Disparities Persist in Inclusion of Female, Pregnant, Lactating, and Older Individuals in Inflammatory Bowel Disease Clinical Trials

Rabinowitz, Loren; Rabinowitz, Danielle G.; Silver, Emily M.; Oxentenko, Amy S.; Williams, K. E.; Silver, Julie K.

doi:10.1053/j.gastro.2022.03.016

Cited by 10 publications

(2 citation statements)

References 19 publications

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“…1 However, there is a paucity of evidence-based treatment guidance for older patients with IBD, who represent less than 5% of participants in IBD clinical trials, leading to substantial practice variability and inferior outcomes. 2 The risk of disease-related complications in older patients is underappreciated: risk of surgery, hospitalization, and corticosteroid treatment are comparable in older vs younger patients. 3 However, older patients are frequently undertreated and mismanaged with long-term corticosteroid use and limited use of steroid-sparing therapies owing to patients' and clinicians' concerns about the safety of immunosuppressive therapy, which is associated with increased morbidity and mortality.…”

Section: Introductionmentioning

confidence: 99%

“…The incidence, prevalence, and health care costs of inflammatory bowel disease (IBD) among older adults are rapidly increasing relative to younger adults, with approximately 1 in 3 patients with IBD expected to be older . However, there is a paucity of evidence-based treatment guidance for older patients with IBD, who represent less than 5% of participants in IBD clinical trials, leading to substantial practice variability and inferior outcomes . The risk of disease-related complications in older patients is underappreciated: risk of surgery, hospitalization, and corticosteroid treatment are comparable in older vs younger patients .…”

Section: Introductionmentioning

confidence: 99%

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Comparative Outcomes and Safety of Vedolizumab vs Tumor Necrosis Factor Antagonists for Older Adults With Inflammatory Bowel Diseases

et al. 2022

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ImportanceObservational comparative effectiveness studies can inform the positioning of biologic therapies for older patients with inflammatory bowel disease (IBD) who are underrepresented in clinical trials.ObjectiveTo compare the effectiveness and safety of vedolizumab vs tumor necrosis factor (TNF) for older patients with IBD.Design, Setting, and ParticipantsThis active comparator, new-user design, comparative effectiveness study was conducted between January 1, 2005, and December 31, 2018, among 754 older patients (aged ≥50 years) with IBD from the Danish National Patient Register. The mean follow-up after treatment initiation took place at 32 to 40 weeks. Statistical analysis was performed from February 1 to April 27, 2022.InterventionsTreatment with vedolizumab or TNF antagonists.Main Outcomes and MeasuresThe primary effectiveness outcome was treatment failure, defined as the composite risk of IBD-related hospitalization, IBD-related surgery, or a new corticosteroid prescription more than 6 weeks after initiation of treatment with biologic therapy. Secondary effectiveness outcomes were time to each individual component of the composite effectiveness outcome. The primary safety outcome was the risk of serious infections, defined as infections requiring hospitalization. A 1:1 propensity score–matched analysis was conducted, accounting for patient-, disease-, and treatment-associated factors.ResultsThe study compared 377 older patients with IBD with incident use of vedolizumab (202 women [53.6%]; mean [SD] age, 61.2 [8.3] years; 177 [46.9%] with Crohn disease) vs 377 patients with incident use of TNF antagonists (206 women [54.6%]; mean [SD] age, 61.3 [8.1] years; 182 [48.3%] with Crohn disease). Overall, vedolizumab was associated with an increased risk of treatment failure compared with TNF antagonists (1-year risk, 45.4% vs 34.7%; adjusted hazard ratio [HR], 1.31; 95% CI, 1.02-1.69), including higher risk of IBD-related hospitalization (1-year risk, 27.8% vs 16.3%; adjusted HR, 1.48; 95% CI, 1.03-2.15) and IBD-related major abdominal surgery (1-year risk, 21.3% vs 8.0%; adjusted HR, 2.39; 95% CI, 1.45-3.94). In subgroup analysis by IBD phenotype, among patients with Crohn disease, vedolizumab was associated with a 77% higher risk of treatment failure (adjusted HR, 1.77; 95% CI, 1.21-2.58), while no difference in risk of treatment failure was seen among patients with ulcerative colitis (adjusted HR, 1.04; 95% CI, 0.75-1.43; P = .03 for interaction). There was no significant difference in the risk of serious infections, overall (1-year risk, 8.2% vs 8.7%; adjusted HR, 1.04; 95% CI, 0.58-1.85) and by IBD phenotype.Conclusions and RelevanceIn this comparative effectiveness study of older patients with IBD, vedolizumab was associated with a higher risk of treatment failure compared with TNF antagonists, particularly among patients with Crohn disease, without offering a significant safety advantage.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%