RMD Open最新文献

{"title":"Systematic screening for multimorbidities in patients with inflammatory rheumatic diseases enhanced preventive medication use and reduced hospitalisations: an exposed-non-exposed study.","authors":"Claire Immediato Daien, Vera Georgescu, Guillaume Decarriere, Grégoire Mercier, Jacques Morel","doi":"10.1136/rmdopen-2024-004490","DOIUrl":"10.1136/rmdopen-2024-004490","url":null,"abstract":"<p><strong>Rational: </strong>Studies are needed to determine if multimorbidity screening and management reduce the rate of multimorbidity accumulation in patients with chronic inflammatory rheumatic diseases (IRD).</p><p><strong>Objectives: </strong>This study evaluates the impact of systematic screening programme on patient care and hospitalisation rates.</p><p><strong>Methods: </strong>Patients with IRD who participated in the screening programme (exposed patients) were identified within the French national health database and matched with controls. Two sets of analysis were performed: one with multivariate analysis and a second using a propensity score matching to ensure comparability between exposed patients and controls. The primary endpoint (PE) was a composite score assessing the dispensation of multimorbidity-preventing drugs, including vaccines, lipid-lowering agents, antiosteoporotic medications and antiplatelet drugs, during the year following the index date.</p><p><strong>Results: </strong>The first analysis included 286 exposed patients and 858 controls, demonstrating a higher rate of meeting the PE in exposed patients (adjusted OR=1.6 (1.2-2.2), p<0.01). Propensity score matching resulted in 281 exposed patients and 281 controls. Exposed patients exhibited a significantly higher rate of meeting the PE compared with controls (54.8% vs 44.5%; OR=1.5; p=0.015), with increased utilisation of vaccines, cholesterol-lowering drugs and antiosteoporotic medications. Furthermore, emergency admission and hospitalisations for fracture, cardiovascular events or infection were significantly less frequent in the exposed group (7.1% vs 15.3%; OR=0.42, p<0.01), with a reduction in severe infections (0.7% vs 3.9%; p=0.03).</p><p><strong>Conclusion: </strong>Systematic multimorbidity screening in patients with IRD boosted preventive medication use and reduced hospital admissions, justifying time and resource allocation for screening.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11448191/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142366422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Forefoot inflammation in recent-onset ACPA-positive and ACPA-negative RA: clinically similar, but different in underlying inflamed tissues.","authors":"Dennis A Ton, Bastiaan T van Dijk, Hanna W van Steenbergen, Annette H M van der Helm-van Mil","doi":"10.1136/rmdopen-2024-004722","DOIUrl":"10.1136/rmdopen-2024-004722","url":null,"abstract":"<p><strong>Objectives: </strong>Although joint swelling is traditionally interpreted as synovitis, recent imaging studies showed that there is also inflammation of tenosynovium and intermetatarsal bursae in the forefoot. We aimed to increase our understanding of differences and similarities regarding forefoot involvement between ACPA-positive and ACPA-negative rheumatoid arthritis (RA) at diagnosis. Therefore, we (1) compared metatarsophalangeal (MTP) joint counts, walking disabilities and inflamed tissues between ACPA groups and (2) studied associations of joint swelling/tenderness and walking disabilities with underlying inflamed tissues within ACPA groups.</p><p><strong>Methods: </strong>171 ACPA-positive and 203 ACPA-negative consecutively diagnosed patients with RA had a physical joint examination (swollen joint count-66/tender joint count-68), filled a Health Assessment Questionnaire including the domain walking and underwent MRI of the MTP joints at diagnosis. Synovitis, tenosynovitis, osteitis and intermetatarsal bursitis (IMB) were assessed. Findings in age-matched healthy controls were applied to define abnormalities on MRI.</p><p><strong>Results: </strong>While ACPA-negative RA patients had more swollen joints (mean SJC 8 vs 6 in ACPA-positives, p=0.003), the number of swollen MTP joints was similar (mean 1 in both groups); walking disabilities were also equally common (49% vs 53%). In contrast, inflamed tissues were all more prevalent in ACPA-positive compared with ACPA-negative RA. Within ACPA-positive RA, IMB was associated independently with MTP-joint swelling (OR 2.6, 95% CI 1.4 to 5.0) and tenderness (OR 3.0, 95% CI 1.8 to 5.0). While in ACPA-negatives, synovitis was associated independently with MTP-joint swelling (OR 2.8, 95% CI 1.4 to 5.8) and tenderness (OR 2.5, 95% CI 1.3 to 4.8). Tenosynovitis contributed most to walking disabilities.</p><p><strong>Conclusions: </strong>Although the forefoot of ACPA-positives and ACPA-negatives share clinical similarities at diagnosis, there are differences in underlying inflamed tissues. This reinforces that ACPA-positive and ACPA-negative RA are different entities.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11448120/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142366421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Conception in women with primary Sjögren's disease.","authors":"Grégoire Martin de Frémont, Véronique Le Guern, Raphaele Seror","doi":"10.1136/rmdopen-2024-004927","DOIUrl":"10.1136/rmdopen-2024-004927","url":null,"abstract":"","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11448192/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142366419","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Change in different classes of chronic back pain suspicious of axial spondyloarthritis: a latent transition analysis of the SPACE cohort.","authors":"Philipp Bosch, Alexandre Sepriano, Mary-Lucy Marques, Désirée van der Heijde, Robert Landewé, Miranda van Lunteren, Liese de Bruin, Manouk de Hooge, Caroline Bastiaenen, Sofia Exarchou, Roberta Ramonda, Karen Minde Fagerli, Floris A van Gaalen, Sofia Ramiro","doi":"10.1136/rmdopen-2024-004584","DOIUrl":"10.1136/rmdopen-2024-004584","url":null,"abstract":"<p><strong>Objectives: </strong>To follow up four previously identified classes 'pure axial spondyloarthritis' (axSpA) ('axial'), 'axSpA with peripheral signs' ('inflammatory back pain+peripheral'), 'axSpA at risk' and 'no spondyloarthritis' ('no SpA'). They reflect the expert-opinion-free construct or 'Gestalt' of chronic back pain suspicious of axSpA. The aim was to assess participants' transitions between these classes over time.</p><p><strong>Methods: </strong>Participants with chronic back pain of ≤2 years duration, suspicious of axSpA from the SPondyloArthritis Caught Early cohort were analysed. Latent class (LCA) and latent transition analysis (LTA) using clinical, laboratory and imaging data at baseline and 2 years were calculated. Conditional and marginal probabilities were obtained, reflecting the probability of a spondyloarthritis feature in a class and the probability of the participant's class membership, respectively. Transitional probabilities were extracted revealing potential switches across classes. The analyses were performed in all participants using imputations for missing data and in participants with full data at baseline and 2 years.</p><p><strong>Results: </strong>Baseline and 2 years LCA models were constructed for 702 participants, resulting in the same four-class model as previously described. LTA revealed only a 3% transition from the 'no SpA' to the 'at-risk' class from baseline to 2 years with all other participants remaining in their initially assigned class. Sensitivity analysis on 384 participants with complete data at both baseline and 2 years showed similar results, underlining the model's robustness.</p><p><strong>Conclusions: </strong>Transitions between the four classes over 2 years were basically inexistent, highlighting the unlikelihood of developing new class-defining features of axSpA after an initial clinical workup.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11448111/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142353033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"On difficulties to define prognostic factors for clinical practice in rheumatoid arthritis.","authors":"Olivier Vittecoq, Pauline Brevet, Baptiste Gerard, Thierry Lequerre","doi":"10.1136/rmdopen-2024-004472","DOIUrl":"10.1136/rmdopen-2024-004472","url":null,"abstract":"<p><p>In rheumatoid arthritis (RA), the identification of prognostic factors (PF) capable of predicting disease outcome, response to treatment or success of dose reduction is an important issue, as these factors are intended to serve as a basis for decision-making. The task is complex from the outset, as the definition of disease prognosis or therapeutic prognosis is not uniquevocal. The heterogeneity of the definitions used partly explains the failure to identify PF that can be applied at an individual level. But other factors also contribute. First, the scope of the disease studied is too broad, including nosologically different entities. Second, potential PF are only measured at a single point of time, whereas changes over a period of time should be taken into account to a greater extent, not forgetting the potential impact of the treatment received during this period. Beyond these limiting factors, one of the main obstacles to the identification of PF is probably the fact that the phase of the disease is not sufficiently taken into account. Predicting the disease outcome when it is well established is a more complex challenge than when it is just beginning, as many factors are likely to interfere. The same applies to therapeutic PF, which should be determined according to disease duration. Difficulties also arise from the approaches used, which are often restricted to a single field of interest whereas they should be much more integrative and call on new large-scale data analysis tools with a view to precision medicine.In RA, prognosis can be defined at two levels: disease outcome, including joint damage and risk of extra-articular manifestations and/or complications, and treatment outcome, including response to therapy, risk of adverse effects and drug-free remission.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11440182/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142353035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Genes deregulated in giant cell arteritis by Nanostring nCounter gene expression profiling in temporal artery biopsies.","authors":"Ilaria Ferrigno, Martina Bonacini, Alessandro Rossi, Maria Nicastro, Francesco Muratore, Luigi Boiardi, Alberto Cavazza, Alessandra Bisagni, Luca Cimino, Angelo Ghidini, Giuseppe Malchiodi, Alessandro Zerbini, Nicolò Pipitone, Carlo Salvarani, Stefania Croci","doi":"10.1136/rmdopen-2024-004600","DOIUrl":"https://doi.org/10.1136/rmdopen-2024-004600","url":null,"abstract":"<p><strong>Objective: </strong>To identify differentially expressed genes in temporal artery biopsies (TABs) from patients with giant cell arteritis (GCA) with different histological patterns of inflammation: transmural inflammation (TMI) and inflammation limited to adventitia (ILA), compared with normal TABs from patients without GCA.</p><p><strong>Methods: </strong>Expression of 770 immune-related genes was profiled with the NanoString nCounter PanCancer Immune Profiling Panel on formalin-fixed paraffin-embedded TABs from 42 GCA patients with TMI, 7 GCA patients with ILA and 7 non-GCA controls.</p><p><strong>Results: </strong>Unsupervised clustering of the samples revealed two distinct groups: normal TABs and TABs with ILA in one group, 41/42 TABs with TMI in the other one. TABs with TMI showed 31 downregulated and 256 upregulated genes compared with normal TABs; they displayed 26 downregulated and 187 upregulated genes compared with TABs with ILA (>2.0 fold changes and adjusted p values <0.05). Gene expression in TABs with ILA resembled normal TABs although 38 genes exhibited >2.0 fold changes, but these changes lost statistical significance after Benjamini-Yekutieli correction. Genes encoding TNF superfamily members, immune checkpoints, chemokine and chemokine receptors, toll-like receptors, complement molecules, Fc receptors for IgG antibodies, signalling lymphocytic activation molecules, JAK3, STAT1 and STAT4 resulted upregulated in TMI.</p><p><strong>Conclusions: </strong>TABs with TMI had a distinct transcriptome compared with normal TABs and TABs with ILA. The few genes potentially deregulated in ILA were also deregulated in TMI. Gene profiling allowed to deepen the knowledge of GCA pathogenesis.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11423731/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142353034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long versus short-term opioid therapy for fibromyalgia syndrome and risk of depression, sleep disorders and suicidal ideation: a population-based, propensity-weighted cohort study.","authors":"Isabel Hurtado, Celia Robles, Salvador Peiró, Aníbal García-Sempere, Fran Llopis, Francisco Sánchez, Clara Rodríguez-Bernal, Gabriel Sanfélix","doi":"10.1136/rmdopen-2024-004466","DOIUrl":"10.1136/rmdopen-2024-004466","url":null,"abstract":"<p><strong>Objective: </strong>Fibromyalgia syndrome (FMS) is characterised by widespread pain and is associated with mood disorders such as depression as well as poor sleep quality. These in turn have been linked to increased risk of suicidal ideation. Clinical guidelines generally do not recommended opioids in FMS, but they are routinely prescribed to a considerable proportion of FMS patients. We assessed the association of long-term opioid prescription for FMS with risk of depression, sleep disorders and suicidal ideation, when compared with short-term opioid use.</p><p><strong>Methods: </strong>Retrospective cohort study combing several population-wide databases covering a population of five million inhabitants, including all adults who received an initial opioid prescription from 2014 to 2018 specifically prescribed for FMS. We examined the occurrence of depression, sleep disorders or suicidal ideation outcomes in patients with an initial long-term opioid prescription (>90 days) versus those who received a short-term treatment (<29 days). We employed multivariable Cox regression modelling and inverse probability of treatment weighting based on propensity scores and we performed several sensitivity analyses.</p><p><strong>Results: </strong>10 334 patients initiated short-term (8309, 80.40%) or long-term (2025, 19.60%) opioids for FMS. In main adjusted analyses, long-term opioid use was associated with an increased risk for depression (HR: 1.58, 95% CI 1.29 to 1.95) and sleep disorder (HR: 1.30, 95% CI 1.09 to 1.55) but not with suicidal ideation (HR: 1.59, 95% CI 0.96 to 2.62). In models assessing outcomes since day 90, an increased risk for suicidal ideation was observed (HR: 1.76, 95% CI 1.05 to 2.98).</p><p><strong>Conclusion: </strong>These findings suggest that continued opioid use for 90 days or more may aggravate depression and sleep problems in patients with FMS when compared with patterns of short-term treatment.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428988/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142308480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predicting the risk of cardiovascular and cerebrovascular event in systemic lupus erythematosus: a Chinese SLE treatment and research group study XXVI.","authors":"Can Huang, Yutong Li, Ziqian Wang, Shudian Lin, Jiu-Liang Zhao, Qian Wang, Xinping Tian, Yanhong Wang, Xinwang Duan, Yongfu Wang, Cheng Zhao, Zhenbiao Wu, Jian Xu, Chen Han, Min Yang, Rui Wu, Xiaofeng Zeng, Mengtao Li","doi":"10.1136/rmdopen-2024-004425","DOIUrl":"10.1136/rmdopen-2024-004425","url":null,"abstract":"<p><strong>Objective: </strong>Patients with systemic lupus erythematosus (SLE) have an increased risk of cardiovascular and cerebrovascular events (CCEs). Furthermore, CCE was a significant factor contributing to mortality in patients with SLE. However, no clinical model exists that can predict which patients are at high risk. The purpose of this study was to develop a practical model for predicting the risk of CCE in people with SLE.</p><p><strong>Methods: </strong>This study was based on the Chinese SLE Treatment and Research Group cohort. A total of 2399 patients, who had a follow-up period of over 3 years and were diagnosed with SLE for less than 1 year at the start of the study, were included. Cox proportional hazards regression and least absolute shrinkage and selection operator regression were used to establish the model. Internal validation was performed, and the predictive power of the model was evaluated.</p><p><strong>Results: </strong>During the follow-up period, 93 patients had CCEs. The prediction model included nine variables: male gender, smoking, hypertension, age of SLE onset >40, cutaneous involvement, arthritis, anti-β2GP1 antibody positivity, high-dose glucocorticoids and hydroxychloroquine usage. The model's C index was 0.801. Patients with a prognostic index over 0.544 were classified into the high-risk group.</p><p><strong>Conclusion: </strong>We have developed a predictive model that uses clinical indicators to assess the probability of CCE in patients diagnosed with SLE. This model has the ability to precisely predict the risk of CCE in patients with SLE. We recommended using this model in the routine assessment of patients with SLE.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11418496/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142308481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Frailty is independently associated with subclinical cardiovascular disease in patients with systemic lupus erythematosus.","authors":"Maria Pappa, Kyriaki Keramiotou, Petros P Sfikakis, Maria G Tektonidou","doi":"10.1136/rmdopen-2024-004527","DOIUrl":"10.1136/rmdopen-2024-004527","url":null,"abstract":"<p><strong>Objectives: </strong>Cardiovascular disease is a leading cause of mortality in systemic lupus erythematosus (SLE). Frailty has been associated with an increased cardiovascular disease risk (CVR) in the general population. We aimed to examine the association between frailty and subclinical cardiovascular disease in patients with SLE.</p><p><strong>Methods: </strong>In this cross-sectional study, we included all patients with SLE who underwent carotid/femoral artery ultrasound in our unit between 2016 and 2018. Clinical and laboratory data were collected at the time of ultrasound testing. Frailty was measured using the Systemic Lupus International Collaborating Clinics-Frailty Index (SLICC-FI). CVR (low, moderate, high, very high) was evaluated by the Systematic COronary Risk Evaluation (SCORE) model. Determinants of atherosclerotic plaque presence were assessed by logistic regression analyses, adjusting for potential confounders.</p><p><strong>Results: </strong>202 patients were included in the study. Atherosclerotic plaques (20.8% carotid, 17.3% femoral) were observed in 52/202 (25.7%) patients (89.1% women, mean (±SD) age 46.7±12.6). Median (IQR) SLICC-FI was 0.08 (0.04-0.10). 39 (19.3%) patients were classified as robust, 91 (45%) as relatively less fit, 59 (29.2%) as least fit and 13 (6.4%) as frail. In univariate analysis, plaque presence was significantly associated with age, disease duration, smoking, hypertension, systolic blood pressure, dyslipidaemia, SCORE, CVR class and SLICC-FI. CVR class (OR 5.16, p=0.000) and SLICC-FI (OR 1.34, p=0.03 per 0.05 point increase) remained significant in multivariate analysis after adjustment for traditional and disease-related CVR factors.</p><p><strong>Conclusions: </strong>SLICC-FI is independently associated with plaque presence. Further studies are warranted to determine whether frailty-specific interventions can reduce CVR in patients with SLE.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11418478/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142308479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: pooled 16-week results from two phase 3 studies.","authors":"M Elaine Husni, Philip J Mease, Joseph F Merola, William Tillett, Nadine Goldammer, Barbara Ink, Jason Coarse, Jérémy Lambert, Vanessa Taieb, Dafna D Gladman","doi":"10.1136/rmdopen-2024-004464","DOIUrl":"10.1136/rmdopen-2024-004464","url":null,"abstract":"<p><strong>Objectives: </strong>To assess impact of bimekizumab treatment on patient-reported outcomes and health-related quality of life (HRQoL) in patients with active psoriatic arthritis (PsA), using 16-week data from two phase 3 studies.</p><p><strong>Methods: </strong>BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug (bDMARD)-naïve) and BE COMPLETE (NCT03896581; tumour necrosis factor inhibitor inadequate response/intolerance (TNFi-IR)) are phase 3 studies of subcutaneous bimekizumab 160 mg Q4W; both were double-blind and placebo-controlled to 16 weeks. Patients were randomised 3:2:1 to bimekizumab, placebo or reference (subcutaneous adalimumab 40 mg Q2W) in BE OPTIMAL; 2:1 to bimekizumab or placebo in BE COMPLETE. Patient-reported outcomes for pain, fatigue, physical function and HRQoL are reported to week 16 using pooled and individual study data for bimekizumab and placebo patients.</p><p><strong>Results: </strong>1073/1112 (96.5%) patients completed week 16 (bimekizumab:‍ 677/698 [97.0%]; placebo: 396/414 [95.7%]). Bimekizumab-treated patients achieved rapid improvements vs placebo in pain, fatigue, physical function and HRQoL by week 4, after a single dose. Improvements continued to week 16 for all patient-reported outcomes, including Pain Visual Analogue Scale (VAS; mean (95% CI) change from baseline: bimekizumab: -‍25.2 [-27.2, -23.1]; placebo:‍ -‍5.7 [-8.2, -3.3]) and FACIT-Fatigue (bimekizumab: 4.5 [3.9, 5.1]; placebo: 1.1 [0.3, 2.0]); both nominal p<0.001. Greater proportions of bimekizumab-treated patients achieved minimal clinically important differences for patient-reported symptoms vs placebo, including FACIT-Fatigue (bimekizumab: 53.1%; placebo: 36.3%) and HAQ-DI (bimekizumab:‍ 53.0%; placebo: 28.7%); both nominal p<0.001.</p><p><strong>Conclusion: </strong>Bimekizumab treatment demonstrated rapid and greater improvements in patient-reported pain, fatigue, physical function and HRQoL to week 16 vs placebo in bDMARD-naïve and TNFi-IR patients.</p><p><strong>Trial registration number: </strong>ClinicalTrials.gov: NCT03895203; NCT03896581.</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":null,"pages":null},"PeriodicalIF":5.1,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11418537/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142308478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}