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Objective: Approximately one third of individuals worldwide have not received a COVID-19 vaccine. Although studies have investigated risk factors linked to severe COVID-19 among unvaccinated people with rheumatic diseases (RDs), we know less about whether these factors changed as the pandemic progressed. We aimed to identify risk factors associated with severe COVID-19 in unvaccinated individuals in different pandemic epochs corresponding to major variants of concern., Methods: Patients with RDs and COVID-19 were entered into the COVID-19 Global Rheumatology Alliance Registry between March 2020 and June 2022. An ordinal logistic regression model (not hospitalized, hospitalized, and death) was used with date of COVID-19 diagnosis, age, sex, race and/or ethnicity, comorbidities, RD activity, medications, and the human development index (HDI) as covariates. The main analysis included all unvaccinated patients across COVID-19 pandemic epochs; subanalyses stratified patients according to RD types., Results: Among 19,256 unvaccinated people with RDs and COVID-19, those who were older, male, had more comorbidities, used glucocorticoids, had higher disease activity, or lived in lower HDI regions had worse outcomes across epochs. For those with rheumatoid arthritis, sulfasalazine and B-cell-depleting therapy were associated with worse outcomes, and tumor necrosis factor inhibitors were associated with improved outcomes. In those with connective tissue disease or vasculitis, B-cell-depleting therapy was associated with worse outcomes., Conclusion: Risk factors for severe COVID-19 outcomes were similar throughout pandemic epochs in unvaccinated people with RDs. Ongoing efforts, including vaccination, are needed to reduce COVID-19 severity in this population, particularly in those with medical and social vulnerabilities identified in this study., (© 2023 American College of Rheumatology.)

Sporadic inclusion body myositis (IBM) is a progressive condition which commonly affects patients aged above 40. IBM does not respond to immunosuppression and no proven treatments are available. Up to 80% of patients develop some degree of swallowing impairment during the disease course. Dysphagia is a source of marked morbidity in IBM and predisposes patients to life-threatening complications such as aspiration pneumonia. The pathophysiology behind dysphagia in IBM is not fully understood. Evidence from imaging demonstrates that impaired swallowing is predominantly underpinned by oropharyngeal deficits. Changes in cricopharyngeal physiology is thought to be an important factor influencing dysphagia in IBM. However, it is unclear whether this is secondary to structural changes within the cricopharyngeus itself or driven by impairment of the muscles promoting pharyngeal clearance. The approach to dysphagia in IBM patients is limited by a lack of validated instruments to reliably assess swallowing function and an absence of effective therapeutic interventions derived from controlled trials targeting dysphagia. Imaging modalities such as the video fluoroscopic swallowing study (VFSS) are commonly used to evaluate dysphagia in IBM. Whilst VFSS is a commonly used technique in clinical practice; cumulative radiation exposure with repeated testing can be a limitation. Alternative imaging techniques could be developed further as outcome measures for assessing swallowing.In this review, we provide an overview of imaging techniques used to assess swallowing and the insight provided from such investigations into the mechanisms behind dysphagia in IBM. We suggest future directions for evaluation and outcome measurement of dysphagia in this population.

Myositis International Health and Research Collaborative Alliance (MIHRA) is a newly formed purpose-built non-profit charitable research organization dedicated to accelerating international clinical trial readiness, global professional and lay education, career development and rare disease advocacy in IIM-related disorders. In its long form, the name expresses the community's scope of engagement and intent. In its abbreviation, MIHRA, conveys linguistic roots across many languages, that reflects the IIM community's spirit with meanings such as kindness, community, goodness, and peace. MIHRA unites the global multi-disciplinary community of adult and pediatric healthcare professionals, researchers, patient advisors and networks focused on conducting research in and providing care for pediatric and adult IIM-related disorders to ultimately find a cure. MIHRA serves as a resourced platform for collaborative efforts in investigator-initiated projects, consensus guidelines for IIM assessment and treatment, and IIM-specific career development through connecting research networks.MIHRA's infrastructure, mission, programming and operations are designed to address challenges unique to rare disease communities and aspires to contribute toward transformative models of rare disease research such as global expansion and inclusivity, utilization of community resources, streamlining ethics and data-sharing policies to facilitate collaborative research. Herein, summarises MIHRA operational cores, missions, vision, programming and provision of community resources to sustain, accelerate and grow global collaborative research in myositis-related disorders.

The present study aimed to evaluate the impact of the existence of an abutment screw-access hole and the filling effects on the fatigue mechanical behavior of a luted lithium-disilicate glass-ceramic. Seventy-two discs (Ø = 10 mm, 1.0 mm in thickness) of lithium disilicate (IPS e.max CAD, Ivoclar AG) were obtained from prefabricated blocks. Thirty-six abutment specimens of an opaque zirconia (Yz - IPS e.max ZirCAD, Ivoclar AG) and titanium (Ti - Luminesse Ti-Cam discs, Talladium Inc.) were confectioned, and allocated according to 6 groups: Yz and Ti rigid (without screw access hole); Yz unfilled, Yz filled, Ti unfilled and Ti filled (with the screw access (Ø = 2.5 mm) in the center). For the unfilled groups, only a polytetrafluoroethylene tape was used. Resin composite (Tetric N-Ceram, Ivoclar AG) was applied to the screw access hole for the filled groups (Yz and Ti). A cyclic fatigue test was carried out (load of 200 N, 10,000 cycles each; 20 Hz of frequency, step size of 100 N until failure detection (radial/cone crack). The fatigue failure load (FFL) and number of cycles until failure (CFF) were recorded for statistical purposes. The stress distribution (MPa) was evaluated by finite element analysis. A statistically positive effect of the abutment material and the presence of the screw access hole was observed (p ≤ 0.05). The rigid groups (without screw access holes) depicted almost 100% of survival after the fatigue tests. Among the other groups, the Yz-filled group showed the best performance (p ≤ 0.05), followed by the Yz unfilled group. The Ti groups depicted lower values of FFL and CFF, with the Ti unfilled group showing the most unfavorable fatigue behavior (p ≤ 0.05). The lowest tensile stress concentration in the restorative material was observed with the use of rigid abutments, the filled groups depicted intermediate values, while unfilled groups showed the highest stress concentration (Yz rigid = 306.3 MPa; Ti rigid = 310.4 MPa < Yz filled = 490.7 MPa; Ti filled = 498.9 MPa < Yz unfilled = 707.6 MPa; Ti unfilled = 719.7 MPa). Therefore, the presence of a screw-access hole decreases the mechanical performance of a lithium disilicate ceramic regardless of the abutment material. In the presence of a screw-access hole, zirconia abutments depicted a higher fatigue failure load when compared with titanium. The filling of the abutment screw-access hole with resin composite increased the mechanical performance of the simulated restoration., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background Objectives: In Brazil, one of the visceral leishmaniasis control measures in urban environments is the elimination of Lutzomyia longipalpis, which occurs through the application of pyrethroid insecticides with residual action in homes and outbuildings. Due to the loss of sensitivity of this vector to these insecticides, the search for more efficient insecticide compounds against L. longipalpis has been intensified. The objective of this work was to evaluate the toxicity of Trixis vauthieri essential oil on adult sandflies of the species L. longipalpis, and identify the phytochemical composition of these essential oils., Methods: Essential oils from leaves collected from T. vauthieri at different times were obtained at concentrations of 5, 10 and 20 mg/mL. Twenty sandflies were exposed to the essential oils and the mortality was evaluated after 1, 2, 4, 16, 24, 48 and 72 h. The chemical constituents of the essential oil were also identified., Results: The essential oils of T. vauthieri at a concentration of 20 mg/mL were the most toxic to sandflies, reaching a mortality rate of 98.33% and 95%, respectively, after 72 h of exposure. The analysis of chemical constituents revealed the presence of triterpenes and/or steroids, tannins, flavonoids, alkaloids, saponins and coumarins., Interpretation Conclusion: The results obtained suggest that T. vauthieri essential oil is fairly promising as an insecticidal potential against L. longipalpis. A more detailed analysis of the oil's phytochemical composition is necessary to identify active and pure compounds that can be used in vector control of visceral leishmaniasis., (Copyright © 2024 Copyright: © 2024 Journal of Vector Borne Diseases.)

Although the public health emergency associated with the COVID-19 pandemic has ended, challenges remain, especially for individuals with rheumatic diseases. We aimed to assess the historical and ongoing effects of COVID-19 on individuals with rheumatic diseases and rheumatology practices globally, with specific attention to vulnerable communities and lessons learned. We reviewed literature from several countries and regions, including Africa, Australia and New Zealand, China, Europe, Latin America, and the US. In this review, we summarize literature that not only examines the impact of the pandemic on individuals with rheumatic diseases, but also research that reports the lasting changes to rheumatology patient care and practice, and health service use. Across countries, challenges faced by individuals with rheumatic diseases during the pandemic included disruptions in health care and medication supply shortages. These challenges were associated with worse disease and mental health outcomes in some studies, particularly among those who had social vulnerabilities defined by socioeconomic, race, or rurality. Moreover, rheumatology practice was impacted in all regions, with the uptake of telemedicine and changes in health care utilization. While many regions developed rapid guidelines to disseminate scientific information, misinformation and disinformation remained widespread. Finally, vaccine uptake among individuals with rheumatic diseases has been uneven across the world. As the acute phase of the pandemic wanes, ongoing efforts are needed to improve health care access, stabilize rheumatology drug supplies, improve public health communication, and implement evidence-based vaccination practices to reduce COVID-19 morbidity and mortality among individuals with rheumatic diseases., (© 2023 American College of Rheumatology.)

Objective: To evaluate the effect of different surface treatments on the morphology, shear bond, and flexural fatigue strength of a repaired translucent zirconia., Methods: Monolithic disc-shaped specimens of translucent zirconia were prepared and ground to simulate repair areas. Four groups underwent different treatments: Air-MDP (air-abrasion with alumina particles and 10-MDP primer), Si -Sil (silica-coated alumina particles with MDP-containing silane), Si -MDP (silica coating with 10-MDP primer), and Uni adhe (universal adhesive). After roughness measurements and treatments, repairs were done using resin composite. Shear bond and flexural (n = 15) fatigue tests were performed. Surface topography, interfacial analysis, fractographic, and finite element analysis were conducted., Results: The zirconia roughness was similar between the groups, however, the surface topography was modified according to the surface treatments. Si -Sil generated higher and more stable bond strength values (20.69 MPa) between translucent zirconia and resin composite when compared to Uni adhe (15.75 MPa) considering the fatigue bond strength scenario, while it was similar to Si -MDP (17.70 MPa) and Air-MDP (18.97 MPa). Regarding the mechanical behavior, Si -Sil (680.83 MPa) also showed higher and significantly different fatigue strength when compared to Uni adhe (584.55 MPa), while both were similar to Si -MDP (634.22 MPa) and Air-MDP (641.86 MPa)., Conclusion: The association of mechanical and chemical approaches is essential for long-term bond strength and optimized mechanical behavior, being air-abrasion protocols and the use of silane and/or MDP-based primers suitable for zirconia repair protocols. It was found that relying solely on a universal adhesive was not as effective as other options available., Clinical Significance: The surface treatment of repair protocols affects translucent zirconia's morphology. To enhance fatigue behavior in repaired monolithic zirconia, air abrasion is crucial. Exclusive use of a universal adhesive is less effective than other choices. A primer containing silane/MDP holds the potential for stable bond strength and optimized mechanical performance., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors.)

Objective: To identify the best evidence on the efficacy of pharmacological interventions in reducing fatigue in people with inflammatory rheumatic and musculoskeletal diseases (I-RMDs) and to summarise their safety in the identified studies to inform European Alliance of Associations for Rheumatology recommendations for the management of fatigue in people with I-RMDs., Methods: Systematic review of adults with I-RMDs conducted according to the Cochrane Handbook. Search strategy ran in Medline, Embase, Cochrane Library, CINAHL Complete, PEDro, OTseeker and PsycINFO. Only randomised controlled trials (RCTs) or controlled clinical trials were eligible. Assessment of risk of bias, data extraction and synthesis performed by two reviewers independently and in duplicate. Data pooled in statistical meta-analyses., Results: From 4151 records, 455 were selected for full-text review, 99 fulfilled the inclusion criteria and 19 RCTs were included in meta-analyses. Adalimumab was superior to placebo in reducing fatigue at 12 and 52 weeks in rheumatoid arthritis (RA) (n=3 and 2 RCTs; mean difference (MD)= -3.03, p<0.001; MD=-2.25, p=0.03, respectively). Golimumab (n=2 RCTs; 24 weeks: MD=-5.27, p<0.001), baricitinib (n=2 RCTs; 24 weeks: MD=-4.06, p<0.001), sarilumab (n=2 RCTs; 24 weeks: MD=-3.15, p<0.001), tocilizumab (n=3 RCTs; 24 weeks: MD=-3.69, p<0.001) and tofacitinib (n=3 RCTs; 12 weeks: MD=-4.44, p<0.001) were also superior to placebo in reducing fatigue in RA. A dose/effect relationship was observed for sarilumab, tocilizumab and tofacitinib. In spondyloarthritis (excluding psoriatic arthritis), secukinumab was superior to placebo in reducing fatigue at 16 weeks (n=2 RCTs; MD=-4.15, p<0.001), with a dose/effect relationship also observed. The narrative results of the RCTs not included in the meta-analysis indicated that several other pharmacological interventions were efficacious in reducing fatigue, with reassuring safety results., Conclusions: Several pharmacological interventions are efficacious and generally safe for managing fatigue in people with I-RMDs., Competing Interests: Competing interests: PMM has received consulting/speaker's fees from Abbvie, BMS, Celgene, Eli Lilly, Galapagos,Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript, and is supported by the National Institute for Health Research (NIHR), University College London Hospitals (UCLH), Biomedical Research Centre (BRC)., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Adult-onset idiopathic inflammatory myopathy (IIM) is associated with an increased cancer risk within the 3 years preceding and following IIM onset. Evidence- and consensus-based recommendations for IIM-associated cancer screening can potentially improve outcomes. This International Guideline for IIM-Associated Cancer Screening provides recommendations addressing IIM-associated cancer risk stratification, cancer screening modalities and screening frequency. The international Expert Group formed a total of 18 recommendations via a modified Delphi approach using a series of online surveys. First, the recommendations enable an individual patient's IIM-associated cancer risk to be stratified into standard, moderate or high risk according to the IIM subtype, autoantibody status and clinical features. Second, the recommendations outline a 'basic' screening panel (including chest radiography and preliminary laboratory tests) and an 'enhanced' screening panel (including CT and tumour markers). Third, the recommendations advise on the timing and frequency of screening via basic and enhanced panels, according to risk status. The recommendations also advise consideration of upper or lower gastrointestinal endoscopy, nasoendoscopy and 18 F-FDG PET-CT scanning in specific patient populations. These recommendations are aimed at facilitating earlier IIM-associated cancer detection, especially in those who are at a high risk, thus potentially improving outcomes, including survival., (© 2023. Springer Nature Limited.)

This study aimed to evaluate the effect of low and high viscosities of dual-cured resin cement on the mechanical fatigue behavior of yttria tetragonal zirconia polycrystals (3Y-TZP) and yttria-stabilized zirconia (4YSZ) adhesively luted to a dentin analogue (glass fiber-reinforced epoxy resin). Ceramic discs were randomly divided into four groups (n = 20) based on the following study factors: dual-cured resin cement viscosities (low and high) and zirconia microstructure (3Y-TZP and 4YSZ). The discs were treated by air abrasion with aluminum oxide particles (50 μm), followed by the application of primer, and then luted with high or low viscosity resin cement to the dentin analogue. Subsequently, the luted sets underwent a step-stress fatigue test, which involved an initial load of 200 N, step increments of 100 N, 10,000 cycles per step, and a frequency of 20 Hz. Data on fatigue failure load (FFL) and the number of cycles for failure (CFF) were collected and analyzed using survival tests, including Kaplan-Meier and Mantel-Cox analyses, as well as Weibull analysis. Additionally, topography analysis, fractographic features, bonding interface analysis, and Raman spectroscopy were performed. The results revealed that 3Y-TZP exhibited superior fatigue behavior compared to 4YSZ, regardless of the viscosity of the resin cement used for luting. Among all groups, 3Y-Low exhibited the best fatigue performance, while 4YSZ luted with low or high viscosity resin cements yielded the lowest fatigue behavior (FFL). There were no significant differences in Weibull modulus among the groups. After air abrasion, both ceramics showed similar topography. Raman analysis indicated that the surface of 3Y-TZP ceramics prior to sintering had a monoclinic phase, which transitioned predominantly to tetragonal phase peaks after sintering. A similar transition was observed in 4YSZ ceramics. In summary, 3Y-TZP exhibited superior mechanical fatigue behavior compared to 4YSZ. The influence of resin cement viscosity on fatigue behavior was more pronounced in 3Y-TZP, with low-viscosity resin cement enhancing its performance. However, the mechanical fatigue behavior of 4YSZ was less affected by the viscosity of the dual-cured resin cement, showing similar results with both low and high viscosities. In conclusion, 3Y-TZP demonstrated superior mechanical fatigue behavior compared to 4YSZ. The impact of resin cement viscosity on fatigue behavior was more pronounced in 3Y-TZP, with low-viscosity resin cement enhancing its performance. Conversely, the mechanical fatigue behavior of 4YSZ was less sensitive to the viscosity of the dual-cured resin cement, resulting in similar outcomes with both low and high viscosities., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Objective: To identify and summarize evidence about the benefits of perioperative pain neuroscience education (PNE) on pain-related and psychosocial outcomes., Methods: Included were reports written in English that carried out PNE or its synonyms; perioperative period; aged ≥ 18 years; interventional studies and observational studies. Secondary studies, conference abstracts, and editorials were excluded. There was no time limitation., Information Sources: PubMed, Virtual Health Library, Cochrane Library, and Science Direct. Search: June 20th 2023. The risk of bias was assessed using the Joanna Briggs Institute checklists, and synthesis followed the recommendations of the Synthesis Without Meta-analysis (SWiM) guideline. Register: Center for Open Science website (10.17605/OSF.IO/ZTNEJ)., Results: The sample consisted of 18 reports. For pain outcomes, it was not possible to attribute PNE benefits because ten reports found improvements in both intervention and control groups. For psychosocial outcomes, fourteen reports found benefits for PNE groups. All the analyzed reports showed low risk of bias., Conclusion: PNE had additional benefits beyond those obtained with conventional treatment for psychosocial outcomes., Practical Implications: Due to the lack of evidence, it was not possible to indicate the clinical use of PNE. It is suggested that further studies are needed aimed at clarifying the possible benefits., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

This study evaluated the mechanical behavior and risk of failure of three CAD-CAM crowns repaired with different resin composites through a three-dimensional (3D) finite element analysis. Three-dimensional models of different cusp-repaired (conventional nanohybrid, bulk-fill, and flowable resin composites) crowns made of zirconia, lithium disilicate, and CAD-CAM resin composite were designed, fixed at the cervical level, and loaded in 100 N at the working cusps, including the repaired one. The models were analyzed to determine the Maximum Principal and Maximum Shear stresses (MPa). Complementary, an in vitro shear bond strength test ( n = 10) was performed to calculate the risk of failure for each experimental group. The stress distribution among the models was similar when considering the same restorative material. The crown material affected the stress concentration, which was higher for the ceramic models (±9 MPa for shear stress; ±3 MPa for tensile stress) than for the CAD-CAM composite (±7 MPa for shear stress; ±2 MPa for tensile stress). The shear bond strength was higher for the repaired CAD-CAM resin composite (±17 MPa) when compared to the ceramics (below 12 MPa for all groups), while the repair materials showed similar behavior for each substrate. The stress distribution is more homogenous for repaired resin composite crowns, and a flowable direct resin composite seems suitable to repair ceramic crowns with less risk of failure.

Background: Inclusion body myositis is the most common progressive muscle wasting disease in people older than 50 years, with no effective drug treatment. Arimoclomol is an oral co-inducer of the cellular heat shock response that was safe and well-tolerated in a pilot study of inclusion body myositis, reduced key pathological markers of inclusion body myositis in two in-vitro models representing degenerative and inflammatory components of this disease, and improved disease pathology and muscle function in mutant valosin-containing protein mice. In the current study, we aimed to assess the safety, tolerability, and efficacy of arimoclomol in people with inclusion body myositis., Methods: This multicentre, randomised, double-blind, placebo-controlled study enrolled adults in specialist neuromuscular centres in the USA (11 centres) and UK (one centre). Eligible participants had a diagnosis of inclusion body myositis fulfilling the European Neuromuscular Centre research diagnostic criteria 2011. Participants were randomised (1:1) to receive either oral arimoclomol 400 mg or matching placebo three times daily (1200 mg/day) for 20 months. The randomisation sequence was computer generated centrally using a permuted block algorithm with randomisation numbers masked to participants and trial staff, including those assessing outcomes. The primary endpoint was the change from baseline to month 20 in the Inclusion Body Myositis Functional Rating Scale (IBMFRS) total score, assessed in all randomly assigned participants, except for those who were randomised in error and did not receive any study medication, and those who did not meet inclusion criteria. Safety analyses included all randomly assigned participants who received at least one dose of study medication. This trial is registered with ClinicalTrials.gov, number NCT02753530, and is completed., Findings: Between Aug 16, 2017 and May 22, 2019, 152 participants with inclusion body myositis were randomly assigned to arimoclomol (n=74) or placebo (n=78). One participant was randomised in error (to arimoclomol) but not treated, and another (assigned to placebo) did not meet inclusion criteria. 150 participants (114 [76%] male and 36 [24%] female) were included in the efficacy analyses, 73 in the arimoclomol group and 77 in the placebo group. 126 completed the trial on treatment (56 [77%] and 70 [90%], respectively) and the most common reason for treatment discontinuation was adverse events. At month 20, mean IBMFRS change from baseline was not statistically significantly different between arimoclomol and placebo (-3·26, 95% CI -4·15 to -2·36 in the arimoclomol group vs -2·26, -3·11 to -1·41 in the placebo group; mean difference -0·99 [95% CI -2·23 to 0·24]; p=0·12). Adverse events leading to discontinuation occurred in 13 (18%) of 73 participants in the arimoclomol group and four (5%) of 78 participants in the placebo group. Serious adverse events occurred in 11 (15%) participants in the arimoclomol group and 18 (23%) in the placebo group. Elevated transaminases three times or more of the upper limit of normal occurred in five (7%) participants in the arimoclomol group and one (1%) in the placebo group. Tubulointerstitial nephritis was observed in one (1%) participant in the arimoclomol group and none in the placebo group., Interpretation: Arimoclomol did not improve efficacy outcomes, relative to placebo, but had an acceptable safety profile in individuals with inclusion body myositis. This is one of the largest trials done in people with inclusion body myositis, providing data on disease progression that might be used for subsequent clinical trial design., Funding: US Food and Drug Administration Office of Orphan Products Development and Orphazyme., Competing Interests: Declaration of interests PMM has received consulting fees and funding support from Orphazyme, paid to his academic institution (University College London) for the oversight and conduct of this study, and has also received honoraria from Abbvie, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. MPM has received research funding from the US National Institutes of Health (NIH), the US Food and Drug Administration, Cure SMA, and PTC Therapeutics; received consulting fees from NeuroDerm and Fulcrum Therapeutics; and served on data and safety monitoring boards for NIH, Eli Lilly and Company, Catabasis Pharmaceuticals, Vaccinex, Neurocrine Biosciences, Voyager Therapeutics, Prilenia Therapeutics Development, ReveraGen BioPharma, and NS Pharma. TB, CS, AR, TDC, KB, ANJ, and KP are previous employees of Orphazyme. MF has received consulting fees from UCB, Argenx, Alexion, and CSL Behring; and research support paid to her institution (Ohio State University) from UCB, Argenx, Alexion, Fulcrum, Avidity, Pharnext, Janssen, and Roche. TEL has served as a consultant for Aavogen, Abata Therapeutics, Abcuro, Acceleron, DrenBio, EMD Serano, Kezar Life Sciences, Ono Pharma, Orphazyme, Regenacy, Sarepta, and Takeda; DSMB was Chair of the data and safety monitoring board for a Pharnext-sponsored clinical trial; and received research support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the NIH (R01 AR076390), the Muscular Dystrophy Association (MDA630399), Horizon Therapeutics, and The Peter and Carmen Lucia Buck Foundation. TM has served as an advisor to Alexion (AstraZeneca), Amicus, AnnJi, Argenx, Arvinas, Ask-Bio, Audentes (now Astellas Gene Therapy), Horizon Therapeutics, Maze Therapeutics, Momenta (now Janssen), Sanofi, Sarepta, Spark Therapeutics, UCB/Ra Pharmaceuticals, and Modis/Zogenix (now UCB); has served on the speaker's bureau for Sanofi-Genzyme, Alexion, and Argenx; has served on the medical advisory board for the Myositis Association, Neuromuscular Disease Foundation, Myasthenia Gravis Foundation of California, and Myasthenia Gravis Foundation of America; has received research funding from the Myositis Association, the Muscular Dystrophy Association, NIH, and from the following commercial sponsors: Alexion, Amicus, AnnJi, Argenx, Audentes/Astellas Gene Therapy, Bristol Myers Squibb, Cartesian Therapeutics, Grifols, ML-Bio, Momenta, Ra Pharmaceuticals, Sanofi, Spark Therapeutics, UCB, and Valerion; and he serves on the data safety monitoring boards for Acceleron, Avexis, Sarepta, and NIH. RJB has received funding from the FDA Office Orphan Products Development grant for his role in this study. MGH receives research funding from the Medical Research Council UK and has previously acted as a consultant for Novartis and Orphazyme. MMD is a consultant for Orphazyme and received funding support, paid to his academic institution (University of Kansas Medical Center, Research Institute), from Orphazyme for the oversight and conduct of this study. He also serves or recently served as a consultant for Abcuro, Amazentis, ArgenX, Astellas, Catalyst, Cello, Covance/Labcorp, CSL-Behring, EcoR1, Janssen, Kezar, MDA, Medlink, Momenta, NuFactor, Octapharma, Priovant, RaPharma/UCB, Roivant Sciences, Sanofi Genzyme, Shire Takeda, Scholar Rock, Spark Therapeutics, Abata/Third Rock, UCB Biopharma and received research grants or contracts or educational grants from Alexion, Alnylam Pharmaceuticals, Amicus, Biomarin, Bristol Myers Squibb, Catalyst, Corbus, CSL-Behring, FDA Office of Orphan Products Development, GlaxoSmithKline, Genentech, Grifols, Kezar, Mitsubishi Tanabe Pharma, Muscular Dystrophy Association, NIH, Novartis, Octapharma, Orphazyme, Ra Pharma/UCB, Sanofi Genzyme, Sarepta Therapeutics, Shire Takeda, Spark Therapeutics, The Myositis Association, Ra Pharma/UCB, Viromed/Healixmith, and The Myositis Association. All other authors declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

We report a large, hospital-wide outbreak of pseudobacteremia by Paenibacillus spp. In total, 139 patients presented at least 1 positive blood culture during a 13-month period. Microbiological experiments indicated that contaminated nonsterile gloves were associated with the pseudobacteremia episodes. The outbreak was resolved by discontinuing the use of the involved brand.

Statement of Problem: The color of monolithic zirconia restorations is obtained by presintering or postsintering coloring techniques. However, studies on the differences in surface characteristics and their influence on color stability are lacking., Purpose: The purpose of this in vitro study was to evaluate the influence of shading and staining techniques for a zirconia ceramic on the surface characteristics and colorimetric parameters (color difference, translucency, and whiteness index) after exposure to coffee or red wine and then polishing., Material and Methods: Ceramic disks (N=30; Ø10×1mm) were allocated into 3 groups: preshaded-shaded by the manufacturer (IPS e.max ZirCAD MT, shade A2); manually shaded-unshaded zirconia (IPS e.max ZirCAD MT, bleaching shade-BL) colored by the brushing technique, before sintering; stained-unshaded zirconia (IPS e.max ZirCAD MT BL) colored by the staining technique, after sintering. Spectrophotometric color assessments ensured the same initial perceived color (Vita Classical A2) for specimens included in the study (∆E 00 <1.77 acceptability threshold). Surface characteristics were assessed by scanning electron microscopy and atomic force microscopy. The specimens were immersed in coffee (n=5) or red wine (n=5) for 12 and 24 days and subsequently polished. The data were statistically and descriptively analyzed for color differences (∆E 00 ), translucency parameters (TP 00 ), and whiteness indexes for dentistry (WI D ), considering acceptability and perceptibility thresholds., Results: The shaded groups found an irregular ceramic surface with uniformly sized zirconia crystals. The stained group found a glass-covered smoother surface. Significant alterations in color parameters (∆E 00 , TP 00 , WI D ) were observed with immersion in pigmenting beverages (P<.001) both after 12 days, and after 24 days. The shaded specimens had greater color alterations after immersion but benefited from the polishing procedure, which reduced color differences below an acceptable threshold in comparison with the baseline. Stained specimens had lower color alterations after immersion, but the polishing protocol was detrimental as it whitened the ceramic by subsurface exposure., Conclusions: The coloring technique influences the surface characteristics of zirconia ceramic and also the color parameters after exposure to colored beverages and polishing., (Copyright © 2023 Editorial Council for The Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.)

Objective: the aim of this study was to evaluate the effect of resin composite layering on discolored substrates to obtain masking ability with monolithic ceramics., Materials and Methods: Four groups (n = 8) of computer-aided design/computer aided manufacturing (CAD/CAM) monolithic ceramics, shade A1, with thicknesses of 1.0 and 1.5 mm, were tested: feldspathic (FC), leucite-reinforced (LC), lithium disilicate-reinforced (LD), and translucent zirconia (5YSZ). Five substrates were used: A1 (used as reference), A3.5, C4, and coppery and silvery metals. The substrates were separated as non-layered or layered (with flowable opaque resin composite (FL), white opaque restorative resin composite (WD), and A1-shaded opaque restorative resin composite (A1D)). Resin composite layers of 0.5 and 1.0 mm were tested. The try-in paste, shade A1, was used as a luting agent. Translucency parameter (TP 00 ) was assessed for the ceramics. Color differences (∆E 00 ) were assessed for the restorative ceramics and resin composite layers over discolored substrates with the CIEDE2000 formula. The results were compared statistically, and descriptively with acceptability (AT, 1.77) and perceptibility (PT, 0.81) thresholds., Results: Feldspathic showed the highest TP 00 (for both ceramic thicknesses) and LD the lowest (for 1.5 mm of ceramic thickness) (P < 0.001). For substrate A3.5, layering with 1.0 mm of A1D or WD ensured ∆E 00 below PT for all ceramics tested (P < 0.001). The use of 0.5 mm of FL or 1.0 mm of A1D associated with ceramics LC, LD, and 5YSZ ensured ∆E 00 below AT for substrates C4 and coppery metal (P < 0.001). Silvery background layered with 0.5 mm of FL presented ∆E 00 below AT for all ceramics and ∆E 00 below PT for lithium disilicate of 1.0 mm of thickness (∆E 00  = 0.72)., Conclusions: Layering severely discolored substrates with selected opaque resin composites ensures masking ability for restoration with CAD/CAM monolithic ceramics., Clinical Significance: Severely discolored substrates are predictably restored with monolithic CAD/CAM ceramics by performing a previous layering of the substrate with opaque resin composite., (© 2023 Wiley Periodicals LLC.)

Background: Patients with active axial spondyloarthritis (axSpA) exhibit more absences and lower levels of productivity in the workplace and household than the general population, which can improve upon treatment., Objectives: The objective of this study is to determine the long-term impact of achieving different levels of clinical response or disease activity on workplace and household productivity in patients with axSpA., Design: RAPID-axSpA (NCT01087762) was a 204-week phase III trial evaluating the safety and efficacy of certolizumab pegol (CZP) in adult patients with active axSpA., Methods: The impact of axSpA on workplace and household productivity was evaluated using the validated arthritis-specific Work Productivity Survey. Outcomes included the percentage of patients achieving Assessment of SpondyloArthritis International Society (ASAS) response and Ankylosing Spondylitis Disease Activity Score (ASDAS) thresholds. This post hoc study used a generalised estimating equations model to determine the association between the threshold of clinical response achieved and patient productivity., Results: Of 218 CZP-randomised patients, 65.1% completed week 204. At baseline, 72.0% were employed outside the home. Of the patients who were unemployed, 42.6% were unable to work due to arthritis. Achievement of higher treatment response thresholds, such as clinical remission, was associated with fewer days affected by workplace absenteeism (ASAS-partial remission: 4.0 days, ASAS40: 8.6 days, ASAS20 but not reaching ASAS40 response: 29.4 days, ASAS20 non-response: 69.2 days; ASDAS-inactive disease: 5.0 days, ASDAS-low disease activity: 15.6 days, ASDAS-high disease activity: 32.7 days, ASDAS-very high disease activity: 93.4 days). Similar associations were found for workplace presenteeism, and household absenteeism and presenteeism., Conclusions: Over 4 years, achievement of higher clinical response thresholds and lower levels of disease activity was associated with fewer cumulative days affected by absenteeism or presenteeism, with clinical remission associated with the greatest improvements in productivity. This highlights the importance of targeting these thresholds to limit the burden of axSpA on society and on patients' daily lives., Competing Interests: M.R. has received speaking fees from AbbVie, BMS, Boehringer Ingelheim, Chugai, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma; is a consultant for AbbVie, Eli Lilly, Novartis and UCB Pharma. P.M.M. has received personal fees from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, GSK, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB Pharma; is a consultant for AbbVie, Amgen, Eli Lilly, Janssen, Merck, Novartis and UCB Pharma. V.T. is an employee of UCB Pharma. N.d.P. is an employee of UCB Pharma. B.H. is an employee and stockholder of UCB Pharma. L.S.G. has received grants from Novartis and UCB Pharma, paid to institution; has received consulting fees from AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer and UCB Pharma., (© The Author(s), 2023.)

Objective: To identify the best evidence on the efficacy of non-pharmacological interventions in reducing fatigue in people with inflammatory rheumatic and musculoskeletal diseases (I-RMDs) and to summarise their safety in the identified studies to inform European Alliance of Associations for Rheumatology recommendations for the management of fatigue in people with I-RMDs., Methods: Systematic review of randomised controlled trials (RCTs) including adults with I-RMDs conducted according to the Cochrane Handbook. Search strategy ran in Medline, Embase, Cochrane Library, CINAHL Complete, PEDro, OTseeker and PsycINFO. Assessment of risk of bias, data extraction and synthesis were performed by two reviewers independently. Data were pooled in meta-analyses., Results: From a total of 4150 records, 454 were selected for full-text review, 82 fulfilled the inclusion criteria and 55 RCTs were included in meta-analyses. Physical activity or exercise was efficacious in reducing fatigue in rheumatoid arthritis (RA) (standardised mean differences (SMD)=-0.23, 95% CI=-0.37 to -0.1), systemic lupus erythematosus (SLE) (SMD=-0.54, 95% CI=-1.07 to -0.01) and spondyloarthritis (SMD=-0.94, 95% CI=-1.23 to -0.66); reduction of fatigue was not significant in Sjögren's syndrome (SMD=-0.83, 95% CI=-2.13 to 0.47) and systemic sclerosis (SMD=-0.66, 95% CI=-1.33 to 0.02). Psychoeducational interventions were efficacious in reducing fatigue in RA (SMD=-0.32, 95% CI=-0.48 to -0.16), but not in SLE (SMD=-0.19, 95% CI=-0.46 to 0.09). Follow-up models in consultations (SMD=-0.05, 95% CI=-0.29 to 0.20) and multicomponent interventions (SMD=-0.20, 95% CI=-0.53 to 0.14) did not show significant reductions of fatigue in RA. The results of RCTs not included in the meta-analysis suggest that several other non-pharmacological interventions may provide a reduction of fatigue, with reassuring safety results., Conclusions: Physica activity or exercise and psychoeducational interventions are efficacious and safe for managing fatigue in people with I-RMDs., Competing Interests: Competing interests: PMM has received consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript, and is supported by the National Institute for Health Research (NIHR), University College London Hospitals (UCLH), Biomedical Research Centre (BRC). EJFS, BF, RG and ED have no disclosures to report., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The occupational activities carried out in hospital environments pose occupational risks to professionals. In psychiatric hospitals, due to the characteristics of the patients treated, professionals are also subjected to other risks, such as physical aggression., Objective: This research aimed to identify the systemic context, highlighting the cause-and-effect relationships that culminate in occupational accidents that occurred with the nursing staff in a psychiatric hospital in Brazil., Methods: The current study is an applied research and was divided into three stages. First, the collection of data related to the case study was made and accidents were analyzed and occupational hazards were identified. In the second stage, from the collected information, occupational safety indicators were defined. Lastly, in the third stage, the qualitative aspect of System Dynamics was applied to perform the systemic analysis and to identify how the different variables were related., Results: The results showed that physical aggression was the main cause of accidents. Regarding safety indicators, while both the level of use of Personal Protective Equipment (PPE) by professionals and the high level of PPE protection were positive aspects, the level of training of professionals to use PPE was a negative aspect. The Causal Link Diagram (CLD) showed that the perception of risk influenced the level of use of PPE and those organizational measures influenced the accident rate., Conclusion: In conclusion, the systemic analysis of the system dynamics can optimize the diagnostic process of occupational accidents in psychiatric hospitals, and especially help to identify the cause and effect among the variables involved., Competing Interests: Declaration of competing interest The authors declare no competing interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Competing Interests: Competing interests: JAS is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (grant numbers K23 AR069688, R03 AR075886, L30 AR066953, P30 AR070253 and P30 AR072577), the Rheumatology Research Foundation (K Supplement Award and R Bridge Award), the Brigham Research Institute, and the R Bruce and Joan M Mickey Research Scholar Fund. JAS has received research support from Amgen and Bristol-Myers Squibb and performedconsultancy for Bristol-Myers Squibb, Gilead, Inova, Janssen and Optum, unrelated to this work. ZSW reports grant support from Bristol-Myers Squibb and Principia/Sanofi and performed consultancy for Viela Bio and MedPace, outside the submitted work. His work is supported by grants from the National Institutes of Health. PMM has received consulting/speaker’s fees from AbbVie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche and UCB, all unrelated to this study (all US<$10 000). PMM is supported by the National Institute for Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre (BRC). Outside of this work he reports personal consulting and/or speaking fees from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer and UCB, and travel assistance from Roche (all US<$10 000). Her work is supported by grants from the National Institutes of Health, Centers for Disease Control, and the Agency for Healthcare Research and Quality. She has performed consulting for Eli Lilly and AstraZeneca, unrelated to this project.

Background and Objectives: Sporadic inclusion body myositis (IBM) is a rare, muscle-wasting disease that negatively affects health-related quality of life. Although a measure that has been developed to assess the impact of IBM, the IBM Functional Rating Scale (IBMFRS) has limited evidence of content validity or reliability, and what constitutes a meaningful change threshold; this study was conducted to address these gaps., Methods: Adult patients with a clinical diagnosis of IBM from the United Kingdom and disease area expert health care professionals from the United States and United Kingdom took part in this study. This study consisted of 5 stages including phone interviews (physicians), face-to-face interviews (patients), face-to-face ratings, phone ratings, and ratings of videos using the IBMFRS., Results: The IBMFRS adequately captures all core functional impacts of IBM, which was corroborated by both patient participants and physicians when debriefing the measure. Physicians and patient participants all thought any change on the measure would be meaningful change for a patient, either improvement or worsening. The quantitative analysis demonstrated good interrater reliability for face-to-face ratings (intraclass correlation coefficient [ICC] >0.7) and for video ratings (ICC >0.9). Intrarater reliability was excellent for face-to-face and video ratings (ICC >0.9). Equivalence between the modes of administration, face-to-face vs phone, was also excellent (ICC >0.9)., Discussion: The IBMFRS is content valid in assessing the key functional impacts of IBM, and any change would be meaningful. It is reliable both within and across raters, and there is equivalence between different modes of administration (face-to-face vs phone)., Competing Interests: P.M. Machado has received consulting/speaker's fees from Abbvie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme A/S, Pfizer, Roche and UCB, and is supported by the National Institute for Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre (BRC). M.M. Dimachkie serves or recently served as a consultant for for Abcuro, Amazentis, ArgenX, Catalyst, Cello, Covance/Labcorp, CSL-Behring, EcoR1, Janssen, Kezar, MDA, Medlink, Momenta, NuFactor, Octapharma, Priovant, RaPharma/UCB, Roivant Sciences Inc, Sanofi Genzyme, Shire Takeda, Scholar Rock, Spark Therapeutics, Abata/Third Rock, UCB Biopharma and UpToDate. M.M. Dimachkie received research grants or contracts or educational grants from Alexion, Alnylam Pharmaceuticals, Amicus, Biomarin, Bristol-Myers Squibb, Catalyst, Corbus, CSL-Behring, FDA/OOPD, GlaxoSmithKline, Genentech, Grifols, Kezar, Mitsubishi Tanabe Pharma, MDA, NIH, Novartis, Octapharma, Orphazyme, Ra Pharma/UCB, Sanofi Genzyme, Sarepta Therapeutics, Shire Takeda, Spark Therapeutics, The Myositis Association, UCB Biopharma/RaPharma, Viromed/Healixmith & TMA. T. Symonds, J. Randall, L. Lloyd-Price and S. Hudgens are employees of Clinical Outcomes Solutions, a health research consultancy that was paid to conduct this research. C. Guldberg was an employee of Orphazyme A/S, the pharmaceutical company that funded this study. Full disclosure form information provided by the authors is available with the full text of this article at Neurology.org/cp., (© 2023 American Academy of Neurology.)

Background: Due to geographic isolation and border controls Aotearoa New Zealand (AoNZ) attained high levels of population coronavirus disease-19 (COVID-19) vaccination before widespread transmission of COVID-19. We describe outcomes of SARS-CoV-2 infection (Omicron variant) in people with inflammatory rheumatic diseases in this unique setting., Methods: This observational study included people with inflammatory rheumatic disease and SARS-CoV-2 infection in AoNZ between 1 February and 30 April 2022. Data were collected via the Global Rheumatology Alliance Registry including demographic and rheumatic disease characteristics, and COVID-19 vaccination status and outcomes. Multivariable logistic regression was used to explore associations of demographic and clinical factors with COVID-19 hospitalisation and death., Findings: Of the 1599 cases included, 96% were from three hospitals that systematically identified people with inflammatory rheumatic disease and COVID-19. At time of COVID-19, 1513 cases (94.6%) had received at least two COVID-19 vaccinations. Hospitalisation occurred for 104 (6.5%) cases and 10 (0.6%) patients died. Lower frequency of hospitalisation was seen in cases who had received at least two vaccinations (5.9%), compared to the unvaccinated (20.6%) or those with a single vaccine dose (10.7%). In multivariable adjusted models, people with gout or connective tissue diseases (CTD) had increased risk of the combined outcome of hospitalisation/death, compared to people with inflammatory arthritis. Glucocorticoid and rituximab use were associated with increased rates of hospitalisation/death. All patients who died had three or more co-morbidities or were over 60 years old., Interpretation: In this cohort with inflammatory rheumatic diseases and high vaccination rates, severe outcomes from SARS-CoV-2 Omicron variant were relatively infrequent. The outcome of Omicron variant infection among vaccinated but SARS-CoV-2 infection-naive people with inflammatory rheumatic disease without other known risk factors were favourable., Funding: Financial support from the American College of Rheumatology (ACR) and European Alliance of Associations for Rheumatology (EULAR) included management of COVID-19 Global Rheumatology Alliance funds., Competing Interests: JB has no conflicts of interest to declare. AM has no conflicts of interest to declare. ND reports personal fees from AstraZeneca, Dyve Biosciences, Horizon, Selecta, Arthrosi, JW Pharmaceutical Corporation, PK Med, LG Chem, JPI, PTC Therapeutics, Protalix, Unlocked Labs, Hikma outside the submitted work. MS reports speaking fees from Novartis. RNK has no conflicts of interest to declare. AC has no conflicts of interest to declare. VQ has no conflicts of interest to declare. SB reports consulting fees from AbbVie, Horizon, Novartis, and Pfizer. SB is an employee of Pfizer, Inc. MGM has no conflicts of interest to declare. JH has research grants from the Rheumatology Research Foundation and the Childhood Arthritis and Rheumatology Research Foundation. JH reports speaking fees from Novartis, Fresenius Kabi, Pfizer, and Biogen. JL has a research grant from Pfizer. PMM has received consulting/speaker's fees from Abbvie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartisg, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript, and is supported by the National Institute for Health Research (NIHR), University College London Hospitals (UCLH), Biomedical Research Centre (BRC). PS reports an honorarium from the COVID-19 Global Rheumatology Alliance. ES reports grants from the COVID-19 Global Rheumatology Alliance, Canada's drug and health technology agency, the Canadian Institute for Health Research, and McMaster University. ES reports honoraria from the Canadian Rheumatology Association and the Canadian Arthritis Patient's Alliance. PR was unable to report his conflicts of interest as he is deceased. ZW reports research grants from BMS, Sanofi, the National Institute of Health and the Rheumatology Research Foundation. ZW reports royalties from the IgG4 symptom severity score and consulting fees from Sanofi, Horizon, MedPace, Viela Bio, Zenas, and Shionogi. ZW reports participation on data monitoring boards for Sanofi, Horizon, Novartis, Visterra/Otsuka, and Shinogi. JY is supported by NIH/NIAMS K24 AR07534 and AHRQ R01HS028024. She has received research grants from Gilead, Aurinia, BMS Foundation and Astra Zeneca and performed consultation for Astra Zeneca, Pfizer, and Aurinia. RG reports personal and/or speaking fees from AbbVie, Janssen, Novartis, Pfizer, Cornerstones and travel assistance from Pfizer (all < $10,000). The views expressed here are those of the authors and participating members of the COVID-19 Global Rheumatology Alliance and do not necessarily represent the views of the American College of Rheumatology (ACR), the European Alliance of Associations for Rheumatology (EULAR), the (UK) National Health Service (NHS), the National Institute for Health Research (NIHR), or the (UK) Department of Health, or any other organisation., (© 2023 The Author(s).)

Purpose: To evaluate the effect of the standardized laparoscopic simulation training program in pyeloplasty, following its implementation and during the COVID-19 pandemic., Material and Methods: A retrospective chart review was performed at Hospital de Clínicas de Porto Alegre, a tertiary referral center in south Brazil, in which 151 patients underwent laparoscopic pyeloplasty performed by residents between 2006-2021. They were divided into three groups: before and after adoption of a standardized laparoscopic simulation training program and during the COVID-19 pandemic. The main outcome was a combined negative outcome of conversion to open surgery, major postoperative complications (Clavien-Dindo III or higher) or unsuccessful procedure, defined as need for redo pyeloplasty., Results: There was a significant reduction in the combined negative outcome (21.1% vs 6.3%), surgical time (mean 200.0 min vs 177.4 min) and length of stay (median 5 days vs 3 days) after the adoption of simulation training program. These results were maintained during the COVID-19 pandemic (combined negative outcome of 6.3%, mean surgical time of 160.1 min and median length of stay of 3 days) despite a reduction in 55.4% of the surgical volume., Conclusion: A structured laparoscopic simulation program can improve outcomes of laparoscopic pyeloplasty during the learning curve., Competing Interests: None declared., (Copyright® by the International Brazilian Journal of Urology.)

Objectives: To determine how much of the effect of vertebral corner inflammation on development of syndesmophytes is explained by vertebral corner fat deposition., Methods: Patients with radiographic axial spondyloarthritis (r-axSpA) from the SIAS (Sensitive Imaging in Ankylosing Spondylitis) cohort and ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial were assessed at T0, T1 (SIAS: 1 year; ASSERT: 24 weeks) and T2 (2 years). Syndesmophytes assessed in each vertebral corner by whole spine low-dose CT (SIAS) or spinal radiographs (ASSERT) at T0 and T2 were considered present if seen by two of two readers. Inflammation (T0) and fat deposition (T0 and T1) on MRI were present if seen by ≥2 of 3 readers (SIAS) or 2 of 2 readers (ASSERT). Vertebral corners showing fat deposition or a syndesmophyte at baseline were ignored. Mediation analysis was applied to determine what proportion of the total effect of inflammation on syndesmophyte formation could be explained via the path of intermediate fat deposition., Results: Forty-nine SIAS patients (with 2667 vertebral corners) and 168 ASSERT patients (with 2918 vertebral corners) were analysed. The presence of inflammation at T0 increased the probability of a new syndesmophyte in the same vertebral corner at T2 by 9.3%. Of this total effect, 0.2% (2% (0.2 of 9.3) of the total effect) went via intermediate new fat deposition. In ASSERT, the total effect was 7.3%, of which 0.8% (10% of the total effect) went via new fat deposition., Conclusion: In r-axSpA, vertebral corner inflammation may lead to syndesmophyte formation but in a minority of cases via visible fat deposition., Competing Interests: Competing interests: AS—honoraria from Novartis, support for meetings from Lilly and UCB. DvdH—grant from Dutch Rheumatism Association; consulting fees from AbbVie, Gilead, Glaxo-Smith-Kline, Lilly, Novartis and UCB Pharma; other interest as director of Imaging Rheumatology. FAvG—grants from Stichting vrienden van Sole Mio, Stichting ASAS, Jacobus stichting, Novartis and UCB; consulting fees from Novartis, MSD, AbbVie, Bristol Myers Squibb and Eli Lilly. MdH—grants from FWRO/FRSR; participation in data safety monitoring board for UCB; member of EULAR Advocacy Committee, Young ASAS leader and ASAS-EULAR taskforce. MR—fees for ASAS CLASSIC Study. PMM—consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB. RL—consulting fees from AbbVie, Amgen, BMS, GSK, Janssen, Eli Lilly, Novartis, Pfizer and UCB; honoraria from AbbVie, Amgen, BMS, GSK, Janssen, Eli Lilly, Novartis, Pfizer and UCB; participation in data safety monitoring board for UCB; chair of quality of care for EULAR. SR—grants from AbbVie, Galapagos, MSD, Novartis, Pfizer and UCB; consulting fees from AbbVie, Eli Lilly, MSD, Novartis, Pfizer, UCB and Sanofi; honoraria from Eli Lilly, MSD, Novartis and UCB. JB, RS, RvdB, XB—nothing to declare., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The purpose of the present study was to characterize the elastic modulus and Poisson's ratio of a resin cement with distinct viscosities, and to evaluate their impact on the static and fatigue strength of a translucent zirconia (4Y-PSZ) after air-abrasion surface treatment. Bar-shaped specimens of two different viscosities of resin cement (high and low) were obtained (25 × 10 × 3 mm). Sonelastic and Maxwell principles tests were performed to determine the elastic modulus and Poisson's ratio of each resin cement. Disc-shaped specimens of 4Y-PSZ were made (Ø = 15 mm, 1.2 mm in thickness) for the mechanical tests and allocated into groups according to two factors: surface treatment (presence or absence of air-abrasion with alumina particles; 45 μm grain-size); cement (absence, low or high viscosity). The static (n = 10) and cyclical (n = 15) biaxial flexural strength tests were performed by piston-on-three-balls geometry. A fatigue strength test was executed (20 Hz, initial stress of 60 MPa [12% of the mean static biaxial flexural strength], followed by increments of 25 MPa [5% of the mean static biaxial flexural strength] at each step of 10,000 cycles until the failure). The obtained data were analyzed by Weibull analysis. Survival rates were tabulated by the Kaplan-Meier test. Complementary analyses of surface roughness, topography, cross-sectional interfacial zone, fractography, and zirconia crystalline content (X-ray diffraction) were also performed. The evaluated resin cements with high and low viscosity presented similar elastic modulus (13.63 GPa; 12.74 GPa) and Poisson's ratio (0.32; 0.30), respectively. The air-abraded groups depicted higher mechanical strength of the zirconia ceramics than non-abraded groups (p˂ 0.05), regardless of the resin cement. 4Y-PSZ adhesively bonded to a high or low viscosity resin cement have statistically similar behavior (p˃ 0.05). The mechanical structural reliability of the 4Y-PSZ was not affected by the factors. Therefore, resin cement with high and low viscosity presented similar properties and potential to fill the zirconia surface, and did not affect the mechanical behavior of 4Y-PSZ. However, the air-abrasion surface treatment increased the static and fatigue flexural strength of the translucent zirconia., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Objective: The idiopathic inflammatory myopathies (IIMs) are heterogeneous diseases thought to be initiated by immune activation in genetically predisposed individuals. We imputed variants from the ImmunoChip array using a large reference panel to fine-map associations and identify novel associations in IIM., Methods: We analyzed 2,565 Caucasian IIM patient samples collected through the Myositis Genetics Consortium (MYOGEN) and 10,260 ethnically matched control samples. We imputed 1,648,116 variants from the ImmunoChip array using the Haplotype Reference Consortium panel and conducted association analysis on IIM and clinical and serologic subgroups., Results: The HLA locus was consistently the most significantly associated region. Four non-HLA regions reached genome-wide significance, SDK2 and LINC00924 (both novel) and STAT4 in the whole IIM cohort, with evidence of independent variants in STAT4, and NAB1 in the polymyositis (PM) subgroup. We also found suggestive evidence of association with loci previously associated with other autoimmune rheumatic diseases (TEC and LTBR). We identified more significant associations than those previously reported in IIM for STAT4 and DGKQ in the total cohort, for NAB1 and FAM167A-BLK loci in PM, and for CCR5 in inclusion body myositis. We found enrichment of variants among DNase I hypersensitivity sites and histone marks associated with active transcription within blood cells., Conclusion: We found novel and strong associations in IIM and PM and localized signals to single genes and immune cell types., (© 2022 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Objectives: To define the instruments for the Assessment of SpondyloArthritis international Society-Outcomes Measures in Rheumatology (ASAS-OMERACT) core domain set for axial spondyloarthritis (axSpA)., Methods: An international working group representing key stakeholders selected the core outcome instruments following a predefined process: (1) identifying candidate instruments using a systematic literature review; (2) reducing the list of candidate instruments by the working group, (3) assessing the instruments' psychometric properties following OMERACT filter 2.2, (4) selection of the core instruments by the working group and (5) voting and endorsement by ASAS., Results: The updated core set for axSpA includes seven instruments for the domains that are mandatory for all trials: Ankylosing Spondylitis Disease Activity Score and Numerical Rate Scale (NRS) patient global assessment of disease activity, NRS total back pain, average NRS of duration and severity of morning stiffness, NRS fatigue, Bath Ankylosing Spondylitis Function Index and ASAS Health Index. There are 9 additional instruments considered mandatory for disease-modifying antirheumatic drugs (DMARDs) trials: MRI activity Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joints and SPARCC spine, uveitis, inflammatory bowel disease and psoriasis assessed as recommended by ASAS, 44 swollen joint count, Maastricht Ankylosing Spondylitis Enthesitis Score, dactylitis count and modified Stoke Ankylosing Spondylitis Spinal Score. The imaging outcomes are considered mandatory to be included in at least one trial for a drug tested for properties of DMARD. Furthermore, 11 additional instruments were also endorsed by ASAS, which can be used in axSpA trials on top of the core instruments., Conclusions: The selection of the instruments for the ASAS-OMERACT core domain set completes the update of the core outcome set for axSpA, which should be used in all trials., Competing Interests: Competing interests: VN-C: grants/honoraria from AbbVie, Janssen, Lilly, Novartis, Pfizer and UCB. ABoonen: grants from AbbVie ad Novartis and honoraria for boards or lectures form Abbvie, Galapagos and Lilly. PJM: research grants, consultation fees and/or speaker honoraria from Abbvie, Aclaris, Amgen, Bristol Myers, Boehringer-Ingelheim, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Lilly, Novartis, Pfizer, SUN Pharma and UCB. MD: consulting fees Pfizer, AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi and UCB Pharma. UK: grant and research support and consultancy fees from AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, GSK, Janssen, MSD, Novartis, Pfizer, Roche and UCB. RBML: honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, GlaxoSmithKline, Janssen, Eli-Lilly, Novartis, Pfizer and UCB Pharma; Director of Rheumatology Consultancy BV. XB: consulting fees AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB. WB-M: research speaker's fees from Janssen, Lilly, Novartis, Pfizer and Biopas. PC: research grants/honoraria from Novartis, Pfizer, Zuellig Pharma and Janssen. LF: employee and shareholder of Pfizer. MG-C: research collaboration with and provides services to Novartis Pharma AG. LG: research grants/honoraria from AbbVie, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer and UCB. BKE: consultancy, research grants and speaker's fees from AbbVie, Amgen, BMS, Eva, Hekma, Janssen, Lilly, MSD, New Bridge, Novartis, Pfizer, Roche, Sanofi‐Aventis and Servier. NH: consultant for Amgen, Abbvie, Eli Lilly, Janssen, Merck, Novartis, Pfizer and UCB. PMM: consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript. WM: consulting fees Abbvie, BMS, Boehringer, Celgene, Lilly, Janssen, Novartis, Pfizer and UCB; research and/or educational grants from Abbvie, Novartis and Pfizer; Chief Medical Officer CARE Arthritis Limited. AM: speaker honoraria for lectures, presentations from Abbvie, UCB, Novartis, Pfizer, Gilead, Janssen, MSD, BMS, Biogen and Lilly. NdP: employee of UCB Pharma. DP: research support from AbbVie, Lilly, MSD, Novartis and Pfizer, consulting fees from AbbVie, Biocad, Gilead, GlaxoSmithKline, Eli Lilly, MSD, Novartis, Pfizer, Samsung Bioepis and UCB and speaker fees from AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Pfizer and UCB. MP: speaker honoraria for lectures, presentations from Novartis and UCB. SR: research grants from Galapagos, MSD, Novartis and Pfizer and consulting fees from AbbVie, Eli Lilly, MSD, Novartis, UCB and Sanofi. I-HS: employee of AbbVie, Immunology Clinical Development, USA. DvdH: consulting fees AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology bv. ABoel, HD, YHK and SvW: no competing interests to declare., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Excitatory synapses are typically described as single synaptic boutons (SSBs), where one presynaptic bouton contacts a single postsynaptic spine. Using serial section block-face scanning electron microscopy, we found that this textbook definition of the synapse does not fully apply to the CA1 region of the hippocampus. Roughly half of all excitatory synapses in the stratum oriens involved multi-synaptic boutons (MSBs), where a single presynaptic bouton containing multiple active zones contacted many postsynaptic spines (from 2 to 7) on the basal dendrites of different cells. The fraction of MSBs increased during development (from postnatal day 22 [P22] to P100) and decreased with distance from the soma. Curiously, synaptic properties such as active zone (AZ) or postsynaptic density (PSD) size exhibited less within-MSB variation when compared with neighboring SSBs, features that were confirmed by super-resolution light microscopy. Computer simulations suggest that these properties favor synchronous activity in CA1 networks., Competing Interests: Declaration of interests The authors declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: To investigate factors associated with severe COVID-19 in people with psoriasis (PsO), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA)., Methods: Demographic data, clinical characteristics and COVID-19 outcome severity of adults with PsO, PsA and axSpA were obtained from two international physician-reported registries. A three-point ordinal COVID-19 severity scale was defined: no hospitalisation, hospitalisation (and no death) and death. ORs were estimated using multivariable ordinal logistic regression., Results: Of 5045 cases, 18.3% had PsO, 45.5% PsA and 36.3% axSpA. Most (83.6%) were not hospitalised, 14.6% were hospitalised and 1.8% died. Older age was non-linearly associated with COVID-19 severity. Male sex (OR 1.54, 95% CI 1.30 to 1.83), cardiovascular, respiratory, renal, metabolic and cancer comorbidities (ORs 1.25-2.89), moderate/high disease activity and/or glucocorticoid use (ORs 1.39-2.23, vs remission/low disease activity and no glucocorticoids) were associated with increased odds of severe COVID-19. Later pandemic time periods (ORs 0.42-0.52, vs until 15 June 2020), PsO (OR 0.49, 95% CI 0.37 to 0.65, vs PsA) and baseline exposure to TNFi, IL17i and IL-23i/IL-12+23i (OR 0.57, 95% CI 0.44 to 0.73; OR 0.62, 95% CI 0.45 to 0.87; OR 0.67, 95% CI 0.45 to 0.98; respectively; vs no disease-modifying antirheumatic drug) were associated with reduced odds of severe COVID-19., Conclusion: Older age, male sex, comorbidity burden, higher disease activity and glucocorticoid intake were associated with more severe COVID-19. Later pandemic time periods, PsO and exposure to TNFi, IL17i and IL-23i/IL-12+23i were associated with less severe COVID-19. These findings will enable risk stratification and inform management decisions for patients with PsO, PsA and axSpA during COVID-19 waves or similar future respiratory pandemics., Competing Interests: Competing interests: PMM has received honoraria from Abbvie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript, and is supported by the National Institute for Health Research (NIHR), University College London Hospitals (UCLH), Biomedical Research Centre (BRC). MS reports a joint, unconditional grant from a consortium of 14 companies supporting the German RABBIT register (AbbVie, Amgen, BMS, Fresenius Kabi, Galapagos, Hexal, Lilly, MSD, Pfizer, Roche, Samsung, Sanofi, Viatris and UCB). SKM reports departmental income from AbbVie, Almirall, Eli Lilly, Janssen-Cilag, Novartis, Sanofi, UCB, outside the submitted work. JL has nothing to disclose. LG reports personal consultant fees/honoraria/travelling support from AbbVie, Amgen, Bristol-Myers Squibb, Biogen, Celgene, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, and UCB, and grants from Sandoz and UC, all unrelated to this manuscript. ND has nothing to disclose. AP has nothing to disclose. AS reports a joint, unconditional grant from a consortium of 14 companies supporting the German RABBIT register (AbbVie, Amgen, BMS, Fresenius Kabi, Galapagos, Hexal, Lilly, MSD, Pfizer, Roche, Samsung, Sanofi, Viatris and UCB) and personal fees from lectures for AbbVie, Amgen, Celltrion, MSD, Janssen, Lilly, Roche, BMS and Pfizer, all unrelated to this work. ACR reports a joint, unconditional grant from a consortium of 12 companies supporting the German RABBIT-SpA register (AbbVie, Amgen, Biogen, Celltrion, Hexal, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, Viatris and UCB) and personal fees from lectures for Novartis, Roche, and Pfizer, all unrelated to this work. BF has nothing to disclose. CGA has nothing to disclose. CGSS has nothing to disclose. CEMG reports grants and/or personal fees from AbbVie, Almirall, Amgen, Anaptysbio, BMS, Boehringer-Ingelheim, Evelo Bioscience, Inmagene, GSK, Janssen, Kyowa Kirin, LEO, Lilly, Novartis, ONO Pharmaceutical, Pfizer and UCB Pharma, outside the submitted work. CL has nothing to disclose. CM-R has nothing to disclose. DW has received personal speaker/consultant fees from AbbVie, BMS, MSD, Pfizer, Roche Chugai, Amgen, Nordic Pharma, UCB, Novartis, Janssen, Lilly, Sandoz, Grunenthal, Galapagos. DAR is Scientific Advisor for GSK, unrelated to this work. DW has nothing to disclose. EFM has received personal consultant fees from Boehringer Ingelheim Portugal, Lda; LPCDR received support for specific activities: grants from Abbvie, Novartis, Lilly Portugal, Amgen Biofarmacêutica, Grünenthal S.A., MSD, Medac and from A. Menarini Portugal-Farmacêutica, S.A.; grants and non-financial support from Pfizer, and non-financial support from Grünenthal GmbH, outside the submitted work. ES has nothing to disclose. ESR reports grants/contracts from Novartis, Pfizer, Amgen and Elea, honoraria from Amgen, Abbvie, BMS, Eli Lilly, Janssen, Novartis, Pfizer, Sandoz, and UCB, support for attending meetings from Abbvie, Pfizer, UCB, and Janssen, and participation on data safety monitoring board or advisory board from Abbvie, Janssen, Pfizer, Amgen, Sandoz and Novartis. FMR has nothing to disclose. FO has nothing to disclose. FRM has nothing to disclose. HS has nothing to disclose. JD has nothing to disclose. JNB reports grants and/or personal fees from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol-Meyers-Squibb, J&J, LEO Pharma, Lilly, Novartis, Pfizer, Samsung, Sun Pharma, and UCB, outside of the submitted work. JH has nothing to disclose. KLH has received non-personal speaker’s fees from Abbvie and grant income from BMS, UCB, and Pfizer, all unrelated to this manuscript, and is supported by the NIHR Manchester Biomedical Research Centre. LG has received consulting fees and/or research support from Abbvie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer and UCB, all unrelated to this manuscript, and research support from UCB. LS has nothing to disclose. LJ has nothing to disclose. LC has not received fees or personal grants from any laboratory, but her institute works by contract for laboratories among other institutions, such as Abbvie Spain, Eisai, Gebro Pharma, Merck Sharp & Dohme España, S.A., Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi Aventis, Astellas Pharma, Actelion Pharmaceuticals España, Grünenthal GmbH and UCB Pharma. MMP has nothing to disclose. MDZ has nothing to disclose. MdlAS has nothing to disclose. MY has nothing to disclose. MD has nothing to disclose. NG-S has nothing to disclose. NR has nothing to disclose. NH has received consulting fees from Abbvie, Eli Lilly, Janssen, Novartis and UCB. PS has nothing to disclose. RG has received consulting/speaker’s fees from Abbvie, Janssen, Novartis, Pfizer, and Cornerstones, all unrelated to this manuscript, and travel grants from Pfizer and Janssen. RH reports consulting fees from AbbVie, GSK, Novartis, Pfizer, Amgen, Biogen, BMS, Galapagos, Lilly, Mylan, Gilead, Janssen, TAKEDA/Shire, Roche/Chugai, research grant from Pfizer, all unrelated to this manuscript. SL-T has nothing to disclose. SB reports consulting fees from AbbVie, Horizon, Novartis, and Pfizer, and is an employee of Pfizer, Inc. TP reports personal consultant fees from Abbvie, Amgen, Biogen, BMS, Celgene, Celltrion, Fresenius-Kabi, Galapagos, Gilead, Janssen, Lilly, MSD, Nordic, Novartis, Pfizer, Roche-Chugai, Sandoz, Sanofi and UCB, all unrelated to this manuscript. TO reports consultancy fees from Merck Sharp & Dohme, unrelated to the present work. WBM has received personal speaker/consultant fees from AbbVie, Pfizer, Amgen, Novartis, Janssen, Lilly, Biopas. ZSW has nothing to disclose. ZZNY has nothing to disclose. JY is supported by NIH/NIAMS K24 AR07534 and AHRQ R01HS028024. She has received research grants from Gilead, Aurinia, BMS Foundation and Astra Zeneca and performed consultation for Astra Zeneca, Pfizer, and Aurinia. PCR has nothing to disclose. CHS reports grants from AbbVie, Sanofi, Novartis, and Pfizer and through consortia with multiple academic partners (psort.org.uk, BIOMAP-IMI.eu), outside the submitted work; she is a member of the British Association of Dermatologists Guideline committee on biologics in psoriasis., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Idiopathic inflammatory myopathies (IIMs) are a group of acquired muscle diseases with muscle inflammation, weakness, and other extra-muscular manifestations. IIMs can significantly impact the quality of life, and management of IIMs often requires a multi-disciplinary approach. Imaging biomarkers have become an integral part of the management of IIMs. Magnetic resonance imaging (MRI), muscle ultrasound, electrical impedance myography (EIM), and positron emission tomography (PET) are the most widely used imaging technologies in IIMs. They can help make the diagnosis and assess the burden of muscle damage and treatment response. MRI is the most widely used imaging biomarker of IIMs and can assess a large volume of muscle tissue but is limited by availability and cost. Muscle ultrasound and EIM are easy to administer and can even be performed in the clinical setting, but they need further validation. These technologies may complement muscle strength testing and laboratory studies and provide an objective assessment of muscle health in IIMs. Furthermore, this is a rapidly progressing field, and new advances are going to equip care providers with a better objective assessment of IIMS and eventually improve patient management. This review discusses the current state and future direction of imaging biomarkers in IIMs., Competing Interests: PM has received consulting/speaker's fees from Abbvie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche, and UCB. MD serves or recently served as a consultant for Abcuro, Amazentis, ArgenX, Astellas, Catalyst, Cello, Covance/Labcorp, CSL-Behring, EcoR1, Janssen, Kezar, MDA, Medlink, Momenta, NuFactor, Octapharma, Priovant, RaPharma/UCB, Roivant Sciences Inc., Sanofi Genzyme, Shire Takeda, Scholar Rock, Spark Therapeutics, Abata/Third Rock, UCB Biopharma, and UpToDate. MD received research grants or contracts or educational grants from Alexion, Alnylam Pharmaceuticals, Amicus, Biomarin, BristolMyers Squibb, Catalyst, Corbus, CSL-Behring, FDA/OOPD, GlaxoSmithKline, Genentech, Grifols, Kezar, Mitsubishi Tanabe Pharma, MDA, NIH, Novartis, Octapharma, Orphazyme, Ra Pharma/UCB, Sanofi Genzyme, Sarepta Therapeutics, Shire Takeda, Spark Therapeutics, The Myositis Association, UCB Biopharma/RaPharma, Viromed/Healixmith, and TMA. BR has served as a consultant for Alexion Pharmaceuticals (now part of AstraZeneca), Takeda Pharmaceuticals, and argenx. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Zubair, Salam, Dimachkie, Machado and Roy.)

Objectives: To compare MRI and conventional radiography of SI joints for detection of structural lesions typical for axial spondyloarthritis (axSpA)., Methods: Adult patients from the Assessment of SpondyloArthritis international Society (ASAS) cohort with symptoms suggestive of axSpA and both SI joint MRI and radiographs available for central reading were included. Radiographs were evaluated by three readers according to the modified New York (mNY) criteria grading system. The presence of structural damage on radiographs was defined as fulfilment of the radiographic mNY criterion and, additionally, a lower threshold for sacroiliitis of at least grade 2 unilaterally. MRI scans were assessed for the presence of structural changes indicative of axSpA by seven readers. Diagnostic performance [sensitivity, specificity, positive and negative predictive values (PPV and NPV) and positive and negative likelihood ratios (LR+ and LR-)] of MRI and radiographs (vs rheumatologist's diagnosis of axSpA) were calculated., Results: Overall, 183 patients were included and 135 (73.7%) were diagnosed with axSpA. Structural lesions indicative of axSpA on MRI had sensitivity 38.5%, specificity 91.7%, PPV 92.9%, NPV 34.6%, LR+ 4.62 and LR- 0.67. Sacroiliitis according to the mNY criteria had sensitivity 54.8%, specificity 70.8%, PPV 84.1%, NPV 35.8%, LR+ 1.88 and LR- 0.64. Radiographic sacroiliitis of at least grade 2 unilaterally had sensitivity 65.2%, specificity 50.0%, PPV 78.6%, NPV 33.8%, LR+ 1.30 and LR- 0.69., Conclusion: Structural lesions of the SI joint detected by MRI demonstrated better diagnostic performance and better interreader reliability compared with conventional radiography., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: To describe obstetric outcomes based on COVID-19 vaccination status, in women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy., Methods: Data regarding pregnant women entered into the COVID-19 Global Rheumatology Alliance registry from 24 March 2020-25 February 2022 were analysed. Obstetric outcomes were stratified by number of COVID-19 vaccine doses received prior to COVID-19 infection in pregnancy. Descriptive differences between groups were tested using the chi-squared or Fisher's exact test., Results: There were 73 pregnancies in 73 women with RMD and COVID-19. Overall, 24.7% (18) of pregnancies were ongoing, while of the 55 completed pregnancies, 90.9% (50) of pregnancies resulted in livebirths. At the time of COVID-19 diagnosis, 60.3% (n = 44) of women were unvaccinated, 4.1% (n = 3) had received one vaccine dose while 35.6% (n = 26) had two or more doses. Although 83.6% (n = 61) of women required no treatment for COVID-19, 20.5% (n = 15) required hospital admission. COVID-19 resulted in delivery in 6.8% (n = 3) of unvaccinated women and 3.8% (n = 1) of fully vaccinated women. There was a greater number of preterm births (PTB) in unvaccinated women compared with fully vaccinated 29.5% (n = 13) vs 18.2% (n = 2)., Conclusions: In this descriptive study, unvaccinated pregnant women with RMD and COVID-19 had a greater number of PTB compared with those fully vaccinated against COVID-19. Additionally, the need for COVID-19 pharmacological treatment was uncommon in pregnant women with RMD regardless of vaccination status. These results support active promotion of COVID-19 vaccination in women with RMD who are pregnant or planning a pregnancy., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objectives: Sporadic inclusion body myositis (IBM) is a debilitating idiopathic inflammatory myopathy (IIM) which affects hand function, ambulation, and swallowing. There is no approved pharmacological therapy for IBM, and there is a lack of suitable outcome measure to assess the effect of an intervention. The IBM scientific interest group under IMACS reviewed the previously used outcome measures in IBM clinical studies to lay the path for developing a core set of outcome measures in IBM., Methods: In this systematised review, we have extracted all outcome measures reported in IBM clinical studies to determine what measures were being used and to assess the need for optimising outcome measures in IBM., Results: We found 13 observational studies, 17 open-label clinical trials, and 15 randomised control trials (RCTs) in IBM. Six-minute walk distance, IBM-functional rating scale (IBM-FRS), quantitative muscle testing, manual muscle testing, maximal voluntary isometric contraction testing, and thigh muscle volume measured by MRI were used as primary outcome measures. Twelve different outcome measures of motor function were used in IBM clinical trials. IBM-FRS was the most used measure of functionality. Swallowing function was reported as a secondary outcome measure in only 3 RCTs., Conclusions: There are inconsistencies in using outcome measures in clinical studies in IBM. The core set measures developed by the IMACS group for other IIMs are not directly applicable to IBM. As a result, there is an unmet need for an IBM-specific core set of measures to facilitate the evaluation of new potential therapeutics for IBM.

Objectives: Sporadic inclusion body myositis (IBM) is the most common acquired myopathy in those aged above 50. It is classically heralded by weakness in the long finger flexors and quadriceps. The aim of this article is to describe five atypical cases of IBM, outlining two potential emerging clinical subsets of the disease., Methods: We reviewed relevant clinical documentation and pertinent investigations for five patients with IBM., Results: The first phenotype we describe is young-onset IBM in two patients who had symptoms since their early thirties. The literature supports that IBM can rarely present in this age range or younger. We describe a second phenotype in three middle-aged women who developed early bilateral facial weakness at presentation in tandem with dysphagia and bulbar impairment followed by respiratory failure requiring non-invasive ventilation (NIV). Within this group, two patients were noted to have macroglossia, another possible rare feature of IBM., Conclusions: Despite the classical phenotype described within the literature IBM can present in a heterogenous fashion. It is important to recognise IBM in younger patients and investigate for specific associations. The described pattern of facial diplegia, severe dysphagia, bulbar dysfunction and respiratory failure in female IBM patients requires further characterisation. Patients with this clinical pattern may require more complex and supportive management. Macroglossia is a potentially under recognised feature of IBM. The presence of macroglossia in IBM warrants further study, as its presence may lead to unnecessary investigations and delay diagnosis.

Inclusion body myositis (IBM) belongs to the group of idiopathic inflammatory myopathies and is characterized by a slowly progressive disease course with asymmetric muscle weakness of predominantly the finger flexors and knee extensors. The disease leads to severe disability and most patients lose ambulation due to lack of curative or disease-modifying treatment options. Despite some genes reported to be associated with hereditary IBM (a distinct group of conditions), data on the genetic susceptibility of sporadic IBM are very limited. This review gives an overview of the disease and focuses on the current genetic knowledge and potential therapeutic implications., (© 2022. The Author(s).)

Vaccination against viruses has rarely been associated with Guillain-Barré syndrome (GBS), and an association with the COVID-19 vaccine is unknown. We performed a population-based study of National Health Service data in England and a multicentre surveillance study from UK hospitals to investigate the relationship between COVID-19 vaccination and GBS. Firstly, case dates of GBS identified retrospectively in the National Immunoglobulin Database from 8 December 2021 to 8 July 2021 were linked to receipt dates of COVID-19 vaccines using data from the National Immunisation Management System in England. For the linked dataset, GBS cases temporally associated with vaccination within a 6-week risk window of any COVID-19 vaccine were identified. Secondly, we prospectively collected incident UK-wide (four nations) GBS cases from 1 January 2021 to 7 November 2021 in a separate UK multicentre surveillance database. For this multicentre UK-wide surveillance dataset, we explored phenotypes of reported GBS cases to identify features of COVID-19 vaccine-associated GBS. Nine hundred and ninety-six GBS cases were recorded in the National Immunoglobulin Database from January to October 2021. A spike of GBS cases above the 2016-2020 average occurred in March-April 2021. One hundred and ninety-eight GBS cases occurred within 6 weeks of the first-dose COVID-19 vaccination in England [0.618 cases per 100,000 vaccinations; 176 ChAdOx1 nCoV-19 (AstraZeneca), 21 tozinameran (Pfizer) and one mRNA-1273 (Moderna)]. The 6-week excess of GBS (compared to the baseline rate of GBS cases 6-12 weeks after vaccination) occurred with a peak at 24 days post-vaccination; first-doses of ChAdOx1 nCoV-19 accounted for the excess. No excess was seen for second-dose vaccination. The absolute number of excess GBS cases from January-July 2021 was between 98-140 cases for first-dose ChAdOx1 nCoV-19 vaccination. First-dose tozinameran and second-dose of any vaccination showed no excess GBS risk. Detailed clinical data from 121 GBS patients were reported in the separate multicentre surveillance dataset during this timeframe. No phenotypic or demographic differences identified between vaccine-associated and non-vaccinated GBS cases occurring in the same timeframe. Analysis of the linked NID/NIMS dataset suggested that first-dose ChAdOx1 nCoV-19 vaccination is associated with an excess GBS risk of 0.576 (95% confidence interval 0.481-0.691) cases per 100 000 doses. However, examination of a multicentre surveillance dataset suggested that no specific clinical features, including facial weakness, are associated with vaccination-related GBS compared to non-vaccinated cases. The pathogenic cause of the ChAdOx1 nCoV-19 specific first dose link warrants further study., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Guarantors of Brain.)

Background and Purpose: Clinical outcome information on patients with neuromuscular diseases (NMDs) who have been infected with SARS-CoV-2 is limited. The aim of this study was to determine factors associated with the severity of COVID-19 outcomes in people with NMDs., Methods: Cases of NMD, of any age, and confirmed/presumptive COVID-19, submitted to the International Neuromuscular COVID-19 Registry up to 31 December 2021, were included. A mutually exclusive ordinal COVID-19 severity scale was defined as follows: (1) no hospitalization; (2) hospitalization without oxygenation; (3) hospitalization with ventilation/oxygenation; and (4) death. Multivariable ordinal logistic regression analyses were used to estimate odds ratios (ORs) for severe outcome, adjusting for age, sex, race/ethnicity, NMD, comorbidities, baseline functional status (modified Rankin scale [mRS]), use of immunosuppressive/immunomodulatory medication, and pandemic calendar period., Results: Of 315 patients from 13 countries (mean age 50.3 [±17.7] years, 154 [48.9%] female), 175 (55.5%) were not hospitalized, 27 (8.6%) were hospitalized without supplemental oxygen, 91 (28.9%) were hospitalized with ventilation/supplemental oxygen, and 22 (7%) died. Higher odds of severe COVID-19 outcomes were observed for: age ≥50 years (50-64 years: OR 2.4, 95% confidence interval [CI] 1.33-4.31; >64 years: OR 4.16, 95% CI 2.12-8.15; both vs. <50 years); non-White race/ethnicity (OR 1.81, 95% CI 1.07-3.06; vs. White); mRS moderately severe/severe disability (OR 3.02, 95% CI 1.6-5.69; vs. no/slight/moderate disability); history of respiratory dysfunction (OR 3.16, 95% CI 1.79-5.58); obesity (OR 2.24, 95% CI 1.18-4.25); ≥3 comorbidities (OR 3.2, 95% CI 1.76-5.83; vs. ≤2; if comorbidity count used instead of specific comorbidities); glucocorticoid treatment (OR 2.33, 95% CI 1.14-4.78); and Guillain-Barré syndrome (OR 3.1, 95% CI 1.35-7.13; vs. mitochondrial disease)., Conclusions: Among people with NMDs, there is a differential risk of COVID-19 outcomes according to demographic and clinical characteristics. These findings could be used to develop tailored management strategies and evidence-based recommendations for NMD patients., (© 2022 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.)

Purpose: Both spondyloarthritis and chronic low back pain (CLBP) significantly impact health-related quality of life (HRQoL). It is important to clarify whether these disorders have different impacts on the several domains of HRQoL as different mechanisms may necessitate different treatment interventions. Moreover, the factors associated with HRQoL can inform more targeted group interventions to promote HRQoL., Methods: We used data from EpiReumaPt, a population-based survey conducted from September 2011 to December 2013. HRQoL was assessed with EuroQoL-5-Dimensions (EQ-5D). Spondyloarthritis was diagnosed by expert opinion (rheumatologist) and predefined criteria. CLBP was diagnosed if low back pain was present on the day of the interview and persisted for > 90 days. Univariable and multivariable linear regression analyses compared HRQoL among subjects with spondyloarthritis, CLBP, and no rheumatic diseases. Multivariable linear regression analyses evaluated HRQoL factors in spondyloarthritis and CLBP subjects., Results: We included 92 spondyloarthritis patients, 1376 CLBP patients, and 679 subjects without rheumatic diseases. HRQoL was similarly affected in spondyloarthritis and CLBP (ß =  - 0.03, 95% CI [- 0.08; 0.03]) in all EQ5D dimensions. A much lower HRQoL was found in spondyloarthritis and CLBP patients compared with subjects without rheumatic diseases (ß =  - 0.14, 95% CI [- 0.19; - 0.10]; ß =  - 0.12, 95% CI [- 0.14; - 0.09], respectively). In spondyloarthritis subjects, multimorbidity and active disease were associated with worse HRQoL (ß =  - 0.18; 95% CI [- 0.24; 0.03]; ß =  - 0.13; 95% CI [- 0.29; - 0.05], respectively), and regular physical exercise was associated with better HRQoL (ß = 0.18; 95% CI [0.10; 0.30]). In CLBP subjects, multimorbidity (β =  - 0.11; 95% CI [- 0.14; - 0.08]), obesity (β =  - 0.04; 95% CI [- 0.08; - 0.01]), and low back pain intensity (β =  - 0.02; 95% CI [- 0.03; - 0.02]) were associated with worse HRQoL, and regular physical exercise (β = 0.08; 95% CI [0.05; 0.11]) was significantly associated with better HRQoL., Conclusion: Spondyloarthritis and CLBP subjects reported similar levels of impairment in the mental, physical, and social domains of HRQoL. Future health plans should address modifiable factors associated with HRQoL in these conditions to achieve better outcomes., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objective: To determine the association between race/ethnicity and COVID-19 outcomes in individuals with systemic lupus erythematosus (SLE)., Methods: Individuals with SLE from the US with data entered into the COVID-19 Global Rheumatology Alliance registry between March 24, 2020 and August 27, 2021 were included. Variables included age, sex, race, and ethnicity (White, Black, Hispanic, other), comorbidities, disease activity, pandemic time period, glucocorticoid dose, antimalarials, and immunosuppressive drug use. The ordinal outcome categories were: not hospitalized, hospitalized with no oxygenation, hospitalized with any ventilation or oxygenation, and death. We constructed ordinal logistic regression models evaluating the relationship between race/ethnicity and COVID-19 severity, adjusting for possible confounders., Results: We included 523 patients; 473 (90.4%) were female and the mean ± SD age was 46.6 ± 14.0 years. A total of 358 patients (74.6%) were not hospitalized; 40 patients (8.3%) were hospitalized without oxygen, 64 patients (13.3%) were hospitalized with any oxygenation, and 18 (3.8%) died. In a multivariable model, Black (odds ratio [OR] 2.73 [95% confidence interval (95% CI) 1.36-5.53]) and Hispanic (OR 2.76 [95% CI 1.34-5.69]) individuals had higher odds of more severe outcomes than White individuals., Conclusion: Black and Hispanic individuals with SLE experienced more severe COVID-19 outcomes, which is consistent with findings in the US general population. These results likely reflect socioeconomic and health disparities and suggest that more aggressive efforts are needed to prevent and treat infection in this population., (© 2022 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Objectives: To update the Assessment of SpondyloArthritis international Society (ASAS)-EULAR recommendations for the management of axial spondyloarthritis (axSpA)., Methods: Following the EULAR Standardised Operating Procedures, two systematic literature reviews were conducted on non-pharmacological and pharmacological treatment of axSpA. In a task force meeting, the evidence was presented, discussed, and overarching principles and recommendations were updated, followed by voting., Results: Five overarching principles and 15 recommendations with a focus on personalised medicine were agreed: eight remained unchanged from the previous recommendations; three with minor edits on nomenclature; two with relevant updates (#9, 12); two newly formulated (#10, 11). The first five recommendations focus on treatment target and monitoring, non-pharmacological management and non-steroidal anti-inflammatory drugs (NSAIDs) as first-choice pharmacological treatment. Recommendations 6-8 deal with analgesics and discourage long-term glucocorticoids and conventional synthetic disease-modifying antirheumatic drugs (DMARDs) for pure axial involvement. Recommendation 9 describes the indication of biological DMARDs (bDMARDs, that is, tumour necrosis factor inhibitors (TNFi), interleukin-17 inhibitors (IL-17i)) and targeted synthetic DMARDs (tsDMARDs, ie, Janus kinase inhibitors) for patients who have Ankylosing Spondylitis Disease Activity Score ≥2.1 and failed ≥2 NSAIDs and also have either elevated C reactive protein, MRI inflammation of sacroiliac joints or radiographic sacroiliitis. Current practice is to start a TNFi or IL-17i. Recommendation 10 addresses extramusculoskeletal manifestations with TNF monoclonal antibodies preferred for recurrent uveitis or inflammatory bowel disease, and IL-17i for significant psoriasis. Treatment failure should prompt re-evaluation of the diagnosis and consideration of the presence of comorbidities (#11). If active axSpA is confirmed, switching to another b/tsDMARD is recommended (#12). Tapering, rather than immediate discontinuation of a bDMARD, can be considered in patients in sustained remission (#13). The last recommendations (#14, 15) deal with surgery and spinal fractures., Conclusions: The 2022 ASAS-EULAR recommendations provide up-to-date guidance on the management of patients with axSpA., Competing Interests: Competing interests: SR received research grants from AbbVie, Galapagos, Novartis, Pfizer and UCB, and consulting fees from AbbVie, Eli Lilly, Novartis, MSD, Pfizer, UCB and Sanofi. EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, and Lilly, and holds research grants from Pfizer and Lilly. AS has received speaker/consulting fees from UCB and Novartis. AO has nothing to declare. CW has nothing to declare. XB received consulting fees and research grants from AbbVie, BMS, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi and UCB. XB is an editorial board member of Annals of Rheumatic Diseases. RBML received consulting fees from AbbVie, Bristol Myers Squibb, Celgene, Jansen, Galapagos, GlaxoSmithKline, Novartis, Pfizer, and UCB, and is director of Rheumatology Consultancy. FEVdB received consulting and/or speaker fees from AbbVie, Amgen, Eli Lilly, Galapagos, Janssen, MoonLake, Novartis, Pfizer and UCB. BB has nothing to declare. AB has nothing to declare. PC received consulting/speaker’s fees from Eli Lilly, Pfizer, AbbVie, Sanofi, Galapagos, Fresenius Kabi, Biogen, MSD, UCB and Novartis. AC received honoraria for lectures from AbbVie, Merck Sharp & Dohme and Novartis. FAvG received grants from Stichting ASAS, and consulting/speaker’s fees from Novartis, UCB, Pfizer, AbbVie, Eli Lilly, Bristol Myers Squibb and Celgene. PG received speaker’s fees from AbbVie. LG received consulting fees and research grants from AbbVie, Eli Lilly, Galapagos, Janssen, MoonLake, Novartis, Pfizer and UCB. JH has received speaker honoraria and participated in advisory boards for AbbVie, Lilly, Novartis and Janssen. MdH has nothing to declare. MH has received speaker’s fees from Novartis. UK has received grant and research support and consultancy fees from AbbVie, Amgen, Biocad, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, Grünenthal, GSK, Janssen, MSD, Novartis, Pfizer, Roche and UCB. CL-M has received speaker/consulting fees from UCB, Novartis, Janssen, Eli Lilly, MSD and AbbVie. PMM has received honoraria from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche, and UCB, and is supported by the National Institute for Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre (BRC). HM-O received grants from Janssen, Novartis and UCB, and consultancy/speaker's fees from AbbVie, Biogen, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB. AM received research grants from UCB and consulting fees from AbbVie, Biogen, BMS, Eli Lilly, Gilead, Novartis, MSD, Pfizer and UCB. VN-C received grants/honoraria from AbbVie, Galapagos, Janssen, Lilly, MoonLake, Novartis, Pfizer and UCB. MJN received grant from Novartis and consultancy/speaker's fees from AbbVie, Eli Lilly, Janssen, Novartis and Pfizer. FMP-S received research grants from AbbVie, Janssen, and Novartis, and consulting fees from AbbVie, Bial, Biogen, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Pharma Kern, UCB and Tecnimed. DP received research support from AbbVie, Eli Lilly, MSD, Novartis, and Pfizer, and consulting fees from AbbVie, Biocad, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, MSD, MoonLake, Novartis, Pfizer, Samsung Bioepis, and UCB, and speaker's fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, MSD, Medscape, Novartis, Peervoice, Pfizer and UCB. FP reports grants and personal fees from Novartis, Lilly and UCB, and personal fees from AbbVie, Amgen, BMS, Celgene, Janssen, Hexal, MSD, Pfizer and Roche. MR received consulting fees from AbbVie, Janssen, Eli Lilly, Novartis, Pfizer and UCB Pharma. MT has nothing to declare. SSZ has received consulting fees from UCB. NZ received research grants from AbbVie, Celgene, NewBridge and Pfizer; consulting fees from AbbVie, Eli Lilly, Pfizer, Gilead, Janssen, Novartis, NewBridge and Roche; and speaker's fees from AbbVie, Apotex, Eli Lilly, Janssen, Novartis, Pfizer, Pierre Fabre, Pharmaline, Roche and Sanofi-Aventis. DvdH received consulting fees from AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer and UCB Pharma, and is director of Imaging Rheumatology., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: We aimed to describe, from the perspective of rheumatologists in Europe, how the coronavirus disease 2019 (COVID-19) pandemic has impacted their management of people with RA and the continuing medical education of physicians., Methods: Rheumatologists participating in the Adelphi RA Disease Specific Programme TM in six European countries were contacted in August and September 2020 for a telephone survey. Rheumatologists were asked seven attitudinal questions on changes to patient management, prescription behaviour and continuing education owing to COVID-19. Results were summarized with descriptive statistics., Results: The telephone survey was completed by 284 rheumatologists. The most commonly reported changes to patient management were increased utilization of video/telephone consultations (66.5% of respondents), fewer visits (58.5%) and limiting physical contact (58.1%). Furthermore, 67.9% of rheumatologists who indicated that prescribing behaviour had changed switched their patients to self-administered medication, and 60.7% reported not starting patients on targeted synthetic DMARDs, biologic originator DMARDs or biosimilar DMARDs. In total, 57.6% of rheumatologists believed that changes in management would persist. Rheumatologists reported that 38.0% of patients expressed concerns about how COVID-19 would impact treatment, including access to treatment and the risk of infection. The biggest impact on rheumatologist education was a switch to online training and conferences., Conclusion: All countries saw changes in patient management and prescribing behaviour, including the rapid uptake of telemedicine. It is important that the international rheumatology community learns from these experiences to prepare better for future pandemics and to address ongoing rheumatologist shortages., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

The first EULAR provisional recommendations on the management of rheumatic and musculoskeletal diseases (RMDs) in the context of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), largely based on expert opinion, were published in June 2020. Since then, an unprecedented number of clinical studies have accrued in the literature. Several SARS-CoV-2 vaccines have been approved for population-wide vaccination programmes in EULAR-affiliated countries. Studies regarding vaccination of patients with (inflammatory) RMDs have released their first results or are underway.EULAR found it opportune to carefully review to what extent the initially consensus expert recommendations stood the test of time, by challenging them with the recently accumulated body of scientific evidence, and by incorporating evidence-based advice on SARS-CoV-2 vaccination. EULAR started a formal (first) update in January 2021, performed a systematic literature review according to EULAR's standard operating procedures and completed a set of updated overarching principles and recommendations in July 2021. Two points to consider were added in November 2021, because of recent developments pertaining to additional vaccination doses., Competing Interests: Competing interests: RBML received honoraria for lecturing and consultation from AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead, Janssen, Eli Lilly, Novartis, Pfizer, UCB, is chair of EULAR’s committee for the quality of care and is owner and director of Rheumatology Consultancy BV. RBML is chair of EULAR’s committee of quality of care. AN received honoraria for lectures and consulting form BMS, UCB, Chigai and Roche. JWJB received honoraria for lectures and consulting from Fresnius, Galapagos, Syneos. GRB received honoraria for lectures and consulting from AbbVie, Amgen, BMS, Gilead, Janssen, Lilly, Novartis, Pfizer, Sanofi-Aventis, Roche, UCB. RC received honoraria for lectures from AbbVie, Janssen, Roche, Sanofi. BC received honoraria for lecturing and consultation from AbbVie, BMS, Celltrion, Galapagos, Gilead, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Roche-Chugai. RC received honoraria for lectures and consulting or travel support from AbbVie, Janssen, Nordic Pharma, Roche and Sanofi. JRC received research grants and consulting from Amgen, AbbVie, BMS, GSK, Janssen, Lilly, Novartis, Pfizer, and chairs the ACR COVID Vaccine Guidance Task Force. OE received honoraria for lecturing and consultation from AbbVie, BMS, Celgene, Gilead, Janssen, Eli Lilly, Novartis, Pfizer and B.I. MWH Consultation and speaker’s fees from ALK and Roche. LH received a speaker’s fee from Grünenthal, honoraria for writing articles from MedMedia, and travel support from AbbVie, Biogen, BMS, MSD, Novartis and Roche. AI received consultancies, honoraria, speaker-fees from AbbVie, MSD, Alfasigma, Celltrion, BMS, Celgene, Eli Lilly, Sanofi, Genzyme, Pfizer, Galapagos, Gilead, Novartis, SOBI and research grants from MSD, Alfasigma, AbbVie. AI is acting president of EULAR. JDI received research grants from Pfizer, Janssen and GSK and honoraria for lectures, conference support from Eli Lilly and Gilead, and speaker/consulting fees from AbbVie, Gilead, Roche and UCB. XM received consulting fees from BMS, Gilead, Janssen, Pfizer, Samsung, UCB. BC received honoraria from AbbVie, BMS, Gilead, Janssen, Lilly, Merck, Novartis, Pfizer, Roche-Chugai, Sanofi and UCB; and research grants from Novartis, Pfizer, and Roche. IBM received research grants from Lilly, Pfizer, BMS, Celgene, Janssen; and consulting fees from AbbVie, BMS, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Sanofi-Aventis and UCB. IBM is past president of EULAR. HS-K received honoraria for lectures and consulting from AbbVie, Amgen, BMS, Gilead, Janssen, Lilly, Novartis, Pfizer, Sanofi-Aventis, Roche and UCB. JSS received grants to his institution from AbbVie, AstraZeneca, Janssen, Lilly, MSD, Pfizer and Roche and provided expert advice for, or had symposia speaking engagements with, AbbVie, Amgen, AstraZeneca, Astro, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO Pharma, Janssen, Lilly, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi and UCB. JSS is editor of the Annals of Rheumatic Diseases. KW received honoraria and consultancy fees from AbbVie, Lilly, Roche, GSK, Novartis, BMS, Pfizer, UCB, Janssen, Regeneron and Sanofi. VN-C received research grants/honoraria from AbbVie, Janssen, Lilly, Novartis, Pfizer, and UCB. PMM received consulting/speaker’s fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche and UCB, all unrelated to this manuscript., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To assess the hierarchy of outcomes contributing to health-related quality of life (HRQoL) in spondyloarthritis (SpA) and rheumatoid arthritis (RA)., Methods: Data from the international cross-sectional COMOSPA and COMORA studies were used. HRQoL was assessed using the EuroQOL 5-dimension 3-level (EQ-5D-3 L). First, multivariable linear regression models were used to identify associations between EQ-5D-3 L (dependent variable) and several demographic and clinical variables (independent variables). Second, a decision tree was built using Chi-square Automatic Interaction Detector, a method of unbiased hierarchical multivariable analysis (dependent variable: EQ-5D-3 L)., Results: In total, 3984 patients with SpA and 3920 patients with RA were included. In SpA, HRQoL was associated with BASFI (adjusted B=-0.006; 95%CI=-0.007 to -0.005), ASDAS (-0.052; -0.071 to -0.033), work productivity loss score (-0.002; -0.003 to -0.002), NSAID treatment (-0.052; -0.083 to -0.020), bDMARD treatment (-0.051; -0.082 to -0.021), university education (-0.051; -0.075 to -0.027) and radiographic sacroiliitis (0.035; 0.004 to 0.030). In RA, HRQoL was associated with modified Health Assessment Questionnaire (MHAQ) (-0.220, -0.253 to -0.188), DAS28-CRP-3v (-0.027, -0.036 to -0.018), work productivity loss score (-0.003, -0.003 to -0.002), presence of erosions (-0.042, -0.065 to -0.020), alcohol consumption ≥3 units/day (0.012, 0.001 to 0.024)) and csDMARD treatment (0.034, 0.001 to 0.066). The decision tree revealed BASFI and MHAQ as first variables with the most discriminative power on EQ-5D-3 L, followed by work productivity loss and disease activity, in both SpA and RA cohorts., Conclusion: In SpA and RA, physical function is the main contributor to HRQoL measured by EQ-5D-3 L, followed by disease activity and work productivity loss., Competing Interests: Competing interests PMM has received consulting/speaker's fees from Abbvie, BMS, Celgene, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche and UCB. EVS has received grants, consulting/speaker's fees from MSD, Celgene, Novartis, Janssen, Abbvie, Pfizer. PC has received speaker's fees from Novartis, Pharmakern, Bial and Amgen. The other authors have declared no conflicts of interest., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)