scholarly journals SAT0472 GOAL-DIRECTED TREATMENT OF OSTEOPOROSIS IN PATIENTS WITH RHEUMATOID ARTHRITIS USING DENOSUMAB FOR FIVE YEARS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1193.1-1193
Author(s):  
Y. Hirano ◽  
Y. Kanayama ◽  
H. Kosugiyama ◽  
N. Ishiguro ◽  
T. Kojima

Background:Osteoporosis (OP) is frequent complication identified in patients with rheumatoid arthritis (RA). Effective treatment must be provided to treat OP in RA (RAOP). Denosumab (DMB) is one of the promising drugs that are currently being used for the treatment of RAOP. We reported the results of 12-month DMB treatment for RAOP as part of Japanese multicenter registry study (TBCR-BONE) in EULAR2016 [1]. Recently, a treatment goal of OP was reported by the American Society for Bone and Mineral Research and the National Osteoporosis Foundation (ASBMR-NOF) working group [2]. This report advocated that the goal of treatment is a T-score of >-2.5 at the femoral neck, total hip (TH) or lumbar spine (LS) on DXA if the primary reason for starting treatment was a T-score of ≤-2.5 at the abovementioned skeletal sites. The working group noted that it was reasonable to expect that initial treatment should offer at least a 50% chance of achieving the treatment goal within 3 to 5 years of initiating therapy. We have reported the achievement rates of treatment goal in RAOP with 3-year DMB treatment on RAOP in EULAR2019 [3].Objectives:The aim of this retrospective study was to evaluate whether 5-year DMB treatment can achieve treatment goal of OP using data from TBCR-BONE.Methods:The study included 46 female patients who had completed 5-year DMB treatment. The LS-BMD analysis included 22 patients with a baseline (BL) LS-BMD T-score of ≤ -2.5. The TH-BMD analysis included 29 patients with a BL TH-BMD T-score of ≤ -2.5. Similar to clinical setting in Japan, 60mg of DMB was administered once every 6 months with a vitamin D3 supplement. BL characteristics, change in T-score over time, and achievement of the treatment goal (T-score>-2.5) were evaluated.Results:BL characteristics of the 46 female patients included: mean age of 69.1 years and RA duration of 16 years. Prednisolone was administered to 37% of the patients. In the LS-BMD analysis, T-scores improved significantly; the mean value at BL was −3.4, which increased to −3.0 at 1 year, −2.6 at 3 years, and ultimately to −2.5 at 5 years. The fraction of patients who achieved the treatment goal was as follows: 36.4% at 1 year, 40.9% at 2 years, 45.5% at 3 years, 50.0% at 4 years, and 54.5% at 5 years (Fig. 1A). The patients who achieved this treatment goal were those who had a significantly lower risk of fracture at BL as determined by FRAX (17.9% vs. 32.2%, p = 0.044), who had significantly higher BL serum TRACP-5b level (572.8 vs. 401.0: p = 0.03), and who had significantly better BL LS-BMD T-scores (−3.0 vs. −3.9, p < 0.01) than the nonachievers. In the TH-BMD analysis, T-scores improved significantly; the mean value at BL was −3.0, and it increased to −3.0 at 1 year, −2.7 at 3 years, and reached −2.7 at 5 years. The fraction of patients who achieved the treatment goal was as follows: 20.7% at 1 year, 31.0% at 2 years, 34.5% at 3 years, 31.0% at 4 years, and 37.9% at 5 years (Fig. 1B). The patients who achieved this treatment goal were those who had significantly better BL TH-BMD T-scores (−2.7 vs. −3.2: p < 0.01) than the nonachievers. Cut-off values at BL for achievement of the treatment goal determined using ROC analysis were −3.1 for the LS-BMD (sensitivity 83.3%, specificity 90.0%) and −2.85 for the TH-BMD (sensitivity 100.0%, specificity 81.0%).Conclusion:The results of this study suggested that achievement of the treatment goal was comparatively easy for those with LS-BMD loss; however, it was comparatively difficult for those with TH-BMD loss. Early initiation or longer duration of DMB therapy may be necessary to improve achievement rates. Likewise, other agents, such as romosozumab, may be considered for those with significant TH-BMD loss.References:[1]Hiranoet al.Ann Rheum Dis 2016; 75 (Suppl 2): 94[2]Cummingset al.J Bone Miner Res 2017; 32: 3-10[3]Hiranoet al.Ann Rheum Dis 2019; 78 (Suppl 2): A940Disclosure of Interests:Yuji Hirano Speakers bureau: Tanabe-Mitsubishi, Pfizer, Eisai, Abbie, Chugai, Bristol-Meyers, Jansen, Astellas, UCB, Eli-Lilly, Asahikasei, Daiichi-Sankyo, Amgen, Yasuhide Kanayama: None declared, Hironobu Kosugiyama: None declared, Naoki Ishiguro Grant/research support from: AbbVie, Asahi Kasei, Astellas, Chugai, Daiichi-Sankyo, Eisai, Kaken, Mitsubishi Tanabe, Otsuka, Pfizer, Takeda, and Zimmer Biomet, Consultant of: Ono, Speakers bureau: Astellas, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, Pfizer, and Taisho Toyama, Toshihisa Kojima Grant/research support from: Chugai, Eli Lilly, Astellas, Abbvie, and Novartis, Consultant of: AbbVie, Speakers bureau: AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eli Lilly, Janssen, Mitsubishi Tanabe, Pfizer, and Takeda

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1119.1-1119
Author(s):  
L. Nacef ◽  
Y. Besbes ◽  
Y. Mabrouk ◽  
H. Ferjani ◽  
K. Maatallah ◽  
...  

Background:The lipid paradox is termed the decreased cholesterol level in rheumatoid arthritis (RA). Nevertheless, the apolipoprotein levels are usually higher than a healthy person and are predictors of cardiovascular events.Objectives:We aimed to describe lipid abnormalities in RA patients and to look for predictor factors of these changes.Methods:The prospective study was carried out on patients with RA who met the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria. These patients were followed in the rheumatology department of the Kassab Institute.We collected the socio-demographic data, biological and immunological parameters.The lipid assessment included: a measurement of total cholesterol (TC), HDL, LDL, and triglycerides (TG). Lipoproteins APOA1 and APOB were measured. All data were collected after patient consent.Results:Of the 47 patients recruited, 78.7% were female. The mean age was 52.5 ±11.06 [32-76]. The average RA progressed from 86.25 ±63 months [5-288] and was erosive in 81.6% of cases. The rheumatoid factor (RF) was positive in 57.8% of patients, and citrullinated antipeptide antibodies (ACPA) were present in 62.2%. Eight patients had a previous CV history.Mean TC was 4.42 ±1.3 [1.2-7.58], mean HDL was 1.38 ±0.73 [0.18-4.10], mean LDL was 2.55 ±1.16 [0.24-5.54]. The mean TG value was 1.28 ±0.6 [0.24-5.54]. TC elevation was found in 9.1% of cases, HDL in 21.3% of cases, LDL in 5.5% of cases, and TG in 16.4% of cases. Mean APOB/APOA1 ratio was 0.67 ±0.18 [0,46-1,11]. LDL elevation was associated to a high DAS28 (p=0.06, r=0.512). APOA1 was associated to a low DAS28 (p=0.04, r=-0.642).The mean value of APO A1 was 1.36 ±0.21 [0.84-1.81], that of APOB was 0.90 ±0.22 [0.58-1.40]. APOA1 values were lower in patients with high-level LDL (p=0.767). The APOB value was associated with lipid disturbance without significant correlation (p=0.291).Conclusion:Lipid test abnormalities can be found in RA patients outside of any known CV risk factors. APOA1 seems to have a protective effect. Screening and treatment of these abnormalities can prevent CV risk.References:[1]Miguel Bernardes and al. Coronary artery calcium score in female rheumatoid arthritis patients: Associations with apolipoproteins and disease biomarkers. Int J Rheum Dis. 2019;00:1–16.[2]Anna So dergren and al. Biomarkers associated with cardiovascular disease in patients with early rheumatoid arthritis. PLOS ONE. August 5, 2019.Disclosure of Interests:None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1432.2-1432
Author(s):  
N. Toroptsova ◽  
O. Dobrovolskaya ◽  
N. Demin ◽  
L. Shornikova

Background:Rheumatoid arthritis (RA) is a complex inflammatory disease that modifies body composition. Using the dual-energy x-ray absorptiometry (DXA) in RA patients could be a method for body composition changes detection.Objectives:To study the body composition using DXA in patients with RA.Methods:The study involved 79 women with RA, median age 60 [55; 65] years. The bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry using «Discovery A» (Hologic, USA). Assessment of body composition was carried out, using the program «Whole body». Sarcopenia (SP) was diagnosed as a decrease in appendicular mass index (AMI) <6.0 kg/m2. Osteoporosis (OP) was diagnosed as a decrease in T-score <-2.5 SD. Osteosarcopenia was determined when T-score was <-1.0 SD, AMI was <6.0 kg/m2, osteosarcopenic obesity - T-score was <-1.0 SD, AMI was <6.0 kg/m2and total fat was >35%.Results:The mean duration of RA was 9 [3; 11] years. The mean body mass index (BMI) was 27.6±4.8 kg/m2. Disease activity score in 28 joints-erythrocyte sedimentation rate was 4.5±1.3 points for the group. 39 (49.3%) patients used oral glucocorticoids continuously. Appendicular muscle mass and AMI were on average 17.8±3.0 kg and 6.8±1.0 kg/m2, respectively. AMI <6 kg/m2was detected in 20 (25.3%) patients. 56 (70.9%) women with RA had total fat > 35%, while only 22 (27.8%) of women with RA had obesity according to BMI (BMI >30 kg/m2). Isolated OP was found in 13 (16.5%), osteosarcopenia in 7 (8.9%) and osteosarcopenic obesity in 13 (16.5%) patients RA. No cases with isolated sarcopenia or sarcopenic obesity were detected. Only 3 (3.8%) patients did not have appendicular muscle mass, AMI and BMD decrease and overfat or obesity.Conclusion:About 97% women with RA had abnormal body composition phenotype: 16,5% - OP, 8.9% -osteosarcopenia, 16,5% - osteosarcopenic obesity and 54,4% - overfat.Disclosure of Interests:None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1079.1-1079
Author(s):  
I. Yoshii

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


2015 ◽  
Vol 24 (4) ◽  
pp. 214-219
Author(s):  
Dan Piperea-Sianu ◽  
◽  
Adela Maria Ceau ◽  
Alexandru G. Croitoru ◽  
Alice Piperea-Sianu ◽  
...  

Introduction. The relationship between periodontal disease (PD) and rheumatoid arthritis (RA) is currently only partially known, both being chronic multifactorial diseases that may share common pathogenic mechanisms and etiological factors. In a previous meta-analysis we concluded that patients with RA are more commonly affected by PD and develop more severe forms of the disease, compared to the general population. Objectives. The current study aimed to assess the degree of periodontal damage and oral hygiene on a group of patients diagnosed with RA. Methods. The study was conducted on a group of 30 patients, 6 sextants being assessed in each patient (180 potentially evaluable sextants). Establishing the degree of periodontal damage and oral hygiene was achieved by determining the Community Periodontal Index of Treatment Needs (CPITN) and Oral Hygiene Index (IHB, also known as OHI). Results. The mean CPITN score/sextant was 1.92. After clinical examination we found 10 edentulous sextants that could not be evaluated. As a result of the distribution of the scores on all the 170 evaluable sextants, we obtained: CPITN 0 – 11.1%, CPITN 1 – 23.6%, CPITN 2 – 32.4%, CPITN 3 – 27.6%, CPITN 4 – 5.3%. After analyzing the oral hygiene index the mean value we found was 16. Distribution of IHB intervals was: IHB 0-12 (40%), IHB 13-24 (53.3%), IHB 25-36 (6.6%). Discussion and conclusions. Comparing our results to data from the literature, in our group of patients with RA the only CPITN index criteria significantly increased, compared to the healthy population, were gingival bleeding on probing and the number of periodontal pockets with 4-5.5 mm depth.


2012 ◽  
Vol 6 (1) ◽  
pp. 392-399 ◽  
Author(s):  
Tetsuya Shinozaki ◽  
Kenichi Saito ◽  
Tsutomu Kobayashi ◽  
Takashi Yanagawa ◽  
Kenji Takagishi

Serum tartrate-resistant acid phosphatase (TRACP) 5b was investigated for use as a marker for diagnosis of giant cell tumor (GCT) of bone and for detection of its recurrence.Four patients with GCT of bone who were initially referred to our hospital were classified as a primary group. Three patients who had local recurrence following curettage were classified as a local recurrence group. Five with no recurrence were classified as a no-recurrence group. Eighteen patients with primary and metastatic malignant bone tumors were also enrolled in the study as a control group. Serum TRACP 5b was measured before the biopsy in all patients and was measured periodically after the operation in patients with GCT of bone. Studentt-tests were used for statistical analyses.TRACP 5b was greater than 1500 Um/dL in all primary group patients. Mean TRACP 5b values decreased gradually with post-operative time, showing lower values until local recurrence. The mean value of TRACP 5b of the local recurrence group (753 ± 68.7 mU/dL) was significantly higher than that of the no-recurrence group (340.6 ± 78.3 mU/dL). The mean value of TRACP 5b of the control group (466.9 ± 130.3 mU/dL) was much lower than that of the primary group and markedly lower than that of the local recurrence group. However, no significant difference was found between the no-recurrence group and the control group.Serum TRACP 5b is a useful and convenient marker for diagnosing GCT of bone and for predicting its recurrence.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 204.1-204
Author(s):  
M. Farrow ◽  
J. Biglands ◽  
S. Tanner ◽  
E. Hensor ◽  
M. H. Buch ◽  
...  

Background:As well as joint damage, rheumatoid arthritis (RA) is also associated with altered body composition known as rheumatoid cachexia (RC). RC is characterised by reduced skeletal muscle and increased (white) fat mass and decreased strength. RC is associated with increased disease severity and disability (1). It is unknown at what stage muscle involvement begins in RA, and if the muscle damage is modifiable when patients achieve disease control.Quantitative MRI (qMRI) can measure the biomarkers associated with RC. MRI T2 is sensitive to fluid related to physiological changes at the molecular level, and is regarded as an indirect measure of muscle inflammation (2). MRI muscle fat fraction (FF) measurements are useful for identifying myosteatosis (3).Objectives:To obtain preliminary estimates of the extent to which muscle imaging phenotype differs between RA and healthy controls (HC); and to describe the RA phenotype at different levels of disease activity.Methods:39 RA patients (comprising three groups) and 13 age and gender directly matched HC had a MRI scan of their dominant thigh. The RA groups were:[1]13 ‘New RA’ - newly diagnosed, treatment naïve[2]13 ‘Active RA’ - diagnosed >1 year, persistent DAS28 >3.2 for >1 year[3]13 ‘Remission RA’ - diagnosed >1 year, persistent DAS28 <2.6 for >1 yearMR images of the mid-thigh were acquired using Dixon imaging to assess FF and a fat-suppressed multi-echo spin-echo to measure T2. Regions of interest were drawn around the quadriceps and hamstrings. All participants had knee extension and flexion torque measured on an isokinetic dynamometer, and isometric dynamometer to measure grip strength. One-Way ANOVA with Dunnett’s post-hoc analysis provided preliminary indication of potential differences between T2, FF, muscle volume and strength measurements between the disease stages.Results:39 RA patients were recruited: 13 new RA (mean age [years] 63 ± 15, DAS28 5.2 ± 3), 13 active RA (mean age [years] 65 ± 10, DAS28 4.8 ± 3), 13 remission RA (mean age [years] 67 ± 19, DAS28 1.7 ± 0.7) and also 13 HC. T2 and FF were higher in RA patients compared to HC (fig. 1). Within the hamstrings for T2, the mean differences between HC versus new, active and remission patients were 4.5ms (95% CI 2.5, 6.4; p<0.001), 3ms (95% CI 1.1, 4.9; p=0.001), and 5.0ms (95% CI 3.0, 6.4; p<0.001) respectively. Quadriceps results were similar. For muscle volume, the mean differences between HC versus new, active and remission patients were -517.3cm3(95% CI -751, -283; p<0.001), -370.5cm3(95% CI -605, -136; p=0.001), and -312.3cm3(95% CI -546. -77; p=0.006) respectively (fig. 2). Knee flexion/extension and handgrip strength were lower in all 3 groups of RA patients compared to HC. For knee flexion, the mean differences between HC versus new, active and remission patients were 18.4Nm (95% CI -35, -1; p=0.03), 10.1Nm (95% CI -27, 7; p=0.3), and 13.3Nm (95% CI -33, 0; p=0.1) respectively.Figure 1.Quantitative T2 and FF MRI of RA patients and healthy controlsConclusion:This pilot study suggests muscle health may be adversely affected in RA patients compared to matched HC. Our results suggest that muscle changes occur in the earliest stages of RA and persist throughout the disease duration, even in clinical remission. If confirmed, these data imply the need for adjunctive muscle intervention to current RA treatment strategies in order to improve patient outcomes.References:[1]Giles JT, et al. Arthritis Care & Research. 2008[2]Maillard SM, et al. Rheumatology (Oxford, England). 2004[3]Grimm A, et al. The Journal of Frailty & Aging. 2018.Figure 2.MRI muscle volume in RA patients and healthy controlsDisclosure of Interests:Matt Farrow: None declared, John Biglands: None declared, Steven Tanner: None declared, Elizabeth Hensor: None declared, Maya H Buch Grant/research support from: Pfizer, Roche, and UCB, Consultant of: Pfizer; AbbVie; Eli Lilly; Gilead Sciences, Inc.; Merck-Serono; Sandoz; and Sanofi, Paul Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche (all paid to employer), Consultant of: AbbVie (consultant, clinical trials, advisor), Bristol-Myers Squibb (consultant, clinical trials, advisor), Lilly (clinical trials, advisor), Merck Sharp & Dohme (consultant, clinical trials, advisor), Novartis (consultant, clinical trials, advisor), Pfizer (consultant, clinical trials, advisor), Roche (consultant, clinical trials, advisor), Samsung (clinical trials, advisor), Sandoz (clinical trials, advisor), UCB (consultant, clinical trials, advisor), Ai Lyn Tan: None declared


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eric Mugabo ◽  
Lotta Velin ◽  
Richard Nduwayezu

Abstract Background Early involvement of students in research processes is an important step in professional development and can increase the academic output of the university. Previous studies indicate low research involvement amongst undergraduate students, however limited research has been done in sub-Saharan Africa. This study aimed to describe the level of research involvement amongst undergraduate students at the College of Medicine and Health Sciences (CMHS) at University of Rwanda (UR) and to assess factors associated with research involvement. Methods This cross-sectional study covered the three CMHS campuses. A survey was shared in class WhatsApp groups from July to September 2020. Data were analyzed using Stata IC 16.0 with descriptive statistics and Fisher’s exact test. P-values < 0.05 were considered statistically significant. Results In total, 324 students participated with the mean age being 23.3 (standard deviation 2.27). Males constituted 65.1% of respondents vs. 33.3% females. The largest portion of respondents were from the School of Medicine and Pharmacy (46.6%), and Medicine was the most frequent department (33.3%). On a Likert scale from 1 to 10, 60.0% of the respondents thought that research was 10/10 important for undergraduate students, with the mean value being 8.8. Rating their interest in taking part in research during undergraduate studies, 48.2% scored it 10/10, with the mean value being 8.57. 80.3% of respondents had attended a research module, course, or workshop; however, only 48.8% had participated in a research project and 72.0% of them had been involved in data collection. Inadequate knowledge about research processes and lack of mentors were the main barriers to research participation in 48.0 and 40.2% of respondents respectively. Establishment of a UR-Undergraduate research support center (77.2%), and involving students in ongoing UR projects (69.4%) were the most frequent suggestions to improve students’ research participation. Conclusion Undergraduate students at the CMHS in the UR have a large research interest, yet their involvement is currently low. Limited knowledge about research processes and shortage of mentors remains potent barriers to participation. Inviting undergraduate students to partake in ongoing projects and establishing a UR undergraduate research support center are recommended to strengthen undergraduate research experience at the UR-CMHS.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 97-98
Author(s):  
J. R. Hoeper ◽  
G. Gauler ◽  
D. Meyer-Olson ◽  
K. Rockwitz ◽  
P. Steffens-Korbanka ◽  
...  

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


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 59.1-60
Author(s):  
Y. Kanayama ◽  
R. Sugimoto

Background:Romosozumab (ROMO), a monoclonal antibody that binds sclerostin, increases bone formation and decreases bone resorption. And although it is a novel therapeutic agent for osteoporosis, which has shown high effects of increasing bone density and inhibiting fragile fracture in overseas clinical trials. However the clinical efficacy for rheumatoid arthritis complicated with osteoporosis (RA-OP) is unknown.Objectives:To evaluate the clinical efficacy of ROMO in patients with RA-OP for 12 months.Methods:RA patients diagnosed according to the 2010 ACR/EULAR criteria. All patients met at least one of the following criteria were eligible; a bone mineral density T score of -2.5 or less at the lumber spine or total hip and either one or more moderate or severe vertebral fractures or two or more mild vertebral fractures. All patients were initiated ROMO from between March and December, 2019. The total number of patients was 13 cases. The ROMO dose was 210mg at once every 1 months. In all cases native or activated vitamin D has been used. We reviewed the results for 12 months about the increase and decrease of bone mineral density (BMD) of lumbar spine(LS) and total hip(TH) by DEXA and bone turnover markers, intact n-terminal propeptide type I procollagen(PINP) and tartrate-resistant acid phopshatate form 5b(TRACP-5b).Results:The gender was all female. The mean age was 73.2 ± 7.6; disease duration was 20.5 ± 16.9 years; the body mass index was 19.7 ± 3.0 and the FRAX was 40.5 ± 16.2. Clinical findings related to RA-OP at baseline were as follows; CRP 1.29 ± 1.66; DAS-CRP 3.43 ± 0.96; HAQ 1.59 ± 0.97 and, bone turnover markers and bone mineral density at baseline were as follows; P1NP 58.1 ± 33.5; TRACP-5b 438 ± 216; LS-BMD and T-score 0.81 ± 0.15 g/cm2 and -2.63 ± 1.05 and TH-BMD 0.54 ± 0.08 g/cm2 and -3.22 ± 0.64 g/cm2. The rate of increased P1NP from baseline to 1, 3, 6 and 12 months were each 114.3 ± 90.6% at 1 month, 131.6 ± 134.3% at 3 month, 122.6 ± 174.3% at 6 month and 80.4 ± 181.6% at 12 month and decreased TRAC-5b were -10.7 ± 20.8% at 1 month, 7.9 ± 36.9% at 3 month, 25.5 ± 64.6% at 6 month and 32.5 ± 77.0% at 12 month. The rate of increased LS-BMD from baseline to 6 and 12 months were 8.6 ± 8.0%, 12.5 ± 11.1% and TH-BMD were 4.3 ± 5.0%, 6.8 ± 6.9% (Fig. 1, 2).Conclusion:Clinical efficacy of ROMO for RA-OP was extremely effective and has the high potential to be an important option in the treatment of RA-OP.References:Disclosure of Interests:None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1056.1-1056
Author(s):  
P. Muñoz Reinoso ◽  
F. J. Toyos Sáenz de Miera ◽  
D. Ruiz-Montesinos ◽  
I. García Hernández ◽  
P. Guerrero Zamora ◽  
...  

Background:Diffuse interstitial lung disease (ILD) is an extra-articular manifestation of rheumatoid arthritis (RA)1,2. The most common pattern is the usual interstitial pneumonia (UIP), conditioning a worse prognosis3.Objectives:To describe epidemiological, clinical, and radiological characteristics and treatment used in a cohort of patients diagnosed with RA and ILD.Methods:Retrospective descriptive study, including patients with a diagnosis of RA and ILD, reviewed in the Rheumatology and Pneumology consultations of the Virgen Macarena University Hospital, from 2010 to 2019. Data obtained from medical records are analyzed. SPSS statistical software is used.Results:26 patients were included, 18 women (69.2%). Median age at diagnosis of ILD was 62 years (53-73). Twelve patients (46.6%) used to smoke. The mean time from RA diagnosis to ILD diagnosis was 79 months (8-264). The RF was positive in 91.3% cases (21) and 87% of them (20) were ACPA positive. Fourteen patients (53.8%) had erosions and 3 (11.5%) had an associated Sjögren’s Syndrome. When ILD was diagnosed, the RA activity by DAS28PCR was moderate (3.28; 2.34-3.28) and 13 patients (54.1%) suffered from dyspnea. The mean value of FVC and DLCO in the first assessment was 84% (63-108) and 71.7% (64-86), respectively. The most frequent radiological pattern of ILD was NINE in 15 patients (57.7%), 6 of them (23.1%) had UIP and 5 (19.3%) presented other patterns. Prior to ILD diagnosis, 24 (92.3%) patients received oral glucocorticoids, 18 (69.2%) cases started treatment with c-DMARD and 11 (42.3%) of them with b-DMARD; the most widely used were methotrexate (MTX) in 17 patients (65.4%) and anti-TNFα in 10 (38.5%). After diagnosis, treatment was changed to 12 patients (46.6%); the most used DMARD was leflunomide, in 11 (42.3%), MTX was maintained in 7 patients (26.9%); the number of anti-TNFα used decreased to 4 cases (15.4%), using instead drugs such as rituximab 5 (19.2%), abatacept 3 (11.5%), baricitinib 2 (7.7%) and anti-IL6 2 (7, 7%). During follow-up, 11 cases (57.9%) remained radiologically stable. A slight deterioration in DLCO was observed (66%; 51-80) and there was one death due to lung disease (UIP).Conclusion:In this study, the most frequent radiological pattern was NINE. Half of the patients used to smoke. At the diagnosis of ILD (at ILD diagnosis), dyspnea was the most relevant clinical symptom, with a slight deterioration in the? respiratory function tests. This represented a change in the therapeutic strategy.References:[1]Olson AL, Swigris JJ, Sprunger DB, et al. Rheumatoid arthritis-interstitial lung disease-associated mortality. Am J Respir Crit Care Med. 2011;183:372-78.[2]Fragoulis GE, Nikiphorou E, Larsen J, Korsten P and Conway R. Methotrexate-Associated Pneumonitis and Rheumatoid Arthritis-Interstitial Lung Disease: Current Concepts for the Diagnosis and Treatment. Front. Med. 2019;6:238.[3]Tanaka N, Kim JS, Newell JD, et al. Rheumatoid arthritis-related lung diseases: CT findings. Radiology. 2004;232:81-91.Disclosure of Interests:None declared


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