Biosimilars of Adalimumab in Inflammatory Bowel Disease: Are we Ready for that?

2019 ◽  
Vol 25 (1) ◽  
pp. 7-12 ◽  
Author(s):  
Marjorie Argollo ◽  
Gionata Fiorino ◽  
Daniela Gilardi ◽  
Federica Furfaro ◽  
Giulia Roda ◽  
...  

Introduction: Biosimilars present a considerable potential to reduce costs related to clinical management allowing health-care providers to reinvest this money, leading to a wider access to an effective biological treatment with monoclonal antibodies (mAb). Infliximab biosimilars have already been incorporated in daily clinical practice and are currently used in all indications for which the reference product (RP) was approved. Areas covered: In the next few years, also adalimumab biosimilars will become available for the treatment of inflammatory bowel disease (IBD). In fact, several of them (ABP501, BI 695501, GP2017, and SB5) have been approved by the European Medicines Agency (EMA) with the same indications of the reference product (Humira ®). Initial preclinical data proved a strong similarity between all biosimilars and the RP. Moreover, phase 3 studies in rheumatoid arthritis and psoriasis showed no differences in terms of efficacy, safety, and immunogenicity. Data on IBD patients are urgently needed. Expert opinion: Biosimilars of adalimumab showed equivalent clinical efficacy to the RP in other immunemediated diseases. However, defining the ideal patient’s profile to receive or to be switched to a biosimilar, choosing one biosimilar vs. another, or cross-switching among biosimilars, will become the next challenge in IBD.

2020 ◽  
Author(s):  
Lauralie Richard ◽  
Geoff Noller ◽  
Sarah Derrett ◽  
Trudy Sullivan ◽  
Fiona Doolan-Noble ◽  
...  

ABSTRACTObjectiveTo explore how adults living with Inflammatory Bowel Disease (IBD) in rural New Zealand manage their condition and engage with health care providers.DesignQualitative exploratory design with semi-structured interviews analysed thematically.Setting and participantsInterviews were conducted with 18 people living with IBD in the Otago region of the South Island.ResultsFive important constructs were identified: 1. Journey to confirming and accepting diagnosis; 2. Importance of the relationship with the health care team; 3. Support from others; 4. Learning how to manage IBD; and 5. Care at a distance - experiences of rurality. Pathways to confirming diagnosis involved two contrasting journeys: a long and slow process where diagnosis remained unclear for a prolonged period, and a more acute process where diagnosis typically came as a shock. Central to the acceptance process was acknowledging the chronicity of the condition, which involved feelings of grief but also the fear of judgement and stigma. Building a strong relationship with the specialist was central to medical management, particularly in the initial stage following diagnosis. Support from others was critical, enabling participants to progress through acceptance of the disease and developing confidence in its everyday management. Participants shared different strategies on how to manage IBD, describing a “trial and error” process of “finding what’s right” at different stages of the condition. Managing IBD rurally involved challenges of access to specialist care, with perceptions of delayed referrals and concerns about disparities in specialist access compared to urban counterparts. Rural living also had financial implications - cost of time and cost of mobilising resources for long travels to the urban centre for treatments.ConclusionsFindings from this study provide a rich understanding of the complex health journeys of people living with IBD and the challenges of managing the condition rurally.STRENGTHS AND LIMITATIONS OF THIS STUDY


2021 ◽  
Vol 116 (1) ◽  
pp. S346-S346
Author(s):  
Allison Bihari ◽  
Nima Hamidi ◽  
Cynthia H. Seow ◽  
Karen J. Goodman ◽  
Eytan Wine ◽  
...  

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S610-S610
Author(s):  
M Iizawa ◽  
L Hirose ◽  
A Tairaka ◽  
N Maya

Abstract Background Patients with inflammatory bowel disease (IBD) have to deal with abdominal symptoms for a long time because the disease often develops at a young age, and radical treatment has not been established. To prevent worsening of symptoms associated with IBD and delay the progression of the disease, and lead a better daily life, patients must self-manage in their daily lives. At this moment, it is not clear which kinds of self-management are effective for IBD patients. Therefore, we conducted a systematic literature review (SLR) to clarify the present status and efficacy of self-management for IBD patients and find out the effective methods of self-management intervention. Methods The SLR was conducted in accordance with the methods recommended by the Cochrane Collaboration Handbook7, to reduce the risk of bias and errors. The searches were performed in Embase, Medline, and Cochrane databases. Additionally, the PsychInfo and the cumulative index of nursing and allied health literature (CINAHL) databases were searched, and relevant articles were included as other sources. Abstracts and full texts were screened to select relevant articles based on the inclusion criteria. A quality assessment was undertaken by using the Cochrane risk of bias tool checklist. Results Fifty studies met the inclusion criteria and were finally included in this review. In 31 studies, the overall population of IBD patients was included. Fourteen studies included only UC patients, 5 studies included only CD patients. Among 50 studies, 33 studies have statistically significant differences in the outcomes. We categorized the interventions and outcomes of all the studies based on Barlow’s study in 2002 and analyzed the efficacy of the intervention on the outcomes. The most common intervention was informational, subsequently management of psychological effects. The most common outcome was Inflammatory Bowel Disease Questionnaire (IBDQ). We found that psychological management and interventions related to problem-solving, goal setting, action plan, and coping skills had a positive effect on the body and psychology of IBD patients. There were six studies that investigated the effects of intervention by online medical care. Half of the online intervention showed an improvement in the use of medical services. Conclusion It is important for IBD patients and health care providers to work together to share the problem, followed by setting goals and decide on an action plan. To succeed in this process, multidisciplinary collaboration is necessary and continuous support by health care providers will be meaningful for IBD patients.


2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 73-74
Author(s):  
A Bihari ◽  
N Hamidi ◽  
C Seow ◽  
K Goodman ◽  
E Wine ◽  
...  

Abstract Background The incidence of childhood-onset inflammatory bowel disease (IBD) diagnoses is increasing in Canada; therefore, more patients will need to transition from pediatric into adult care. The literature on transition in IBD patients has focused mainly on preparation and while transition success is often referenced, it is not clearly defined. Prior research on IBD transition success has only focused on the perspectives of the health care providers. Taking into consideration that transition is a process that greatly relies on patient involvement, patient perspectives should be represented in defining its success. Aims The primary aim is to understand patients’ perspectives on the outcomes that characterize a successful transition from pediatric to adult care. Methods This study paired a theoretical position of naturalistic inquiry with the method of qualitative description. Purposive sampling was used to recruit patients from IBD clinics at the University of Alberta and the University of Calgary. Inclusion criteria included transition within the last two years, diagnoses with IBD for at least a year prior to transitioning, and absence of comorbidities. Virtual semi-structured interviews were conducted using an established interview guide. Interviews were transcribed verbatim and then analyzed concurrently with data collection by latent content analysis using NVivo computer software. Participant recruitment and data analysis continued until no further themes emerged from the data, which signaled that thematic saturation was achieved. Results Thematic saturation was achieved after 17 interviews. Among participants, 58.8% were female; 47% had a diagnosis of Crohn’s, 47% of ulcerative colitis, and one individual was diagnosed with both. The median age at diagnosis was 15 years (IQR, 3.5). The majority (94%) of participants viewed their transition as being successful. Overall, the major themes that emerged from the data were: 1. relationship with one’s adult care team, characterized predominantly as the patient being comfortable with their new team; 2. health outcomes, characterized by disease remaining stable, and medication adherence; 3. independence in one’s care, characterized by making and attending appointments on their own, asking questions and in general having an awareness about your health and disease; 4. care stability, characterized by no drop off in care, and regular contact and follow up by their provider. Conclusions Young adults with IBD define pediatric transition success in four themes: relationship with care team, health outcomes, independence in one’s care, and care stability. Through understanding what transition success looks like from the patients’ perspectives, health care providers can help patients achieve success as they define it. Funding Agencies None


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Karoline Freeman ◽  
Ronan Ryan ◽  
Nicholas Parsons ◽  
Sian Taylor-Phillips ◽  
Brian H. Willis ◽  
...  

Abstract Background Our knowledge of the incidence and prevalence of inflammatory bowel disease (IBD) is uncertain. Recent studies reported an increase in prevalence. However, they excluded a high proportion of ambiguous cases from general practice. Estimates are needed to inform health care providers who plan the provision of services for IBD patients. We aimed to estimate the IBD incidence and prevalence in UK general practice. Methods We undertook a retrospective cohort study of routine electronic health records from the IQVIA Medical Research Database covering 14 million patients. Adult patients from 2006 to 2016 were included. IBD was defined as an IBD related Read code or record of IBD specific medication. Annual incidence and 12-month period prevalence were calculated. Results The prevalence of IBD increased between 2006 and 2016 from 106.2 (95% CI 105.2–107.3) to 142.1 (95% CI 140.7–143.5) IBD cases per 10,000 patients which is a 33.8% increase. Incidence varied across the years. The incidence across the full study period was 69.5 (95% CI 68.6–70.4) per 100,000 person years. Conclusions In this large study we found higher estimates of IBD incidence and prevalence than previously reported. Estimates are highly dependent on definitions of disease and previously may have been underestimated.


Author(s):  
I. V. Oleksiienko

Annotation. At the turn of the 21st century, chronic inflammatory bowel disease (CIBD) has become a global disease with accelerating morbidity in industrialized countries with a prevalence exceeding 0.3%. These data underscore the need for research into the prevention of inflammatory bowel disease and innovations in health care systems to manage this complex and costly disease. The information from a personal anamnesis of 40 women patients with ulcerative colitis (clinical group (main). In the second group (control), 30 practically healthy pregnant women with a physiological course of gestation were included, which did not have in their history of inflammatory intestinal diseases. Statistical processing of research results was performed using the software package Statistica 6.0. The arithmetic mean (M) and the standard deviation error (± m) (p<0.05) were determined, as well as the odds ratio (OR), confidence interval (CI) at p=95%. It was found that for women with ulcerative colitis is characterized by the presence of a history of obstetric pathology, such as: spontaneous miscarriage of OR 3.33, 95% CI [1.06-10.53], p=0.04 and blood secretions of OR 3.0, 95% CI [1.00-8.98], p=0.0496; among extragenital pathology in the anamnesis: children's infectious diseases of OR 4.85, 95% CI [1.25-18.85], p=0.02, chronic bronchitis of OR 7.54, 95% CI [1,56-36, 41], p=0.01, varicose veins OR 4.33, 95% CI [1.11-16.95], p=0.035, chronic gastritis OR 6.0, 95% CI [1,23-29, 31], p=0.03, anemia of OR 15.0, 95% CI [4.53-49.68], p<0.0001, allergy history of OR 6.65, 95% CI [1.73-25.60], p=0.006; among gynecological complications – premenstrual syndrome OR 6.0, 95% CI [1.55-23.15], p=0.009, algomenorrhea OR 8.14, 95% CI [2.12-31.24], p=0.002 , salpingo-oophoritis, OR 7.54, 95% CI [1.56-36.41], p=0.01. Because CIBD during pregnancy is associated with an increased risk of adverse effects on the mother and fetus, information on socio-anamnestic and clinical analysis of pregnant women with ulcerative colitis will be useful to health care providers in making decisions about CIBD during pregnancy.


Sign in / Sign up

Export Citation Format

Share Document