Can We Extrapolate Data from One Immune-Mediated Inflammatory Disease to Another One?

2019 ◽  
Vol 26 (2) ◽  
pp. 248-258 ◽  
Author(s):  
Fernando Magro ◽  
Rosa Coelho ◽  
Armando Peixoto
Keyword(s):  
Rheumatoid Arthritis ◽  
Inflammatory Diseases ◽  
Analytical Techniques ◽  
Approval Process ◽  
Homogeneous Population ◽  
Post Translational Modifications ◽  
Innovator Product ◽  
Immune Mediated ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Immune-mediated inflammatory diseases share several pathogenic pathways and this pushes sometimes to extrapolate from one disease or indication to others. A biosimilar can be defined as a biotherapeutic product which is similar in terms of quality, safety, and efficacy to an already licensed reference biotherapeutic product. We review the substrate for extrapolation, the current approval process for biosimilars and the pioneering studies on biosimilars performed in rheumatoid arthritis patients. A biosimilar has the same amino acid sequence as its innovator product. However, post-translational modifications can occur and the current analytical techniques do not allow the final structure. To test the efficacy in one indication, a homogeneous population should be chosen and immunogenicity features are essential in switching and interchangeability. CT-P13 (Remsima™; Inflectra™) is a biosimilar of reference infliximab (Remicade®). It meets most of the requirements for extrapolation. Nevertheless, in inflammatory bowel diseases (IBD) we need more studies to confirm the postulates of extrapolation from rheumatoid arthritis and ankylosing spondylitis to IBD. Furthermore, an effective pharmacovigilance schedule is mandatory to look for immunogenicity and side effects.

scholarly journals P795 Risk of incident paradoxical immune-mediated inflammatory diseases in patients with inflammatory bowel diseases treated with anti-TNF therapies: a nationwide Danish cohort study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S625-S625
Author(s):  
D WARD ◽  
S Gørtz ◽  
N Nyboe Andersen ◽  
J Kirchgesner ◽  
T Jess
Keyword(s):  
Rheumatoid Arthritis ◽  
Cohort Study ◽  
Inflammatory Bowel Diseases ◽  
Hidradenitis Suppurativa ◽  
Inflammatory Diseases ◽  
Hazard Ratios ◽  
Immune Mediated ◽  
Bowel Diseases ◽  
Lag Period ◽  
Inflammatory Bowel

Abstract Background Tumour necrosis factor (TNF) has a central role in the pathophysiology of immune-mediated inflammatory diseases (IMIDs) including rheumatoid arthritis, psoriasis, hidradenitis suppurativa, and inflammatory bowel diseases (IBD). However, there have been case reports of patients receiving an anti-TNF therapy for one IMID subsequently developing a second IMID. We conducted a nationwide cohort study investigating the risk of incident IMID following anti-TNF exposure in patients with IBD in Denmark. Methods We followed patients with IBD from 1 January 2005 or date of IBD diagnosis (whichever occurred last) to an outcome event including incident diagnosis of hidradenitis suppurativa, arthropathic psoriasis, other forms of psoriasis, or rheumatoid arthritis; or emigration, death or 31 December 2018 (whichever occurred first). Patients were defined as exposed after a 3-month lag period from first anti-TNF infusion throughout follow-up, analogous to an intention-to-treat design. The lag period was censored from analyses to avoid including incipient IMIDs, unlikely to be caused by newly initiated anti-TNF treatment. We excluded patients initiating anti-TNF or with an outcome diagnosis before either 1 January 2005 or IBD diagnosis. We used Cox regression models with age as the underlying timescale, and sex, type of IBD (Crohn’s disease or ulcerative colitis), and calendar period of IBD diagnosis (in 5 year groups) as strata to estimate hazard ratios for each outcome, comparing anti-TNF users and non-users. Results Incidence rates (and 95% confidence intervals [CI]) as events per 100 000 person-years among anti-TNF users and non-users were, respectively, 138 (109–173) and 25.6 (22.0–29.7) for hidradenitis suppurativa, 26.3 (15.6–44.4) and 7.81 (5.95–10.2) for arthropathic psoriasis, 1177 (1085–1277) and 204 (121–189) for other forms of psoriasis, and 152 (121–189) and 95.6 (88.5–103) for rheumatoid arthritis. Hazard ratios (and 95% C.I.) were increased for hidradenitis suppurativa 2.91 (2.15–3.94), arthropathic psoriasis 2.62 (1.40–4.93), other forms of psoriasis 4.76 (4.27–5.31), and rheumatoid arthritis 2.35 (1.83–3.01). Conclusion The results indicate that patients with IBD receiving anti-TNF have an increased risk of IMIDs. An almost 5-fold increase in the risk of psoriasis is consistent with previous reports of psoriasiform skin lesions related to anti-TNF use. However, as more severe IBD is likely to be associated with both initiating anti-TNF and the incidence of other inflammatory diseases, the results are subject to confounding by indication. Thus, these results should be considered preliminary, and we plan to further address confounding by using propensity score methods.

scholarly journals IBD considerations in spondyloarthritis

2020 ◽  
Vol 12 ◽  
pp. 1759720X2093941
Author(s):  
Caroline Di Jiang ◽  
Tim Raine
Keyword(s):  
Inflammatory Diseases ◽  
Drug Dosing ◽  
Inflammatory Conditions ◽  
Gastrointestinal Pathology ◽  
Immune Mediated ◽  
Form Part ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Gastrointestinal Inflammation ◽  
The Difference

Spondyloarthritis (SpA) may be regarded a family of auto-inflammatory conditions with inflammation focused on the joints. These form part of a wider family of immune-mediated inflammatory diseases, which include inflammatory bowel diseases (IBD). These conditions share common elements of pathophysiology and it is perhaps unsurprising, therefore, that individuals with SpA frequently manifest gastrointestinal inflammation, to which the physician managing the patient with SpA must be alert. In this article, we review the shared epidemiology and pathophysiology of these conditions, before discussing approaches to diagnosis and management of inflammatory gastrointestinal pathology in patients seen in rheumatology clinics. In particular, we discuss the difference between non-specific gastrointestinal inflammation commonly described in this patient group and the more specific diagnosis of Crohn’s disease or ulcerative colitis. We describe the appropriate diagnostic workup for patients suspected of having IBD. In addition, we discuss how a diagnosis of IBD can inform treatment selection, highlighting important differences in treatment choice, drug dosing, monitoring and drug safety for this particular comorbid patient population.

scholarly journals Belgian IBD Research Group [BIRD] Position Statement 2019 on the Use of Adalimumab Biosimilars in Inflammatory Bowel Diseases

2019 ◽  
Vol 14 (5) ◽  
pp. 680-685 ◽  
Author(s):  
Michaël Somers ◽  
Peter Bossuyt ◽  
Marc Ferrante ◽  
Harald Peeters ◽  
Filip Baert
Keyword(s):  
Inflammatory Bowel Disease ◽  
Research Group ◽  
Bowel Disease ◽  
Inflammatory Diseases ◽  
Safety Data ◽  
Position Statement ◽  
European Medicines Agency ◽  
Immune Mediated ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Abstract The emergence of biosimilars is generally considered as an opportunity to guarantee accessibility to affordable treatments and to enhance financial sustainability of national health systems. Since 2017, five biosimilars of adalimumab were approved by the European Medicines Agency [EMA] for use in inflammatory bowel disease: ABP 510, SB5, GP2017, FKB327, and MSB11022. In this position statement, the available efficacy and safety data of the different adalimumab biosimilars in immune-mediated inflammatory diseases are summarised. Furthermore, the Belgian IBD research group [BIRD] formulates statements concerning the use of adalimumab biosimilars in inflammatory bowel disease.

scholarly journals Glucocorticoid dose-dependent risk of type 2 diabetes in six immune-mediated inflammatory diseases: a population-based cohort analysis

2020 ◽  
Vol 8 (1) ◽  
pp. e001220
Author(s):  
Jianhua Wu ◽  
Sarah L Mackie ◽  
Mar Pujades-Rodriguez
Keyword(s):  
Rheumatoid Arthritis ◽  
Type 2 Diabetes ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Inflammatory Diseases ◽  
Population Based ◽  
Immune Mediated ◽  
Inflammatory Bowel ◽  
Dose Dependent

IntroductionIn immune-mediated inflammatory diseases, there is a lack of -estimates of glucocorticoid dose–response diabetes risk that consider changes in prescribed dose over time and disease activity.Research design and methodsPopulation-based longitudinal analysis of electronic health records from the UK Clinical Practice Research Datalink, linked to hospital admissions and the mortality registry (1998–2017). We included 100 722 adult patients without diabetes history, diagnosed with giant cell arteritis or polymyalgia rheumatica (n=32 593), inflammatory bowel disease (n=29 272), rheumatoid arthritis (n=28 365), vasculitis (n=6082), or systemic lupus erythematosus (n=4410). We estimated risks and HRs of type 2 diabetes associated with time-variant daily and total cumulative prednisolone-equivalent glucocorticoid dose using Cox regression methods.ResultsAverage patient age was 58.6 years, 65 469 (65.0%) were women and 8858 (22.6%) had a body mass index (BMI) ≥30 kg/m2. Overall, 8137 (8.1%) people developed type 2 diabetes after a median follow-up of 4.9 years. At 1 year, the cumulative risk of diabetes increased from 0.9% during periods of non-use to 5.0% when the daily prednisolone-equivalent dose was ≥25.0 mg. We found strong dose-dependent associations for all immune-mediated diseases, BMI levels and underlying disease duration, even after controlling for periods of active systemic inflammation. Adjusted HR for a <5.0 mg daily dose versus non-use was 1.90, 95% CI 1.44 to 2.50; range 1.70 for rheumatoid arthritis to 2.93 for inflammatory bowel disease.ConclusionsWe report dose-dependent risks of type 2 diabetes associated with glucocorticoid use for six common immune-mediated inflammatory diseases. These results underline the need for regular diabetic risk assessment and testing during glucocorticoid therapy in these patients.

scholarly journals The Influence of Corticosteroids, Immunosuppressants and Biologics on Patients With Inflammatory Bowel Diseases, Psoriasis and Rheumatic Diseases in the Era of COVID-19: A Review of Current Evidence

2021 ◽  
Vol 12 ◽  
Author(s):  
Mengyuan Zhang ◽  
Xiaoyin Bai ◽  
Wei Cao ◽  
Junyi Ji ◽  
Luo Wang ◽  
...  
Keyword(s):  
Rheumatic Diseases ◽  
Inflammatory Diseases ◽  
Underlying Mechanism ◽  
Current Evidence ◽  
Antiviral Immune Response ◽  
Systemic Corticosteroids ◽  
Immune Mediated ◽  
Bowel Diseases ◽  
Immunocompromised Status ◽  
Inflammatory Bowel

Patients with inflammatory bowel disease, psoriasis or other rheumatic diseases treated with corticosteroids, immunomodulators and biologics might face additional risk during COVID-19 epidemic due to their immunocompromised status. However, there was still no unanimous opinion on the use of these therapy during COVID-19 epidemic. Current studies suggested that systemic corticosteroids might increase the risk of hospitalization, as well as risks of ventilation, ICU, and death among patients with immune-mediated inflammatory diseases. Anti-TNF agent was associated with lower rate of hospitalization, as well as lower risks of ventilation, ICU, and death. No significant changes in rates of hospitalization, ventilation, ICU and mortality were observed in patients treated with immunomodulators or biologics apart from anti-TNF agents. The underlying mechanism of these results might be related to pathway of antiviral immune response and cytokine storm induced by SARS-COV-2 infection. Decision on the use of corticosteroids, immunomodulators and biologics should be made after weighing the benefits and potential risks based on individual patients.

scholarly journals Prevalence and Outcomes of COVID-19 Among Patients With Inflammatory Bowel Disease—A Danish Prospective Population-based Cohort Study

2020 ◽  
Author(s):  
Mohamed Attauabi ◽  
Anja Poulsen ◽  
Klaus Theede ◽  
Natalia Pedersen ◽  
Lone Larsen ◽  
...  
Keyword(s):  
Inflammatory Diseases ◽  
Population Based ◽  
Disease Course ◽  
Biologic Therapies ◽  
Population Based Study ◽  
Immune Mediated ◽  
Related Hospitalisation ◽  
Bowel Diseases ◽  
National Cohort ◽  
Inflammatory Bowel

Abstract Background and Aims As no population-based study has investigated the susceptibility and disease course of COVID-19 among patients with inflammatory bowel diseases [IBD], we aimed to investigate this topic in a population-based setting. Methods Two cohorts were investigated. First, a nationwide cohort of all IBD patients diagnosed with COVID-19 was prospectively followed to investigate the disease courses of both diseases. Second, within a population-based cohort of 2.6 million Danish citizens, we identified all individuals tested for SARS-CoV-2 to determine the occurrence of COVID-19 among patients with and without IBD and other immune-mediated inflammatory diseases [IMIDs]. Results Between January 28, 2020 and June 2, 2020, a total of 76 IBD patients with COVID-19 were identified in the national cohort and prospectively followed for 35 days (interquartile range [IQR]: 25–51). A large proportion [n = 19: 25%] required a COVID-19-related hospitalisation for 7 days [IQR: 2–8.5] which was associated with being 65 years or older (odds ratio [OR] = 23].80, 95% confidence interval [CI] 6.32–89.63, p &lt;0.01) and presence of any non-IMID comorbidity [OR = 8.12, 95% CI 2.55–25.87, p &lt;0.01], but not use of immunomodulators [p = 0.52] or biologic therapies [p = 0.14]. In the population-based study, 8476 of 231 601 [3.7%] residents tested positive for SARS-CoV-2; however, the occurrence was significantly lower among patients with IBD [62 of the 2486 patients = 2.5%, p &lt;0.01] and other IMIDs [531 of 16 492 patients = 3.2%, p &lt;0.01] as compared with patients without IMIDs. Conclusions Patients with IMIDs, including IBD, had a significantly lower susceptibility to COVID-19 than patients without IMIDs, and neither immunosuppressive therapies nor IBD activity were associated with the disease course of COVID-19.

scholarly journals Association between chronic immune-mediated inflammatory diseases and cardiovascular risk

Heart ◽  
2017 ◽  
Vol 104 (2) ◽  
pp. 119-126 ◽  
Author(s):  
Jose Miguel Baena-Díez ◽  
Maria Garcia-Gil ◽  
Marc Comas-Cufí ◽  
Rafel Ramos ◽  
Daniel Prieto-Alhambra ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cardiovascular Disease ◽  
Cardiovascular Risk ◽  
Connective Tissue ◽  
Connective Tissue Disorders ◽  
Population Attributable Fractions ◽  
Immune Mediated ◽  
Attributable Fractions ◽  
Bowel Diseases ◽  
Inflammatory Bowel

ObjectiveTo examine the association between chronic immune-mediated diseases (rheumatoid arthritis, systemic lupus erythematosus or the following chronic immune-mediated inflammatory diagnoses groups: inflammatory bowel diseases, inflammatory polyarthropathies, systemic connective tissue disorders and spondylopathies) and the 6-year coronary artery disease, stroke, cardiovascular disease incidence and overall mortality; and to estimate the population attributable fractions for all four end-points for each chronic immune-mediated inflammatory disease.MethodsCohort study of individuals aged 35–85 years, with no history of cardiovascular disease from Catalonia (Spain). The coded diagnoses of chronic immune-mediated diseases and cardiovascular diseases were ascertained and registered using validated codes, and date of death was obtained from administrative data. Cox regression models for each outcome according to exposure were fitted to estimate HRs in two models 1 : after adjustment for sex, age, cardiovascular risk factors and 2 further adjusted for drug use. Population attributable fractions were estimated for each exposure.ResultsData were collected from 991 546 participants. The risk of cardiovascular disease was increased in systemic connective tissue disorders (model 1: HR=1.38 (95% CI 1.21 to 1.57) and model 2: HR=1.31 (95% CI 1.15 to 1.49)), rheumatoid arthritis (HR=1.43 (95% CI 1.26 to 1.62) and HR=1.31 (95% CI 1.15 to 1.49)) and inflammatory bowel diseases (HR=1.18 (95% CI 1.06 to 1.32) and HR=1.12 (95% CI 1.01 to 1.25)). The effect of anti-inflammatory treatment was significant in all instances (HR=1.50 (95% CI 1.24 to 1.81); HR=1.47 (95% CI 1.23 to 1.75); HR=1.43 (95% CI 1.19 to 1.73), respectively). The population attributable fractions for all three disorders were 13.4%, 15.7% and 10.7%, respectively.ConclusionSystemic connective tissue disorders and rheumatoid arthritis conferred the highest cardiovascular risk and population impact, followed by inflammatory bowel diseases.

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