La spondyloarthrite axiale (axSpA) est une maladie inflammatoire chronique se manifestant sous la forme de rhumatismes à l’origine de douleurs lombaires et au niveau du bassin [1], [2]. Chez les patients atteints d’une axSpA active sévère après échec des anti-inflammatoires non stéroïdiens (AINS), un traitement anti-TNF peut-être utilisé selon les recommandations de la SFR [3]. Suite à une modification du résumé des caractéristiques du produit du certolizumab pegol (CZP) en octobre 2020 par l’agence Européenne des médicaments, chez les patients présentant une rémission persistante après au moins un an de traitement par CZP définie par un ASDAS < 1,3, une dose d’entretien réduite de 200 mg toutes les 4 semaines (Q4 W) peut être envisagée [4]. L’objectif de cette étude est d’estimer l’impact budgétaire de la réduction de dose d’entretien de CZP en France. La perspective de l’Assurance maladie a été considérée dans le modèle d’impact budgétaire (MIB) en considérant le coût des traitements et de leur administration, les transports médicaux, les événements indésirables, les poussées de la maladie et le suivi médical des patients. Un scénario de référence avec le dosage du CZP en entretien au schéma thérapeutique normal (200 mg Q2W) a été comparé à un scénario avec une dose d’entretien réduite de CZP (200 mg Q4W) après une année en rémission persistante sous CZP. La dose d’entretien réduite a été appliquée à 44 % des patients traités par CZP sur la base du pourcentage de patients en rémission persistance dans l’étude C-OPTIMISE [5]. Un risque légèrement plus élevé de poussée de la maladie lors de la dose d’entretien de Q4W par rapport à Q2W a été pris en compte (21 % vs 16,4 %) [5]. Un horizon temporel de trois ans a été pris en compte. La population cible a été estimée à partir des données épidémiologiques françaises de la SFR appliquées à la prévalence de la population française (2021) en tenant compte d’une augmentation annuelle de 0,20 % et des données publiées dans l’avis de la Commission de la Transparence de CZP [6], [7], [8]. La population cible annuelle de CZP dans cette indication est estimée à 13 946 patients. Des parts de marché identiques entre les deux scénarios ont été considérées. Les comparateurs retenus dans le MIB étaient les anti-TNF alpha (princeps et biosimilaires) conformément aux recommandations de la SFR (2018) [3]. Au total, 5331 patients sont traités par CZP sur 3 ans dans le MIB. La dose d’entretien réduite du CZP chez les patients en rémission persistante après 1 an de traitement entraîne une économie cumulée de 8,971 millions d’euros (M€) sur un horizon temporel de 3 ans. Cette économie est principalement due à la réduction des coûts d’acquisition (8,967 M€) malgré des coûts additionnels de prise en charge des poussées légèrement supérieurs (61 743 €). Des analyses de sensibilité sur les parts de marché et la population cible ont montré des résultats cohérents avec l’analyse principale. Une réduction de dose du CZP chez les patients présentant une rémission persistante après au moins un an de traitement permet de générer des économies sur les coûts d’acquisition des traitements et de leur administration en dépit d’une augmentation marginale du coût de prise en charge des poussées. La dose d’entretien réduite de CZP dans le traitement de l’axSpA génère une économie de 8,971 M€ sur un horizon temporel de 3 ans comparé au dosage du CZP en entretien au schéma thérapeutique normal tout en permettant un maintien de la rémission en entretien comparable.

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.

To estimate the healthcare resource consumption of rheumatoid arthritis (RA) patients treated with certolizumab pegol (CZP) during routine clinical practice in France. ECLAIR was a prospective, non-interventional, multicenter study conducted in France over three years (2014–2017), in patients with moderate-to-severe, active RA starting first-line treatment with CZP followed during routine clinical practice. This study recruited 170 rheumatologists and 6 internal medicine specialists, and was designed to be representative of the French RA population. Of the 792 enrolled patients, 733 formed the full analysis set (FAS). Here, we describe the frequency of physician consultations, nurse and physiotherapist visits, hospitalisation/emergency room visits and medical procedures for the FAS. Data are reported for patients with 12-month, 24-month and 36-month visit data. In the FAS, healthcare provider consultations related to RA decreased with time; these were reported in 44.6% (243/545), 40.3% (184/457) and 37.4% (82/219) of patients with 12-, 24- and 36-month visit data, respectively. These consultations were mainly performed by rheumatologists and general practitioners. Hospitalisations >1 day in length and emergency room visits also declined with time and were reported, respectively, in 13.0% (71/545) and 7.5% (41/545) of patients with 12-month data; 10.1% (46/457) and 2.4% (11/457) of patients with 24-month data, and 11.4% (25/219) and 2.7% (6/219) of patients with 36-month data. Medical procedures (including magnetic resonance imaging, computerised tomography scans, and scintigraphy) also decreased with time, reported in 47.3% (258/545), 46.0% (210/457) and 32.9% (72/219) of patients documented at 12, 24 and 36 months, respectively. This was the first prospective, real-world study of an anti-TNF conducted in France, and provides insight on healthcare resource consumption in RA patients treated with CZP. As consultations did not influence the likelihood of patient drop-out, results suggest a decline in resource consumption over time, including physician consultations, hospitalisations/emergency room visits, and medical procedures.

To evaluate the performance of clinical markers of early treatment failure as predictors of late treatment failure in patients with rheumatoid arthritis (RA) in everyday clinical practice. Data from a 1-year interim analysis of the ECLAIR study, which followed patients with RA starting treatment with certolizumab pegol (CZP) in France, were used. Patients were evaluated at study entry and at 3-monthly routine consultations thereafter. Disease activity was assessed at each visit using CDAI, DAS28(ESR) and HAQ-DI. Early treatment response was measured at Week 12, at which point patients with missing data or no longer taking CZP were excluded from the analysis. Late treatment response was measured at 1 year, at which point linear interpolation, LOCF or NRI were used to impute missing data. Non-response at Week 12 was defined as CDAI>10, ΔDAS28(ESR)<1.2, or ΔHAQ-DI<0.22; and at 1 year as CDAI>22, DAS28(ESR)>3.2, or HAQ-DI>0.5. Positive predictive value (PPV; proportion of treatment failures at 1 year in Week 12 non-responders), sensitivity and specificity were used to evaluate the predictive performance of each tool. Overall, 792 patients were enrolled, of whom 730 were analyzed. The PPV for CDAI (assessed in 532 patients) was 88.8%, indicating that most patients identified as non-responders at Week 12 failed to respond at 1 year. Specificity was also high (96.0%), indicating that <5% of patients who achieved CDAI response at 1 year were non-responders at Week 12. Similar analyses performed for DAS28(ESR) and HAQ-DI produced PPVs of 69.0% and 75.4%, respectively. This study was the first conducted under real-life conditions in France to demonstrate a strong relationship between early and late treatment failure. Simple tools such as CDAI, assessed during routine consultations, may be reliable markers to predict treatment failure without the need for complementary biological tests.

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

L’objectif principal de cette étude qualitative était d’explorer le vécu des hommes suite à la perte précoce d’une grossesse.Treize hommes ont participé à un entretien semi-directif qui permettait d’aborder l’humeur, la culpabilité, la relation de couple, les stratégies de faire face, le soutien, les représentations de la perte ainsi que de la différence de vécu entre hommes et femmes.L’analyse thématique des entretiens a permis de mettre en évidence l’impact psychologique d’une fausse couche auprès de certains hommes. Si la tristesse était fréquemment rapportée, la culpabilité était également présente, notamment vis-à-vis de la détresse de leur conjointe. Bien que les hommes interrogés souhaitaient soutenir leur conjointe, plusieurs ont évoqué leurs difficultés à remplir ce rôle de soutien.Ces résultats soulignent la nécessité de mieux considérer les difficultés des hommes lors d’une fausse couche et de les impliquer davantage dans la prise en charge de celle-ci.The experience and psychological consequences of a miscarriage have been widely studied but mainly among women. This qualitative study aims to examine the experience of men whose woman has had a spontaneous abortion.Thirteen men who have lost an early pregnancy during the five past years participated to a semi-directive interview. The interview was based on the analytical framework previously established and took into account various themes such as psychological experience, marital relationship, guilt, coping strategies, social support given to the spouse, and significance of the loss. All the interviews have been transcribed and studied with a thematic analyse.Results underline the difficulties linked to the experience of miscarriage among men. Many of them were shocked and have had a sustainable significant distress expressed by sadness, tears or depressive symptoms. In addition to their own difficulties, men have to confront women's distress and want to be a support. Guilt was expressed more or less directly, concerning the miscarriage but also concerning men's reactions toward women. Some of them who encountered psychological problems found very difficult not to be able to support their wife. A miscarriage is a difficult event for a couple and two men interviewed separated shortly after. Several coping strategies were used by men, the most common were seeking social support and avoidance. As in women, significance of the loss was different among men, some of them have lost a child, others an embryo or a life project.Results show the variety of feelings and reactions of men that highlight the need to consider their psychological distress. While all men are not equally involved in miscarriage, difficulties encountered by some of them can last several months. Given this results, support interventions for males seems interesting.

To identify factors associated with high levels of fear related to rheumatic disease in patients with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA). Cross-sectional assessment of unselected patients with RA (ACR/EULAR criteria) or axSpA (ASAS criteria) attending routine appointments in France during 2014–2015. Patients completed the self-reported “Opinions and fears of patients with chronic inflammatory rheumatism” (QOC-RIC) questionnaire,1including 18 fear items related to progression/consequences of the disease and 5 related to treatment; each scored 0–10 (10 indicating “totally agree”). Descriptive analysis reported the percentage of patients with scores ≥7/10. Hierarchical descending cluster analysis identified homogeneous pt groups (clusters) according to their fears. Backward stepwise multiple linear regression (multiple imputation for missing data) explored association between fear scores and a range of patient characteristics. 672 patients recruited by 100 rheumatologists were analysed. For RA (n=432) and axSpA (n=240), respectively, 74% and 45% were female, mean(SD) age was 58(±13) and 47(±13) years, 77% and 73% were treated with biologics. RA and axSpA patients met the accepted ACR/EULAR or ASAS criteria, respectively. Four clusters were identified, grouping patients with similar fear intensity scores: highest (31.6%), high (21.9%), moderate (32.7%), low (13.8%). Highest fear scores were associated with gender (female vs male; OR[95%CI]=2.16[1.17–3.98]), employment status (employed vs retired; 2.80[1.47–5.33]), helplessness (AHI score; ≥20 vs <20; 4.90[2.39–10.03]), anxiety (HADS anxiety score; >10 vs <8; 5.06[2.19–11.69]) and depression (HADS depression score; ≥8 vs <8; 3.61[1.45–9.01]). A trend to higher fear scores was observed for patients with axSpA vs RA (1.98[0.99–3.94]). The most fearful patients were more likely to be women with higher helplessness and anxiety/depression scores. Fearfulness may reflect overall psychological distress in this patient population and interventions to decrease these fears should be assessed.

In France, the ECLAIR non-interventional, multicenter study was initiated to follow up real-world, moderate-to-severe, active RA patients treated with certolizumab pegol (CZP), prospectively for up to 3 years. In 2003, prescription of glucocorticoids (GCs) in French patients with active RA was evaluated,1 showing that >50% received GCs, although GC use has not been comprehensively studied to date.1The objective is to describe baseline characteristics of French RA patients starting CZP, such as disease and treatment history, and concomitant medication. The ECLAIR study, run by 170 rheumatologists and 6 internal medicine specialists, was designed to be representative of the French RA population. Baseline data, collected from treating physicians and patients via questionnaires, included history of RA treatments and concomitant diseases and their treatments. 791 patients were included: 790 were used for analysis, 1 was excluded for lack of signed informed consent. Patient characteristics: mean (SD) age 55.0 (13.1); 78.7% female; RA duration 8.9 (9.1) years; 73.4% rheumatoid factor positive; DAS28(ESR) 4.9 (1.3); disease activity moderate for 50.1% and high for 41.1% of patients. Mean HAQ-DI total score: 1.28 (0.69). Concomitant diseases: 23.2% (183/790) of patients had vascular disorders, 19.1% (151/790) metabolism and nutrition disorders and 17.5% (138/790) musculoskeletal and connective tissue disorders. Concomitant treatments included NSAIDs in 35.2% of patients, steroids in 51.4% of patients and cDMARDs in 64.6% of patients (MTX: 53.5%, leflunomide: 9.0%, hydroxychloroquine: 2.8%, sulfasalazine: 2.4%, azathioprine: 0.3%, thalidomide: 0.1%). ECLAIR is the first anti-TNF, prospective, real-world study conducted in France, providing insights into the population of RA patients treated with anti-TNF therapy such as CZP. Baseline data showed that half of patients on CZP received GCs, similar to previous reports in the French RA population.1Further targeted statistical analyses on ECLAIR data could clarify trends associated with concomitant medication. REFERENCES: 1. Saraux A. J Rheumatol 2006 Jul;33:1258-6

Background In France, the ECLAIR non-interventional, multicenter study was initiated to follow up moderate to severe, active rheumatoid arthritis (RA) patients treated prospectively with CZP up to 3 years. The study is designed to provide real world evidence on RA evolution and disability progression with CZP in France. In 2003, the prescription of GCs in patients with active RA in France was evaluated and showed that >50% received GCs, although use of GCs has not been comprehensively studied to date.1 Objectives To describe the baseline characteristics of French RA patients starting CZP, such as disease and treatment history and concomitant medication. Methods The ECLAIR study, run by 170 rheumatologists and 6 internal medicine specialists, was designed to be representative of the French RA population. Baseline data, provided by the treating physician or through patient questionnaires, included history of RA treatments, concomitant diseases and treatments. The current baseline analysis was of descriptive nature; no formal statistical comparison was implemented. Results 791 patients were included: 790 used for analysis, 1 excluded due to lack of signed informed consent. Patient characteristics: mean (SD) age 55.0 (13.1) years; 78.7% female; RA duration 8.9 (9.1) years; 73.4% rheumatoid factor positive; DAS28(ESR) 4.9 (1.3); disease activity was moderate for 50.1% and high for 41.1% of patients. Mean HAQ-DI total score was 1.28 (0.69). Concomitant diseases: 23.2% (183/790) of pts had vascular disorders (mainly hypertension: 19.5%), 19.1% (151/790) metabolism and nutrition disorders (dyslipidemia: 12.0%, diabetes: 5.1%) and 17.5% (138/790) musculoskeletal and connective tissue disorders (osteoporosis: 6.2%, Sjögren9s syndrome: 2.4%). Previous treatments were: NSAIDs in 54.4% (430/790) patients, steroids in 77.3% (611/790) patients, cDMARDs in 97.7% (772/790) patients (MTX: 94.1%, other DMARD: 51.8%) and bDMARDs in 31.9% (252/790) patients (anti-TNFs: 29.5%, other biologic: 12.8%). Concomitant treatments included NSAIDs in 35.2% patients, steroids in 51.4% patients and cDMARDs in 64.6% patients (MTX: 53.5%, leflunomide: 9.0%, hydroxychloroquine: 2.8%, sulfasalazine: 2.4%, azathioprine: 0.3%, thalidomide: 0.1%). Conclusions ECLAIR is the first anti-TNF prospective real-life study conducted in France, providing insights on RA patients treated with anti-TNF therapy, such as CZP. Baseline data showed that a third of patients received CZP as monotherapy and a half of patients on CZP also received GCs, which is similar to that reported earlier in the French RA population.1 Further targeted statistical analyses of ECLAIR data after study finalization could clarify trends associated with concomitant medication. References Saraux A. J Rheumatol 2006;33:1258–1265. Acknowledgements The authors acknowledge Costello Medical Consulting for editorial assistance which was funded by UCB Pharma. Disclosure of Interest A. Saraux Consultant for: UCB Pharma, R.-M. Flipo Consultant for: UCB Pharma, F. Fagnani Consultant for: UCB Pharma, I. Bru Employee of: UCB Pharma, G. Cukierman Employee of: UCB Pharma, J.-M. Joubert Employee of: UCB Pharma, W. Czarlewski Employee of: UCB Pharma, J. Dunkel Employee of: UCB Pharma, J. Massol Consultant for: UCB Pharma, B. Combe Consultant for: UCB Pharma

Background Few studies have analyzed the impact of rheumatoid arthritis (RA) on workplace insertion and occupation of patients in France. However, the overall negative impact of RA on work capacity has been shown previously. Objectives To investigate the contribution of different socio-economic and clinical factors to absenteeism and loss of work capacity in a population of RA patients below 60 years of age in France in 2012. Methods A national retrospective survey was conducted in a population of patients recruited by rheumatologists practising in hospitals or private practices during a visit, and/or were members of a patients association (ANDAR). The patients responded to a structured telephone interview with an investigator. The data collected included the current employment situation and its history, the functional impact of RA (Health Assessment Questionnaire [HAQ] score), the frequency of flares, work stoppages and disability allowance. Results 503 patients agreed to participate, and 488 were interviewed (97%). In this study population (mean age 49.5±7.7 years and 84.4% women), the disease duration of RA was 12.2 (±9.2) years. 364 patients (74.6%) were employed, 31 (6.4%) unemployed and 93 (19.1%) were out of the labor market. For the 31 unemployed patients, the impact of RA occured as a factor of loss of employment and restriction of access to the labor market. For the 93 patients out of the labor market, discontinuation of professional activity was due to RA for three quarters of them (73%), explained by fatigue (75%), pain or stiffness (25%), or difficulty in moving (25%). The main results of the group of 364 patients in employment according to the HAQ score are shown below. The mean HAQ score was low (0.8) and the mean disease duration was 11.6 years. The proportion of patients receiving biological treatment was very high (60.4%), compared with 24.8% of patients under 60 years of age in the French national representative claims database (“Echantillon Généraliste des Bénéficiaires”) in 2011. This high proportion may also explain the low HAQ. With a HAQ score equal or greater than 1.5, 68.4% of patients reported at least one work stoppage in the last 12 months for an average of 91.6 days; this proportion was 48.3% for all active employees (p<0.0001). Regression analyses suggest that the HAQ score is the major factor contributing to absenteeism, regardless of patients9 socio-economic characteristics. Conclusions The impact of RA on work capacity is important, affecting work stoppages, loss of employment and part-time work. Lost productivity associated with RA is related to the level of HAQ, which suggests that better control of the disease would reduce this loss of productivity. Acknowledgements The authors acknowledge Costello Medical Consulting for editorial assistance which was funded by UCB Pharma. Disclosure of Interest P. Bertin: None declared, F. Fagnani Grant/research support: UCB Pharma, Consultant for: CEMKA-EVAL, A. Duburcq Grant/research support: UCB Pharma, Consultant for: CEMKA-EVAL, A. Woronoff: None declared, P. Chauvin: None declared, G. Cukierman Employee of: UCB Pharma, S. Tropé-Chirol: None declared, J.-M. Joubert Employee of: UCB Pharma, G. Kobelt: None declared DOI 10.1136/annrheumdis-2014-eular.2361

Background Claims databases are useful tools to conduct epidemiological studies on representative samples in terms of patient’s profile, drug use and pattern of care. Objectives To describe the characteristics and medical management of RA patients in France over the period 2009/2010 and compare to a control group in terms of comorbidity. Methods The EGB database (total adult population around 380,000) is a national representative sample of individuals covered by the main French Public Sickness Fund. It collects all items of medical resource consumption in hospital and ambulatory setting. Beneficiaries of full coverage are identified due to the presence of any severe chronic diseases among a list of 30 defined by the Sickness Fund. RA patients were selected as benefiting from full coverage for the diagnosis ICD-10 M05-06 on January 1, 2009. A control group matched on sex, age and eligibility to “CMUc” (“Couverture Maladie Universelle complémentaire”, an indicator of precarious living conditions) was identified in the EGB to compare the frequency of comorbidities (n=3,888). Results 1,296 individuals with RA were identified, corresponding to a crude prevalence rate of 3.47/1,000. The gender ratio M/F was 0.33, mean age 63.3±14.8 years, with a time since admission to full coverage for RA of 8.8±7.2 years (<2 years in 23.8% of patients). Table 1 presents the frequencies of comorbidity among RA patients and controls as defined through eligibility to the corresponding full coverage. Of identified RA patients, 214 (16.5%) received a biological agent: a TNF-inhibitor in 85% of cases (etanercept 51.3%, adalimumab 20.1%, infliximab 12.6%, rituximab 9.8%, abatacept 4.2%, tocilizumab 0.5%, anakinra 0.5%). Over the period 2009/2010, 79.4% of patients treated with biological agents received/took only one drug, 15% two, and 5.6% three drugs. Among 71 RA patients treated with first-line biological agents, a TNF-inhibitor was most frequently prescribed (71.9%), followed by rituximab (19.7%), abatacept (7%) and tocilizumab (1.4%). Conclusions This analysis suggested that TNF-inhibitor adherence was similar in France to the results derived from other registries. Some differences were observed in frequencies of certain comorbidities between RA patients and controls (decrease in Alzheimer’s Disease, increase in hypertension and Ischemic Heart Disease) but further analysis should be performed to confirm this preliminary finding by taking into account more relevant clinical criteria for identifying comorbidities. Acknowledgements The authors acknowledge Costello Medical Consulting for editorial assistance which was funded by UCB Pharma. Disclosure of Interest B. Fautrel Consultant for: UCB Pharma, J.-M. Joubert Employee of: UCB Pharma, G. Cukierman Employee of: UCB Pharma, C. Laurendeau Consultant for: UCB Pharma, J. Gourmelen Grant/research support from: UCB Pharma, F. Fagnani Consultant for: UCB Pharma

To investigate the contribution of different socio-economic and clinical factors to absenteeism in the workplace in a population of Rheumatoid Arthritis (RA) patients currently in employment. A national retrospective survey was conducted in French RA patients (age <60, either employed or unemployed) recruited by rheumatologists or who were members of a patients’ association (ANDAR). Patient-reported outcomes, socio-economic characteristics and various measures of productivity loss were collected using structured telephone interviews. Multivariate regression analyses were performed to identify the contributing factors to absenteeism. A sample of 503 patients agreed to participate, of which 488 were evaluable. 364 patients (74.6%) were in employment, 31 (6.4%) were unemployed and 93 (19.1%) were out of the labor market. Among the 364 patients currently in employment, 102 (28.0%), 138 (37.9%) and 124 (34.1%) were in ACR functional class of I, II and III/IV, respectively. The mean HAQ scores were 0.6, 1.4 and 1.5 (p<0.0001), and 2.9%, 16.7% and 29.0% (p<0.0001), respectively, had an occupational disability status. An overall proportion of 48.3% patients declared an RA associated work absence over the last year. This proportion increased from 28.4% in ACR I to 62% in ACR III/IV group, and from 7.8% to 31.4% (p<0.0001), respectively, for absence >1 month. Despite a high uptake of biologic agents (60.4%) among these patients, RA was active for a significant period of time; mean 2.2 (±3.2) months in ACR I group and 4.8 (±4.2) months in ACR III/IV group. Regression analyses suggested that ACR functional class and frequencies and duration of flares were the major factors contributing to absenteeism, far ahead of any other socio-economic characteristics. Loss of productivity due to RA could be further reduced through better control of disease activity.

To describe the current medical management of Rheumatoid Arthritis (RA) patients in routine practice in a national representative sample of patients, focusing on biological agents (BA) uptake. The EGB database is a 1/97 representative sample of the national claims database covering the whole French population. RA patients were identified as adults (age >18) benefiting from full coverage (“ALD” eligibility criteria) for RA (ICD-10 codes M05-06) on January 1, 2009. Patients treated by BA were defined as RA patients with at least one claim for at least one BA over the period. BA-naïve treated patients were identified by the absence of a BA claim during the first 3 months of the study period, followed by at least one BA claim. Over the 3-year period, 236 patients had a BA reimbursed and 5,336 deliveries by pharmacists were observed. The proportion of BA users, either alone or in combination, was 14.0% in 2009, and 70 patients (32.7%) used a BA in combination with methotrexate. Among patients treated by BA, 85.2% used at least one TNF inhibitor during the study period. Etanercept had the highest delivery record (58.1%), followed by adalimumab (28.8%) and infliximab (15.3%). Among the whole group of patients treated by BA, 13.6% were delivered rituximab at least once. Over the period, a proportion of 73.3% of patients had one BA agent only, 19.1% experienced one switch and 7.6% had two or more switches. At 18 months, drug survival rate of the mix of first-line biologics was 71.8% [95% CI: 60.1% - 80.6%]. Claims database is a useful tool to describe the medical management of RA patients. These observations suggest that BA clinical use in RA disease management in France is similar to other existing European registries data.

To examine the resource utilization and direct costs of care associated with use of biologic agents therapy among prevalent rheumatoid arthritis (RA) patients based on retrospective health care claims data. The database (EGB) is a 1/97 representative sample of the national claim database covering the whole French population. RA patients were identified as adults (age >18) benefiting from full coverage (ALD eligibility criteria) for RA (ICD-10 M05-06) on January 1, 2009 and still alive on December 31st, 2010. Biologics treated patients (BTP) were defined as RA patients with ≥1 claim for biologics in 2010. All health expenses were assessed from the payer's perspective. A log-linear generalised model was used to adjust the costs in comparing BTP versus patients not treated by biologics (BNP). A total of 1,234 RA patients were identified of whom 199 (16.0%) were treated with biologics (BTP) including TNF inhibitors in 85% of cases. In comparing patients not treated by biologics (BNP) versus BTP, the proportion of male patients (24.1% versus 24.1% p=0.99) nor the time since registration for RA coverage (8.5 versus 9.0 years p=0.33) were significantly different but BTP patients were significantly younger 55.2 years ± 12.9 versus 64.1 years ± 14.5 (p<0.0001). The unadjusted per capita annual expenses of BTP were three times higher than in BNP (15,581 € versus 4,892 € - p<0.0001). Drug costs were respectively 8,477 € (54.4% of total) versus 1,151€ (23.5% of total) (p <0.0001) and in-patient care 4,878 € (31.3% of total) versus 1,696 € (34.7% of total) (p< 0.0001). After adjustment for age, the mean annual extra cost of patients on biologics was in the range 11,000 € - 12,000 €. When compared to similar data prior to the era of biologics, the structure of medical expenses in RA patients has shifted from in-patient care towards drugs.