Barriers and Expectations for Patients in Post-Osteoporotic Fracture Care in France: The EFFEL Study.

OBJECTIVES: This study aimed to quantify the relative importance of barriers to better secondary prevention of osteoporotic fractures and of care expectations expressed by patients with osteoporotic fractures in France. METHODS: A qualitative exploration of potential barriers to care and expectations was undertaken through a systematic literature review and in-depth patients interviews. A list of 21 barriers and 21 expectations was identified. These were presented to 324 subjects with osteoporotic fractures, identified in a representative sample of the French population, in the form of best-worst scaling questionnaires. Patients rated the relative importance of the attributes, and arithmetic mean importance scores were calculated and ranked. A Bayesian hierarchical model was also performed to generate a relative importance score. Latent class analysis was performed to identify potential subgroups of patients with different response profiles. RESULTS: A total of 7 barriers were rated as the most important, relating to awareness of osteoporosis and coordination of care. The highest-ranked barrier, "my fracture is not related to osteoporosis," was significantly more important than all the others (mean importance score 0.45; 95% confidence interval 0.33-0.56). A similar ranking of attributes was obtained with both the arithmetic and the Bayesian approach. For expectations, no clear hierarchy of attributes was identified. Latent class analysis discriminated 3 classes of respondents with significant differences in response profiles (the educated environmentalists, the unaware, and the victims of the system). CONCLUSIONS: Better quality of care of osteoporosis and effective secondary fracture prevention will require improvements in patient education, training of healthcare professionals, and coordination of care.

Three-year clinical outcomes in patients with rheumatoid arthritis treated with certolizumab pegol: results from the observational ECLAIR study.

OBJECTIVES: To describe the long-term effectiveness and safety of certolizumab pegol in patients with moderate-to-severe rheumatoid arthritis (RA) in a real-world setting in France. METHODS: ECLAIR was a 3-year longitudinal, prospective, observational, multicentre study. The primary objective was to describe the EULAR response after 1 year of certolizumab pegol treatment. Other endpoints included DAS28, clinical disease activity index, health assessment questionnaire disability index, fatigue assessment scale, patient's assessment of arthritis pain, patient and physician global assessments of disease activity, patient quality of life, and long-term safety. RESULTS: A total of 792 patients were enrolled, of whom 776 comprised the safety set, and 733 the full analysis set. In the full analysis set, 559, 469 and 430 patients had a 12-, 24- and 36-month visit, respectively. This included 378, 296 and 246 patients still receiving certolizumab pegol at these visits. The percentage of EULAR responders was 75.3% (305/405 patients with an available EULAR response) at 12, 76.5% (261/341) at 24, and 79.6% (226/284) at 36 months. Among those still receiving certolizumab pegol, the percentage of EULAR responders was 81.7% (237/290) at 12, 81.1% (185/228) at 24, and 87.3% (158/181) at 36 months. Sustained improvements were observed in other effectiveness outcomes. Overall, 45.1% (350/776) of patients experienced 776 adverse drug reactions. No new safety signals were identified. CONCLUSIONS: This is the first prospective, observational study of an anti-TNF treatment in France. The results confirm the effectiveness and safety profile of certolizumab pegol treatment in patients with RA in a real-world setting.

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.

OBJECTIVES: To develop and validate an outcome measure for assessing fears in patients with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA). METHODS: Fears 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. RESULTS: 672 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)). CONCLUSIONS: Overall, 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.

Reporting of patient-perceived impact of rheumatoid arthritis and axial spondyloarthritis over 10 years: a systematic literature review.

OBJECTIVE: RA and axial SpA have an important impact on patients' lives. The objective of this study was to explore the reporting of different aspects of that impact in publications, with a focus on differences between diseases and over time. METHODS: A systematic literature review retrieved all articles reporting on the life impact of RA or axial radiographic SpA in adults published within the last 10 years and issued from European research. The data were classified into physical impact (including pain, functional assessment and fatigue), psychological impact (including psychological distress and coping) and social impact (including relationships, family and social life). The number of articles published over time was analysed by linear regression. RESULTS: In all, 1352 abstracts were screened and 149 publications (40,056 patients) were analysed: 129 articles (86.5%) concerned RA and 16 (10.7%) concerned axial SpA. The mean number of articles reporting on the physical aspects of impact was 11.4 (s.d. 4.8) per 2-year period, but increased more than 2-fold (from 7 articles in 2001-3 to 15 in 2010-11), in particular due to recent publications on fatigue, whereas the number of articles on psychological aspects [mean 12.4 (s.d. 4.0)] decreased markedly after 2006. Publications reporting on social aspects [mean 8.2 (s.d. 4.1)] remained globally stable. CONCLUSION: In the era of biologics, there is an interest in the patient-perceived life impact of RA and axial SpA in the European literature, but the impact of RA has been the subject of greater exploration. There are clearly trends over time in the reporting of impact.

Translational research in immune and inflammatory diseases; what are the challenges, expected advances, and innovative therapies?

Despite very different aetiologies and clinical expressions, advancing knowledge in the physiopathology and treatment of immune and inflammatory diseases (IID) prompts us to consider them as a whole. These are chronic, often incapacitating and painful illnesses that progress and destroy organs. Management by discipline too often leads to erroneous diagnoses and sometimes inappropriate treatment. More integrated translational research would further understanding of the complex relationships between cytokines and organ damage, which vary with the conditions and patients, making it possible to develop new biomarkers and personalize treatment. The research in France has very many strengths but its organization is fragmented. Better coordinated research into IID, which could be based on creating a strategic valorization field (domaine de valorisation stratégique, DVS) and thematic multi-organization institute (Institut thématique multi-organismes ITMO), would advance patient management.

Early non-response to certolizumab pegol in rheumatoid arthritis predicts failure to achieve low disease activity at 1 year: data from a prospective observational study.

OBJECTIVE: To evaluate the performance of clinical criteria for predicting late treatment failure in patients with early non-response to certolizumab pegol (CZP). METHODS: A protocol-specified analysis of interim data from ECLAIR, a 3-year longitudinal, prospective, observational, multicentre study of patients with active rheumatoid arthritis (RA) initiating CZP treatment in France, was conducted. Clinical measures assessed were Clinical Disease Activity Index (CDAI), Disease Activity Score-28 with erythrocyte sedimentation rate (DAS28(ESR)) and Health Assessment Questionnaire Disability Index (HAQ-DI). Early non-response was measured at 3 months (M3) and failure to achieve low disease activity (LDA) at 12 months (M12). RESULTS: 574/792 enrolled patients were treated at M3. The numbers available for predictability analyses were 532 (CDAI), 434 (DAS28(ESR)) and 496 (HAQ-DI). Of the three indices evaluated, the highest predictor of non-response value was observed for the CDAI (88.8% (95% CI 81.0 to 94.1)), indicating that up to 88% of patients identified as non-responders at M3 failed to achieve LDA at M12, regardless of baseline disease severity or treatment history. The specificity for this measure was also very high (96.0%), indicating that less than 5% of patients who achieved CDAI response at M12 had not responded at M3. Similar predictability was observed for DAS28(ESR), but only in patients with high disease activity at baseline and/or those previously treated by a biological disease-modifying antirheumatic drug. CONCLUSION: CDAI non-response at M3 is a predictor of failure to achieve the therapeutic target of LDA at M12 in patients with RA initiating treatment with CZP.

Fragility fractures in France: epidemiology, characteristics and quality of life (the EPIFRACT study).

Between 1 and 2% of people aged 50 years and over living at home in France are likely to experience a fragility fracture each year. Three-quarters of these individuals are not diagnosed with osteoporosis and lose the opportunity for appropriate care. PURPOSE: To estimate the incidence of fragility fractures in France and to describe the characteristics of individuals with such fractures and of their fractures. METHODS: In April-May 2018, a postal survey was performed in France targeting a representative panel of 15,000 individuals aged ≥ 50 years, who were invited to complete a questionnaire. If they reported experiencing a fracture in the previous 3 years, they were asked to provide information on demographics, fracture type, risk factors for fractures and osteoporosis diagnosis. Only fragility fractures were considered, and these were classified as major (associated with increased mortality) or minor, based on the fracture site. RESULTS: Around 13,914 panellists returned an exploitable questionnaire (92.8%). About 425 participants reported ≥ 1 fragility fracture (453 fractures), corresponding to a 12-month incidence rate of 1.4% [95%CI: 1.2, 1.6]. Incidence was higher in women (1.99% [1.87, 2.05]) than in men (0.69% [0.38, 0.86]) and increased with age. Around 157 fractures (34.6%) were classified as major. Participants reporting major fractures were older than those reporting minor fractures (mean age: 72.6 ± 11.3 vs 67.1 ± 10.6) and more likely to report previous corticosteroid use (odds ratio: 1.90 [95%CI: 1.13, 3.18]). No other patient characteristic was associated with fracture severity. About 117 participants with fractures (27.5%) had undergone bone densitometry, and 97 (22.8%) declared having received a diagnosis of osteoporosis. CONCLUSIONS: Around 340,000 people aged ≥ 50 years living at home in France are estimated to experience osteoporotic fractures each year. However, > 75% of panellists reporting fractures were never diagnosed with osteoporosis and thus did not have the opportunity to receive appropriate care.

Real-world care for individuals aged over fifty with fractures in France: Evidence for a wide care gap-The EPIFRACT Study.

OBJECTIVES: To describe the care trajectories of adults aged ≥50 years with fragility fractures in France. METHODS: A postal questionnaire was sent to 15,000 individuals aged ≥50 years extracted from a representative panel of the French population (METASKOPE) in April-May 2018. Respondents experiencing a single fragility fracture in the previous three years constituted the study population. Information was collected regarding diagnosis, hospitalisations, physician visits and treatment related to the fractures. RESULTS: 13,914 participants returned a questionnaire (92.8%), of whom 436 reported a single fragility fracture. Their mean age was 68.7±10.3 years. 11.9% of this sample had undergone bone densitometry (DXA) prior to the fracture and 11.9% had received a diagnostic of osteoporosis. Following the fracture, a further 17.4% underwent DXA and 8.5% were diagnosed with osteoporosis. 74.3% of fractures were initially managed in an emergency department and 29.6% led to immediate hospitalisation. Prior to fracture, 3.4% received a specific anti-osteoporotic treatment, 10.1% vitamin D and 6.4% calcium supplementation. After the fracture, these figures rose to 10.8%, 26.8% and 19.0% respectively. 86.2% participants made at least one follow-up visit to a physician. CONCLUSIONS: The rate of DXA screening following fragility fractures in subjects over fifty is very low. Most patients with fragility fractures did not receive a diagnosis of osteoporosis. The proportion of patients treated with a specific anti-osteoporotic treatment after a fracture is low even though around half consulted their general practitioner after the fracture. Practice guidelines are thus not being adhered to in everyday clinical practice in France.

Burden of severe spondyloarthritis in France: A nationwide assessment of prevalence, associated comorbidities and cost.

OBJECTIVES: To estimate the number of patients with severe spondyloarthritis (SpA) in France, describe their comorbidities and document and value their healthcare resource consumption. METHODS: Data were retrieved from an insurance claims database covering a 1/97 random sample of the French population. All patients benefiting from full insurance coverage ("ALD") for severe SpA in 2012 (including cases with structural damage and/or frequent flares) were identified, together with a control group frequency-matched by age and gender. Severe comorbidities were documented through ALD categories. Healthcare resource consumption was documented and valued from the payer's perspective. Rates of comorbidities and costs were compared in SpA patients versus controls using non-parametric testing. RESULTS: Overall, 827 patients with ALD status for severe SpA were identified (control group: n=2.481), corresponding to a prevalence rate of 0.18% [0.17-0.19] for SpA with ALD in the general population. Severe comorbidities more frequent in patients with SpA than in controls included inflammatory bowel disorders (odds ratio: 15.0 [6.2-36.2]), hypertension (2.5 [1.6-3.9]), atrial fibrillation (4.3 [1.9-9.6]) and major depressive disorder (2.1 [1.3-3.6]). Mean per capita annual direct healthcare expenditure was 3.6 [3.2-4.1]-fold higher in SpA patients (€6,122 [€5,838-€6,406]) than in controls (€1,682 [€1,566-€1,798]). Extrapolating to all patients in France, total healthcare cost attributable to severe SpA patients was €391 [€355-€426] million, with medication accounting for 53.8% of this cost. CONCLUSIONS: The burden of severe SpA in France is substantial, due to the high prevalence, high direct costs and associated comorbidities.

Does management of erectile dysfunction after radical prostatectomy meet patients' expectations? Results of a national survey (REPAIR) by the French Urological Association.

INTRODUCTION: Little stress has been placed on patients' satisfaction with regard to management of erectile dysfunction (ED) after radical prostatectomy (RP) and on how physicians' and patients' views may differ in this respect. AIM: To assess the extent to which urologists' perceptions of their patients' expectations and the actual needs expressed by these patients coincide with regard to ED and its management. METHODS: Those French urologists who provisionally accepted to participate in the survey (760/1,272; 59.7%) received a physician survey instrument, 10 patient data forms to be completed during the first 10 consultations of patients who had undergone RP less than 12 months previously, and 10 copies of a questionnaire for patients to complete. MAIN OUTCOME MEASURES; Patient-reported sexual activity, satisfaction with sexual activity (Male Sexual Health Questionnaire), and treatment expectations; urologists' subjective assessment of the importance given by their patients to ED; the timing they propose for starting ED treatment. RESULTS: Overall, 535/1,272 urologists (42%) returned the physician survey instrument (45.6 +/- 8.7 years, 28-67) and 2,644 patients completed the patient questionnaire (64.0 +/- 6.1 years, 44-79). The percentage of patients having intercourse pre RP was highly age-dependent (89% at 55-59 years; 56% at > or = 70 years); 70-75% of patients claimed to be satisfied with their pre-RP sexual activity. Post RP, 27-53% of patients (depending upon length of follow-up), who were sexually active pre RP, had intercourse. Only 18% (< 5 months' follow-up) or 28% (> 5 months' follow-up) were satisfied. Over half (53%)--and especially the younger patients--expected early ED treatment (1 or 3 months post RP). Agreement between patients' expectations and urologists beliefs on timing of ED treatment was poor. At the 1- or 2-month visits, 73% of patients were already finding ED frustrating. CONCLUSIONS: Erectile dysfunction is an important issue for patients who have undergone RP. Urologists tend to underestimate patients' distress and desire for early treatment.

How urologists manage erectile dysfunction after radical prostatectomy: a national survey (REPAIR) by the French urological association.

INTRODUCTION: There is little sound information on how urologists manage erectile dysfunction (ED) arising after radical prostatectomy (RP) in a real-world situation. AIM: To perform a national survey of how French urologists manage ED after RP in routine practice. MAIN OUTCOME MEASURES: Choice of first-line treatment, type of treatment (rehabilitation of erectile function vs. treatment on demand for intercourse), and timing and duration of treatment. METHODS: All French urologists were invited to take part in a survey; 59.7% accepted provisionally (760/1,272). They received the survey questionnaire and 10 patient data forms to be completed during the visits of the first 10 patients with fewer than 12 months follow-up post-RP. These were returned to an independent third party for analysis. RESULTS: The final response rate was 535/1,272 (42%). Before performing RP, 80% of the urologists assessed sexual activity and 76% erectile function; 9% did neither. Thirty-eight percent reported that they systematically proposed ED treatment to their patients post-RP ("routine prescribers"). The remainder was treated on occasion, either at the patients' request (49%) or at their own discretion (13%). Routine prescribers tended to be younger and had performed more RPs in the preceding year. Most urologists (88%) always used the same first-line treatment: regular intracavernosal injections (ICIs) for rehabilitation, 39%; ICI on demand for intercourse, 30%; phosphodiesterase type 5 (PDE5) inhibitors on demand, 16%, or regular PDE5 inhibitors for rehabilitation, 8%; alternating ICI and PDE5 inhibitors, 7%; vacuum device, <1%. ED treatment was initiated within 3 months of RP by 72% of the urologists (92% of routine prescribers). The percentage of urologists recommending ED treatment for 6 months was 20%, 38% for 1 year, and 33% for 2 years. CONCLUSION: ED was commonplace after RP. French urologists reported a proactive attitude to ED treatment, many favoring pharmacologic rehabilitation therapy. ICI was their first-line treatment of choice.

Early non-response to certolizumab pegol in rheumatoid arthritis predicts treatment failure at one year. Data from a randomised phase III clinical trial.

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 (400mg qd reduced to 200mg 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: Three hundred and eighty two 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 12months. 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.

Development and application of a questionnaire to assess patient beliefs in rheumatoid arthritis and axial spondyloarthritis.

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.

Correction to: Development and application of a questionnaire to assess patient beliefs in rheumatoid arthritis and axial spondyloarthritis.

The original version of this article was revised due to a retrospective Open Access order.

An e-health interactive self-assessment website (Sanoia®) in rheumatoid arthritis. A 12-month randomized controlled trial in 320 patients.

INTRODUCTION: Sanoia is an online interactive electronic e-health platform developed to allow patient self-assessment and self-monitoring. The objective was to assess in rheumatoid arthritis (RA) patients, the efficacy on patient-physician interactions, of giving access to Sanoia. METHODS: In this French, multi-center, 12-months randomized controlled trial (CarNET: NCT02200068), patients with RA and internet access were randomized to: access without incentives to the Sanoia platform after minimal training, or usual care. The primary outcome was the change from baseline in patient-physician interactions, by the patient-reported Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) questionnaire. The number of accesses to Sanoia was recorded and satisfaction with the platform was assessed through a 0-10 numeric rating scale. Analyses were in intention to treat (ITT), on SAS. RESULTS: Of 320 RA patients (159 Sanoia versus 161 usual care), mean (standard deviation) age was 57.0 (12.7) years, mean (SD) disease duration was 14.6 (11.1) years, 216 (67.5%) were taking a biologic and 253 (79.1%) were female. Mean (SD) PEPPI scores at baseline and 12 months were 38.6 (8.2) and 39.2 (8.0) (delta=+0.60 [5.52]) versus 39.7 (7.3) and 38.8 (8.0) (delta=-0.91 [6.08]) in the Sanoia and control group, respectively (P=0.01). Although mean satisfaction with the platform was very high (1.46 [1.52]), 41 patients (25.7%) never accessed Sanoia. CONCLUSION: Giving RA patients access to the interactive Sanoia e-health platform led to a small improvement in patient-perceived patient-physician interactions. A disjunction between patient satisfaction and access to the platform was noted. E-Health platforms are promising in RA.

Healthcare service utilisation costs attributable to rheumatoid arthritis in France: Analysis of a representative national claims database.

OBJECTIVE: To estimate healthcare service utilisation costs of patients with rheumatoid arthritis in France and to estimate the fraction of these costs attributable to RA. METHOD: The "Échantillon généraliste des bénéficiaires" (EGB) is a 1/97 random sample of the main national claims database covering the French population. A cohort of patients with rheumatoid arthritis was constituted of all adults benefiting from full coverage for rheumatoid arthritis (ICD-10 M05-06) on 1st january 2009. A control group matched for age and gender was identified. Health expenditures were assessed from the payer's perspective for the year 2010. RESULTS: The annual per capita reimbursed total health expenditure was €6,404 in 2010, an amount around two times higher than in the control group €3,095 (P<0.0001). The main contributors to this extra cost were outpatient care (+€2,407; 72.7%), including medication (+€1,686; 50.0%), and inpatient care (+€903; 27.3%). Patients treated by biological agents generated an age-adjusted per capita annual expenditure about three times higher than untreated patients (€15,757 versus €4,640). CONCLUSION: Only half of medical expenditure by patients with rheumatoid arthritis is attributable to their disease and use of biological agents has become a major driver of cost.

Impact of rheumatoid arthritis on career progression, productivity, and employability: The PRET Study.

OBJECTIVES: To evaluate the impact of rheumatoid arthritis (RA) on career, productivity, and employability. METHODS: A retrospective cross-sectional survey was conducted in 2012-2013 in France among patients with RA who were younger than 60 years of age and employed or unemployed. Patients were either recruited during a rheumatologist visit or among members of a nationwide patient-support organization (ANDAR). They completed a questionnaire on the functional impact of RA evaluated by the Health Assessment Questionnaire (HAQ) and on the impact of their disease on work ability. RESULTS: Of 488 surveyed patients, 364 (74.6%) were actively employed, 31 (6.4%) were job seekers, and 93 (19.1%) had left the workforce. In the employed group, mean age was 48.9 years; 82.1% of patients were women; mean RA duration was 11.6 years; and the HAQ score correlated strongly with various markers for decreased productivity including sick leaves, temporary or permanent work discontinuation, and having unwillingly downgraded from a full-time to a part-time work schedule or changed to a different job. Among job seekers, 54% had lost their previous job because of their RA. CONCLUSION: RA is associated with various forms of work disability, which are directly related to the severity of disease-related functional impairments.

Modeling of the clinical and economic impact of a risk-sharing agreement supporting a treat-to-target strategy in the management of patients with rheumatoid arthritis in France.

OBJECTIVES: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

[Results from the observational study EPIGRAM: management of excess weight in general practice and follow-up of patients treated with orlistat]. / Résultats de l'étude observationnelle EPIGRam: prise en charge de l'obésité et du surpoids en médecine générale, suivi de la cohorte traitée par l'orlistat.

The EPIGRAM pharmacoepidemiological study was conducted in general practitioners (GPs) prescribing orlistat (Xenical) in order to describe, under real clinical conditions, the management of obese or overweight patients, as well as a 1-year follow-up of a patient cohort treated with orlistat. A total of 714 GPs participated in this study and recruited a total of 6801 patients. Forty percent were treated with orlistat, 76% were women and 63% presented with a comorbidity. With a mean body mass index of 33.1+/-5.1 kg/m2, 85% of the patients treated with orlistat were in agreement with the indications of this drug. Comparison of patients treated and not treated with orlistat did not allow identification of any key factor able to predict prescription of the treatment. Patients treated with orlistat on inclusion and reviewed at least once by their doctor were followed up for an average of 11 months and a maximum of 23 months. Between 64% and 77% of patients stopped treatment with orlistat during the follow-up period. The treatment cost was the main reason for definitive treatment discontinuation for more than 50% of the patients. The average weight loss was 5% and 9% after 3 and 12 months of treatment, respectively.