Esophagus to Small Intestine

Am J Gastroenterol. 2023;118(4):674−84

Kappelman MD, Adimadhyam S, Hou L, Wolfe AE, Smith S, Simon AL, Moyneur É, Reynolds JS, Toh S, Dobes A, Parlett LE, Haynes K, Selvan M, Ma Q, Nair V, Burris J, Dorand JE, Dawwas GK, Lewis JD, Long MD

Real-world evidence comparing vedolizumab and ustekinumab in anti-tumor necrosis factor-experienced patients with Crohn’s disease


Introduction: Many patients with Crohn’s disease (CD) lose response or become intolerant to anti-tumor necrosis factor (TNF) therapy and sub-sequently switch out of class. The authors compared the effectiveness and safety of ustekinumab to vedolizumab in a large, geographically di-verse US population of TNF-experienced patients with CD.
Methods: They conducted a retrospective cohort study using longitudinal claims data from a large US insurer (Anthem, Inc.), and identified pa-tients with CD initiating vedolizumab or ustekinumab with anti-TNF treatment in the prior 6 months. The primary outcome was treatment persis-tence for > 52 weeks. Secondary outcomes included (i) all-cause hospitalization, (ii) hospitalization for CD with surgery, (iii) hospitalization for CD without surgery, and (iv) hospitalization for infection. Propensity score fine stratification was used to control for demographic and baseline clini-cal characteristics and prior treatments.
Results: Among 885 new users of ustekinumab and 490 new users of vedolizumab, no difference in treatment persistence (adjusted risk ratio = 1.09 [95% confidence interval: 0.95−1.25]) was observed. Ustekinumab was associated with a lower rate of all-cause hospitalization (adjusted hazard ratio [aHR] = 0.73 [0.59−0.91]), non-surgical CD hospitalization (aHR = 0.58 [0.40−0.83]), and hospitalization for infection (aHR = 0.56 [0.34−0.92]).

Discussion: This real-world comparative effectiveness study of anti-tumor necrosis factor-experienced patients with Crohn’s disease (CD) initiating vedolizumab or ustekinumab showed similar treatment persistence rates beyond 52 weeks, although secondary outcomes such as all-cause hospitalizations, non-surgical CD hospitalizations, and hospitalizations for infection favored ustekinumab initiation. The authors, therefore, ad-vocate for individualized decision making in this medically refractory population, considering patient preference and other factors such as cost and route of administration.

M.D. Kappelman, M.D., Associate Professor, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA,
E-Mail: michael_kappelman@med.unc.edu

DOI: 10.14309/ajg.0000000000002068

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