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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.

Misinterpretation of patient beliefs may complicate shared decision-making in rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). The objective of this study was to develop a questionnaire to assess patients’ beliefs about their disease and its treatment, and to identify patient characteristics associated with these beliefs. All beliefs reported by > 5% of 50 patients in a previous study were reformulated with a partnering patient organization into statements with which participants could rate their agreement on a scale of 0–10 (totally disagree to totally agree). The resulting Questionnaire for Arthritis Dialogue (QuAD) was made available to patients with RA or axSpA. A score ≥ 7 was considered a strongly held belief. Associations between patient characteristics and individual lifestyle beliefs were assessed using multiple logistic regression. The 21-item QuAD was completed by 672 patients (432 RA, 240 axSpA; mean [±SD] age 54.2 [± 14.2]; 63.7% female). The most widely held beliefs were related to uncertainty about progression (n = 354, 54.0%), heredity (n = 309, 47.8%), and flare triggers (n = 283, 42.7%). The unwarranted belief that physical activity is deleterious to disease activity was associated with markers of psychological distress and lower educational levels. The beliefs of patients with RA or axSpA about their disease are wide-ranging. Since these may be unwarranted and may lead to inappropriate behaviors, physicians should discuss these beliefs with their patients. The QuAD may facilitate this dialogue, and may also be useful in population studies to standardize the assessment and evolution of beliefs over time. People with long-term inflammatory conditions such as rheumatoid arthritis (RA; inflammation of the joints) and axial spondyloarthritis (axSpA; inflammation of the spine) may hold a number of beliefs about their disease, including some that are not supported by current scientific evidence (e.g., “I think that my disease was triggered by a vaccination”). Some beliefs, especially those relating to the role of lifestyle factors (such as exercise, diet, smoking, and drinking alcohol), may encourage people living with severe diseases to change their behavior in a way that has an effect on their disease. Within this project, we developed a questionnaire to identify the most common beliefs held by people living with RA or axSpA, which is called the “Questionnaire for Arthritis Dialogue (QuAD).” We also examined whether certain characteristics (or traits) of people living with RA or axSpA are linked to beliefs not currently supported by scientific evidence. A total of 672 people living with RA or axSpA in France were asked to complete the questionnaire (QuAD). The questionnaire included 21 opinion statements that they scored from 0 (totally disagree) to 10 (totally agree). A score of more than 7 was interpreted to mean that the person significantly agreed with the opinion. Based on the responses to specific opinion statements in the questionnaire, we were able to identify possible links between beliefs that are not supported by scientific evidence (e.g., “I think that flare-ups of my disease are triggered by physical effort”), and characteristics of people living with severe diseases. Our findings suggested that beliefs about lifestyle and inflammatory diseases varied from person to person, were sometimes inconsistent (the most widely held beliefs were sometimes contradictory), and were often not supported by scientific evidence. The belief that physical activity had negative effects on the disease was linked to poor education and psychological issues (such as anxiety and helplessness). People living with axSpA were more likely to believe their disease was a result of their genetic make-up, whereas those with RA more often believed their disease was caused by emotional issues. People living with axSpA were also more likely to believe that physical activity could be beneficial for their disease, and less likely to believe that their disease was caused by smoking. Our results suggest that doctors need to discuss with their patients how they might believe lifestyle is associated with their disease. This will help to dispel any unnecessary concerns, and to encourage their patients to take up healthy lifestyles and habits that are beneficial for their disease management. It may also be beneficial for health care providers to discuss the beliefs identified in this study during educational programs about inflammatory diseases, for the benefit of people living with RA or axSpA. Electronic supplementary material The online version of this article (10.1007/s10067-018-4172-5) contains supplementary material, which is available to authorized users.

Background Patients (pts) with chronic inflammatory rheumatic diseases (CIRDs) such as rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA) have fears related to their disease that can negatively impact health-related quality of life and compromise treatment adherence. Objectives To develop and validate a patient-reported outcome (PRO) questionnaire to explore fears related to CIRDs using the Fears Assessment in Inflammatory Rheumatic Diseases (FAIR) Scale. Methods The preliminary questionnaire included 44 items (23 related to fears) most frequently cited by pts in a qualitative study of 50 French pts.1 Each item was formulated as an affirmative sentence and scored from 0 (completely disagree) to 10 (totally agree). Item scores were summed to provide a total score. The questionnaire was finalised and validated. Pts diagnosed with RA (EULAR/ACR criteria) or axSpA (ASAS criteria), recruited during routine visits by 100 participating rheumatologists across France, completed the preliminary questionnaire, HAD (Hospital Anxiety and Depression) and AHI (Arthritis Helplessness Index) scores. Redundant items (inter-item correlation coefficient >0.65) were eliminated. For the others, internal consistency (Cronbach alpha) and the factorial structure of the scale (principal component analysis) were assessed. Pts were classified according to their level of fears (cluster analysis) and corresponding score thresholds were determined (ROC analysis). The final questionnaire was independently translated into English and back into French twice, with reconciliation of the translated texts. Results 672 pts were included: 432 RA pts (mean±SD disease duration was 13.1±11.4 years, DAS28[ESR] was 2.6±1.2, 77.3% were taking biologics) and 240 axSpA pts (disease duration was 13.8±10.6 years, BASDAI was 3.3±2.2, 72.7% were taking biologics). The final FAIR Scale included 10 questions (Table) with total scores ranging 0–100. Mean±SD scores were 51.2±25.4 in RA and 60.5±22.9 in axSpA. Three pt groups were identified, characterised by high, moderate and low level of fears (17.2%, 41.1% and 41.7% of the population, respectively). The corresponding thresholds of the total score were 77 and 51, respectively. Fear scores were correlated with HAD scores for anxiety (r=0.47) and depression (r=0.40) and with the AHI (r=0.50). Conclusions The FAIR Scale is a 10-question PRO to evaluate disease-related fears in CIRD pts. In this pt population, 17.2% had high fear scores, contrasting with a disease that is often well-controlled. The FAIR Scale was associated with psychological distress. This psychometrically-validated and easy to use questionnaire could be used to improve pt-physician dialogue in CIRDs and also be of value in clinical studies. Further validation in other populations is needed. References Berenbaum F. PloS One 2014; 9(12):e114350. Acknowledgements The authors acknowledge Costello Medical Consulting, funded by UCB Pharma, for editorial assistance. This study was funded by UCB Pharma and Arthritis Foundation Olivier Courtin. Disclosure of Interest L. Gossec Grant/research support from: UCB Pharma, Lilly, Consultant for: AbbVie, BMS, Celgene, Janssen, Novartis, MSD, UCB, P. Chauvin: None declared, C. Hudry: None declared, G. Cukierman Employee of: UCB Pharma, V. Saulot: None declared, F. Russo-Marie: None declared, T. de Chalus Employee of: UCB Pharma, J. M. Joubert Employee of: UCB Pharma, A. Saraux Consultant for: UCB Pharma, F. Berenbaum: None declared

International audience; Objectives: To compare different early clinical criteria of non-response determined at three months as predictors of clinical failure at one year in patients with rheumatoid arthritis starting therapy with certolizumab pegol.Methods:Data were derived from a randomised Phase III clinical trial in patients with rheumatoid arthritis who failed to respond to methotrexate monotherapy. Patients included in this post-hoc analysis were treated with certolizumab pegol (400 mg qd reduced to 200 mg qd after one month) and with methotrexate. The study duration was twelve months. Response at three months was determined with the American College of Rheumatology-50, Disease Assessment Score-28 ESR, Health Assessment Questionnaire and the Clinical Disease Activity Index. The performance of these measures at predicting treatment failure at twelve months defined by the American College of Rheumatology-50 criteria was determined, using the positive predictive values as the principal evaluation criterion.Results:382 patients were available for analysis and 225 completed the twelve-month follow-up. At Week 52, 149 (38.1%) patients met the American College of Rheumatology-50 response criterion. Positive predictive values ranged from 81% for a decrease in Health Assessment Questionnaire- disability index score since baseline >0.22 to 95% for a decrease in Disease Assessment Score-28 score since baseline ≥1.2. Sensitivity was ≤70% in all cases. Performance of these measures was similar irrespective of the definition of treatment failure at 12 months.Conclusions:Simple clinical measures of disease activity can predict future treatment failure reliably and are appropriate for implementing treat-to-target treatment strategies in everyday practice.

To evaluate the cost-effectiveness of a Treat-to-Target strategy with certolizumab pegol in patients with rheumatoid arthritis in the context of a pay-for-performance agreement in which medication costs are refunded in case of discontinuation during the first 3 months of treatment.The Treat-to-Target strategy consisted of a systematic switch to second-line tumor necrosis factor (TNF)α inhibitor in case of an unmet ACR50 response at 3 months compared to current routine clinical practice. A reference cohort treated first-line with certolizumab pegol according to current practice without systematic switching was considered as the comparator. A decision-tree model was constructed to estimate clinical outcome (health assessment questionnaire-disability index or HAQ-DI score), time spent in ACR50 response (ACR 50), and direct costs of treatment over a 2-year period. HAQ scores were derived from American College of Rheumatology 50 (ACR50) responses. All TNFα inhibitors were assumed to have equivalent efficacy and tolerability. Costs were estimated at 2013 French retail prices (date of the pay-for-performance agreement).The mean duration of an ACR50 response was 1.23 years in the Treat-to-Target strategy certolizumab pegol cohort vs 0.98 years in the reference cohort, resulting in a mean gain in HAQ at 24 months of 0.117. The Treat-to-Target strategy with a mix of TNFα inhibitors as second-line therapy was more expensive than the reference strategy in absolute terms, but this difference was entirely offset by the pay-for-performance agreement. The Treat-to-Target strategy was, thus, cost-neutral over a 2-year period after the payback of CZP cost for patients not achieving the target at 3 months.In the context of a pay-for-performance agreement, the management of patients with rheumatoid arthritis using a Treat-to-Target strategy with certolizumab pegol in first line is dominant compared to standard use of this drug in the French setting in 2013.

International audience; Objectives: To explore beliefs and apprehensions about disease and its treatment in patients with rheumatoid arthritis and spondyloarthritis. Methods: 25 patients with rheumatoid arthritis and 25 with spondyloarthritis participated in semi-structured interviews about their disease and its treatment. The interviews were performed by trained interviewers in participants' homes. The interviews were recorded and the main themes identified by content analysis. Results: Patients differentiated between the underlying cause of the disease, which was most frequently identified as a hereditary or individual predisposition. In patients with rheumatoid arthritis, the most frequently cited triggering factor for disease onset was a psychological factor or life-event, whereas patients with spondyloarthritis tended to focus more on an intrinsic vulnerability to disease. Stress and overexertion were considered important triggering factors for exacerbations, and relaxation techniques were frequently cited strategies to manage exacerbations. The unpredictability of the disease course was a common source of anxiety. Beliefs about the disease and apprehensions about the future tended to evolve over the course of the disease, as did treatment expectations. Conclusions: Patients with rheumatoid arthritis and spondyloarthritis hold a core set of beliefs and apprehensions that reflect their level of information about their disease and are not necessarily appropriate. The physician can initiate discussion of these beliefs in order to dispel misconceptions, align treatment expectations, provide reassurance to the patient and readjust disease management. Such a dialogue would help improve standards of care in these chronic and incapacitating diseases.

Background Patients (pts) with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA) have personal fears related to their disease which can impact therapeutic strategy. 1 We previously reported high levels of fears in RA and axSpA pts in a French multicenter survey. 2 Objectives To identify factors associated with high levels of fears in RA and axSpA pts. Methods This national cross-sectional study was performed in 2014–2015 in France. 2 Rheumatologists recruited 6–20 pts with RA (ACR/EULAR criteria) or axSpA (ASAS criteria). Pts self-completed the “Opinions and fears of pts with chronic inflammatory rheumatism” (QOC-RIC) questionnaire 2 comprising 44 items including 23 questions on pt fears; each scored between 0–10 (10 = “totally agree”). Eighteen questions related to progression and consequences of the disease and 5 questions related to treatment. For each fear, descriptive analysis explored the percentage of pts with scores ≥7/10. A cluster analysis was run on the whole population to identify homogeneous groups (clusters) of pts according to their fears and beliefs (hierarchical ascendant classification). A multivariate multinomial logistic regression model using backward selection and multiple missing data imputation explored the variables (eg. epidemiological, socioeconomic, clinical) with p Results Overall, 672 pts recruited by 100 rheumatologists were analyzed (432 RA, 240 axSpA). For RA and axSpA pts respectively, 74.0% and 45.2% were female, average age was 58.3 (±13.1) and 47.0 (±13.2) years, and 77.3% and 72.7% were treated with biologics. Mean Disease Activity Score 28 (DAS28[ESR]) in RA pts was 2.64 (±1.24) and mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in axSpA pts was 3.3 (±2.2). Four pt clusters were identified corresponding to very high (31.6%), high (21.9%), moderate (32.7%) or low (13.8%) levels of fears (Figure). Variables related to the highest fear cluster were gender (female vs male; OR=2.38, p=0.013), high Pt Global Assessment of Disease Activity (PtGA [VAS]; >60 vs ≤30; OR=3.03, p=0.029), anxiety (HADS, anxiety score; >10 vs Conclusions Pts with the highest fears were most likely to be women with higher PtGA and anxiety/depression scores. Fears may reflect overall psychological distress in this population of pts and interventions to decrease these fears should be further assessed. References Nestoriuc Y. Arthritis Care Res 2010;62:791–9; Gossec L. Ann Rheum Dis 2015;74(S2):323 Acknowledgement The authors acknowledge Costello Medical Consulting, funded by UCB Pharma, for writing and editorial assistance. This study was funded by UCB Pharma and Arthritis Foundation Olivier Courtin. Disclosure of Interest L. Gossec: None declared, P. Chauvin: None declared, C. Hudry: None declared, M. Poussiere: None declared, T. de Chalus Employee of: UCB Pharma, V. Saulot: None declared, F. Russo-Marie: None declared, J. Joubert Employee of: UCB Pharma, A. Saraux: None declared, F. Berenbaum: None declared

Background Patients with chronic inflammatory disorders such as rheumatoid arthritis (RA) or spondyloarthritis (SpA) create personal sets of fears and beliefs related to their disease. These fears and beliefs may influence the patient-physician relationship and potentially treatment adherence. Little is known about these fears and beliefs in the era of biologics.1 Objectives To describe the most frequent fears and beliefs in RA and SpA patients. Methods Cross-sectional assessment of unselected patients with a diagnosis of RA (ACR/EULAR criteria) or axial SpA (ASAS criteria) in France in 2014. The study was proposed to all rheumatologists in France and consecutive patients recruited through the first 51 rheumatologists agreeing to participate. A self-reported 44-item questionnaire (25 items on fears, 19 on beliefs) was built and preliminarily validated for this study. Each item was scored 0–10 (10 indicating higher fears/beliefs).2 The analysis was descriptive for the 5 fears and the 5 beliefs, most frequently scored as ≥7/10, in both axSpA and RA patients. Results Overall, 226 patients (161 RA and 65 SpA; 64.4% female) were analyzed: mean disease duration 11.9 vs 13.8 years and mean patient9s global assessment 31/100 vs 41/100 for RA vs SpA patients, respectively. Of 25 fear items, the 6 most frequently-reported fears were: “afraid of suffering again” (66.7% scored this as ≥7/10), “afraid of losing control and autonomy” (61.4%), “afraid of being a burden for relatives” (59.6%), “afraid of losing all joint mobility” (58.9%), “afraid of the spread of the disease to other joints” (58.6%) and “afraid of the consequences of my disease on my professional activity” (58.6%). Of 19 belief items, the 5 most frequently-reported beliefs were: “flares are triggered by fatigue” (41.7%), “physical activity reduces flares” (38.7%), “flares are triggered by changes in the weather” (37.3%), “flares are triggered by physical effort” (37.1%) and “the disease is linked to a genetic cause” (36.9%). Conclusions This study highlights the main fears and beliefs from a patient perspective using a novel questionnaire specific for chronic inflammatory arthritis. Consistent work needs to be performed to better document the effect of these fears and beliefs on adherence, disease care and progression. References Gossec L. Rheumatology 2014;53(7):1274–1278. Berenbaum F. Plos One 2014;9(12) [Epub] Acknowledgements The authors acknowledge Costello Medical Consulting for editorial assistance which was funded by UCB Pharma. Disclosure of Interest L. Gossec: None declared, P. Chauvin Consultant for: UCB Pharma, C. Hudry: None declared, F. Mathoret-Philibert: None declared, M. Poussiere: None declared, T. de Chalus Employee of: UCB Pharma, F. Russo-Marie: None declared, J. M. Joubert Employee of: UCB Pharma, A. Saraux: None declared, F. Berenbaum: None declared