Biologic Care Pathway for Inflammatory Bowel Disease

Overseen By Natalie Willett, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jennifer Jones

Must be taking: Anti TNF biologics

Disqualifiers: Fibrostenotic strictures, Abscesses, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 50 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a structured approach, called a biologic care pathway, can improve treatment delivery for people with Inflammatory Bowel Disease (IBD), including Crohn's disease and ulcerative colitis. The study compares regular care to care using this new pathway to assess which is better for patient health and healthcare efficiency. Individuals starting an anti-TNF biologic therapy, a medication that reduces inflammation, might be suitable for the trial. This pathway may include treatments like Entyvio (Vedolizumab), a biologic medication for IBD. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance IBD treatment strategies.

Do I need to stop my current medications for this trial?

The protocol does not specify if you need to stop your current medications. However, since the trial involves starting an Anti TNF biologic therapy, it's best to discuss with the trial coordinators or your doctor.

What prior data suggests that this biologic care pathway is safe for inflammatory bowel disease patients?

Research has shown that biologic medicines, such as those used to treat inflammatory bowel disease (IBD), are generally safe. Studies have found that medications like vedolizumab work effectively and are well-tolerated by patients, including older adults. Another study found that vedolizumab and similar medicines offer comparable safety across different age groups.

However, one study noted that vedolizumab might not be as effective as other anti-TNF medicines, but this does not affect its safety. Overall, biologic treatments have been safely used in many patients with IBD, supporting their inclusion in standardized treatment plans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Biologic Care Pathway for treating Inflammatory Bowel Disease (IBD) because it offers a more personalized approach compared to the traditional treatments like corticosteroids, aminosalicylates, and immunosuppressants. Unlike standard care, which often targets inflammation broadly, the Biologic Care Pathway tailors treatment based on specific biological markers, potentially leading to more effective and targeted relief of symptoms. This innovative pathway could mean fewer side effects and better outcomes for patients by focusing on the underlying biological processes unique to each individual's condition.

What evidence suggests that this Biologic Care Pathway is effective for Inflammatory Bowel Disease?

Research shows that biologic therapies can effectively treat inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis. For example, studies have found that 66% of patients with Crohn's disease went into remission without needing steroids when treated with adalimumab, a type of biologic medicine. In cases of ulcerative colitis, vedolizumab, another biologic, proved more effective over five years compared to other treatments like anti-TNF (tumor necrosis factor) medications. These findings suggest that biologic treatments can help manage IBD symptoms and improve patient health. In this trial, participants will either receive care through a biologic care pathway, which includes vedolizumab, or continue with care as usual. Following a structured biologic care plan may further enhance these benefits by standardizing treatment methods. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Crohn's Disease, Ulcerative Colitis, or other IBDs who are starting anti-TNF biologic therapy. It excludes those with severe intestinal complications, active infections, cancer, or any reason they can't have biologic treatments.

Inclusion Criteria

I am starting treatment with an Anti-TNF biologic or its biosimilar.

Exclusion Criteria

Perforating complications

I currently have an infection.

I have been diagnosed with cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive care through a biologic care pathway or usual care

50 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biologic Care Pathway

Trial Overview The study tests a Biologic Care Pathway (BCP) to see if it improves patient outcomes in IBD treatment compared to usual care without BCP. The focus is on the integration of BCP into clinical practice and its effects on health outcomes and healthcare efficiency.

How Is the Trial Designed?

Group I: Biologic Care Pathway Experimental Treatment 1 Intervention

Care through a biologic care pathway

Group II: Control Active Control 1 Intervention

Care as usual

Who Is Running the Clinical Trial?

Jennifer Jones

Lead Sponsor

Trials

3

Recruited

300+

Nova Scotia Health Authority

Collaborator

Trials

302

Recruited

95,300+

Published Research Related to This Trial

Vedolizumab is a monoclonal antibody that effectively targets the α4β7 integrin to inhibit gut lymphocyte trafficking, providing a safe treatment option for patients with moderate to severe Crohn's disease and ulcerative colitis.

Unlike anti-TNF agents, which some patients may become intolerant to or lose response over time, vedolizumab offers a promising alternative for those who are primary nonresponders or have developed antidrug antibodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vedolizumab as a Treatment for Crohn's Disease and Ulcerative Colitis. Ha, C., Kornbluth, A.[2022]

In a study of 257 patients with inflammatory bowel disease receiving either infliximab or vedolizumab, higher levels of infliximab were statistically associated with the occurrence of adverse events (AEs), particularly when excluding common symptoms like fatigue and abdominal pain.

Vedolizumab levels above 18 μg/mL were also linked to an increase in AEs, but no specific adverse events were directly associated with higher drug levels, indicating that while AEs are rare, further research is needed to clarify these relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Infliximab and Vedolizumab Trough Levels with Reported Rates of Adverse Events: A Cross-Sectional Study. Veisman, I., Barzilay, O., Bruckmayer, L., et al.[2021]

Including vedolizumab as a preferred first-line biologic treatment for ulcerative colitis (UC) and Crohn's disease (CD) in a health plan formulary can lead to significant cost savings, ranging from $0.13 million to $1.63 million in the first year and up to $4.68 million by the third year.

The analysis suggests that using vedolizumab earlier in treatment, rather than as a second-line option, not only improves patient access to effective therapy but also reduces overall healthcare costs for the health plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budget Impact of Adding Vedolizumab to a Health Plan Formulary as Another First-Line Biologic Option for Ulcerative Colitis and Crohn's Disease. Wilson, M., Lucas, A., Cameron, A., et al.[2022]

In a study of 90 patients with inflammatory bowel diseases (52 with Crohn's disease and 38 with ulcerative colitis), vedolizumab demonstrated effectiveness in achieving clinical remission, with remission rates of 42.89% at week 12 and 61.9% at week 26 for Crohn's disease, and 28.94% at week 12 and 36.66% at week 26 for ulcerative colitis.

The treatment was associated with mucosal healing rates of 36.11% in Crohn's disease and 43.4% in ulcerative colitis, and no new safety concerns were identified, indicating that vedolizumab is a safe and effective option for patients in Latin America.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VEDOLIZUMAB IN THE MANAGEMENT OF INFLAMMATORY BOWEL DISEASES: A BRAZILIAN OBSERVATIONAL MULTICENTRIC STUDY. Perin, RL., Damião, AOMC., Flores, C., et al.[2019]

In a study of over 240,000 patients with inflammatory bowel disease (IBD), only about 6-10% received vedolizumab (VDZ) within 30 days of their diagnosis, indicating a significant delay in treatment that could limit its effectiveness.

Patients who started VDZ early were generally younger and more likely to be female, contrasting with guidelines that recommend earlier use of VDZ, especially for older patients at higher risk for infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

P042 Early Versus Later Use of Vedolizumab In IBD: Patient Characteristics And Treatment Patterns In The Real World (RALEE). Kuharic, M., Krugliak Cleveland, N., Candela, N., et al.[2023]

Approximately half of the 302 million covered lives in the US had access to advanced therapies for ulcerative colitis (UC) and Crohn's disease (CD) as first-line treatments, with vedolizumab showing the widest coverage.

The analysis indicates that an individualized treatment approach integrating newer therapies is becoming feasible, as 81% of patients had access to vedolizumab without prior biologic exposure, and 95% had access after one prior biologic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Market Access Analysis of Biologics and Small-Molecule Inhibitors for Inflammatory Bowel Disease Among US Health Insurance Policies. Dulai, PS., Osterman, MT., Lasch, K., et al.[2020]

In patients treated with vedolizumab, the incidence of opportunistic infections was low, at 0.7 per 100 patient-years in clinical trials and 1.0 in long-term safety studies, indicating a favorable safety profile for this medication.

No cases of serious infections like progressive multifocal leukoencephalopathy or hepatitis B/C viral reactivation were reported, and most patients continued treatment without significant issues, suggesting vedolizumab is a safe option for managing inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Frequency of Opportunistic Infections in Patients Receiving Vedolizumab in Clinical Trials and Post-Marketing Setting. Ng, SC., Hilmi, IN., Blake, A., et al.[2023]

In a study of 456 patients with Crohn's disease (CD) and ulcerative colitis (UC) using vedolizumab, only about 60% of CD patients and 56% of UC patients continued treatment after 14 weeks without needing hospitalization, surgery, or corticosteroids, indicating a moderate level of treatment persistence.

The study found that the use of steroids within the first two months of starting vedolizumab was a strong predictor of continued steroid use later on in CD patients, while the rates of IBD-related surgeries and serious infections were low, at 1.9% and 5.9% respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Early Experience With Vedolizumab in the United States. Kochar, B., Jiang, Y., Winn, A., et al.[2022]

Vedolizumab, a gut-selective integrin blocker for Crohn's disease and ulcerative colitis, showed a similar rate of serious adverse events (35.9%) compared to anti-TNF drugs (32.1%) in a study analyzing 499 reports for vedolizumab and 119,620 for anti-TNFs.

The study identified 22 groups of adverse events associated with vedolizumab, including 9 with serious outcomes, suggesting potential cardiovascular risks; however, these findings are preliminary and require further investigation through long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the real-world safety profile of vedolizumab using the United States Food and Drug Administration adverse event reporting system. Cross, RK., Chiorean, M., Vekeman, F., et al.[2023]

A systematic review of seven randomized controlled trials involving biologic drugs for ulcerative colitis found no significant differences in the rate of adverse events among adalimumab, golimumab, and vedolizumab during the induction phase, and infliximab, adalimumab, golimumab, and vedolizumab during the maintenance phase.

Vedolizumab showed the most favorable safety profile during the induction phase, while infliximab was favored during the maintenance phase, suggesting that while all biologics are generally safe, some may have advantages in specific treatment phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis. Moćko, P., Kawalec, P., Pilc, A.[2018]

In a Danish study of 56 bio-naïve patients with ulcerative colitis (UC) and Crohn's disease (CD), vedolizumab demonstrated effectiveness in achieving clinical remission, with rates of 40% for UC and 47.4% for CD at 52 weeks.

Vedolizumab was well-tolerated, with only one serious adverse event reported, indicating a favorable safety profile for patients starting this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vedolizumab as first-line biological therapy in elderly patients and those with contraindications for anti-TNF therapy: a real-world, nationwide cohort of patients with inflammatory bowel diseases. Attauabi, M., Höglund, C., Fassov, J., et al.[2022]

This study will evaluate the impact of a standardized care pathway for treating inflammatory bowel disease (IBD) with biologics across eight centers in the Netherlands, involving at least 200 patients over a total study period of 27 months.

The primary goal is to assess improvements in disease control using the IBD-Control questionnaire, while also examining secondary outcomes related to quality of life, patient experiences, and cost-effectiveness, aiming to reduce variations in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value-based care pathway for inflammatory bowel disease: a protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period. van Linschoten, RCA., van Leeuwen, N., Nieboer, D., et al.[2022]

Vedolizumab is an effective treatment for moderate-to-severe inflammatory bowel diseases like Crohn's disease and ulcerative colitis, with a well-established safety profile based on extensive clinical trial data and real-world studies.

The safety data indicates no unexpected long-term risks, making vedolizumab a strong candidate for combination therapies in patients with complex or refractory cases of inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on the safety of long-term vedolizumab use in inflammatory bowel disease. Honap, S., Netter, P., Danese, S., et al.[2023]

Citations

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Comparative Outcomes and Safety of Vedolizumab vs ... This study suggests that vedolizumab is associated with a higher risk of treatment failure compared with TNF antagonists, without offering any safety advantage ...

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Newer Biologics Show Similar Safety, Efficacy in Older vs ... Younger and older individuals had similar rates of achieving endoscopic remission (22.4% vs 23.4%; P =.83). Secondary efficacy outcomes were ...

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Treatment sequences, outcomes, healthcare utilization, and ... In patients with ulcerative colitis, vedolizumab as first-line advanced therapy demonstrated superior effectiveness in persistence without ...

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Effectiveness and safety of vedolizumab in biologically ... This study demonstrates the effectiveness and safety of VDZ as a first-line biological, particularly among elderly patients. Keywords: Vedolizumab, inflammatory ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1590865825007364

Vedolizumab in inflammatory bowel disease: Real-world ... Vedolizumab is effective and safe in IBD patients. XAI yielded promising results in identifying the most important predictors of SFCR and development of AEs.