scholarly journals P396 Acceptance of switch, patient satisfaction and adverse events after switch from adalimumab originator to biosimilar SB5 in patients with Inflammatory Bowel Disease in a real-life setting

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S406-S406
Author(s):  
T De Somer ◽  
N Deprez ◽  
D Baert ◽  
M Deceuninck ◽  
I Huys ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Patient Satisfaction ◽  
Adverse Events ◽  
Bowel Disease ◽  
Real Life ◽  
Great Majority ◽  
Patient Acceptance ◽  
Nocebo Effect ◽  
Time Points ◽  
Inflammatory Bowel

Abstract Background SB5 is approved as a biosimilar of the adalimumab originator. However, data on patient acceptance of switch from originator to biosimilar, patient satisfaction, adverse events and nocebo effects are lacking, especially in the inflammatory bowel disease (IBD) population. We sought to elucidate these issues in a real-life switch IBD population. Methods IBD patients, in clinical remission or stable response, treated with adalimumab originator in 2 Belgian centers were offered to participate in this phase IV, interventional trial. Switch was voluntary and was offered after being informed about biosimilars. Satisfaction with the switch and local discomfort after injection (within and after 30 minutes) was semi-quantitatively (visual analogue scales (VAS)) assessed at baseline and 8 weeks, 6 months and 12 months after switch. Reasons for non-switch, discontinuation and adverse events were documented. Results An acceptance of switch rate of 79.3% was observed. Fifteen patients reported 22 reasons for refusal; the most common were fear for a flare (n = 8), ease to stay on the originator (n = 4) and absence of trust in biosimilars (n = 3). No patient-related demographic factors associated with refusal of switch could be defined. By month 12, 28 patients discontinued SB5 for several reasons; the most frequent being high anti-adalimumab antibodies at baseline (n = 5), secondary loss of response (n = 3), injection site pain (ISP) (n = 8) and other adverse events (n = 10) not causally related to SB5. At month 12 after switch, 74.5% of the study population was still treated with SB5 (table 1). The median VAS for local discomfort up to 30 minutes after injection of the originator was 1/10 and increased significantly to values between 2 and 3/10 at the different time points on SB5 (p < 0.001 for all) (table 2). However, the median VAS for local discomfort after 30 minutes was between 0 and 1/10 at all time points, which was not significantly different compared to the originator. Nevertheless, satisfaction with the decision to switch was high and remained stable over the different time points with a median VAS between 7 and 8/10, which was not significantly different compared to baseline. Conclusion After being well informed, the great majority of patients treated with adalimumab originator is willing to switch to biosimilar SB5. The rate of satisfaction under treatment with SB5 is high and remains stable over time. The most important reasons for discontinuation were adverse events, which could be mostly attributed to the nocebo effect and to ISP. Of note, patients in general report a higher, temporary, local discomfort within 30 minutes after injection with SB5.

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 < 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.

scholarly journals P477 Italian real-life study evaluating the long-term effectiveness of vedolizumab for the treatment of inflammatory bowel disease: the elderly cohort

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S419-S422
Author(s):  
D Pugliese ◽  
G Privitera ◽  
A Armuzzi
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Bowel Disease ◽  
Real Life ◽  
Treatment Persistence ◽  
Diagnosis Of Cancer ◽  
Inflammatory Bowel ◽  
New Diagnosis

Abstract Background Vedolizumab (VDZ) is the first biological therapy for Inflammatory Bowel Disease (IBD) tested, in pivotal trials, on patients up to 80 years old and has usually been presented as a safer choice in frail patients. However, real-world data on the effectiveness and safety of VDZ in elderly (≥ 65 years) are scarce. The aim of this study is to explore the effectiveness and safety of VDZ in a large real-life cohort of elderly IBD patients, with a 2 years follow-up. Methods The Long-term Italian Vedolizumab Effectiveness (LIVE) study included CD and UC patients started on VDZ from April 2016 to June 2017 at 40 centres of the Italian Group for the study of inflammatory bowel disease (IG-IBD). Patients were prospectively followed-up to June 2019. Co-primary endpoints were to evaluate cumulative VDZ treatment persistence and safety. Results Of 966 patients, 174 (18%; 81 CD, 93 UC) were ≥ 65 years old at enrolment. Mean disease duration at baseline was 10.9 years ± SD10 (CD 12.5 ± 11, UC 9.6 ± 9). VDZ was used as a first biologic therapy in 78 patients (44.8%). 25 patients (14.4%) had a history of previous cancer. The majority of CD patients had a stricturing behaviour (45, 55.6%) and had already undergone surgery (41, 49.4%). 48 UC patients (51.6%) had extensive colitis. Moderate-to-severe endoscopic activity was present in 80% of CD and in 92% of UC, according to SES-CD and endoscopic Mayo score, respectively. Cumulative VDZ treatment persistence at 12 and 24 months was 71.8% (71.6% CD and 72.0% UC) and 54% (54.2% CD and 53.8%% UC), respectively. 52.9% (40 CD; 52 UC), 4.0%, 3.5%% and 2.9% of patients were on concomitant steroids at baseline, 6, 12, and 24 months, respectively. Clinical remission at 12 and 24 months was achieved in 28.7% (31 CD and 29 UC) and in 31.6% (25 CD and 30 UC) of patients. Mean C-reactive protein was 15.6 mg/l ± SD 20 (CD 15.9 ± 21; UC 15.2 ± 19) at baseline and dropped to 8.4 mg/l ± 10 (CD 8.0 ± 8, UC 8.9 ± 11) at 12 months and to 5.9 mg/l ± 6 (CD 5.8 ± 5, UC 6 ± 7) at 24 months. Dose escalation was necessary for 20.3% and 24.7% of patients within the first 12 and 24 months. 44 adverse events were reported: 16 infections.,6 new diagnosis of cancer/dysplasia (2 colon, 1 kidney, 1 prostate, 1 lung, 1 melanoma), 4 arthritis, 3 skin rash, 2 drug-induced cholestasis,11 miscellaneous. 11 patients (6.3%) underwent VDZ withdrawal because of adverse events (6 new diagnosis of cancer/dysplasia; 4 infections; 1 cholestasis). One patient died for pneumonia complications. Conclusion In this preliminary analysis of the largest reported real-world cohorts of elderly IBD patients treated with VDZ, up to 55% of patients persisted on therapy after two years; an acceptable safety profile was observed throughout the entire follow-up period.

DISCONTINUATION RATES FOLLOWING A SWITCH FROM A REFERENCE TO A BIOSIMILAR BIOLOGIC IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS

2020 ◽  
Vol 57 (3) ◽  
pp. 232-243 ◽  
Author(s):  
Natália Sousa Freitas QUEIROZ ◽  
Rogerio SAAD-HOSSNE ◽  
Renata de Sá Brito FRÓES ◽  
Francisco Guilherme Cancela e PENNA ◽  
Stefania Burjack GABRIEL ◽  
...  
Keyword(s):  
Systematic Review ◽  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Bowel Disease ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Drug Discontinuation ◽  
Nocebo Effect ◽  
Inflammatory Bowel ◽  
Nocebo Effects

ABSTRACT BACKGROUND: Biologics have revolutionized the treatment of inflammatory bowel disease (IBD). However, these drugs had a significant influence on treatment-related costs, which resulted in the development of biosimilars. OBJECTIVE: This systematic review and meta-analysis aimed to evaluate the drug discontinuation rate in the IBD population who switched from originator to biosimilars in real-world switching studies and address potential nocebo effects as reasons for drug discontinuation. METHODS: Medline (via PubMed), EMBASE, Cochrane Library, and abstract databases of selected congresses were screened for reports of monoclonal antibody (mAb) switching with a minimum post-switch follow-up of >6 months or three infusions. All available information on discontinuation rates was assessed. RESULTS: A total of 30 observational studies were included, involving 3,594 patients with IBD. Twenty-six studies reported a switch from infliximab to CT-P13, two studies involved a switch to SB2, and switching information was not available in two studies. The discontinuation rates were 8%, 14%, and 21% at 6, 12, and 24 months, respectively. The main reasons for drug discontinuation and their respective risks were: disease worsening (2%), remission (4%), loss of adherence (4%), adverse events (5%), and loss of response (7%). The quality of the evidence ranged from low to very low depending on the outcome analyzed. Subjective symptoms leading to drug discontinuation were infrequently reported, and the nocebo effect was clearly assessed in just one of the included papers. CONCLUSION: Discontinuation rates following a switch to a biosimilar in patients with IBD increase over time. However, it was not possible to confirm the nocebo effect as a reason for discontinuation. Therefore, long-term studies evaluating the use of biosimilars to monitor adverse events and potential nocebo effects in post-marketing surveillance are still needed.

scholarly journals Predicting disease course in ulcerative colitis using stool proteins identified through an aptamer-based screen

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Sanam Soomro ◽  
Suresh Venkateswaran ◽  
Kamala Vanarsa ◽  
Marwa Kharboutli ◽  
Malavika Nidhi ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Fecal Calprotectin ◽  
Disease Monitoring ◽  
Disease Course ◽  
Lipocalin 2 ◽  
Time Points ◽  
Inflammatory Bowel ◽  
Stool Samples

AbstractIn the search for improved stool biomarkers for inflammatory bowel disease (IBD), an aptamer-based screen of 1129 stool proteins was conducted using stool samples from an IBD cohort. Here we report that of the 20 proteins subsequently validated by ELISA, stool Ferritin, Fibrinogen, Haptoglobin, Hemoglobin, Lipocalin-2, MMP-12, MMP-9, Myeloperoxidase, PGRP-S, Properdin, Resistin, Serpin A4, and TIMP-1 are significantly elevated in both ulcerative colitis (UC) and Crohn’s disease (CD) compared to controls. When tested in a longitudinal cohort of 50 UC patients at 4 time-points, fecal Fibrinogen, MMP-8, PGRP-S, and TIMP-2 show the strongest positive correlation with concurrent PUCAI and PGA scores and are superior to fecal calprotectin. Unlike fecal calprotectin, baseline stool Fibrinogen, MMP-12, PGRP-S, TIMP-1, and TIMP-2 can predict clinical remission at Week-4. Here we show that stool proteins identified using the comprehensive aptamer-based screen are superior to fecal calprotectin alone in disease monitoring and prediction in IBD.

scholarly journals A86 INFLAMMATORY BOWEL DISEASE PATIENTS’ SATISFACTION WITH TELEHEALTH: DURING THE COVID-19 PANDEMIC

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 56-57
Author(s):  
M Painchaud ◽  
S Singh ◽  
R M Penner
Keyword(s):  
Inflammatory Bowel Disease ◽  
Patient Satisfaction ◽  
Quality Of Care ◽  
Bowel Disease ◽  
Online Survey ◽  
Ease Of Use ◽  
Term Care ◽  
Continuous Contact ◽  
Inflammatory Bowel

Abstract Background Due to the COVID-19 pandemic, clinics were forced to implement telehealth into clinical practice. Inflammatory bowel disease (IBD) patients are a unique population that require long-term care to achieve and maintain deep remission of disease. Thus, they require stable and continuous contact with healthcare providers, often with multiple appointments. We examined an IBD predominant practice, also providing care for general gastrointestinal (GI) conditions in Kelowna, British Columbia. As telehealth has the potential to become a standard of care for clinics, patient satisfaction must be considered. We hypothesize that with the efficacy and ease of remote appointments, there will be an increase in patient satisfaction, quality of care, and quality of communication. Aims We aim to compare the level of patient satisfaction between in-person appointments pre-pandemic, and current remote appointment telehealth practices. Methods An online survey was sent to the 608 patients who had participated in one or more remote appointment between March 15-June 15, 2020. The survey compared the level of patient satisfaction, quality of care, and quality of communication between patient and doctor before and during the pandemic. It was also determined if patients would elect to continue with remote appointments in the future due to ease of use, and time/financial resources saved. Results Of the 273 participants, 80% were IBD patients while 20% were treated for other GI conditions. A total of 78% reported that they would elect to continue with remote appointments as their primary point of care with their doctor. The remaining 22% reported that they prefer in-person visits due to the necessity of a physical exam, yet specified that communication by these remote means was still of good quality. Levels of patient satisfaction before and during the pandemic remained consistent, where 59% of patients assigned a satisfaction rating of 10 (highest) to their pre-pandemic in-person appointments, and 54% of patients assigned a rating of 10 to their remote appointments during the pandemic. Similar consistent results were found for quality of care and quality of communication. A total of 70% of patients reported that if this service had not been available, they would have sought out other forms of care; 18% of the total responses considering emergency care. Conclusions IBD patients at Kelowna Gastroenterology perceived similar levels of satisfaction, quality of care, and quality of communication with both in-person and telehealth appointments. This suggests that telehealth practices may be a cost-effective, sustainable appointment style that provides comparable quality to in-person appointments. Funding Agencies None

scholarly journals The burden and management of anemia in Greek patients with inflammatory bowel disease: a retrospective, multicenter, observational study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kalliopi Foteinogiannopoulou ◽  
Konstantinos Karmiris ◽  
Georgios Axiaris ◽  
Magdalini Velegraki ◽  
Antonios Gklavas ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Clinical Laboratory ◽  
Real Life ◽  
Extraintestinal Manifestations ◽  
Extraintestinal Manifestation ◽  
Multicenter Observational Study ◽  
Treatment Data ◽  
Inflammatory Bowel ◽  
Anemia Treatment

Abstract Background Anemia is a common extraintestinal manifestation of Inflammatory Bowel Disease (IBD) affecting negatively the patients’ quality of life. The aim of this study was to determine the frequency and real-life management of anemia in IBD patients in Greece. Methods This study was conducted in 17 Greek IBD referral centers. Demographic, clinical, laboratory, IBD and anemia treatment data were collected and analyzed retrospectively. Results A total of 1394 IBD patients [560 ulcerative colitis (UC), 834 Crohn’s disease (CD)] were enrolled. Anemia at any time was reported in 687 (49.3%) patients of whom 413 (29.6%) had episodic and 274 (19.7%) had recurrent/persistent anemia. Anemia was diagnosed before IBD in 45 (6.5%), along with IBD in 269 (39.2%) and after IBD in 373 (54.3%) patients. In the multivariate analysis the presence of extraintestinal manifestations (p = 0.0008), IBD duration (p = 0.026), IBD related surgeries and hospitalizations (p = 0.026 and p = 0.004 accordingly) were risk factors of recurrent/persistent anemia. Serum ferritin was measured in 839 (60.2%) IBD patients. Among anemic patients, 535 (77.9%) received treatment. Iron supplementation was administered in 485 (90.6%) patients, oral in 142 (29.3%) and intravenous in 393 (81%). Conclusions The frequency of anemia in IBD patients, followed at Greek referral centers, is approximately 50%. Development of recurrent/persistent anemia may be observed in 20% of cases and is independently associated with the presence of extraintestinal manifestations, IBD duration, IBD related surgeries and hospitalizations. Anemia treatment is administered in up to $$4/5$$ 4 / 5 of anemia IBD patients with the majority of them receiving iron intravenously.

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