scholarly journals P343 Efficacy of adalimumab in mild-to-moderate inflammatory bowel disease: Real-life data from single-centre experience in the long-term period

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S329-S330
Author(s):  
F Akyüz ◽  
A Ormeci ◽  
N Namazova ◽  
M Guzel ◽  
A Abbasgoulizadeh ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Response Rate ◽  
Real Life ◽  
Loss Of Response ◽  
Endoscopic Remission ◽  
Inflammatory Bowel

Abstract Background Adalimumab (ADA) is one of the most preferred anti-TNF agents because of its ease of use in real life. We aimed to evaluate the efficacy of ADA in the long-term period of inflammatory bowel disease (IBD) patients. Methods Patients treated with adalimumab (ADA) as the first- and second-line biological treatment for mild to moderate active IBD between January 2009 and March 2019 were included. The clinical and endoscopic response rate of ADA were evaluated, retrospectively. Remission was defined in ulcerative colitis patients (UC), if stool frequency ≤ 3/day with no bleeding and no mucosal lesions at the colonoscopy. Remission was defined in Crohn’s disease patients (CD) if CDAI < 150 and mucosal healing at the colonoscopy. Results Fifty-eight patients (81% Crohn’s disease, 58.6% biologic naive) were included in this study. Mean age was 41.4 ± 12.3 years old (19–67 years) and 46.6% of them were female. Median follow-up time was 57 months in UC and 65 months in Crohn’s disease (CD). Infliximab experience rate before ADA in UC and CD was 36.4%, 42.6%, respectively. CD’s related surgery rate was 43.5%; surgery rate 87.5% before ADA therapy and 12.5% after ADA treatment. Clinical and endoscopic remission rates were 81.8% / 63.6% and 89.4%/ 63.4 in UC and CD, respectively at the end of follow-up period. Loss of response rate was 20% in UC and 28.3% in CD (table). Mean months for loss of response were 42 ± 25.4 months and 29.7 ± 12 months in UC and CD, respectively. Clinical remission was obtained by dose escalation in 66% of CD patients who had response loss. Loss of response rate was not significantly different between IFX naive and IFX experienced patients (p > 0.05). There was no significant adverse event during the follow-up period. Conclusion In real life, the efficacy of ADA treatment is high in mild-to-moderate active IBD. Endoscopic remission was also acceptable for this group of patients.

scholarly journals Long-term follow up after switching from original infliximab to an infliximab biosimilar: real-world data

2019 ◽  
Vol 12 ◽  
pp. 175628481985805 ◽  
Author(s):  
María Fernanda Guerra Veloz ◽  
María Belvis Jiménez ◽  
Teresa Valdes Delgado ◽  
Luisa Castro Laria ◽  
Belén Maldonado Pérez ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Events ◽  
Reactive Protein ◽  
Loss Of Response ◽  
Mayo Score ◽  
Inflammatory Bowel

Background: Several studies have reported positive efficacy outcomes for patients with inflammatory bowel disease treated with CT-P13, an infliximab biosimilar. Data from follow-up periods longer than 1 year are still scarce. Here, we assessed the long-term efficacy data, loss of response and safety after switching from infliximab to CT-P13 in patients with inflammatory bowel disease. Methods: This was a prospective single-center observational study involving patients with moderate-to-severe Crohn’s disease and ulcerative colitis switched from infliximab to CT-P13 treatment and reviewed up to 24 months. Efficacy and loss of response were measured using the Harvey–Bradshaw (HB) index and partial Mayo score for patients with Crohn’s disease and ulcerative colitis respectively. C-reactive protein, infliximab drug levels, adverse events and antidrug antibodies were also monitored throughout the study. Results: A total of 64 patients with Crohn’s disease and 36 patients with ulcerative colitis were included. Most of them (72%) remained on CT-P13. Overall, 28% of patients discontinued the therapy due to loss of response, adverse events or long-lasting clinical remission. Remission at 18 and 24 months occurred in 69.9% and 68.5% of patients, respectively. Dose increase was performed in 22% of patients, with remission being reached in 60% of them. HB index, partial Mayo score, C-reactive protein and infliximab drug levels did not show significant changes. Serious adverse events were reported in 14% of patients. Overall, two patients developed low levels of antidrug antibodies. Conclusions: Most of the patients switching from original infliximab were maintained on CT-P13 at 2 years of follow up with a good profile of efficacy and safety.

scholarly journals Management of Crohn’s disease in an immunosuppressed COVID-19-positive patient: safety-driven prioritisation of nutritional therapy as a bridge to restarting immunosuppression

2021 ◽  
Vol 14 (3) ◽  
pp. e239404
Author(s):  
Clare Harris ◽  
Richard James Harris ◽  
Louise Downey ◽  
Markus Gwiggner
Keyword(s):  
Risk Factors ◽  
Inflammatory Bowel Disease ◽  
Patient Safety ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Nutritional Therapy ◽  
Interleukin 12 ◽  
Inflammatory Bowel ◽  
Term Maintenance

Active inflammatory bowel disease (IBD), combined immunosuppression and corticosteroid therapy have all been identified as risk factors for a poor outcome in COVID-19 infection. The management of patients with both COVID-19 infection and active IBD is therefore complex. We present the case of a 31-year-old patient with Crohn’s disease, on dual immunosuppression with infliximab and mercaptopurine presenting with inflammatory small bowel obstruction and COVID-19 infection. The case highlights the use of nutritional therapy, which remains underused in the management of adults with IBD, to manage his flare acutely. Following negative SARS-CoV-2 PCR testing and SARS-CoV-2 IgG testing confirming an antibody response, ustekinumab (anti-interleukin 12/23) was prescribed for long-term maintenance.

The Incidence of Deep Venous Thrombosis and Pulmonary Embolism among Patients with Inflammatory Bowel Disease: A Population-based Cohort Study

2001 ◽  
Vol 85 (03) ◽  
pp. 430-434 ◽  
Author(s):  
James Blanchard ◽  
Donald Houston ◽  
Andre Wajda ◽  
Charles Bernstein
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Pulmonary Embolism ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Population Based ◽  
Incidence Rates ◽  
Increased Risk ◽  
Inflammatory Bowel

Summary Background: There is an impression mostly from specialty clinics that patients with inflammatory bowel disease (IBD) have an increased risk of venous thromboembolic disorders. Our aim was to determine the incidence of deep venous thrombosis (DVT) and pulmonary embolism (PE) from a population-based database of IBD patients and, to compare the incidence rates to that of an age, gender and geographically matched population control group. Methods: IBD patients identified from the administrative claims data of the universal provincial insurance plan of Manitoba were matched 1:10 to randomly selected members of the general population without IBD by year, age, gender, and postal area of residence using Manitoba Health’s population registry. The incidence of hospitalization for DVT and PE was calculated from hospital discharge abstracts using ICD-9-CM codes 451.1, 453.x for DVT and 415.1x for PE. Rates were calculated based on person-years of follow-up for 1984-1997. Comparisons to the population cohort yielded age-adjusted incidence rate ratios (IRR). Rates were calculated based on person-years of follow-up (Crohn’s disease = 21,340, ulcerative colitis = 19,665) for 1984-1997. Results: In Crohn’s disease the incidence rate of DVT was 31.4/10,000 person-years and of PE was 10.3/10,000 person-years. In ulcerative colitis the incidence rates were 30.0/10,000 person-years for DVT and 19.8/10,000 person-years for PE. The IRR was 4.7 (95% CI, 3.5-6.3) for DVT and 2.9 (1.8-4.7) for PE in Crohn’s disease and 2.8 (2.1-3.7) for DVT and 3.6 (2.5-5.2) for PE, in ulcerative colitis. There were no gender differences for IRR. The highest rates of DVT and PE were seen among patients over 60 years old; however the highest IRR for these events were among patients less than 40 years. Conclusion: IBD patients have a threefold increased risk of developing DVT or PE.

Perianal Abscesses in Infants Are Not Associated With Crohn’s Disease in a Surgical Cohort

2019 ◽  
Vol 14 (6) ◽  
pp. 773-777
Author(s):  
Mariëlle Roskam ◽  
Tim de Meij ◽  
Reinoud Gemke ◽  
Roel Bakx
Keyword(s):  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Bowel Disease ◽  
Disease Risk ◽  
Age Of Onset ◽  
Faecal Calprotectin ◽  
Young Infants ◽  
Inflammatory Bowel

Abstract Aims The aim of this study is to search for an association between infantile perianal abscesses and [development of] Crohn’s disease in a surgical population of children. Methods Patients who were surgically treated in the Amsterdam UMC between January 2000 and December 2014 were included in this retrospective cohort study. Data collected include: sex, date of birth, underlying conditions, age of onset, additional symptoms, pus cultures, endoscopic examination, histological examination, magnetic resonance imaging, faecal calprotectin levels, antibiotic treatment, surgical treatment strategy, and number of recurrences. Follow-up data were gathered from medical records and by contacting the patients and/or parents or the general practitioner. Results The study consisted of 62 patients of whom 60 were boys. Median age was 5 months [range 0–17 months]; 92% were under 1 year of age at diagnosis. A minority of patients had accompanying symptoms. In total, 72 abscesses were treated, 19 fistulas and 23 abscesses with fistula-in-ano. Follow-up data of 46 patients [74%] were available; none of the patients developed Crohn’s disease. Conclusions We found no association between isolated perianal abscesses as presenting symptom in early childhood and [development of] Crohn's disease. In young infants with isolated perianal disease, risk for inflammatory bowel disease seems low. In this specific population there seems no place for routine performance of endoscopic investigations. One should always take the risk of very-early-onset inflammatory bowel disease into account. Further research with a larger cohort of children and a longer follow-up time is required.

scholarly journals P417 Long-term deep remission after adalimumab discontinuation in Crohn’s disease patients

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S423-S423
Author(s):  
L Melotti ◽  
F Rizzello ◽  
C Calabrese ◽  
N Dussias ◽  
P Gionchetti
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Mucosal Healing ◽  
Treatment Withdrawal ◽  
Biologic Agent ◽  
Drug Discontinuation ◽  
Endoscopic Remission ◽  
Observational Cohort

Abstract Background Adalimumab is a safe and effective drug in treatment of Crohn’s Disease (CD). Current literature is not definitive regarding an exact timing for treatment withdrawal and disease relapses after drug discontinuation. Methods We conducted a single-centre, retrospective, observational cohort study involving patients affected by Crohn’s Disease (CD) treated with adalimumab. Of 575 patients treated with adalimumab for CD, 149 patients suspended treatment for stable deep remission (clinical steroid-free, biochemical, endoscopic remission defined as mucosal healing). Of these, 126 have a minimum follow up of 4 years, the other 23 where lost or finished the follow-up. Patients were assessed clinically, laboratoristically and endoscopically for 4 years. Relapse was defined as clinical (HBI > 4) and biochemical (PCR > 0.5 mg/dL). Results Of the 126 patients with 4 years follow-up, 64 (51%) maintained deep remission during the 4 year follow-up period. Of these, 38 (59%) were on exit-therapy with thiopurines. Twenty-seven patients (18%) had relapsed by year 1, 24 (18%) by year 2, 8 (6%) by year 3, and 1 (0.8%) by year 4. Relapses needed surgical therapy in 9 (15%) cases, whereas 36 (60%) were retreated with adalimumab and 4 (7%) with another biologic agent. The remaining 11 patients (18%) were treated only with a course of steroids. Conclusion Patients who suspend treatment with adalimumab for stable deep remission maintain remission in the long term in approximately half of cases. The majority of relapses occur in the first 24 months after discontinuation.

scholarly journals P533 Adalimumab 80mg every other week in inflammatory bowel disease: Treatment intensification outcomes in real life clinical practice

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S507-S509
Author(s):  
M I Calvo Moya ◽  
I Omella Usieto ◽  
I El Hajra Martinez ◽  
E Santos Perez ◽  
Y Gonzalez Lama ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Practice ◽  
Bowel Disease ◽  
Smoking Habit ◽  
Real Life ◽  
Fecal Calprotectin ◽  
Treatment Intensification ◽  
Loss Of Response ◽  
Inflammatory Bowel

Abstract Background Adalimumab (ADA) intensification is recommended for inadequate or loss of response in inflammatory bowel disease (IBD) patients. A new presentation of ADA 80mg administered every other week (eow) has been approved as an alternative to ADA 40mg every week (ew). Data regarding impact of ADA 80mg eow in clinical practice is still scarce. The aim of this study was to assess long-term durability, safety and cost-effectiveness of treatment with ADA 80mg eow in patients with IBD. Methods A retrospective cohort study in a tertiary hospital that included all IBD patients under intensified maintenance therapy with ADA 80mg eow was performed. Durability was calculated considering the time from the first dose to treatment withdrawn or to the end of follow-up. Biological remission (BR) was defined as CR together with fecal calprotectin (FC) <250µg/g and C-reactive protein (CRP) <5mg/dl. Economic impact of ADA 80mg eow was estimated considering current price of both ADA 40mg and ADA 80mg pens at our centre. Results Sixty-three patients (52 CD and 11 CU) were included; median age 47 (IQR 39–59), 54% male; median duration of the disease before ADA of 11 years (IQR 6–20); 30% were active smokers. Among CD patients, 56% had ileal disease, 17% colonic and 27% ileocolonic. The inflammatory behavior was the most frequent (52%) and 31% had perianal disease. In UC, 55% had extensive colitis. 44 patients (70%) were bio-naïve and 36 (57%) received immunosuppressants at baseline. At the time of escalation, 48 patients (76%) were symptomatic. After intensification, 52 (83%) patients (CD 42 and UC 10) achieved CR and 46 (73%) BR. The changes in the levels of FC, CRP and ADA were significant (p <0.001) (Graphs 1–3). 22 patients (35%) discontinued treatment after a median of 6.5 (IQR 5–10) months due to: 11 no clinical response (50%), 4 loss of response (18%), 3 adverse events (14%) (psoriasis) and 4 endoscopic progression (18%). 44 patients (70%) remained under treatment and in CR (median follow-up 17 months, IQR 13–24) (Graph 4) and with a median ADA levels of 10.46 mg/l (IQR 7.34–15.25). Use of ADA 80 eow regimen saved 223500€ in patients who maintained treatment. In the multivariate analysis, being in CR when intensifying reduced the risk of treatment discontinuation by 87% (HR 0.13, 95%CI 0.02–0.99; p<0.001), having reached BR by 99.5% (HR 0.05, 95%CI 0.02–0.14; p <0.001) and having ADA levels ≥5 mg/l after intensification by 68% (HR 0.32, 95%CI 0.13–0.75; p = 0.02). Smoking habit was associated with treatment withdrawn (HR 1.74, 95%CI 1.02–2.96; p=0.04). Conclusion ADA intensification to 80mg eow in IBD patients is safe, effective and may reduce costs in real life clinical practice. Early intensification, even in CR, may enhance ADA treatment durability.

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

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

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

scholarly journals DOP26 Real-life dosing patterns and concomitant drug use among ustekinumab-treated patients with Crohn’s disease

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S066-S066
Author(s):  
C G af Björkesten ◽  
T Ilus ◽  
T Hallinen ◽  
E Soini ◽  
A Eberl ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Maintenance Treatment ◽  
Real Life ◽  
Dosage Interval ◽  
Biologic Agent ◽  
Life Study ◽  
Insufficient Response

Abstract Background Real-life long-term evidence on ustekinumab treatment in patients with Crohn’s disease (CD) is limited. We performed a retrospective non-interventional nation-wide chart review study of dosing and long-term clinical outcomes in Finnish CD patients treated with ustekinumab (FINUSTE2, EUPAS30920). Methods FINUSTE2 was carried out in 17 Finnish centres. Eligible patients were adults with CD, receiving an intravenous (IV) first dose of ustekinumab during 2017 or 2018. Data on disease activity, dosage, and concomitant medications were collected at baseline, 16 weeks, and 1 year from treatment initiation. All measurements on ustekinumab trough concentrations (TC) were recorded. Results The study included 155 patients (48% female) with a mean age of 44 and disease duration of 14 years. The disease was stricturing or penetrating in 69% of patients, 59% had prior CD-related surgeries, and 96% had a treatment history of at least one biologic agent. After one IV dose and one to two subcutaneous (SC) doses at 8 to 16 weeks, 140 patients (93%) continued to maintenance treatment with SC ustekinumab, of which nearly three-quarters with a dosage interval of 8 weeks (Figure 1). Of 93 patients with a follow-up of at least 1 year, 77 were still on ustekinumab. During follow-up, 55 patients (39%) had their ustekinumab dose adjusted, mostly (n = 44, 31.4%) as a shortening of the dosage interval. Forty-nine patients had in total 65 ustekinumab TC measurements performed, with a mean of 2.2 µg/ml at 16 weeks (n = 23) and 2.7 µg/ml at 1 year (n = 25). In 67% of cases, the reason for measuring TC was lack of or insufficient response. No anti-drug antibodies appeared at any time point. The proportion of patients on ustekinumab monotherapy increased significantly, from 34% (n = 52) at baseline to 54% (n = 79/146; p < 0.001) at 16 weeks and 64% (n = 49/77; p < 0.01) at 1 year. Correspondingly, corticosteroid use decreased significantly, and a trend towards reduced use of immunomodulators was observed (Figure 2). Conclusion In this nationwide real-life study, treatment with ustekinumab in patients with longstanding and complicated CD was persistent and allowed for significant corticosteroid tapering. A vast majority started the maintenance treatment with an 8-week dosage interval and nearly one-third of all patients required a dose increase, suggesting a highly refractory disease phenotype. The lack of detected antidrug antibodies during follow-up indicates low immunogenicity for ustekinumab.

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