Safety of Hydrocortisone Premedication Discontinuation in Patients with Inflammatory Bowel Disease on Maintenance Therapy with Infliximab: a Prospective Clinical and Pharmacological Study

2020 ◽  
Author(s):  
My-Linh Tran-Minh ◽  
Jean-Marc Gornet ◽  
Marianne Maillet ◽  
Pascal Houze ◽  
Marion Simon ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Combination Therapy ◽  
Maintenance Therapy ◽  
Clinical Response ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Pharmacological Study ◽  
Infusion Reaction ◽  
Tertiary Referral Centre ◽  
Inflammatory Bowel

Abstract Background Hydrocortisone premedication reduces the risk of antibodies to infliximab [ATIs] formation in patients receiving infliximab [IFX] therapy for inflammatory bowel disease [IBD]. Aim We aimed to determine the safety of hydrocortisone premedication withdrawal in IBD patients with sustained clinical response on maintenance therapy with IFX. Methods We performed an observational prospective pharmacoclinical study in a tertiary referral centre, including all consecutive IBD outpatients with no previous IFX infusion reaction and in clinical remission on maintenance IFX [alone or in combination therapy] for at least 6 months. This cohort was followed for 1 year after discontinuation of hydrocortisone premedication. Results Among the 268 IBD outpatients, 95 patients met the inclusion criteria [mean age 38 years; 64% male; 80% Crohn’s disease; 45% combination therapy]. The median IFX duration was 5 years [0.54–14] with a mean infused dose of 533 mg [200–1000] and a mean interval duration of 7.9 weeks [4–10]. None of the patients developed permanent ATIs or infusion-related reaction at 1 year. Four patients developed transient ATIs without loss of clinical response. There was no significant variation of infliximab serum trough levels [5.5 µg/mL vs 5.9 µg/mL] measured at the time of the three IFX infusions before and after hydrocortisone withdrawal. Loss of response rate to IFX was 18% at 1 year. Conclusions Hydrocortisone discontinuation is safe in IBD patients with sustained clinical remission on maintenance therapy with IFX. Our data suggest that routine premedication with hydrocortisone is unnecessary in patients in prolonged remission under IFX maintenance therapy.

Efficacy of Granulocyte and Monocyte Adsorptive Apheresis in Patients With Inflammatory Bowel Disease Showing Lost Response to Infliximab

2020 ◽  
Vol 14 (9) ◽  
pp. 1264-1273 ◽  
Author(s):  
Yoko Yokoyama ◽  
Koji Sawada ◽  
Nobuo Aoyama ◽  
Naoki Yoshimura ◽  
Minako Sako ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Combination Therapy ◽  
Clinical Response ◽  
Bowel Disease ◽  
Infusion Reaction ◽  
Cutaneous Lesions ◽  
Skin Reactions ◽  
Adsorptive Apheresis ◽  
Clinical Indices ◽  
Inflammatory Bowel

Abstract Background and Aims In inflammatory bowel disease [IBD] patients, antibody-to-infliximab [ATI] generation is responsible for loss of response [LOR] and infusion reaction [IR] to infliximab. An immuno-therapeutic approach is considered an option to overcome LOR. Granulocyte/monocyte adsorptive apheresis [GMA] using an Adacolumn has been shown to have clinical efficacy together with immunomodulatory effects in IBD patients. Methods We developed an ATI-CAI assay utilizing a C1q immobilized plate and applied it to measure ATI in patients who were receiving infliximab, including 56 with sustained response, 76 with LOR and six with IR. Furthermore, 14 patients with LOR and two with paradoxical skin reactions who received infliximab + GMA combination therapy were analysed. Results Fourteen patients with LOR, seven with Crohn’s disease and seven with ulcerative colitis, showed significantly improved clinical indices [p = 0.0009], and decreased ATI [p = 0.0171] and interleukin-6 [p = 0.0537] levels at week 8 following initiation of infliximab + GMA therapy. Nine patients who received combination therapy achieved remission, which was maintained to week 24 with infliximab alone. Additionally, cutaneous lesions in two patients with IR were improved. ATI-CAI assay efficiency was not influenced by infliximab concentration during the test. Pre- and post-infliximab infusion ATI levels were not different. Patients with ATI greater than the 0.153 μg/mL cut-off value were likely to experience LOR [odds ratio 3.0]. Conclusions Patients who received infliximab + GMA therapy appeared to regain clinical response to infliximab by a decrease in ATI level. Furthermore, the concentration of infliximab in the test did not influence ATI measurement, but was associated with clinical response.

scholarly journals P837 Changes in the intestinal microbiota of patients with inflammatory bowel disease during an 8-week infliximab infusion cycle

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S649-S649
Author(s):  
G Seong ◽  
J H Song ◽  
J Shin ◽  
S M Kong ◽  
E R Kim ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Species Richness ◽  
Maintenance Therapy ◽  
Intestinal Microbiota ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Microbial Composition ◽  
Infliximab Infusion ◽  
Faecal Samples ◽  
Inflammatory Bowel

Abstract Background This study investigated changes in the intestinal microbiota during 8-week infliximab maintenance therapy in inflammatory bowel disease (IBD) patients with clinical remission. Microbial compositional differences were analysed according to the trough level of infliximab (TLI) and mucosal healing (MH) status. Methods 16S rRNA gene-based microbiome profiling was performed on 10 and 74 faecal samples from 10 healthy volunteers and 40 adult IBD patients, respectively. All enrolled IBD patients were in clinical remission during infliximab maintenance therapy. To identify changes in the intestinal microbiota, faecal sampling occurred at 1–2 weeks (1W) and 7–8 weeks (7W) after infliximab infusion. TLI was measured by ELISA at 8 weeks immediately before the subsequent infusion; MH was evaluated by endoscopy within 3 months. Results No significant differences were found in microbial composition, species richness, and diversity indices between 1W and 7W samples or in microbial composition and diversity between healthy volunteer and 1W or 7W samples. However, 7W faecal samples from the patients with TLI≥5 μg/ml showed increased species richness compared with TLI<5 μg/ml, and patients with MH showed increased species diversity compared with non-MH. Beta-diversity analysis showed clustering between samples in the MH and non-MH groups. LefSe analysis identified differential expression of Faecalibacterium prausnitzii group between TLI < 5 μg/ml and TLI ≥ 5 μg/ml and MH and non-MH groups. Conclusion There were no significant changes in the intestinal microbiota during an 8-week infliximab infusion cycle in IBD patients with clinical remission; however, microbial composition, species richness, and diversity were associated with TLI and MH status.

scholarly journals Relationship between Serum Adalimumab Levels and Clinical Outcome in the Treatment of Inflammatory Bowel Disease

2019 ◽  
Vol 37 (6) ◽  
pp. 444-450 ◽  
Author(s):  
Joaquín Hinojosa ◽  
Fernando Muñoz ◽  
Gregorio Juan Martínez-Romero
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Outcome ◽  
Maintenance Therapy ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Meta Analysis ◽  
Serum Levels ◽  
Mucosal Healing ◽  
Endoscopic Remission ◽  
Inflammatory Bowel

Background: Adalimumab (ADA) is an anti-tumor necrosis factor agent that has been shown to be effective in inducing and maintaining remission in adult patients with inflammatory bowel disease. The relationship between the ADA trough levels and clinical efficacy has been demonstrated, but there is variability in the definition of the most suitable range for its clinical applicability. Summary: A review of published studies during the last 5 years on ADA serum levels and its relationship with the clinical outcome was performed. The studies selected included 7 observational studies, a systematic review, a meta-analysis and a post hoc analysis of a clinical trial. The reported ADA levels that discriminate patients in clinical remission from those with active disease range from 4.5 to 8 µg/mL. This therapeutic range varies when considering endoscopic remission (7.5 to >13.9 µg/mL). Although the sample of patients with ulcerative colitis is small, a tendency to reach higher levels of ADA is observed in both clinical and endoscopic remission. Key Messages: The optimal therapeutic cut-off point of serum ADA levels ranges from 4.5–5 to 12 µg/mL, where ADA levels are associated with an adequate clinical monitoring of the disease during maintenance therapy. These ranges vary according to the target, suggesting levels of 4.8 µg/mL as the cut-off for clinical remission and levels ≥7.5 µg/mL for mucosal healing/endoscopic response. Controlled prospective studies are required to determine the optimal therapeutic interval of ADA serum levels both as induction and as maintenance therapy.

scholarly journals P219 Disease-specific avoidance is a predictor for fatigue in inflammatory bowel disease patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S250-S252
Author(s):  
L Fierens ◽  
I Van de Pavert ◽  
M Walentynowicz ◽  
S Coenen ◽  
P Geens ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Stool Frequency ◽  
Avoidance Behaviour ◽  
Tertiary Referral Centre ◽  
Cross Sectional ◽  
Patient Reported ◽  
Inflammatory Bowel ◽  
Disease Specific

Abstract Background A substantial group of patients with inflammatory bowel disease (IBD) experience fatigue, even while in clinical remission. At present, disease-specific behaviours that maintain or worsen symptom burden including fatigue have not been explored. We developed a questionnaire evaluating IBD-specific avoidance behaviour and investigated how this relates to self-reported fatigue. Methods This study was a close collaboration between the psychology and gastroenterology department of our tertiary referral centre. A 72-item IBD-specific avoidance behaviour questionnaire (IBD-B) was generated based on literature review and input from clinicians and a patient focus group (n = 10). Between July 2018 and March 2019, 500 consecutive IBD patients were included at our infusion unit (wave 1) (participation rate 79%, 48% male, 66% Crohn’s disease (CD), median age 40). Patients completed the 72-item IBD-B, a demographic questionnaire, patient-reported outcome assessing disease activity (PRO2) and a Visual Analogue Scale (VAS) for fatigue. Test–retest reliability was assessed in 89 patients (54% male, 70% CD, median age of 40) who completed the IBD-B, PRO2 and VAS fatigue scale a second time after 4–12 weeks (wave 2). Clinical remission was defined as an abdominal pain score ≤1 and a liquid to very soft stool frequency ≤1.5 in CD patients and as no rectal bleeding and a stool frequency ≤1 in patients with ulcerative colitis (UC). A principal component analysis (PCA) was then used to reduce the number of items and investigate the underlying factor structure of the IBD-B. The predictive value of IBD-specific behaviours for fatigue was finally investigated both cross-sectionally and prospectively. Results At wave 1, 46% and 69% of CD and UC patients, respectively, were in clinical remission. PCA suggested a reduction of the 72-item to a final 25-item IBD-B and a seven-factor solution for use in clinical practice (loading factors >0.5, Table 1). The final 25-item IBD-B showed good psychometric properties. The median (IQR) total IBD-B and fatigue scores were, respectively, 29 (40-20) and 52 (77-25) for patients in clinical remission compared with 38 (48-28) and 74 (87-50) for patients not in clinical remission (both p < 0.01). Both cross-sectional and prospective significant correlations between IBD-B factors and fatigue were demonstrated (Table 2). Conclusion The IBD-B is a valuable tool to accurately measure IBD-specific avoidance behaviour in IBD patients. IBD patients without clinical remission report higher IBD-B values and show a higher correlation between avoidance behaviour and fatigue. Further research should now focus on identifying predictors for fatigue in IBD patients in clinical remission.

scholarly journals A157 THE EFFECTIVENESS OF A STANDARDIZED BIOLOGIC CARE PATHWAY IN THE MANAGEMENT AND TREATMENT OF INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 21-22
Author(s):  
N Willett ◽  
C Heisler ◽  
N Nazer ◽  
B Currie ◽  
K Phalen-Kelly ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Cohort Study ◽  
Combination Therapy ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Multivariate Analyses ◽  
Care Pathway ◽  
Endoscopic Remission ◽  
Inflammatory Bowel ◽  
The Mean

Abstract Background Inflammatory Bowel Disease (IBD) is a class of chronic immune-mediated diseases. Biologics have revolutionized the treatment of IBD. Existing literature suggests significant variation exists in the use of biologic treatment among physicians, from provider-specific prescribing to completion of the pre-biologic workup. These differences may influence the effectiveness of achieving and maintaining long-term remission. Clinical care pathways may serve to standardize the use of biologics in the treatment of IBD leading to improvements in patient outcomes and consistency of care provided from different specialists. Aims To determine if the use of biologics to treat IBD managed within a standardized biologic care pathway (BCP) is safer and more effective compared to the current standard of care. Methods This was a retrospective, real-world cohort study of a prospectively implemented evidence-based BCP at the Nova Scotia Collaborative IBD (NSCIBD) program between 2015 and 2019. Patient inclusion criteria consisted of any adult with a diagnosis of IBD (including Crohn’s Disease, ulcerative colitis, IBD-Unclassified) aged 18 years or older who was managed within the NSCIBD program. Preliminary descriptive analyses of the data are presented. Data collection is ongoing and multivariate analyses will be presented in full at CDDW. Results In total 249 patients were included in the cohort study (111 BCP patients, 138 non-BCP patients). The mean age was 49 years (range of 17–86 years). Sixty-nine percent (171/249) of patients were diagnosed with CD, 28% (70/249) with UC, and 3% (8/249) with IBD-U. The mean duration of disease was 13 years (range of 0–36 years). Use of combination therapy was similar between the cohorts with 64% of BCP patients (n=102) and 63% of non-BCP patients (n=123) on combination therapy. Thirty-eight percent of the BCP cohort required dosing interval changes vs. 29% in the non-BCP cohort (0.24 fold higher in BCP cohort). Seventy-one percent of the BCP patients were exposed to TDM vs. 41% of the non-BCP cohort (0.40-fold more TDM in pathway cohort). Although 34% of BCP patients and 38% of non-BCP cohort patients reached clinical remission (n=103 and 125, respectively), 38% of BCP patients and 21% of non-BCP patients achieved endoscopic remission (0.5-fold lower in the non-BCP cohort), (n=29 and 53, respectively). Conclusions Preliminary analyses suggest patients managed within a BCP have their biologic management guided more often by the results of TDM and objective biomarkers than those not managed within a BCP. Although clinical remission was observed to be similar between the cohorts, attainment of endoscopic remission was more likely amongst patients managed within the BCP. Additional multivariate analyses will be presented at CDDW with a larger cohort size. Funding Agencies None

scholarly journals THE SAFETY, TOLERABILITY, AND EFFECTIVENESS OF BIOLOGICS/SMALL MOLECULE THERAPY IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE AND CIRRHOSIS

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S45-S46
Author(s):  
Muyi Li ◽  
Sameer Khan ◽  
Deborah Proctor ◽  
Jill Gaidos ◽  
Badr Al-Bawardy
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Small Molecules ◽  
Small Molecule ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Infusion Reaction ◽  
Mucosal Healing ◽  
Biologic Agents ◽  
Inflammatory Bowel

Abstract Introduction Biologic agents and small molecules have been shown to be effective and relatively safe in the treatment of inflammatory bowel disease (IBD). However, data is lacking regarding the use of these agents in patients with IBD and concomitant cirrhosis. The aim of this study is to examine the safety, tolerability and effectiveness of biologics and small molecules in patients with IBD and concomitant cirrhosis. Methods This is a retrospective study of adult patients diagnosed with both IBD and cirrhosis (by liver biopsy or Fibroscan) treated with biologic agents or small molecule agents between 2012 and 2020 within the Yale-New Haven Hospital system. We included patients on tofacitinib or any of the following biologic agents: infliximab, adalimumab, certolizumab pegol, golimumab, vedolizumab, ustekinumab. Primary outcomes were rates of adverse events (infection, infusion reaction, IBD-related hospitalization) and mortality. Secondary outcomes were clinical remission (defined by the physician global assessment) and mucosal healing (Mayo endoscopic score of 0 or 1 for ulcerative colitis (UC) and absence of erosion/ulcerations in Crohn’s disease (CD)). Results A total of 18 patients (72% CD, 28% UC) with median age of 50 (26–73) years were included (Table 1). Decompensated cirrhosis was present in 33.3% of the population prior to initiation of biologic/small molecule therapy. The most common etiology of cirrhosis was primary sclerosing cholangitis at 38.9%. IBD therapy included: infliximab/adalimumab (44.5%), vedolizumab (27.7%), and ustekinumab (22.2%) and tofacitinib (5.6%). A total of 4 patients (22.2%) were on concomitant corticosteroid therapy and 3 on combination therapy with thiopurines (Table 2). Adverse events occurred in 27.7% (n=5; 1 infusion reaction and 4 infections). The 4 patients with infections included: 2 on infliximab/adalimumab, 1 on ustekinumab, 1 on vedolizumab. Two of these patients were on concomitant thiopurines and 1 on corticosteroid. Biologic therapy was stopped in 3 patients, 2 for non-response and 1 for an infusion reaction. Mortality rate was 11% and all were liver-related. Clinical remission was achieved in 66.7% and mucosal healing was noted in 72.7% (8/11). Conclusions In this cohort of patients with IBD and cirrhosis, biologic/small molecule therapies were effective for IBD. Approximately a quarter of patients experienced adverse events that were mainly due to infections. Larger studies are needed to elucidate the relative safety of different biologic agents and small molecules in IBD patients with cirrhosis.

scholarly journals Real-world effectiveness of vedolizumab in inflammatory bowel disease: week 52 results from the Swedish prospective multicentre SVEAH study

2021 ◽  
Vol 14 ◽  
pp. 175628482110233
Author(s):  
Carl Eriksson ◽  
Sara Rundquist ◽  
Vyron Lykiardopoulos ◽  
Ruzan Udumyan ◽  
Per Karlén ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Real World ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Real World Data ◽  
Inflammatory Bowel

Background: Prospectively and systematically collected real-world data on vedolizumab are scarce. We aimed to assess the long-term clinical effectiveness of vedolizumab in inflammatory bowel disease (IBD). Methods: This study was a prospective, observational, multicentre study. Overall, 286 patients with active IBD were included (Crohn’s disease, n = 169; ulcerative colitis, n = 117). The primary outcomes were clinical response at week 12 and clinical remission at week 52, based on the Harvey Bradshaw Index and the partial Mayo Clinic score. Secondary outcomes included clinical remission at week 12, clinical response at week 52, corticosteroid-free clinical remission at week 52, changes in biochemical measures, and health-related quality of life (HRQoL). Results: At baseline, 88% of the patients were exposed to anti-TNF and 41% of the patients with Crohn’s disease had undergone ⩾1 surgical resection. At week 12, clinical response was 27% and remission 47% in Crohn’s disease; corresponding figures in ulcerative colitis were 52% and 34%. Clinical response, remission and corticosteroid-free remission at week 52 were 22%, 41% and 40% in Crohn’s disease and 49%, 47% and 46% in ulcerative colitis, respectively. A statistically significant decrease in median faecal-calprotectin and C-reactive protein was observed at 12 and 52 weeks in patients with Crohn’s disease and ulcerative colitis. The HRQoL measures Short Health Scale and EuroQol 5-Dimensions improved in both Crohn’s disease and ulcerative colitis patients ( p < 0.001). Clinical disease activity at baseline was inversely associated with clinical remission at week 52. Conclusion: Vedolizumab proved effective for the treatment of refractory IBD in clinical practice.

scholarly journals P470 Ustekinumab Trough Levels are not Associated with Clinical Response in Inflammatory Bowel Disease Patients

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S460-S461
Author(s):  
Z Zelinkova ◽  
A Lipovska ◽  
K Otottova ◽  
J Lucenicova ◽  
B Kadleckova
Keyword(s):  
Inflammatory Bowel Disease ◽  
Maintenance Therapy ◽  
Clinical Response ◽  
Dose Escalation ◽  
Real World ◽  
Bowel Disease ◽  
Original Response ◽  
Mayo Score ◽  
Inflammatory Bowel ◽  
Trough Levels

Abstract Background Ustekinumab (UST) has been shown to effectively induce and maintain remission in inflammatory bowel disease (IBD). Only a few studies thus far have focused on UST pharmacokinetics suggesting that both, trough levels after i.v. induction as well as trough levels during stable maintenance might be associated with clinical and endoscopic response to UST. Data from real-world cohorts in this setting are scarce. Therefore, the aim of our study was to assess whether clinical response to UST was associated with a specific pharmacokinetic pattern. Methods All IBD patients treated with UST in one tertiary IBD centre between January 2017 and August 2020 were retrospectively retrieved from the database. Disease activity was assessed by Harvey-Bradshaw index (HBI) and partial Mayo score in Crohn’s disease (CD) and ulcerative colitis (UC) pts; respectively. Clinical response was defined as a decrease of HBI of ≥2 points or partial Mayo score ≥3 points. Patients not responding to therapy by week 16, or loosing original response received dose escalation from 90mg s.c. every 8 weeks to 90mg every 4 weeks. UST through levels were assessed by commercially available ELISA kit (IDKmonitor®) at week 8 after i.v. induction and/or during maintenance therapy after a minimum period of 16 weeks of treatment. Results In total, 61 IBD patients were included (mean age 38 years, range 22–70; 38 women; 54 CD/6 UC/1 IBD-U). All patients were antiTNF experienced, minority (11; 18%) had also been treated with vedolizumab prior UST. Thirty-nine pts (64%) were responders, out of these 15 pts (38%) required dose escalation at some point of the treatment due to secondary loss of response. UST through levels at week 8 were significantly higher than the maintenance levels (mean 5.6±SEM 0.7µg/mL vs. 2.2±0.3µg/mL; p&lt;0.001). There were no significant differences between responders and non-responders neither in trough levels after induction (5±0.8µg/mL vs. 6.4±1.1µg/mL, p=n.s.), nor in trough levels during maintenance therapy (2.3± 0.4µg/mL vs. 1.9 ±0.4µg/mL, p=n.s.). Patients requiring dose escalation did not differ from stable responders in maintenance trough levels (2.4±0,6 µg/mL vs. 2,3 ±0,4 µg/mL). Conclusion In this limited size real-world cohort of IBD patients, we found no difference in pharmacokinetics between reponders and non-reponders to ustekinumab.

scholarly journals P552 Withdrawal of immunomodulator medications (IM) in children with inflammatory bowel disease on combination therapy of IM and biologics

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S468-S470
Author(s):  
A Chandrakumar ◽  
M Carroll ◽  
J deBruyn ◽  
K Jacobson ◽  
H Huynh ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Combination Therapy ◽  
Median Duration ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Factors Associated ◽  
Pediatric Study ◽  
First Relapse ◽  
Inflammatory Bowel

Abstract Background Anti-tumor necrosis factor (anti-TNF) antagonists such as infliximab (IFX) are widely used for the treatment of inflammatory bowel disease (IBD). Early studies suggested that combination therapy with IFX and an immunomodulator drug (IM) such as azathioprine (AZA) or methotrexate (MTX) may help in optimising biologic pharmacokinetics, minimising immunogenicity, and improving outcomes. On the other hand, IM especially AZA, may increase infection and cancer risks with no clear evidence on long-term benefits of combination therapy. As such, stopping IM and continuation of an anti-TNF agent as a monotherapy in patients in remission seem to be a sensible strategy. However, there is no evidence to prove the efficacy of this strategy. The aim of this work was to examine frequency and factors associated with the first relapse after IM withdrawal in a cohort of children with IBD on combination therapy. Methods In a retrospective multicenter pediatric study, we determined the percentage of patients and investigated potential factors associated with the first relapse in a cohort of children and young adults with IBD on combination therapy of anti-TNF and IM after stopping IM. Cox regression analysis was used to assess factors associated with IBD relapse following IM withdrawal. Results A total of 79 patients (42, males, 62 Crohn’s disease) with 74 (93.7%) on IFX were included. In addition to the anti-TNF agent, 33 (41.8%) were on AZA and the rest were on MTX. The median duration of combination therapy was 2.0 (IQR 1.2–2.8) years. All participants were in clinical remission at the time of IM withdrawal. The median duration of follow-up after IM withdrawal was 11.0 (IQR 5.0–16.2) months. Only 8 (10.1%) patients relapsed over that period of follow-up. Age, sex, disease phenotype at diagnosis, family history of IBD, type of IM, and biochemical markers and clinical disease activity indices prior to IM stoppage did not predict a future relapse. Among those with CD on IFX who maintained remission, the median last IFX trough level before IM withdrawal was 6.25 Ug/ml (IQR: 4.04–8.70) vs. 3.8 Ug/ml (IQR: 2.40–11.6) in those who relapsed (p = 0.4). Conclusion Over short-term follow-up, the majority of children on combination therapy of IM and an anti-TNF agent remain in clinical remission after IM withdrawal.

scholarly journals P438 Real-life effectiveness and safety of ABP501, an adalimumab biosimilar, in inflammatory bowel disease: a multicentre Italian study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S397-S397
Author(s):  
B Barberio ◽  
F Zingone ◽  
A Ferronato ◽  
A Buda ◽  
P Melatti ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Real Life ◽  
Infusion Reaction ◽  
Categorical Variables ◽  
Azathioprine Therapy ◽  
Inflammatory Bowel ◽  
T1 And T2

Abstract Background Recently, various adalimumab (ADA) biosimilars have been approved by the EMA with the same indications of the reference product (Humira), despite the lack of data in terms of efficacy and safety in patients with inflammatory bowel disease (IBD). The aim of our study was to verify the effectiveness and tolerability of ABP501, an ADA Biosimilar, in IBD in the short-term. Methods All consecutive moderate-to-severe IBD patients who completed induction with ABP501 at three Italian IBD Units (Padua, Santorso, Feltre) were included. We collected data on partial Mayo (p-Mayo) Score, Harvey–Bradshaw Index (HBI), C reactive protein (CRP), faecal calprotectin (FC), concomitant steroid and azathioprine therapy at baseline (T0), after induction (T1) and at six months (T2). Information on the need for optimisation and adverse events (AEs) were also collected. Continuous and categorical variables were expressed as mean with standard deviation and frequency with percentages, respectively. Comparisons between variables were conducted using a t-test and chi-square test. Data were analysed using STATA11.1 software. Results Thirty-three IBD patients [17 with ulcerative colitis (CU), 18 with Crohn’s disease (CD)] that completed induction (T1) were considered, with 18 of them who completed at least six months of therapy (T2). Clinical remission was achieved by 14/33 (45.5%) and 8/18 (44.4) patients at T1 and T2, respectively. Steroid-free clinical remission was obtained by 14/33 (42.4%) and 8/18 (44.4) patients at T1 and T2, respectively. After induction FC tended to decrease from baseline to T2, without reaching statistical significance (p = 0.1). However, a significant decrease in CRP levels (p &lt; 0.02) was observed. After induction, AEs occurred in 11 (33.3%) patients: 2 had an infection, 8 reported headache or myalgia or arthralgia, and one experienced a local infusion reaction. Moreover, AEs were observed in 6/18 (33.3%) at T2: 5 had arthralgia and 1 had a local infusion reaction. After induction 4/33 (12.12%) stopped therapy for lack of response, whereas the dropout occurred in 6/12 (33.3%) at six months (4 for loss of response and 2 for adverse events). Finally, 7/33 (21.2%) and 5/18 (27.7%) patients needed therapeutic optimisation at T1 and T2, respectively. Conclusion ABP501 seemed to be successful in achieving clinical remission and steroid-free clinical remission, but further data are required. Overall the therapy was well tolerated.

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