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Background <p>We compared real-world outcomes among patients with ulcerative colitis (UC) prescribed second-line tumour necrosis factor inhibitor (TNFi) versus non-TNFi therapy after a first-line TNFi.</p> Methods <p>We included adults with ≥ 2 claims for UC and ≥ 1 medical or pharmacy claim for a UC-approved TNFi as first-line therapy between 1 January 2015 and 30 June 2022 from the Healthcare Integrated Research Database. Second-line therapy was identified by one or more claims for a different TNFi or non-TNFi. The primary outcome was inadequate response, a composite of at least one of switch/add alternative advanced therapy, augment with conventional therapy, dose escalation, glucocorticoid intensification, UC-related hospitalisation, or UC-related surgery. We used multivariable logistic regression with trimmed inverse probability treatment weighting (IPTW) to calculate adjusted odds of inadequate response with second-line TNFi versus non-TNFi.</p> Results <p>Among 921 IPTW-weighted patients (second-line TNFi, <i>n</i> = 281; non-TNFi, <i>n</i> = 640), 62% of the TNFi cohort versus 49% non-TNFi had inadequate response (chi-square <i>p</i> = 0.001; odds ratio [95% CI], 1.76 [1.31–2.37], <i>p</i> &lt; 0.001). Mean/median time to inadequate response among patients with inadequate response within 1 year was 139/125 days (TNFi) and 150/130 days (non-TNFi). The most common criterion for inadequate response was addition of new conventional therapy (35% second-line TNFi vs. 25% non-TNFi, <i>p</i> &lt; 0.01); switch to or addition of alternative advanced therapy (30% vs. 15%, <i>p</i> &lt; 0.01), and dose increase of oral glucocorticoids (14% vs. 9%, <i>p</i> &lt; 0.05) were also significantly more common among patients in the TNFi cohort than the non-TNFi cohort. Total healthcare costs were modestly higher in the TNFi cohort.</p> Conclusions <p>These results suggest that patients with UC have higher odds of inadequate response with a second TNFi versus non-TNFi after a first TNFi failure. Switching to an alternate mechanism of action for second-line therapy yielded better clinical outcomes.</p>

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Real-world outcomes of tumour necrosis factor inhibitor (TNFi) cyclers versus mechanism-of-action switchers among ulcerative colitis patients who failed first-line TNFi

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月20日

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  • Navneet Upadhyay,
  • Amita Ketkar,
  • Can Mert,
  • Alexandra Wallem,
  • Simin K. Baygani,
  • Tariku J. Beyene,
  • Deborah A. Fisher,
  • Tracey Quimbo,
  • Raven A. Perez,
  • Michael Grabner,
  • J. Casey Chapman

摘要

Background

We compared real-world outcomes among patients with ulcerative colitis (UC) prescribed second-line tumour necrosis factor inhibitor (TNFi) versus non-TNFi therapy after a first-line TNFi.

Methods

We included adults with ≥ 2 claims for UC and ≥ 1 medical or pharmacy claim for a UC-approved TNFi as first-line therapy between 1 January 2015 and 30 June 2022 from the Healthcare Integrated Research Database. Second-line therapy was identified by one or more claims for a different TNFi or non-TNFi. The primary outcome was inadequate response, a composite of at least one of switch/add alternative advanced therapy, augment with conventional therapy, dose escalation, glucocorticoid intensification, UC-related hospitalisation, or UC-related surgery. We used multivariable logistic regression with trimmed inverse probability treatment weighting (IPTW) to calculate adjusted odds of inadequate response with second-line TNFi versus non-TNFi.

Results

Among 921 IPTW-weighted patients (second-line TNFi, n = 281; non-TNFi, n = 640), 62% of the TNFi cohort versus 49% non-TNFi had inadequate response (chi-square p = 0.001; odds ratio [95% CI], 1.76 [1.31–2.37], p < 0.001). Mean/median time to inadequate response among patients with inadequate response within 1 year was 139/125 days (TNFi) and 150/130 days (non-TNFi). The most common criterion for inadequate response was addition of new conventional therapy (35% second-line TNFi vs. 25% non-TNFi, p < 0.01); switch to or addition of alternative advanced therapy (30% vs. 15%, p < 0.01), and dose increase of oral glucocorticoids (14% vs. 9%, p < 0.05) were also significantly more common among patients in the TNFi cohort than the non-TNFi cohort. Total healthcare costs were modestly higher in the TNFi cohort.

Conclusions

These results suggest that patients with UC have higher odds of inadequate response with a second TNFi versus non-TNFi after a first TNFi failure. Switching to an alternate mechanism of action for second-line therapy yielded better clinical outcomes.