Background and Objectives <p>Mirikizumab and risankizumab are both anti-IL23 therapies approved for moderate-to-severe ulcerative colitis (UC); however, there is no comparative data to guide their clinical use.</p> Methods <p>We performed an exploratory retrospective cohort study in the TriNetX Research Network in adult patients with UC who initiated mirikizumab or risankizumab. The primary outcome was hazard of oral and/or IV corticosteroid use within 180&#xa0;days. The secondary outcomes were therapy change, colectomy and fecal calprotectin (FCP) response, defined as either a level &lt; 200&#xa0;µg/g or a decline of &gt; 50%. 1:1 propensity score matching (PSM) was performed for demographics, comorbid conditions, laboratory values and prior UC medications. Risk was expressed as adjusted hazard ratio with 95% confidence intervals (CI).</p> Results <p>There were 98 patients in the mirikizumab cohort (mean age 43.6 ± 18, 58.1% male, 80% White, 72.1% bio-exposed) and 147 patients in the risankizumab cohort (mean age 45.8 ± 17.5, 57.1% male, 80% White, 65.3% bio-exposed). Ustekinumab exposure was similar between the two cohorts (28.5% vs. 22.4%, <i>p</i> = 0.28). After PSM (<i>n</i> = 72); there was a lower incidence of corticosteroid use in the mirikizumab cohort compared to risankizumab cohort (31.9% vs. 44.4%, aHR 0.56, 95% CI 0.32–0.96, log rank <i>p</i> = 0.03). There was a lower incidence of corticosteroid use in the mirikizumab bio-exposed cohort compared to risankizumab, however, no difference in the bio-naïve cohort. There was no difference in the incidence of therapy change. Zero patients required colectomy. There was a higher proportion of patients with FCP &lt; 200&#xa0;µg/g (42.8% vs. 16%, <i>p</i> = 0.03) in the mirikizumab cohort. Rates of adverse events were low.</p> Conclusion <p>Our exploratory study in a predominantly bio-exposed cohort suggests mirikizumab use for induction of remission was associated with decreased corticosteroid use and higher FCP response compared to risankizumab in UC.</p> Graphical Abstract <p></p>

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Comparative effectiveness of mirikizumab and risankizumab in patients with ulcerative colitis: A propensity-matched cohort study

  • Gursimran S. Kochhar,
  • Parambir S. Dulai,
  • Himsikhar Khataniar,
  • Aakash Desai

摘要

Background and Objectives

Mirikizumab and risankizumab are both anti-IL23 therapies approved for moderate-to-severe ulcerative colitis (UC); however, there is no comparative data to guide their clinical use.

Methods

We performed an exploratory retrospective cohort study in the TriNetX Research Network in adult patients with UC who initiated mirikizumab or risankizumab. The primary outcome was hazard of oral and/or IV corticosteroid use within 180 days. The secondary outcomes were therapy change, colectomy and fecal calprotectin (FCP) response, defined as either a level < 200 µg/g or a decline of > 50%. 1:1 propensity score matching (PSM) was performed for demographics, comorbid conditions, laboratory values and prior UC medications. Risk was expressed as adjusted hazard ratio with 95% confidence intervals (CI).

Results

There were 98 patients in the mirikizumab cohort (mean age 43.6 ± 18, 58.1% male, 80% White, 72.1% bio-exposed) and 147 patients in the risankizumab cohort (mean age 45.8 ± 17.5, 57.1% male, 80% White, 65.3% bio-exposed). Ustekinumab exposure was similar between the two cohorts (28.5% vs. 22.4%, p = 0.28). After PSM (n = 72); there was a lower incidence of corticosteroid use in the mirikizumab cohort compared to risankizumab cohort (31.9% vs. 44.4%, aHR 0.56, 95% CI 0.32–0.96, log rank p = 0.03). There was a lower incidence of corticosteroid use in the mirikizumab bio-exposed cohort compared to risankizumab, however, no difference in the bio-naïve cohort. There was no difference in the incidence of therapy change. Zero patients required colectomy. There was a higher proportion of patients with FCP < 200 µg/g (42.8% vs. 16%, p = 0.03) in the mirikizumab cohort. Rates of adverse events were low.

Conclusion

Our exploratory study in a predominantly bio-exposed cohort suggests mirikizumab use for induction of remission was associated with decreased corticosteroid use and higher FCP response compared to risankizumab in UC.

Graphical Abstract