Biologic Care Pathway for Inflammatory Bowel Disease

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Jennifer Jones

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Inflammatory Bowel Disease (IBD) includes a group of chronic inflammatory conditions of the gastrointestinal system and is composed of Crohn's disease and ulcerative colitis. As an immune-mediated disease, IBD treatment options include the use of biologic medicines including anti-tumor necrosis alpha factor (also called anti-TNFs) medication. Despite biologic medicines being an important part of IBD management, there is inconsistency in the way these medications are used. Implementation of evidence-based, standardized biologic care pathways (BCP) can improve treatment related outcomes. Previous research has shown that using a clinical care pathway, such as a BCP, is a feasible method to support clinical decision making and may improve disease-related outcomes for patients. The researchers propose a prospective study to determine how well a BCP can be incorporated into clinical practice, improve patient health outcomes, and reduce healthcare system redundancies. Also, the impact of a BCP on outcomes for patients treated with the help of a standardized BCP compared to those in patients treated without the use of a BCP will be studied. The results of this study will inform how best to incorporate evidence-based BCPs into real-world practice and support the wide-spread adoption of BCPs in clinical practice.

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 data supports the idea that Biologic Care Pathway for Inflammatory Bowel Disease is an effective treatment?

The available research shows that Vedolizumab, a drug used in the Biologic Care Pathway for Inflammatory Bowel Disease, is effective for treating Crohn's disease and ulcerative colitis. It is particularly useful for patients who do not respond well to other treatments like anti-TNF drugs. Studies indicate that Vedolizumab is safe and works by targeting specific parts of the immune system to reduce inflammation. Additionally, using biologics like Vedolizumab earlier in the treatment process can lead to better outcomes compared to delaying their use. ^{1 2 3 4 5}

What safety data is available for Vedolizumab (Entyvio) in treating inflammatory bowel disease?

Vedolizumab, a gut-selective integrin blocker for Crohn's disease and ulcerative colitis, has been evaluated for safety using the FDA Adverse Event Reporting System. A study found 499 reports of adverse events (AEs) for vedolizumab, with 35.9% being serious. Compared to anti-TNF drugs, vedolizumab showed signals for 22 groups of AEs, including cardiovascular issues. Another study linked higher vedolizumab levels (>18 μg/mL) with more AEs, though no specific AEs were consistently associated. These findings are hypothesis-generating, and longer-term studies are needed to fully assess safety. ^{6 7 8 9 10}

Is the drug used in the Biologic Care Pathway for Inflammatory Bowel Disease a promising treatment?

Yes, the drug vedolizumab is a promising treatment for inflammatory bowel disease. It is effective for people with Crohn's disease and ulcerative colitis, especially for those who haven't responded well to other treatments. It works by targeting specific cells in the gut to reduce inflammation, and it has been shown to be safe for long-term use. ^{1 2 11 12 13}

Research Team

Eligibility Criteria

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 18 years old or older.

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.

Treatment Details

Interventions

• Biologic Care Pathway (Monoclonal Antibodies)

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.

Participant Groups

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+

Karen Oldfield

Nova Scotia Health Authority

Chief Executive Officer since 2021

Past Chair of the Board of Governors of Saint Mary’s University

Dr. Robert Strang

Nova Scotia Health Authority

Chief Medical Officer

MD

Findings from Research

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 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 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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Vedolizumab as a Treatment for Crohn's Disease and Ulcerative Colitis. [2022]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

P042 Early Versus Later Use of Vedolizumab In IBD: Patient Characteristics And Treatment Patterns In The Real World (RALEE). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Market Access Analysis of Biologics and Small-Molecule Inhibitors for Inflammatory Bowel Disease Among US Health Insurance Policies. [2020]

6. United States 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The Early Experience With Vedolizumab in the United States. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Association of Infliximab and Vedolizumab Trough Levels with Reported Rates of Adverse Events: A Cross-Sectional Study. [2021]

10. Brazil pubmed.ncbi.nlm.nih.gov

VEDOLIZUMAB IN THE MANAGEMENT OF INFLAMMATORY BOWEL DISEASES: A BRAZILIAN OBSERVATIONAL MULTICENTRIC STUDY. [2019]

11. England pubmed.ncbi.nlm.nih.gov

An update on the safety of long-term vedolizumab use in inflammatory bowel disease. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Low Frequency of Opportunistic Infections in Patients Receiving Vedolizumab in Clinical Trials and Post-Marketing Setting. [2023]

13. United States 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. [2022]