Objectives The aim of the study was to assess the contemporary frequency of adverse pregnancy outcomes in women with rheumatoid arthritis (RA) and to identify associated factors.Methods This French prospective multicentre cohort included pregnant women with RA between 2015 and 2021. Maternal characteristics, disease activity, treatments and pregnancy outcomes were analysed. Outcomes of pregnancies in women with RA were compared in univariable analysis with those of matched general population women from the 2016 and 2021 French perinatal surveys assessing maternal and neonatal health. Multivariable logistic regressions were performed to identify factors associated with adverse outcomes.Results A total of 100 pregnancies in 90 women with RA were analysed. Mean maternal age was 33.7±5.0 years and 57.6% were nulliparous. During pregnancy, 46% received glucocorticoids and 39% biologic disease-modifying antirheumatic drugs. Compared with the 359 controls from the general population, preterm birth (OR 2.08, 95% CI 1.04 to 4.09) and small for gestational age (SGA) (ORSGA 10th percentile 2.11, 95% CI 1.12 to 3.94; ORSGA 3rd percentile 3.21, 95% CI 1.13 to 9.44) rates were higher in RA pregnancies. SGA was associated with nulliparity (adjusted OR (aOR) 4.38, 95% CI 1.12 to 9.78), whereas preterm birth was associated with maternal age (aOR 1.14, 95% CI 1.01 to 1.30) and exposure to glucocorticoids at doses ≥10 mg/day during pregnancy (aOR 4.91, 95% CI 1.30 to 10.59).Conclusion In this contemporary cohort mostly followed in tertiary care centres, pregnancies in women with RA remained at increased risk of preterm birth and SGA. Exposure to systemic glucocorticoids at doses ≥10 mg/day emerged as a risk factor for preterm birth, although a contribution of maternal disease activity cannot be entirely excluded.
OBJECTIVES:To characterize the longitudinal evolution of B-cell biomarkers in patients with primary Sjögren's disease (SjD) and analyse their association with the clinical disease course. METHODS:We analysed data from the French multicentre prospective ASSESS cohort. Patients fulfilling AECG criteria with ≥2 visits including both immunological assessments and ClinESSDAI scores over a 5 years follow-up were included. Baseline B-cell biomarkers included immunoglobulin levels, monoclonal component, cryoglobulinaemia, complement fractions, RF and β2-microglobulin. Disease activity was assessed using ClinESSDAI score. Associations between the number of abnormal B-cell markers and disease activity were analysed using ANOVA and Kruskal-Wallis tests. Changes in IgG were evaluated according to the biological domain of the STAR index, defined as a relative decrease ≥10%. RESULTS:Among the 395 ASSESS participants, 362 met inclusion criteria. Mean follow-up was 56.4 months (±10.6), with a mean of 5.3 visits per patient (±0.5). B-cell biomarkers remained stable in 80.5%. According to STAR criteria, 43.1% were classified as biological responders to the biological domain of STAR based on IgG decrease, occurring mostly within the first year, without correlation with changes in ClinESSDAI or ESSPRI. Although baseline ClinESSDAI did not differ by the number of B-cell abnormalities (P = 0.096), patients with multiple B-cell activity markers-particularly ≥5-had an increased risk of persistent or worsening disease (OR 4.6, 95% CI 1.2-17.8; P = 0.002). CONCLUSION:B-cell biomarkers profile in SjD is largely stable over time. However, a high baseline 'B-cell burden' identifies patients at risk of poorer outcomes, supporting their use for stratification and monitoring.
OBJECTIVES:The VACIMRA trial demonstrated that delaying MTX initiation in RA by 1 month after the 13-valent pneumococcal conjugate vaccine (PCV13) improves humoral responses at 1 and 12 months. Whether this delay impacts disease activity and radiographic progression over 1 year remains uncertain. METHODS:This ancillary study compared changes in disease activity (DAS28-ESR) from inclusion (M0) to months 1, 2, 3, 6 and 12 between patients with early RA who started MTX immediately vs 1 month after PCV13. Structural progression was assessed using the van der Heijde-modified Sharp score (mSHS) on X-rays at inclusion, 6 and 12 months. The primary outcome was the proportion of patients in remission (DAS28-ESR < 2.6) or low disease activity (LDA) (DAS28-ESR ≤ 3.2) at 1 year. RESULTS:Among 276 VACIMRA participants, 100 were enrolled at the Montpellier centre (96 analysable at M0, 83 at M12). Both groups had similar baseline characteristics: mean age 58 ± 14 years, DAS28-ESR 4.88 ± 0.94, total mSHS 1.53 ± 3.62. Treatments during follow-up were comparable except for MTX cumulative dose at 1, 3, 6 months. At 12 months, remission (53.7% vs 46.3%, P = 0.51) and LDA rate (75.6% vs 61.0%, P = 0.15) were similar. DAS28-ESR was similar at 1 and 3 months but favoured the DELAY group at 6 (2.66 ± 1.07 vs 3.28 ± 1.34, P = 0.02) and 12 months (2.23 ± 1.03 vs 3.00 ± 1.16, P < 0.01). mSHS progression was comparable at 6 and 12 months. CONCLUSION:Deferring MTX for 1 month after PCV13 to enhance immunity did not worsen RA disease control, radiographic progression or treatment escalation after 1 year of follow-up.
OBJECTIVES:This study aimed to evaluate the prevalence of suspected fibromyalgia using the Fibromyalgia Rapid Screening Tool (FiRST) and its impact on disease burden, disability, TNF inhibitor (TNFi) initiation, and treatment retention over 10 years in patients with axial spondyloarthritis (axSpA) from the DESIR cohort. METHODS:The FiRST questionnaire was administered annually from year 7 to year 10. Missing FiRST data were imputed using longitudinal multiple imputation. Patients were classified as suspected fibromyalgia-positive at baseline if they were FiRST-positive (FiRST ≥5/6) at least twice after multiple imputation. Associations with disease outcomes over the 10-year period were assessed using mixed models for repeated measures, adjusted for TNFi use. TNFi initiation and retention over 10 years were compared using Kaplan-Meier analyses. RESULTS:The estimated prevalence of suspected fibromyalgia was 21.7% (144/663; 95% CI: 18.6-25.1). At baseline, suspected fibromyalgia was associated with a lower prevalence of HLA-B27 positivity and radiographic sacroiliitis, but similar rates of magnetic resonance imaging sacroiliitis and elevated C-reactive protein. Over 10 years, suspected fibromyalgia was consistently associated with higher self-reported disease activity, poorer health-related quality of life, and greater disability. Permanent disability at 10 years occurred more frequently in patients with suspected fibromyalgia (26.4% vs 9.4%; P < .001). TNFi initiation was more frequent (64.4% vs 46.1%), but treatment persistence at 1 year was significantly lower (42.0% vs 64.2%) in this group. CONCLUSIONS:Suspected fibromyalgia is common and clinically relevant in axSpA. It is associated with higher disease burden, increased biologic use, and poorer treatment persistence.
BACKGROUND/OBJECTIVE:Adherence to treatment in axial spondyloarthritis (axSpA) remains poorly documented, with estimates ranging from 28.2% to 70.6%. Psychological factors may influence adherence. This study aimed to assess adherence to biological disease-modifying antirheumatic drugs (bDMARDs) and evaluate the impact of catastrophizing, fibromyalgia, anxiety, and depression on adherence. METHODS:We conducted a 1-year multicenter cross-sectional study, including consecutive axSpA patients fulfilling ASAS criteria. Participants completed a self-administered questionnaire covering demographic data, disease characteristics, and activity scores. Adherence was assessed using the Girerd scale (GS); psychological assessments included the Pain Catastrophizing Scale (PCS), Fibromyalgia Rapid Screening Tool (FIRST), and Hospital Anxiety and Depression Scale (HADS). RESULTS:Among 500 patients, 49.2% showed good adherence (GS=0). Prevalence of catastrophizing, fibromyalgia, anxiety, and depression was 17.2%, 21.4%, 25.6%, and 11.0%, respectively. Good adherence was significantly associated with older age (mean 53.3 vs. 45.9 y; p<0.001), retirement status (26.4% vs. 12.6%; p<0.001), and lower educational level (OR: 1.84; 95% CI: 1.23-2.75; p=0.003). Poor adherence was linked to anxiety (OR: 1.53; 95% CI: 1.02-2.30; p=0.041) and catastrophizing (OR: 1.61; 95% CI: 1.00-2.58; P=0.049). In multivariate analysis, younger age (OR: 0.96; 95% CI: 0.95-0.98; p<0.001) and anxiety (OR 1.72; 95% CI: 1.05-2.81; p=0.031) remained significantly associated with poor adherence. CONCLUSIONS:About half of axSpA patients had suboptimal adherence to bDMARDs. Younger age, anxiety, and catastrophizing were associated with poor adherence and should be considered in patient management.
Les progrès observés depuis 30 ans dans le domaine de la spondyloarthrite axiale (axSpA) n’ont pas permis de répondre à toutes les questions se posant actuellement dans cette pathologie. Ce manuscrit présente les conclusions de la réunion de la French spondyloArthitiS Task force (FAST) qui s’est tenue à Besançon les 28 et 29 septembre 2023. Un travail préalable en sous-groupe a eu pour objectif d’évaluer l’état actuel des connaissances et d’identifier les besoins non couverts dans différents domaines de la axSpA sélectionnés par le comité de pilotage. Ces différents éléments ont fait l’objet d’une discussion collégiale durant les deux jours de réunion en présentiel. Les différents points de discussion ont ainsi été individualisés en tant que besoins non satisfaits : des biomarqueurs pour le diagnostic précoce et l’activité de la maladie, un dossier électronique commun dédié à la SpA à l’échelle nationale, une meilleure compréhension de la dysbiose dans la maladie, une check-list pour l’adressage au rhumatologue, l’adaptation des seuils des autoquestionnaires au sexe féminin, la mise en place de programmes de dépistage des comorbidités, les nouveaux outils d’imagerie, les approches cellulaires et multi-omiques en recherche, le regroupement, au niveau national, de différentes cohortes et registres, les études de stratégies thérapeutiques, la définition consensuelle de la maladie difficile à traiter et de sa prise en charge, le stade préclinique de la maladie, la maîtrise de l’IA en tant qu’outil dans les différents aspects de la recherche. Ces éléments peuvent représenter un cadre pour l’agenda de la recherche sur l’axSpA pour les années à venir.
OBJECTIVE:Our study aimed to estimate the incidence and risk factors of cancer among rheumatoid arthritis (RA) patients treated with tocilizumab (TCZ) and followed for five years in the French registry (REGATE). METHOD:The REGATE registry is a French prospective cohort study investigating the safety of TCZ in RA (registration no: 910346). Data were collected using an e-CRF between 2011 and 2016 and with a questionnaire specifically distributed to participating centers that reported malignancies in REGATE. We mainly focused on solid cancers, hematological malignancies, and non-melanoma skin cancers (NMSC). To identify potential risk factors associated with cancer, we performed a univariate analysis and a multivariate analysis using Cox proportional hazards models. RESULTS:Our study included 1496 patients with RA who were treated with TCZ for a mean duration of 32.0 (±22.0) months and followed for an average of 47 (±15.2) months, resulting in a total exposure of 3990.9 patient-years (PY). Of these patients, 63 (4.2%) were diagnosed with a total of 75 cancers during the follow-up period (35 solid neoplasms, 11 hematological malignancies, 3 melanomas, and 26 NMSC). The overall incidence of cancer excluding NMSC was 7.5/1000 PY (exposure time). Our multivariate analysis revealed that high age (HR=1.05 [1.02-1.08]), current smoker (HR=2.65 [1.27-5.53]) and male 2.38 [1,18-4,80]) were independent risk factors for solid cancers. Age and active smoking were associated with higher risk of hematological malignancies. CONCLUSION:We found no additional risk factors of cancer for RA patients under TCZ, beyond those already known in the general population.
OBJECTIVE:The objective of this study was to assess whether polypharmacy (PP) was associated with treatment response and serious adverse events (SAEs) in early rheumatoid arthritis (RA). Additionally, we aimed to investigate whether PP could serve as a surrogate marker for comorbidities. METHODS:We used data from the French cohort ESPOIR, a prospective study of early RA. PP was defined as a categorical variable stratified into two or three categories according to median of distribution in the cohort. A logistic regression model was used. We assessed the occurrence of SAEs (severe infections, hospitalizations, deaths) throughout a 10-year follow-up period. RESULTS:The proportion of patients who achieved DAS 28 remission (REM) one year after the initiation of the first disease-modifying antirheumatic drug (DMARD) was 32.1% in the PP group versus 67.9% in the non-PP group (P = 0.07) from 497 patients included. At five years, the proportion with REM was 45.0% in the PP group versus 56.3% in the non-PP group (P = 0.03). Patients taking two or more medications (excluding RA therapy) had a 40% lower likelihood of achieving REM at five years (adjusted odds ratio [OR] 0.60 [95% confidence interval (CI) 0.38-0.94], P = 0.03). At 10 years, patients receiving multiple medications had a 43% lower probability of achieving REM (adjusted OR 0.57 [95% CI 0.34-0.94], P = 0.02). The incidence of SAEs was 61 per 1,000 person-years. Among patients who developed SAEs, 86.4% were in the PP group and 49.8% were in the non-PP group (P = 0.03). CONCLUSION:PP is associated with a poorer treatment response and increased risk of SAEs. PP may serve as a good surrogate marker of comorbidities in epidemiologic studies.
OBJECTIVES:The aim of the study was to determine the frequency of adverse pregnancy outcomes in women with spondyloarthritis (SpA) in comparison to controls from the French general population, and to identify factors associated with these adverse pregnancy outcomes. METHODS:This French prospective multicentre cohort study included pregnant women with SpA (both axial and peripheral) according to their treating rheumatologist between December 2015 and June 2021. Maternal characteristics, disease activity, treatments, and pregnancy outcomes were analysed. Outcomes of pregnancies in women with SpA were compared to that of matched (1:4) general population women from the 2016 and 2021 French National Perinatal Surveys, including pregnancy, neonatal, and maternal outcomes. For adverse pregnancy outcomes that are significantly more frequent in patients with SpA, logistic regression analysis was performed to identify potential risk factors. RESULTS:A total of 135 SpA pregnancies in 124 women were analysed: they have a mean age of 32.1 years, a mean disease duration of 6.3 years, and 50.4% were nulliparous. Small for gestational age (SGA) was the most common adverse pregnancy outcome and occurred more frequently in women with SpA compared to controls (17.4% vs 9.8%, odds ratios = 1.94, 95% CI 1.09-3.39). Other adverse pregnancy outcomes rates, including preterm birth and caesarean delivery, were comparable to the general population. No predictor of SGA was identified in women with SpA. CONCLUSIONS:In this contemporary cohort, compared to the general population, SpA was associated with a higher risk of SGA, but no other adverse pregnancy outcomes, providing reassurance for most pregnant women with SpA.
Objectives This post hoc analysis evaluated change from baseline (Δ) in weight/body mass index (BMI) and association with disease activity or lipid changes in tofacitinib‐treated patients with rheumatoid arthritis (RA). Methods Data up to month 12 were pooled from eight phase 3 and 3b/4 studies of patients with RA receiving tofacitinib 5 or 10 mg twice daily or tofacitinib 11 mg modified‐release once daily (alone or combined with conventional synthetic disease‐modifying antirheumatic drugs), or placebo. Assessments included Δweight/BMI and the proportion of patients with weight gain ≥5%, at months 3, 6, and 12. Correlations between ∆weight/∆BMI and baseline/∆Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28‐4[ESR]), baseline C‐reactive protein (CRP), and ∆lipids were assessed. Statistical analysis included a longitudinal linear mixed model for repeated measures. Results The analysis included 5,335 patients (tofacitinib 5 mg twice daily [n = 2,349], 10 mg twice daily [n = 1,611], 11 mg once daily [n = 694], and placebo [n = 681]). Increases in least squares mean Δweight and ΔBMI were significantly greater (P < 0.05) at months 3 and 6 with all tofacitinib doses versus placebo; increases continued to month 12. Significantly greater (at least P < 0.05) proportions of tofacitinib‐treated patients (all doses) had weight gain ≥5% at months 3 and 6 versus placebo. There were weak correlations between weight/BMI changes with tofacitinib and DAS28‐4(ESR), baseline CRP, or lipid changes. Conclusion Patients receiving tofacitinib experienced weight and BMI changes (primarily increases) over time, with weak correlations with disease activity or lipids.
BACKGROUND:Pneumococcal vaccination is recommended for patients with rheumatoid arthritis. Because immunosuppressant therapies for rheumatoid arthritis hinder vaccine efficacy, vaccination should be administered before initiating immunosuppressive drugs. We aimed to compare humoral responses in patients with rheumatoid arthritis receiving the pneumococcal 13-valent conjugate vaccine (PCV13) before methotrexate initiation or simultaneously. METHODS:In this randomised, multicentre, open-label trial, patients were recruited from 26 rheumatology departments in 22 university hospitals and four general hospitals in France. Adult patients (aged 18-80 years) with active rheumatoid arthritis (Disease Activity Score in 28 joints >3·2), who were naive to targeted disease-modifying anti rheumatic drugs (DMARDs), had not had methotrexate or leflunomide in the past 3 months, and had no previous pneumococcal vaccinations were included. Patients were excluded in case of treatment with methotrexate or with leflunomide within the previous 3 months and absolute or relative contraindications to methotrexate. Patients were vaccinated with PCV13 at randomisation, before being randomly assigned (1:1) to either the immediate group (methotrexate treatment [maximum dose 15 mg per week] initiated at the same time as PCV13 vaccine) or the delay group (methotrexate initiated 1 month after PCV13 vaccine). Randomisation was stratified by sex (self-reported) and DMARD naive status. 2 months later, patients in both groups were vaccinated with the 23-valent pneumococcal polysaccharide vaccine. Humoral responses, disease activity, infections, and adverse events were assessed at baseline and at 1, 3, 6, and 12 months after PCV13. The primary outcome was the responder rate at 1 month, defined by positive responses against at least three of five target serotypes (ie, 1, 3, 5, 7F, and 19A). Responders were defined according to a 2 or more-fold increase in IgG concentrations with ELISA or opsonophagocytic assay compared with baseline. The main analysis was performed in the modified intention-to-treat population, including all randomly assigned patients with a valid measure of the primary endpoint, analysed in their assigned group. There was no involvement of people with lived experience in the study design or implementation. The trial was registered at ClinicalTrials.gov (NCT01942174) and is completed. FINDINGS:Between Sept 27, 2013, and Oct 10, 2019, 276 patients with rheumatoid arthritis were randomly assigned. 27 patients were excluded, of whom four patients dropped out, and 249 patients were included in the modified intention-to-treat population (126 [51%] in the delay group and 123 [49%] in the immediate group). 174 (70%) patients were female and 75 (30%) were male, the mean age at enrolment was 55·6 years (SD 14·8). Responder rates were higher in the delay group compared with the immediate group for IgG concentrations (relative risk 1·46 [95% CI 1·10-1·92]; p=0·02) and for opsonophagocytic assay activity (1·65 [1·25-2·19]; p=0·01), adjusted for sex and true DMARD naive status. At 12 months, antibody functional activity was significantly higher for eight of 13 serotypes in the delay group. Cumulative doses of corticosteroids and the number of patients who had targeted DMARDs were similar between groups throughout. 72 (11%) of 649 adverse events were serious (including one vaccine-related serious adverse event) in both groups and were equally frequent between groups, and the rheumatoid arthritis disease activity score remained comparable during follow-up. INTERPRETATION:In patients with early rheumatoid arthritis, the PCV13 vaccine administered 1 month before methotrexate allowed for improved immunological responses without significant effect on disease control during one year of follow-up. Future steps are to confirm these results with PCV20 or PCV21 and assess the best time frame for the booster vaccine. FUNDING:Government of France and Pfizer. TRANSLATION:For the French translation of the abstract see Supplementary Materials section.
Background: Rheumatoid arthritis (RA) regularly affects women of childbearing age1. A higher obstetric morbidity in women with RA is suggested in the literature in several countries, but no comparison between patients with RA and women in the general population is available for France. Objectives: The aim of the study was to compare adverse fetal, maternal and pregnancy outcomes in women with RA with matched controls from the French general population. Methods: We conducted a matched comparative study of RA patients included in the GR2 (Groupe de Recherche sur la Grossesse et les Maladies Rares) national multicentre cohort from 2014 to June 2021 and controls from the French general population included in the French national perinatal surveys (Enquête Nationale Périnatale)2. The latter is a national survey carried out for one week every 5 years and recording around 13 000 births. As births before 22 gestational week (GW) and birth weights < 500 grams were excluded from the French national perinatal survey, the same exclusion criteria were applied to women with RA from the GR2 cohort. Each pregnancy in patients with RA was matched to 4 pregnancies in controls on age group (≤ 29, 30-34, 35-39, or ≥ 40 years), parity, area of residence, and gemellity. These matching variables were chosen according to their association with adverse pregnancy outcomes (potential confounders). Births in the GR2 cohort between 2015 and 2018 were matched to births in the 2016 survey and those between 2019 and 2021 were matched to births in the 2021 survey. RStudio's MatchIt package was used to match RA patients to controls. The frequency of each adverse pregnancy outcome was compared between the two groups using Fisher's exact test or Chi-2. Odds ratios (OR) and their 95% confidence intervals (CI) were calculated for each variable. Results: Of the 92 patients with RA included in the GR2 cohort, 83 (including one twin pregnancy) were retained after excluding births before 22 GW and/or birth weight < 500 grams. They were matched with 332 control pregnancies from the French national perinatal survey (180 pregnancies from the 2016 survey and 152 from the 2021 survey). The mean age of RA patients was 33.7 (± 5.06) years and 53% were nulliparous. Preterm birth was significantly higher in newborns of RA patients than in newborns of controls (16.9% versus 6.3%, p < 0.01). Among the cases of preterm birth, only one case of extreme prematurity (at 30 GW) and no case of very extreme prematurity were found in the GR2 cohort. However, there was no significant difference for gestational diabetes nor macrosomia (despite the use of corticosteroids at least once during pregnancy in 42.1% of RA patients), gestational hypertension, low birth weight, severe postpartum hemorrhage, maternal or neonatal transfer to intensive care unit or congenital malformation between the two populations (Table 1). Conclusion: This study found an increased risk of preterm delivery in RA patients compared with control women in the French general population, which is consistent with an increased risk observed in other countries. These results raise the need for particular attention to obstetrical follow-up in these patients and providing useful insights for physician-patient dialogue. Table 1. Matched comparative analysis of adverse fetal, maternal and pregnancy outcomes in RA patients (GR2 cohort) and control women of the French general population (2016 and 2021 French national perinatal surveys). REFERENCES: [1] Van den Brandt S. Arthritis Res Ther. 2017;19(1):64. [2] https://enp.inserm.fr/ Acknowledgements: The GR2 Cohort is supported by the French Society of Rheumatology, the French Internal Medicine Society, and unrestricted grants from UCB. Disclosure of Interests: None declared.
Introduction La fibromyalgie (FM) peut être considérée soit comme un diagnostic différentiel soit comme une comorbidité de la spondyloarthrite axiale (ax-SpA). L’objectif a été d’évaluer la prévalence de la FM suspectée par le questionnaire FiRST [1] et son impact sur la maladie durant les 10 premières années de suivi des patients de la cohorte DESIR [2]. Patients et méthodes Patients : ax-SpA inclus dans la cohorte DESIR–données recueillies :*le questionnaire FiRST n’a été disponible qu’à partir de la 7e année (M 84) puis tous les ans jusqu’à 10 ans (M120).*les données cliniques (BASDAI,ASDAS) et thérapeutiques (date de début et de fin de la première biothérapie) ont été recueillies selon les modalités de la cohorte DESIR. Analyse statistique Suspicion de FM : Un malade a été considéré comme fibromyalgique (FM+) dès lors qu’ il répondait « oui » à au moins 5 des 6 questions du questionnaire FiRST. *Estimation de la prévalence de FM : Le % de malades FM+ a été estimé sur la totalité des patients (N=708) de la cohorte par imputation multiple à chacune des 4 visites (de M84 à M120). *Impact de la FM : Cette analyse a porté sur 663 patients (exclusion des 45 patients sortis de la cohorte pour un autre diagnostic que celui d’ax-SpA). Un malade a été considéré FM+ dès lors qu’il avait été considéré FiRST+ à au moins 1 des 4 visites. Son impact a été évalué–au départ de la cohorte (visite M0) sur le phénotype de l’ax-SpA (paramètres cliniques,HLA-B27,atteinte structurale (radios) et inflammatoire (IRM) des sacro-iliaques(SI))-durant les 10 années de suivi sur l’activité symptomatique de la maladie (BASDAI,ASDAS) ainsi que sur la première biothérapie ( % de malades traités et maintenance thérapeutique, modèle de Cox)) Résultats Le pourcentage de malades estimés FM+ était de (m(IC95 %)) 18,5 (17,6–19,4) % à la visite de M84 et de 18,2 (17,3–19,1) % ; 18,4 %(17,5–19,3) ; et 20,3 %(19,3–21,2) pour les visites successives annuelles jusqu’à M120.–La présence d’une FM (estimée présente chez 136 des 663 patients soit 20,5 %) était associée au début de la cohorte à une plus grande fréquence d’enthésiopathie (67,6 % versus (vs) 53,0 %,p=0. 002) et de psoriasis cutané (25,0 % vs 15,4 %, p=0,008) ; par contre les signes objectifs d’ax-SpA étaient similaires dans les 2 groupes (atteinte radiographique des SI :14,2 % vs 17,9 %, présence d’une inflammation des SI à l’IRM :36,8 % vs 35,8 %, HLA B27 positivité :55,9 % vs 60,2 %)–La présence d’une FM était également associée à une activité de la maladie plus importante durant les 10 années de suivi(BASDAI :47,3+19,4vs 31,0+20,5,p<0,001,ASDAS :2,6+0,9 vs 2,0+0,9,p<0,001).-La présence d’une FM était associée à une plus grande probabilité d’initier une biothérapie durant les 10 années de suivi (68,9(59,9-75,9) % vs 43,7(38,6-48,5) %, p<0. 001) mais également à un moins bon maintien thérapeutique ( % de malade toujours sous traitement un an après l’initiation de la biothérapie : 35,7(25,1–50,8) % vs 64,0(57,9–70,7) %, p<0. 0001). Conclusion Cette étude confirme la fréquence élevée de la fibromyalgie au cours de l’ax-SpA. Dans cette cohorte, la similitude des signes objectifs de la maladie entre les 2 groupes (FM+ vs FM-) suggère qu’il s’agit plus d’une comorbidité que d’une erreur diagnostique. Son impact négatif sur les critères d’activité et le traitement de la maladie souligne l’importance de détecter une fibromyalgie en pratique quotidienne pour adapter la prise en charge du patient.
Introduction: Les recommandations nationales et internationales proposent la réalisation d’une évaluation globale systématique standardisée (EGSS) annuelle dans la prise en charge des rhumatismes inflammatoires chroniques (RIC). Celle-ci comprend une évaluation de l’activité et la sévérité de la maladie, mais aussi l’éducation du patient sur la maladie, les connaissances des traitements pharmacologiques et non-pharmacologiques, l’adhésion aux traitements et le dépistage des comorbidités. L’objectif de cette mise au point est de rappeler la définition d’une EGSS, de présenter les preuves de leur efficacité et de faire un état des lieux des pratiques d’une EGSS en France à partir d’une enquête adressée à 72 services de rhumatologie et 186 rhumatologues libéraux.Méthodes: Une revue de la littérature a été menée dans la base de données Pubmed afin d’identifier les essais contrôlés randomisés (ECR) ou les méta-analyses rapportant l’efficacité d’une intervention pluridisciplinaire dans les RIC ou dans d’autres maladies chroniques. Deux enquêtes en ligne ont été adressées à tous les services de rhumatologie en France et à un échantillon de rhumatologues libéraux comprenant respectivement 34 et 19 questions. Ces questionnaires permettaient de déterminer le profil du centre/rhumatologue répondeur, l’existence d’une EGSS et les freins ou les éléments facilitateurs à sa mise en place.Résultats: La recherche bibliographique a identifié 872 articles dont 24 ont finalement été inclus: 16 ECR et 8 méta-analyses. Seuls 3 articles concernaient les RIC dont une méta-analyse combinant 10 ECR et 2 études d’extension dans la polyarthrite rhumatoïde (PR). Parmi ces 3 études, 2 ECR dans le lupus systémique et la sclérodermie systémique ont montré un impact favorable d’une approche multidisciplinaire respectivement sur le SLEDAI et la force de préhension et l’ouverture buccale tandis que la méta-analyse dans la PR n’a pas démontré de bénéfice sur l’amélioration du handicap ou sur l’activité de la maladie.Une réponse au questionnaire a été obtenue pour 72 centres et 186 rhumatologues. Un tiers des centres avaient déjà mis en place une EGSS au cours d’une HDJ. 70 % des centres estimaient prendre en charge > 10 patients par mois en y consacrant en moyenne 35 minutes de temps-rhumatologue et 90 minutes de temps cumulé pour tous les autres professionnels de santé (PDS) participants au programme. Les PDS impliqués étaient majoritairement l’infirmier (92 %), le diététicien (56 %) et le kinésithérapeute (56 %). Les principaux freins à la mise en place d’une EGSS étaient l’absence de ressources paramédicales suffisantes, le manque de valorisation économique et l’absence d’adhésion des rhumatologues traitants tandis que la motivation des patients ressortait plutôt comme un élément facilitateur.Conclusion: Bien que la réalisation d’une EGSS soit recommandée par les sociétés savantes, les preuves de leur efficacité dans les RIC sont minces. De plus, seuls 36 % des centres répondeurs ont mis en place un tel programme. Cette enquête permet de soulever les freins et les éléments facilitateurs afin de trouver des solutions pour étendre cette pratique.
Introduction L’obésité est un facteur de risque de polyarthrite rhumatoïde (PR) et est associée à une activité de la maladie plus élevée. Dans les recommandations de la SFR, nous avons proposé d’accompagner les patients obèses à perdre du poids pour la prise en charge de leur maladie et de ses comorbidités. Néanmoins, peu d’études ont réellement évalué l’impact d’une perte de poids volontaire sur l’activité de la maladie. L’objectif de ce travail était d’évaluer si les variations de poids dans les suites de conseils donnés au cours d’un bilan de dépistage des comorbidités chez les patients obèses atteints de PR permettent de modifier l’activité de leur rhumatisme. Matériels et méthodes Nous avons réalisé une étude observationnelle rétrospective sur la base de données des patients suivis au CHU de Montpellier atteints d’obésité et de PR ayant eu un bilan de dépistage systématique des comorbidités. Nous avons réalisé un recueil de données de différents paramètres d’activité et de paramètres anthropomorphiques à intervalles réguliers sur une durée maximale de 7ans. Le critère de jugement principal était la modification significative du DAS-28 CRP au cours du suivi en fonction des variations de poids. Les critères de jugement secondaires étaient la modification du NAD, NAG, EVA et CRP. Nous avons réalisé des analyses de corrélation selon un modèle linéaire généralisé GEE, et des analyses de corrélation linéaires univariées ainsi que des analyses de variance en utilisant le poids comme variable semi-quantitative pour les différents composants du DAS-28 CRP. Le suivi de la variation du poids a été censuré en cas de changement de traitement de fond. Résultats Nous ne retrouvons pas de corrélation significative entre la perte ou le gain de poids et l’activité de la maladie (p=0,279). Parmi les différentes composantes du DAS-28 CRP, nous retrouvons une corrélation significative en faveur d’une diminution de l’EVA et du NAG avec une augmentation du poids (respectivement r=0,16, p=0,002 et r=0,18, p=0,03). Discussion Les résultats de cette étude sont à l’opposé de ceux qui étaient attendus. Ces résultats pourraient s’intégrer dans le « paradoxe de l’obésité », dans lequel la perte de poids s’explique par un état d’hypermétabolisme secondaire à la PR elle-même, témoin d’un état de mauvaise santé, plutôt que d’une modification volontaire du mode de vie. Néanmoins, les patients de cette étude ont été incités à perdre du poids et nous avons vérifié l’absence d’évènement intercurrent (cancer, infection…). Néanmoins, dans d’autres domaines tels que l’insuffisance cardiaque et la fertilité, on retrouve également un effet néfaste à la perte de poids. Celle-ci pourrait alors être expliquée par une perte de masse musculaire qui elle, joue un rôle protecteur. Conclusion Ces résultats nécessitent d’être confirmés dans d’autres études. Ils soulèvent néanmoins la question d’une évaluation de la masse maigre des patients obèses et de l’importance de la promotion de l’activité physique en parallèle de la perte de poids.
Background The Assessment of SpondyloArthritis international Society-European Alliance of Associations for Rheumatology recommendations for axial spondyloarthritis (axSpA) management include patient assessment for biological disease-modifying antirheumatic drug (bDMARD) treatment response after at least 12 weeks of treatment. The current treat-to-target strategy for axSpA is to achieve inactive disease (ID; Axial Spondyloarthritis Disease Activity Score (ASDAS) <1.3) or at least low disease activity (LDA; 1.3≤ASDAS<2.1).To investigate the association between treatment response at week 12 and/or week 24 and attainment of the ASDAS<2.1 treat-to-target recommendation at week 52 in bDMARD-naïve patients with radiographic (r-)axSpA treated with ixekizumab (IXE).Methods This post hoc analysis included patients randomly assigned to IXE 80 mg every 4 weeks from COAST-V (NCT02696785), a phase 3 trial in bDMARD-naïve patients with r-axSpA. The proportion of patients who achieved ASDAS<2.1 at week 52 was measured among those who attained or not clinically important improvement (CII, ∆ASDAS≥1.1) response, and among those with ID, LDA and high or very high disease activity at week 12 and/or week 24. Non-response was assumed for missing data.Results Amongst 81 patients, 47 (58.0%) achieved ASDAS CII at week 12, with 70.2% (n=33) achieving ASDAS<2.1 at week 52. At week 24, 52 (64.2%) patients achieved ASDAS CII, with 71.2% (n=37) achieving ASDAS<2.1 at week 52. Of the 24 patients who did not achieve ASDAS CII at either week 12 or week 24, 5 (20.8%) achieved ASDAS<2.1 at week 52.Conclusion This analysis reinforces the current recommendation that continuing treatment in those achieving ASDAS CII at week 12 and/or week 24 increases the likelihood of obtaining ID/LDA at week 52.Trial registration number NCT02696785.