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 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.

Long-term Disease Behavior and Surgical Intervention Analysis in Hospitalized Patients with Crohn's Disease in China: A Retrospective Cohort Study

2021 ◽  
Author(s):  
Xiaoyin Bai ◽  
Huimin Zhang ◽  
Gechong Ruan ◽  
Hong Lv ◽  
Yue Li ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Large Scale ◽  
Hospitalized Patients ◽  
Disease Classification ◽  
Real World Data ◽  
Disease Behavior ◽  
Initial Classification

Abstract Background There is lack of real-world data for disease behavior and surgery of Crohn’s disease (CD) from large-scale Chinese cohorts. Methods Hospitalized patients diagnosed with CD in our center were consecutively included from January 2000 to December 2018. Disease behavior progression was defined as the initial classification of B1 to the progression to B2 or B3. Clinical characteristics including demographics, disease classification and activity, medical therapy, development of cancers, and death were collected. Results Overall, 504 patients were included. Two hundred and thirty one (45.8%) patients were initially classified as B1; 30 (13.0%), 71 (30.7%), and 95 (41.1%) of them had disease progression at the 1-year follow-up, 5-year follow-up, and overall, respectively. Patients without location transition before behavior transition were less likely to experience behavior progression. However, patients without previous exposure to a corticosteroid, immunomodulator, or biological agent had a greater chance of experiencing behavior progression. When the long-term prognosis was evaluated, 211 (41.9%) patients underwent at least one CD-related surgery; 108 (21.4%) and 120 (23.8%) of these patients underwent surgery before and after their diagnosis, respectively. An initial classification as B1, no behavior transition, no surgery prior to diagnosis, and previous corticosteroid exposure during follow-up were associated with a lower risk of undergoing surgery. Conclusions This study depicts the clinical features and factors associated with behavior progression and surgery among hospitalized CD patients in a Chinese center. Behavior progression is associated with a higher probability of CD-related surgery, and strengthened therapies are necessary for them in the early phase.

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 P451 Short-and long-term effectiveness of ustekinumab in patients with Crohn’s disease: real-world data from a German IBD cohort

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S405-S405
Author(s):  
A Kubesch ◽  
L Rueter ◽  
K Farrag ◽  
T Krause ◽  
K Stienecker ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Treatment Options ◽  
Real World Data ◽  
Free Response ◽  
Faecal Calprotectin ◽  
Short And Long Term

Abstract Background The IL-12/23 inhibitor ustekinumab (UST) opened up new treatment options for patients with Crohn’s disease (CD). Due to the recent approval, Real-World German data on long-term efficacy and safety are lacking. This study aimed to assess the clinical course of CD patients under UST therapy and to identify potential predictive markers. Methods Patients with CD receiving UST treatment in three hospitals and two outpatient centres were included and retrospectively analysed. Rates for short- and long-term remission and response were analysed with the help of clinical (Harvey–Bradshaw Index [HBI]) and biochemical (C-reactive protein [CRP], faecal calprotectin [fCal]) parameters for disease activity. Results Data from 180 patients were evaluated. One hundred six patients had a follow-up of at least 8 weeks and were included. 96.2% of the patients were pre-exposed to anti- TNFα agents and 34.4% to both anti-TNFα and anti-integrin. The median follow-up was 49.1 weeks (95% CI 42.03–56.25). At week 8, 51 patients (54.8%) showed response to UST, and 24 (24.7%) were in remission. At week 48, 39 (41.9%) responded to UST, and 20 patients (21.5%) were in remission. Steroid-free response and remission at week eight were achieved by 30.1%, and 19.3% of patients. At week 48, 26.9% showed steroid-free response to UST, and 15.1% of the initial patient population was in steroid-free remission. Clinical response at week 16 was independently associated with remission at week 48. Conclusion Our study confirms short- and long-term UST effectiveness and tolerability in a cohort of multi-treatment exposed patients.

scholarly journals Short and Long-Term Effectiveness of Ustekinumab in Patients with Crohn’s Disease: Real-World Data from a German IBD Cohort

2019 ◽  
Vol 8 (12) ◽  
pp. 2140 ◽  
Author(s):  
Alica Kubesch ◽  
Laurenz Rueter ◽  
Karima Farrag ◽  
Thomas Krause ◽  
Klaus Stienecker ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Treatment Options ◽  
Fecal Calprotectin ◽  
Real World Data ◽  
Free Response ◽  
Short And Long Term

Background and Aims: The IL-12/23 inhibitor ustekinumab (UST) opened up new treatment options for patients with Crohn’s disease (CD). Due to the recent approval, real-world German data on long-term efficacy and safety are lacking. This study aimed to assess the clinical course of CD patients under UST therapy and to identify potential predictive markers. Methods: Patients with CD receiving UST treatment in three hospitals and two outpatient centers were included and retrospectively analyzed. Rates for short- and long-term remission and response were analyzed with the help of clinical (Harvey–Bradshaw Index (HBI)) and biochemical (C-reactive protein (CRP), Fecal calprotectin (fCal)) parameters for disease activity. Results: Data from 180 patients were evaluated. One-hundred-and-six patients had a follow-up of at least eight weeks and were included. 96.2% of the patients were pre-exposed to anti- TNFα agents and 34.4% to both anti-TNFα and anti-integrin antibodies. The median follow-up was 49.1 weeks (95% CI 42.03-56.25). At week 8, 51 patients (54.8%) showed response to UST, and 24 (24.7%) were in remission. At week 48, 48 (51.6%) responded to UST, and 25 patients (26.9%) were in remission. Steroid-free response and remission at week eight was achieved by 30.1% and 19.3% of patients, respectively. At week 48, 37.6% showed steroid-free response to UST, and 20.4% of the initial patient population was in steroid-free remission. Conclusion: Our study confirms short- and long-term UST effectiveness and tolerability in a cohort of multi-treatment-exposed patients.

scholarly journals P289 A French nationwide prospective study on patients with Crohn’s disease and ulcerative colitis treated with Infliximab-biosimilar CT-P13 in a real-life setting: two-year follow-up of the ReFLECT study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S320-S321
Author(s):  
Y Bouhnik ◽  
S Nancey ◽  
M Assing ◽  
N Mammar ◽  
D Laharie
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Disease Activity ◽  
Safety Data ◽  
Real Life ◽  
Life Study ◽  
Mayo Score ◽  
Real Life Setting

Abstract Background ReFLECT study was carried out to investigate real-life use of CT-P13, the first monoclonal antibody biosimilar to infliximab (IFX) originator. Methods This multicentre, prospective, observational study was conducted in France to assess characteristics of patients (pts) receiving CT-P13, its effectiveness and safety in a real-life setting. Eligible were both pts who had been switched from IFX originator (IFXS) and IFX-naïve pts started on CT-P13 (IFXN). These interim descriptive statistical analyses are about pts with Crohn’s disease (CD) and ulcerative colitis (UC). Results Among the 1370 adult pts included between October 2016 and April 2019, data were analysed for 508 CD pts (48.6% males; mean age ± SD: 37.7±13.7; median [Q1;Q3] disease duration: 6.2 [1.9;13.7] years; 323 IFXN/145 IFXS) and 213 UC pts (54%; 42.9±17.2; 5.4 [1.6;12.8]; 154 IFXN/46 IFXS). Previous biologics other than IFX were taken by 32.9% of CD and 39.0% of UC pts; 31% (CDS) and 23% (UCS) of pts were switched from IFX originator to CT-P13. At the time of the first administration of CT-P13, disease had been more active in IFXN vs IFXS pts: 52.9% vs 13.3% in CD with a median [Q1;Q3] Harvey Bradshaw Index (HBI) of 4 [1;8] vs 1 [0;2] and, 82.9% vs 33.3% in UC with a median Mayo Score of 7 [3;10] vs 2 [0;4]. In IFXS pts, disease activity remained stable after 2 years of treatment with median differences of HBI and Mayo score since first administration of 1 [0;2] and 0 [-4;1]. In IFXN pts, median differences of HBI and Mayo score since first administration were -2 [-7;1] and -7 [-8;-5]; CT-P13 brought disease activity down to levels below or comparable to those seen in IFXS pts. Reasons for CT-P13 withdrawing and safety data are reported in Tables 1 and 2. Conclusion Year 2 follow-up data indicate that CT-P13 effectively induced improvement in disease activity in IFXN pts with CD or UC and maintained stable activity in IFXS pts. This real-life study did not highlight any new safety concerns.

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