scholarly journals Granulocyte-Monocyte Apheresis in Steroid-Dependent, Azathioprine-Intolerant/Resistant Moderate Ulcerative Colitis: A Prospective Multicenter Study

2017 ◽  
Vol 2017 ◽  
pp. 1-5
Author(s):  
Gianni Imperiali ◽  
Arnaldo Amato ◽  
Maria Maddalena Terpin ◽  
Ivo Beverina ◽  
Aurora Bortoli ◽  
...  

Background. Granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative colitis, although it is limited by costs and variability of results. Aim. To assess effectiveness of granulocyte-monocyte apheresis in patients with steroid-dependent, azathioprine-intolerant/resistant moderate ulcerative colitis. Methods. Consecutive patients fulfilling inclusion criteria were prospectively enrolled, treated by apheresis, and followed up for 12 months. The primary end point of the study was steroid-free clinical remission at 12 months, with no need for biologic therapy or surgery. Results. From January to December 2013, 33 patients were enrolled. After one year of follow-up, 12 (36%) patients had clinical remission, were steroid-free, and had no need for biological therapy or surgery; 3 (9%) cases showed a clinical response (but not clinical remission). Moreover, 12 (36%) patients required biologic therapy, 4 (12%) underwent colectomy, and in the other 2 (6%) a reduction, but not withdrawal, of steroid dose was achieved. Conclusions. Our study shows that a standard course of granulocyte-monocyte apheresis is associated with a 36% steroid-free clinical remission in patients with steroid-dependent, azathioprine-intolerant or resistant moderate ulcerative colitis. Apheresis might represent an alternative to biologic therapy or surgery in this specific subgroup of patients. This trial is registered with Clinicaltrial.gov NCT03189888.

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S539-S539
Author(s):  
M Sina ◽  
E Pengili ◽  
X Pemaj ◽  
D Osmanaj ◽  
I Bibolli ◽  
...  

Abstract Background Corticosteroids are indicated for induction of remission in moderate to severe ulcerative colitis (UC) patients. However, due to their adverse effects associated with long-term use, steroids are not indicated as a maintenance therapy. The aim of this study was to assess the steroid sparing effect of adalimumab (ADA) in steroid-dependent UC patients. Methods This is a prospective study carried out at a tertiary hospital center in Albania from 2016–2020, including consecutive moderate-to-severe UC patients. All patients received biologic therapy with subcutaneous ADA 160/80mg at weeks 0/2 followed by 40mg every 2 weeks. We evaluated the steroid-sparing effect of ADA measuring the number of steroid–free patients and the average steroid dose at baseline before initiating biologic treatment and at week 8, 24, 52, 104, 156. Clinical remission was defined as total Mayo score ≤ 2 points. Results We enrolled 26 UC patients, mean age 47.3 ± 16.1 (24–85) years, 55.6% were females. The average disease duration before starting ADA was 7.3 ± 7.0 years (range 1–33); 44.4% had pancolitis and 55.6% left side colitis. 8(29.6%) patients were on combination therapy with azathioprine. 17/26 (65.4%) patients were taking prednisone at the time of the first ADA injection with an average dose of 17.7mg. The number of steroid-free patients at week 8, 24, 52, 104 and 156 was 12/26 (46.2%), 16/26 (61.5%), 15/21 (71.4%), 11/14 (78.6%), 8/9 (88.9%) respectively. At the end of the follow-up (week 156), the proportion of steroid free patient was significantly higher than at baseline [88.9% (8/9) vs 34.6% (7/26), p=0.005]. The reduction of the average dose of prednisone (8.8 mg, 4 mg, 6.8mg, 3.8mg and 3,8mg at week 8, 24, 52, 104 and 156 respectively), was also statistically significant (p<0.01). Clinical remission rates were 7.7% (2/26) at week 8, 47.6% (10/21) at week 52, 42.9% (6/14) at week 104 and 44.4 % (4/9) at week 156. Conclusion In our cohort, ADA administration to moderate–to severe UC significantly reduced the steroid dose and the proportion of patients taking cortisone during 3 years follow-up.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S325-S326
Author(s):  
J W Y Mak ◽  
N T K Yuen ◽  
T C F Yip ◽  
R H M Lam ◽  
B K H Lam ◽  
...  

Abstract Background 5-aminosalicylic acid (ASA) has been the mainstay of treatment for ulcerative colitis (UC). However, it is unclear whether the medication can be stopped in patients with stable disease. We aimed to examine whether 5-ASA can be safely withdrawn in UC patients who have been in steroid-free clinical remission for at least 1 year. Methods This is a retrospective cohort study using a territory-wide healthcare database in Hong Kong. Primary outcome was development of UC flare defined as a composite of new corticosteroid use, UC-related hospitalization or surgery within 5 years after stopping-5ASA. UC patients who were on oral 5-ASA ≥ 2grams daily for at least 1 year, who had C-reactive protein <1mg/dL and no escalation of 5-ASA dosage, no UC-related hospitalization and no use of corticosteroid in the past 1 year were included. UC patients who were on biologics were excluded. Patients were classified as stopping 5-ASA if 5-ASA had ever been withdrawn for at least 90 days within the follow-up period. We performed multivariable Cox regression models adjusting for demographics, blood parameters and immunosuppressants used. Adjusted hazard ratio (aHR) with 95% confidence interval (CI) was reported comparing groups stopping 5-ASA and those continuing 5-ASA. Results A total of 1408 patients with UC were included with a median follow-up duration of 41.8 months [Interquartile range (IQR): 17.2-60 months)]. Stopping 5-ASA was not associated with an increased risk of UC flare (aHR 0.99, 95% CI 0.76-1.30, p=0.722). Higher haemoglobin level at baseline was protective against flare (aHR 0.91, 95% CI 0.85-0.97, p=0.03), while higher CRP level at baseline was associated with an increased risk of flare (aHR 1.06, 95% CI 1.03-1.09, p<0.001). Results were similar in sensitivity analysis investigating stopping 5-ASA for ≥ 180 days which showed no difference in risk of flare comparing groups continuing and stopping 5-ASA (aHR 1.02, 95%CI 0.71-1.48,p=0.912). There were no differences in the risk of requiring colectomy (HR: 2.23, 95% CI 0.67-7.49, p=0.193) or development of colorectal cancer (HR: 0.76, 95% CI 0.22-2.65, p=0.671) in patients who stopped 5-ASA and those who continued 5-ASA. Conclusion Stopping 5-ASA in patients with UC who have been in clinical remission for over one year was not associated with increased risk of flare. These results should be validated in prospective randomized controlled trial.


2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S72-S72
Author(s):  
Ahmed Elmoursi ◽  
Courtney Perry ◽  
Terrence Barrett

Abstract Background Stricturing Crohn’s disease (CD) constitutes a severe phenotype often associated with a high degree of morbidity (3). Surgical resection is first-line therapy for symptomatic strictures, but most patients relapse without subsequent medical therapy (4–5). Biologics are the mainstay for inducing and maintaining remission, but some cases are refractory despite maximum dosage of therapy. Reports of dual biological therapy (DBT) in refractory, stricturing CD are sparse, and prior case reports document only clinical remission (1). To contribute further knowledge regarding the use of DBT in stricturing CD, we present the case of a refractory CD patient who achieved deep remission with ustekinumab and vedolizumab. Case Presentation A 35 year old non-smoking, Caucasian male was referred to our clinic in 2014 for refractory CD complicated by multiple strictures. Prior to establishing care with us, he received two jejunal resections and a sigmoid resection. Previously failed therapies included azathioprine with infliximab, adalimumab, and certolizumab. He continued to progress under our care despite combination methotrexate/certolizumab, as well as methotrexate/golimumab. He underwent proctocolectomy with end ileostomy in 2015 and initiated vedolizumab q8weeks post-operatively. He reoccurred in 2018, when he presented with an ulcerated ileal stricture. He was switched from vedolizumab to ustekinumab q8weeks and placed on prednisone, but continued to progress, developing significant hematochezia requiring hospitalization and blood transfusions. Ileoscopy performed during hospital admission confirmed severe, ulcerating disease in the ileum with stricture. Ustekinumab dosing was increased to q4weeks, azathioprine was initiated, and he underwent stricturoplasty. Follow-up ileoscopy three months later revealed two ulcers in the neo- TI (Figure 1). Vedolizumab q8weeks was initiated in addition to ustekinumab q4weeks and azathioprine 125mg. After four months on this regimen the patient felt better, but follow-up ileoscopy showed two persistent ulcers in the neo-TI. Vedolizumab dosing interval was increased to q4weeks. After four months, subsequent ileoscopy demonstrated normal neo-TI (Figure 2). Histologic evaluation of biopsies confirmed deep remission of crohn’s disease. No adverse side effects have occurred with maximum doses of both ustekinumab and vedolizumab combination therapy. Discussion This case supports both the safety and efficacy of ustekinumab and vedolizumab dual biologic therapy for treatment of severe, refractory Crohn’s disease. While there are reports of DBT inducing clinical remission, this case supports efficacy for vedolizumab and ustekinumab combination therapy to induce deep histologic remission. Large practical clinical trials are needed to better investigate the safety and efficacy of DBT with vedolizumab and ustekinumab, but our case suggests this combination may be a safe and efficacious therapy for refractory CD patients.


2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
J W H Koh ◽  
C H Ng ◽  
M H Lee ◽  
Y H Chin ◽  
Z H Ong ◽  
...  

Abstract Introduction Biologics are recommended by both the ACG and ECCO community for the treatment of ulcerative colitis. Yet, current literature has yet to estimate the rate of colectomies after biologic therapy, and thus a pooled meta-analysis was conducted the rate of colectomies in 1month, 6 months, 1 year, 2years and five years after biologics. Method Medline and Embase were searched for articles examining biologics use in moderate to severe UC or acute severe UC (ASUC) from inception to 21st May 2020. Analysis of proportions were undertaken after a freeman-tukey double arcsine transformation. Results The pooled overall colectomy rates of ASUC and moderate to severe UC were 9% (CI: 4% - 14%) at one month, 18% (CI: 13% - 25%) at six months, 21% (CI:16% - 27%) at one year, 29% (CI:24% - 34%) at two years and 38% (CI:30% - 45%) at five years. Additionally, colectomy rates were consistently lower comparing between articles before and after 2010. At one-year, overall colectomy rate following infliximab use was at 25%, golimumab at 15%, vedolizumab at 14%, and adalimumab at 3%. Conclusions Colectomy rates in the era of biologics ranged from 8% to 38% and lower post-2010 showing significant improvement in management and supporting the utility of biologics in Ulcerative colitis management.


2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S50-S51
Author(s):  
Randi Opheim ◽  
Kristian Moum ◽  
Bjørn Moum

Abstract Background Patients with inflammatory bowel diseases (IBD) have experienced changes to the routine management of their conditions during the coronavirus disease (COVID-19) pandemic. The disease as well IBD treatment frequently require immunosuppressant medications, which could increase their risk of infection. The aim of this study was to determine patients’ experience of the health care service, including the restrictions of hospitals visits made in Norway from Mars 12th 2020. Method From June 18 to September 18 2020, all patients at the IBD outpatient clinic at Oslo University Hospital in Norway on biological therapy or other immunosuppressant’s were included. A questionnaire including patients concerns regarding their disease, medical therapy and COVID-19, as well as their health care service needs in follow-up during the COVID-19 pandemic. Results Altogether 506 IBD patients answered a paper-based questionnaire. The mean age was 40.78 (SD 14.71), 289/506 (57%) men, ulcerative colitis 199/506 (39%), Crohn’s disease 307/506 (61%). Sixty-three patients (12.5%) used biological therapy in combination with azathioprine or steroids. Ninety-one (18.2%) were in obligated quarantine with negative test. Five patients (4.9%) tested positive to SARS- CoV-2 of the 98 patients tested, (1.0% of the total sample). One third of the IBD patients perceived they had increased risk for being infected by SARS- CoV-2 because of the immunosuppressive drugs they used. Nonetheless, 496/506 (98.6%) of the patients adhered to continuing their medication. One-hundred and sixty-one (32.3%) voluntarily isolated, and 21/506 (4.2%) was in sick leave being afraid of being infected. Furthermore, 20/506 (4.0%) cancelled their consultation because they were afraid of being infected from SARS- CoV-2 at the hospital. The hospital changed physical consultation to telephone consultation for 75/506 (15.0%) of the patients. Thirty-eight patients (7.6%) reported that they were afraid of going to the hospital because of restrictions due to the COVID-19 pandemic, and 18/506 (3.6%) did not feel safe when at hospital. Approximately half of the IBD patients (219/506) were satisfied with the information provided by physician about medical treatment for IBD and Covid-19 while 398/506 (77.3%) were satisfied with the information from health-care providers about restrictions due to COVID-19. There were no statistical differences between Crohn’s disease and ulcerative colitis. Conclusion IBD patients on biological treatment and immunosuppressives took precautions because of fear of being infected with SARS- CoV-2. At the same time, they adhere to medical treatment regimens and follow-up at the hospital. Most patients were satisfied with the information they received from physicians and other health-care workers. One percent tested positive to SARS-CoV-2.


2019 ◽  
Vol 91 (8) ◽  
pp. 41-46
Author(s):  
O V Knyazev ◽  
T V Shkurko ◽  
A V Kagramanova ◽  
A A Lishchinskaya ◽  
M Yu Zvyaglova ◽  
...  

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.


2014 ◽  
Vol 8 ◽  
pp. S198-S199
Author(s):  
T. Molnar ◽  
A. Bálint ◽  
T. Nyári ◽  
K. Farkas ◽  
R. Bor ◽  
...  

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Khalid Hamid Changal ◽  
Mubbasher Ameer Syed ◽  
Tawseef Dar ◽  
Muhammad Asif Mangi ◽  
Mujeeb Abdul Sheikh

Introduction. Common femoral endarterectomy (CFE) has been the therapy of choice for common femoral artery atherosclerotic disease (CFA-ASD). In the past, there was inhibition to treat CFA-ASD endovascularly with stents due to fear of stent fracture and compromise of future vascular access site. However, recent advances and new evidence suggest that CFA may no longer be a ‘stent-forbidden zone’. In the light of new evidence, we conducted a meta-analysis to determine the use of endovascular treatment for CFA-ASD and compare it with common femoral endarterectomy in the present era.Methods. Using certain MeSH terms we searched multiple databases for studies done on endovascular and surgical treatment of CFA-ASD in the last two decades. Inclusion criteria were randomized control trials, observational, prospective, or retrospective studies evaluating an endovascular treatment or CFE for CFA-ASD. For comparison, studies were grouped based on the treatment strategy used for CFA-ASD: endovascular treatment with selective stenting (EVT-SS), endovascular treatment with routine stenting (EVT-RS), or common femoral endarterectomy (CFE). Primary patency (PP), target lesion revascularization (TLR), and complications were the outcomes studied. We did proportional meta-analysis using a random-effect model due to heterogeneity among the included studies. If confidence intervals of two results do not overlap, then statistical significance is determined.Results. Twenty-eight studies met inclusion criteria (7 for EVT-RS, 8 for EVT-SS, and 13 for CFE). Total limbs involved were 2914 (306 in EVT-RS, 678 in EVT-SS, and 1930 in CFE). The pooled PP at 1 year was 84% (95% CI 75-92%) for EVT-RS, 78% (95% CI 69-85%) for EVT-SS, and 93% (95% CI 90-96%) for CFE. PP at maximum follow-up in EVT-RS was 83.7% (95% CI 74-91%) and in CFE group was 88.3% (95% CI 81-94%). The pooled target lesion revascularization (TLR) rate at one year was 8% (95% CI 4-13%) for EVT-RS, 19% (95% CI 14-23%) for EVT-SS, and 4.5% (95% CI 1-9%) for CFE. The pooled rate of local complications for EVT-RS was 5% (95% CI 2-10%), for EVT-SS was 7% (95% CI 3 to 12%), and CFE was 22% (95% CI 14-32%). Mortality at maximum follow-up in CFE group was 23.1% (95% CI 14-33%) and EVT-RS was 5.3% (95% CI 1-11%).Conclusion. EVT-RS has comparable one-year PP and TLR as CFE. CFE showed an advantage over EVT-SS for one-year PP. The complication rate is lower in EVT RS and EVT SS compared to CFE. At maximum follow-up, CFE and EVT-RS have similar PP but CFE has a higher mortality. These findings support EVT-RS as a management alternative for CFA-ASD.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S383-S384
Author(s):  
E Dubois ◽  
A Moens ◽  
J Sabino ◽  
M Ferrante ◽  
S Vermeire

Abstract Background Data about long-term prognostic and therapeutic outcome of patients with ulcerative proctitis (UP) are scarce. Real-world data are very important as these patients are usually excluded from participation in randomised controlled clinical trials. Methods All patients diagnosed with ulcerative colitis limited to the rectum (further defined as UP) and followed at our referral centre between 1998 and 2018, were identified via an automated search of electronic medical records and were reviewed for long-term therapeutic outcome. Treatment success was defined as clinical remission (complete disappearance of UP-related symptoms as judged by the treating physician) and endoscopic inactive disease (Mayo endoscopic sub-score of 0 or 1 on sigmoidoscopy) if available at last follow-up. Results From a total of 1561 patients with ulcerative colitis (UC), 168 patients with UP were identified (54% female, mean age at diagnosis 36 years). While the majority (118 patients or 70%) had proctitis since diagnosis, another 50/168 (30%) were diagnosed with left-sided colitis or extensive colitis but had a predominant disease course of proctitis afterwards. Nearly, all patients received treatment with 5-ASA but 71 patients (42%) were refractory to rectal ± oral therapy with 5-ASA and corticosteroids necessitating azathioprine in 41 patients (24%) and/or biological therapies in 59 patients (35%). Azathioprine was started as monotherapy in 34 patients. Anti-TNF was the first-line biological in 45 and vedolizumab in 14 patients. After a median follow-up of 76.5 months (IQR 34.3–143.8), clinical remission was observed in 143 patients (85%) and in 52/71 patients with 5-ASA refractory proctitis (73%). In this last group, clinical remission rates were significantly higher for patients treated with biologicals (44/59 or 75%) as compared with patients treated with azathioprine (8/34 or 24%; p < 0.0001). Conclusion Ten per cent of patients with ulcerative colitis from our referral centre cohort had disease confined to the rectum. With a median follow-up of more than 6 years, good clinical outcomes were recorded with 85% of patients achieving clinical remission. Nevertheless, more than one third needed escalation to biologicals to control the proctitis. Long-term outcome in patients on biologicals was superior to azathioprine. Our data do not suggest inferior outcomes for patients with proctitis compared with left-sided or extensive colitis.


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