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RMD Open
Journal Prestige (SJR): 2.169

Citation Impact (citeScore): 3
Number of Followers: 1

This is an Open Access Journal

Open Access journal
ISSN (Online) 2056-5933
Published by BMJ Publishing Group

[62 journals]

Risk of malignancy in rheumatoid arthritis patients initiating biologics:
an historical propensity score matched cohort study within the French
nationwide healthcare database
- Authors: Seror, R; Lafourcade, A, De Rycke, Y, Pinto, S, Castaneda, J, Fautrel, B, Mariette, X, Tubach, F.
  Abstract: ObjectiveTo compare the risk of malignancy between patients with rheumatoid arthritis (RA) initiating their first biological disease-modifying antirheumatic drug (bDMARD) and those continuing conventional synthetic DMARDs (csDMARDs).MethodsNine-year historical Propensity Score (PS) matched cohort study within the French national healthcare database (87% of the French population; ~57 million people), including adults RA without malignancy. Exposures started with the first use of any systemic treatment (csDMARDs and/or bDMARDs). Incident users of bDMARDs were matched on a dynamic PS to patients continuing csDMARDs. Their risk of malignancy was compared by Cox model.ResultsFrom 1 January 2007 to 31 December 2014, 83 706 patients with RA started their first systemic treatment (63 837 remained on csDMARDs and 19 869 initiated a bDMARD during follow-up). After dynamic PS matching, 19 727 bDMARD initiators were compared with 19 727 RA remaining on csDMARDs. They did not statistically differ in risk of overall malignancies (HR 0.99 (95% CI 0.86 to 1.14)), solid cancer (HR 0.95 (95% CI 0.82 to 1.11)), nor lymphoma (HR 1.35 (95% CI 0.72 to 2.53)). Results were similar when bDMARDs were given as monotherapy or in association with csDMARDs. Analyses restricted to patients starting TNF inhibitor as first bDMARD compared with matched RA remaining on csDMARDs, provided similar results (HR for overall malignancy 1.03 (95% CI 0.88 to 1.21)). Sensitivity analyses, varying carry-over periods (up to 5 years) to define risk periods, provided similar results.ConclusionsIn this historical cohort study within the French nationwide healthcare database, the risk of overall, solid or haematological malignancies did not significantly differ between patients with RA initiating bDMARD and those continuing csDMARDs.
  Keywords: Open access
  PubDate: 2022-06-23T06:39:03-07:00
  DOI: 10.1136/rmdopen-2021-002139
  Issue No: Vol. 8, No. 2 (2022)
Meaning of patient global assessment when joint counts are low in
rheumatoid arthritis
- Authors: Felson, D; Feathers, V, Naik, C, Solomon, D. H, Weinblatt, M. E, Shadick, N.
  Abstract: ObjectiveIn patients with rheumatoid arthritis (RA) with low 28-joint tender and swollen joint counts but who assessed their disease as active, to evaluate whether activity reflected RA symptoms.MethodsWe carried out a cross-sectional study of patients in BRASS, a cohort of patients with established RA who had 28-joint counts assessed, scored their disease activity, identified their painful joints, and answered questions about other sites of pain and fatigue. Patients and their rheumatologists were asked about the presence of fibromyalgia. We examined whether patients reported pain in joints excluded from the 28-joint joint count (feet, ankles, hips, neck) and pain or symptoms probably unrelated to RA including low back pain, headache and fibromyalgia. Fatigue was not classified. Analyses were descriptive.ResultsOf 272 patients, 49 had tender and swollen joint counts
  Keywords: Open access
  PubDate: 2022-06-23T06:39:03-07:00
  DOI: 10.1136/rmdopen-2022-002346
  Issue No: Vol. 8, No. 2 (2022)
Increased risk of cardiovascular events and death in the initial phase
after discontinuation of febuxostat or allopurinol: another story of the
CARES trial
- Authors: Ghang, B.-z; Lee, J. S, Choi, J, Kim, J, Yoo, B.
  Abstract: ObjectivesThe Cardiovascular Safety of Febuxostat or Allopurinol in Patients with Gout (CARES) trial suggested a higher risk of cardiovascular (CV) death from febuxostat than from allopurinol. However, a significant number of patients died after discontinuation of febuxostat or allopurinol. We investigated whether major adverse cardiovascular events (MACE) and CV death were increased because of discontinuation of febuxostat or allopurinol using the CARES trial data.MethodsWe compared the MACE that occurred during administration and after discontinuation in the initial phase after discontinuation, and we compared the CV and non-CV mortality rates in the initial phase after discontinuation to determine the impact of discontinuation of febuxostat or allopurinol.ResultsAmong 6190 patients, the incidence rate per 100 person-years for MACE was 3.11 during administration and 6.71 after discontinuation. MACE was significantly increased after discontinuation compared with that during administration within 1 month (HR 7.40; 95% CI 5.38 to 10.17) and 6 months (HR 5.22; 95% CI 4.26 to 6.39). In the analysis excluding death induced by adverse events that occurred up to 1 day after the last medication, the CV mortality rate was higher than the non-CV mortality rate within 6 months (45.7% vs 27.9%, p=0.0001). In addition, changes in serum uric acid levels from baseline to the last measurement before discontinuation were significantly associated with higher MACE risk after drug discontinuation (HR 1.14; 95% CI 1.04 to 1.26).ConclusionsMACE and CV death were increased in the initial stage after discontinuation of febuxostat or allopurinol in patients with gout.
  Keywords: Open access
  PubDate: 2022-06-22T07:36:24-07:00
  DOI: 10.1136/rmdopen-2021-001944
  Issue No: Vol. 8, No. 2 (2022)
Low-dose CT hounsfield units: a reliable methodology for assessing
vertebral bone density in radiographic axial spondyloarthritis
- Authors: Marques, M. L; Pereira da Silva, N, van der Heijde, D, Reijnierse, M, Baraliakos, X, Braun, J, van Gaalen, F. A, Ramiro, S.
  Abstract: ObjectiveStudying vertebral bone loss in radiographic axial spondyloarthritis (r-axSpA) has been challenging due to ectopic bone formation. We cross-sectionally analysed low-dose CT (ldCT) trabecular bone density Hounsfield units (HU) measurements and calculated inter-reader reliability at the vertebral level in patients with r-axSpA.MethodsLdCT scans of 50 patients with r-axSpA from the sensitive imaging in ankylosing spondylitis study, a multicentre 2-year prospective cohort were included. Trabecular bone HU taken from a region of interest at the centre of each vertebra (C3-L5) were independently assessed by two trained readers. HU mean (SD), and range were provided at the vertebral level, for each reader and centre separately. Inter-reader reliability and agreement were assessed using intraclass correlation coefficients (ICC; single measurements, absolute agreement, two-way mixed effects models); smallest detectable difference and Bland-Altman plots.ResultsOverall, 1100 vertebrae were assessed by each reader. HU values decreased from cranial to caudal vertebrae. For readers 1 and 2 respectively, the highest mean (SD) HU value was obtained at C3 (354(106) and 355(108)), and the lowest at L3 (153(65) and 150 (65)). Inter-reader reliability was excellent (ICC(2,1):0.89 to 1.00). SDD varied from 4 to 8. For most vertebrae, reader 1 scored somewhat higher than reader 2 (mean difference of scores ranging from –0.6 to 2.9 HU). Bland-Altman plots showed homoscedasticity.ConclusionLdCT measurement of HU is a feasible method to assess vertebral bone density in r-axSpA with excellent inter-reader reliability from C3 to L5. These results warrant further validation and longitudinal assessment of reliability.
  Keywords: Open access
  PubDate: 2022-06-22T07:36:24-07:00
  DOI: 10.1136/rmdopen-2021-002149
  Issue No: Vol. 8, No. 2 (2022)
Levelling the playing field of RMD research across Europe to address
patients needs: the emerging EULAR Research Centre
- Authors: Reuter, K; Haupt, C, Molto, A, Cope, A, van Vollenhoven, R. F, Elewaut, D, Lories, R, McInnes, I. B.
  Abstract: Herein, we describe the Research Centre launched by the European Alliance of Associations for Rheumatology (EULAR) in 2020. The Centre aims to facilitate collaborative research on rheumatic and musculoskeletal diseases (RMD) across Europe. RMDs disable millions of people in Europe and worldwide. Despite progress with improved therapeutics and strategic interventions in several RMDs, there are no cures, and their collective impact remains substantial. Access to RMD-related care, policies prioritizing RMDs, and related research, education, training, and funding differ significantly across European countries. Building a new equipoise in opportunity and capacity across Europe will facilitate optimal understanding of those different factors that influence the epidemiology, pathogenesis, treatment, and outcomes in RMDs. The EULAR Research Centre aims to address the significant barriers to accelerating RMD research across Europe. It provides an RMD research roadmap of unmet needs, expert services, infrastructures, networks, research resources, training, education, and mentoring. It will place RMD research in the ideal position to benefit from forthcoming remarkable advances in digital, biological, and social science anticipated in the coming decades.
  Keywords: Open access, EULAR papers
  PubDate: 2022-06-17T08:16:27-07:00
  DOI: 10.1136/rmdopen-2022-002456
  Issue No: Vol. 8, No. 2 (2022)
Active counselling and well-controlled disease result in a higher
percentage of women with rheumatoid arthritis that breast feed: results
from the PreCARA study
- Authors: Kemper, E; Ghalandari, N, Wintjes, H, Van Steensel-Boon, A, Kranenburg, L, Mulders, A, Crijns, H, Smeele, H, Dolhain, R. J. E.
  Abstract: ObjectivesPrevious research has demonstrated that patients with rheumatoid arthritis (RA) are less likely to breast feed their offspring. Treatment options for RA during lactation have expanded and the importance of counselling is recognised. The aim of the current research was to study breast feeding among women with RA who benefit from these developments.MethodsPatients were derived from the Preconceptional Counselling in Active Rheumatoid Arthritis (PreCARA) cohort. Patients were treated according to a modified treat-to-target approach aimed at remission and received pregnancy counselling, including counselling on breast feeding. Postpartum visits were scheduled at 4–6, 12 and 26 weeks post partum. Prevalence of breast feeding at each postpartum visit was compared with a historical reference cohort (Pregnancy-induced Amelioration of Rheumatoid Arthritis cohort) and the general population.ResultsData on 171 pregnancies were available for the current analysis. 120 (70.2%) patients with RA initiated breast feeding. 103/171 (60.2%), 68/171 (39.8%) and 45/171 (26.3%) patients with RA breast fed their offspring at 4–6, 12 and 26 weeks post partum, respectively. These percentages were higher at all postpartum visits compared with the historical reference cohort (p
  Keywords: Open access
  PubDate: 2022-06-15T08:31:47-07:00
  DOI: 10.1136/rmdopen-2022-002194
  Issue No: Vol. 8, No. 2 (2022)
Pollutants: a candidate as a new risk factor for osteoarthritis--results
from a systematic literature review
- Authors: Deprouw, C; Courties, A, Fini, J.-B, Clerget-Froidevaux, M.-S, Demeneix, B, Berenbaum, F, Sellam, J, Louati, K.
  Abstract: BackgroundConsidering non-classical environmental risk factors for osteoarthritis (OA), a systematic literature review (SLR) was performed to summarise existing knowledge on associations between OA and pollutants.MethodsPubMed was used to identify studies reporting data on OA and pollutants in humans (examples of MeSH terms: "Pesticides" or "Polychlorinated Biphenyls" or ‘Lead’). Reports included epidemiological clinical studies, pollutant assessments in ex vivo OA joint, and in vitro effects of pollutants on chondrocytes.ResultsAmong the 193 potentially relevant articles, 14 were selected and combined with 9 articles obtained by manual search. Among these 23 articles there were: (1) 11 epidemiological studies on the relationship between OA and pollutants exposure, (2) 8 on pollutant concentrations in ex vivo OA joint, (3) 4 on the in vitro effects of pollutants on human chondrocytes. Epidemiological studies investigating mainly chlorinated and fluorinated pollutants suggested a possible link with OA. In cross-sectional studies, radiographic knee OA prevalence increased with higher serum lead levels. There was also a relationship between serum lead levels and serum/urine joint biomarkers. A high concentration of heavy metals in the cartilage tidemark was found in ex vivo joints. In vitro, the viability of chondrocytes was reduced in presence of some pollutants. However, the level of knowledge currently remains low, justifying the need for new methodologically sound studies.ConclusionsThis SLR supports the hypothesis of a possible involvement of pollutants in OA disease risk. Large-scale epidemiological and biological studies and ideally big-data analysis are needed to confirm that pollutants could be risk factors for OA.
  Keywords: Open access
  PubDate: 2022-06-14T07:10:43-07:00
  DOI: 10.1136/rmdopen-2021-001983
  Issue No: Vol. 8, No. 2 (2022)
Improved patient-reported outcomes in patients with psoriatic arthritis
treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2
- Authors: Ostor, A. J. K; Soliman, A. M, Papp, K. A, Padilla, B, Wang, Z, Eldred, A, de Vlam, K, Kivitz, A.
  Abstract: ObjectivesDetermine the impact of 24-week risankizumab (RZB) versus placebo (PBO) on patient-reported outcomes (PROs) in patients with psoriatic arthritis (PsA) and inadequate response to one or two biologics (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR).MethodsPatients in the Phase 3 trial, KEEPsAKE 2, were randomised (1:1) to RZB 150 mg or PBO by subcutaneous injection. PROs assessed: 36-Item Short-Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy—Fatigue (FACIT-Fatigue), Patient’s Assessment of Pain by visual analogue scale (VAS), Patient’s global assessment of disease activity (PtGA), EuroQoL-5 Dimension-5 Level (EQ-5D-5L) and Work Productivity and Activity Impairment—PsA (WPAI-PsA). Least squares mean change from baseline at week 24 was compared between RZB versus PBO by mixed-effects repeated regression modelling.ResultsAt week 24, RZB versus PBO treatment resulted in significant differences (95% CIs) in mean change from baseline in ranked secondary endpoints SF-36 physical component summary score (3.9 (2.4 to 5.3); p
  Keywords: Open access
  PubDate: 2022-06-14T07:10:43-07:00
  DOI: 10.1136/rmdopen-2022-002286
  Issue No: Vol. 8, No. 2 (2022)
High prevalence of chondrocalcinosis and frequent comorbidity with calcium
pyrophosphate deposition disease in patients with seronegative rheumatoid
arthritis
- Authors: Krekeler, M; Baraliakos, X, Tsiami, S, Braun, J.
  Abstract: BackgroundThe crystal-induced calcium pyrophosphate deposition disease (CPPD) clinically appearing as pseudogout differs from the mere radiographic finding of chondrocalcinosis (CC) but may cause symptoms resembling rheumatoid arthritis (RA).ObjectiveTo study the prevalence of CPPD and CC in rheumatic diseases focusing on differences between seropositive and seronegative RA.Patients and methodsIn a retrospective study design, we analysed records and radiographs of consecutive new patients presenting to our centre between January 2017 and May 2020. 503 patients were identified based on expert diagnoses: 181 with CPPD, 262 with RA, 142 seropositive (54.2%) and 120 seronegative RA, gout (n=30) and polymyalgia rheumatica (n=30), mean symptom duration
  Keywords: Open access
  PubDate: 2022-06-14T07:10:43-07:00
  DOI: 10.1136/rmdopen-2022-002383
  Issue No: Vol. 8, No. 2 (2022)
Therapeutic drug monitoring of biopharmaceuticals in inflammatory
rheumatic and musculoskeletal disease: a systematic literature review
informing EULAR points to consider
- Authors: Krieckaert, C; Hernandez-Breijo, B, Gehin, J. E, le Meledo, G, Balsa, A, Jani, M, Mulleman, D, Navarro-Compan, V, Wolbink, G, Isaac, J, van Tubergen, A.
  Abstract: The objectives of this review were to collect and summarise evidence on therapeutic drug monitoring (TDM) of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases and to inform the EULAR Task Force for the formulation of evidence-based points to consider. A systematic literature review (SLR) was performed, covering technical aspects and (clinical) utility of TDM, to answer 13 research questions. MEDLINE, Embase and Cochrane were searched until July 2020. American College of Rheumatology and EULAR abstracts were also considered for inclusion. Data were extracted in evidence tables and risk of bias assessment was performed. For the search on technical aspects, 678 records were identified, of which 22 papers were selected. For the clinical utility search, 3846 records were identified, of which 108 papers were included. Patient-related factors associated with biopharmaceutical blood concentrations included body weight, methotrexate comedication and disease activity. The identification of a target range was hampered by study variability, mainly disease activity measures and study type. Evidence was inconsistent for multiple clinical situations in which TDM is currently applied. However, for some particular scenarios, including prediction of future treatment response, non-response to treatment, tapering and hypersensitivity reactions, robust evidence was found. There is currently no evidence for routine use of proactive TDM, in part because published cost-effectiveness analyses do not incorporate the current landscape of biopharmaceutical costs and usage. This SLR yields evidence in favour of TDM of biopharmaceuticals in some clinical scenarios, but evidence is insufficient to support implementation of routine use of TDM.
  Keywords: Open access, EULAR papers
  PubDate: 2022-06-03T07:07:38-07:00
  DOI: 10.1136/rmdopen-2022-002216
  Issue No: Vol. 8, No. 2 (2022)
Effects of diet on the outcomes of rheumatic and musculoskeletal diseases
(RMDs): systematic review and meta-analyses informing the 2021 EULAR
recommendations for lifestyle improvements in people with RMDs
- Authors: Gwinnutt, J. M; Wieczorek, M, Rodriguez-Carrio, J, Balanescu, A, Bischoff-Ferrari, H. A, Boonen, A, Cavalli, G, de Souza, S, de Thurah, A, Dorner, T. E, Moe, R. H, Putrik, P, Silva-Fernandez, L, Stamm, T, Walker-Bone, K, Welling, J, Zlatkovic-Svenda, M, Guillemin, F, Verstappen, S. M. M.
  Abstract: BackgroundA EULAR taskforce was convened to develop recommendations for lifestyle behaviours in rheumatic and musculoskeletal diseases (RMDs). In this paper, the literature on the effect of diet on the progression of RMDs is reviewed.MethodsSystematic reviews and meta-analyses were performed of studies related to diet and disease outcomes in seven RMDs: osteoarthritis (OA), rheumatoid arthritis (RA), systemic lupus erythematosus, axial spondyloarthritis, psoriatic arthritis, systemic sclerosis and gout. In the first phase, existing relevant systematic reviews and meta-analyses, published from 2013 to 2018, were identified. In the second phase, the review was expanded to include published original studies on diet in RMDs, with no restriction on publication date. Systematic reviews or original studies were included if they assessed a dietary exposure in one of the above RMDs, and reported results regarding progression of disease (eg, pain, function, joint damage).ResultsIn total, 24 systematic reviews and 150 original articles were included. Many dietary exposures have been studied (n=83), although the majority of studies addressed people with OA and RA. Most dietary exposures were assessed by relatively few studies. Exposures that have been assessed by multiple, well conducted studies (eg, OA: vitamin D, chondroitin, glucosamine; RA: omega-3) were classified as moderate evidence of small effects on disease progression.ConclusionThe current literature suggests that there is moderate evidence for a small benefit for certain dietary components. High-level evidence of clinically meaningful effect sizes from individual dietary exposures on outcomes in RMDs is missing.
  Keywords: Open access, Press releases, EULAR papers
  PubDate: 2022-06-02T09:17:35-07:00
  DOI: 10.1136/rmdopen-2021-002167
  Issue No: Vol. 8, No. 2 (2022)
Effect of tofacitinib on pain, fatigue, health-related quality of life and
work productivity in patients with active ankylosing spondylitis: results
from a phase III, randomised, double-blind, placebo-controlled trial
- Authors: Navarro-Compan, V; Wei, J. C.-{-}Chung, Van den Bosch, F, Magrey, M, Wang, L, Fleishaker, D, Cappelleri, J. C, Wang, C, Wu, J, Dina, O, Fallon, L, Strand, V.
  Abstract: BackgroundAnkylosing spondylitis (AS) impacts quality of life. We assessed patient-reported outcomes (PROs), pain, fatigue, health-related quality of life (HRQoL) and work productivity in a phase III trial of tofacitinib.MethodsAdults with AS and with inadequate response/intolerance to ≥2 non-steroidal anti-inflammatory drugs received tofacitinib 5 mg twice daily or placebo for 16 weeks. Afterwards, all received open-label tofacitinib until week 48. Change from baseline to week 48 was determined for PROs: total back pain; nocturnal spinal pain; Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) overall spinal pain (Q2); Functional Assessment of Chronic Illness Therapy-Fatigue; BASDAI fatigue (Q1); AS Quality of Life (ASQoL); Short Form-36 Health Survey Version 2 (SF-36v2); EuroQoL-Five Dimension-Three Level health profile and Visual Analogue Scale; and the Work Productivity and Activity Impairment (WPAI) questionnaire. Improvements from baseline ≥minimum clinically important difference, and scores ≥normative values at week 16 were evaluated.ResultsIn 269 randomised and treated patients, at week 16, there were greater least squares mean improvements from baseline with tofacitinib 5 mg twice daily versus placebo in BASDAI overall spinal pain (–2.85 vs –1.34), BASDAI fatigue (–2.36 vs –1.08), ASQoL (–4.03 vs –2.01) and WPAI overall work impairment (–21.49 vs –7.64) (all p
  Keywords: Open access
  PubDate: 2022-06-02T07:06:20-07:00
  DOI: 10.1136/rmdopen-2022-002253
  Issue No: Vol. 8, No. 2 (2022)