scholarly journals Long-Term Effectiveness and Safety of Infliximab, Golimumab and Golimumab-IV in Rheumatoid Arthritis Patients from a Canadian Prospective Observational Registry

2020 ◽  
Author(s):  
Proton Rahman ◽  
Philip Baer ◽  
Ed Keystone ◽  
Denis Choquette ◽  
Carter Thorne ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Randomized Clinical Trials ◽  
Disease Duration ◽  
Routine Care ◽  
Treatment Modalities ◽  
The Mean ◽  
Over Time

Abstract Background: Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care.Methods: RA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival.Results: Of the 890 IFX-, 530 GLM-SC- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0-86.6%, the mean ages from 55.8-57.7 and the mean disease duration from 6.5-8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM-SC and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM-SC and GLM-IV-treated patients, respectively. Conclusion: Differences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM.Trial Registration: NCT00741793

scholarly journals Long-term effectiveness and safety of infliximab, golimumab and golimumab-IV in rheumatoid arthritis patients from a Canadian prospective observational registry

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Proton Rahman ◽  
Philip Baer ◽  
Ed Keystone ◽  
Denis Choquette ◽  
Carter Thorne ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Randomized Clinical Trials ◽  
Disease Duration ◽  
Routine Care ◽  
Treatment Modalities ◽  
The Mean ◽  
Over Time

Abstract Background Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care. Methods RA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival. Results Of the 890 IFX-, 530 GLM- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0–86.6%, the mean ages from 55.8–57.7 and the mean disease duration from 6.5–8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM- and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM- and GLM-IV-treated patients, respectively. Conclusion Differences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM. Trial registration ClinicalTrials.gov Identifier: NCT00741793 (Retrospectively registered on August 26, 2008).

scholarly journals Long-Term Effectiveness and Safety of Infliximab, Golimumab and Golimumab-IV in Rheumatoid Arthritis Patients from a Canadian Prospective Observational Registry

2020 ◽  
Author(s):  
Proton Rahman ◽  
Philip Baer ◽  
Ed Keystone ◽  
Denis Choquette ◽  
Carter Thorne ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Randomized Clinical Trials ◽  
Disease Duration ◽  
Routine Care ◽  
Treatment Modalities ◽  
The Mean ◽  
Over Time

Abstract Background Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care. Methods RA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival. Results Of the 890 IFX-, 530 GLM-SC- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0-86.6%, the mean ages from 55.8-57.7 and the mean disease duration from 6.5-8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM-SC and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM-SC and GLM-IV-treated patients, respectively. Conclusion Differences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM.

scholarly journals POS0616 LONG-TERM EFFECTIVENESS AFTER MULTIPLE CYCLES WITH RITUXIMAB FOLLOWING AN ON-FLARE RETREATMENT STRATEGY IN PATIENTS WITH RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 545-546
Author(s):  
D. Bertrand ◽  
N. Pype ◽  
T. Conings ◽  
D. De Cock ◽  
S. Pazmino ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Global Health ◽  
Adverse Events ◽  
Disease Activity ◽  
University Hospital ◽  
C Cycle ◽  
Patient Reported ◽  
Efficacious Drug ◽  
Over Time

Background:Rituximab is known as an efficacious drug for the treatment of Rheumatoid Arthritis (RA). The recommended administration schedule consist of 2 infusions of 1000 mg with a 2-week interval. In Belgium an on-flare retreatment strategy is followed, making evaluation of effectiveness over time challenging. Moreover the patient’s view on this strategy is unclear.Objectives:To explore long-term effectiveness and safety of rituximab in daily clinical practice in patients with RA.Methods:Data of patients diagnosed with RA and treated with rituximab in a tertiary university hospital were retrospectively collected. For every cycle, clinical data were recorded at the time of the first and second infusion, the 16-week visit and the visit on which the treating rheumatologist decided to prescribe a new cycle. Data on demographics, previous RA treatment, disease activity, patient-reported outcomes, adverse events related to rituximab, dose and number of cycles were collected from 01/01/2006 until 01/12/2019 or until discontinuation of rituximab. The visit on which rituximab was prescribed for the first time was considered as the baseline visit. The data were analysed descriptively.Results:Data of 66 patients with RA were collected. The median (IQR) age was 57.0 (47.0-65.0) years at baseline and 56% (37/66) were female. Most patients were seropositive (RF 91% and ACPA 92%), and had erosive (71%) or nodular disease (53%). The median (IQR) disease duration was 12.5 (4.0-18.3) years. In total, 94% of the patients had failed at least one other biological Disease-modifying Antirheumatic Drug (bDMARD) before starting rituximab. Overall, patients received a median (IQR) of 3 (2-7) cycles of rituximab. Seven of the 66 patients (11%) discontinued rituximab and changed to another bDMARD after a median (IQR) of 1 (1-6) cycles and 11% were treated with a lower dose than 2x1000mg. The median (IQR) interval between the first 2 cycles was 7.0 (6.0-10.0) months, after which this increased to up to one year (interval between cycle 2-3: 10.0 (7.0-13.0) months, cycle 3-4: 12.0 (7.3-15.5) months). The overall median (IQR) follow-up time was 45.5 (14.8-82.3) months. The efficacy of rituximab remained after repeated cycles: after every treatment with rituximab, a reduction in disease activity based on the disease activity score in 28 joints (DAS28) could be noticed (figure 1A). The evolution in patients’ (PaGH) and physicians’ global health (PhGH) assessment followed the same pattern as the DAS28-score (Figure 1B). High PaGH-scores could be noticed at every start of a new rituximab cycle. The proportion of patients with a PaGH-score above 20 ranged from 84% - 100%, 74% - 100% and 66% - 86% at the first infusion, second infusion and week 16 visits, respectively. Rituximab was considered to be well-tolerated. In total, 23 adverse events in 12 patients were recorded and none of them were serious.Conclusion:Rituximab can be considered a highly efficacious drug for RA treatment in daily practice. There were no major side effects and there was an increasing treatment interval over time. However, a healthy survivor effect should be kept in mind when interpreting the results. It should be noted that with the on-flare retreatment strategy, every new rituximab cycle was preceded by a rise in PaGH-scores, which reflects a state of impaired wellbeing reported by patients. This should be further studied with qualitative methods and in a randomized trial setting comparing on-flare with fixed-interval retreatment to evaluate optimal effectiveness.Figure 1.Evolution in median - interquartile range disease activity (DAS28CRP) (A) and patients’ (PaGH) and physicians’ global health (PhGH) (B) over the different rituximab cycles. The disease activity, PaGH and PhGH were measured at baseline, the time of the first and second infusion, W16 and the visit on which a new rituximab cycle was prescribed. The dotted lines represent a DAS28CRP-score of 2.6 (remission cut-off) and 3.2 (low disease activity cut-off). C: cycle; W: week; VAS: visual analogue scale.Disclosure of Interests:None declared

scholarly journals AB0101 THE IMPACT OF TIME SPAN TO ACHIEVE BOOLEAN REMISSION FOR MAINTAINING DISEASE ACTIVITY AFTER ACQUISITION IN RHEUMATOID ARTHRITIS PATIENT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1079.1-1079
Author(s):  
I. Yoshii
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Duration ◽  
Remission Rate ◽  
Mean Value ◽  
Time Span ◽  
Mean Values ◽  
The Mean ◽  
The Relationship

Background:Boolean remission criteria is one most popular and stringent criteria in treating patient with rheumatoid arthritis (RA), because it may guarantees a stable clinical course after attaining remission.Objectives:Impact of time span from initiation to achieving Boolean remission on maintaining disease activity, daily activities, and quality of life after attaining Boolean remission was investigated from daily clinical practice data.Methods:685 patients with RA since August 2010 under the T2T strategy were treated. They were monitored for their TJC, SJC, PGA, EGA, CRP, and disease activity indices such as CDAI, SDAI, DAS28, and Boolean criteria at every visit. HAQ-DI score, pain score using visual analog scale (PS-VAS), and EQ-5D were also monitored, and the quality of life score (QOLS) calculated from EQ-5D was determined at every visit from the time of diagnosis (baseline).Of 685 patients, 465 patients had achieved Boolean remission >1 times, and were consecutively followed up for >3 years. These patients were enrolled in the study. Time span from the first visit to first Boolean remission was calculated. The relationship between the time span and each of background parameters, and the relationship between the time span and each of the mean values of the SDAI score, HAQ score, PS-VAS, SHS, and QOLS at the first Boolean remission and thereafter was evaluated statistically.Patients were subsequently divided into the G ≤ 6 and G > 6 groups based on the achievement of first Boolean remission within two groups: time span G ≤ 6 months and G > 6 months. The two groups were compared with regard to the SDAI score, HAQ score, PS-VAS, SHS, and QOLS at first visit and at the time of first Boolean remission, and the mean values of these parameters after remission were evaluated statistically. Moreover, changes of these parameters and the mean Boolean remission rate after the first remission, and SDAI remission rate at the first Boolean remission to thereafter were compared between the two groups statistically.Results:Out of 465 patients, females comprised 343 (73.7%), and the mean age was 67.8 years (range, from 21–95 years). The mean disease duration at first visit was 6.1 years (range, from 1 months–45 years). The mean follow up length was 88.1 months (range: 36–122 months; median: 85 months) and mean time span from the first visit to the first Boolean remission was 8.1 months. The mean SDAI score, HAQ score, PS-VAS, and the QOLS at first visit were 13.3, 0.467, 33.2, and 0.834, respectively. Among the study parameters, PS-VAS and QOLS were significantly correlated with the time span. For parameters at the first Boolean remission, HAQ-DI score, PS-VAS, and QOLS demonstrated significant correlation with the time span, whereas SDAI, HAQ-DI score, PS-VAS, SHS, and QOLS after the Boolean remission demonstrated significant correlation with the time span.The comparison between the G ≤ 6 and the G > 6 groups revealed that the disease duration, HAQ score, and PS-VAS at baseline in the G > 6 were significantly higher than that in the G ≤ 6 group, and QOLS in the G ≤ 6 group was significantly higher than that in the G > 6 group at baseline. Similarly, the HAQ score and PS-VAS at the first Boolean remission in the G > 6 group were significantly higher than that in the G ≤ 6 group, whereas QOLS in the G ≤ 6 group demonstrated no significant difference compared with that in the G > 6 group.The mean value of the SDAI score after the first Boolean remission in the G > 6 group was significantly higher than that in the G ≤ 6 group. Similarly, the SDAI score, HAQ score, and PS-VAS after the first Boolean remission in the G > 6 group were also significantly higher than those in the G ≤ 6 group, and the mean value of the QOLS in the G ≤ 6 group were significantly higher than that in the G > 6 group. The Boolean remission rate and SDAI remission rate after the first Boolean remission were significantly higher in the G ≤ 6 group than those in the G > 6 group.Conclusion:Attaining Boolean remission ≤ 6 months for RA has significant benefit for more stable disease control, that leads good maintenance of ADL.Disclosure of Interests:None declared

scholarly journals 134 Long-Term Deutetrabenazine Treatment Is Associated with Sustained Treatment Response in Tardive Dyskinesia: Results from an Open-Label Extension Study

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 284-285 ◽  
Author(s):  
Robert A. Hauser ◽  
Hadas Barkay ◽  
Hubert H. Fernandez ◽  
Stewart A. Factor ◽  
Joohi Jimenez-Shahed ◽  
...  
Keyword(s):  
Adverse Events ◽  
Percentage Change ◽  
Extension Study ◽  
Total Daily Dose ◽  
Open Label ◽  
Daily Dose ◽  
Open Label Extension ◽  
The Mean ◽  
Over Time

Abstract:Background:In the 12-week ARM-TD and AIM-TD studies evaluating deutetrabenazine for the treatment of tardive dyskinesia (TD), the percentage of patients achieving ≥50% response was higher in the deutetrabenazine-treated group than in the placebo group. These studies also showed low rates of overall adverse events (AEs) and discontinuations associated with deutetrabenazine. The current open-label study evaluated the long-term efficacy and safety of deutetrabenazine in patients with TD.Methods:Patients with TD who completed ARM-TD or AIM-TD could enroll in this open-label, single-arm extension study, titrating up over 6 weeks to a maximum total daily dose of deutetrabenazine 48 mg/day on the basis of dyskinesia control and tolerability. The proportion of Abnormal Involuntary Movement Scale (AIMS; items 1-7) responders was assessed based on response rates for achieving ≥50% improvement from baseline in the open-label extension study. AlMS score was assessed by local site raters for this analysis.Results:343 patients enrolled in the extension study. At Week 54 (n=249; total daily dose [mean ± standard error]: 38.6±0.66 mg), the mean percentage change from baseline in AIMS score was –40%; 48% of patients achieved a ≥50% response and 59% of those had already achieved a ≥50% response at Week 15. Further, 34% of those who had not achieved a ≥50% response at Week 15 achieved a ≥50% response at Week 54. At Week 106 (n=169; total daily dose: 39.6±0.77 mg), the mean percentage change from baseline in AIMS score was –45%; 55% of patients achieved a ≥50% response, 59% of those patients had already achieved a ≥50% response at Week 15, and 41% of those who had not achieved a ≥50% response at Week 15 but who reached Week 106 achieved a ≥50% response. At Week 132 (n=109; total daily dose: 39.7±0.97 mg), the mean percentage change from baseline in AIMS score was –61%; 55% of patients achieved a ≥50% response, 61% of those patients had already achieved a ≥50% response at Week 15, and 43% of those who had not achieved a ≥50% response at Week 15 but who reached Week 132 achieved a ≥50% response. Completer analysis suggests that long-term efficacy was not due to dose increases over time. Treatment with deutetrabenazine was generally well tolerated. There were 623 patient-years of exposure through Week 158, and exposure-adjusted incidence rates (incidence/patient-years) of adverse events of special interest were 0.01 for akathisia and restlessness, 0.07 for somnolence and sedation, 0.04 for parkinsonism, and 0.05 for depression.Conclusions:Patients who received long-term treatment with deutetrabenazine achieved response rates that were indicative of clinically meaningful long-term benefit. Results from this open-label trial suggest the possibility of increasing benefit over time with individual dose titration of deutetrabenazine.Funding Acknowledgements:This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel.

Demodex folliculorum in patients with rheumatoid arthritis

2007 ◽  
Vol 52 (1) ◽  
Author(s):  
Ihsan Ciftci ◽  
Umit Dundar ◽  
Zafer Cetinkaya ◽  
Mustafa Kulac ◽  
Nilay Kiyildi ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Disease Duration ◽  
Demodex Folliculorum ◽  
Das 28 ◽  
Immunosuppressed Patients ◽  
The Mean ◽  
Demodex Mites ◽  
Assessment Of Disease Activity

AbstractThe objective of this study was to investigate the incidence and density of Demodex folliculorum in the patients with rheumatoid arthritis (RA). Forty-one patients with RA and twenty-seven age and sex matched healthy controls were enrolled in this study. Disease Activity Score (DAS 28) was used for the assessment of disease activity. Out of 41 patients, 33 were females and 8 males. The mean disease duration was 10.9 ± 8.2 years. The mean DAS 28 was 3.8 ± 1.2. No statistically significant differences in the incidence and density of Demodex mites were found between patients with RA and controls. Although immunosuppression is thought to be a risk factor for the D. folliculorum infestation no such correlations could be found in the 41 immunosuppressed patients with RA, therefore, further studies with larger groups are needed.

scholarly journals Comparative analyses of responsiveness between the Rheumatoid Arthritis Impact of Disease score, other patient-reported outcomes and disease activity measures: secondary analyses from the ARCTIC study

RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000754 ◽  
Author(s):  
Karen Holten ◽  
Joseph Sexton ◽  
Tore K Kvien ◽  
Anna-Birgitte Aga ◽  
Espen A Haavardsholm
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Inflammatory Markers ◽  
Disease Duration ◽  
Treat To Target ◽  
Patient Reported ◽  
Short Disease Duration ◽  
Activity Measures ◽  
The Mean ◽  
Disease Activity Measures

ObjectiveTo evaluate the responsiveness of the Rheumatoid Arthritis Impact of Disease (RAID) score compared with other patient-reported outcome measures (PROMs), inflammatory markers and clinical disease activity measures in patients with early rheumatoid arthritis (RA).MethodsDisease-modifying antirheumatic drug–naïve patients with RA with short disease duration were included in the treat-to-target ARCTIC trial and followed for 24 months. The responsiveness of the RAID score was evaluated using standardised response mean (SRM) and relative efficiency (RE) with respect to tender joints by Ritchie Articular Index (RAI). SRMs and REs were also calculated for other PROMs, inflammatory markers and clinical outcome measures. An SRM with value above 0.80 was considered high.Results230 patients with RA were included. The mean±SD symptom duration was 7.1±5.4 months and the baseline mean±SD  RAID score was 4.49±2.14. At 3 months of follow-up, the mean±SD change score for RAID was −2.25±1.98  and the SRM (95%  CI) −1.13 (−1.33 to −0.96). The RAID score showed high responsiveness both at 3 and 6 months (SRM≥0.80) and was more sensitive in detecting change than the reference, tender joints assessed by RAI.ConclusionsThe RAID score proved to be highly responsive to change in patients with RA with short disease duration who followed a treat-to-target strategy. The RAID score was more efficient in detecting change than the reference (RAI) as well as most other PROMs.

scholarly journals AB0212 FLARE RISK AFTER DISCONTINUING LONG-TERM METHOTREXATE TREATMENT IN PATIENTS HAVING RHEUMATOID ARTHRITIS WITH LOW DISEASE ACTIVITY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1406.1-1407
Author(s):  
S. H. Nam ◽  
J. S. Lee ◽  
S. J. Choi ◽  
W. J. Seo ◽  
J. S. Oh ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Disease Activity ◽  
Logistic Regression Analysis ◽  
Weekly Dose ◽  
Low Disease Activity ◽  
Disease Flare ◽  
The Mean

Background:Several recent studies have reported that MTX could be discontinued in patients with low disease activity who are taking biologic DMARDs or tofacitinib. However, there are limited studies on whether MTX could be discontinued in patients with low disease activity who have taken MTX for a long term.Objectives:We investigated the disease flare rate in patients with rheumatoid arthritis (RA) who achieved low disease activity following long-term methotrexate (MTX) treatment and the factors related to flare.Methods:This retrospective longitudinal cohort study included patients with RA and low disease activity who were exposed to MTX for >10 years. Disease flare was defined as an increase in DAS28 of >1.2 within 6 months of discontinuation of MTX. Logistic regression analysis was performed to identify the factors associated with flare.Results:In total, 97 patients with RA were included in the study. The mean baseline DAS28 was 1.96 ± 0.56. The median cumulative MTX dose was 11.7g; the median duration of exposure to MTX was 19 years. Following MTX discontinuation, flare occurred in 43 (44.3%) patients; the mean time to flare was 98 ± 37.7 days. According to univariable logistic regression analysis, C-reactive protein, erythrocyte sedimentation rate (ESR) at discontinuation, the average ESR in the 6 months before discontinuation of MTX, a weekly dose of MTX before discontinuation, and use of other conventional synthetic DMARDs were associated with a higher risk of disease flare. In multivariable analysis, a weekly dose of MTX before discontinuation (OR, 1.014; 95% CI, 1.014–1.342; p = 0.031) was significantly associated with flare risk.Conclusion:Among patients with RA who achieved low disease activity with long-term treatment with MTX, more than half of the patients remained flare free after MTX discontinuation. A higher MTX dose before discontinuation was associated with a high flare risk.Disclosure of Interests:None declared

scholarly journals AB0800 HEMATOLOGICAL MARKERS OF SYSTEMIC INFLAMMATION IN PATIENTS RHEUMATOID ARTHRITIS (RA) AND SPONDYLOARTHRITIS (SPA)

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1424.2-1424
Author(s):  
B. Targonska-Stepniak ◽  
K. Grzechnik ◽  
M. Majdan
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Systemic Inflammation ◽  
Inflammatory Markers ◽  
Global Assessment ◽  
Disease Duration ◽  
Atherogenic Index ◽  
Functional Scores ◽  
The Mean ◽  
Positive Correlations

Background:An appropriate assessment of disease activity is essential in the management of patients with chronic inflammatory joint diseases, rheumatoid arthritis (RA) and spondyloarthritis (SpA). Hematological parameters [Neutrophil-To-Lymphocyte (NLR), Platelet-To-Lymphocyte (PLR) and Monocyte-To- Lymphocyte (MLR) ratios] have been demonstrated to be good, promising indicators of systemic inflammation status in different diseases, additionally to conventional inflammatory markers [erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)]. However results remain conflicting in rheumatic patients.Objectives:The goal of the study was to determine the role of NLR, PLR, MLR in assessing inflammatory disease activity and to compare the biomarkers in RA and SpA patients.Methods:An observational study was conducted in patients with RA and SpA (ankylosing spondylitis and psoriatic arthritis) treated in the Department of Rheumatology and Connective Tissue Diseases, Medical University of Lublin, Poland. Demographic and clinical information was obtained through structured interview, review of medical records and laboratory tests. The following disease activity and functional scores were registered: CRP and ESR levels, swollen and tender joints counts (SJC, TJC), DAS28 (ESR), HAQ, BASDAI, BASFI, patient global assessment (PtGA) and physician global assessment (PGA) rated on a visual analogue scale (VAS).The study group consisted of 95 patients (58 women, 37 men), with the mean (SD) age 45.4 (9.9), disease duration 10.0 (8.4) years. There were 58 (61.1%) patients with RA (44 women, 14 men) and 37 (38.9%) patients with SpA. The mean age and disease duration were statistically not different in both patients’ groups. The mean (SD) DAS28 was 4.21 (1.8) in RA patients; in SpA patients BASDAI 4.9 (2.6) and BASFI 5.0 (2.8).Results:In the whole group (95 patients) and in the SpA group, we found positive correlations between the PLR value and the following parameters CRP, ESR; between NLR and CRP, ESR; between MLR and CRP. In the RA group positive correlations were observed between PLR and CRP, ESR; NLR and CRP; MLR did not correlate with CRP and ESR.In RA patients, there were statistically significant correlations between values of PLR and DAS28 (r=0.356, p=0.006), TJC (r=0.308, p=0.02), SJC (r=0.318, p=0.016), PtGA (r=0.372, p=0.008). No significant correlation was found between NLR, MLR and other disease activity scores.In SpA patients, we found a significant correlation between NLR and PtGA (r=0.488, p=0.04). No significant correlations were found between NLR, PLR, MLR and BASDAI, BASFI.The group of RA patients as compared with SpA, was characterized by significantly higher value of PLR [respectively 207.8 (94.0) vs 169.9 (77.7), p=0.04]. In turn, SpA patients compared with RA, were characterized by unfavorable metabolic parameters: higher atherogenic index [respectively 4.03 (0.8) vs 3.57 (1.1), p=0.03], lower HDL-cholesterol [47.4 (10.7) vs 56.1 (16.4) mg/dl (p=0.006); higher serum uric acid [5.6 (1.2) vs 4.5 (1.4) mg/dl (p=0.0001)], higher waist measurement [96.1 (14.2) vs 85.9 (11.5) cm (p=0.0003).Conclusion:In our study we found, that in patients with RA, PLR was associated with both clinical and inflammatory markers of disease activity; in SpA patients NLR, PLR and MLR were associated with conventional inflammatory markers (CRP, ESR). Hematological inflammatory biomarkers may reflect disease activity and could represent potential parameters to evaluate disease activity not only in RA, but also in SpA.Disclosure of Interests:Bozena Targonska-Stepniak Speakers bureau: Berlin-Chemie/Menarini, KRKA, Medac, Santen, Krzysztof Grzechnik: None declared, Maria Majdan Speakers bureau: Roche, Medac

scholarly journals OP0154-HPR EFFECT OF NURSE-LED-CARE ON PATIENT OUTCOMES IN RHEUMATOID ARTHRITIS IN GERMANY: A MULTICENTRE RANDOMISED CONTROLLED TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 97-98
Author(s):  
J. R. Hoeper ◽  
G. Gauler ◽  
D. Meyer-Olson ◽  
K. Rockwitz ◽  
P. Steffens-Korbanka ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Standard Of Care ◽  
Research Support ◽  
Current Standard ◽  
Clinical Nurse ◽  
Clinical Nurse Specialists ◽  
The Mean ◽  
Secondary Outcomes ◽  
Over Time

Background:Inflammatory rheumatic disorders are very complex and require high medical resources. However, there is a shortage of care for these patients, which results in suboptimal reach of therapy objectives. Nevertheless, these very objectives need to be pursued quickly to prevent permanent joint damage. In order to ensure adequate care, multidisciplinary teams which include clinical nurse specialists are required. These clinical nurse specialists play an important role in improving standard-of-care in addition to the rheumatologist. The current standard of care ensures that essential medical provision remains intact, however, psychological, social, rehabilitative and educational needs are often skipped due to time constraints. While studies from e.g. the UK and Denmark have already supported the non-inferiority of nurse-led care (NLC)1, no such studies have yet been published in Germany.Objectives:To demonstrate the non-inferiority of NLC to the current standard-of-care, rheumatologist-led care (RLC), for patients with seropositive rheumatoid arthritis (RA) with induction, escalation or change of therapy regarding disease activity as well as different patient reported outcomes (PROs).Methods:This trial was conducted as a prospective multi-centered RCT with a non-inferiority design over the course of 12 months. Based on power calculations, 236 adults with RA were included in the study and randomized to either NLC or RLC. The primary outcome measure is disease activity (DAS28), assessed at baseline (T0), 6 weeks (T1), 3,6, 9, and 12 months (T3, T6, T9, T12). Secondary measures are health related quality of life (RAID), functionality (FFbH) and depression (PHQ9).Results:There are no significant differences between intervention group (IG) (n=117) and control group (CG) (n=119) at baseline. The mean age of the IG is 58.80 years (SD=12.09) and of the CG 58.34 years (SD=11.72). 72.4% of the IG and 78.1% of the CG are female. The mean duration of symptoms was 147 months (SD=144.63) for the IG and 116 months (108.89) for the CG. The mean DAS28 for the IG is 4.36 (SD=1.24) and 4.51 (SD=1.24) for the CG.A mixed one-way repeated measures ANOVA showed that the DAS28 improves significantly over time, Huyn-FeldtF(4.42, 751.72) = 105.701,p< .001, partialη2= 0.383, but the interaction of the DAS28 and the randomization is not significant, Huyn-FeldtF(4.42, 751.72) = 1.464,p= 0.260, partialη2= 0.009. No main effect for randomization was found, meaning that the IG and CG did not differ significantly,F(1, 170) = 1.005,p= 0.317, partialη2= 0.006.The Mann-Whitney-Test showed that the change of the secondary outcomes does not depend on the randomization FFbHU= 4978.50,Z= -.755,p=.450. RAIDU= 5121.00,Z= -.539,p=.590. PHQ9U= 4800.50,Z= -1.281,p=.200. The secondary outcomes improve significantly over time, as shown by a Wilcoxon Signed Rank test for the FFbHZ= -5.589,p< .001, the RAIdZ= -9.884,p< .001 and the PHQ9Z= -7.960,p< .001.Conclusion:The results support the non-inferiority of NLC in the management of RA regarding the primary and secondary outcome measures and provide first evidence that NLC could improve care and help carry the doctors’ workflow.Figure 1.Figure 2.References:[1]de Thurah A, Esbensen BA, Roelsgaard IK, et al. Efficacy of embedded nurse-led versus conventional physician-led follow-up in rheumatoid arthritis: a systematic review and meta-analysis. RMD Open 2017;3:e000481.Disclosure of Interests:Juliana R Hoeper: None declared, Georg Gauler Consultant of: Abbvie, Lilly, MSD, Speakers bureau: Abbvie, Celgene, Novartis, Sanofi,, Dirk Meyer-Olson Grant/research support from: Novartis, Sandoz Hexal, Consultant of: Abbvie, Amgen, Bristol Myers Squibb, Chugai, Lilly, Mylan, Novartis, Sandoz Hexal, Sanofi, Speakers bureau: Abbvie, Bristol Myers Squibb, Chugai, Lilly, Novartis, Pfizer, Sandoz Hexal, Sanofi, Karin Rockwitz Consultant of: Janssen Cilag, Speakers bureau: Janssen Cilag, Patricia Steffens-Korbanka Consultant of: Abbvie, Chugai, Novartis, Sanofi, Mylan, Lilly, Speakers bureau: Abbvie, Chugai, Novartis, Sanofi, Lilly, Carsten Stille: None declared, Jochen Walter Consultant of: Pfizer, Speakers bureau: AbbVie, Frauenhofer Institut, Gilead, Janssen-Cilag, Medac, Novartis, Pfizer, Martin Welcker Grant/research support from: Abbvie, Novartis, UCB, Hexal, BMS, Lilly, Roche, Celgene, Sanofi, Consultant of: Abbvie, Actelion, Aescu, Amgen, Celgene, Hexal, Janssen, Medac, Novartis, Pfizer, Sanofi, UCB, Speakers bureau: Abbvie, Aescu, Amgen, Biogen, Berlin Chemie, Celgene, GSK, Hexal, Mylan, Novartis, Pfizer, UCB, Joerg Wendler Consultant of: Janssen, AbbVie, Sanofi, Speakers bureau: Roche, Chugai, Janssen, AbbVie, Novartis, Jan Zeidler: None declared, Kirsten Hoeper Consultant of: AbbVie, Celgene,, Speakers bureau: Abbvie, Chugai, Novartis, Lilly, Celgene, Sandoz Hexal

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