Dennis J. Baumgardner, MD, Clinician Researcher Award Oral Presentation

Background/Significance:

Subcutaneous (SC) and intravenous (IV) anti–tumor necrosis factor (anti-TNF) therapies are established treatments for moderate-to-severe ulcerative colitis (UC). While both routes are effective, direct comparative data are limited due to few head-to-head trials. Differences in pharmacokinetics, administration burden, and patient preference may influence outcomes. We sought to compare the efficacy and safety of SC versus IV anti-TNF agents in inducing and maintaining clinical remission in adults with UC.

Purpose:

To evaluate whether SC anti-TNF therapy is comparable to IV anti-TNF therapy in achieving clinical remission and maintaining safety in moderate-to-severe UC.

Methods:

We conducted a systematic review and meta-analysis following PRISMA guidelines. PubMed, Scopus, Web of Science, Embase, and Cochrane Central were searched from inception through May 2025 for randomized controlled trials (RCTs) and observational studies comparing SC (adalimumab, golimumab, CT-P13 SC) and IV (infliximab, CT-P13 IV) anti-TNFs in adults with UC (Mayo score ≥6). The primary outcome was clinical remission (Mayo score ≤2, no sub score >1) during induction (6–14 weeks) and maintenance (30–54 weeks). Safety outcomes included adverse events (AEs) and serious adverse events (SAEs). Random-effects models were used for direct comparisons; network meta-analysis was performed for indirect RCT comparisons via shared placebo arms. Risk of bias was assessed using Cochrane and ROBINS-I tools.

Results:

Nine studies (5 RCTs, 4 observational; n=3,201) met inclusion criteria. Direct comparisons (3 observational studies, n=620) demonstrated no significant difference in remission at week 14 (OR 1.12, 95% CI 0.89–1.41) or week 52 (OR 0.98, 95% CI 0.76–1.27). Network meta-analysis of RCTs (n=2,581) showed comparable efficacy at week 8 (OR 1.15, 95% CI 0.85–1.56) and week 52 (OR 1.08, 95% CI 0.79–1.47). AE rates were similar (SC 45.3% vs IV 47.1%; OR 0.94, 95% CI 0.78– 1.14), as were SAE rates (SC 8.2% vs IV 9.1%; OR 0.90, 95% CI 0.65–1.24). Heterogeneity was moderate (I2=45%). Subgroup analyses by biologic-naïve status yielded consistent findings.

Conclusion:

SC and IV anti-TNFs show comparable efficacy and safety in achieving and maintaining UC remission. These findings support personalized treatment decisions based on administration route and patient preference. Head-to-head RCTs are needed to confirm these results.