scholarly journals P473 Long-term follow-up of switching from original adalimumab to adalimumab biosimilar: real-world data in IBD

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S416-S416 ◽  
Author(s):  
C Padilla Suarez ◽  
K Webb ◽  
N Persad ◽  
J Sercombe ◽  
E Tyler ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
C Reactive Protein ◽  
Drug Levels ◽  
Reactive Protein ◽  
Loss Of Response ◽  
Mayo Score

Abstract Background Studies have reported good efficacy outcomes for patients with inflammatory bowel disease (IBD) treated with biosimilars. There are limited long-term data. We assessed the long-term efficacy data and safety after switching from adalimumab to adalimumab biosimilars in patients with IBD. Methods A prospective single-centre observational study involving patients with Crohn’s disease or ulcerative colitis switched from adalimumab to adalimumab biosimilar and reviewed up to 12months. 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. Blood tests including C-reactive protein, adalimumab drug levels and anti-drug antibodies were monitored. We have recorded side effects and possible serious adverse effects. The plan is to continue the study for 24 months. Results 109 patients with IBD have completed at least 6 months of treatment with adalimumab biosimilar, 12 of which have ulcerative colitis and 97 Crohn’s disease. Most of them (88%) continued on biosimilar after 6 months. Patients discontinued the therapy due to loss of response or development of antibodies in one case. Two patients were switched to a different biosimilar due to the presence of side effects which were however not serious. Of those who remained on the treatment, 74.5% were in clinical remission at 6 months and 71.4% at 9 months. HB index, partial Mayo score, C-reactive protein and adalimumab drug levels did not show significant changes. We have not reported any serious adverse events. We hope than by February, at least 60% of these patients will have been on Adalimumab for 12 months and further amended date would be added. Conclusion Most of the patients switching from original adalimumab were maintained on biosimilar at 6 and 12months of follow-up with similar efficacy and safety as the original drug.

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 P457 Long-term follow-up of patients with IBD after switching from original adalimumab to adalimumab biosimilar during COVID 19 pandemic

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S451-S451
Author(s):  
K Klimova ◽  
C Padilla Suarez
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Side Effects ◽  
Crohn's Disease ◽  
Reactive Protein ◽  
Loss Of Response ◽  
Mayo Score ◽  
Long Term Follow Up

Abstract Background Studies have reported good efficacy outcomes for patients with inflammatory bowel disease (IBD) treated with biosimilars. There are limited long term data. We assessed the long-term efficacy data and safety after switching from adalimumab to adalimumab biosimilar Imraldi in patients with IBD. Methods A prospective single-centre observational study involving patients with Crohn’s disease or ulcerative colitis switched from adalimumab originator to adalimumab biosimilar and reviewed up to 24months. 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. Blood tests including C-reactive protein, adalimumab drug levels and antidrug antibodies were monitored. We have recorded side effects and possible serious adverse effects including COVID 19 infection. Results 113 patients were switched to Adalimumab biosimilar Imraldi from Adalimumab originator between January 2019 to March 2019. After 12 months of treatment, 25 patients interrupted treatment and 89 (78.8%) continued. These were analysed after 24 months of treatment - 57 (52.3%) continued on Imraldi. Of those who discontinued, 9 were switched back to Adalimumab originator due to side effects, and 34 stopped treatment - 16 patients due to loss of response, 11 patients developed antibodies, 5 underwent a surgery, 4 were in remission and 4 did not tolerate side effects. There was no statistical difference in CRP or Adalimumab levels prior to switch, at 12 months and at 24 months between the patients who continued or discontinued treatment. Overall, 18 of the patients who completed 24 months of treatment reported side effects, most frequently pain after injection (9 patients), followed by skin rash and recurrent infections (in 3 patients each). No patient was diagnosed with COVID 19 during until now. Conclusion After 24 months of follow up, 52.3% patients continued on adalimumab biosimilar and no serious side effects were reported. In particular, none of our patients acquired COVID 19 infection.

Non-Invasive Assessment of Inflammation and Treatment Response in Patients with Crohn’s Disease and Ulcerative Colitis using Contrast-Enhanced Ultrasonography Quantification

2015 ◽  
Vol 24 (4) ◽  
pp. 457-465 ◽  
Author(s):  
Mihai Socaciu ◽  
Lidia Ciobanu ◽  
Brindusa Diaconu ◽  
Claudia Hagiu ◽  
Andrada Seicean ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Contrast Enhanced ◽  
Before And After ◽  
Contrast Enhanced Ultrasonography ◽  
The Difference

ackground & Aim: Novel biological therapies in Crohn’s disease (CD) or Ulcerative colitis (UC) require a proper follow-up for the assessment of bowel inflammation. While endoscopy is the standard method, the imaging techniques using contrast, particularly contrast enhanced ultrasonography (CEUS), are better tolerated by the patients and can be used more frequently. Our aim was to find the usefulness of dynamic CEUS quantification as compared to endoscopy in the assessment of disease activity and in the follow-up under therapy of the patients suffering from either CD or UC. Method: We have prospectively evaluated 67 patients with UC and 46 with CD, diagnosed by ileo-colonoscopy and biopsy, comparing the endoscopic scores with clinical scores, C reactive protein (CRP), intestinal wall thickness, layer scores after CEUS and TIC parameters (using SonoLiver® software – Imax, RT, TTP, mTT and AUC). For 25 patients with UC and 13 with CD we performed comparisons of the parameters before and after 3 months of treatment and correlated them with the changes in the endoscopic scores. Results: For UC, time-intensity curves (TIC) volume parameters (AUC) correlated better with endoscopy (ρ=0.64) than the clinical score (ρ =0.62). Other parameters such as CRP and thickness showed significant but less strong correlation, while TIC flow parameters (RT, TTP and mTT) did not show a significant correlation. Results were similar for CD (ρ=0.64 for Imax vs ρ=0.58 for CDAI). The best predictor for endoscopic improvement in both UC and CD was ln(AUC), with a Wilcoxon Z score of 3.76 and 2.61, respectively. There was also a good correlation between the difference of its values and the difference in endoscopic scores before and after the treatment (rho is 0.68 in UC and 0.73 in CD). Abbreviations: CD: Crohn’s disease; CDAI: Crohn‘s disease activity index; CDEIS: Crohn‘s disease endoscopic index of severity; CEUS: Contrast-enhanced ultrasonography; CICDA: Composite index of CD activity; CRP: C-reactive protein; IBD: Inflammatory bowel disease; Imax: Maximum intensity; ln(AUC): Natural logarithm of AUC; MPI: Maximum peak intensity; mTT: Mean transit time; ROI: Region of interest; RT: Rise time; SES-CD: Simple endoscopic score for Crohn‘s disease; TIC:

scholarly journals P527 Investigating fatigue in vedolizumab-treated patients with ulcerative colitis or Crohn’s disease from a Belgian registry

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S503-S503
Author(s):  
E Louis ◽  
V Muls ◽  
P Bossuyt ◽  
A Colard ◽  
A Nakad ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Ad Hoc ◽  
Analysis Data ◽  
Real World Data ◽  
Mayo Score ◽  
Chronic Illness Therapy

Abstract Background Vedolizumab (VDZ) has demonstrated remission in ulcerative colitis (UC) and Crohn’s disease (CD), but its impact on patient (pt) fatigue is not well understood. Herein we report interim fatigue analysis data from a Belgian registry of VDZ-treated pts. Methods Ad-hoc analysis from the prospective observational Belgian VDZ registry (started, November 2016; data cutoff, February 2019), a sub-study of the European VDZ post-authorization safety study (ENcePP EUPAS6469) included pts aged ≥18 years with UC or CD with ongoing VDZ intravenous therapy (≥2 weeks) at recruitment. At baseline (recruitment) and every 6 months, physicians collected data (follow-up was 3 years or 1 year after last dose if VDZ was discontinued [whichever occurred first] and pts completed the 13-Item Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale. Clinical remission was defined as Harvey-Bradshaw Index (HBI) score <5 for CD, and partial Mayo score (pMS) <2 with no individual subscore >1 for UC. This analysis explored the association (using generalized estimating equations) between all available FACIT-F total scores and baseline demographic, clinical, and treatment characteristics in the treatment analysis set (TAS; pts had ≥1 VDZ dose and ≥1 year of follow-up records). Results The registry enrolled 202 VDZ-treated UC and CD pts from 19 Belgian centres. TAS included 141 pts (UC 47, CD 94); median follow-up was 537 days; 140/141 pts had ≥1 FACIT-F score. In the UC and CD groups, respectively, 68% and 42% of pts were male; median (IQR) age at index date was 51 (37–59) and 40 (29–52); and baseline median (IQR) FACIT-F total score was 39 (32–46) and 32 (24–40). Lower FACIT-F score (more fatigue) was associated with higher pMS in UC (p<0.001), and higher HBI score (p=0.01) and having ongoing fistulas at baseline (p=0.01) in CD (Table). Less fatigue was associated with being in remission at baseline in both UC and CD (p<0.01). Being male was associated with less fatigue in the overall population and CD (p<0.01), but not in UC alone. Baseline occurrence of extra intestinal manifestations (EIMs) was associated with more fatigue in the overall group (p=0.037); however few pts (UC 4; CD 8) had EIMs. UC pts had less fatigue than CD pts (p=0.004). From baseline to month 24, the change in median (IQR) FACIT-F total score was -3.0 (-12.0 to 5.0) points for UC and 3.5 (-1.0 to 18.0) for CD. Conclusion These real-world data from a long-term registry study of VDZ-treated pts in Belgium demonstrate that higher pMS and HBI score, active fistulae, and EIM occurrence at baseline may be associated with more fatigue in IBD pts. Pts treated with VDZ had no significant change in FACIT-F total score over 24 months.

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 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 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.

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