. 2024 Feb 16:6:100178.

doi: 10.1016/j.crphar.2024.100178. eCollection 2024.

Analysis of survival rate and persistence predictors of baricitinib in real-world data from a large cohort of rheumatoid arthritis patients

Simone Parisi¹, Becciolini Andrea², Ditto Maria Chiara¹, Alberto Lo Gullo³, Larosa Maddalena⁴, Scolieri Palma⁵, Addimanda Olga⁶, Reta Massimo⁶, Marino Paroli⁷, Caccavale Rosalba⁷, Visalli Elisa⁸, Foti Rosario⁸, Amato Giorgio⁸, De Lucia Francesco⁸, Dal Bosco Ylenia⁸, Foti Roberta⁸, Farina Antonella⁹, Girelli Francesco¹⁰, Bernardi Simone¹⁰, Camellino Dario⁴, Bianchi Gerolamo⁴, Colina Matteo^{11

12}, Andracco Romina¹³, Mansueto Natalia¹³, Ferrero Giulio¹³, Del Medico Patrizia¹⁴, Molica Colella Aldo¹⁵, Franchina Veronica¹⁶, Molica Colella Francesco¹⁷, Lumetti Federica¹⁸, Sandri Gilda¹⁹, Salvarani Carlo¹⁹, Priora Marta²⁰, Ianniello Aurora²¹, Nucera Valeria²¹, Santilli Daniele², Lucchini Gianluca², Giuditta Adorni², Di Donato Eleonora², Bravi Elena²², Platè Ilaria²², Arrigoni Eugenio²², Bezzi Alessandra²³, Focherini Maria Cristina²³, Mascella Fabio²³, Bruzzese Vincenzo⁵, Ravagnani Viviana²⁴, Fiorenza Alessia²⁵, Rovera Guido²⁵, Vitetta Rosetta²⁵, Marchetta Antonio²⁶, Volpe Alessandro²⁶, Ometto Francesca²⁷, Ariani Alarico², Fusaro Enrico¹

Affiliations

¹ Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Rheumatology Unit, Turin, Italy.
² Azienda Ospedaliero-Universitaria di Parma, Department of Medicine, Internal Medicine and Rheumatology Unit, Parma, Italy.
³ Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi Ospedale Garibaldi-Nesima, Rheumatology Unit, Catania, Italy.
⁴ Azienda Sanitaria Locale 3 Genovese, Division of Rheumatology - Medical Specialties Department, Genoa, Italy.
⁵ Ospedale Nuovo Regina Margherita, Internal Medicine and Rheumatology Unit, Rome, Italy.
⁶ IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola, Department of Internal Medicine-Rheumatology, Bologna, Italy.
⁷ University of Rome La Sapienza, Department of Clinical, Anesthesiological and Cardiovascular Sciences, Polo Pontino, Latina, Italy.
⁸ Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Catania, Division of Rheumatology, A.O.U. "Policlinico San Marco", Catania, Italy.
⁹ ASUR Area Vasta 4 Fermo, Ospedale A Murri, Internal Medicine Unit, Rheumatology outpatient clinic, Fermo, Italy.
¹⁰ Morgagni-Pierantoni Hospital, Rheumatology Unit, Forlì, Italy.
¹¹ Azienda USL di Imola, Department of Internal Medicine and Oncology. Service of Rheumatology, Imola, Italy.
¹² University of Bologna, Department of Biomedical and Neuromotor Sciences, Imola, Italy.
¹³ Hospital Santa Corona Pietra Ligure, Internal Medicine Unit, Rheumatology outpatient clinic, Unit of Diagnostic and Interventional Radiology, Pietra Ligure, Italy.
¹⁴ Civitanova Marche Hospital, Rheumatology outpatient clinic, Internal Medicine Unit, Civitanova Marche, Italy.
¹⁵ Azienda Ospedaliera Papardo Piemonte, Rheumatology Unit, Messina, Italy.
¹⁶ Azienda Ospedaliera Papardo Piemonte, Oncology Unit, Messina, Italy.
¹⁷ Università degli Studi di Milano-Bicocca, Internal Medicine Unit, Milan, Italy.
¹⁸ University Hospital Modena, Rheumatology Unit, Modena, Italy.
¹⁹ University of Modena and Reggio Emilia, Rheumatology Unit, Modena and Reggio Emilia, Italy.
²⁰ ASL 15 Cuneo, Rheumatology Day Hospital and outpatient clinic, Mondovì, Italy.
²¹ ASL 13 Novara, Rheumatology Outpatient Unit, Novara, Italy.
²² Guglielmo da Saliceto Hospital, Department of Medicine, Internal Medicine and Rheumatology Unit, Piacenza, Italy.
²³ ASL 13 Rimini, Internal Medicine and Rheumatology Unit, Rimini, Italy.
²⁴ Santa Chiara Hospital of Trento, Rheumatology Unit, Trento, Italy.
²⁵ PO S Andrea di Vercelli, Unit of Rheumatology, Vercelli, Italy.
²⁶ IRCCS Ospedale Sacro Cuore Don Calabria, Rheumatology Unit, Negrar, Italy.
²⁷ Azienda ULSS 6 Euganea, Rheumatology Outpatient Clinic, Padova, Italy.

PMID: 38419949
PMCID: PMC10899020
DOI: 10.1016/j.crphar.2024.100178

Analysis of survival rate and persistence predictors of baricitinib in real-world data from a large cohort of rheumatoid arthritis patients

Simone Parisi et al. Curr Res Pharmacol Drug Discov. 2024.

. 2024 Feb 16:6:100178.

doi: 10.1016/j.crphar.2024.100178. eCollection 2024.

Authors

Affiliations

¹ Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Rheumatology Unit, Turin, Italy.
² Azienda Ospedaliero-Universitaria di Parma, Department of Medicine, Internal Medicine and Rheumatology Unit, Parma, Italy.
³ Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi Ospedale Garibaldi-Nesima, Rheumatology Unit, Catania, Italy.
⁴ Azienda Sanitaria Locale 3 Genovese, Division of Rheumatology - Medical Specialties Department, Genoa, Italy.
⁵ Ospedale Nuovo Regina Margherita, Internal Medicine and Rheumatology Unit, Rome, Italy.
⁶ IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola, Department of Internal Medicine-Rheumatology, Bologna, Italy.
⁷ University of Rome La Sapienza, Department of Clinical, Anesthesiological and Cardiovascular Sciences, Polo Pontino, Latina, Italy.
⁸ Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Catania, Division of Rheumatology, A.O.U. "Policlinico San Marco", Catania, Italy.
⁹ ASUR Area Vasta 4 Fermo, Ospedale A Murri, Internal Medicine Unit, Rheumatology outpatient clinic, Fermo, Italy.
¹⁰ Morgagni-Pierantoni Hospital, Rheumatology Unit, Forlì, Italy.
¹¹ Azienda USL di Imola, Department of Internal Medicine and Oncology. Service of Rheumatology, Imola, Italy.
¹² University of Bologna, Department of Biomedical and Neuromotor Sciences, Imola, Italy.
¹³ Hospital Santa Corona Pietra Ligure, Internal Medicine Unit, Rheumatology outpatient clinic, Unit of Diagnostic and Interventional Radiology, Pietra Ligure, Italy.
¹⁴ Civitanova Marche Hospital, Rheumatology outpatient clinic, Internal Medicine Unit, Civitanova Marche, Italy.
¹⁵ Azienda Ospedaliera Papardo Piemonte, Rheumatology Unit, Messina, Italy.
¹⁶ Azienda Ospedaliera Papardo Piemonte, Oncology Unit, Messina, Italy.
¹⁷ Università degli Studi di Milano-Bicocca, Internal Medicine Unit, Milan, Italy.
¹⁸ University Hospital Modena, Rheumatology Unit, Modena, Italy.
¹⁹ University of Modena and Reggio Emilia, Rheumatology Unit, Modena and Reggio Emilia, Italy.
²⁰ ASL 15 Cuneo, Rheumatology Day Hospital and outpatient clinic, Mondovì, Italy.
²¹ ASL 13 Novara, Rheumatology Outpatient Unit, Novara, Italy.
²² Guglielmo da Saliceto Hospital, Department of Medicine, Internal Medicine and Rheumatology Unit, Piacenza, Italy.
²³ ASL 13 Rimini, Internal Medicine and Rheumatology Unit, Rimini, Italy.
²⁴ Santa Chiara Hospital of Trento, Rheumatology Unit, Trento, Italy.
²⁵ PO S Andrea di Vercelli, Unit of Rheumatology, Vercelli, Italy.
²⁶ IRCCS Ospedale Sacro Cuore Don Calabria, Rheumatology Unit, Negrar, Italy.
²⁷ Azienda ULSS 6 Euganea, Rheumatology Outpatient Clinic, Padova, Italy.

PMID: 38419949
PMCID: PMC10899020
DOI: 10.1016/j.crphar.2024.100178

Abstract

Objectives: The persistence in therapy of rheumatoid arthritis drugs and particularly bDMARD is a limiting factor for their long-term use. The randomized controlled trials (RCTs) may not reflect real-world contexts due to strict inclusion and exclusion criteria. Baricitinib, which targets both JAK1 and JAK2, has been used in Italy for several years. The aim of this multi-center study is to assess the real world persistence on therapy of baricitinib in RA patients and to identify predictive factors of baricitinib's survival rate.

Methods: This is a retrospective, multicentric, Italian, longitudinal study. All patients were enrolled according to the following criteria: a) age ≥ 18 years old; b) diagnosed with RA according 2010 ACR/EULAR classification criteria; c) treated with baricitinib. In order to describe baricitinib clinical efficacy, the survival rate was evaluated by The Kaplan-Meier curve. Then, predictive factors of drug retention rate were assessed by performing the Cox analysis, identifying which risk factors influenced treatment persistence.

Results: Overall, we included 478 patients treated with baricitinib. Among them, 380 (79.5%) were females. Baricitinib's survival rate was 94.6% at 6 months, 87.9% at 12 months, 81.7% at 24 months and 53.4% at 48 months. The Cox analysis regression showed that a higher bDMARDs/tsDMARD line of therapy seems to be a negative prognostic factor for the drug retention rate (HR 1.26 CI 95% 1.07-1.49, p = 0.006.

Conclusion: Real-life study confirms baricitinib effectiveness up to 4 years, but previous treatment with bDMARDs was a negative prognostic factor for its survival rate.

Keywords: Baricitinib; Comorbidity; JAK inhibitors; Line of treatment; Prognostic factor; Real world; Rheumatoid arthritis; Survival rate; bDMARD; tsDMARD.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

**Fig. 1**
4-year survival rate of Baricitinib.

See this image and copyright information in PMC

Cited by

The Real-World Effectiveness, Persistence, Adherence, and Safety of Janus Kinase Inhibitor Baricitinib in Rheumatoid Arthritis: A Long-Term Study.
Calvo-Garcia A, Ramírez Herráiz E, Llorente Cubas IM, Varas De Dios B, Benedí González J, Morell Baladrón A, García-Vicuña R. Calvo-Garcia A, et al. J Clin Med. 2024 Apr 25;13(9):2517. doi: 10.3390/jcm13092517. J Clin Med. 2024. PMID: 38731045 Free PMC article.
Real-World Evidence for Baricitinib in the Treatment of Rheumatoid Arthritis in Spain: A Systematic Literature Review.
Rosas J, Belzunegui J, Hernández-Cruz B, Aguirregabiria I, Moyano S, Cobo A, Díaz-Cerezo S. Rosas J, et al. Adv Ther. 2025 May;42(5):2403-2428. doi: 10.1007/s12325-025-03161-3. Epub 2025 Mar 22. Adv Ther. 2025. PMID: 40120028 Free PMC article.
Real-world effectiveness and retention rate of upadacitinib in patients with rheumatoid arthritis: results from a multicentre study.
Baldi C, Gentileschi S, Li Gobbi F, Cazzato M, Delle Sedie A, Gaggiano C, D'Ignazio E, Lepri G, De Lorenzo C, Nannini C, Niccoli L, Panaccione A, Di Cato L, Di Matteo A, Picchianti-Diamanti A, Guiducci S, Frediani B, Benucci M. Baldi C, et al. Clin Exp Med. 2025 Feb 5;25(1):50. doi: 10.1007/s10238-025-01578-2. Clin Exp Med. 2025. PMID: 39909970 Free PMC article.
Effectiveness and Predictors of Long-Term Treatment Response to Tofacitinib in Rheumatoid Arthritis Cohort: General Analysis and Focus on High-Cardiovascular-Risk Subgroup-A Multicenter Study.
Priora M, Becciolini A, Celletti E, Di Penta M, Lo Gullo A, Paroli M, Bravi E, Andracco R, Nucera V, Ometto F, Lumetti F, Farina A, Del Medico P, Colina M, Ravagnani V, Scolieri P, Larosa M, Visalli E, Addimanda O, Vitetta R, Volpe A, Bezzi A, Girelli F, Molica Colella AB, Caccavale R, Di Donato E, Adorni G, Santilli D, Lucchini G, Arrigoni E, Sabatini E, Platè I, Mansueto N, Ianniello A, Fusaro E, Ditto MC, Bruzzese V, Camellino D, Bianchi G, Serale F, Foti R, Amato G, De Lucia F, Bosco YD, Foti R, Reta M, Fiorenza A, Rovera G, Marchetta A, Focherini MC, Mascella F, Bernardi S, Sandri G, Giuggioli D, Salvarani C, Franchina V, Molica Colella F, Ferrero G, Ariani A, Parisi S. Priora M, et al. Medicina (Kaunas). 2024 Dec 2;60(12):1982. doi: 10.3390/medicina60121982. Medicina (Kaunas). 2024. PMID: 39768862 Free PMC article.
Influence of Safety Warnings on the Prescribing Attitude of JAK Inhibitors for Rheumatoid Arthritis in Italy.
Paroli M, Becciolini A, Lo Gullo A, Parisi S, Bravi E, Andracco R, Nucera V, Ometto F, Lumetti F, Farina A, Del Medico P, Colina M, Ravagnani V, Scolieri P, Larosa M, Priora M, Visalli E, Addimanda O, Vitetta R, Volpe A, Bezzi A, Girelli F, Molica Colella AB, Caccavale R, Di Donato E, Adorni G, Santilli D, Lucchini G, Arrigoni E, Platè I, Mansueto N, Ianniello A, Fusaro E, Ditto MC, Bruzzese V, Camellino D, Bianchi G, Serale F, Foti R, Amato G, De Lucia F, Dal Bosco Y, Foti R, Reta M, Fiorenza A, Rovera G, Marchetta A, Focherini MC, Mascella F, Bernardi S, Sandri G, Giuggioli D, Salvarani C, De Andres MI, Franchina V, Molica Colella F, Ferrero G, Raffeiner B, Ariani A. Paroli M, et al. J Clin Med. 2024 Jul 4;13(13):3929. doi: 10.3390/jcm13133929. J Clin Med. 2024. PMID: 38999494 Free PMC article.

References

1. Aletaha D., Neogi T., Silman A.J., et al. Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62(9):2569–2581. doi: 10.1002/art.27584. 2010 Sep. PMID: 20872595. - DOI - PubMed
1. Baldi C., Berlengiero V., Falsetti P., et al. Baricitinib retention rate: 'real-life' data from a mono-centric cohort of patients affected by rheumatoid arthritis. Front. Med. 2023;10 doi: 10.3389/fmed.2023.1176613. PMID: 37448804; PMCID: PMC10336222. - DOI - PMC - PubMed
1. Bilgin E., Ceylan F., Duran E., et al. Efficacy, retention and safety of tofacitinib in real-life: hur-bio monocentric experience. Turk. J. Med. Sci. 2020;51(1):297–308. doi: 10.3906/sag-2007-123. - DOI - PMC - PubMed
1. Chalan P., van den Berg A., Kroesen B.J., Brouwer L., Boots A. Rheumatoid arthritis, immunosenescence and the hallmarks of aging. Curr. Aging Sci. 2015;8(2):131–146. doi: 10.2174/1874609808666150727110744. PMID: 26212057; PMCID: PMC5388800. - DOI - PMC - PubMed
1. Choy E.H., Miceli-Richard C., Gonzalez-Gay M.A., et al. The effect of jak1/jak2 inhibition in rheumatoid arthritis: efficacy and safety of baricitinib. Clin. Exp. Rheumatol. 2019;7:694–704. - PubMed

LinkOut - more resources

Full Text Sources
Research Materials
- NCI CPTC Antibody Characterization Program
Miscellaneous
- NCI CPTAC Assay Portal

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Analysis of survival rate and persistence predictors of baricitinib in real-world data from a large cohort of rheumatoid arthritis patients

Affiliations

Analysis of survival rate and persistence predictors of baricitinib in real-world data from a large cohort of rheumatoid arthritis patients

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

LinkOut - more resources

Full Text Sources

Research Materials

Miscellaneous

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Related information

LinkOut - more resources

Full Text Sources

Research Materials

Miscellaneous