scholarly journals P281 Evaluation of trough level and disease activity after switch from adalimumab originator to biosimilar in patients with Inflammatory Bowel Disease

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S314-S315
Author(s):  
N Deprez ◽  
T De Somer ◽  
D Baert ◽  
M Deceuninck ◽  
I Huys ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Biochemical Parameters ◽  
Trough Level ◽  
Secondary Outcome ◽  
Inflammatory Bowel ◽  
Trough Levels ◽  
Over Time ◽  
Phase Iv

Abstract Background SB5 is approved as a biosimilar to the adalimumab (ADA) originator. Bio- and efficacy equivalence, as well as comparable safety and immunogenicity have been demonstrated in Phase I and III randomised clinical trials. In this study we want to describe the trough levels and effectiveness of switch to a biosimilar in a real-life Inflammatory Bowel Disease (IBD) population. Methods In 2 Belgian IBD centres, patients in clinical remission or stable response and treated with ADA originator were offered to enter a phase IV, interventional trial of switch to biosimilar SB5. Assessments were done at baseline, at 8 weeks, 6 and 12 months post-switch. Therapy type and dosing regimen remained unchanged the first 8 weeks; after week 8, dose adjustments could be made based on trough level and/or at the discretion of the treating physician. Trough serum ADA concentrations were measured by enzyme-linked immunosorbent assay (ELISA). The primary outcome measurement was the description of ADA trough level over time after the switch. The secondary outcome measurements were secondary loss of response (SLOR) (defined at physician’s discretion), disease activity scores and biochemical assessments (faecal calprotectin (fCal), leukocyte count (LC) and C-reactive protein (CRP)). Results In the study, 110 patients were enrolled from whom 84 had Crohn’s disease and 26 had ulcerative colitis. By 12 months, SB5 was stopped in 5 patients because of high ADA antidrug antibodies at both baseline and at week 8. Nine patients presented with SLOR of whom 3 discontinued treatment with SB5, the remaining 6 patients received treatment optimisation. Table 1 displays the core results concerning the ADA trough levels over time. Table 2a and 2b display disease activity scores and biochemical parameters at the different time points. Conclusion In this pragmatic, interventional phase IV trial, ADA trough levels remain within the therapeutic range after switch from originator to SB5. The proportion of patients in our study with SLOR is in line with what is described in literature. In patients persisting on SB5, no change in disease activity over time is observed, based on both disease activity scores and biochemical parameters.

Tu1113 Fecal Microbial Composition of Inflammatory Bowel Disease (IBD) Patients With Changing Disease Activity Over Time

2013 ◽  
Vol 144 (5) ◽  
pp. S-765-S-766
Author(s):  
Edgar Wills ◽  
Daisy Jonkers ◽  
Paul Savelkoul ◽  
Marie J. Pierik ◽  
Ad Masclee ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Microbial Composition ◽  
Inflammatory Bowel ◽  
Over Time

scholarly journals Distinct Cutoff Values of Adalimumab Trough Levels Are Associated With Different Therapeutic Outcomes in Patients With Inflammatory Bowel Disease

2019 ◽  
Vol 1 (3) ◽  
Author(s):  
Sang Hyoung Park ◽  
Badr Al-Bawardy ◽  
Satimai Aniwan ◽  
Sunanda V Kane ◽  
Nayantara Coelho-Prabhu ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Cutoff Value ◽  
Reactive Protein ◽  
Therapeutic Outcomes ◽  
Inflammatory Bowel ◽  
Relationship Of ◽  
The Relationship ◽  
Trough Levels

Abstract Background and Aims We aimed to evaluate the relationship of serum adalimumab trough levels (ATL) with disease activity of inflammatory bowel disease (IBD) patients in a large, well-characterized referral center-based cohort. Methods We compared serum ATL between those with clinical, biochemical, or endoscopic/radiologic disease activity and those without. Results A total of 236 patients with IBD were included. Higher cutoff levels were associated with endoscopic and/or radiologic responses (cutoff value: 5.3 mcg/mL, P = 0.003) compared with improvement in C-reactive protein (cutoff value: 4.3 mcg/mL, P = 0.031). Conclusions Higher cutoff ATL was associated with endoscopic and/or radiologic response.

Clinical implications of assay specific differences in f-calprotectin when monitoring inflammatory bowel disease activity over time

2016 ◽  
Vol 52 (3) ◽  
pp. 344-350 ◽  
Author(s):  
Karin Amcoff ◽  
Mats Stridsberg ◽  
Maria Lampinen ◽  
Anders Magnuson ◽  
Marie Carlson ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Clinical Implications ◽  
Inflammatory Bowel ◽  
Over Time

scholarly journals P485 Switching infliximab biosimilar: No adverse impact on inflammatory bowel disease control or drug levels with the first or second switch

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S426-S427
Author(s):  
R Luber ◽  
R O’Neill ◽  
S Singh ◽  
Z Arkir ◽  
P Irving
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Disease Control ◽  
Bowel Disease ◽  
Trough Level ◽  
Clinical Disease ◽  
Drug Levels ◽  
Clinical Disease Activity ◽  
Inflammatory Bowel ◽  
Activity Indices

Abstract Background Biological medicines account for a significant cost to healthcare systems. With the advent of anti-tumour necrosis factor biosimilars, switching from originator to biosimilar has enabled cost saving in inflammatory bowel disease (IBD) without compromising disease control. However, with more biosimilars entering the market, the effect on IBD activity and pharmacokinetics (PK) of a second switch to another biosimilar is uncertain. This study aims to assess the effect on disease activity and drug levels associated with switching from infliximab (IFX) biosimilar Remsima® (Celltrion, Hungary) to another biosimilar, Flixabi® (Samsung Bioepis, The Netherlands), and to compare those switching for the first and second time. Methods All IBD patients on IFX biosimilar Remsima® were prospectively followed during their switch to Flixabi® in a single centre. Baseline data including C-reactive protein (CRP), trough IFX level, and clinical disease activity indices were collected; Harvey Bradshaw Index for Crohn’s disease (CD) and Simple Clinical Colitis Activity Index for ulcerative colitis (UC). These indices were repeated after at least two infusions of Flixabi®. Results 221 patients (179 CD, 42 UC) on stable IFX treatment were included in the study. 174 (79%) were on a concomitant immunomodulator. 5 (2%) patients ceased IFX prior to follow-up due to sustained remission, and 3 (1%) patients discontinued due to factors not directly related to drug or disease. 112 patients had PK analysis performed pre and post switch. An increase in IFX trough level was observed after switching IFX biosimilars; baseline median (IQR) trough level of 4.5µg/ml (2.9–6.3) compared with post switch of 5.1µg/ml (3.4–7.0) (p = 0.02). There was no difference in clinical scores or CRP post switch, and no new anti-IFX antibodies were detected. 107 patients (48%) were switching IFX agent for the second time, of which 51 had PK analysis performed. A similar increase in median IFX trough level was observed post switch in those switching for the first (4.7 vs. 6.1 µg/ml, p = 0.03) and second (4.0 vs. 4.5µg/ml, p = 0.05) times (Figure 1). No change in clinical disease activity or CRP occurred in either group. Concomitant immunomodulator and disease classification had no impact on change in IFX level (p = 0.72 and 0.37, respectively, on univariate analysis). Conclusion In a cohort of IBD patients switching to a new IFX biosimilar either for the first or second time, an increase in IFX level was observed with no impact on clinical and biochemical disease activity indices. Switching IFX biosimilars in IBD appears safe in the short term with respect to maintaining drug pharmacokinetic profile and disease control whether switching for the first or second time.

The association of infliximab trough levels with disease activity in pediatric inflammatory bowel disease

2015 ◽  
Vol 50 (9) ◽  
pp. 1110-1117 ◽  
Author(s):  
Daniël R. Hoekman ◽  
Johannan F. Brandse ◽  
Tim G. de Meij ◽  
Thalia Z. Hummel ◽  
Mark Löwenberg ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Pediatric Inflammatory Bowel Disease ◽  
Inflammatory Bowel ◽  
Trough Levels

scholarly journals Clinical Relevance of Anti-TNF Antibody Trough Levels and Anti-Drug Antibodies in Treating Inflammatory Bowel Disease Patients

2020 ◽  
pp. 1-10
Author(s):  
Ilana Reinhold ◽  
Sena Blümel ◽  
Jens Schreiner ◽  
Onur Boyman ◽  
Jan Bögeholz ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Clinical Disease ◽  
Therapeutic Drug ◽  
Real World Data ◽  
Significant Treatment ◽  
Infusion Reactions ◽  
Inflammatory Bowel ◽  
Trough Levels

<b><i>Background and Aims:</i></b> The majority of patients treated with anti-tumor necrosis factor (TNF) therapy develop anti-drug antibodies (ADAs), which might result in loss of treatment efficacy. Strict guidelines on measuring trough levels (TLs) and ADA in clinical routine do not exist. To provide real-world data, we took advantage of our tertiary inflammatory bowel disease (IBD) center patient cohort and determined indicators for therapeutic drug monitoring (TDM) and actual consequences in patient care. <b><i>Methods:</i></b> We retrospectively collected clinical data of 104 IBD patients treated with infliximab or adalimumab in our IBD clinic. Patients with TL and ADA measurements between June 2015 and February 2018 were included. <b><i>Results:</i></b> The main reason for determining TL was increased clinical disease. Subtherapeutic TLs were found in 33 patients, therapeutic TLs in 33 patients, and supratherapeutic TLs in 38 patients. Adjustments in anti-TNF therapy occurred more frequently (<i>p</i> = 0.01) in patients with subtherapeutic TL (24 of 33 patients; 73%) as compared to patients with therapeutic and supratherapeutic TLs (26 of 71 patients; 37%). No correlation could be found between TL and disease activity (<i>p</i> = 0.16). Presence of ADA was found in 16 patients, correlated with the development of infusion reactions (OR: 10.6, RR: 5.4, CI: 2.9–38.6), and was associated with subtherapeutic TL in 15 patients (93.8%). Treatment adaptations were based on TL and/or ADA presence in 36 of 63 patients. <b><i>Conclusions:</i></b> TDM showed significant treatment adaptations in patients with subtherapeutic TL. Conversely, in patients with therapeutic and supratherapeutic TLs, reasons for adaptations were based on considerations other than TL, such as clinical disease activity. Further studies should focus on decision-making in patients presenting with supratherapeutic TL in remission.

Infliximab trough levels are decreasing over time in patients with inflammatory bowel disease on maintenance treatment with infliximab

2019 ◽  
Vol 31 (2) ◽  
pp. 187-191 ◽  
Author(s):  
Eleni Orfanoudaki ◽  
Maria Gazouli ◽  
Kalliopi Foteinogiannopoulou ◽  
Eirini Theodoraki ◽  
Evangelia Legaki ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Maintenance Treatment ◽  
Inflammatory Bowel ◽  
Trough Levels ◽  
Over Time

scholarly journals Trajectories of Fatigue in Inflammatory Bowel Disease

2021 ◽  
Author(s):  
Birte Klusmann ◽  
Joke Fleer ◽  
K Annika Tovote ◽  
Rinse K Weersma ◽  
Hendrik M van Dullemen ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Latent Class ◽  
Medical Center ◽  
Well Being ◽  
Fatigue Severity ◽  
Inflammatory Bowel ◽  
The University ◽  
Over Time

Abstract Background Fatigue is one of the most frequently reported symptoms by patients with inflammatory bowel disease (IBD), both during active disease phases as well as during clinical remission. This study addressed whether different trajectories of fatigue over time can be identified among patients with IBD. Subsequently, we compared the demographic and clinical characteristics between trajectories. Methods The current study included 849 patients with IBD diagnosed with either Crohn disease (CD; n = 511) or ulcerative colitis (UC; n = 338) who visited the University Medical Center in Groningen (the Netherlands) at least 3 times during a 9-year follow-up. We conducted latent class growth analyses to identify distinct trajectories. Results In all patients with IBD (and in the subgroup with CD), we found 5 trajectories for fatigue. In the UC subgroup, we found 4 fatigue trajectories. One trajectory present in both patients with CD (11.45%) and patients with UC (4.75%) was characterized by chronic elevated levels of fatigue across time. Women and parents were more prevalent in trajectories with higher fatigue severity. We also found significant associations among the fatigue trajectories with disease activity and psychological well-being. Conclusions The results clearly showed the existence of distinct fatigue paths over time in patients with IBD. Those reporting more chronic elevated levels of fatigue also reported greater disease activity and reduced well-being. Therefore, reducing disease activity may be important for the treatment of fatigue. In addition, given the significant association with well-being, it is possible that reducing fatigue may improve self-reported well-being.

scholarly journals Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease

2018 ◽  
Vol 11 ◽  
pp. 175628481880124 ◽  
Author(s):  
Viktoria Bergqvist ◽  
Mohammad Kadivar ◽  
Daniel Molin ◽  
Leif Angelison ◽  
Per Hammarlund ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Disease Activity ◽  
Bowel Disease ◽  
Clinical Disease ◽  
Clinical Disease Activity ◽  
Inflammatory Bowel ◽  
Trough Levels

Background: As the patents of originator biologics are expiring, biosimilar versions are becoming available for the treatment of inflammatory bowel disease (IBD). However, published switch studies of the first infliximab biosimilar, CT-P13, have delivered ambiguous results that could be interpreted as showing a trend towards inferior effectiveness in Crohn’s disease (CD) compared with ulcerative colitis (UC). The aim of this study was to investigate the effectiveness and safety of switching IBD patients from treatment with Remicade to CT-P13. Methods: In this prospective observational cohort study, all adult IBD patients on Remicade treatment, at four hospitals, were switched to CT-P13. The primary endpoint was change in clinical disease activity at 2, 6, and 12 months after the switch. Secondary endpoints were subgroup analyses of patients with and without concomitant immunomodulators; changes in biomarkers, quality of life, drug trough levels and anti-drug antibodies (ADAbs); and adverse events. Results: A total of 313 IBD patients were switched (195 CD; 118 UC). There were no significant changes in clinical disease activity, quality of life, biomarkers (except a small but significant increase in albumin in CD) including F-calprotectin, drug trough levels, or proportion of patients in remission. Disease worsening rates were 14.0% for CD and 13.8% for UC; and 2.7% developed ADAbs and 2.2% developed serious adverse events. Conclusions: This is the largest study of switched IBD patients published to date, and it demonstrates that switching from Remicade to CT-P13 may be done with preserved therapeutic effectiveness and safety in both CD and UC.

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