Dataset related to article "Efficacy and safety of baricitinib in 446 patients with rheumatoid arthritis: a real-life multicentre study"
- Giacomo Maria Guidelli1
- Ombretta Viapiana2
- Nicoletta Luciano3
- Maria De Santis3
- Nicola Boffini4
- Luca Quartuccio5
- Domenico Birra6
- Edoardo Conticini7
- Maria Sole Chimenti8
- Chiara Bazzani9
- Eleonora Bruschi10
- Marta Riva11
- Lorenzo Maria Canziani12
- Gerolamo Bianchi13
- Maria Rosa Pozzi11
- Massimiliano Limonta10
- Roberto Gorla9
- Roberto Perricone8
- Bruno Frediani7
- Paolo Moscato6
- Salvatore De Vita5
- Lorenzo Dagna14
- Maurizio Rossini2
- Carlo Selmi15
- 1. IRCCS Humanitas Research Hospital , Rozzano, Milan, IT
- 2. Azienda Ospedaliera Universitaria Integrata, Verona, University of Verona, Italy
- 3. IRCCS Humanitas Research Hospital, Rozzano, Milan, IT
- 4. IRCCS San Raffaele Scientific Institute, Milan and Vita-Salute San Raffaele University, milan, Italy
- 5. Azienda Sanitaria Universitaria Integrata and University of Udine, Italy
- 6. AOU San Giovanni di Dio e Ruggi d'Aragona, Salerno, Italy
- 7. Policlinico Le Scotte, University of Siena, Italy
- 8. Department of Medicina dei Sistemi, University of Rome Tor Vergata, Italy
- 9. Spedali Civili, Brescia, Italy
- 10. ASST Papa Giovanni XXIII, Bergamo, Italy
- 11. San Gerardo Hospital, Monza, Italy
- 12. IRCCS Humanitas Research Hospital, Rozzano, Milan AND Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy
- 13. ASL3 Genovese, Genova, Italy
- 14. IRCCS San Raffaele Scientific Institute, Milan and Vita-Salute San Raffaele University, milan, Italy.
- 15. IRCCS Humanitas Research Hospital, Rozzano, Milan, AND Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy
Description
This record contains data related to article "Efficacy and safety of baricitinib in 446 patients with rheumatoid arthritis: a real-life multicentre study".
Objectives: Baricitinib, an oral Janus kinase (JAK) 1-2 inhibitor, is currently used along biologic DMARDs (bDMARDs) after the failure of methotrexate (MTX) in rheumatoid arthritis (RA). We investigated the efficacy and safety of baricitinib in real life.
Methods: We prospectively enrolled 446 RA patients treated with baricitinib from 11 Italian centres. Patients were evaluated at baseline and after 3, 6, and 12 months. They were arrayed based on previous treatments as bDMARD-naïve and bDMARD-insufficient responders (IR) after the failure or intolerance to bDMARDs. A sub-analysis differentiated the effects of methotrexate (MTX) and the use of oral glucocorticoids (OGC).
Results: Our cohort included 150 (34%) bDMARD-naïve and 296 (66%) bDMARD-IR patients, with 217 (49%) using baricitinib as monotherapy. Considering DAS-28-CRP as the primary outcome, at 3 and 6 months, 114/314 (36%) and 149/289 (51.6%) patients achieved remission, while those in low disease activity (LDA) were 62/314 (20%) and 46/289 (15.9%), respectively; finally at 12 months 81/126 (64%) were in remission and 21/126 (17%) in LDA. At all-timepoints up to 12 months, bDMARDs-naïve patients demonstrated a better clinical response, independently of MTX. A significant reduction in the OGC dose was observed at 3 and 12 months in all groups. The serum positivity for both rheumatoid factors (RF) and anti-citrullinated protein antibodies (ACPA) conferred a lower risk of stopping baricitinib due to inefficacy. Fifty-eight (13%) patients discontinued baricitinib due to adverse events, including thrombotic events and herpes zoster reactivation.
Conclusions: Real-life data confirm the efficacy and safety profiles of baricitinib in patients with RA and provide evidence that drug survival is higher in bDMARDs-naïve and seropositive patients
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Related works
- Is supplement to
- 33338001 (PMID)