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EFFECTIVENESS OF BARICITINIB IN THE BASIC THERAPY OF
ACTIVE RHEUMATOID ARTHRITIS
Muhammadieva S.M.
Abdusolieva Z.T.
Nabidzhonova D.D.
Tashkent Medical Academy
https://doi.org/10.5281/zenodo.14964722
The purpose of our study
was to evaluate the efficacy and safety of
baricitinib (BARI) in patients with rheumatoid arthritis (RA) who have not
achieved low activity or remission according to EULAR criteria under the
influence of synthetic disease-modifying drugs or biological agents.
Materials and methods.
10 patients with a definite diagnosis of RA were
under observation (ACR-1987, EULAR-2010 criteria). Among the included
patients, there were 7 women and three men, ranging in age from 31 to 64 years
(mean age 51.67 years). The patients had an advanced (in 3 patients) or late (in
7 patients) clinical stage of erosive arthritis with predominant damage to the
small joints of the hands, the radiological stage was not lower than 3.
Seropositive variant of RA was diagnosed in 9 patients, seronegative rheumatoid
factor (RF) variant of RA occurred in 1 patient. All patients were seropositive for
ADC antibodies to cyclic citrullinated peptide. The degree of disease activity
according to the DAS28 index ranged from 4.71 to 6.65 points (average value
5.81 ± 2.1 points), and in 13 patients it corresponded to the level of high activity
(DAS28 index > 5.1) and only in 2 people the DAS28 index was less than 5.1
points.
All patients received standard antirheumatic therapy before the
appointment of BARI, which was not effective enough. Due to the continued
activity of the disease, all patients were prescribed BARI at a dose of 4 mg once a
day (a daily dose of 4 mg).
The analysis was carried out taking into account BARI therapy for 6
months: monthly monitoring of the effectiveness and safety of the treatment
regimen used. The effectiveness of BARI therapy was assessed based on the
dynamics of clinical and laboratory parameters reflecting the activity of RA:
dynamics of the DAS28-4 index (ESR), CDAI, SDAI, RAPID3, ACR criteria
20/50/70. Along with this, we took into account the dynamics of generally
accepted immunological parameters – C-reactive protein (CRP) and RF.
Assessment of the safety of therapy with the inclusion of BARI was carried out
by recording possible adverse events associated with taking the studied drug, as
well as based on the dynamics of standard laboratory tests.
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Clinical and laboratory parameters were monitored with an analysis of the
initial parameters and their dynamics after 3 and 6 months.
The results of the study.
As noted earlier, the baseline values, primarily
the DAS28 index, in the vast majority of patients (86.67%) corresponded to the
level of high disease activity. At the same time, it should be emphasized that
after 1 month, under the influence of BARI treatment, positive dynamics was
observed in a number of clinical and laboratory parameters: there was a
decrease in the DAS28, CDAI, SDAI, RAPID indices, combined in a number of
patients with a decrease in ESR, CRP and RF. After 3 months. After treatment
with BARI, there was a further decrease in the clinical signs of RA activity, while
there was a significant decrease in the DAS28 index compared to the baseline
value in all 10 patients: from 1.09 to 2.50 points (by an average of 1.61 points).
The positive dynamics of all the indices used was significant already at the stage
of the 3-month course of therapy, with a decrease in the simplified activity
indices (SDAI and CDAI) occurring by more than 50%. After 6 months of
treatment, all total indicators of RA activity remained at the achieved level for 3
months and were also significantly lower than the corresponding indices at the
time of inclusion in the study. Moreover, after 6 months of treatment, only one
patient had high RA activity according to the DAS28 index, although this
indicator decreased by 1 point compared to the baseline value.
As follows from the presented results, the average number of painful joints
decreased from 11.6 to 5.4 after 3 months and to 4.6 after 6 months of
treatment, and the average number of swollen joints decreased from 7.1 to 2 and
1.7, respectively. At the same time, all patients noted an improvement in their
overall health after both 3 and 6 months of treatment, which was reflected in the
average values of this indicator, which decreased by almost half. As for the
laboratory parameters, their dynamics turned out to be less pronounced.
Nevertheless, when analyzing the changes in CRP and RF using nonparametric
statistics, we found significant differences compared to the initial indicators.
As for serious adverse events, they were not reported in any of the 10
patients, all controlled generally accepted laboratory parameters remained
within normal values, with the exception of one patient who had a transient
increase in aminotransferase levels by no more than 20% of the initial normal
level. The patients' adherence to the treatment of BARI was satisfactory.
In conclusion,
it should be noted that based on our clinical observations on
the use of BARI in RA, we have obtained convincing evidence of the high efficacy
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and safety of this drug in patients with insufficient response to standard basic
RA therapy.
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