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Real-world Clinical Effectiveness and Safety of Vedolizumab and Adalimumab in Biologic-naive Patients With Crohn's Disease: Results From the EVOLVE Study.
Yarur, Andres J; Bressler, Brian; Brett, Neil R; Bassel, Marielle; Adsul, Shashi; Kamble, Pravin; Mantzaris, Gerassimos J.
Afiliación
  • Yarur AJ; Cedars-Sinai Medical Center, Los Angeles, CA.
  • Bressler B; St. Paul's Hospital, Vancouver, BC, Canada.
  • Brett NR; PPD, part of Thermo Fisher Scientific, Montreal, QC, Canada.
  • Bassel M; PPD, part of Thermo Fisher Scientific, Montreal, QC, Canada.
  • Adsul S; Takeda Pharmaceuticals International AG, Zurich, Switzerland.
  • Kamble P; Takeda Pharmaceuticals International, Cambridge, MA.
  • Mantzaris GJ; White Cross-The Athens Clinic and HYGEIA Hospital, Athens, Greece.
J Clin Gastroenterol ; 2024 Aug 02.
Article en En | MEDLINE | ID: mdl-39102457
ABSTRACT
GOALS This study evaluated the real-world effectiveness and safety of vedolizumab versus adalimumab over 12 months of treatment in biologic-naive patients with Crohn's disease (CD), using data from the EVOLVE study.

BACKGROUND:

A comparison of vedolizumab and adalimumab may help to better position them in the therapeutic algorithm for moderate-to-severe CD. STUDY Data were collected from medical records of patients with CD aged ≥18 years initiating treatment with adalimumab or vedolizumab between May 2014 and July 2017. Adjusted analyses were performed using inverse probability weighting to account for differences in baseline characteristics. Cumulative rates for clinical effectiveness outcomes and treatment persistence were estimated using Kaplan-Meier analyses. Disease-related exacerbations, serious adverse events (SAEs), and serious infections (SIs) were also assessed.

RESULTS:

Data from 218 vedolizumab- and 144 adalimumab-treated patients were analyzed. Adjusted cumulative rates of clinical remission were greater with vedolizumab than with adalimumab (66.3% vs. 46.4%; P=0.006). Probability of treatment persistence was higher with vedolizumab (89.3% vs. 77.5%; P=0.024); probabilities of clinical response (68.5% vs. 61.1%; P=0.586) and mucosal healing (67.7% vs. 56.0%; P=0.562) were similar. SAEs were less likely to occur with vedolizumab [hazard ratio, 0.45 (95% confidence interval, 0.22-0.93)]; however, the likelihood of SIs [0.27 (0.06-1.20)], CD exacerbations [0.91 (0.56-1.47)], and CD-related surgeries [1.55 (0.21-11.15)] was comparable between the 2 groups.

CONCLUSIONS:

In a real-world setting, biologic-naive patients with CD treated with vedolizumab demonstrated a greater likelihood of drug persistence and achieving clinical remission, with equivalent rates of response and mucosal healing versus adalimumab-treated patients.

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Clin Gastroenterol Año: 2024 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Clin Gastroenterol Año: 2024 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Estados Unidos