Effectiveness and safety profile of tofacitinib and baricitinib in rheumatoid arthritis patients: results from a 24-month real-life prospective study in Southern-Italy

The primary objectives of the study were to evaluate the efficacy and safety of tofacitinib and baricitinib up to 24 months of follow-up in patients with rheumatoid arthritis (RA) treated in Southern Italy. Patients’ data, activity index, and clinimetric scores were collected at baseline (T0), six...

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Main Authors: M. Tasso, N. Bertolini, E. Mostacciuolo, S. Passavanti, J.M.E. Luppino, A. Del Puente, R. Peluso, F. Santelli, R. Scarpa, L. Costa, F. Caso
Format: Article
Language:English
Published: PAGEPress Publications 2022-12-01
Series:Reumatismo
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Online Access:https://reumatismo.org/index.php/reuma/article/view/1511
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author M. Tasso
N. Bertolini
E. Mostacciuolo
S. Passavanti
J.M.E. Luppino
A. Del Puente
R. Peluso
F. Santelli
R. Scarpa
L. Costa
F. Caso
author_facet M. Tasso
N. Bertolini
E. Mostacciuolo
S. Passavanti
J.M.E. Luppino
A. Del Puente
R. Peluso
F. Santelli
R. Scarpa
L. Costa
F. Caso
author_sort M. Tasso
collection DOAJ
description The primary objectives of the study were to evaluate the efficacy and safety of tofacitinib and baricitinib up to 24 months of follow-up in patients with rheumatoid arthritis (RA) treated in Southern Italy. Patients’ data, activity index, and clinimetric scores were collected at baseline (T0), six (T6), twelve (T12), and twenty-four (T24) months following treatment initiation. At six, twelve, and twenty-four months, adverse events and treatment cessation were also recorded. Sixty-eight patients (mean age: 62.2±10.9 years; mean RA duration: 15±9.6 years) were enrolled over a period of 12 weeks. At baseline, twenty-four patients (35.3%) were treated with tofacitinib, and forty-four patients (64.7%) were treated with baricitinib. The baseline mean disease activity was moderate as measured by DAS28- ESR (5.0±1.0), DAS 28 CRP (4.69±0.94), and SDAI (26.87±10.73) score. Before beginning JAKinhibs therapy, thirty-two patients (61.8%) were taking bDMARDs, while the remaining thirty-six (38.2%) were bDMARDs-naïve. The 24-month retention rate for JAKinhibs was 91.1%. Six months after beginning treatment with JAKinhibs, a statistically significant improvement was observed in all evaluated activity indices and clinimetric scores. Improvement was confirmed during the 12- and 24-month follow-up evaluations. The positive correlation between baseline-T6 SDAI delta and discontinuation of JAKinhibs (p=0.02) suggests that RA worsening in the first six months may be a predictor of therapy withdrawal. Patients with RA responded favorably to tofacitinib and baricitinib in this prospective, real-world study from a single center in Southern Italy. Efficacy was observed despite an underlying persistent and treatment-resistant disease.
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spelling doaj.art-36c0e1477318460fb40c0fe3656af5f62022-12-30T13:47:27ZengPAGEPress PublicationsReumatismo0048-74492240-26832022-12-0174310.4081/reumatismo.2022.1511Effectiveness and safety profile of tofacitinib and baricitinib in rheumatoid arthritis patients: results from a 24-month real-life prospective study in Southern-ItalyM. Tasso0N. Bertolini1E. Mostacciuolo2S. Passavanti3J.M.E. Luppino4A. Del Puente5R. Peluso6F. Santelli7R. Scarpa8L. Costa9F. Caso10Rheumatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, NaplesRheumatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, NaplesRheumatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, NaplesRheumatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, NaplesRheumatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, NaplesRheumatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, NaplesRheumatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, NaplesDepartment of Political Science, University of Naples Federico II, NaplesRheumatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, NaplesRheumatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, NaplesRheumatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples The primary objectives of the study were to evaluate the efficacy and safety of tofacitinib and baricitinib up to 24 months of follow-up in patients with rheumatoid arthritis (RA) treated in Southern Italy. Patients’ data, activity index, and clinimetric scores were collected at baseline (T0), six (T6), twelve (T12), and twenty-four (T24) months following treatment initiation. At six, twelve, and twenty-four months, adverse events and treatment cessation were also recorded. Sixty-eight patients (mean age: 62.2±10.9 years; mean RA duration: 15±9.6 years) were enrolled over a period of 12 weeks. At baseline, twenty-four patients (35.3%) were treated with tofacitinib, and forty-four patients (64.7%) were treated with baricitinib. The baseline mean disease activity was moderate as measured by DAS28- ESR (5.0±1.0), DAS 28 CRP (4.69±0.94), and SDAI (26.87±10.73) score. Before beginning JAKinhibs therapy, thirty-two patients (61.8%) were taking bDMARDs, while the remaining thirty-six (38.2%) were bDMARDs-naïve. The 24-month retention rate for JAKinhibs was 91.1%. Six months after beginning treatment with JAKinhibs, a statistically significant improvement was observed in all evaluated activity indices and clinimetric scores. Improvement was confirmed during the 12- and 24-month follow-up evaluations. The positive correlation between baseline-T6 SDAI delta and discontinuation of JAKinhibs (p=0.02) suggests that RA worsening in the first six months may be a predictor of therapy withdrawal. Patients with RA responded favorably to tofacitinib and baricitinib in this prospective, real-world study from a single center in Southern Italy. Efficacy was observed despite an underlying persistent and treatment-resistant disease. https://reumatismo.org/index.php/reuma/article/view/1511Rheumatoid ArthritisJAK inhibitorsTofacitinibBaricitinib
spellingShingle M. Tasso
N. Bertolini
E. Mostacciuolo
S. Passavanti
J.M.E. Luppino
A. Del Puente
R. Peluso
F. Santelli
R. Scarpa
L. Costa
F. Caso
Effectiveness and safety profile of tofacitinib and baricitinib in rheumatoid arthritis patients: results from a 24-month real-life prospective study in Southern-Italy
Reumatismo
Rheumatoid Arthritis
JAK inhibitors
Tofacitinib
Baricitinib
title Effectiveness and safety profile of tofacitinib and baricitinib in rheumatoid arthritis patients: results from a 24-month real-life prospective study in Southern-Italy
title_full Effectiveness and safety profile of tofacitinib and baricitinib in rheumatoid arthritis patients: results from a 24-month real-life prospective study in Southern-Italy
title_fullStr Effectiveness and safety profile of tofacitinib and baricitinib in rheumatoid arthritis patients: results from a 24-month real-life prospective study in Southern-Italy
title_full_unstemmed Effectiveness and safety profile of tofacitinib and baricitinib in rheumatoid arthritis patients: results from a 24-month real-life prospective study in Southern-Italy
title_short Effectiveness and safety profile of tofacitinib and baricitinib in rheumatoid arthritis patients: results from a 24-month real-life prospective study in Southern-Italy
title_sort effectiveness and safety profile of tofacitinib and baricitinib in rheumatoid arthritis patients results from a 24 month real life prospective study in southern italy
topic Rheumatoid Arthritis
JAK inhibitors
Tofacitinib
Baricitinib
url https://reumatismo.org/index.php/reuma/article/view/1511
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