scholarly journals P338 effectiveness and safety of biological therapies in elderly inflammatory bowel diseases patients results from a multi center study of Geteccu

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S363-S364
Author(s):  
C J Suarez Ferrer ◽  
F Mesonero ◽  
B Caballol ◽  
R Saiz Chumillas ◽  
I Bastón-Rey ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Inflammatory Bowel Diseases ◽  
Clinical Remission ◽  
Biological Treatment ◽  
Moderate Activity ◽  
Biological Drugs ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Multi Center Study

Abstract Background Biological drugs are being increasingly used for the treatment of inflammatory bowel diseases (IBD) in elderly patients. Despite the particular characteristics of this population subgroup, the efficacy and safety of these treatments in real clinical practice is poorly evaluated. Methods Retrospective and multicenter study of GETECCU, carried out in 28 Spanish hospitals. Patients with IBD who started biological treatment (Infliximab, Adalimumab, Golimumab, Ustekinumab or Vedolizumab) aged 65 years or older were included. Efficacy (clinical- at the criteria of the responsible physician-, biochemical and endoscopic) was assessed at 12-14 weeks and at 52 weeks of treatment. Adverse effects such as tumors or serious infections were also recorded. Results A total of 570 patients were included, baseline characteristics are shown in Table 1. Biologics used were: Infliximab (214, 37.5%), Adalimumab (167, 29.3%), Golimumab (16, 2.8%), Ustekinumab (73, 12.8%) and Vedolizumab (100, 17.5%). After 12-14 weeks of treatment, in 38.7% (220) of the cases clinical remission had been achieved and in 47.7% (270) there was clinical response without remission. However, 80 patients (13.9%) had no response, resulting in treatment discontinuation due to primary failure. At week 52, only 379 patients (66.5%) continued on biological treatment: 216 (57%) were in clinical remission (216, 57.0%) while 129 (34%) had response without remission and 34 (9%)had no response. In addition, 119 patients (21%) had an endoscopic study performed: 47 (39,5%) presented with endoscopic remission, 38 (31,9%) with mild activity, 28 (23,5%) with moderate activity and 6, (5.1%) with severe activity. At the end of the follow-up, only 60% of the patients continued on biological treatment, being the reason for withdraw lack of efficacy or due to the report of adverse side effects. Regarding treatment safety in this population, 12.1% (68 patients) suffered an infectious complication with a microbiological diagnosis, requiring hospitalization in 62.1% of the cases. In addition, 39 patients (6.9%) were diagnosed with a tumor until the end of the follow-up, noting that 34.2% of the cases continued on biological therapy after the diagnosis. Likewise, in 25 patients (36.8%) this infection forced discontinuation of biological treatment. Finally, 10 patients stopped biological treatment due to a serious adverse reaction to it Conclusion Response rates to biological treatment in elderly patients are similar to those described in the general population, with approximately one third of failures happening during the first year. However, a remarkable proportion of patients developed a serious adverse effect that could be related to treatment

scholarly journals P360 Safety and clinical efficacy of double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicentre study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S342-S342
Author(s):  
S Mazza ◽  
A Fascì ◽  
V Casini ◽  
C Ricci ◽  
F Munari ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Inflammatory Bowel Diseases ◽  
Clinical Remission ◽  
Comparable Efficacy ◽  
Potential Cost ◽  
Safety And Efficacy ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Double Switch

Abstract Background Since infliximab (IFX) patent expiry in 2015, several IFX biosimilars have been licensed in EU for all indications, including inflammatory bowel diseases (IBD). IFX biosimilars currently available in Italy include CT-P13 and SB2, both of which demonstrated comparable efficacy, safety and immunogenicity with IFX originator in IBD patients. Safety and clinical efficacy of single switch from originator IFX to CT-P13 have also been confirmed in a prospective clinical trial. On the contrary, data regarding multiple therapeutic switching of IFX originator with CT-P13 and SB2 are currently lacking. Methods This study was aimed to evaluate the safety and efficacy of double switch from IFX originator to CT-P13 and subsequently to SB2 in patients with IBD. From November 2018 to May 2019, patients undergoing IFX double switch in 8 Centres in Lombardy were retrospectively analysed. The overall rate of IFX discontinuation, incidence and type of adverse events (AE) and proportion of patients on clinical remission over time were recorded. Data were compared with a control group of 66 IBD patients single switched from IFX originator to CT-P13. Results Fifty-two double-switched IBD patients were enrolled (63% M, mean age 41 years, 75% Crohn’s disease, 25% ulcerative colitis). Main indications for IFX therapy were moderate to severe disease (50%) and steroid-dependent disease (25%). The overall 24- and 48-week IFX discontinuation rates following second switch (CTP13->SB2) were 2% (95% CI 0–6%) and 14% (95% CI 3–25%), respectively. During a median follow-up of 40 weeks (18–48), 4 patients (12%) experienced a total of 6 AE (2 cutaneous, 2 infectious, 1 articular and 1 immunological), leading to IFX discontinuation in 3 cases (6%). No infusion reactions were observed. At week 24 following second switch, 49 (94%) patients were in clinical remission, the remaining 3 patients not being in remission already at the time of second switch. Only one patient lost response after week 24, 48 (92%) of patients being in clinical remission at the end of follow-up. No differences in IFX discontinuation, AE and clinical remission rates were found between double-switched and single-switched patients. No clinical parameters were found to predict safety and efficacy outcomes. Conclusion The study supports both safety and efficacy of the double switch from IFX originator to CT-P13 and SB2 in patients with IBD, and demonstrates its non-inferiority to a single switch strategy, with potential cost implications.

scholarly journals P295 VALIDation of the IBD-Disk instrument for assessing disability in inflammatory bowel diseases in a population-based cohort: The VALIDate study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S299-S301
Author(s):  
C Le Berre ◽  
A Bourreille ◽  
M Flamant ◽  
G Bouguen ◽  
L Siproudhis ◽  
...  
Keyword(s):  
Internal Consistency ◽  
Inflammatory Bowel Diseases ◽  
Population Based ◽  
Large Cohort ◽  
Inactive Disease ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Physician Patient ◽  
Over Time

Abstract Background Inflammatory bowel diseases (IBD) are disabling disorders. The IBD-Disability Index (IBD-DI) was developed for quantifying disability in IBD patients but is difficult to use. The IBD-Disk is a shortened and visual adaptation of the IBD-DI. It has not been validated yet. The main objectives were to validate the IBD-Disk in a large cohort of IBD patients and to assess its variability over time. Methods From March 2018 to July 2019, IBD patients from three university-affiliated hospitals responded twice to both IBD-Disk and IBD-DI at 3–12 months intervals (NCT03590639). Validation included concurrent validity, reproducibility, internal consistency, and evaluation of IBD-Disk correlation with IBD activity. Variability was assessed by comparing scores between baseline and follow-up visits. Results A total of 559 patients (73% Crohn’s disease, 27% ulcerative colitis) were included and 389 were followed up (Table 1). There was a good correlation between IBD-Disk and IBD-DI scores (r = 0.75, p < 0.001) (Figure 1). The IBD-Disk was significantly higher in patients with active disease according to Physician/Patient Global Assessment (Figure 2), clinical scores (Figure 3), and biomarkers levels, compared with patients with inactive disease. Reproducibility was excellent (intra-class correlation coefficient = 0.90), as well as internal consistency (Cronbach’s α = 0.89). The IBD-Disk score significantly decreased in patients becoming inactive over time. Conclusion This is the first study to validate the IBD-Disk in a large cohort of IBD patients, demonstrating that it is a valid and reliable tool for quantifying disability in clinical practice. Further studies are warranted to assess its correlation with endoscopic activity, to explore its responsiveness to change, and to evaluate the factors associated with disability.

scholarly journals P163 Changes in diagnostic delay in inflammatory bowel diseases over the years: a retrospective single-centre analysis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S220-S220
Author(s):  
M Di Ruscio ◽  
F Vernia ◽  
A Variola ◽  
G Lunardi ◽  
S Resimini ◽  
...  
Keyword(s):  
Median Time ◽  
Inflammatory Bowel Diseases ◽  
Biological Treatment ◽  
Diagnostic Delay ◽  
Delayed Diagnosis ◽  
Age Related ◽  
Time To Diagnosis ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
The Difference

Abstract Background Delayed diagnosis is common in inflammatory bowel diseases (IBD) and has been reported to be longer for patients with Crohn’s disease (CD) than for those with ulcerative colitis (UC). Aims of study were to assess the median time to diagnosis in IBD patients, to examine whether diagnostic delay (DD) has improved over the years and its impact on biological treatment and need for surgery. Methods A retrospective monocentric study including IBD patients living in the area of Verona (Italy), diagnosed up to 2019 and followed-up for at least 6 months at IRCCS Sacro Cuore—Don Calabria, Negrar, was carried out. DD was defined as the period (months) from symptoms onset to histological diagnosis of IBD and reported as <6 months, 6–12 months and >12 months. Results Six-hundred-six patients (255 CD; 351 UC; 308 males; 298 females) were enrolled. Median DD was 10 (IQR 2–12), 6 (IQR 1–12) and 2 (IQR 1–7) months <2000, between 2001–2010, and >2010, respectively. Median time to diagnosis was not significantly longer in CD than in UC patients (4 vs. 3 months; IQR 1- 12). No sex- or age-related differences in DD were observed. Using the Mann–Whitney test, DD was longer in patients diagnosed <2000 and between 2001–2010, than in those diagnosed >2010 (p = 0.0000 and p = 0.0004). Comparing DD <2000 and >2010, the statistical difference was reported for UC (p = 0.0000) but not for CD (p = 0.2756). Considering the use of biologics over the years, patients diagnosed between 2000–2010, and >2010 were compared (194 CD and 333 UC), reporting a significant increase in their use both for CD (30 vs. 60; p = 0.0008) and UC (28 vs. 43; p = 0.0000). DD did not influence the need for biological treatment in both diseases (p = 0.987 for CD; p = 0.433 for UC). Considering a DD <6, 6–12, and >12 percentages of patients needing biologics were respectively 53.4%, 63.6% and 56.5% for CD and 28.5%, 34.1% and 26.3% for UC. Seventy-two CD and 27 UC patients needed surgery. Analyzing the time to surgery, DD did not influence the rate of resections in CD (p = 0.6559), as well as in UC (p = 0.2792). Conclusion In our cohort, DD has significantly decreased over the last years, more for UC than CD patients. This is probably related to the increased awareness of patients on disease and of general practitioners in sending them to the specialist. Considering the published literature, UC and CD did not differ in DD; moreover age at diagnosis did not affect DD in our patients. DD did not influence the need for biological treatment or surgery rates in both diseases. These results are probably related to the difference in disease extension and severity among the patients enrolled. An analysis on targeted patients at higher risk for bowel damage is presently under way.

scholarly journals History of Inflammatory Bowel Diseases

2019 ◽  
Vol 8 (11) ◽  
pp. 1970 ◽  
Author(s):  
Giovanni Clemente Actis ◽  
Rinaldo Pellicano ◽  
Sharmila Fagoonee ◽  
Davide Giuseppe Ribaldone
Keyword(s):  
20Th Century ◽  
Inflammatory Bowel Diseases ◽  
Intestinal Tuberculosis ◽  
Unknown Etiology ◽  
Biological Drugs ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Novel Strategy ◽  
Definition Of ◽  
Therapeutic Research

Inflammatory bowel diseases (IBD) are characterized by chronic inflammation of the intestinal mucosa and unknown etiology. In this review, we identified three main eras in the IBD history. Between the 19th and the 20th century, the primary task had been the definition of the diagnostic criteria in order to differentiate the new entity from intestinal tuberculosis. In the 20th century, an intense and prolific therapeutic research prevailed, culminating in the introduction of biological drugs in the clinical setting. Since the beginning of the 21st century, traditional definition criteria have been challenged by holistic criteria in an effort to seek a still unattained cure. Centuries of worldwide efforts on IBD etiology and therapy search have culminated in this novel strategy.

scholarly journals Articular manifestations in patients with inflammatory bowel disease treated with vedolizumab

Rheumatology ◽  
2020 ◽  
Vol 59 (11) ◽  
pp. 3275-3283 ◽  
Author(s):  
Anastasia Dupré ◽  
Michael Collins ◽  
Gaétane Nocturne ◽  
Franck Carbonnel ◽  
Xavier Mariette ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Inflammatory Bowel Diseases ◽  
Bowel Disease ◽  
Bowel Diseases ◽  
History Of ◽  
Musculoskeletal Manifestations ◽  
Inflammatory Bowel

Abstract Objective Vedolizumab (VDZ) has been incriminated in the occurrence of articular manifestations in patients with inflammatory bowel diseases (IBDs). The aim of this study was to describe musculoskeletal manifestations occurring in IBD patients treated by VDZ and to identify risk factors. Methods In this retrospective monocentric study, we included all consecutive patients treated by VDZ for IBD in our hospital. Incident musculoskeletal manifestations occurring during VDZ treatment were analysed and characteristics of patients with and without articular inflammatory manifestations were compared. Results Between 2013 and 2017, 112 patients were treated with VDZ for IBD: ulcerative colitis (n = 59), Crohn’s disease (n = 49) and undetermined colitis (n = 4). Four patients (3.6%) had a history of SpA, whereas 13 (11.6%) had a history of peripheral arthralgia. Some 102 (91.1%) patients had previously received anti-TNF. After a mean (S.d.) follow-up of 11.4 (8.6) months, 32 (28.6%) patients presented 35 musculoskeletal manifestations, of which 18 were mechanical and 17 inflammatory. Among the latter, 11 had axial or peripheral SpA, 5 had early reversible arthralgia and 1 had chondrocalcinosis (n = 1). Among the 11 SpA patients, only 3 (2.6%) had inactive IBD and may be considered as paradoxical SpA. The only factor associated with occurrence of inflammatory manifestations was history of inflammatory articular manifestation [7/16 (43.8%) vs 10/80 (12.5%), P = 0.007]. Conclusion Musculoskeletal manifestations occurred in almost 30% of IBD patients treated with VDZ, but only half of them were inflammatory. Since most of the patients previously received anti-TNF, occurrence of inflammatory articular manifestations might rather be linked to anti-TNF discontinuation than to VDZ itself.

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