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En 2050, 279 millions d'individus souffriront d'arthrose de la main dans le monde. Les traitements actuels (AINS en topique, AINS oraux, Paracétamol) sont peu efficaces et, si la prescription n'est pas respectée, associés à des effets indésirables. L'étude FLEXOA avait comme objectif d'étudier l'efficacité sur les symptômes et la tolérance d'une combination d'extraits de CL et BS chez des sujets souffrant d'arthrose digitale. FLEXOA est une étude multicentrique, randomisée, contrôlée contre placebo, en double aveugle. Les sujets devaient avoir au moins 40 ans, un IMC ≤ 35 kg/m2, souffrir d'arthrose digitale répondant aux critères de l'American College of Rheumatology (ACR) et déclarer, à l'inclusion, une douleur persistante depuis plusieurs mois comprise entre 40 et 80 mm sur une Echelle Visuelle Analogique (EVA) de 100 mm. Les sujets recevaient chaque jour soit 2 comprimés (1 matin/1 le soir) d'extraits de CL/BS ou de placebo pendant 3 mois. Un comprimé de CBTIL contenait 237,35 mg (200,0 mg de curcumine) d'extrait sec de CL (CURTIL03), 51,3 mg (33,34 mg d'acides boswelliques) d'extrait sec de BS (BOSTIL01) et 1,4 mg de vitamine D3. Le critère de jugement principal était le changement de la douleur (EVA) entre l'inclusion et 3 mois de traitement. Les critères de jugement secondaires étaient l'évolution de la douleur (EVA), de la fonction (FIHOA), de la qualité de vie (SF-36), l'évaluation globale par le patient (PGA), l'état acceptable par le patient (Patient Acceptable Symptoms State (PASS), EVA < 40 mm), la force de préhension, la consommation d'antalgiques ainsi que la tolérance au traitement. L'analyse statistique a été réalisée sur les populations Intent-to-treat (ITT) en utilisant le logiciel SAS version 9,4 et and R version 3,6. La signification statistique correspondait à un niveau de confiance de 95 % et une valeur p < 0,05. 162 sujets ont été randomisés (ITT : n = 83 CBTIL ; n = 79 placebos) et 149 sujets ont terminé l'étude (PP : n = 75 CBTIL ; n = 74 placebos). La population ITT présentait à l'inclusion les caractéristiques démographiques et cliniques suivantes : âge moyen de 63 ± 8,6 ans, 76,5 % étaient des femmes, IMC moyen de 26,2 ± 4,07 kg/m2 et une EVA moyenne de 59,18 ± 12,00 mm. Après 3 mois de traitement, la diminution de l'EVA douleur dans la population ITT était significativement plus importante dans le groupe CBTIL que dans le groupe placebo (différence−7,29 mm, [−15,83 ;1,25], p = 0,034)). La différence entre les groupes était déjà significative après 1 mois de traitement (différence −6,22, [−13,21 ;0,77] ; p = 0,044). Le pourcentage de sujets atteignant le PASS (EVA < 40 mm) après 1 mois (CBTIL : 47,50 % vs Placebo : 28,95 %, p = 0,025) et 3 mois (CBTIL : 58,97 % vs placebo : 41,89 %, p = 0,049) de traitement était significativement plus élevé dans le groupe CBTIL que dans le groupe placebo. Une amélioration significative a été observée dans le groupe CBTIL par rapport au placebo pour les critères suivants : l'évaluation globale du patient(PGA), le score SF-36 douleur et sur la question de santé générale. Les autres variables n'étaient pas significativement différentes entre les deux groupes. Dans l'arthrose digitale, CBTIL diminuait significativement la douleur et améliorait l'état de santé général des sujets, sans induire d'effets indésirables. Vu la faible efficacité des traitements pharmacologiques proposés à ce jour et leur mauvaise tolérance à long terme, CBTIL est une option thérapeutique qui doit être envisagée chez les patients souffrant d'arthrose de la main. [ABSTRACT FROM AUTHOR]

Objectives: We aimed to study if smartphone applications could support the self-management of RA, while investigating engagement and potential negative psychological effects with app-use., Methods: App-based Education and GOal-setting in RA (AEGORA) was a multicentre randomised controlled trial with 2:1:1-allocation to usual care or two versions of an app-based self-management intervention for RA. The 16-week programme involved patient education, goal-setting, and remote monitoring of the Rheumatoid Arthritis Impact of Disease (RAID) instrument, either weekly or monthly depending on randomisation. The primary end point was improvement in the Arthritis Self-Efficacy Scale (ASES) after 16 weeks. Secondary endpoints included non-inferiority regarding the Pain Catastrophizing Scale (PCS) and superiority regarding patient-reported physical activity, sleep quality and RAID. App engagement and RAID-scores were analysed descriptively., Results: Overall, 122 patients were included: mean (SD) disease duration 12 (9) years, mean (SD) age 58(11), 68% female, mean (SD) DAS28-CRP 2.4(0.9). The intervention did not improve the ASES-score over usual care (β: 0.44, p= 0.87). Non-inferiority was established for the PCS (β -0.95 [95% CI -3.30 to + 1.40] favouring the intervention). Other predefined outcomes did not differ. App retention steadily declined to 43% by 16 weeks. Although the RAID remained stable over time overall, 35% of app users reported ≥1 episode of clinically relevant worsening over 16 weeks., Conclusion: This app-based self-management intervention was not superior to usual care regarding self-efficacy improvement. However, remote symptom monitoring provided valuable insight and did not increase pain catastrophising, alleviating concerns regarding the psychological impact of remote monitoring with apps., Trial Registration Number: clinicaltrials.gov, NCT05888181., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objectives: To investigate if patients with early rheumatoid arthritis responding insufficiently to initial methotrexate (MTX) and bridging glucocorticoids (GCs) could benefit from early but temporary etanercept introduction as a second remission-induction attempt., Methods: CareRA2020 (NCT03649061) was a 2-year, open-label, multicentre, pragmatic randomised controlled trial. Treatment-naïve patients started MTX and GC bridging (COBRA-Slim: CS). Within a time window from week (W) 8 until W32, early insufficient responders (28-joint Disease Activity Score - C-reactive Protein (DAS28-CRP) >3.2 between W8 and W32 or ≥2.6 at W32) were randomised to a Standard-CS strategy (adding leflunomide first) or Bio-induction-CS strategy (adding etanercept for 24 weeks). Additional treatment adaptations followed the treat-to-target principle. Longitudinal disease activity (DAS28-CRP) over 104 weeks (primary outcome), achievement of DAS28-CRP <2.6 28 weeks after randomisation, and biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) use at W104 were compared between randomisation groups., Results: Following CS treatment, 142 patients were early responders; 55 early insufficient responders received Standard-CS and 55 Bio-induction-CS. Superiority of Bio-induction-CS over Standard-CS could not be demonstrated (ß=-0.204, (95% CI -0.486 to 0.078), p=0.157) for the primary outcome. More patients on Bio-induction-CS achieved DAS28-CRP <2.6 at 28 weeks after randomisation (59% (95% CI 44% to 72%) vs 44% (95% CI 31% to 59%) in Standard-CS) and they were treated less frequently with b/tsDMARDs at W104 (19/55, 35%) compared with Standard-CS (29/55, 53%)., Conclusion: Half of the patients responded well to initial COBRA-Slim induction therapy. In early insufficient responders, adding etanercept for 6 months did not improve disease control over 104 weeks versus adding leflunomide first. However, temporary introduction of etanercept resulted in improved disease control early after randomisation and less patients on b/tsDMARDs at W104., Trial Registration Number: NCT03649061., Ctr Pilot Approval Belgium: S59474, EudraCT number: 2017-004054-41., Competing Interests: Competing interests: RJ received consulting fees from Novartis, Pfizer, Amgen, AbbVie; speakers fee from Novartis; support for meeting/travel from Fresenius Kabi; and participation on advisory board from AbbVie, Amgen, Novartis and Fresenius Kabi. KT received consulting fees and payment/honoraria for speakers/manuscript writing/education from Eli Lilly, AbbVie, Amgen, Novartis, Pfizer, Celgene, Otsuka, Celltrion, Galapagos, Viatris, UCB and Sandoz. JV received support for meeting/travel from UCB and Novartis. SA received support for meeting/travel from Eli Lilly, payment/honoraria for speakers/manuscript writing/education from Eli Lilly, and was member of Research Foundation – Flanders (FWO) expert panel. AD received consulting fees from Amgen, support for meeting/travel from Galapagos, Eli Lilly, Sanofi and UCB; participation on data safety monitoring board/advisory board from Agmen. MD reported a grant from Research Foundation – Flanders (FWO), and support for meeting/travel from AbbVie, Novartis, Galapagos and UCB. EDM reported a grant from Research Foundation – Flanders (FWO). RW received consulting fees from Galapagos, and payment/honoraria for speakers/manuscript writing/education from Galapagos and Celltrion. PV received institution grants from Pfizer, Galapagos; consulting fees from Galapagos, Sidekick Health, Pfizer and Boehringer Ingelheim; payment/honoraria for speakers/manuscript writing/education from Eli Lilly, Galapagos and Roularta; support for meeting/travel from AbbVie; participation on data safety monitoring board/advisory board from Eli Lilly, Galapagos, Pfizer, AbbVie, Celltrion and vice president of the Royal Belgian Society for Rheumatology. The remaining authors declared no disclosures., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Rheumatoid arthritis (RA) considerably impacts patients' lives. Patients' confidence in their ability to manage this impact, or self-efficacy, can be supported with self-management interventions. One approach is to use mobile health (mHealth) applications, which can additionally provide insight into disease impact by remotely monitoring patient-reported outcomes. However, user engagement with mHealth-apps is variable, and concerns exist that remote monitoring might make patients overly attentive to symptoms., Methods: App-based Education and GOal setting in RA (AEGORA) is a multicentre, pragmatic randomised controlled trial investigating an mHealth-based self-management intervention to improve self-efficacy and remotely monitor disease impact in patients with RA. The intervention is provided via an adapted version of the application Sidekick (Sidekick Health, Reykjavik, Iceland) and consists of education, goal setting, lifestyle advice, and remote assessment of the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire. Across two centres, 120 patients will be recruited and randomised (2:1:1) to usual care or intervention group A/B (study app with weekly/monthly prompts to complete the RAID, respectively). Outcomes are assessed at baseline and after 4-6 months. The primary endpoint is a clinically important improvement (≥ 5.5/110) in the Arthritis Self-Efficacy Scale in the combined intervention group compared to usual care. Secondary endpoints are (a) non-inferiority regarding pain catastrophising, as a measure of symptom hypervigilance; (b) superiority regarding the RAID, sleep quality, and physical activity; and (c) participant engagement with the study app. Finally, the relationship between engagement, prompted frequency of RAID questionnaires, and the primary and secondary outcomes will be explored., Discussion: The AEGORA trial aims to study the effectiveness of mHealth-based, multicomponent self-management support to improve self-efficacy in the context of RA, while providing potentially valuable insights into temporal disease activity dynamics and the feasibility and possible negative effects of remote symptom monitoring in this population., Trial Registration: Clinicaltrials.gov NCT05888181. Retrospectively registered on March 23, 2023. Study inclusion started on March 3, 2023., (© 2023. The Author(s).)

Objectives: To delineate the impact of peripheral musculoskeletal manifestations on stratification of disease phenotype and outcome in new-onset spondyloarthritis (SpA), using a prospective observational nationwide inception cohort, the BelGian Inflammatory Arthritis and spoNdylitis cohorT (Be-Giant)., Methods: Newly diagnosed adult SpA patients, fulfilling the Assessment of SpondyloArthritis International Society (ASAS) criteria for axial or peripheral SpA, were included in Be-Giant and prospectively followed every six months. Peripheral involvement (defined as arthritis, enthesitis and/or dactylitis) was determined in relation to clinically similar patient subsets at baseline and disease activity patterns during two-year follow-up, identified through K-means cluster analysis and latent class growth analysis., Results: From November 2010 to March 2020, 367 patients were enrolled in Be-Giant, of whom 162 (44%) had peripheral manifestations. Two patient clusters [A, axial predominant (n = 248) and B, peripheral predominant (n = 119)] were identified at diagnosis. Longitudinal analysis (n = 115) revealed two trajectories of disease activity in each cluster: one with persistently high disease activity over time ('High'), the other rapidly evolving to low disease activity ('Low'). In cluster A patients, peripheral manifestations predisposed to the 'High' trajectory [odds ratio (OR) = 2.0, 95% CI: 1.3, 3.1, P = 0.001], despite more rapid initiation of biologics compared with patients without peripheral manifestations (hazard ratio (HR)  = 2.1, 95% CI: 1.0, 4.4, P = 0.04 - Cox proportional-hazards model)., Conclusion: Peripheral musculoskeletal manifestations are major determinants of phenotypical diversity in new-onset SpA. Intriguingly, stratification of axial SpA according to concomitant peripheral involvement identified an endotype with an unfavorable outcome despite more prompt therapeutic intensification with biologics. These observations justify an endotype-tailored approach beyond current ASAS/EULAR management recommendations., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Introduction: The main objective of this study was to assess the level of nursing support received by biologic-naïve rheumatological patients treated with golimumab during their first cycle., Methods: Adult patients (N = 119; aged 46.9 ± 13.4 years (mean ± standard deviation); 49.6% males), with rheumatoid arthritis (N = 40), ankylosing spondylitis (N = 58) or psoriatic arthritis (N = 21), and treated with golimumab (first tumor necrosis factor-α inhibitor) during a first reimbursement cycle were included by 17 Belgian centers. Patients were categorized in three levels of nursing support (intense, medium, or low). They filled in a non-validated and exploratory questionnaire about satisfaction, quality, and helpfulness of information., Results: The nursing support was considered intense, medium, or low for 98 (82.4%), 10 (8.4%), and 11 (9.2%) patients, respectively. All disease activity scores improved versus baseline, and 90% of the patients qualified for treatment prolongation without major differences between nursing level groups. The proportion of patients able to self-inject golimumab was 88, 90, and 73% in the intense, medium, and low support groups, respectively. Satisfaction was high in all three nursing support groups., Conclusions: This prospective open-label study has confirmed the short-term effectiveness of golimumab in three rheumatological diseases, with most of the patients qualifying for reimbursement renewal. The limited sample size and the fact that the vast majority of patients benefited from an intense nursing support did not allow drawing definite conclusions concerning the impact of the nursing level on the treatment effectiveness and changes in the disease activity. Nurses seem however to play a crucial role in this short-term study but this remains to be confirmed in a longer-term study.

Objective: To determine the link between extraarticular manifestations (EAMs) and baseline characteristics in patients with axial spondyloarthritis (SpA), and to define their potentially differential prognostic value in 2 large, independent Belgian axial SpA cohorts with distinct recruitment periods., Methods: Information on demographic and clinical characteristics and extraarticular manifestations (EAMs) was obtained from patients with axial SpA originating from the (Be)Giant (Belgian Inflammatory Arthritis and Spondylitis) cohort, which includes consecutive axial SpA patients whose data have been collected since 2010, and from the ASPECT (Ankylosing Spondylitis Patients Epidemiological Cross-sectional Trial) cohort, a Belgian registry of cross-sectional data collected between February 2004 and February 2005 from consecutive patients with ankylosing spondylitis (AS) or probable AS., Results: Among the 1,250 Belgian patients studied, disease duration was associated with risk of developing inflammatory bowel disease (IBD), with an increase in risk by 20% per 10 years of disease duration (relative risk [RR] 1.2, P = 0.026), and associated with risk of developing acute anterior uveitis, with an increase in risk by 30% per 10 years of disease duration (RR 1.3, P < 0.001). In the subgroup of 171 newly diagnosed patients with prospective follow-up data, higher mean C-reactive protein levels over time were demonstrated in those with acute anterior uveitis or IBD compared to those without EAMs or those with psoriasis alone (each P = 0.01)., Conclusion: The risk of developing acute anterior uveitis or IBD, but not psoriasis, in patients with axial SpA seems to increase with disease duration and appears to be linked to a higher cumulative exposure to inflammation, thus providing a possible explanation for the differential structural progression observed in those with axial SpA., (© 2018, American College of Rheumatology.)