Effectiveness and safety of Janus Kinase inhibitors in patients with rheumatoid arthritis, results from a multicenter observational “real-life” GIRRCS (Gruppo Italiano di Ricerca in Reumatologia Clinica e Sperimentale) study
10 affiliations
- 1Department of Precision Medicine, Rheumatology Unit, University of Campania “Luigi Vanvitelli”, Naples, Italy
- 2Department of Medical and Surgical Sciences, Rheumatology Clinic, University of Foggia, Foggia, Italy
- 3Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, Rheumatology Section-″P. Giaccone″, University of Palermo, Palermo, Italy
- 4Department of Medicine and Post-Acute Care, Rheumatology Unit, “Ospedale del Mare” Hospital, Naples, Italy
- 5Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy
- 6Research and Clinical Unit of Immunorheumatology, Department of Medicine and Surgery, Università Campus Bio-Medico Di Roma, Rome, Italy
- 7Rheumatology Unit, Papardo Hospital, Messina, Italy
- 8Rheumatic and Systemic Autoimmune Diseases Unit, Department of Interdisciplinary Medicine (DIM), University of Bari Medical School, Bari, Italy
- 9Frangipane Bellizzi” Hospital, Internal Medicine Unit, Ariano Irpino, Avellino, Italy
- 10Department of Biotechnological and Applied Clinical Sciences, University of L′Aquila, L′Aquila, Italy
Abstract
Objectives: To evaluate the “real-life” effectiveness and safety of Janus kinase inhibitors (JAKis) in patients with rheumatoid arthritis (RA) and to analyze the impact of cardiometabolic comorbidities on these outcomes.
Methods: Patients with RA treated with JAKis were evaluated for disease activity scores, patient-reported outcomes (PROs), and safety in a 12‑month multicenter observational study conducted within the GIRRCS (Gruppo Italiano di Ricerca in Reumatologia Clinica e Sperimentale). Patients were grouped and compared according to the presence of type 2 diabetes (T2D), cardiometabolic multimorbidity (defined as the simultaneous presence of two or more among high blood pressure, T2D, and/or dyslipidaemia), and age ≥ 65 years.
Results: 440 patients treated with JAKis were included (82.9% female; mean age 61.0 ± 11.0 years); 41.4% had high blood pressure, 39.0% obesity, 28.4% dyslipidaemia, 14.3% T2D, and 3.2% a history of cardiovascular events. A statistically significant improvement was observed in all disease activity measures and PROs over the follow-up period. These improvements seemed to be not influenced by the presence of T2D, cardiometabolic multimorbidity, or age ≥ 65 years. During follow-up, a cumulative adverse events incidence of 18.9% was reported; these were mostly mild and reversible, with no life-threatening events. Drug discontinuation due to adverse events occurred in 7.7% of assessed patients (34 discontinuations due to adverse events). Safety outcomes appeared to be not significantly affected by T2D, cardiometabolic multimorbidity, or age ≥ 65 years.
Conclusions: In our “real-life” multicenter cohort in patients with RA, JAKis demonstrated effectiveness with an acceptable safety profile despite the relatively short follow-up and the lack of power to assess clinically relevant differences for rare events. The safety profile should therefore be interpreted with appropriate caution. The presence of T2D, cardiometabolic multimorbidity, and age ≥ 65 years did not appear to adversely influence treatment response or safety.
Key Points
• TJAK inhibitors were effective in reducing disease activity and improving patient-reported outcomes in real-life patients with RA.
• Type 2 diabetes, cardiometabolic multimorbidity, and older age did not appear to impair treatment effectiveness of JAK inhibitors in patients with RA.
• Most adverse events of JAK inhibitors were mild, reversible, and infrequently led to treatment discontinuation.
• These findings may support the use of JAK inhibitors in clinically complex real-life RA populations encountered in daily practice.
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BibTeX
@article{iacono2026effectiveness,
title = {{Effectiveness and safety of Janus Kinase inhibitors in patients with rheumatoid arthritis, results from a multicenter observational “real-life” GIRRCS (Gruppo Italiano di Ricerca in Reumatologia Clinica e Sperimentale) study}},
author = {Daniela Iacono and Maura Raimondi and Valentina Marino and Flavia Riccio and Maria Laura Marchesano and Alessandra Milone and Addolorata Corrado and Cinzia Rotondo and Ilaria Firenze and Lidia La Barbera and Chiara Rizzo and Simona Montalbano and Luca Navarini and Alberto Lo Gullo and Marianna Oliva and Elvira Favoino and Ida Orlando and Francesco Paolo Cantatore and Paola Cipriani and Enrico Tirri and Roberto Giacomelli and Federico Perosa and Giuliana Guggino and Piero Ruscitti and Francesco Ciccia},
journal = {Clinical Rheumatology},
year = {2026},
month = sep,
doi = {10.1007/s10067-026-08373-8},
url = {https://doi.org/10.1007/s10067-026-08373-8},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Effectiveness and safety of Janus Kinase inhibitors in patients with rheumatoid arthritis, results from a multicenter observational “real-life” GIRRCS (Gruppo Italiano di Ricerca in Reumatologia Clinica e Sperimentale) study
AU - Daniela Iacono
AU - Maura Raimondi
AU - Valentina Marino
AU - Flavia Riccio
AU - Maria Laura Marchesano
AU - Alessandra Milone
AU - Addolorata Corrado
AU - Cinzia Rotondo
AU - Ilaria Firenze
AU - Lidia La Barbera
AU - Chiara Rizzo
AU - Simona Montalbano
AU - Luca Navarini
AU - Alberto Lo Gullo
AU - Marianna Oliva
AU - Elvira Favoino
AU - Ida Orlando
AU - Francesco Paolo Cantatore
AU - Paola Cipriani
AU - Enrico Tirri
AU - Roberto Giacomelli
AU - Federico Perosa
AU - Giuliana Guggino
AU - Piero Ruscitti
AU - Francesco Ciccia
PY - 2026
DA - 2026/09/02
JO - Clinical Rheumatology
DO - 10.1007/s10067-026-08373-8
UR - https://doi.org/10.1007/s10067-026-08373-8
AB - Objectives: To evaluate the “real-life” effectiveness and safety of Janus kinase inhibitors (JAKis) in patients with rheumatoid arthritis (RA) and to analyze the impact of cardiometabolic comorbidities on these outcomes. Methods: Patients with RA treated with JAKis were evaluated for disease activity scores, patient-reported outcomes (PROs), and safety in a 12‑month multicenter observational study conducted within the GIRRCS (Gruppo Italiano di Ricerca in Reumatologia Clinica e Sperimentale). Patients were grouped and compared according to the presence of type 2 diabetes (T2D), cardiometabolic multimorbidity (defined as the simultaneous presence of two or more among high blood pressure, T2D, and/or dyslipidaemia), and age ≥ 65 years. Results: 440 patients treated with JAKis were included (82.9% female; mean age 61.0 ± 11.0 years); 41.4% had high blood pressure, 39.0% obesity, 28.4% dyslipidaemia, 14.3% T2D, and 3.2% a history of cardiovascular events. A statistically significant improvement was observed in all disease activity measures and PROs over the follow-up period. These improvements seemed to be not influenced by the presence of T2D, cardiometabolic multimorbidity, or age ≥ 65 years. During follow-up, a cumulative adverse events incidence of 18.9% was reported; these were mostly mild and reversible, with no life-threatening events. Drug discontinuation due to adverse events occurred in 7.7% of assessed patients (34 discontinuations due to adverse events). Safety outcomes appeared to be not significantly affected by T2D, cardiometabolic multimorbidity, or age ≥ 65 years. Conclusions: In our “real-life” multicenter cohort in patients with RA, JAKis demonstrated effectiveness with an acceptable safety profile despite the relatively short follow-up and the lack of power to assess clinically relevant differences for rare events. The safety profile should therefore be interpreted with appropriate caution. The presence of T2D, cardiometabolic multimorbidity, and age ≥ 65 years did not appear to adversely influence treatment response or safety. Key Points • TJAK inhibitors were effective in reducing disease activity and improving patient-reported outcomes in real-life patients with RA. • Type 2 diabetes, cardiometabolic multimorbidity, and older age did not appear to impair treatment effectiveness of JAK inhibitors in patients with RA. • Most adverse events of JAK inhibitors were mild, reversible, and infrequently led to treatment discontinuation. • These findings may support the use of JAK inhibitors in clinically complex real-life RA populations encountered in daily practice.
SN - 0770-3198
SN - 1434-9949
ER -