Petra Rózsa ◽  
Lóránt Gönczi ◽  
Barbara Dorottya Lovász ◽  
Zsuzsanna Kürti ◽  
...  
Keyword(s):  
Clinical Symptoms ◽  
Point Of Care ◽  
Short Review ◽  
Gastrointestinal Diseases ◽  
Fecal Calprotectin ◽  
Gastrointestinal Infections ◽  
Bowel Diseases ◽  
And Performance ◽  
Irritable Bowel

Abstract: The diagnostics of gastrointestinal diseases have evolved significantly in the past few decades. Besides endoscopy and conventional imaging modalities, there is a growing interest for rapid point-of-care laboratory tests to help discriminate between diseases with similar clinical symptoms and/or help the follow-up of chronic conditions, predicting relapses. The fecal calprotectin testing is a routine diagnostic tool in many countries. It is also more and more accessible in Hungary as well. We aim to present a short review on the role and performance of fecal calprotectin test in the diagnosis and follow-up of gastrointestinal diseases, especially inflammatory bowel diseases, gastrointestinal infections, irritable bowel syndrome and pediatric conditions. By presenting the different cut-off values, sensitivity and specificity rates representative for each disease, we hope to further aid clinicians in decision-making regarding these conditions. Orv Hetil. 2019; 160(9): 322–328.

scholarly journals P428 Early and Late Fecal Calprotectin Remission - Analysis of a proactive Therapeutic Drug Monitoring Treatment Protocol

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S432-S432
Author(s):  
J Pedro ◽  
I Rodrigues ◽  
F Damião ◽  
S Fernandes ◽  
A R Gonçalves ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Clinical Outcomes ◽  
Drug Monitoring ◽  
Clinical Remission ◽  
Treatment Protocol ◽  
Surrogate Marker ◽  
Fecal Calprotectin ◽  
Therapeutic Drug ◽  
Monitoring Treatment

Abstract Background Fecal calprotectin (Fc) is an adequate surrogate marker for endoscopic activity in inflammatory bowel disease. The timing of Fc remission may have prognostic implications in patients under biologic therapy. Methods Using a prospectively maintained database we followed 135 patients under a proactive therapeutic drug monitoring (pTDM) protocol aiming at an Infliximab trough level (IFXTL) between 5-10 µg/mL with sequential measurements of Fc. We evaluated the rates of early (at week 14) and late (after week 14) Fc remission (<250 µg/g) and associated clinical outcomes at 2-years of follow up. Results 77 patients (57.0%) reached early Fc remission and 30 patients (22.2%) reached late Fc remission. Patients with late Fc remission presented higher Fc at baseline (1708.5 μg/g [681-3483] vs 803 μg/g [339-1477], P=0.006) and lower IFXTL at week 14 (2.71 µg/mL [1.24-6.30] vs 6.59 µg/mL [3.41-10.63], P=0.001) than patients with early Fc remission. However, by the end of follow-up, IFXTL were similar in both groups: 7.94 µg/mL (4.79-11.25) vs 8.54 µg/mL (6.49-11.07), P=0.514. In patients without early Fc remission, week 14 IFXTL did not differ between those with and without late Fc remission (2.71 µg/mL [1.24-6.30] vs 3.47 µg/mL [0.945-6.94], P=0.957), but significantly increased in late responders by the end of follow-up: 8.54 µg/mL (6.49-11.07) vs 4.37 µg/mL (1.77-7.49), P=0.002. Patients with early and late Fc remission presented similar rates of clinical remission (88.3% vs 83.0%, P=0.493), steroid-free clinical remission (79.1% vs 92.9% P=0.239), lower rates of IFX discontinuation (14.3% vs 16.7%, P=0.756), hospitalization (11.7% vs 13.3%, P=0.815), and surgery (1.3% vs 3.3%, P=0.485). Conclusion The magnitude of Fc at baseline and IFXTL at week 14 significantly influence the timing of Fc remission. The use of PTDM results in similar pharmacokinetics and clinical outcomes in both groups.

scholarly journals P536 Effectiveness, safety and persistence of treatment with ustekinumab in a cohort of patients with moderate-to-severe refractory Crohn’s Disease

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S509-S510
Author(s):  
A I Morales Bermúdez ◽  
A M Bravo Aranda ◽  
M Martinez Burgos ◽  
R Olmedo Martín
Keyword(s):  
Clinical Remission ◽  
Real Life ◽  
Fecal Calprotectin ◽  
University Hospital ◽  
Reactive Protein ◽  
Kaplan Meier ◽  
Regional University ◽  
History Of ◽  
One Year

Abstract Background Ustekinumab has proved its efficacy and safety in moderate-to-severe Crohn′s disease (CD). However, the real practice setting differs from clinical trials. Our aim was to evaluate the effectiveness and safety of ustekinumab in a cohort of real-life practice patients with CD mostly refractory to anti-TNF α agents. Methods Observational retrospective single-center study. All patients undergoing treatment with ustekinumab at the Digestive Diseases Department of the Regional University Hospital of Málaga and at least 16 weeks of follow-up after induction were included. The primary outcome was steroid-free clinical remission (Harvey-Bradshaw Index ≤4) at 24 and 52 weeks. Secondary objectives were combined biological remission (fecal calprotectin levels <250 mcg/g and C-reactive protein <10 mg/dl), safety and persistence of ustekinumab during the follow-up period. Results A total of 89 patients with CD treated with ustekinumab (59,6% women; median disease duration 10 years) were included. The median follow-up was 60 weeks and 55 patients reached one year of follow-up. A 39,3% of the patients had history of previous abdominal surgery and 27% had been treated with 2 or more biologics. A 25,8% and 12,4% of the patients were on steroids and immunosupresants at the induction. The percentages of steroid-free clinical remission at 24 and 52 weeks were 42% and 54% respectively (Figure 1). Combined biological remission at 24 and 52 weeks was achieved in 33% and 45% of the patients respectively. Ustekinumab persistence was 88% at 12 months of follow-up (Figure 2). There were 14 suspensions mainly due to lack of response. Only 13 adverse events were documented in 9 patients (11.5%), none of them serious. Figure 1. Steroid-free clinical and biological remission percentages of ustekinumab at 16,24,52,76 and 104 weeks. Figure 2. Kaplan-Meier curve showing the durability of ustekinumab throughout the follow-up period. Conclusion Ustekinumab was effective and safe in a high proportion of patients with CD that were resistant to conventional immunosuppressant and antitumor necrosis factor drugs in this real-life practice cohort.

Subspinal impingement: clinical outcomes of arthroscopic decompression with one year minimum follow up

2018 ◽  
Vol 28 (9) ◽  
pp. 2756-2762 ◽  
Author(s):  
Frankl Michal ◽  
Eyal Amar ◽  
Ran Atzmon ◽  
Zachary Sharfman ◽  
Barak Haviv ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
One Year

scholarly journals Minimally Invasive Lumbar Spinal Decompression in Elderly Patients with Magnetic Resonance Imaging Morphological Analysis

2018 ◽  
Vol 12 (2) ◽  
pp. 285-293 ◽  
Author(s):  
Seungman Ha ◽  
Youngho Hong ◽  
Seungcheol Lee
Keyword(s):  
Minimally Invasive ◽  
Elderly Patients ◽  
Clinical Outcomes ◽  
Spinal Stenosis ◽  
Clinical Symptoms ◽  
Morphological Features ◽  
Radiological Parameters ◽  
Significant Difference ◽  
Lumbar Spinal

<sec><title>Study Design</title><p>Case-control study.</p></sec><sec><title>Purpose</title><p>In this study, we aimed to investigate clinical outcomes and morphological features in elderly patients with lumbar spinal stenosis (LSS) who were treated by minimally invasive surgery (MIS) unilateral laminectomy for bilateral decompression (ULBD) using a tubular retractor.</p></sec><sec><title>Overview of Literature</title><p>Numerous methods using imaging have been attempted to describe the severity of spinal stenosis. But the relationship between clinical symptoms and radiological features remains debatable.</p></sec><sec><title>Objective</title><p>In this study, we aimed to investigate clinical outcomes and morphological features in elderly patients with LSS who were treated by MIS-ULBD.</p></sec><sec><title>Methods</title><p>We methodically assessed 85 consecutive patients aged &gt;65 years who were treated for LSS. The patients were retrospectively analyzed in two age groups: 66–75 years (group 1) and &gt;75 years (group 2). Clinical outcomes were assessed using the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and the modified MacNab criteria. Outcome parameters were compared between the groups at the 1-year follow-up. Core radiologic parameters for central and lateral stenosis were analyzed and clinical findings of the groups were compared.</p></sec><sec><title>Results</title><p>At the 1-year follow-up, patients in both groups 1 and 2 demonstrated significant improvement in their VAS and ODI scores. All clinical outcomes, except postoperative ODI, were not significantly difference between the groups. In addition, no significant difference was noted in the preoperative radiological parameters between the groups. There was no statistically significant correlation between radiological parameters and clinical symptoms or their outcomes. Moreover, no differences were noted in perioperative adverse events and in the need for repeat surgery at follow-ups between the groups.</p></sec><sec><title>Conclusions</title><p>MIS-ULBD by tubular approach is a safe and effective treatment option for elderly patients with LSS. Clinical outcomes in patients with LSS and aged &gt;75 years were comparable with those in patients with LSS and aged 66–75 years. Moreover, we did not find any correlation between radiological parameters and clinical outcomes in either of the two patient groups.</p></sec>

scholarly journals A Canadian Study toward Changing Local Practice in the Diagnosis of Pediatric Celiac Disease

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Seema Rajani ◽  
Hien Q. Huynh ◽  
Leanne Shirton ◽  
Cheryl Kluthe ◽  
Donald Spady ◽  
...  
Keyword(s):  
Celiac Disease ◽  
Fractional Excretion ◽  
Fecal Calprotectin ◽  
Mucosal Inflammation ◽  
Diagnostic Strategy ◽  
Mucosal Disease ◽  
One Year ◽  
Hla Haplotypes ◽  
Gastrointestinal Permeability

Background. The European Society for Pediatric Gastroenterology, Hepatology and Nutrition endorses serological diagnosis (SD) for pediatric celiac disease (CD). The objective of this study was to pilot SD and to prospectively evaluate gastrointestinal permeability and mucosal inflammation at diagnosis and after one year on the gluten-free diet (GFD). We hypothesized that SD would be associated with similar short term outcomes as ED.Method. Children, 3–17 years of age, referred for possible CD were eligible for SD given aTTG level ≥200 U/mL, confirmed by repeat aTTG and HLA haplotypes. Gastrointestinal permeability, assessed using sugar probes, and inflammation, assessed using fecal calprotectin (FC), at baseline and after one year on a GFD were compared to patients who had ED.Results. Enrolled SD (n=40) and ED (n=48) patients had similar demographics. ED and SD groups were not different in baseline lactulose: mannitol ratio (L : M) (0.049 versus 0.034;p=0.07), fractional excretion of sucrose (%FES; 0.086 versus 0.092;p=0.44), or fecal calprotectin (FC; 89.6 versus 51.4;p=0.05). At follow-up, urine permeability improved and was similar between groups, L : M (0.022 versus 0.025;p=0.55) and %FES (0.040 versus 0.047;p=0.87) (p>0.05). FC improved but remained higher in the SD group (37.1 versus 15.9;p=0.04).Conclusion. Patients on the GFD showed improved intestinal permeability and mucosal inflammation regardless of diagnostic strategy. This prospective study supports that children diagnosed by SD have resolving mucosal disease early after commencing a GFD.

scholarly journals P360 Safety and clinical efficacy of double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicentre study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S342-S342
Author(s):  
S Mazza ◽  
A Fascì ◽  
V Casini ◽  
C Ricci ◽  
F Munari ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Inflammatory Bowel Diseases ◽  
Clinical Remission ◽  
Comparable Efficacy ◽  
Potential Cost ◽  
Safety And Efficacy ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Double Switch

Abstract Background Since infliximab (IFX) patent expiry in 2015, several IFX biosimilars have been licensed in EU for all indications, including inflammatory bowel diseases (IBD). IFX biosimilars currently available in Italy include CT-P13 and SB2, both of which demonstrated comparable efficacy, safety and immunogenicity with IFX originator in IBD patients. Safety and clinical efficacy of single switch from originator IFX to CT-P13 have also been confirmed in a prospective clinical trial. On the contrary, data regarding multiple therapeutic switching of IFX originator with CT-P13 and SB2 are currently lacking. Methods This study was aimed to evaluate the safety and efficacy of double switch from IFX originator to CT-P13 and subsequently to SB2 in patients with IBD. From November 2018 to May 2019, patients undergoing IFX double switch in 8 Centres in Lombardy were retrospectively analysed. The overall rate of IFX discontinuation, incidence and type of adverse events (AE) and proportion of patients on clinical remission over time were recorded. Data were compared with a control group of 66 IBD patients single switched from IFX originator to CT-P13. Results Fifty-two double-switched IBD patients were enrolled (63% M, mean age 41 years, 75% Crohn’s disease, 25% ulcerative colitis). Main indications for IFX therapy were moderate to severe disease (50%) and steroid-dependent disease (25%). The overall 24- and 48-week IFX discontinuation rates following second switch (CTP13-&gt;SB2) were 2% (95% CI 0–6%) and 14% (95% CI 3–25%), respectively. During a median follow-up of 40 weeks (18–48), 4 patients (12%) experienced a total of 6 AE (2 cutaneous, 2 infectious, 1 articular and 1 immunological), leading to IFX discontinuation in 3 cases (6%). No infusion reactions were observed. At week 24 following second switch, 49 (94%) patients were in clinical remission, the remaining 3 patients not being in remission already at the time of second switch. Only one patient lost response after week 24, 48 (92%) of patients being in clinical remission at the end of follow-up. No differences in IFX discontinuation, AE and clinical remission rates were found between double-switched and single-switched patients. No clinical parameters were found to predict safety and efficacy outcomes. Conclusion The study supports both safety and efficacy of the double switch from IFX originator to CT-P13 and SB2 in patients with IBD, and demonstrates its non-inferiority to a single switch strategy, with potential cost implications.

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