PMID- 38135860 OWN - NLM STAT- MEDLINE DCOM- 20240202 LR - 20240223 IS - 1434-9949 (Electronic) IS - 0770-3198 (Print) IS - 0770-3198 (Linking) VI - 43 IP - 2 DP - 2024 Feb TI - ToRaRI (Tofacitinib in Rheumatoid Arthritis a Real-Life experience in Italy): Effectiveness, safety profile of tofacitinib and concordance between patient-reported outcomes and physician's global assessment of disease activity in a retrospective study in Central-Italy. PG - 657-665 LID - 10.1007/s10067-023-06836-w [doi] AB - INTRODUCTION: The use of Janus Kinase Inhibitors (JAK-Is) in rheumatoid arthritis (RA) has entered in daily practice. In consideration of ORAL-Surveillance trial and the new EULAR recommendations, real-world data are needed to assess Jak-Is safety and effectiveness. The multicenter study presented here aimed to evaluate effectiveness and safety of tofacitinib in a real-life cohort. METHODS: A retrospective analysis was performed from September 2021 to December 2022. Data were collected when tofacitinib was started (T0) and after 3 (T3), 6 (T6) and 12 (T12) months of treatment. The primary objective was to analyze the efficacy and safety of tofacitinib. Safety was assessed by recording adverse events (AEs) with and without discontinuation. The secondary objective was to assess the difference between Patient-Reported Outcomes (PROs) and Physician's Global Assessment of disease activity (PhGA). RESULTS: 122 patients were included in the study from the following rheumatology Centers: Pisa, Ancona, Florence (two Centers), Siena, and Sardinia. A statistically significant improvement in DAS-28-CRP, CDAI and SDAI score was observed at T3, T6, compared to baseline (p < 0.001). Improvement was confirmed in patients who reach T12. Patients naive to bDMARDs showed a shorter remission time and higher remission rates. There was also a statistically significant improvement in PROs compared to baseline (p < 0.001). The improvement was rapid and was consistent with PhGA. The 12-month retention rate for tofacitinib was 89.35%. Reasons to stop tofacitinib were: insufficient response (7), gastrointestinal symptoms (2), infection (1), malignancy (1), Zoster (1), pruritus sine materia (1). CONCLUSIONS: Tofacitinib is safe and effective in our RA cohort. It induces higher remission rates in patients naive to bDMARDs, suggesting that there may be a benefit using it as first-line therapy. Additionally, improvement in PROs was consistent with PhGA scores, demonstrating how tofacitinib affects both the objective and subjective components of disease activity. Key Points 1. JAK inhibitors are considered at a similar level as biologic agents in terms of effectiveness. 2. After ORAL-Surveillance results, real-world data are needed to assess the benefit/risk profile of Jaki. 3. Disagreement between patients and physicians has been previously reported with biologic therapy among patients with rheumatoid arthritis, with patients rating disease activity higher than physicians. 4. Jak inhibitors could reduce this discrepancy, due to their mechanism of action. CI - (c) 2023. The Author(s). FAU - D'Alessandro, Francesco AU - D'Alessandro F AD - Rheumatology Unit, University of Pisa, Pisa, Italy. f.dalessandro4@studenti.unipi.it. FAU - Cazzato, Massimiliano AU - Cazzato M AUID- ORCID: 0000-0002-9437-8359 AD - Rheumatology Unit, University of Pisa, Pisa, Italy. maxxmed@live.com. FAU - Laurino, Elenia AU - Laurino E AD - Rheumatology Unit, University of Pisa, Pisa, Italy. FAU - Morganti, Riccardo AU - Morganti R AD - Section of Statistics, University of Pisa, Pisa, Italy. FAU - Bardelli, Marco AU - Bardelli M AD - Rheumatology Unit-Department of Medicine, Surgery and Neurosciences-University Hospital Siena, Siena, Italy. FAU - Frediani, Bruno AU - Frediani B AD - Rheumatology Unit-Department of Medicine, Surgery and Neurosciences-University Hospital Siena, Siena, Italy. FAU - Buongarzone, Claudia AU - Buongarzone C AD - Internal Medicine Residency Programme, Marche Polytechnic University, Ancona, Italy. FAU - Moroncini, Gianluca AU - Moroncini G AD - Clinica Medica, Marche Polytechnic University Hospital, Ancona, Italy. FAU - Guiducci, Serena AU - Guiducci S AD - Department of Experimental and Clinical Medicine, Division of Rheumatology, University of Florence, Florence, Italy. FAU - Cometi, Laura AU - Cometi L AD - Department of Experimental and Clinical Medicine, Division of Rheumatology, University of Florence, Florence, Italy. FAU - Benucci, Maurizio AU - Benucci M AD - Rheumatology Unit, S.Giovanni Di Dio Firenze Hospital, Florence, Italy. FAU - Ligobbi, Francesca AU - Ligobbi F AD - Rheumatology Unit, S.Giovanni Di Dio Firenze Hospital, Florence, Italy. FAU - Marotto, Daniela AU - Marotto D AD - Reumatology Unit Asl Gallura Olbia, Olbia, Italy. FAU - Mosca, Marta AU - Mosca M AD - Rheumatology Unit, University of Pisa, Pisa, Italy. LA - eng PT - Journal Article PT - Multicenter Study DEP - 20231223 PL - Germany TA - Clin Rheumatol JT - Clinical rheumatology JID - 8211469 RN - 0 (Antirheumatic Agents) RN - 0 (Janus Kinase Inhibitors) RN - 87LA6FU830 (tofacitinib) RN - 0 (Pyrroles) RN - 0 (Piperidines) RN - 0 (Pyrimidines) SB - IM MH - Humans MH - *Antirheumatic Agents/adverse effects MH - Retrospective Studies MH - *Janus Kinase Inhibitors/adverse effects MH - *Arthritis, Rheumatoid/diagnosis MH - Pyrroles/adverse effects MH - Patient Reported Outcome Measures MH - Treatment Outcome MH - *Piperidines MH - *Pyrimidines PMC - PMC10834550 OTO - NOTNLM OT - Jak inhibitors OT - Patient-reported outcomes OT - Physician's global assessment OT - Rheumatoid arthritis EDAT- 2023/12/23 12:42 MHDA- 2024/02/02 06:43 PMCR- 2023/12/23 CRDT- 2023/12/22 23:34 PHST- 2023/10/21 00:00 [received] PHST- 2023/11/26 00:00 [accepted] PHST- 2023/11/21 00:00 [revised] PHST- 2024/02/02 06:43 [medline] PHST- 2023/12/23 12:42 [pubmed] PHST- 2023/12/22 23:34 [entrez] PHST- 2023/12/23 00:00 [pmc-release] AID - 10.1007/s10067-023-06836-w [pii] AID - 6836 [pii] AID - 10.1007/s10067-023-06836-w [doi] PST - ppublish SO - Clin Rheumatol. 2024 Feb;43(2):657-665. doi: 10.1007/s10067-023-06836-w. Epub 2023 Dec 23.