The Handscan is a novel objective optical imaging device for disease follow-up and management in rheumatoid arthritis patients. We aim to examine the association between the baseline outcomes of the Handscan, disease activity levels and joint swelling. The Handscan measures differences in laser light absorption between joints of fingers and wrists and adjacent reference tissue, indicating the presence or absence of inflammation. The device gives an optical spectral transmission (OST) index per joint. The average of these indices is represented in the total optical score (TOS). Associations between TOS and DAS28 at subject level and OST and swelling at joint level were examined. 484 RA patients were included. Compared to patients with high disease activity (defined by DAS28), TOS was significantly lower in patients with moderate (estimated coefficient B: − 7.09, P < 0.001), low disease activity (B: − 6.99, P < 0.001) and patients in remission (B: − 7.72, P < 0.001) but could not distinguish between the latter three disease states. TOS was significantly lower in females (B: − 3.2, P < 0.001). OST was significantly higher in swollen than non-swollen joints (B: 0.28, P < 0.001). TOS was significantly higher in patients with high disease activity than in those in remission or with low and moderate disease activity. The difference in TOS between males and females should be accounted for in the interpretation of this outcome. The OST at joint level discriminates swollen from non-swollen joints and could be a more promising tool than the overall optical activity reflected in TOS.
BackgroundWeight gain is one of the most feared patient-reported adverse event of glucocorticoids, however the effect of low-dose prednisolone on body weight and composition in RA still has to be unraveled.ObjectivesCurrent study is a substudy of the GLORIA trial.[1]We report changes in body weight of the whole study population, and relate these to changes in disease activity, and changes in body composition in a subgroup of patients.MethodsThe GLORIA trial, a pragmatic, placebo-controlled, double-blind, randomised controlled trial investigated the balance of benefit and harm of 2 years of prednisolone 5 mg/day added to standard care in 451 patients with active RA aged 65+.[1]In current study 449 patients were included, and body weight and disease activity score of 28 joints (DAS28) were measured at baseline and after 3, 6, 12, 18 and 24 months. In 57 patients body composition was assessed at baseline and after 2 years with dual-energy X-ray absorptiometry. Data were analysed with longitudinal mixed models, and log-ratio analysis to evaluate the mutual changes in body composition, given as the proportions total lean mass, total fat mass, and total bone mass.ResultsBody weight changed by mean (95% CI) 0.9 (0.3;1.6) kg on prednisolone after 2 years, versus –0.4 (–1.1;0.2) kg on placebo, with a difference between treatment groups of 1.3 (0.5;2.2) kg (p<0.01). In multivariable regression analysis, the effect of AUC DAS28 0–2 years was not significantly associated with weight change (p=0.18).The change in body composition after 2 years was different in prednisolone compared to placebo patients (log-ratio analysis, p=0.02; Table 1). Prednisolone patients showed small but favorable changes in body composition, i.e. lean mass increases exceeding fat mass increases, with trends in differences for total lean mass and lean mass index, and even significant differences for appendicular lean mass (p=0.02), and its corresponding index (p<0.01). No differences in change were seen in total fat mass, nor in fat distribution over the body, i.e. trunk, extremities and head (log-ratio analysis, p=0.93).ConclusionPatients with active RA aged 65+ treated with prednisolone 5 mg/day for 2 years gained about 1 kg in weight, compared to non-significant weight loss on placebo. This weight gain is a direct effect of the glucocorticoid treatment, and not significantly dependent of decrease in disease activity. The small increase in weight is mostly (appendicular) lean mass, rather than increase or redistribution of fat mass traditionally associated with glucocorticoid treatment.Reference[1]Boers M, et al; GLORIA Trial consortium. Low dose, add-on prednisolone in patients with rheumatoid arthritis aged 65+: the pragmatic randomised, double-blind placebo-controlled GLORIA trial. Ann Rheum Dis. 2022.Table 1.Changes in body composition components after 2 years of prednisolone (5 mg/day) or placebo.Prednisolone (n=28)Placebo (n=27)baseline2-year changebaseline2-year changeDifference in changep-valueBody weight (kg)77.4 (13.3)0.9(–0.5;2.3)79.0(12.2)–0.7(–2.2;0.7)1.6(–0.4;3.6)0.12Body composition0.02*Total fat mass (kg)28.8(8.6)0.3(–0.7;1.2)29.4(7.0)–0.4(–1.4;0.6)0.7(–0.7;2.1)Total lean mass (kg)46.4(9.0)0.7(–0.1;1.4)47.3(10.3)–0.3(–1.1;0.5)1.0(–0.1;2.1)Total bone mass (kg)2.2 (0.5)–0.008 (–0.05;0.03)2.3 (0.5)0.03 (–0.008;0.07)0.04 (–0.02;0.1)Body composition in detailFat massratio trunk/appendicular1.06(0.30)–0.01(–0.04;0.02)1.09(0.23)–0.02(–0.05;0.02)0.00(–0.04;0.05)0.85Lean massappendicular (kg)18.5(4.1)0.4(0.0;0.8)19.4(5.0)–0.3(–0.8;0.2)0.7(0.1;1.4)0.02LMI (kg/m2)15.8(2.1)0.3(0.0;0.5)16.8(2.7)–0.1(–0.4;0.2)0.4(0.0;0.7)0.05ALMI (kg/m2)6.3(1.0)0.2(0.0;0.3)6.9(1.4)–0.1(–0.3;0.0)0.3(0.1;0.5)<0.01Data are presented as mean (SD) or mean (95% CI), unless otherwise specified; LMI=Lean Mass Index; ALMI=Appendicular Lean Mass Index;*overall test (log-ratio analysis).AcknowledgementsWe thank all patients and trial collaborators – listed in previous published main manuscript of the GLORIA trial – for their participation in the trial.21 We thank the nuclear medicine department of the Maasstad hospital, Medical Center Leeuwarden and Groene Hart hospital (all in the Netherlands) for performing the bodyscans.Disclosure of InterestsNone Declared.
ObjectivesTo investigate the effect of 2 years of add-on prednisolone 5 mg/day on body weight and composition in patients with active rheumatoid arthritis (RA) aged 65+ and the relation with disease activity.MethodsThe Glucocorticoid Low-dose Outcome in RheumatoId Arthritis trial, a pragmatic, placebo-controlled, double-blind, randomised controlled trial investigated the balance of benefit and harm of 2 years of prednisolone 5 mg/day added to standard care in 451 patients with active RA aged 65+. In the current study, 449 patients were included, and body weight and Disease Activity Score of 28 Joints were measured at baseline and after 3, 6, 12, 18 and 24 months. In 57 patients, body composition was assessed at baseline and after 2 years with dual-energy X-ray absorptiometry. Data were analysed with longitudinal mixed models.ResultsThe mean (95% CI) change in body weight was 0.9 (0.3 to 1.6) kg in the prednisolone group and –0.4 (–1.1 to 0.2) kg in the placebo group (difference 1.3 (0.5–2.2), (p<0.01)). The treatment effect was independent of disease activity suppression and comprised mostly increase in (appendicular) lean mass after 2 years. There was no significant increase in total fat mass, nor redistribution of fat mass from peripheral to central tissues.ConclusionsPatients with active RA aged 65+ treated with prednisolone 5 mg/day for 2 years gained about 1 kg in weight, compared with minimal—non-significant—weight loss on placebo. Our data suggest that the small increase in weight is mostly lean mass, rather than increase or redistribution of fat mass traditionally associated with glucocorticoid treatment.
BackgroundThe handscan is a new technologic device which uses diffuse optical transmission in combination with blood flow modulation. It is a non-invasive measurement of joint inflammation potentially more sensitive than the clinical evaluation of the joints by a rheumatologist[.1 However, more clinical data is necessary before this new device can be implemented in the daily clinical practice.ObjectivesThis study investigates the additional value of the handscan in decision making in the daily practice for patients with rheumatoid arthritis.MethodsAt our outpatient clinic we started a registry for rheumatoid arthritis patients with a disease duration of at least two years. During this period, a handscan will be made for all patients before every regular visit. Both the patient and the treating rheumatologist will be blinded to the handscan outcome. Primary outcome is the association between DAS28 score and the total optical score (TOS) of the handscan per visit.ResultsThe study started in December 2017, until now 100 patients are included. The mean age was 61.1 years, the mean disease duration at time of inclusion 11.2 years, 67% were rheumatoid factor positive, 51% were anti-CCP positive. In figure 1 we show the association between DAS28 and the TOS in a linear model.Currently there is no validated cut off point for the TOS (negative or positive score for inflammation). In our group of 100 patients the median TOS was 10, the most discriminating TOS was found to be 17 using chi-square test as depicted in table 1.Abstract AB1170 – Table 1Crosstab for total optical score of the handscan versus DAS28DAS28TOS<17TOS≥17TotalP-value Mean2.543.072.560.068Std0.901.721.12Median2.553.132.61N76 (4missings)19 (1missing)95 (5missings)Abstract AB1170 – Figure 1ConclusionsIn this preliminary evaluation of the first 100 patients, we observed a limited positive correlation between the total optical score of the handscan and the DAS28. The TOS above 17 associates with moderate to severe disease activity. The definite clinical value of the handscan needs to be determined with longitudinal measurements and it’s predictive value versus the DAS28. The ongoing current registry aims to answer these questions.Reference[1] Van Onna M, Ten Cate DF, Tsoi KL, et al. Assessment of disease activity in patients with rheumatoid arthritis using optical spectral transmission measurements, a non-invasive imaging technique. Ann Rheum Dis2016;75:511–8. doi:10.1136/annrheumdis-2015-207315Disclosure of InterestA. Al Hasan Grant/research support from: this reserach is supported by an unrestricted grant from Stichting De Friesland, R. Bos Grant/research support from: this reserach is supported by an unrestricted grant from Stichting De Friesland, N. Veeger: None declared, D. Zhang: None declared, L. Hendriks: None declared, F. Wink: None declared, A. Schilder: None declared, F. Reimann: None declared, K. Bergsma: None declared
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