The Retention Rate and Safety of JAK Inhibitors in Rheumatoid Arthritis: Real Word Data from a Monocentric Cohort
Abstract
:1. Introduction
2. Materials and Methods
2.1. The Study Design, Patients, and Setting
2.2. Statistical Analysis
3. Results
3.1. Clinical Characteristics
3.2. Drug Retention Rate
3.3. Adverse Events
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Clinical Features | TOF (n = 56) | BAR (n = 88) | UPA (n = 59) | FIL (n = 33) | TOT (n = 236) |
---|---|---|---|---|---|
Age at JAKi start (years) | 61.7 ± 11.9 | 66.4 ± 12.5 | 60 ± 11.8 | 64.8 ± 11.7 | 63.6 ± 12 |
Female sex (%) | 89.3 | 88.6 | 83 | 87.9 | 87.3 |
Disease Duration at JAKi start (years) | 14.9 ± 9.9 | 14.8 ± 9.9 | 13 ± 7.9 | 13.5 ± 9 | 14.8 ± 10 |
RF positivity (%) | 69.6 | 82.9 | 78 | 84.8 | 78.8 |
ACPA positivity (%) | 73.2 | 79.5 | 84.7 | 81.8 | 79.7 |
Erosions (%) | 55.4 | 57.9 | 45.8 | 39.4 | 51.7 |
ILD(%) | 26.8 | 19.3 | 3.39 | 9 | 15.7 |
Hypertension(%) | 42.9 | 46.9 | 35.6 | 39.4 | 41.9 |
Diabetes (%) | 12.5 | 11.4 | 6.8 | 3 | 8.9 |
Dyslipidaemia (%) | 21.6 | 20.5 | 16.9 | 9 | 19.9 |
Previous malignancy (%) | 4.1 | 11.4 | 0 | 9 | 7.6 |
Treatment Features | TOF (n = 56) | BAR (n = 88) | UPA (n = 59) | FIL (n = 33) | TOT (n = 236) |
---|---|---|---|---|---|
Concomitant GC use (%) | 76.8 | 70.4 | 61 | 84.8 | 71.6 |
Concomitant MTX use (%) | 50 | 35.2 | 37.3 | 45.5 | 40.7 |
Concomitant LEF use (%) | 7.1 | 13.6 | 11.8 | 6 | 10.6 |
Concomitant HCQ use (%) | 8.9 | 14.8 | 11.8 | 15.1 | 12.7 |
Concomitant SASP use (%) | 1.7 | 2.3 | 5 | 3 | 2.9 |
Naïve * (%) | 19.6 | 31.8 | 37.3 | 23.3 | 29.7 |
Second-line treatment (%) | 33.9 | 25 | 16.9 | 15.2 | 23.7 |
Third-line treatment (%) | 8.9 | 18.2 | 20.3 | 18.2 | 16.5 |
Fourth-line or beyond treatment(%) | 37.5 | 23.9 | 25.4 | 39.4 | 29.7 |
Prior TNFi use (%) | 51.8 | 53.4 | 40.7 | 45.4 | 48.7 |
Prior aIL-6R use (%) | 41 | 27.3 | 30.5 | 39.4 | 20.3 |
Prior CTLA4-Ig use (%) | 44.6 | 38.6 | 32.2 | 42.2 | 38.9 |
Prior RTX use (%) | 17.9 | 9 | 3.4 | 9 | 9.7 |
Prior JAKi use (%) | 10.7 | 1.14 | 28.8 | 24.2 | 13.6 |
JAKi treatment | |||||
Ongoing at the last observation (%) | 37.5 | 46.6 | 69.4 | 53.5 | 51.3 |
Overall discontinuation due to inefficacy (%) | 33.9 | 20.4 | 16.9 | 9 | 21.1 |
Discontinuation due to primary inefficacy (%) | 7 | 9 | 11.9 | 9 | 9.7 |
Discontinuation due to secondary inefficacy (%) | 28.6 | 10.2 | 5 | 0 | 11.4 |
Discontinuation due to adverse events (%) | 26.8 | 34 | 13.6 | 36.4 | 27.6 |
DDR (%) | First-Line | Second-Line | D2T | p Value |
---|---|---|---|---|
BAR | 2.7 | 28.3 | 50 | 0.085 |
TOF | 11.4 | 31.4 | 57.1 | 0.058 |
UPA | 5.6 | 27.8 | 66.7 | 0.004 |
FIL | 20 | 20 | 60 | 0.610 |
ALL JAKis | 15.8 | 28.1 | 56.1 | <0.001 |
Univariable | Multivariable | |||
---|---|---|---|---|
Covariate | HR [95% CI] | p Value | HR [95% CI] | p Value |
Disease duration | 1.02 (1.00–1.04) | 0.035 | 1.02 (0.99–1.04) | 0.121 |
ACPA | 1.04 (0.55–1.96) | 0.515 | ||
RF | 0.69 (0.37–1.29) | 0.268 | ||
Previous bDMARDS | 1.13 (1.03–1.25) | 0.012 | ||
TNFi | 1.95 (1.16–3.27) | 0.013 | ||
TCZ | 2.59 (1.46–4.63) | 0.001 | 1.83 (0.87–2.02) | 0.182 |
Comorbidities (yes/no) | 1.53 (0.88–2.61) | 0.084 | ||
JAKi as first-line treatment | 0.25 (0.13–0.46) | <0.001 | 0.37 (0.21–0.66) | <0.001 |
JAKi as second-line treatment | 1.58 (0.86–2.89) | 0.144 | ||
JAKi in D2T | 2.16 (1.28–3.64) | 0.004 | 1.38 (0.90–2.11) | 0.140 |
Univariable | Multivariable | |||
---|---|---|---|---|
Covariate | HR [95% CI] | p | HR [95% CI] | p |
Disease duration | 1.05 (1.00–1.09) | 0.011 | 1.05 (1.01–1.09) | 0.006 |
Positive RF and/or ACPA | 0.13 (0.015–1.06) | 0.039 | 0.41 (0.17–0.97) | 0.043 |
ACPA | 0.51(0.14–1.88) | 0.366 | ||
RF | 0.59 (0.17–2.04) | 0.551 | ||
Previous bDMARDS | 1.12 (0.97–1.30) | 0.117 | ||
TNFi | 2.43 (0.81–7.39) | 0.095 | 1.12 (0.51–2,43) | 0.784 |
TCZ | 6.35 (1.58–25.52) | 0.009 | 2.03 (0.97–4.23) | 0.059 |
JAKi first line | 1.26 (0.06–1.03) | 0.080 | ||
JAKi second line | 0.75 (0.24–2.31) | 0.166 | ||
JAKi D2T | 3.33 (1.04–10.62) | 0.054 | 0.95 (0.40–2.42) | 0.970 |
TOF | BAR | UPA | FIL | TOT | |
---|---|---|---|---|---|
Herpes zoster (%) | 0 | 2.3 | 1.7 | 0 | 1.3 |
MACEs (%) | 1.8 | 1.1 | 0 | 0 | 0.85 |
Malignancies (%) | 1.8 | 4.5 | 0 | 0 | 2.1 |
Hypersensitivity reactions (%) | 1.8 | 1.1 | 0 | 6 | 1.69 |
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Donzella, D.; Bellis, E.; Crepaldi, G.; Data, V.; Gatto, M.; Lomater, C.; Liperoti, G.; Marucco, E.; Saracco, M.; Iagnocco, A. The Retention Rate and Safety of JAK Inhibitors in Rheumatoid Arthritis: Real Word Data from a Monocentric Cohort. J. Clin. Med. 2024, 13, 3494. https://doi.org/10.3390/jcm13123494
Donzella D, Bellis E, Crepaldi G, Data V, Gatto M, Lomater C, Liperoti G, Marucco E, Saracco M, Iagnocco A. The Retention Rate and Safety of JAK Inhibitors in Rheumatoid Arthritis: Real Word Data from a Monocentric Cohort. Journal of Clinical Medicine. 2024; 13(12):3494. https://doi.org/10.3390/jcm13123494
Chicago/Turabian StyleDonzella, Denise, Elisa Bellis, Gloria Crepaldi, Valeria Data, Mariele Gatto, Claudia Lomater, Gaetano Liperoti, Elena Marucco, Marta Saracco, and Annamaria Iagnocco. 2024. "The Retention Rate and Safety of JAK Inhibitors in Rheumatoid Arthritis: Real Word Data from a Monocentric Cohort" Journal of Clinical Medicine 13, no. 12: 3494. https://doi.org/10.3390/jcm13123494