PMID- 38322101
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240308
IS  - 0034-6233 (Print)
IS  - 2084-9834 (Electronic)
IS  - 0034-6233 (Linking)
VI  - 61
IP  - 6
DP  - 2023
TI  - Multicenter evaluation of tofacitinib retention and safety in rheumatoid 
      arthritis - why cardiovascular risk factors do not equate to overt risk.
PG  - 414-423
LID - 10.5114/reum/175626 [doi]
AB  - INTRODUCTION: This multicenter, real-world, retrospective cohort study aimed to 
      assess the effectiveness and safety of tofacitinib (TOFA) in rheumatoid arthritis 
      (RA). MATERIAL AND METHODS: Two hundred nine patients with active RA treated with 
      TOFA, unresponsive to at least 2 conventional synthetic disease-modifying drugs, 
      were recruited. Clinical characteristics were extracted from an electronic 
      registry and supplemented with manual chart review and data linkage with 
      ambulatory care. Drug retention and reasons for discontinuation were evaluated. 
      RESULTS: Median (interquartile range) follow-up in the whole sample was 16.9 
      (5.93-31.7) months. Mean (standard deviation) age was 51.44 (+/-11.84) years, with 
      female predominance (n = 168, 80.4%). Only 30 patients (14.4%) had no 
      pre-existing traditional cardiovascular (CV) risk factor at TOFA initiation. 
      Tofacitinib retention rates were high, with median survival estimated at 89.3% at 
      6 months, 82.4% at 12 months, and 60.4% at 24 months. Ineffectiveness was the 
      primary cause of discontinuation (n = 50). The rate of adverse events (AEs) was 
      relatively low, with lipid abnormalities, blood count alterations, and infectious 
      events among the most common. No major adverse CV event was reported. The 
      incidence rate of AEs necessitating treatment switch was 60.34 (95% CI: 37-92) 
      per 1,000 person-years of follow-up. Presence of multiple (> 3) CV risk factors 
      was associated with lower odds of TOFA retention and treatment effectiveness. 
      CONCLUSIONS: Tofacitinib demonstrated high retention rates and a favorable safety 
      profile in RA patients, including those with traditional CV risk factors. 
      Tofacitinib may be a valuable treatment option for RA patients when combined with 
      individualized CV risk management. Further studies are warranted to explore the 
      long-term effects of TOFA and its CV impact in larger populations.
CI  - Copyright: (c) 2023 Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji w 
      Warszawie.
FAU - Felis-Giemza, Anna
AU  - Felis-Giemza A
AUID- ORCID: 0000-0003-2198-8225
AD  - Biologic Therapy Center, National Institute of Geriatrics, Rheumatology and 
      Rehabilitation, Warsaw, Poland.
FAU - Moskal, Mateusz
AU  - Moskal M
AUID- ORCID: 0009-0006-1368-9937
AD  - Department of Rheumatology and Immunology, Faculty of Medicine and Health 
      Sciences, Andrzej Frycz Modrzewski University, Krakow, Poland.
FAU - Proc, Krzysztof
AU  - Proc K
AUID- ORCID: 0000-0002-2246-8611
AD  - Clinical Department of Rheumatology and Internal Medicine, University Clinical 
      Hospital in Wroclaw, Poland.
FAU - Guzera, Zbigniew
AU  - Guzera Z
AUID- ORCID: 0009-0006-0263-0964
AD  - Swietokrzyskie Centrum Reumatologii, St. Luke Hospital, Konskie, Poland.
FAU - Stajszczyk, Marcin
AU  - Stajszczyk M
AUID- ORCID: 0000-0002-3939-7194
AD  - Department of Rheumatology and Autoimmune Diseases, Silesian Center for 
      Rheumatology, Orthopedics and Rehabilitation, Ustron, Poland.
FAU - Palej, Karolina
AU  - Palej K
AUID- ORCID: 0009-0006-1797-9800
AD  - Biologic Therapy Center, National Institute of Geriatrics, Rheumatology and 
      Rehabilitation, Warsaw, Poland.
FAU - Chmurzynska, Kornelia
AU  - Chmurzynska K
AUID- ORCID: 0000-0002-8301-105X
AD  - Department of Connective Tissue Diseases, National Institute of Geriatrics, 
      Rheumatology and Rehabilitation, Warsaw, Poland.
FAU - Wiland, Piotr
AU  - Wiland P
AUID- ORCID: 0000-0001-9999-0267
AD  - Department of Rheumatology and Internal Medicine, Wroclaw Medical University, 
      Wroclaw, Poland.
FAU - Batko, Krzysztof
AU  - Batko K
AUID- ORCID: 0009-0009-5711-4870
AD  - Department of Research and Development, Medicine Economy Law Society (MELS) 
      Foundation, Krakow, Poland.
FAU - Batko, Bogdan
AU  - Batko B
AUID- ORCID: 0000-0003-3999-8093
AD  - Department of Rheumatology and Immunology, Faculty of Medicine and Health 
      Sciences, Andrzej Frycz Modrzewski University, Krakow, Poland.
LA  - eng
PT  - Journal Article
DEP - 20240118
PL  - Poland
TA  - Reumatologia
JT  - Reumatologia
JID - 20130190R
PMC - PMC10839916
OTO - NOTNLM
OT  - cardiovascular risk factors
OT  - real-world data
OT  - rheumatoid arthritis
OT  - tofacitinib
COIS- Karolina Palej, Kornelia Chmurzynska, and Krzysztof Batko declare no conflict of 
      interest.
EDAT- 2023/01/01 00:00
MHDA- 2023/01/01 00:01
PMCR- 2023/01/01
CRDT- 2024/02/07 03:55
PHST- 2023/09/27 00:00 [received]
PHST- 2023/11/21 00:00 [accepted]
PHST- 2023/01/01 00:01 [medline]
PHST- 2023/01/01 00:00 [pubmed]
PHST- 2024/02/07 03:55 [entrez]
PHST- 2023/01/01 00:00 [pmc-release]
AID - 175626 [pii]
AID - 10.5114/reum/175626 [doi]
PST - ppublish
SO  - Reumatologia. 2023;61(6):414-423. doi: 10.5114/reum/175626. Epub 2024 Jan 18.