scholarly journals Central sensitization, illness perception and obesity should be considered when interpreting disease activity in axial spondyloarthritis

Rheumatology ◽  
2021 ◽  
Author(s):  
Stan C Kieskamp ◽  
Davy Paap ◽  
Marlies J G Carbo ◽  
Freke Wink ◽  
Reinhard Bos ◽  
...  
Keyword(s):  
Disease Activity ◽  
Central Sensitization ◽  
Illness Perceptions ◽  
Axial Spondyloarthritis ◽  
Pain Catastrophizing ◽  
Illness Perception ◽  
Patient Characteristics ◽  
Symptom Duration ◽  
Patient Reported ◽  
R Domain

Abstract Objectives Many patients with axial spondyloarthritis (axSpA) report persistent pain even when treated with anti-inflammatory agents. Our aim was to explore the presence of central sensitization (CS) and different types of illness perceptions in patients with axSpA, and to assess their associations with disease activity assessments. Methods Consecutive outpatients from the Groningen Leeuwarden Axial Spondyloarthritis (GLAS) cohort were included. Besides standardized assessments, patients filled out the Central Sensitization Inventory (CSI), Illness Perception Questionnaire (IPQ-R) and Pain Catastrophizing Scale (PCS). Univariable and multivariable linear regression analyses were used to investigate the association between questionnaire scores, patient characteristics and disease activity assessments ASDASCRP, BASDAI and CRP. Results We included 182 patients with a mean symptom duration of 21.6 years. Mean ASDASCRP was 2.1, mean BASDAI 3.9, and median CRP 2.9. Mean CSI score was 37.8 (scale 0–100) and 45% of patients scored ≥40, indicating a high probability of CS. CSI score, IPQ-R domain identity (number of symptoms the patient attributes to their illness), and IPQ-R domain treatment control (perceived treatment efficacy), and obesity were significantly and independently associated with both ASDASCRP and BASDAI, explaining a substantial proportion of variation in these disease activity scores (R2=0.35 and R2=0.47, respectively). Only obesity was also independently associated with CRP. Conclusion CS may be common in patients with long-term axSpA. CS, as well as specific illness perceptions and obesity were all independently associated with the widely used (partially) patient-reported disease activity assessments ASDASCRP and BASDAI. Treating physicians should take this into account in the follow-up and treatment of their patients.

scholarly journals OP0080 CENTRAL SENSITIZATION AND ILLNESS PERCEPTIONS SHOULD BE TAKEN INTO ACCOUNT WHEN INTERPRETING DISEASE ACTIVITY IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 54.1-54
Author(s):  
S. Kieskamp ◽  
D. Paap ◽  
M. Carbo ◽  
F. Wink ◽  
R. Bos ◽  
...  
Keyword(s):  
Disease Activity ◽  
Central Sensitization ◽  
Illness Perceptions ◽  
Axial Spondyloarthritis ◽  
Pain Catastrophizing ◽  
Symptom Duration ◽  
Treatment Control ◽  
Research Support ◽  
Illness Identity

Background:Up to 40% of ankylosing spondylitis patients report persistently high pain scores of >4 (scale of 0-10) even after responding to long-term TNF-alpha blocking therapy.[1] In other rheumatic diseases, nociplastic pain (due to altered functioning of the nervous system leading to peripheral and central sensitization) is common.[2] In axial spondyloarthritis (axSpA), patient illness and pain perceptions were shown to influence disease outcome.[3] Therefore, we hypothesized that central sensitization and patients’ illness perceptions are associated with persistently high disease activity in axSpA.Objectives:To investigate to what extent central sensitization, pain catastrophizing and patients’ perceptions play a role in axSpA and to explore associations with disease activity.Methods:Between April and September 2019, consecutive outpatients from the Groningen Leeuwarden axSpA (GLAS) cohort,[4] an ongoing large prospective cohort, were included in this study. Besides the standardized assessments, patients filled out three additional questionnaires: Central Sensitization Inventory (CSI), Pain Catastrophizing Scale (PCS) and Revised Illness Perception Questionnaire (IPQ-R). Univariable and multivariable linear regression analyses were used to investigate the association of CSI, PCS and each of the eight subscales of the IPQ-R, and disease activity assessments ASDAS-CRP, BASDAI, and CRP. We corrected for the following potential confounders: gender, symptom duration, BMI, educational level, smoking status and HLA-B27 status.Results:Of 171 included patients, 58% were male, 79% were HLA-B27 positive, median symptom duration was 21 (IQR 10-32), mean ASDAS-CRP 2.1 ± 1.0, mean BASDAI 3.9 ± 2.2 and median CRP 2.9 (IQR 1.2-6.3). Mean CSI score was 37.8 ± 14.1 (scale of 0-100), and 44% of patients scored ≥40 on the CSI.[5] Median PCS score was 15 (IQR 7-22) (scale of 0-52), median IPQ-R illness identity subscore 3 (IQR 2-4) (scale of 0-14) and mean IPQ-R treatment control subscore 18.1 ± 3.4 (scale of 5-25). In univariable regression analysis, CSI and PCS scores and IPQ-R subscores all showed significant associations with ASDAS-CRP, and all except the IPQ-R subscale personal control showed significant associations with BASDAI. Only IPQ-R treatment control was significantly associated with CRP. Central sensitization, two IPQ-R subscales (perceived treatment control and the number of symptoms patients attributed to their axSpA: illness identity) and BMI were independently associated with disease activity assessments BASDAI (R2=0.46) and ASDAS-CRP (R2=0.36) (Figure 1).Conclusion:In this axSpA population with long-term disease, 44% scored above the CSI cutoff point of 40, indicating a high probability of central sensitization. CSI score, illness identity and treatment control were independently associated with disease activity assessments.References:[1]Arends Set al.Clin Exp Rheumatol 2017;35(1):61-8.[2]Meeus Met al.Semin Arthritis Rheum 2012;41(4):556-67.[3]Van Lunteren Met al. Arthritis Care Res (Hoboken) 2018;70(12):1829-39.[4]Arends Set al.Arthritis Res Ther 2011;13(3):R94.[5]Neblett Ret al.J Pain 2013;14(5):438-45.Disclosure of Interests:Stan Kieskamp: None declared, Davy Paap: None declared, Marlies Carbo: None declared, Freke Wink Consultant of: Abbvie, Janssen, Reinhard Bos: None declared, Hendrika Bootsma Grant/research support from: Unrestricted grants from Bristol-Myers Squibb and Roche, Consultant of: Consultant for Bristol-Myers Squibb, Roche, Novartis, Medimmune, Union Chimique Belge, Speakers bureau: Speaker for Bristol-Myers Squibb and Novartis., Suzanne Arends Grant/research support from: Grant/research support from Pfizer, Anneke Spoorenberg: None declared

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 FRI0304 SERUM IGG-UNDERGALACTOSYLATION PROFILES REFLECT CUMULATIVE EXPOSURE TO SYSTEMIC INFLAMMATION IN SPONDYLOARTHRITIS PATIENTS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 742.1-742
Author(s):  
A. S. De Craemer ◽  
Z. Lukasik ◽  
L. Meuris ◽  
L. Deroo ◽  
T. Renson ◽  
...  
Keyword(s):  
Disease Activity ◽  
Systemic Inflammation ◽  
Magnetic Resonance Images ◽  
Cumulative Exposure ◽  
Symptom Duration ◽  
Inflammatory Lesions ◽  
Serum Igg ◽  
Asas Classification Criteria ◽  
Patient Reported ◽  
Independent Association

Background:Inflammation in spondyloarthritis (SpA) is often not reflected by elevated acute phase reactants such as C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR). It has been shown that IgG glycosylation patterns are subject to specific alterations (i.e. undergalactosylation) in chronic inflammatory diseases. Since these changes only occur in persistent inflammatory processes, lasting at least one to two t1/2of IgG (24 days), it was hypothesized that IgG-glycan profiles could serve as a surrogate marker for chronic inflammation in SpA patients.Objectives:To assess the value of serum IgG-undergalactosylation in SpA patients in relation to outcome measures for disease activity, determined by patient reported outcomes, serum inflammatory markers and imaging outcomes.Methods:Serum samples were obtained from SpA patients at the baseline visit of Be-Giant: a Belgian observational cohort including SpA patients who fulfill the ASAS classification criteria for axial or peripheral SpA. IgG Fc N-glycans were released directly in whole serum by endo-β-N-acetyl-glucosaminidase fromStreptococcus pyogenes(EndoS), fluorescently labeled with ATPS and analyzed by capillary electrophoresis, rendering glycan profiles with six peaks (Figure 1). Relative peak heights were combined in the undergalactosylation score (UGS), capturing the relative upregulation of non-galactosylated glycans normalized to the total peak height (1). Baseline radiographs (X-SIJ) and magnetic resonance images (MRI) of the sacroiliac joints (SIJ) were assessed by three calibrated readers for sacroiliitis (fulfillment of the modified New York criteria; grading 0 to 4 per SIJ) and for inflammatory lesions according to the Spondyloarthritis Research Consortium of Canada (SPARCC) method (score from 0 – 72) respectively. Grades and inflammatory lesions that were seen by at least 2 readers were used for further analysis.Figure 1.Example of a serum IgG-specific glycan profile. Adapted from (1), with permission.Results:Glycan profiles were obtained from 376 SpA patients; UGS was scaled (mean = 0, SD = 1) for further analysis. UGS was independently associated with ASDAS-CRP (β1= 0.15, 95% CI 0.04 – 0.26, p = 0.006) and BASFI (β1= 0.44, 95% CI 0.16 – 0.72, p = 0.002) but not with BASDAI (β1= 0.12, 95% CI -0.13 – 0.38, p = 0.34). UGS showed a weak to moderate correlation with CRP (Rs= 0.30, p < 0.001) and ESR (Rs= 0.27, p <0.001). In axial SpA, UGS was significantly higher in patients with ankylosing spondylitis compared to non-radiographic axial SpA (OR = 2.41, 95% CI 1.60 – 3.73, p < 0.001) and showed an independent association with the total grading of the SIJ (β1= 0.44, 95% CI 0.09 – 0.80, p = 0.01, Figure 2) and SPARCC score (β1= 2.64, 95% CI 0.98 – 4.31, p = 0.002). All models were adjusted for age, gender, BMI, CRP, anti-TNF treatment and symptom duration.Conclusion:This study shows and independent association of serum IgG undergalactosylation with disease activity and functional impairment in SpA patients. Moreover, UGS was significantly higher in advanced compared to early-stage axial disease and therefore may reflect the cumulative exposure to systemic inflammation.References:[1]Vanderschaeghe D, Meuris L, Raes T, et al. Endoglycosidase S Enables a Highly Simplified Clinical Chemistry Procedure for Direct Assessment of Serum IgG Undergalactosylation in Chronic Inflammatory Disease. Mol Cell Proteomics. 2018;17(12):2508-17.Figure 2.Correlation between UGS and X-SIJ total grading of sacroiliitis. R = Spearman’s correlation coefficient.Disclosure of Interests:Ann-Sophie De Craemer: None declared, Zuzanna Lukasik: None declared, Leander Meuris: None declared, Liselotte Deroo: None declared, Thomas Renson: None declared, Manouk de Hooge: None declared, Philippe Carron: None declared, Annelies Van Hecke: None declared, Nico Callewaert: None declared, Filip van den Bosch Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Dirk Elewaut: None declared

THU0400 CLINICAL COURSE OF EARLY AXIAL SPONDYLOARTHRITIS OVER TEN YEARS: LONG-TERM RESULTS FROM THE GERMAN SPONDYLOARTHRITIS INCEPTION COHORT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 437-437
Author(s):  
D. Poddubnyy ◽  
V. Rios Rodriguez ◽  
M. Torgutalp ◽  
M. Verba ◽  
J. Callhoff ◽  
...  
Keyword(s):  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Clinical Course ◽  
Symptom Duration ◽  
Disease Course ◽  
Inception Cohort ◽  
Research Support ◽  
Low Disease Activity ◽  
Similar Disease

Background:Previous studies showed that patients with non-radiographic and radiographic axial spondyloarthritis (nr- and r-axSpA) have similar disease burden and similar response to anti-inflammatory therapy given similar level of inflammatory activity. Only little is known, however, about long-term disease course in patients with early axSpA.Objectives:To investigate the long-term (up to 10 years) clinical course of patients with early axSpA.Methods:In total, 525 patients with early axSpA (r-axSpA with symptom duration ≤10 years and nr-axSpA with symptom duration ≤5 years) from the German Spondyloarthritis Inception Cohort (GESPIC) were included. The final patient classification was based on central reading results in 458 patients with available pelvic X-rays, and on local rheumatologist judgement in 67 patients. A total of 251 patients were finally classified as r-axSpA and 274 as nr-axSpA. Clinical evaluation, which included disease activity (BASDAI, C-reactive protein – CRP, ASDAS) as well as therapy recording, was performed at baseline and every 6 months thereafter until year 2 and annually thereafter till year 10. Treatment was conducted at the discretion of the local rheumatologist.Results:Since the cohort has started prior to introduction of TNF inhibitors (TNFi), only 2% patients received TNFi at baseline that increased to 23% at year 10 (15% in nr-axSpA and 31% in r-axSpA) – Figure 1. The use of NSAIDs and csDMARDs decreased in both groups (Figure 1), while use of systemic steroids did not change substantially (9% at baseline, 8% at year 10). The proportion of patients with low disease activity according to BASDAI (<4) was higher in r-axSpA as compared to nr-axSpA at almost all time points, while the proportion of patients with low disease activity according to ASDAS (<2.1), as well as with ASDAS inactive disease (<1.3) was similar between nr-axSpA and r-axSpA (Figure 2). In the group of patients who completed year 10 (n=134 in total, 68 with nr-axSpA, 67 with r-axSpA) the same trends in therapy and disease activity were observed.Conclusion:Patients with nr-axSpA and r-axSpA showed a similar disease course in terms of disease activity on the group level. The drop-out rate in this observational cohort was overall high, but comparable between groups. The lower proportion of patients with nr-axSpA being treated with TNFi might reflect a later introduction of TNFi for this indication.Acknowledgments:GESPIC has been financially supported by the German Federal Ministry of Education and Research as well as by Abbott, Amgen, Centocor, Schering–Plough, and Wyeth. From 2010 till 2019 GESPIC has been supported by Abbvie.Disclosure of Interests:Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Murat Torgutalp: None declared, Maryna Verba: None declared, Johanna Callhoff: None declared, Mikhail Protopopov Consultant of: Novartis, Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Judith Rademacher: None declared, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma

FRI0277 EFFECTIVENESS OF BDMARDS IN AS AND NR-AXSPA PATIENT POPULATIONS: EXPERIENCE FROM THE CORRONA REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 725.1-726
Author(s):  
T. Hunter ◽  
T. Blachley ◽  
W. Malatestinic ◽  
L. Harrold ◽  
B. Dube ◽  
...  
Keyword(s):  
Disease Activity ◽  
Patient Characteristics ◽  
Response Rates ◽  
Tender Joint Count ◽  
Research Support ◽  
Tender Joint ◽  
Clinical Registry ◽  
Modest Improvement ◽  
Asas Criteria ◽  
Patient Reported

Background:Axial spondyloarthritis (axSpA) consists of ankylosing spondylitis (AS), also referred to as radiographic axSpA (r-axSpA) and non-radiographic axSpA (nr-axSpA). AxSpA can lead to reduced mobility, pain, fatigue, and impact quality of life. While bDMARDs are available for treatment, the literature lacks studies exploring their real-world effectiveness in clinical registry patients with axSpA.Table 1.Demographic characteristics and clinical response rates of AxSpA patientsTable 2.TNFi drug survival rate results of early and late disease courseObjectives:To describe patient characteristics of bDMARD initiators among the AS and nr-axSpA populations and the effectiveness of bDMARDs at the 6-month (± 3) post-initiation follow-up (FU) visit in the Corrona PsA/SpA Registry.Methods:This study included patients aged ≥ 18 years with AS per modified NY criteria and nr-axSpA per ASAS criteria enrolled between 3/2013 and 9/2019. Concurrently diagnosed patients with PsA were excluded. Baseline characteristics, such as demographic, clinical, disease activity, treatment, and patient-reported outcomes (PRO), were collected for those initiating a bDMARD at enrollment or during FU; response rates and mean change in disease activity and PRO between initiation and 6-month FU were calculated.Results:The AS (n=179) and nr-axSpA (n=32) bDMARD initiators groups were similar at initiation for mean age (AS: 49.1 yrs, nr-axSpA: 48.9 yrs), ASDAS scores (AS: 2.9, nr-axSpA: 2.8) and patient global assessment (AS: 59.6, nr-axSpA: 60.0). The two groups were different for time from disease duration (AS 8.5 yrs, nr-axSpA, 6.6 yrs), current NSAID use (AS: 64.2%, nr-axSpA: 46.9%) and naivete to cDMARDS (AS: 70.4%, nr-axSpA: 40.6%), TNFs (AS: 47.5%, nr-axSpA: 21.9%), non-TNFs (AS: 96.1%, nr-axSpA: 93.8%) and bDMARDs (AS: 46.9%, nr-axSpA: 21.9%). Patients were similarly impacted by their condition for BASDAI (AS: 5.0, nr-axSpA, 5.6), pain (AS: 55.8, nr-axSpA, 60.8) and fatigue (AS: 51.6, nr-axSpA, 59.9), but there was an imbalance in tender joint count (AS: 2.6, nr-axSpA, 13.4).At 6-month FU, both populations experienced minimal or no change in ASDAS scores (AS: -0.3, nr-axSpA: 0.0) remaining in a high state of disease activity (ASDAS, ≥2.2). A small percent of both groups achieved ASAS20 (AS: 20.1%; nr-axSpA: 21.9%) and ASAS40 (AS: 14 %, nr-axSpA: 15.6%). Further, bDMARD initiators had minimal decreases in BASDAI (AS: -0.6, nr-axSpA: -0.8), pain (AS: -8.5, nr-axSpA: -12.2), and fatigue (AS: -5.0, nr-axSpA: -7.9) scores.Conclusion:AS and nr-axSpA bDMARD initiators had a modest improvement in outcomes at six months. Twenty percent or fewer patients achieved ASAS20 or ASAS40, with many having residual impairment based on ASDAS, BASDAI, pain, and fatigue outcomes at six months. While patients are initiating biologic agents, room for improvement exists as many are not achieving optimal treatment response of inactive (ASDAS, <1.3) or low disease activity (ASDAS, <2.1).Disclosure of Interests:Theresa Hunter Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Taylor Blachley Employee of: Corrona, LLC, William Malatestinic Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Leslie Harrold Shareholder of: Corrona, LLC – shareholder, Grant/research support from: Pfizer – grant/research support, Consultant of: AbbVie, BMS, Roche – consultant, Employee of: Corrona, LLC – employment, Blessing Dube Employee of: Corrona, LLC, Meghan Glynn Shareholder of: Corrona, LLC – shareholder, Grant/research support from: Pfizer – grant/research support, Employee of: Corrona, LLC – employment, Jeffrey Lisse Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau

scholarly journals Recruitment via social media: advantages and potential biases

2019 ◽  
Vol 5 ◽  
pp. 205520761986722 ◽  
Author(s):  
Catherine Benedict ◽  
Alexandria L Hahn ◽  
Michael A Diefenbach ◽  
Jennifer S Ford
Keyword(s):  
Social Media ◽  
Illness Perceptions ◽  
Negative Mood ◽  
Patient Characteristics ◽  
Adolescent And Young Adult ◽  
Group Differences ◽  
Chi Square ◽  
Patient Reported ◽  
Participant Characteristics ◽  
Cancer And Fertility

Background Adolescent and young adult (AYA) cancer survivors are under-represented in research. Social media is increasingly used for recruitment given its ability to reach large audiences. Differences in participant characteristics and potential biases due to recruitment source are not well understood. Purpose This study aimed to: (a) compare recruitment strategies (hospital-based v. social media) in enrollment metrics, and (b) among enrolled participants, evaluate group differences in patient characteristics and patient reported outcomes (PROs). Methods Preliminary data from a cancer and fertility study with female AYAs were evaluated. Hospital-based recruitment used electronic medical records (EMR) to identify eligible patients. Social media recruitment involved posting on partner organizations’ social media outlets. PROs included validated measures related to the parent study. Descriptive statistics evaluated recruitment metrics. Independent samples t-tests and chi-square identified differences in participant characteristics and PROs based on recruitment. Results Social media yielded a higher enrollment rate (37%; n = 54/146) compared with hospital-based recruitment (7%; n = 21/289) and required fewer study resources. Compared with hospital-based recruitment, participants from social media were more likely to be White ( p = 0.01), with a longer time since treatment ( p = 0.03); and reported higher levels of reproductive concern ( p = 0.004) and negative mood ( p = 0.02), and more negative illness perceptions ( ps < 0.05). Conclusion Recruitment via social media may be a more effective and efficient strategy compared with hospital-based methods. However, group differences were identified that could bias findings and limit generalizability. Advantages of social media should be considered with an understanding of how methodology may impact enrollment and results.

scholarly journals Real-world evidence of TNF inhibition in axial spondyloarthritis: can we generalise the results from clinical trials?

2020 ◽  
Vol 79 (7) ◽  
pp. 914-919 ◽  
Author(s):  
Gareth T Jones ◽  
Linda E Dean ◽  
Ejaz Pathan ◽  
Rosemary J Hollick ◽  
Gary J Macfarlane
Keyword(s):  
Clinical Trials ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Treatment Response ◽  
Real World ◽  
Axial Spondyloarthritis ◽  
British Society ◽  
Symptom Duration ◽  
Clinical Records ◽  
Trial Participants

Management guidelines assume that results from clinical trials can be generalised, although seldom is data available to test this assumption. We aimed to determine the proportion of patients commencing tumour necrosis factor inhibition (TNFi) who would have been eligible for relevant clinical trials, and whether treatment response differs between these groups and the trials themselves. The British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS) recruited a real-world cohort of TNFi-naïve spondyloarthritis patients with data collection from clinical records and patient questionnaires. Participant characteristics were extracted from trials identified from a recent Health Technology Assessment of TNFi for ankylosing spondylitis/non-radiographic axial spondyloarthritis. Descriptive statistics were used to determine the differences, including treatment response, between BSRBR-AS participants who would/would not have been eligible for the clinical trials and with trial participants. Among 2420 BSRBR-AS participants, those commencing TNFi (34%) had shorter symptom duration (15 vs 22 years) but more active disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 6.4 vs 4.0; Bath Ankylosing Spondylitis Disease Functional Index (BASFI) 6.2 vs 3.8). Of those commencing TNFi, 41% met eligibility criteria for ≥1 of fourteen relevant trials; they reported higher disease activity (BASDAI 6.9 vs 6.1) and poorer function (BASFI 6.6 vs 6.0). 61.7% of trial participants reported a positive treatment response, vs 51.3% of BSRBR-AS patients (difference: 10.4%; 95% CI 4.4% to 16.5%). Potential eligibility for trials did not influence treatment response (difference 2.0%; -9.4% to 13.4%). Fewer patients in the real world respond to TNFi than is reported in the trial literature. This has important implications for the generalisability of trial results, and the cost-effectiveness of TNFi agents.

scholarly journals Development and psychometric validation of a patient-reported outcome measure to assess fears in rheumatoid arthritis and axial spondyloarthritis: the Fear Assessment in Inflammatory Rheumatic diseases (FAIR) questionnaire

2017 ◽  
Vol 77 (2) ◽  
pp. 258-263 ◽  
Author(s):  
Laure Gossec ◽  
Pierre Chauvin ◽  
Alain Saraux ◽  
Christophe Hudry ◽  
Gabrielle Cukierman ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Internal Consistency ◽  
Validation Study ◽  
Outcome Measure ◽  
Axial Spondyloarthritis ◽  
Psychometric Validation ◽  
Routine Practice ◽  
Inflammatory Rheumatic Diseases ◽  
Patient Reported

ObjectivesTo develop and validate an outcome measure for assessing fears in patients with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA).MethodsFears were identified in a qualitative study, and reformulated as assertions with which participants could rate their agreement (on a 0–10 numeric rating scale). A cross-sectional validation study was performed including patients diagnosed with RA or axSpA. Redundant items (correlation >0.65) were excluded. Internal consistency (Cronbach’s α) and factorial structure (principal component analysis) were assessed. Patients were classified into fear levels (cluster analysis). Associations between patient variables and fear levels were evaluated using multiple logistic regression.Results672 patients were included in the validation study (432 RA, 240 axSpA); most had moderate disease activity and were prescribed biologics. The final questionnaire included 10 questions with high internal consistency (α: 0.89) and a single dimension. Mean scores (±SD) were 51.2 (±25.4) in RA and 60.5 (±22.9) in axSpA. Groups of patients with high (17.2%), moderate (41.1%) and low (41.7%) fear scores were identified. High fear scores were associated with high Arthritis Helplessness Index scores (OR 6.85, 95% CI (3.95 to 11.87)); high Hospital Anxiety and Depression Scale anxiety (OR 5.80, 95% CI (1.19 to 4.22)) and depression (OR 2.37, 95% CI (1.29 to 4.37)) scores; low education level (OR 3.48, 95% CI (1.37 to 8.83)); and high perceived disease activity (OR 2.36, 95% CI (1.10 to 5.04)).ConclusionsOverall, 17.2% of patients had high fear scores, although disease was often well controlled. High fear scores were associated with psychological distress. This questionnaire could be useful both in routine practice and clinical trials.

scholarly journals The Sex Influence on Response to Tumor Necrosis Factor-α Inhibitors and Remission in Axial Spondyloarthritis

2017 ◽  
Vol 45 (2) ◽  
pp. 195-201 ◽  
Author(s):  
Ennio Lubrano ◽  
Fabio Massimo Perrotta ◽  
Maria Manara ◽  
Salvatore D’Angelo ◽  
Olga Addimanda ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Response To Treatment ◽  
Inactive Disease ◽  
Disease Remission ◽  
Female Patients ◽  
Patient Reported ◽  
Factor Α ◽  
Necrosis Factor

Objective.The aim of this study was to evaluate the influence of sex on response to treatment and disease remission in patients with axial spondyloarthritis (axSpA).Methods.In this retrospective multicenter study, patients with axSpA, according to the Assessment of Spondyloarthritis international Society (ASAS) criteria for axSpA, and treated with adalimumab, etanercept, golimumab, or infliximab, were studied. We compared clinical characteristics, patient-reported outcomes, disease activity, function, and response to treatment in male and female patients with this disease.Results.Three hundred forty patients with axSpA (270 with ankylosing spondylitis, 19 with psoriatic arthritis with axial involvement, and 51 with nonradiographic axSpA) were studied. Male subjects had a significantly higher prevalence of grade IV sacroiliitis, higher levels of serum C-reactive protein, lower Maastricht Ankylosing Spondylitis Enthesitis Score, and fatigue when compared with females. Further, Kaplan-Meier survival curves showed that the rate of partial remission, ASAS40 response, and Ankylosing Spondylitis Disease Activity Score (ASDAS) major improvement, but not ASDAS inactive disease, were significantly lower in female patients.Conclusion.Our data suggest that female sex was associated with a lower rate of response to treatment and of disease remission in patients with axSpA treated with antitumor necrosis factor-α drugs.

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