Background: fracture risks assessment and determination of bone mineral density are modern methods, generally accepted and widely used. However, they have limitations and disadvantages for the dynamic evaluation of bone remodeling processes in RA-patients with low BMD. The investigation of bone resorption markers is an important issue. Aims: to compare the antiresorptive activity of denosumab and alendronic acid in patients with rheumatoid arthritis and osteoporosis using β-CTX and osteocalcin (OC). Materials and methods: forty-two patients were included in the study (16 patients were treated with denosumab, 13 patients – with alendronic acid, 13 patients - control group without any osteoporosis treatment). The quantitative determination of β-CTX and OC as well as dual-energy X-ray absorptionometry (DXA) were carried out for all patients at the first visit with consecutive investigation of bone resorption markers 3 months after. The predictive capacity was determined using the ratio of observed fractures/expected fractures by FRAX. Results: The level of β-CTX 16% (median 861.6 pg/ml vs. 724.6 pg/ml, p = 0.049) and OC 39% (median 13.9 ng/ml vs 8.5 ng/ml, p = 0.047) decreased significantly in 3 month in RA patients treated with denosumab. The decrease of β-CTX (median 858.9 pg/ml vs. 821.8 pg/ml) and OC (median 14.8 ng/ml vs. 13.9 ng/ml) was observed in the group of patients treated with alendronic acid, but not reached statistical significance. Conclusions: denosumab had showed better antiresorptive activity compared with bisphosphonates, which was registered 3 month after the start of the treatment.
The COVID-19 pandemic has significantly changed the understanding of the safety profile of therapies for immunoinflammatory rheumatic diseases (IRDs). This is primarily due to the negative impact of a number of basic anti-inflammatory drugs (DMARDs) and biological DMARDs on the course and outcomes of a new coronavirus infection. A number of studies have shown that anti-B-cell therapy (rituximab) gave a statistically significant increase in the risk of severe COVID-19 and an increase in mortality. At the same time, the analysis of real clinical practice data dictated the need to establish a number of restrictions on the use of certain classes of biological DMARDs and to search for alternative therapy programs to maintain control over disease activity.Purpose of the study – to evaluate the efficacy and safety of the drug Artlegia® (olokizumab), solution for subcuta neous injection, 160 mg/ml – 0.4 ml, manufactured by R-Pharm JSC, Russia) for the treatment of patients with rheuma toid arthritis in real clinical practice after switching with rituximab during the COVID-19 pandemic.Materials and methods. The study included 14 patients with a confirmed diagnosis of rheumatoid arthritis (RA), who were previously on rituximab therapy at a dose of 1000–500 mg twice with an interval of 2 weeks, who received at least one course of therapy with this drug. As RA worsened, patients were switched to olokizumab against the background of standard DMARDs. At 4, 8, 12 weeks after the switch, the severity of pain was assessed on the VAS scale, the number of painful and swollen joints (TJC28 and TSC28), the level of acute phase markers of inflammation, the DAS28 disease activity index calculated using ESR and CRP, and the CDAI (clinical activity index), functional state index HAQ, as well as assessment of the safety profile of therapy.Results. Data analysis was performed using median values (Me) were used for data analysis. A significant decrease of TJC28 was after the injection of olokizumab (Artlegia®) in 8 and 12 weeks (Me baseline = 10; Me 8 weeks = 4; Me 12 weeks = 4; p<0.05) and a decrease of TSC28 in 4, 8 and 12 weeks (Me baseline = 9; Me 4 weeks = 3.5; Me 8 weeks = 2.5; Me 12 weeks = 2.0; p<0.05). Laboratory markers of inflammation showed a decrease in CRP and ESR levels after 4 weeks of treatment (CRP: Me baseline = 21, Me 4 weeks = 1 (p<0.05); ESR: Me baseline = 31, Me 4 weeks = 7 (p<0.05)). Positive dynamics persisted at 8 and 12 weeks (CRP: Me 8 weeks = 1, Me 12 weeks = 0; ESR: Me 8 weeks = 4, Me 12 weeks = 5). The level of CRP by the fourth week 4 became within the normal range, regardless of the initial values. All activity indices improved from the fourth week in each evaluation period compared to baseline: DAS28-ESR: Me baseline = 5.52, Me 4 weeks = 3.59, Me 8 weeks = 3.33, Me 12 weeks = 3.22 (p<0.05); DAS28-CRP: Me baseline = 5.39, Me 4 weeks = 3.71, Me 8 weeks = 3.35, Me 12 weeks = 3.45 (p<0.05); CDAI: Me baseline = 28.5, Me 4 weeks = 18.0, Me 8 weeks = 16.5, Me 12 weeks = 16.0 (p<0.05). All patients showed a reduction in pain (VAS scale) by week 8. The functional status of patients, according to the HAQ index, showed a significant decrease only by the 12th week of the study: Me baseline = 1.62, Me 12 weeks = 1.31 (p<0.05).Conclusion. The study found that switching from rituximab to olokizumab was effective and safe during the COVID-19 pandemic.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.