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Objectives: While multiple studies have investigated treatment persistence rates with intravenous abatacept, limited information is available about real-world treatment continuation with the subcutaneous form. The international ASCORE study described the characteristics and treatment persistence of real-world patients with rheumatoid arthritis (RA) receiving subcutaneous abatacept. This article presents the findings of the French cohort., Methods: This was an observational study in French RA patients who initiated subcutaneous abatacept between August 2014 and January 2017. The primary endpoint was treatment maintenance at 2 years, analysed according to the number of previous biologic therapies., Results: Of 546 evaluable patients, 281 (51.5%) were biologic-naive, 265 (48.5%) had experienced failure with 1 (n=134; 24.5%) or ≥2 (n=131; 24.0%) biologic therapies. At enrolment, patients who had experienced failure with ≥1 biologic therapy had more erosions and a longer duration of RA compared with biologic-naive patients, but had comparable mean disease activity scores. Overall, 43.0% of patients (95% confidence interval 38.6-47.2) were still taking subcutaneous abatacept at 2 years, which was comparable with that in other countries participating in ASCORE. The abatacept persistence rate was higher in biologic-naive patients (48.8%) than in those with 1 (40.9%) or ≥2 (32.8%) biologic therapy failures. The main reason for discontinuing abatacept was lack of efficacy (46.6%)., Conclusions: In current practice in France, the rate of subcutaneous abatacept persistence at 2 years was comparable with that of the intravenous form. Treatment persistence was higher when abatacept was used as first-line versus later-line biologic therapy.

Objectives: Biologic disease-modifying antirheumatic drugs (bDMARDs) are prescribed sequentially in the treatment of rheumatoid arthritis (RA). Healthcare decision makers continue to debate their use, mainly because of their high costs. Our aim was to perform an economic evaluation for France of bDMARD sequences for treatment of moderate-to-severe RA after inadequate response or intolerance to conventional DMARDs (eg, methotrexate)., Methods: A discretely integrated condition event simulation was developed to track the course of patients from first bDMARD through switches to further lines in a sequence. The model included 11 events, 91 conditions, and 21 controlling equations. Inputs were obtained from a meta-analysis of clinical trials, a French registry, national drug lists, and databases. Survival, time with minimal activity, quality-adjusted life-years (QALYs), and total costs were output. Structural and probabilistic sensitivity analyses were conducted., Results: Sequences starting with etanercept biosimilars (ETB) cost less, with ETB-abatacept-infliximab the least expensive: the mean lifetime discounted total cost was €116 912 per patient, with a mean of 11.166 QALYs. Most other strategies were dominated or led to small QALY gains (0.0008-0.0329). Only ETB-tocilizumab-abatacept made it onto the efficiency frontier, but at €955 778 per QALY gained. These results were confirmed in several scenarios and uncertainty analyses., Conclusion: Given minor differences in QALYs gained between bDMARD sequences with large cost differences, starting with biosimilars was more efficient than starting with branded products. Our model and findings should provide French and other decision makers with useful tools to address the challenges of comparing sequences of treatments for RA., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objectives: Abatacept retention rates were evaluated in the French cohort in the prospective ACTION study (2010-2013), which included patients with moderate-to-severe rheumatoid arthritis managed in everyday clinical practice and started on intravenous abatacept therapy., Methods: Two-year abatacept retention rates were evaluated in 455 patients classified according to treatment line, body mass index (BMI), and status for rheumatoid factor (RF) and anti-citrullinated peptide antibody (ACPA)., Results: After 2 years, the overall abatacept retention rate was 44%. The retention rate was non-significantly higher in the patients with vs. without a history of unresponsiveness to at least one biologic (48.1% vs. 41.8%, respectively). No significant retention rate differences were found across BMI categories (444 patients; <25, 45.5%; ≥25 to <30, 48.9%; and ≥30, 36.6%). Neither were any significant differences demonstrated according to RF and ACPA status (RF+ and ACPA+, 45.7%; RF+ or ACPA+, 43.8%; and FR- and ACPA-, 39.1%)., Conclusion: The 44% 2-year retention rate in the French ACTION cohort supports the usefulness of abatacept therapy. In this study, retention was not associated with treatment line, BMI, or antibody status., (Copyright © 2019 Société française de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.)

Objective: Information and education are recommended for patients with inflammatory arthritis including rheumatoid arthritis (RA) and spondyloarthritis (SpA). However, there is no consensus on which knowledge is essential to enhance patients' self-management. The aim of this study was to determine such knowledge., Methods: Based on published knowledge questionnaires (KQs) collected by a systematic literature review, a list of items was elaborated, classified in domains and sub domains. A Delphi process was performed with rheumatologists, healthcare professionals and patients in 2014-2015, selecting the items considered useful., Results: Three published KQs were analysed: 2 for RA; 1 for SpA and 5 unpublished KQs were collected. In the KQs, 90 knowledge items were mentioned for RA and 67 for SpA. The 1 st Delphi round enlarged the list to 322 items for RA and 265 items for SpA. The second round selected 69 and 59 knowledge items for RA and SpA respectively, of which 36 (52%) and 34 (57%) were not present or modified from the published KQs. Key domains included treatment strategies, managing cDMARDs and bDMARDs, managing symptomatic medications. Knowledge on non-pharmacological treatment concerned pain and fatigue, physical activity, adaptative skills to personal and professional environment, patient-HP communication and shared decision-making., Conclusion: The present study provides a corpus of knowledge considered essential for patients in the self-management of their arthritis. The selection of many items reflects recent emphasis on professional recommendations and the patients' perspective. Future work should lead to the development of new updated KQs for patients with inflammatory arthritis., (Copyright © 2019. Published by Elsevier Masson SAS.)

Objectives: Five TNF inhibitor (TNFi) agents are marketed for spondyloarthritis (SpA): 1 soluble receptor (SR) and 4 monoclonal antibodies (mAbs). From 15% to 30% of patients stop the first TNFi in the first 2 years, but we lack recommendations on the choice of the second TNFi. The aim here was to assess drug survival of a second TNFi in SpA and its determinants., Methods: This was a multicenter observational study of SpA patients who started a first TNFi in 2013 and 2014 and were followed to 2018. For the first and second TNFi, we retrospectively collected data on initiation and discontinuation dates, type of TNFi, and reasons for withdrawal. Kaplan-Meier plots and log-rank tests were used to compare drug survival. Factors associated with drug survival of the second TNFi were analyzed by univariate Cox regression analyses., Results: We included 244 patients. During a follow-up of 7,838 patient-months, 101 (41%) received 1 TNFi, and 143 (59%) switched to a second TNFi. Mean drug intake duration was significantly greater with the first than second TNFi: 21.7 (SD 19.6) and 15.4 (SD 13.6) months (P<0.001). When switching to another mAb or from an SR to an mAb (or the reverse), mean drug survival did not differ: 14.4 (SD 12.7) and 16 (SD 14.1) months (P=0.35). Factors associated with retaining the second TNFi were male sex (P=0.054) and age<41 years at SpA diagnosis (P=0.022). On multivariable analysis, only age<41 years at diagnosis remained independently associated with maintenance of the second TNFi., Conclusion: In SpA patients, drug survival is significantly longer with the first than second TNFi. Male sex and age<41 years at diagnosis were associated with retaining the second TNFi., (Copyright © 2019 Société française de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.)

Objective: To assess the patients' information about biosimilars and to identify the patients' incentives and deterrents to concur with the use of biosimilars., Methods: Nation-wide cross-sectional study assessing information and concerns about biosimilars of French patients treated for rheumatic inflammatory diseases, whether they were treated or not by a biological DMARD. The assessment was available online from March to July 2017., Results: Among the 629 respondents, 43% knew what biosimilars were. The main sources of information were rheumatologists and patient associations. Among patients treated with a biosimilar, 44% were not informed before they received the treatment. The patients' concerns focused on the non-similar molecular structure (46%), efficacy (60%) and safety (57%) comparatively to the originator biologic. 15% of respondents would refuse to switch their biologic to its biosimilar. More than 50% of respondents would warily accept to switch medications and interrupt the treatment if in doubt. Being informed about biosimilars and a good understanding of the definition of biosimilars were characteristics associated with better adherence to biosimilars. The rheumatologist was considered the most influent source of information about biosimilars and was considered reliable when deciding to switch a biologic to its biosimilar. Patient were reluctant to substitution of the medications by pharmacists (2%). Medico-economical issues acted as an incentive and a deterrent to accept the switch of medication., Conclusion: Biosimilars are largely unknown to patients. Information seems to be instrumental in improving the patients' adherence to biosimilars and could help preserving the therapeutic relationship and avoiding a nocebo effect., (Copyright © 2019 Société française de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.)

Objective: To assess the implementation of European recommendations for use of TNF inhibitors for spondyloarthritis (SpA), rheumatologists' level of knowledge of and adherence to the recommendations, and potential barriers to the application of recommendations., Methods: We conducted a retrospective study among 42 rheumatologists who initiated a first subcutaneous TNF inhibitor for SpA in 2013 or 2014. Thirty items from national and international recommendations were separated into 3 domains: indication, pretherapeutic monitoring, and management under TNF inhibitors. A standardized data collection procedure was used to gather data from medical files to assess the application of each recommendation. Questionnaires assessing the knowledge, level of adherence to each recommendation, and potential barriers to their implementation were sent to rheumatologists., Results: Rheumatologists applied a mean of 60% of items from domains A and B, but less than 50% from domain C items. Recommendations regarding the search for previous infection and the prevention of future infections were the ones most often applied. However, < 60% of rheumatologists assessed cancer and other diseases before TNF inhibitor initiation. More than 95% of rheumatologists knew of the recommendations and had a high level of adherence. Lack of time, difficulties accessing specialized consultations, and lack of flexibility in the recommendations explained rheumatologists' difficulties in applying the recommendations., Conclusion: Despite high levels of knowledge of, and adherence to, recommendations for using TNF inhibitors for SpA, rheumatologists' application was limited because of a lack of human and material resources.

Objectives: Excess adipose tissue in obese individuals may have immunomodulating properties and pharmacokinetics consequences. Previous studies have suggested that obesity could negatively affect the response to anti-TNF-α agents, notably infliximab (IFX). We aimed to determine whether body mass index (BMI) is involved in the response to IFX in rheumatoid arthritis (RA)., Methods: We retrospectively examined data for 76 RA patients receiving IFX. BMI was calculated before treatment, and change from baseline in DAS28, pain on a visual analog scale, erythrocyte sedimentation rate, C-reactive protein level, tender and swollen joint count was analysed at 6 months after treatment. The primary outcome was decrease in DAS28 ≥1.2. Secondary outcomes were good response and remission according to EULAR., Results: At baseline, the median [interquartile range] BMI was 26.6 [22.6-30.6] kg/m2. The number of patients with normal weight, overweight and obesity was 25, 29 and 22. In multivariable analyses, IFX treated patients with lower BMI showed a more frequent DAS28 decrease ≥1.2 (25.5 [22.3-28.3] vs. 28.0 [23.2-32.5], p=0.02, odds ratio [OR] 0.88 [95% confidence interval 0.79-0.98]), EULAR good response (25.3 [21.9-27.5] vs. 27.5 [24.3-31.2], p=0.03, OR 0.87 [0.76-0.99]) and EULAR remission, although not significant (25.3 [21.9-26.4] vs. 27.5 [23.2-30.9], p=0.14, OR 0.88 [0.75-1.04])., Conclusions: Obesity may negatively influence the response to IFX in RA. These data could help physicians to choose biologic agents for obese RA patients.

Introduction: Hydroxychloroquine (HCQ) is an important medication for treating systemic lupus erythematosus (SLE). Its blood concentration ([HCQ]) varies widely between patients and is a marker and predictor of SLE flares. This prospective randomised, double-blind, placebo-controlled, multicentre study sought to compare standard and adjusted HCQ dosing schedules that target [HCQ] ≥1000 ng/ml to reduce SLE flares., Patients and Methods: [HCQ] was measured in 573 patients with SLE (stable disease and SELENA-SLEDAI≤12) treated with HCQ for at least 6 months. Patients with [HCQ] from 100 to 750 ng/ml were randomised to one of two treatment groups: no daily dose change (group 1) or increased HCQ dose to achieve the target [HCQ] (group 2). The primary end point was the number of patients with flares during 7 months of follow-up., Results: Overall, mean [HCQ] was 918±451 ng/ml. Active SLE was less prevalent in patients with higher [HCQ]. A total of 171 patients were randomised and followed for 7 months. SLE flare rates were similar in the two groups (25% in group 1 vs 27.6% in group 2; p=0.7), but a significant spontaneous increase in [HCQ] in both groups between inclusion and randomisation strongly suggested improved treatment adherence. Patients at the therapeutic target throughout follow-up tended to have fewer flares than those with low [HCQ] (20.5% vs 35.1%, p=0.12)., Conclusions: Although low [HCQ] is associated with higher SLE activity, adapting the HCQ dose did not reduce SLE flares over a 7-month follow-up.

Objective: Psoriasis could be a paradoxical reaction to tumor necrosis factor-α antagonist therapy and it has been reported with rituximab therapy. Our objective was to assess the rates of new-onset and flare of preexisting psoriasis in patients taking rituximab for rheumatoid arthritis (RA)., Methods: The nationwide multicenter prospective AutoImmunity and Rituximab (AIR) registry was set up in 2006 by the French Society for Rheumatology to collect data on patients taking rituximab for joint diseases. We identified patients with RA in the registry who had psoriasis listed as an adverse drug reaction, and we obtained additional information from their physicians if needed. We computed the incidence rates of new-onset and flare of preexisting psoriasis according to the rituximab exposure time., Results: Among the 1927 patients in the registry with RA, 2 had new-onset and 5 had flare of preexisting psoriasis after a median followup of 39.2 weeks. Incidence rates were 1.04/1000 person-years (95% CI 0.13 to 3.8) for new-onset psoriasis and 2.6/1000 person-years (95% CI 0.84 to 6.1) for flare of preexisting psoriasis. Rituximab rechallenge in the 2 new-onset cases and in 2 flare cases was not followed by recurrence or exacerbation of psoriasis. Two of the 5 flare cases developed after discontinuation of methotrexate., Conclusion: Despite the small number of cases observed, leading to wide CI, the incidence rates in our study do not support a causative role of rituximab therapy in new-onset or flare of preexisting psoriasis in patients with RA.

Objective: To determine in real-life conditions the safety of treatment with rituximab (RTX) in patients with rheumatoid arthritis (RA) regarding malignancies., Methods: Analysis of safety data from a cohort of RA patients who received at least one course of RTX. RA patients with previous malignancies were followed-up and compared to the group of patients with no history of malignancy., Results: One hundred and eighty-six RA patients, 33 (17.7%) males, the mean age and disease duration were 55.8 ± 13.0 and 14.5 ± 11.1 years, respectively. The mean follow-up was 22.3 ± 15.1 months, corresponding to a follow-up of 346 pt-years of RTX exposure. Among these, 24 (12.9%) patients had a history of a prior malignancy. Five cancers were diagnosed during follow-up with four new malignancies (1 prostate, 1 breast, 1 colon and 1 cervical cancers) and one recurrence of a known breast cancer. The overall cancer rate was 1.45/100 pt-years (95%CI: 0.19 to 2.70), which is comparable to previously studied DMARD-treated cohorts. No new hematopoietic neoplasms were reported and the six lymphomas that have been in remission prior to RTX-therapy remained under follow-up. The baseline demographic and disease characteristics and the cancer-risk of the 24 patients who presented with a prior malignancy were similar to those with no cancer history (162 patients)., Conclusions: Although based on a modest number of observed cancers, and despite selection bias (12.9% of prior malignancies in our RTX treated RA), this observational study suggests that RTX does not increase the cancer risk in RA patients., (Copyright © 2010 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.)

Background: To describe the rate and timing of DMARD start in patients with early inflammatory arthritis in France, and to determine the factors leading to this treatment start., Methods: The ESPOIR cohort study collects data on patients presenting with early arthritis. Baseline characteristics were assessed, and Cox regression analysis was performed to estimate the likelihood of starting DMARD treatment over time, adjusting for patient-, disease- and physician characteristics., Results: Of the 775 analysed patients, 598 (77.2%) received at least 1 DMARD during the follow-up period, after a median time of 4.0 months. In general, a higher tender joint count, involvement of the hands, involvement of more than 3 joint groups, presence of abnormal CRP-levels or CCP-antibodies significantly increased the likelihood of being treated (p<0.01 for all determinants), as well as a positive result on the bilateral foot-squeeze test (p<0.04). In addition, a significant hetero-geneity in therapeutic strategy across the 14 tested French regions was found: adjusted hazard ratios for DMARD start ranged from 1 to 2.15 (p<0.01), depending on the region where a patient was followed. For anti-CCP test and swollen joint count we demonstrated a statistically significant interaction with geographic region, implying that these tests are interpreted differently across regions. The same factors that increased the likelihood to start a DMARD were related to an earlier start., Conclusion: Rate and timing of treatment start with DMARDs in patients with early inflammatory arthritis in France is determined by well known clinical and biochemical variables. Apart from these variables, however, unknown and intangible factors that seem to cluster geographically are responsible for important variations in practice performance.

Efficacy is mainly based on long experience but must be weighed against potentially severe adverse effects.

(1) Juvenile idiopathic arthritis is a chronic inflammatory rheumatic disorder of unknown cause. Spontaneous remission is frequent. Between 10% and 20% of patients have ocular involvement. (2) Nonsteroidal antiinflammatory drugs and physiotherapy are the cornerstones of patient management. Intra-articular steroid injection generally provides several months of relief. The place of immunosuppressants is difficult to ascertain, given their uncertain benefits and established long-term risks in children. There is no curative treatment at present.

Objective: To evaluate the quality of patient information about fluoroscopy-guided rheumatologic procedures, and to look for an impact on the patient's experience of the procedure., Methods: One hundred and nineteen patients completed questionnaires before and after undergoing fluoroscopy-guided interventions. We looked for associations between the information supplied by the rheumatologist who recommended the procedure and pain, anxiety, awareness of potential complications, and the match between patient expectations and actual experience., Results: 62.8% of patients reported receiving information about the procedure. Only 20.5% reported receiving specific information about potential adverse events, although 80.9% felt this information would have been useful. Most patients (74.8%) would have liked to receive additional information. Only 10.1% patients were given written information. Mean (+/-SD) anticipated pain severity as assessed in the waiting room before the procedure on a 0-10 scale was 4.5+/-2.4 in women and 4.2+/-2.3) in men. Actual pain severity during the procedure as assessed on the same scale was 2.7+/-2.6 in women and 2.2+/-1.6 in men. The level of information about the procedure did not influence anticipated or actual pain severity. Anxiety was reported by 59.8% patients and was more common in women (P<0.001), in patients given written information (P=0.05), and in patients undergoing their first intervention (P=0.05). Information was perceived as alleviating anxiety by 69.9% patients, and 77.3% of patients felt they would experience less anxiety if they had the procedure a second time. Only 21.2% patients were able to name a potential adverse event, and this proportion was not influenced by receiving written information. A mismatch between expectations about the procedure or its duration and actual experience was reported by 17 (17/69, 24.6%) and 34 (34/98, 34.7%) patients, respectively, with no significant differences across study subgroups., Conclusion: Information about interventional rheumatology procedures is required for ethical principles and legislation. Patients increasingly expect detailed information, which may increase the likelihood that the procedure unfolds smoothly. Our results indicate a need for optimizing patient information. Standardized written material deserves to be evaluated as a means of better meeting the informational needs of patients.

(1) There is no agreed treatment for patients with rheumatoid arthritis in whom first-line options, including methotrexate, have failed. Recent slow-acting antirheumatic drugs have not been compared with one another, but they seem to have similar risk-benefit ratios. Etanercept, a TNF-alpha antagonist, is the most convenient to use. (2) Adalimumab is the third TNF-alpha antagonist to be marketed in France for use in rheumatoid arthritis, after etanercept and infliximab. (3) The clinical evaluation dossier mentions no data from comparative trials with other slow-acting antirheumatic drugs used in refractory rheumatoid arthritis. (4) Placebo-controlled trials show that adalimumab alone has very modest efficacy. The best results are obtained when adalimumab is combined with methotrexate. On the basis of the least demanding criterion (ACR 20%), about two-third of patients are improved by this combination. (5) Clinical trials show that it is pointless to continue treatment with adalimumab for more than three months if efficacy is inadequate. (6) Adalimumab, like other TNF-alpha antagonists, can have potentially serious adverse effects, linked mainly to its immunosuppressive action. Opportunistic infections and cases of tuberculosis have been reported, even during short treatment periods. Many questions remain regarding long-term treatment effects, such as the risk of lymphoma, autoimmune disorders, and onset or aggravation of demyelinising diseases. (7) Adalimumab is given once every two weeks, subcutaneously, while etanercept 25 mg is given as two subcutaneous injections per week, and infliximab is given as an intravenous infusion every 8 weeks. (8) In practice, for patients with rheumatoid arthritis who do not respond to methotrexate and to other classical slow-acting antirheumatic drugs, etanercept is the best choice among recent slow-acting antirheumatic drugs.

Objective: To analyse drug consumption in the first years of rheumatoid arthritis (RA) in France, the Netherlands, and Norway, in a longitudinal study between 1991 and 1993., Patients and Methods: The EURIDISS cohort followed up over three years included 695 RA subjects with less than 5 years disease duration. Clinical and biological parameters, drug consumption according to ATC classification, and use of local treatment were recorded., Results: In the Netherlands consumption of second-line treatment occurred early on, and remained constant over time. In France, it was consumed by half of the subjects and decreased during follow-up (p<0.001). In Norway, 50% of the subjects were on second-line treatment at the outset. NSAIDs rather than corticoids were the most widely consumed. Patients underwent frequently local treatments with decrease frequency of infiltrations over time (p<0.001)., Conclusion: Second-line treatments were used in the first years of disease development, following varying sequences in the different countries.

A significant proportion of patients with rheumatoid arthritis have an aggressive, severe disease that may contribute to excess mortality. It has been suggested that early, aggressive therapy might improve the prognosis of these patients with active, severe rheumatoid arthritis. Combinations of disease modifying anti-rheumatic drugs including antimalarials are increasingly used in patients with active disease. While several open trials showed encouraging results, some controlled studies gave less support for the use of combination therapy. Ongoing controlled trials of double or triple combination therapy, such as hydroxychloroquine, methotrexate and sulphasalazine, should help define its place in treating patients with rheumatoid arthritis.