Current Research in Pharmacology and Drug Discovery (Jan 2024)

Analysis of survival rate and persistence predictors of baricitinib in real-world data from a large cohort of rheumatoid arthritis patients

  • Simone Parisi,
  • Becciolini Andrea,
  • Ditto Maria Chiara,
  • Alberto Lo Gullo,
  • Larosa Maddalena,
  • Scolieri Palma,
  • Addimanda Olga,
  • Reta Massimo,
  • Marino Paroli,
  • Caccavale Rosalba,
  • Visalli Elisa,
  • Foti Rosario,
  • Amato Giorgio,
  • De Lucia Francesco,
  • Dal Bosco Ylenia,
  • Foti Roberta,
  • Farina Antonella,
  • Girelli Francesco,
  • Bernardi Simone,
  • Camellino Dario,
  • Bianchi Gerolamo,
  • Colina Matteo,
  • Andracco Romina,
  • Mansueto Natalia,
  • Ferrero Giulio,
  • Del Medico Patrizia,
  • Molica Colella Aldo,
  • Franchina Veronica,
  • Molica Colella Francesco,
  • Lumetti Federica,
  • Sandri Gilda,
  • Salvarani Carlo,
  • Priora Marta,
  • Ianniello Aurora,
  • Nucera Valeria,
  • Santilli Daniele,
  • Lucchini Gianluca,
  • Giuditta Adorni,
  • Di Donato Eleonora,
  • Bravi Elena,
  • Platè Ilaria,
  • Arrigoni Eugenio,
  • Bezzi Alessandra,
  • Focherini Maria Cristina,
  • Mascella Fabio,
  • Bruzzese Vincenzo,
  • Ravagnani Viviana,
  • Fiorenza Alessia,
  • Rovera Guido,
  • Vitetta Rosetta,
  • Marchetta Antonio,
  • Volpe Alessandro,
  • Ometto Francesca,
  • Ariani Alarico,
  • Fusaro Enrico

Journal volume & issue
Vol. 6
p. 100178

Abstract

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Objectives: The persistence in therapy of rheumatoid arthritis drugs and particularly bDMARD is a limiting factor for their long-term use. The randomized controlled trials (RCTs) may not reflect real-world contexts due to strict inclusion and exclusion criteria. Baricitinib, which targets both JAK1 and JAK2, has been used in Italy for several years. The aim of this multi-center study is to assess the real world persistence on therapy of baricitinib in RA patients and to identify predictive factors of baricitinib's survival rate. Methods: This is a retrospective, multicentric, Italian, longitudinal study. All patients were enrolled according to the following criteria: a) age ≥ 18 years old; b) diagnosed with RA according 2010 ACR/EULAR classification criteria; c) treated with baricitinib. In order to describe baricitinib clinical efficacy, the survival rate was evaluated by The Kaplan–Meier curve. Then, predictive factors of drug retention rate were assessed by performing the Cox analysis, identifying which risk factors influenced treatment persistence. Results: Overall, we included 478 patients treated with baricitinib. Among them, 380 (79.5%) were females. Baricitinib's survival rate was 94.6% at 6 months, 87.9% at 12 months, 81.7% at 24 months and 53.4% at 48 months. The Cox analysis regression showed that a higher bDMARDs/tsDMARD line of therapy seems to be a negative prognostic factor for the drug retention rate (HR 1.26 CI 95% 1.07–1.49, p = 0.006. Conclusion: Real-life study confirms baricitinib effectiveness up to 4 years, but previous treatment with bDMARDs was a negative prognostic factor for its survival rate.

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