Weight and BMI Patterns in Biological Based IBD Patients and Its Finacial Impact
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases Weight Changes. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Primary Objective To determine the pattern of weight and body mass index (BMI) changes in biologic-treated patients with inflammatory bowel disease (IBD). Secondary Objectives To evaluate the correlation between BMI and biologic drug dosing. To estimate the direct financial burden of biologic therapy according to BMI categories. To assess whether higher BMI is associated with increased treatment requirements.
Detailed description
Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic conditions associated with reduced quality of life and impaired productivity. Due to recurrent disease activity and progressive structural damage, IBD imposes a significant burden on both public and private healthcare systems.
The use of advanced therapies for moderate to severe IBD has provided substantial benefits in recent decades, including reductions in hospitalization and surgery rates. Anti-Tumor Necrosis Factor-alpha (anti-TNF-α) agents typically constitute the first line of advanced therapy for both CD and UC. However, between 10% and 40% of patients may not respond to treatment (primary non-responders), and approximately 12% may lose response over time, particularly with infliximab (IFX).
Several mechanisms may contribute to IFX treatment failure. Immunogenicity, where antibodies form against the monoclonal antibody, is a primary factor. Other factors affecting IFX clearance include overweight and obesity. Drug clearance is influenced by the volume of distribution, which depends on patient weight. Additionally, excess adipose tissue can alter the pharmacokinetics of anti-TNF agents and exert endocrine and immunological effects through the release of adipocytokines, potentially contributing to the pathogenesis of inflammatory conditions. Therefore, excessive body weight may partly explain IFX therapy failure in some cases.
Obesity appears to negatively affect the response to immunosuppressants and anti-TNF agents. However, studies examining the relationship between obesity, anti-TNF response, and autoimmune diseases have reported inconsistent results. For example, an analysis of three randomized controlled trials of IFX in dermatology and rheumatology found no statistically significant differences in response rates across BMI groups. In contrast, a prospective cohort study in patients with rheumatoid arthritis reported that obese patients treated with IFX had lower clinical response rates. A systematic review and meta-analysis found that obesity was associated with a 60% higher likelihood of losing response to anti-TNF agents compared to non-obese patients with rheumatoid arthritis, ankylosing spondylitis, and psoriasis. However, this association has not been confirmed in patients with IBD.
To date, few studies have examined the influence of obesity or overweight on endoscopic remission in IBD. In a recent cohort study of IFX-treated patients, Singh et al. (2018) found no significant reduction in mucosal healing in obese patients after adjusting for covariates (CI: 0.12-2.35; p=0.31). Other recent studies have demonstrated that body composition parameters, such as subcutaneous adiposity index, visceral adiposity index, and skeletal muscle mass index, are independent factors correlated with active Crohn's disease, with visceral adiposity negatively impacting disease activity.
Primary outcome measures
- Pattern of Weight Changes in Biologic-Treated IBD Patients [Time frame: Monthly assessment for 12 month]
Eligibility criteria
Inclusion criteria
- Patients must have received infliximab (IFX) therapy for at least 14 weeks and completed the on-label induction regimen (5 mg/kg IV at weeks 0, 2, and 6), regardless of the dose at the time of blood collection (patients receiving optimized doses are eligible).
- Patients may be on IFX monotherapy or in combination with one of the following medications at the time of selection: aminosalicylates, antibiotics, prednisone, azathioprine, 6-mercaptopurine, or methotrexate.
Exclusion criteria
- Patients receiving IFX in combination with tacrolimus, cyclosporine, sirolimus, mycophenolate mofetil, another immunobiological agent, or tofacitinib.
- Patients with insufficient data in their electronic medical records.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07495800 · 4-2026-300824