Giacomo Maria Guidelli1, Ombretta Viapiana2, Nicoletta Luciano1, Maria De Santis1, Nicola Boffini3, Luca Quartuccio4, Domenico Birra5, Edoardo Conticini6, Maria Sole Chimenti7, Chiara Bazzani8, Eleonora Bruschi9, Marta Riva10, Lorenzo Maria Canziani11, Gerolamo Bianchi12, Maria Rosa Pozzi10, Massimiliano Limonta9, Roberto Gorla8, Roberto Perricone7, Bruno Frediani6, Paolo Moscato5, Salvatore De Vita4, Lorenzo Dagna3, Maurizio Rossini2, Carlo Selmi13. 1. Rheumatology and Clinical Immunology, Humanitas Research Hospital IRCCS, Rozzano, Milan, Italy. 2. Rheumatology, Azienda Ospedaliera Universitaria Integrata, Verona, University of Verona, Italy. 3. Rheumatology, IRCCS San Raffaele Scientific Institute, Milan and Vita-Salute San Raffaele University, milan, Italy. 4. Rheumatology, Azienda Sanitaria Universitaria Integrata and University of Udine, Italy. 5. Internal Medicine, AOU San Giovanni di Dio e Ruggi d'Aragona, Salerno, Italy. 6. Rheumatology, Policlinico Le Scotte, University of Siena, Italy. 7. Rheumatology, Allergy and Clinical Immunology, Department of Medicina dei Sistemi, University of Rome Tor Vergata, Italy. 8. Rheumatology and Clinical Immunology, Spedali Civili, Brescia, Italy. 9. Rheumatology, ASST Papa Giovanni XXIII, Bergamo, Italy. 10. Rheumatology, San Gerardo Hospital, Monza, Italy. 11. Division of Rheumatology and Clinical Immunology, Humanitas Clinical and Research Center, IRCCS, Rozzano, Milan, and Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy. 12. Rheumatology, ASL3 Genovese, Genova, Italy. 13. Division of Rheumatology and Clinical Immunology, Humanitas Clinical and Research Center, IRCCS, Rozzano, Milan, and Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy. carlo.selmi@humanitas.it.
Abstract
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.
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.