scholarly journals Can Patient‐Reported Symptoms Be Used to Measure Disease Activity in Systemic Sclerosis?

2020 ◽  
Vol 72 (10) ◽  
pp. 1459-1465 ◽  
Author(s):  
Laura Ross ◽  
Wendy Stevens ◽  
Michelle Wilson ◽  
Gemma Strickland ◽  
Jennifer Walker ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Disease Activity ◽  
Patient Reported ◽  
Measure Disease Activity

The Association Between Disease Activity and Duration in Systemic Sclerosis

2010 ◽  
Vol 37 (11) ◽  
pp. 2299-2306 ◽  
Author(s):  
JENNIFER G. WALKER ◽  
RUSSELL J. STEELE ◽  
MIREILLE SCHNITZER ◽  
SUZANNE TAILLEFER ◽  
MURRAY BARON ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Disease Activity ◽  
Disease Duration ◽  
Activity Index ◽  
Disease Onset ◽  
Depression Scale ◽  
Disease Activity Index ◽  
Cross Sectional ◽  
Diffuse Disease ◽  
Patient Reported

Objective.The absence of a standardized disease activity index has been an important barrier in systemic sclerosis (SSc) research. We applied the newly derived Valentini Scleroderma Disease Activity Index (SDAI) among our cohort of patients with SSc to document changes in disease activity over time and to assess possible differences in activity between limited and diffuse disease.Methods.Cross-sectional study of a national cohort of patients enrolled in the Canadian Scleroderma Research Group Registry. Disease activity was measured using the SDAI. Depression scores were measured using the Centre for Epidemiologic Studies Depression Scale (CES-D).Results.A total of 326 out of 639 patients had complete datasets at the time of this analysis; 87% were female, of mean age 55.6 years, with mean disease duration 14.1 years. SDAI declined steeply in the first 5 years after disease onset and patients with diffuse disease had 42% higher SDAI scores than patients with limited disease with the same disease duration and depression scores (standardized relative risk 1.42, 95% CI 1.21, 1.65). Patients with higher CES-D scores had higher SDAI scores relative to patients with the same disease duration and disease subset (standardized RR 1.22, 95% CI 1.14, 1.31). Among the 10 components that make up the SDAI, only skin score (standardized OR 0.59, 95% CI 0.43, 0.82) and patient-reported change in skin (standardized OR 0.64, 95% CI 0.45, 0.92) decreased with increasing disease duration. High skin scores (standardized OR 32.2, 95% CI 15.8, 72.0) were more likely and scleredema (standardized OR 0.58, 95% CI 0.37, 0.92) was less likely to be present in patients with diffuse disease. High depression scores were associated with positive responses for patient-reported changes in skin and cardiopulmonary function.Conclusion.Disease activity declined with time and patients with diffuse disease had consistently higher SDAI scores. Depression was found to be associated with higher patient activity scores and strongly associated with patient self-response questions. The role of depression should be carefully considered in future applications of the SDAI, particularly as several components of the score rely upon patient recall.

Reliability, Validity and Responsiveness of Physical Activity Monitors in Patients with Inflammatory Myopathy

Rheumatology ◽  
2021 ◽  
Author(s):  
Bonny Rockette-Wagner ◽  
Didem Saygin ◽  
Siamak Moghadam-Kia ◽  
Chester Oddis ◽  
Océane Landon-Cardinal ◽  
...  
Keyword(s):  
Physical Activity ◽  
Construct Validity ◽  
Disease Activity ◽  
Retest Reliability ◽  
Activity Monitors ◽  
Muscle Testing ◽  
Patient Reported ◽  
Physical Activity Monitors ◽  
Global Disease Activity ◽  
Test Retest Reliability

Abstract Objective Idiopathic inflammatory myopathies (IIM) cause proximal muscle weakness, which affect activities of daily living. Wearable physical activity monitors (PAMs) objectively assess continuous activity with potential clinical usefulness in IIM assessment. We examined the psychometric characteristics for PAM outcomes in IIM. Methods Adult IIM patients were prospectively evaluated (baseline, 3 and 6-months) in an observational study. A waist-worn PAM (ActiGraph GT3X-BT) assessed average step counts/min, peak 1-min cadence, and vector magnitude/min. Validated myositis core set measures (CSM) including manual muscle testing (MMT), physician global disease activity (MD global), patient global disease activity (Pt global), extra-muscular disease activity (Ex-muscular global), HAQ-DI, muscle enzymes, and patient-reported physical function were evaluated. Test-retest reliability, construct validity, and responsiveness were determined for PAM measures and CSM using Pearson correlations and other appropriate analyses. Results 50 adult IIM patients enrolled [mean (SD) age, 53.6 (±14.6); 60% female, 94% Caucasian]. PAM measures showed strong test-retest reliability, moderate-to-strong correlations at baseline with MD global (r=-0.37- -0.48), Pt-global (r=-0.43- -0.61), HAQ-DI (r=-0.47- -0.59) and MMT (r = 0.37–0.52), and strong discriminant validity for categorical MMT and HAQ-DI. Longitudinal association with MD global (r=-0.38- -0.44), MMT (r = 0.50–0.57), HAQ-DI (r=-0.45- -0.55), and functional tests (r = 0.30–0.65) were moderate-to-strong. PAM measures were responsive to MMT improvement (≥10%) and moderate-to-major improvement on ACR/EULAR myositis response criteria. Peak 1-min cadence had the largest effect size and Standardized Response Means (SRMs). Conclusion PAM measures showed promising construct validity, reliability, and longitudinal responsiveness; especially peak 1-min cadence. PAMs provide valid outcome measures for future use in IIM clinical trials.

scholarly journals SAT0611-HPR LOW ADHERENCE TO RECOMMENDED PHYSICAL THERAPY IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS: A MIXED-METHOD CONTENT AND UTILIZATION ANALYSIS.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1266.2-1266
Author(s):  
E. Vanautgaerden ◽  
M. Kaerts ◽  
W. Dankaerts ◽  
K. De Vlam ◽  
T. Swinnen
Keyword(s):  
Physical Therapy ◽  
Disease Activity ◽  
Mixed Method ◽  
Axial Spondyloarthritis ◽  
Physical Therapists ◽  
Skills Training ◽  
Treatment Modalities ◽  
Patient Reported ◽  
Global Disease Activity ◽  
Therapy Sessions

Background:Patients with axial spondyloarthritis (axSpA) encounter limitations during daily activities and societal participation which seriously impart health-related quality of life. Optimal management of axSpA consists of combined pharmacological and non-pharmacological treatment modalities, including the encouragement of exercise and the consideration of physical therapy given the latter’s superior efficacy1. Few studies investigated the use of physical therapy and the alignment of treatment content with practice recommendations among patients with axSpA.Objectives:1) To estimate physical therapy use in patients with axSpA in a real life cohort; 2) to quantitatively and qualitatively describe the content of these physical therapy sessions; 3) explore possible determinants of physical therapy use and content.Methods:This cross-sectional study included 197 patients diagnosed with axSpA (Males/Females: 62.4/37.6%; mean±SD, age 42.6±12.0, BASDAI 3.7±2.1, BASFI 3.6±2.4, BASMI 3.1±1.8) and recruited during their routine consultation. The mixed-method approach included questionnaires (physical therapy use and content, medication, depression/anxiety (HADS), fear (TSK), physician global disease activity (PGDA)) and an in-depth qualitative interview (content of physical therapy). Interviews were analyzed using the Qualitative Analysis Guide of Leuven by two physical therapists. Spearman’s Rho correlations guided the exploration of determinants of physical therapy use and content.Results:Less than half (42.6%, n=84) of the axSpA of patients were in treatment with a physiotherapist. Most patients (40.0%) reported a physical therapy frequency of 1x/week. Session duration was typically 30 minutes (51.7% of the sample) and longer in fewer cases (30.0%). Exercise was in only 31.7% the cornerstone of their sessions. The majority of subjects (53.3%) were classified as receiving ‘passive therapy only’, with 10% of cases in the ‘exercise only’ and 36.7% in the ‘combination therapy’ groups. Interviews also revealed a lack of clear patient-centered treatment goals. We found moderate associations between physical therapy use/content parameters and medication, spinal mobility, fear, anxiety, depression, physician’s global disease activity versus (p<.05), but no relationship with patient-reported pain or disease activity.Conclusion:Despite the importance of exercise and the added value of physical therapy in axSpA, few patients engaged in physical therapy sessions that include exercise training of adequate dosage. Remarkably, physical therapy utilization seems to be predominantly guided by psychological factors. Professional education for physical therapists should therefore include skills training in the management of complex clinical presentations2. Last, future research should prepare the evidence-based implementation of state-of-the-art physical therapy guidelines in axSpA.References:[1]van der Heijde D, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017 Jun;76(6):978-991.[2]Swinnen TW, et al. Widespread pain in axial spondyloarthritis: clinical importance and gender differences. Arthritis Res Ther. 2018 Jul 27;20(1):156.Disclosure of Interests:Evelyne Vanautgaerden: None declared, Marlies Kaerts: None declared, Wim Dankaerts: None declared, Kurt de Vlam Grant/research support from: Celgene, Eli Lilly, Pfizer Inc, Consultant of: AbbVie, Eli Lilly, Galapagos, Johnson & Johnson, Novartis, Pfizer Inc, UCB, Thijs Swinnen: None declared

scholarly journals AB0369 EFFICACY AND SAFETY OF RITUXIMAB ORIGINATOR AND BIOSIMILAR IN PRIMARY SJÖGREN’S SYNDROME IN A REAL-LIFE SETTING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1485.3-1485
Author(s):  
F. Carubbi ◽  
A. Alunno ◽  
P. Cipriani ◽  
V. Pavlych ◽  
C. DI Muzio ◽  
...  
Keyword(s):  
Disease Activity ◽  
Real Life ◽  
Primary Sjögren’S Syndrome ◽  
Efficacy And Safety ◽  
Research Support ◽  
Treatment Groups ◽  
Real Life Setting ◽  
Patient Reported ◽  
Time Point

Background:Over the last 2 decades rituximab (RTX) has been widely used, albeit off-label, in primary Sjögren’s syndrome (pSS). Several studies reported that B-lymphocyte depletion with RTX is effective in this disease not only by reducing disease activity but also by affecting the inflammation and the lymphoid organization that occur in target tissues. With the recent release of several RTX biosimilars (bRTX) on the market, the demonstration of their interchangeability with RTX originator (oRTX) is required.Objectives:To compare efficacy and safety of oRTX and bRTX in pSS patients in a real-life setting.Methods:Clinical records of pSS patients referring to a tertiary rheumatology clinic were retrospectively evaluated. Patients having received at least 2 courses of either oRTX or bRTX (1000 mg IV infusion, repeated after 2 weeks -1 course- and the course repeated after 24 weeks) with complete data at baseline and after 3, 6, 9 and 12 months of treatment were enrolled. Disease activity was assessed with the EULAR SS disease activity index (ESSDAI) and its clinical version without the biological domain (ClinESSDAI). Patient-reported symptoms were assessed with the EULAR SS Patient Reported Index (ESSPRI).Results:Seven patients that received oRTX and 7 patients that received bRTX were enrolled. Baseline clinical features, including ESSDAI and ESSPRI were similar in the 2 treatment groups. Both compounds significantly reduced ESSDAI and ESSPRI as early as 3 months and no difference between the groups was observed at any time point (Figure 1). Of interest, ESSDAI slowly decreased until month 6 when the most pronounced reduction was observed. Conversely, ESSPRI dropped to its lowest values already at month 3. With regard to safety, at 12 months of follow-up no adverse event was observed in any of the treatment groups.Conclusion:At 12 months of follow-up, oRTX and bRTX display similar efficacy and safety profiles. The improvement of patient reported outcomes is faster than the improvement of disease activity with both compounds. Our data support interchangeability of oRTX and bRTX in pSS.References:[1]Carubbi F et al. Arthritis Res Ther. 2013;15(5):R172[2]Carubbi F et al. Lupus. 2014;23(13):1337-49Figure 1 ESSDAI and ESSPRI values at every time point in the 2 treatment groups. Asterisks indicate p values <0.05 compared to the other treatment group at the same time pointDisclosure of Interests:Francesco Carubbi Speakers bureau: Francesco Carubbi received speaker honoraria from Abbvie and Celgene outside this work., Alessia Alunno: None declared, Paola Cipriani Grant/research support from: Actelion, Pfizer, Speakers bureau: Actelion, Pfizer, Viktoriya Pavlych: None declared, claudia di muzio: None declared, Roberto Gerli: None declared, Roberto Giacomelli Grant/research support from: Actelion, Pfizer, Speakers bureau: Abbvie, Roche, Actelion, BMS, MSD, Ely Lilly, SOBI, Pfizer

scholarly journals AB0330 HIGH REMISSION RATES IN RA – REAL LIFE DATA FROM BARITICINIB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1463.2-1464
Author(s):  
S. Bayat ◽  
K. Tascilar ◽  
V. Kaufmann ◽  
A. Kleyer ◽  
D. Simon ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Cox Regression ◽  
Real Life ◽  
Inadequate Response ◽  
Research Support ◽  
Das 28 ◽  
Patient Reported ◽  
One Year

Background:Recent developments of targeted treatments such as targeted synthetic DMARDs (tsDMARDs) increase the chances of a sustained low disease activity (LDA) or remission state for patients suffering rheumatoid arthritis (RA). tsDMARDs such as baricitinib, an oral inhibitor of the Janus Kinases (JAK1/JAK2) was recently approved for the treatment of RA with an inadequate response to conventional (cDMARD) and biological (bDMARD) therapy. (1, 2).Objectives:Aim of this study is to analyze the effect of baricitinb on disease activity (DAS28, LDA) in patients with RA in real life, to analyze drug persistance and associate these effects with various baseline characteristics.Methods:All RA patients were seen in our outpatient clinic. If a patient was switched to a baricitinib due to medical reasons, these patients were included in our prospective, observational study which started in April 2017. Clinical scores (SJC/TJC 76/78), composite scores (DAS28), PROs (HAQ-DI; RAID; FACIT), safety parameters (not reported in this abstract) as well as laboratory biomarkers were collected at each visit every three months. Linear mixed effects models for repeated measurements were used to analyze the time course of disease activity, patient reported outcomes and laboratory results. We estimated the probabilities of continued baricitinib treatment and the probabilities of LDA and remission by DAS-28 as well as Boolean remission up to one year using survival analysis and explored their association with disease characteristics using multivariable Cox regression. All patients gave informed consent. The study is approved by the local ethics.Results:95 patients were included and 85 analyzed with available follow-up data until November 2019. Demographics are shown in table 1. Mean follow-up duration after starting baricitinib was 49.3 (28.9) weeks. 51 patients (60%) were on monotherapy. Baricitinib survival (95%CI) was 82% (73% to 91%) at one year. Cumulative number (%probability, 95%CI) of patients that attained DAS-28 LDA at least once up to one year was 67 (92%, 80% to 97%) and the number of patients attaining DAS-28 and Boolean remission were 31 (50%, 34% to 61%) and 12(20%, 9% to 30%) respectively. Median time to DAS-28 LDA was 16 weeks (Figure 1). Cox regression analyses did not show any sufficiently precise association of remission or LDA with age, gender, seropositivity, disease duration, concomitant DMARD use and number of previous bDMARDs. Increasing number of previous bDMARDs was associated with poor baricitinib survival (HR=1.5, 95%CI 1.1 to 2.2) while this association was not robust to adjustment for baseline disease activity. Favorable changes were observed in tender and swollen joint counts, pain-VAS, patient and physician disease assessment scores, RAID, FACIT and the acute phase response.Conclusion:In this prospective observational study, we observed high rates of LDA and DAS-28 remission and significant improvements in disease activity and patient reported outcome measurements over time.References:[1]Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Annals of the rheumatic diseases. 2015 Feb;74(2):333-40.[2]Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, et al. Baricitinib in Patients with Refractory Rheumatoid Arthritis. The New England journal of medicine. 2016 Mar 31;374(13):1243-52.Figure 1.Cumulative probability of low disease activity or remission under treatment with baricitinib.Disclosure of Interests:Sara Bayat Speakers bureau: Novartis, Koray Tascilar: None declared, Veronica Kaufmann: None declared, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Johannes Knitza Grant/research support from: Research Grant: Novartis, Fabian Hartmann: None declared, Susanne Adam: None declared, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, EIT Health, EU-IMI, DFG, Universität Erlangen (EFI), Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB

scholarly journals Mobile App-based documentation of patient-reported outcomes — 3-months results from a proof-of-concept study on modern rheumatology patient management

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Jutta G. Richter ◽  
Christina Nannen ◽  
Gamal Chehab ◽  
Hasan Acar ◽  
Arnd Becker ◽  
...  
Keyword(s):  
Disease Activity ◽  
Disease Surveillance ◽  
Patient Management ◽  
Activity Index ◽  
Retention Rate ◽  
Likert Scale ◽  
Mobile App ◽  
Proof Of Concept ◽  
Concept Study ◽  
Patient Reported

Abstract Background Mobile medical applications (Apps) offer innovative solutions for patients’ self-monitoring and new patient management opportunities. Prior to routine clinical application feasibility and acceptance of disease surveillance using an App that includes electronic (e) patient-reported outcome measures (PROMs) warrant evaluation. Therefore, we performed a proof-of-concept study in which rheumatoid arthritis (RA) patients used an App (RheumaLive) to document their disease. Methods Accurate PROM reporting via an App in comparison to paper-based versions was investigated to exclude media bias. Sixty participants recruited from 268 consecutive RA outpatients completed paper-based and electronic PROMs (Hannover Functional Questionnaire/derived HAQ; modified RA disease activity index) using the App at baseline and follow-up visits. Between visits, patients used their App on their own smartphone according to their preferences. The equivalence of PROM data and user experiences from patients and physicians were evaluated. Results Patients’ (78.3% female) mean (SD) age was 50.1 (13.1) years, disease duration 10.5 (9.1) years, and paper-based HAQ 0.78 (0.59). Mean confidence in Apps scored 3.5 (1.1, Likert scale 1 to 6). ePROMs’ scores obtained by patients’ data entry in the App were equivalent to paper-based ones and preferred by the patients. After 3 months, the App retention rate was 71.7%. Patients' overall satisfaction with the App was 2.2 (0.9, Likert scale 1 to 6). Patients and physicians valued the App, i.e., for patient-physician interaction: 87% reported that it was easier for them to document the course of the disease using the App than “only” answering questions about their current health during routine outpatient visits. Further App use was recommended in 77.3% of the patients, and according to physicians, in seven patients, the App use contributed to an increased adherence to therapy. Conclusion Our study provides an essential basis for the broader implementation of medical Apps in routine care. We demonstrated the feasibility and acceptance of disease surveillance using a smartphone App in RA. App use was convincing as a reliable option to perform continuous, remote monitoring of disease activity and treatment efficacy. Trial registration ClinicalTrials.gov, NCT02565225. Registered on September 16, 2015 (retrospectively registered).

scholarly journals POS0583 ENGINEERED GLOVE TO EVALUATE THE SPEED OF THE HANDS’ MOVEMENTS IN RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 524.3-525
Author(s):  
M. Patanè ◽  
L. Carmisciano ◽  
E. Hysa ◽  
E. Gotelli ◽  
A. Signori ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Health Assessment ◽  
Continuous Variable ◽  
Test System ◽  
Movement Speed ◽  
Healthy Controls ◽  
Activity Class ◽  
Patient Reported ◽  
Opposition Movements

Background:Rheumatoid arthritis (RA) is a long-term, progressive, and disabling autoimmune disease1. The disease activity can be quantified by the Disease Activity Score 28-joint count – C reactive protein (DAS28crp)2; the evaluation of disability function (DF) is actually mainly performed only by subjective Patient Reported Outcomes (PROs) like Health Assessment Questionnaire (HAQ)3; to investigate the functional aspects of RA hands it is usually used the grip strength (GS)4. However, in the scientific literature no tool, which objectively evaluates movement speed, has been reported. The Hand Test System (HTS, ETT) is an engineered glove (RAGLOVE), nowadays applied for neuroscience studies to evaluate hand motility5Objectives:To objectively evaluate the RA hand’s speed of the fine movements, through the HTS and to compared with a group of age and sex matched healthy controls. To verify the correspondence with the HAQ, DAS28, GS.Methods:55 consecutives RA patients (pts) (6 males, age 61 ± 16 years, mean duration of disease 12 ± 8 years), classified according to 2010 ACR/EULAR criteria6, and 50 matched healthy controls (HCs) were enrolled. After consent, all participants undergone HTS test that recognizes the touches between the finger tips during the opposition movements of the hands in standard sequences of movements, after dressed the glove. A multiple finger evaluation (MFE) and a single finger evaluation (SFE) were performed using a dedicated software that provided the physician the following quantitative parameters: Touch Duration (TD), Inter Tapping Interval (ITI) and Movement Rate (MR). Average time for hand 2 minutes. RA pts compiled the HAQ, performed the GS and a DAS28cpr was performed.The student’s t-test was used to compare the glove’s parameters between the groups whereas the analysis of variance (ANOVA) was utilized to verify potential differences between the populations. In order to evaluate the single correlations, the r and p values of Pearson were employed.Results:For MFE, glove parameters TD and ITI were significantly higher in RA pts than HCs, whereas; MR was significantly lower in RA pts compared to HCs (all p <0.001).For SFE non-affected fingers (not swollen and not tender) of RA pts performed better than a clinically affected fingers, but in any case significantly worse than average HCs fingers (p < 0.001).There is a statistically significant correlation between the GS and MR (r= 0.39 p=0.003) and TD (r=-0.33 p=0.015).TD, ITI e MR of RA pts showed a significant correlation with the total score of the HAQ (r = 0.56, r = 0.39, r = -0.56, all p < 0.001;). DAS28, considered as a continuous variable, proved to be significantly correlated with the TD (r = 0.36, p = 0.009). When the RA patients were grouped according to the disease activity by DAS28cpr7, there was an increase of one third of the TD’s logarithm for each increase in the activity class (linear regression with ordinal predictors, beta = 0.33; 95%CI 0.03, 0.63,p < 0.0297). Finally, even RA pts in remission showed a TD significantly higher compared with HCs (p= 0.034).Conclusion:The RAGLOVE is shown as a new safe and fast tool to evaluate a new objective parameter in the hand’s functionality: the speed of finger movements. In RA pts, an inversely proportional correlation emerges between the speed of movement and disease activity.The significant correlation found with HAQ, highlights the loss of motility of the hands as one of the main determinant of disability. The RAGLOVE is now tested in RA patients undergoing treatment.References:[1]Hakkinen et al Ann Rheum Dis. 2005;[2]Van Der Heijde et al J of Rheum. 1993;[3]Fries et al Arthritis Rheum. 1980;[4]Mathiowetz et al J Hand Surg Am. 1984;[5]Carmisciano et al Eur J Neurol. 2020;[6]Aletaha et al. Ann Rheum Dis. 2010;[7]Aletaha et al Arthritis Rheum 2005.Disclosure of Interests:None declared

scholarly journals AB0562 SLEEP HYGIENE: COULD IT BE A CONFOUNDING FACTOR FOR SLEEP QUALITY IN SYSTEMIC SCLEROSIS?

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1578.2-1578
Author(s):  
N. Gokcen ◽  
A. Komac ◽  
F. Tuncer ◽  
A. Yazici ◽  
A. Cefle
Keyword(s):  
Systemic Sclerosis ◽  
Sleep Quality ◽  
Disease Activity ◽  
Beck Depression Inventory ◽  
Sleep Disturbances ◽  
Activity Index ◽  
Univariate Analysis ◽  
Sleep Hygiene ◽  
Healthy Controls ◽  
Clinical Variables

Background:Sleep disturbances have been described in Systemic Sclerosis (SSc). Confounding factors related to sleep quality are also investigated. Although sleep hygiene plays an important role in sleep quality, as far as we know, there are not enough data to show the effect of sleep hygiene on sleep quality of SSc.Objectives:To investigate sleep hygiene, its impact on sleep quality, and its association with demographic-clinical factors in patients with SSc, rheumatoid arthritis (RA), and healthy controls.Methods:The study was designed as cross-sectional. Forty-nine patients with SSc who fulfilled the 2013 ACR/EULAR classification criteria for SSc, 66 patients with RA who fulfilled 1987 revised classification criteria, and 30 healthy controls were included in the study. All participants were female. Demographic and clinical variables were documented. Disease activity index of both SSc and RA was calculated. SSc patients were assessed by questionnaires including Short Form 36 (SF-36), The Health Assessment Questionnaire Disability Index (HAQ-DI), Beck Anxiety and Beck Depression Inventory, Pittsburg Sleep Quality Index (PSQI), Sleep Hygiene Index (SHI). Additionally, RA patients and healthy controls were estimated by HAQ-DI, Beck Anxiety and Beck Depression Inventory, PSQI, and SHI. Logistic regression analysis was used to determine the predictors of sleep quality.Results:Preliminary results of the study were given. The baseline demographics were similar among groups. When comparing groups according to HAQ-DI, Beck Anxiety and Beck Depression Inventory, PSQI, and SHI, we found higher scores in SSc and RA rather than healthy controls (p<0.001, p=0.001, p=0.001, p<0.001, p=0.003; respectively). While depression and sleep hygiene were determined as the risk factors of sleep quality in SSc in univariate analysis, depression (OR=1.380, 95%CI: 1.065−1.784, p=0.015) and sleep hygiene (OR=1.201, 95%CI: 1.003−1.439, p=0.046) were also found in multivariate logistic model. In RA patients, while health status, depression, and anxiety were found as risk factors according to the univariate analysis, depression (OR=1.120, 95%CI: 1.006−1.245, p=0.038) was the only factor according to multivariate logistic model (Table).Conclusion:Although depression is a well-known clinical variable impacting on sleep quality, sleep hygiene should also be kept in mind as a confounding factor.References:[1]Milette K, Hudson M, Körner A, et al. Sleep disturbances in systemic sclerosis: evidence for the role of gastrointestinal symptoms, pain and pruritus. Rheumatology (Oxford). 2013 Sep;52(9):1715-20.[2]Sariyildiz MA, Batmaz I, Budulgan M, et al. Sleep quality in patients with systemic sclerosis: relationship between the clinical variables, depressive symptoms, functional status, and the quality of life. Rheumatol Int. 2013 Aug;33(8):1973-9.TableUnivariate logistic regression analysis of clinical variables to assess predictors of sleep qualitySystemic sclerosisRheumatoid arthritisOR (95% CI)pOR (95% CI)pHAQ-DI1.019 (0.882−1.177)0.8011.089 (1.011−1.173)0.025BDI score1.293 (1.082−1.547)0.0051.129 (1.036−1.230)0.006BAI score1.080 (0.997−1.169)0.0591.122 (1.038−1.214)0.004SHI1.200 (1.060−1.357)0.0041.048 (0.965−1.137)0.264Disease activitya0.707 (0.439−1.138)0.1531.446 (0.839−2.492)0.185aDisease activity was calculated by Valentini disease activity index for SSc and DAS28-CRP for RA.Disclosure of Interests:None declared

scholarly journals Safety and efficacy of faecal microbiota transplantation by Anaerobic Cultivated Human Intestinal Microbiome (ACHIM) in patients with systemic sclerosis: study protocol for the randomised controlled phase II ReSScue trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048541
Author(s):  
Anna-Maria Hoffmann-Vold ◽  
Håvard H Fretheim ◽  
Vikas K Sarna ◽  
Imon Barua ◽  
Maylen N Carstens ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Pilot Study ◽  
Phase Ii ◽  
Intestinal Microbiome ◽  
Induction Phase ◽  
Inflammatory Disorder ◽  
Faecal Microbiota ◽  
Safety And Efficacy ◽  
Faecal Microbiota Transplantation ◽  
Patient Reported

IntroductionIn the multisystem inflammatory disorder systemic sclerosis (SSc), gastrointestinal tract (GIT) affliction is highly prevalent. There are no known disease modifying therapies and the negative impact is substantial. Aiming for a new therapeutic principle, and inspired by recent work showing associations between gut microbiota changes and GIT symptoms in SSc, we performed a pilot study on faecal microbiota transplantation (FMT) with the single-donor bacterial culture ‘Anaerobic Cultivated Human Intestinal Microbiome (ACHIM)’. Motivated by positive pilot study signals, we designed the ReSScue trial as a phase II multicentre, placebo-controlled, randomised 20-week trial to evaluate safety and efficacy on lower GIT symptoms of FMT by ACHIM in SSc.Methods and analysesWe aim to include 70 SSc participants with moderate to severe lower GIT symptoms, defined by the validated patient-reported University of California Los Angeles Scleroderma Clinical Trial Consortium GIT 2.0 2.0 questionnaire. The trial includes three parts. In part A1 (induction phase) lasting from week 0 to week 12, participants will be randomised 1:1 to repeat infusions of 30 mL ACHIM or placebo at week 0 and 2 by gastroduodenoscopy. In part A2, which is an 8-week subsequent maintenance phase, all study participants will receive 30 mL ACHIM at week 12 and followed until week 20 on continued blind. In part B, which will last until the last participant completes part A2, the participants will be followed through a maximum 16-week extended monitoring period, for longer-term data on safety and intervention effects. Primary endpoint is change from baseline to week 12 in UCLA GIT subscale scores of diarrhoea or bloating, depending on the worst symptom at baseline evaluated separately for each patient. Secondary endpoints are safety measures and changes in UCLA GIT scores (total, diarrhoea and bloating).Ethics and disseminationThis protocol was approved by the Northern Norwegian Committee for Medical Ethics. Study findings will be published.Trial registration numberNCT04300426; Pre-results.Protocol versionV.3.1.

Sign in / Sign up

Export Citation Format

Share Document