scholarly journals P358 An observational, prospective cohort study to evaluate the long term safety and effectiveness of intravenous CT-P13 (biosimilar of infliximab) in patients with Crohn’s Disease or Ulcerative Colitis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S378-S379
Author(s):  
J H Cheon ◽  
H W Kang ◽  
S J Lee ◽  
S H Kim
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Events ◽  
Special Interest ◽  
Prospective Cohort ◽  
Study Drug ◽  
Hbv Reactivation ◽  
Study Drug Administration

Abstract Background CT-P13 is the world’s first approved biosimilar infliximab for all indications of the reference infliximab. The purpose of this study was to assess long term safety and effectiveness of CT-P13 intravenous (IV) in patients with Crohn’s Disease (CD) and Ulcerative Colitis (UC). We now present the result of safety and effectiveness of CT-P13 in patient with CD, UC for up to 5 years from this longitudinal, observational, prospective cohort Phase IV study. Methods The study was conducted from 17 April 2014 to 28 February 2020 in 22 and 21 study centres, in Korea and European Union, respectively. Patients were administered 5 mg/kg of CT-P13 by IV at weeks 0, 2 and 6 and every 8 weeks thereafter. The primary objective was to evaluate adverse events of special interest (AESI) including HBV reactivation, congestive heart failure, opportunistic infections, serious infection including sepsis, tuberculosis, serum sickness (delayed hypersensitivity reactions), hematologic reactions, systemic lupus erythematosus/lupus like syndrome, demyelinating disorders, lymphoma, hepatobiliary events, hepatosplenic T cell lymphoma (HSTCL), intestinal or perianal abscess (in CD), serious infusion reactions during a re-induction regimen following disease flare, sarcoidosis/sarcoid-like reactions, paediatric malignancy, leukaemia, malignancy, colon carcinoma, dysplasia (in UC), skin cancer, pregnancy exposure and bowel stenosis, stricture and obstruction (in CD). Results A total of 470 patients with inflammatory bowel disease (IBD) were analysed. Overall 352 (74.9%) patients have been continuously treated for more than 1 year and the mean duration of drug exposure was 26.3 months. The safety profile of CT-P13 and switching from the reference infliximab to CT-P13 was well-tolerated. A total of 329 (70.0%) patients experienced at least one treatment-emergent adverse event (TEAE). Adverse events of special interest of CT-P13 were analysed by safety analysis set (Table 1). Immunogenicity testing was optional and 72 (15.3%) patients had at least one ADA positive after first infusion of study drug. The incidence of TEAEs in ADA positive subset (83.3%) were slightly higher compared to the incidence of TEAEs in ADA negative subset (76.6%). The effectiveness results of clinical remission for each indication was generally well maintained after the study drug administration (Table 2). Conclusion The results show that CT-P13 was well-tolerated and efficacious in IBD patients. There was no new safety and effectiveness findings in patients who have been exposed to CT-P13 or patients who have switched treatment from the reference infliximab to CT-P13.

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 Long-Term Complications of Appendectomy: A Systematic Review

2018 ◽  
Vol 107 (3) ◽  
pp. 189-196 ◽  
Author(s):  
T. Rasmussen ◽  
S. Fonnes ◽  
J. Rosenberg
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Incisional Hernia ◽  
Opposite Pattern ◽  
Meta Analyses ◽  
Low Prevalence

Background and Aims: Appendectomy is a common surgical procedure, but no overview of the long-term consequences exists. Our aim was to systematically review the long-term complications of appendectomy for acute appendicitis. Materials and Methods: This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A protocol was registered on PROSPERO (CRD42017064662). The databases PubMed and EMBASE were searched for original reports on appendectomy with n ≥ 500 and follow-up >30 days. The surgical outcomes were ileus and incisional hernia; other outcomes were inflammatory bowel disease, cancer, fertility, and mortality. Results: We included 37 studies. The pooled estimate of the ileus prevalence was 1.0% over a follow-up period of 4.6 (range, 0.5–15) years. Regarding incisional hernia, we found a pooled estimate of 0.7% prevalence within a follow-up period of 6.5 (range, 1.9–10) years. Ulcerative colitis had a pooled estimate of 0.15% prevalence in the appendectomy group and 0.19% in controls. The opposite pattern was found regarding Crohn’s disease with a pooled estimate of 0.20% prevalence in the appendectomy group and 0.12% in controls. No clear pattern was found regarding most of the examined cancers in appendectomy groups compared with background populations. Pregnancy rates increased after appendicitis compared with controls in most studies. Mortality was low after appendectomy. Conclusion: Appendectomy had a low prevalence of long-term surgical complications. We did not find any significant other long-term complications, though the prevalence of Crohn’s disease was higher and the prevalence of ulcerative colitis was lower after appendectomy than in controls. Appendectomy did not impair fertility.

scholarly journals Aspirin in the aetiology of Crohn’s disease and ulcerative colitis: a European prospective cohort study

2011 ◽  
Vol 34 (6) ◽  
pp. 649-655 ◽  
Author(s):  
S. S. M. Chan ◽  
R. Luben ◽  
M. M. Bergmann ◽  
H. Boeing ◽  
A. Olsen ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Cohort Study ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Prospective Cohort Study ◽  
Prospective Cohort

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.

564 AN INFLAMMATORY DIET AND RISK OF CROHN'S DISEASE AND ULCERATIVE COLITIS: A PROSPECTIVE COHORT STUDY

2020 ◽  
Vol 158 (6) ◽  
pp. S-116 ◽  
Author(s):  
Chun-Han Lo ◽  
Paul Lochhead ◽  
Hamed Khalili ◽  
Mingyang Song ◽  
Kristin E. Burke ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Cohort Study ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Prospective Cohort Study ◽  
Prospective Cohort

scholarly journals P603 Persistence of vedolizumab maintenance therapy: Findings from a Belgian registry

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S503-S504
Author(s):  
E Louis ◽  
V Muls ◽  
P Bossuyt ◽  
A Colard ◽  
A Nakad ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Maintenance Therapy ◽  
Disease Activity ◽  
Real World ◽  
Clinical Remission ◽  
Disease Activity Score ◽  
Activity Score

Abstract Background Clinical trials and observational studies have demonstrated the clinical efficacy of vedolizumab (VDZ) as maintenance therapy for Crohn’s disease (CD) and ulcerative colitis (UC). This report presents long-term data on persistence of VDZ maintenance therapy in real-world clinical practice in Belgium. Methods The Belgian VDZ Registry (ENCePP EUPAS6469) enrolled 202 VDZ-treated ulcerative colitis (UC) or Crohn’s disease (CD) adult patients (26% with no prior use of anti-TNF therapy) from 19 centres across Belgium. The median length of VDZ therapy prior to enrolment was 11 months. Patients were followed-up every 6 months after enrolment with the assessment of IBD features, use of biologics, and disease activity. Clinical remission was defined as the Harvey–Bradshaw Index (HBI) <5 or partial Mayo Score (pMS) <2. Missing value imputation (last observation carried forward) was used to partially account for missing disease activity scores. If a 6-monthly disease activity score was missing, the disease activity score from the previous 6-monthly assessment was used. Results The mean duration of VDZ therapy, including use prior to enrolment, was 31 months, with 68% of CD patients and 75% of UC patients using VDZ therapy for 48 months. Clinical remission rate after 42 months of VDZ therapy was higher in UC (84%) than CD (67%), and higher for patients without prior anti-TNF therapy (87%) than those with prior anti-TNF therapy (70%). Fifty-seven (29.4%) patients discontinued VDZ during follow-up, due to loss of response (n = 40), adverse event (n = 7), clinical remission (n = 4), pregnancy planning (n = 3), and patient choice (n = 3). Conclusion These real-world long-term Belgian data demonstrate a high persistence of VDZ maintenance therapy among both CD and UC patients, with highest clinical remission rates seen in patients with UC and those with no prior anti-TNF therapy.

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