Behavioral Graded Activity+ (BGA+) for Osteoarthritis: A Paradigm Shift from Disease-Based Treatment to Personalized Activity Self-Management

Three promising directions for improving care for osteoarthritis (OA) include novel education strategies to target unhelpful illness and treatment beliefs; methods to enhance the efficacy of exercise interventions; and innovative, brain-directed treatments. Here we explain that each of those three promising directions can be combined through a paradigm-shift from disease-based treatments to personalized activity self-management for patients with OA. Behavioral graded activity (BGA) accounts for the current understanding of OA and OA pain and allows a paradigm shift from a disease-based treatment to personalized activity self-management for patients with OA. To account for the implementation barriers of BGA, we propose adding pain neuroscience education to BGA (referred to as BGA+). Rather than focusing on the biomedical (and biomechanical) disease characteristics of OA, pain neuroscience education implies teaching people about the underlying biopsychosocial mechanisms of pain. To account for the lack of studies showing that BGA is “safe” with respect to disease activity and the inflammatory nature of OA patients, a trial exploring the effects of BGA+ on the markers of inflammation is needed. Such a trial could clear the path for the required paradigm shift in the management of OA (pain) and would allow workforce capacity building that de-emphasizes biomedical management for OA.

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POS0369 ELEVATED EXPRESSION OF TIM-3 ON NEUTROPHILS CORRELATES WITH DISEASE ACTIVITY AND SEVERITY OF ANKYLOSING SPONDYLITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.3516 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 414.2-415

Author(s):

X. Huang ◽

T. W. Li ◽

J. Chen ◽

Z. Huang ◽

S. Chen ◽

...

Keyword(s):

Flow Cytometry ◽

Ankylosing Spondylitis ◽

Disease Activity ◽

Immune Cells ◽

Clinical Manifestations ◽

Innate Immune ◽

Innate Immune Cells ◽

Bacterial Killing ◽

Markers Of Inflammation ◽

Significant Difference

Background:Ankylosing spondylitis (AS) is a type of common, chronic inflammatory disease that compromises the axial skeleton and sacroiliac joints, causing inflammatory low back pain and progressive spinal stiffness, over time some patients develop spinal immobility and ankylosis which can lead to a decrease in quality of life. The last few decades, evidence has clearly indicated that neutrophil also plays key roles in the progression of AS. However, the immunomodulatory roles and mechanisms of neutrophils in AS are poorly understood. T-cell immunoglobulin and mucin domain-containing protein 3 (Tim-3) has been reported as an important regulatory molecule, expressed and regulated on different innate immune cells, plays a pivotal role in several autoimmunity diseases. Recent study indicates that Tim3 is also expressed on neutrophils. However, the frequency and roles of Tim3-expressing neutrophils in AS was not clear.Objectives:In this study, we investigated the expression of Tim3 on neutrophils in AS patients and explored the correlation between the level of Tim3-expressing neutrophils and the disease activity and severity of AS.Methods:Patients with AS were recruited from Guangdong Second Provincial General Hospital (n=62). Age/sex-matched volunteers as Healthy controls (HC) (n=39). The medical history, clinical manifestations, physical examination, laboratory measurements were recorded. The expression of costimulatory molecules including programmed death 1 (PD-1), Tim-3 on neutrophils were determined by flow cytometry. The mRNA expression of PD-1 and Tim-3 was determined by real-time PCR. The levels of Tim3-expressing neutrophils in AS patients were further analyzed for their correlation with the markers of inflammation such as ESR,CRP,WBC and neutrophil count(NE), as well as disease activity and severity of AS. The expression of Tim3 on neutrophils was monitored during the course of treatment (4 weeks).Results:The expression of Tim3 on neutrophils in patients with AS was increased compared to the HC (Figure 1A). However, significant difference was observed in the frequency of PD-1-expressing neutrophils between AS patients and HC (Figure 1B). The expression analysis of Tim-3 mRNA, but not PD-1, confirmed the results obtained from flow cytometry (Figure 1C). The level of Tim3-expressing neutrophils in patients with AS showed an positive correlation with ESR, CRP and ASAS-endorsed disease activity score (ASDAS) (Figure 1D). Moreover, the frequency of Tim3-expressing neutrophils in active patients(ASDAS≥1.3) was increased as compare with the inactive patients (ASDAS<1.3) (Figure 1E). As shown in Figure 1F, the frequency of Tim3-expressing neutrophils decreased after the treatment.Conclusion:Increased Tim-3 expression on neutrophils may be a novel indicator to assess disease activity and severity in AS, which may serves as a negative feedback mechanism preventing potential tissue damage caused by excessive inflammatory responses in AS patients.References:[1]Han, G., Chen, G., Shen, B. & Li, Y., Tim-3: an activation marker and activation limiter of innate immune cells. FRONT IMMUNOL 4 449 (2013).[2]Vega-Carrascal, I. et al., Galectin-9 signaling through TIM-3 is involved in neutrophil-mediated Gram-negative bacterial killing: an effect abrogated within the cystic fibrosis lung. J IMMUNOL 192 2418 (2014).Figure 1.(A,B)The expression of Tim3 and PD-1 on neutrophils in AS and HC were determined by flow cytometry.(C) The expression of Tim3 and PD-1 on neutrophils in AS and HC were determined by RT-PCR.(D)The correction between Tim3-expressing neutrophils and ESR,CRP,ASDAS.(E) The expression of Tim3 on neutrophils in active and inactive patients.(F) Influence of treatment on the frequency of Tim3-expressing neutrophils.Disclosure of Interests:None declared

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SAT0432 EFFECT OF SEX ON DISEASE CHARACTERISTICS AND DISEASE IMPACT IN PATIENTS WITH PSORIATIC ARTHRITIS (PsA): INSIGHTS FROM THE REAL-WORLD, OBSERVATIONAL MULTINATIONAL PsABio COHORT

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2771 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1171.1-1173

Author(s):

M. T. Nurmohamed ◽

I. Van der Horst-Bruinsma ◽

A. W. Van Kuijk ◽

S. Siebert ◽

P. Bergmans ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Physical Functioning ◽

Real World ◽

Comprehensive Treatment ◽

Diagnosis Delay ◽

Health State ◽

Research Support ◽

Disease Characteristics ◽

Disease Impact

Background:Female sex has been associated with more severe disease and poorer treatment outcomes in PsA. These observations are often based on small populations or national cohorts/registries.Objectives:To investigate the effects of sex on disease characteristics and disease impact in PsA, using data of 929 consecutive patients (pts) from PsABio.Methods:PsABio is a real-world, non-interventional European study in PsA pts treated with UST or TNFi based on their rheumatologist’s choice. Observed male and female baseline (BL) data were described and compared using 95% CI.Results:Women in PsABio (n=512 [55%]) were numerically older than men (mean [SD]: 50.5 [12.7] / 48.7 [12.3] years, respectively). Women were more obese (BMI >30), % (95% CI): F: 35 (30, 39), M: 24 (20, 29), men more overweight (BMI >25–30): F: 31 (27, 36), M:51 (46, 57). Age at diagnosis, delay from first symptom to diagnosis, and disease duration were similar for both sexes.Women entered PsABio more often on 3rd line treatment, whereas men started on 1st-line biologic treatment more often (F/M 1st line 47%/55%; 2nd line 34%/33%; 3rd line 20%/12%). Numerically, concomitant MTX was given more often to women vs men (32% vs 27%). At BL, 60% of women and 64% of men were on NSAIDs; 7.9% and 2.5% on antidepressant drugs. Women had significantly more comorbidities, with numerically more cardiovascular disease and anxiety/depression, and 3 times more IBD.Women had significantly higher 68 tender joint counts (TJC): 13.0 vs 10.4, while 66 swollen joint counts were not significantly different: 5.8 vs 5.5. Axial or combined axial-peripheral disease was similarly frequent, in 29% of women and 26% of men (Figs. 1, 2).Clinical Disease Activity index for PSoriatic Arthritis (cDAPSA) was higher in women (31.8 vs 27.3); pt-reported levels of pain, global disease activity (VAS scales) and higher TJC contributed to this. While enthesitis prevalence (based on Leeds Enthesitis Index) was comparable, men had significantly more frequent dactylitis, nail disease and worse skin psoriasis. At BL, 3.4% of women vs 7.1% of men, were in MDA.Regarding physical functioning (HAQ-DI), impact of disease (PSAID-12) and quality of life (EQ5D-3L health state), women with PsA starting a biologic (b)DMARD, expressed significantly greater negative impact and more limitations due to their disease (Fig. 2).Conclusion:In routine care, women with PsA starting a bDMARD presented with worse outcomes over a range of assessments compared with men (higher pt-reported pain and disease activity, TJC, and worse physical functioning and QoL), while men had worse dactylitis and psoriasis. Follow-up analysis will report whether the effects of biologic therapy are different in both sexes. The increased prevalence of associated features related to pain and impact on functioning and QoL may indicate the need for a more comprehensive treatment approach for women to avoid unnecessary and premature bDMARD stop or switch.Acknowledgments:This study was funded by Janssen.Disclosure of Interests:Michael T Nurmohamed Grant/research support from: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Consultant of: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Irene van der Horst-Bruinsma Grant/research support from: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Consultant of: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Arno WR van Kuijk Grant/research support from: Janssen, Stefan Siebert Grant/research support from: BMS, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Elisa Gremese Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Wim Noel Employee of: Janssen Pharmaceuticals NV, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Elke Theander Employee of: Janssen-Cilag Sweden AB, Josef S. Smolen Grant/research support from: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Consultant of: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB

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Gender differences in patient journey to diagnosis and disease outcomes: results from the European Map of Axial Spondyloarthritis (EMAS)

Clinical Rheumatology ◽

10.1007/s10067-020-05558-7 ◽

2021 ◽

Author(s):

Marco Garrido-Cumbrera ◽

◽

Denis Poddubnyy ◽

Laure Gossec ◽

Raj Mahapatra ◽

...

Keyword(s):

Gender Differences ◽

Psychological Distress ◽

Disease Activity ◽

Healthcare Professionals ◽

Unmet Needs ◽

Axial Spondyloarthritis ◽

Diagnostic Delay ◽

Hla B27 ◽

Patient Journey ◽

Disease Characteristics

Abstract Introduction/objectives To evaluate the journey to diagnosis, disease characteristics and burden of disease in male and female patients with axial spondyloarthritis (axSpA) across Europe. Method Data from 2846 unselected patients participating in the European Map of Axial Spondyloarthritis (EMAS) study through an online survey (2017–2018) across 13 countries were analysed. Sociodemographic characteristics, lifestyle, diagnosis, disease characteristics and patient-reported outcomes (PROs) [disease activity –BASDAI (0–10), spinal stiffness (3–12), functional limitations (0–54) and psychological distress (GHQ-12)] were compared between males and females using chi-square (for categorical variables) and student t (for continuous variables) tests. Results In total, 1100 (38.7%) males and 1746 (61.3%) females participated in the EMAS. Compared with males, females reported considerable longer diagnostic delay (6.1 ± 7.4 vs 8.2 ± 8.9 years; p < 0.001), higher number of visits to physiotherapists (34.5% vs 49.5%; p < 0.001) and to osteopaths (13.3% vs 24.4%; p < 0.001) before being diagnosed and lower frequency of HLA-B27 carriership (80.2% vs 66.7%; p < 0.001). In addition, females reported higher degree of disease activity in all BASDAI aspects and greater psychological distress through GHQ-12 (4.4 ± 4.2 vs 5.3 ± 4.1; p < 0.001), as well as a greater use of alternative therapies. Conclusion The patient journey to diagnosis of axSpA is much longer and arduous in females, which may be related to physician bias and lower frequency of HLA-B27 carriership. Regarding PROs, females experience higher disease activity and poorer psychological health compared with males. These results reflect specific unmet needs in females with axSpA needing particular attention. Key Points• Healthcare professionals’ perception of axSpA as a predominantly male disease may introduce some bias during the diagnosis and management of the disease. However, evidence about male-female differences in axSpA is scarce.• EMAS results highlight how female axSpA patients report longer diagnostic delay and higher burden of the disease in a large sample of 2846 participants of 13 European countries.• Results reflect unmet needs of European female patients. Healthcare professionals should pay close attention in order to accurately diagnose and efficiently manage axSpA cases while further research should be developed on the cause of reported gender differences.

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AB0304 IMMUNOGENICITY OF BIOLOGIC DRUGS IN THE CLINICAL PRACTICE IN THE BULGARIAN POPULATION OF PATIENTS SUFFERING FROM RHEUMATOID ARTHRITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.923 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1451.3-1451

Author(s):

K. Kraev ◽

M. Geneva-Popova ◽

S. Popova

Keyword(s):

Rheumatoid Arthritis ◽

Clinical Practice ◽

Disease Activity ◽

Clinical Response ◽

Neutralizing Antibodies ◽

Tnf Alpha ◽

Drug Bioavailability ◽

Drug Induced ◽

Etanercept Treatment ◽

Markers Of Inflammation

Background:Biological drugs are protein derivatives that, as such, are highly immunogenic. In recent years there have been many conflicting opinions about the role of drug immunogenicity in clinical practice.Objectives:To evaluate the drug immunogenicity of TNF-alpha blocking drugs (etanercept and adalimumab) used to treat patients with rheumatoid arthritis. To determine whether their presence can alter the effect of treatment and to evaluate their role in the clinical practice of rheumatologists.Methods:121 patients with rheumatoid arthritis, as well as 31 healthy controls, similar in sex and age, were examined. They were all monitored at 0, 6, 12 and 24 months from the start of TNF-alpha blocker treatment. Demographics, vital signs, markers of inflammation such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and disease activity indices were examined at each visit, respectively. Drug-induced neutralizing antibodies, as well as drug bioavailability in patients treated with adalimumab, were examined by ELISA.Results:Drug-induced neutralizing antibodies to adalimumab were detected in 11.57% of patients at 6 month, in 17.64% of patients at 12 month, and 24.8% at 24 month. Drug-induced neutralizing antibodies to etanercept were not detected at 6 months, at 7.77% at 12 months, at 9.63% of patients at 24 months. Of the adalimumab patients who were having drug-induced antibodies, 92.59% had low drug bioavailability, while the remaining 7.41% of patients showed normal drug bioavailability despite the presence of drug-induced neutralizing antibodies. In terms of worsening of the disease activity, a positive correlation was found with the presence of drug antibodies - Pearson Correlation = 0.701, p = 0.001. Patients with poor clinical response and available drug antibodies receiving adalimumab were slightly more than those treated with etanercept at 12 and 24 months but the difference is non-significant-U = 0.527, p> 0.05 and U = 0.623, p> 0.05, respectively.Conclusion:Presence of drug-induced neutralizing antibodies in patients treated with adalimumab and etanercept has been associated with poor clinical response and worsening of the patient’s condition. Testing of drug-induced neutralizing antibodies as well as the drug bioavailability of the drug used can be used as reliable biomarkers in clinical rheumatology.References:[1]Benucci M., F.Li Gobbi, M. Meacii et al., “Antidrug antibodies against TNF-blocking agents: correlations between disese activity, hypersensitivity reactions, and different classes of immunoglobulins”, Biologics and Targets and Therapy, 2015: 9 7 -2.[2]Chen D., Y. Chen, W. Tsai et al., “ Significant associations of antidrug antibody levels with serum drug trough levels and therapeutic response of adalimumab and etanercept treatment in rheumatoid arthritis”, Ann Rheum Dis. 2015 Mar; 74 (3).[3]Kalden J. and H. Schulze-Koops, “ Immunogenicity and loss of response to TNF inhibitors: implications for rheumatoid arthritis treatment ”, Nature Reviews Rheumatology, 2017 volume 13, 707–718.[4]Wolf-Henning Boehnck, N. Brembilla, “ Immunogenicity of biological therapies: causes and consequences, ” Expert Review of Clinical Immunology, Vol 14, 2018, Issue 6, 513-523Disclosure of Interests:None declared

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SAT0039 ADAPTIVE DEEP LEARNING FOR THE PREDICTION OF INDIVIDUAL DISEASE ACTIVITY IN PATIENTS WITH RHEUMATOID ARTHRITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2712 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 950.1-950

Author(s):

M. Hügle ◽

G. Kalweit ◽

U. Walker ◽

A. Finckh ◽

R. Muller ◽

...

Keyword(s):

Neural Network ◽

Rheumatoid Arthritis ◽

Disease Activity ◽

Deep Neural Networks ◽

Disease Duration ◽

Research Support ◽

Disease Characteristics ◽

Individual Disease ◽

Active Disease ◽

Research Grant

Background:Rheumatoid arthritis (RA) lacks reliable biomarkers that predict disease evolution on an individual basis, potentially leading to over- and undertreatment. Deep neural networks learn from former experiences on a large scale and can be used to predict future events as a potential tool for personalized clinical assistance.Objectives:To investigate deep learning for the prediction of individual disease activity in RA.Methods:Demographic and disease characteristics from over 9500 patients with 65.000 visits from the Swiss Quality Management (SCQM) database were used to train and evaluate an adaptive recurrent neural network (AdaptiveNet). Patient and disease characteristics along with clinical and patient reported outcomes, laboratory values and medication were used as input features. DAS28-BSR was used to predict active disease and future numeric individual disease activity by classification and regression, respectively.Results:AdaptiveNet predicted active disease defined as DAS28-BSR>2.6 at the next visit, with an overall accuracy of 75.6% and a sensitivity and specificity of 84.2% and 61.5%, respectively. Apart from DAS28-BSR, the most influential characteristics to predict disease activity were joint pain, disease duration, age and medication. Longer disease duration, age >50 or antibody positivity marginally improved prediction performance. Regression allowed forecasting individual DAS28-BSR values with a mean squared error of 0.9.Conclusion:Deep neural networks have the capacity to predict individual disease outcome in RA. Low specificity remains challenging and might benefit from alternative input data or outcome targets.References:[1] Hügle M, Kalweit G, Hügle T, Boedecker J. A Dynamic Deep Neural Network For Multimodal Clinical Data Analysis. Be Publ Stud Comput Intell Springer Verl. 2020.Figure 1.Examples of true disease activity and corresponding predictions of AdaptiveNet by regression analysis. Predictions are made step to step from the current to next visit.Disclosure of Interests:Maria Hügle Paid instructor for: Lilly, Gabriel Kalweit: None declared, Ulrich Walker Grant/research support from: Ulrich Walker has received an unrestricted research grant from Abbvie, Consultant of: Ulrich Walker has act as a consultant for Abbvie, Actelion, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, MSD, Novartis, Pfizer, Phadia, Roche, Sandoz, Sanofi, and ThermoFisher, Paid instructor for: Abbvie, Novartis, and Roche, Speakers bureau: Abbvie, Actelion, Bristol-Myers Squibb, Celgene, MSD, Novartis, Pfizer, Phadia, Roche, Sandoz, and ThermoFisher, Axel Finckh Grant/research support from: Pfizer: Unrestricted research grant, Eli-Lilly: Unrestricted research grant, Consultant of: Sanofi, AB2BIO, Abbvie, Pfizer, MSD, Speakers bureau: Sanofi, Pfizer, Roche, Thermo Fisher Scientific, Rudiger Muller Consultant of: AbbVie, Nordic, Sandoz, Almut Scherer: None declared, Joschka Boedecker: None declared, Thomas Hügle Grant/research support from: Abbvie, Novartis, Consultant of: Abbvie, Pfizer, Novartis, Roche, Lilly, BMS

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A systematic review of behavioural and exercise interventions for the prevention and management of chemotherapy-induced peripheral neuropathy symptoms

Journal of Cancer Survivorship ◽

10.1007/s11764-021-00997-w ◽

2021 ◽

Author(s):

Mary Anne Lagmay Tanay ◽

Jo Armes ◽

Rona Moss-Morris ◽

Anne Marie Rafferty ◽

Glenn Robert

Keyword(s):

Peripheral Neuropathy ◽

Health Management ◽

Experimental Studies ◽

Self Management ◽

Cochrane Library ◽

Pharmacological Interventions ◽

Behavioural Interventions ◽

Exercise Interventions ◽

Beneficial Effects ◽

Recommended Treatment

Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) can result in functional difficulties. Pharmacological interventions used to prevent CIPN either show low efficacy or lack evidence to support their use and to date, duloxetine remains the only recommended treatment for painful CIPN. Non-pharmacological interventions such as exercise and behavioural interventions for CIPN exist. Purpose The aims were to (1) identify and appraise evidence on existing behavioural and exercise interventions focussed on preventing or managing CIPN symptoms, (2) describe psychological mechanisms of action by which interventions influenced CIPN symptoms, (3) determine the underpinning conceptual models that describe how an intervention may create behaviour change, (4) identify treatment components of each intervention and contextual factors, (5) determine the nature and extent of patient and clinician involvement in developing existing interventions and (6) summarise the relative efficacy or effectiveness of interventions to lessen CIPN symptoms and to improve quality of life, balance and muscle strength. Methods A systematic search of Ovid Medline, Cochrane Library, EMBASE, PsycINFO, Health Management Information Consortium, Global Health and CINAHL was performed to identify articles published between January 2000 to May 2020, followed by OpenGrey search and hand-searching of relevant journals. Studies that explored behavioural and/or exercise interventions designed to prevent or improve symptoms of CIPN in adults who had received or were receiving neurotoxic chemotherapy for any type of cancer, irrespective of when delivered within the cancer pathway were included. Results Nineteen randomised controlled trials and quasi-experimental studies which explored behavioural (n=6) and exercise (n=13) interventions were included. Four studies were rated as methodologically strong, ten were moderate and five were weak. Ten exercise and two behavioural interventions, including those that improved CIPN knowledge and self-management resources and facilitated symptom self-reporting, led to reduced CIPN symptoms during and/or after chemotherapy treatment. Conclusions The extent of potential benefits from the interventions was difficult to judge, due to study limitations. Future interventions should incorporate a clear theoretical framework and involve patients and clinicians in the development process. Implications for Cancer Survivors Our findings show exercise interventions have beneficial effects on CIPN symptoms although higher quality research is warranted. Behavioural interventions that increase patient’s CIPN knowledge, improve self-management capacity and enable timely access to symptom management led to reduced CIPN symptoms.

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Riboflavin Supplementation in Patients with Crohn’s Disease [the RISE-UP study]

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz208 ◽

2019 ◽

Vol 14 (5) ◽

pp. 595-607 ◽

Cited By ~ 3

Author(s):

Julius Z H von Martels ◽

Arno R Bourgonje ◽

Marjolein A Y Klaassen ◽

Hassan A A Alkhalifah ◽

Mehdi Sadaghian Sadabad ◽

...

Keyword(s):

Oxidative Stress ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Disease Activity ◽

Clinical Symptoms ◽

Fish Analysis ◽

Markers Of Inflammation ◽

Anti Inflammatory ◽

Faecal Microbiome ◽

Chronic Intestinal Inflammation

Abstract Background and Aims Crohn’s disease [CD] is characterised by chronic intestinal inflammation and dysbiosis in the gut. Riboflavin [vitamin B2] has anti-inflammatory, antioxidant and microbiome-modulatory properties. Here, we analysed the effect of riboflavin on oxidative stress, markers of inflammation, clinical symptoms, and faecal microbiome in patients with CD. Methods In this prospective clinical intervention study, patients received 100 mg riboflavin [DSM, Nutritional Products Ltd] daily for 3 weeks. Clinical disease activity [Harvey-Bradshaw Index: HBI], serum biomarkers of inflammation and redox status [plasma free thiols], and faecal microbiome taxonomical composition and functionality [fluorescent in situ hybridisation: FISH; and metagenomic shotgun sequencing: MGS], were analysed before and after riboflavin intervention. Results In total, 70 patients with CD with varying disease activity were included. Riboflavin supplementation significantly decreased serum levels of inflammatory markers. In patients with low faecal calprotectin [FC] levels, IL-2 decreased, and in patients with high FC levels, C-reactive protein [CRP] was reduced and free thiols significantly increased after supplementation. Moreover, HBI was significantly decreased by riboflavin supplementation. Riboflavin supplementation led to decreased Enterobacteriaceae in patients with low FC levels as determined by FISH; however, MGS analysis showed no effects on diversity, taxonomy, or metabolic pathways of the faecal microbiome. Conclusions Three weeks of riboflavin supplementation resulted in a reduction in systemic oxidative stress, mixed anti-inflammatory effects, and a reduction in clinical symptoms [HBI]. FISH analysis showed decreased Enterobacteriaceae in patients with CD with low FC levels, though this was not observed in MGS analysis. Our data demonstrate that riboflavin supplementation has a number of anti-inflammatory and anti-oxidant effects in CD.

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Effectiveness of an online self-management tool, OPERAS (an On-demand Program to EmpoweR Active Self-management), for people with rheumatoid arthritis: a research protocol

10.21203/rs.2.11788/v2 ◽

2019 ◽

Author(s):

Johnathan Tam ◽

Diane Lacaille ◽

Teresa Liu-Ambrose ◽

Chris D Shaw ◽

Hui Xie ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Physical Activity ◽

Disease Activity ◽

Disease Status ◽

Management Tool ◽

Self Management ◽

Secondary Outcome ◽

On Demand ◽

Management Ability ◽

Web App

Abstract Background. Active self-management is a process where patients are fully engaged in managing their health in daily life by having access to contextualized health data and tailored guidance to support a healthy lifestyle. The current study aims to determine whether an e-health intervention which incorporates symptom/disease activity monitoring and physical activity counselling can improve self-management ability in patients with rheumatoid arthritis (RA). Methods. The Empowering active self-management of arthritis: Raising the bar with OPERAS (an On-demand Program to EmpoweR Active Self-management) project is a randomized controlled trial which uses a delayed control design. 134 participants with RA will be randomized to either start the intervention immediately (Immediate Group) or start 6 months later (Delayed Group). The intervention involves: 1) use of a Fitbit-compatible web app to record and monitor their RA disease activity, symptoms and time spent on physical activity and a Fitbit; 2) group education and individual counselling by a physiotherapist (PT), and 3) 6 phone calls with a PT. The primary outcome measure is self-management ability measured by the Patient Activation Measure. Secondary outcome measures include disease status, fatigue, pain, depressive symptoms, and characteristics of habitual behavior. In addition, time spent in physical activity and sedentary activity with a wearable multi-sensor device (SenseWear Mini). Following the 6-month intervention, we will interview a sample of participants to examine their experiences with the intervention. Discussion. The results of this study will help to determine whether this technology-enhanced self-management intervention improves self-management ability and their health outcomes for people living with RA. A limitation of this study is that participants will need to self-report their symptoms, disease status, and treatment use through questionnaires on the OPERAS web app. The user-friendly interface, reminder emails from the research staff, and tailored guidance from PTs will encourage participants to actively engage with the app. Trial Registration. Date of last update in ClinicalTrials.gov: January 2, 2019 ClinicalTrials.gov Identifier: NCT03404245

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Evolution of patient characteristics in the era of biological treatment of psoriatic arthritis: 18-year Belgian experience from the Leuven Spondyloarthritis Biologics Cohort (BioSPAR)

Rheumatology Advances in Practice ◽

10.1093/rap/rkab085 ◽

2021 ◽

Author(s):

Alla Ishchenko ◽

Johan Joly ◽

Neerinckx Barbara ◽

Rik Lories ◽

Kurt de Vlam

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Prospective Cohort ◽

Biological Treatment ◽

Structural Damage ◽

Clinical Manifestations ◽

Tender Joint Count ◽

Tnf Inhibitor ◽

Disease Characteristics ◽

Over Time

Abstract Objectives Biological treatments revolutionized the management of psoriatic arthritis (PsA) by significantly improving clinical manifestations and preventing structural damage. Both result in better quality of life and improved physical functioning. Since the introduction of the first TNF inhibitor (TNFi) in the early 2000s, therapeutic options for PsA are increasing steadily and a new generation of biologicals, including anti interleukin (IL)-17 and anti IL23 strategies, allows distinct targeted approaches. The purpose of this study was to investigate whether the demographic, clinical and disease characteristics of PsA patients that are selected for first-line biological treatment, changed over time since the introduction of biologicals. Methods Patients with a clinical diagnosis of PsA were included in the KU Leuven BioSPAR registry, a prospective cohort of spondyloarthritis (SpA) and PsA patients treated with biologicals and targeted synthetic disease modifying anti-rheumatic drugs (tsDMARDs) such as apremilast and JAK inhibitors. Demographics, prior DMARD use, disease characteristics and disease activity parameters were recorded at the initiation of biological treatment and subsequently every 3-months for the first 2 years and later every 6 months. The patient data were compared in three treatment periods, corresponding with availability of the first and the second generation of TNF inhibitors and the third generation of biologicals. Results Analysis of 185 Caucasian patients with PsA from our prospective cohort showed longer disease duration and higher disease activity with higher tender joint count (TJC), swollen joint count (SJC) and higher CRP in the first as compared with the later time periods. The demographic characteristics and prior DMARD use did not change over time. Skin and nail psoriasis were more frequent in earlier compared with the later treatment periods. The bio-DMARD survival rate was similar in the early and later treatment periods. Conclusion The population of patients, selected for treatment escalation, changed over time since the introduction of biologicals. Our results suggest that with years of experience, PsA patients might be considered earlier and for therapy intensification in patients with less active disease as compared with profiles in the early days of biological treatment.

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Feasibility and Domain Validation of Rheumatoid Arthritis (RA) Flare Core Domain Set: Report of the OMERACT 2014 RA Flare Group Plenary

The Journal of Rheumatology ◽

10.3899/jrheum.141169 ◽

2015 ◽

Vol 42 (11) ◽

pp. 2185-2189 ◽

Cited By ~ 32

Author(s):

Susan J. Bartlett ◽

Vivian P. Bykerk ◽

Roxanne Cooksey ◽

Ernest H. Choy ◽

Rieke Alten ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Clinical Care ◽

Joint Disease ◽

Self Management ◽

International Studies ◽

Core Domain ◽

Ongoing Work ◽

Activity Measures ◽

Core Domain Set

Objective.The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Flare Group was established to develop an approach to identify and measure RA flares. An overview of our OMERACT 2014 plenary is provided.Methods.Feasibility and validity of flare domains endorsed at OMERACT 11 (2012) were described based on initial data from 3 international studies collected using a common set of questions specific to RA flare. Mean flare frequency, severity, and duration data were presented, and domain scores were compared by flare status to examine known-groups validity. Breakout groups provided input for stiffness, self-management, contextual factors, and measurement considerations.Results.Flare data from 501 patients in an observational study indicated 39% were in flare, with mean (SD) severity of 6.0 (2.6) and 55% lasting > 14 days. Pain, physical function, fatigue, participation, and stiffness scores averaged ≥ 2 times higher (2 of 11 points) in flaring individuals. Correlations between flare domains and corresponding legacy instruments were obtained: r = 0.46 to 0.93. A combined definition (patient report of flare and 28-joint Disease Activity Score increase) was evaluated in 2 other trials, with similar results. Breakout groups debated specific measurement issues.Conclusion.These data contribute initial evidence of feasibility and content validation of the OMERACT RA Flare Core Domain Set. Our research agenda for OMERACT 2016 includes establishing duration/intensity criteria and developing criteria to identify RA flares using existing disease activity measures. Ongoing work will also address discordance between patient and physician ratings, facilitate application of flare criteria to clinical care, elucidate the role of self-management, and finalize recommendations for RA flare measurement.

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