Long-Term Comparative Outcomes of TNF-α Antagonists vs. Vedolizumab as First-Line Biologic Therapy for Refractory...

Area of Science:

• Gastroenterology
• Immunology
• Clinical Pharmacology

Background:

• Optimal first-line biologic therapy for refractory ulcerative proctitis (UP) is unclear due to patient exclusion from clinical trials.
• This study addresses the evidence gap by comparing TNF inhibitors (TNFi) and vedolizumab in UP patients.

Purpose of the Study:

• To evaluate real-world outcomes of first-line TNF inhibitors versus vedolizumab in ulcerative proctitis.
• To compare corticosteroid use, healthcare utilization, and colectomy rates between these biologic therapies.

Main Methods:

• Retrospective cohort study using the TriNetX database (1995-2023).
• Propensity score matching to balance patient characteristics and baseline treatments.
• Primary outcomes assessed at 6, 12, and 24 months: corticosteroid use, ER visits, hospitalizations, and colectomy.

Main Results:

• Among 641 patients, adalimumab, infliximab, and vedolizumab were common first-line biologics.
• TNFi therapy was associated with significantly reduced ER visits and hospitalizations at 6 and 12 months compared to vedolizumab.
• No significant differences in corticosteroid use or colectomy rates were observed between TNFi and vedolizumab at any time point.

Conclusions:

• First-line TNFi therapy in ulcerative proctitis is linked to lower short-term healthcare utilization compared to vedolizumab.
• Corticosteroid use did not differ significantly between the two treatment groups.
• Findings require cautious interpretation due to potential unmeasured confounding factors like endoscopic disease activity.