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Article ; Online: Systematic literature review informing the 2022 EULAR recommendations for screening and prophylaxis of chronic and opportunistic infections in adults with autoimmune inflammatory rheumatic diseases

George E Fragoulis / Jan Schoones / Delphine Courvoisier / Elena Nikiphorou / Mrinalini Dey / James Galloway / Kimme L Hyrich / Sizheng Zhao

RMD Open, Vol 8, Iss

2022 Volume 2

Abstract: Objective To conduct a systematic literature review (SLR) on the screening and prophylaxis of opportunistic and chronic infections in autoimmune inflammatory rheumatic diseases (AIIRD).Methods SLR (inception-12/2021) based on the following search domains: ...

Abstract	Objective To conduct a systematic literature review (SLR) on the screening and prophylaxis of opportunistic and chronic infections in autoimmune inflammatory rheumatic diseases (AIIRD).Methods SLR (inception-12/2021) based on the following search domains: (1) infectious agents, (2) AIIRD, (3) immunosuppressives/immunomodulators used in rheumatology, (4) screening terms and (5) prophylaxis terms. Articles were retrieved having the terms from (1) AND (2) AND (3) plus terms from (4) OR(5). Databases searched: PubMed, Embase and Cochrane Library. Exclusion criteria: studies on postoperative infections, paediatric AIIRD, COVID-19, vaccinations and non-Εnglish literature. Study quality was assessed with Newcastle-Ottawa scale for non-randomised controlled trials (RCTs), RoB-Cochrane for RCTs, AMSTAR2 for SLRs.Results From 5641 studies were retrieved, 568 full-text articles were assessed for eligibility, with 194 articles finally included. For tuberculosis, tuberculin skin test (TST) is affected by treatment with glucocorticoids and conventional synthetic disease modifying anti-rheumatic drugs (DMARDs) and its performance is inferior to interferon gamma release assay (IGRA). Agreement between TST and IGRA is moderate to low. For hepatitis B virus (HBV): risk of reactivation is increased in patients positive for hepatitis B surface antigen. Anti-HBcore positive patients are at low risk for reactivation but should be monitored periodically with liver function tests and/or HBV-viral load. Risk for Hepatitis C reactivation is existing but low in patients treated with biological DMARDs. For Pneumocystis jirovecii, prophylaxis treatment should be considered in patients treated with prednisolone ≥15–30 mg/day for >2–4 weeks.Conclusions Different screening and prophylaxis approaches are described in the literature, partly determined by individual patient and disease characteristics.
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2022-11-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Infection profile of immune-modulatory drugs used in autoimmune diseases

Catherine Smith / Andrew Cope / Elena Nikiphorou / Mrinalini Dey / James Galloway / Kimme L Hyrich / Katie Bechman / Sizheng Zhao

RMD Open, Vol 8, Iss

analysis of summary of product characteristic data

2022 Volume 2

Abstract: Objective Serious infection remains a concern when prescribing immune-modulatory drugs for immune-mediated inflammatory diseases. The ‘summary of product characteristics’ (SmPCs) provide information on adverse events for example, infections, from ... ...

Abstract	Objective Serious infection remains a concern when prescribing immune-modulatory drugs for immune-mediated inflammatory diseases. The ‘summary of product characteristics’ (SmPCs) provide information on adverse events for example, infections, from clinical trials and postmarketing pharmacovigilance.This review aimed to compare infection frequency, site and type across immune-modulatory drugs, reported in SmPCs.Methods The Electronic Medicines Compendium was searched for commonly prescribed immune-modulatory drugs used for: rheumatoid arthritis, spondyloarthritis, connective tissue disease, autoimmune vasculitis, autoinflammatory syndromes, inflammatory bowel disease, psoriasis, multiple sclerosis and/or other rarer conditions.Information was extracted on infection frequency, site and organisms. Frequency was recorded as per the SmPCs: very common (≥1/10); common (≥1/100 to<1/10); uncommon (≥1/1,000 to<1/100); rare (≥1/10,000 to<1/1,000); very rare (<1/10 000).Results 39 drugs were included, across 20 indications: 9 conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), 6 targeted synthetic DMARDs, 24 biologic (b)DMARDs.Twelve infection sites were recorded. Minimal/no site information was available for most csDMARDs, certolizumab pegol and rituximab. Upper respiratory tract was the most common site, especially with bDMARDs. Lower respiratory, ear/nose/throat and urinary tract infections were moderately common, with clustering within drug groups.Data for 27 pathogens were recorded, majority viruses, with herpes simplex and zoster and influenza most frequent. Variable/absent reporting was noted for opportunistic and certain high-prevalence infections for example, Epstein-Barr.Conclusion Our findings show differences between drugs and can aid treatment decisions alongside real-world safety data. However, data are likely skewed by trial selection criteria and varying number of trials per drug and highlight the need for robust postmarketing pharmacovigilance.
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2022-11-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Analysing and reporting of observational data

Bruno Fautrel / Tanja A Stamm / Ziga Rotar / Delphine S Courvoisier / Maarten de Wit / Sytske Anne Bergstra / Simon R Stones / Joanna Kedra / Anja Strangfeld / Kimme L Hyrich / Lykke M Ørnbjerg

RMD Open, Vol 7, Iss

a systematic review informing the EULAR points to consider when analysing and reporting comparative effectiveness research with observational data in rheumatology

2021 Volume 3

Keywords	Medicine ; R
Language	English
Publishing date	2021-12-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Correction

Yi Pan / Sam Norton / James M Gwinnutt / Lianne Kearsley-Fleet / Deborah P M Symmons / Mark Lunt / Adam Young / BSRBR-RA Control Centre Consortium / Kimme L Hyrich / Suzanne M M Verstappen

PLoS ONE, Vol 15, Iss 4, p e

Not all moderate disease is the same - Identification of disability trajectories among patients with rheumatoid arthritis and moderate disease activity.

2020 Volume 0231481

Abstract: This corrects the article DOI:10.1371/journal.pone.0215999.]. ...

Abstract	[This corrects the article DOI:10.1371/journal.pone.0215999.].
Keywords	Medicine ; R ; Science ; Q
Language	English
Publishing date	2020-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Not all moderate disease is the same - Identification of disability trajectories among patients with rheumatoid arthritis and moderate disease activity.

Yi Pan / Sam Norton / James M Gwinnutt / Lianne Kearsley-Fleet / Deborah P M Symmons / Mark Lunt / Adam Young / BSRBR-RA Control Centre Consortium / Kimme L Hyrich / Suzanne M M Verstappen

PLoS ONE, Vol 14, Iss 5, p e

2019 Volume 0215999

Abstract: Background United Kingdom guidelines for the use of biologic disease modifying anti-rheumatic drugs (bDMARDS) for rheumatoid arthritis (RA) require patients to have active disease (Disease Activity Score [DAS28] >5.1) and have failed ≥2 previous ... ...

Abstract	Background United Kingdom guidelines for the use of biologic disease modifying anti-rheumatic drugs (bDMARDS) for rheumatoid arthritis (RA) require patients to have active disease (Disease Activity Score [DAS28] >5.1) and have failed ≥2 previous conventional synthetic DMARDs (csDMARD). Patients with moderate disease activity (MDA) do not meet these criteria, yet often have poor outcomes. This study aimed to identify trajectory groups of disability scores over three years in RA patients with MDA. Methods The study included biologic-naïve patients receiving csDMARDs only with MDA (3.2 <DAS28≤ 5.1) when recruited to the control cohort of the British Society for Rheumatology Biologics Register-RA (BSRBR-RA). Disability scores, measured using the Health Assessment Questionnaire (HAQ), were recorded every six months for three years. Trajectories of HAQ scores over follow-up were assessed using latent class growth models (LCGMs). Baseline age, gender, DAS28, symptom duration, rheumatoid factor status, number of prior csDMARDs and co-morbidities were assessed as potential predictors of group membership. Results In total, 1274 patients were included (mean age: 61 years (standard deviation: 12), 71.4% women). The best fitting model included seven HAQ trajectories. These trajectories were horizontal over follow-up and were related to baseline HAQ: very-low (6.8%, baseline (BL) HAQ: 0.22), low (11.5%, BL HAQ: 0.41), low-moderate (17.0%, BL HAQ: 0.93), moderate (13.4%, BL HAQ: 1.09), high-moderate (19.5%, BL HAQ: 1.61), severe (23.2%, BL HAQ: 1.98) and very-severe (8.6%, BL HAQ: 2.54). Higher DAS28, older age, female gender, longer disease duration and more co-morbidities were independently associated with higher HAQ trajectory group. Conclusion There is substantial heterogeneity in baseline HAQ scores in this population, and the trajectories of HAQ scores after baseline are, on average, relatively flat. As bDMARD therapy has been shown to improve HAQ scores, patients with MDA but high HAQ scores may benefit from a ...<br />
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2019-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Towards stratified treatment of JIA

Stephanie J.W. Shoop-Worrall / Saskia Lawson-Tovey / Lucy R. Wedderburn / Kimme L. Hyrich / Nophar Geifman / Aline Kimonyo / Alyssia McNeece / Andrew Dick / Andrew Morris / Annie Yarwood / Athimalaipet Ramanan / Bethany R. Jebson / Chris Wallace / Daniela Dastros-Pitei / Damian Tarasek / Elizabeth Ralph / Emil Carlsson / Emily Robinson / Emma Sumner /

Fatema Merali / Fatjon Dekaj / Helen Neale / Hussein Al-Mossawi / Jacqui Roberts / Jenna F. Gritzfeld / Joanna Fairlie / John Bowes / John Ioannou / Melissa Kartawinata / Melissa Tordoff / Michael Barnes / Michael W. Beresford / Michael Stadler / Paul Martin / Rami Kallala / Sandra Ng / Samantha Smith / Sarah Clarke / Soumya Raychaudhuri / Stephen Eyre / Sumanta Mukherjee / Teresa Duerr / Thierry Sornasse / Vasiliki Alexiou / Victoria J. Burton / Wei-Yu Lin / Wendy Thomson / Zoe Wanstall

EBioMedicine, Vol 100, Iss , Pp 104946- (2024)

machine learning identifies subtypes in response to methotrexate from four UK cohortsResearch in context

2024

Abstract: Summary: Background: Methotrexate (MTX) is the gold-standard first-line disease-modifying anti-rheumatic drug for juvenile idiopathic arthritis (JIA), despite only being either effective or tolerated in half of children and young people (CYP). To ... ...

Abstract	Summary: Background: Methotrexate (MTX) is the gold-standard first-line disease-modifying anti-rheumatic drug for juvenile idiopathic arthritis (JIA), despite only being either effective or tolerated in half of children and young people (CYP). To facilitate stratified treatment of early JIA, novel methods in machine learning were used to i) identify clusters with distinct disease patterns following MTX initiation; ii) predict cluster membership; and iii) compare clusters to existing treatment response measures. Methods: Discovery and verification cohorts included CYP who first initiated MTX before January 2018 in one of four UK multicentre prospective cohorts of JIA within the CLUSTER consortium. JADAS components (active joint count, physician (PGA) and parental (PGE) global assessments, ESR) were recorded at MTX start and over the following year.Clusters of MTX ‘response’ were uncovered using multivariate group-based trajectory modelling separately in discovery and verification cohorts. Clusters were compared descriptively to ACR Pedi 30/90 scores, and multivariate logistic regression models predicted cluster-group assignment. Findings: The discovery cohorts included 657 CYP and verification cohorts 1241 CYP. Six clusters were identified: Fast improvers (11%), Slow Improvers (16%), Improve-Relapse (7%), Persistent Disease (44%), Persistent PGA (8%) and Persistent PGE (13%), the latter two characterised by improvement in all features except one. Factors associated with clusters included ethnicity, ILAR category, age, PGE, and ESR scores at MTX start, with predictive model area under the curve values of 0.65–0.71. Singular ACR Pedi 30/90 scores at 6 and 12 months could not capture speeds of improvement, relapsing courses or diverging disease patterns. Interpretation: Six distinct patterns following initiation of MTX have been identified using methods in artificial intelligence. These clusters demonstrate the limitations in traditional yes/no treatment response assessment (e.g., ACRPedi30) and can form the basis ...
Keywords	Juvenile idiopathic arthritis ; Machine learning ; Treatment outcome ; Epidemiology ; Methotrexate ; Medicine ; R ; Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2024-02-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: SARS-CoV-2 vaccine safety in adolescents with inflammatory rheumatic and musculoskeletal diseases and adults with juvenile idiopathic arthritis

Gözde Kübra Yardımcı / Eric Hachulla / Laure Gossec / Loreto Carmona / Patrick Durez / Pedro M Machado / Eric Toussirot / Umut Kalyoncu / Xavier Mariette / Simona Rednic / Viviane Queyrel / Raphaele Seror / Anja Strangfeld / Kimme L Hyrich / Saskia Lawson-Tovey / Julija Zepa / Nicolas Roux / Bernd Raffeiner / Daniel Clemente /

Theodoros Dimitroulas / Inita Bulina / Emőke Šteňová / Eva Strakova / Pavol Masaryk / Elsa Mateus / Ana M. Rodrigues / Amelie Leurs / Anna Carbone / Jose AG Puerta / Natalia de la Torre Rubio / Rachel Jeffrey / Sharon Floyd / Vanda Mylnarikova

RMD Open, Vol 8, Iss

data from the EULAR COVAX physician-reported registry

2022 Volume 2

Abstract: Background There is a lack of data on SARS-CoV-2 vaccination safety in children and young people (CYP) with rheumatic and musculoskeletal diseases (RMDs). Current vaccination guidance is based on data from adults with RMDs or CYP without RMDs.Objectives ... ...

Abstract	Background There is a lack of data on SARS-CoV-2 vaccination safety in children and young people (CYP) with rheumatic and musculoskeletal diseases (RMDs). Current vaccination guidance is based on data from adults with RMDs or CYP without RMDs.Objectives To describe the safety of SARS-COV-2 vaccination in adolescents with inflammatory RMDs and adults with juvenile idiopathic arthritis (JIA).Methods We described patient characteristics, flares and adverse events (AEs) in adolescent cases under 18 with inflammatory RMDs and adult cases aged 18 or above with JIA submitted to the European Alliance of Associations for Rheumatology COVAX registry.Results A total of 110 cases were reported to the registry. Thirty-six adolescent cases were reported from four countries, most with JIA (42%). Over half (56%) reported early reactogenic-like AEs. One mild polyarthralgia flare and one serious AE of special interest (malaise) were reported. No CYP reported SARS-CoV-2 infection postvaccination.Seventy-four adult JIA cases were reported from 11 countries. Almost two-thirds (62%) reported early reactogenic-like AEs and two flares were reported (mild polyarthralgia and moderate uveitis). No serious AEs of special interest were reported among adults with JIA. Three female patients aged 20–30 years were diagnosed with SARS-CoV-2 postvaccination; all fully recovered.Conclusions This is an important contribution to research on SARS-CoV-2 vaccine safety in adolescents with RMDs and adults with JIA. It is important to note the low frequency of disease flares, serious AEs and SARS-CoV-2 reinfection seen in both populations, although the dataset is limited by its size.
Keywords	Medicine ; R
Language	English
Publishing date	2022-07-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: SARS-CoV-2 breakthrough infections among vaccinated individuals with rheumatic disease

Gözde Kübra Yardımcı / Laure Gossec / Loreto Carmona / Zara Izadi / Jinoos Yazdany / Pedro M Machado / Anja Strangfeld / Rebecca Grainger / Emily Sirotich / Carly Harrison / Philip C Robinson / Jean Liew / Milena Gianfrancesco / Kimme L Hyrich / Lindsay Jacobsohn / Saskia Lawson-Tovey / Stephanie Rush / Suleman Bhana / Paul Sufka /

Julija Zepa / Abdurrahman Tufan / Martin Schäfer / Claire Cook / Fatemah Abutiban / Jeffrey Sparks / Leanna Wise / Zachary Wallace / Naomi J Patel / Samar Al Emadi / Inita Bulina / Christine Graver / Emily Kowalski / Jonathan Hausmann / Clairissa Ja / Elsa Frãzao-Mateus / Frances Stafford / Dfiza Dey / Genevieve Katigbak / Lauren Kaufman / Marco Ulises Martínez-Martínez / Greta Reyes-Cordero / Evelyn Salido / Ellison Smith / David Snow / Monique Gore-Massy

RMD Open, Vol 8, Iss

results from the COVID-19 Global Rheumatology Alliance provider registry

2022 Volume 1

Keywords	Medicine ; R
Language	English
Publishing date	2022-04-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Factors associated with severe COVID-19 in people with idiopathic inflammatory myopathy

Carlo Alberto Scirè / Laure Gossec / Loreto Carmona / Jinoos Yazdany / Pedro M Machado / Guillermo J Pons-Estel / Christophe Richez / Marie Holmqvist / Rebecca Grainger / Jean W Liew / Emily Sirotich / Philip C Robinson / Kristin M D’Silva / Su-Ann Yeoh / Milena Gianfrancesco / Kimme L Hyrich / Lindsay Jacobsohn / Saskia Lawson-Tovey / Elsa F Mateus /

Suleman Bhana / Jonathan S Hausmann / Paul Sufka / Tiffany Y-T Hsu / Arundathi Jayatilleke / Martin Schäfer / Ana Carolina de Oliveira e Silva Montandon / Paula Jordan / Samuel Katsuyuki Shinjo / Zachary Wallace / Sofía Ornella / Monique Gore-Massy / Victor R Pimentel-Quiroz / Monica Vasquez del Mercado / Edgard Torres dos Reis Neto / Laurindo Ferreira da Rocha Junior / Maria Eugenia D'Angelo Exeni / Edson Velozo

RMD Open, Vol 8, Iss

results from the COVID-19 Global Rheumatology Alliance physician-reported registry

2022 Volume 2

Abstract: Objectives To investigate factors associated with severe COVID-19 in people with idiopathic inflammatory myopathy (IIM).Methods Demographic data, clinical characteristics and COVID-19 outcome severity of adults with IIM were obtained from the COVID-19 ... ...

Abstract	Objectives To investigate factors associated with severe COVID-19 in people with idiopathic inflammatory myopathy (IIM).Methods Demographic data, clinical characteristics and COVID-19 outcome severity of adults with IIM were obtained from the COVID-19 Global Rheumatology Alliance physician-reported registry. A 3-point ordinal COVID-19 severity scale was defined: (1) no hospitalisation, (2) hospitalisation (and no death) and (3) death. ORs were estimated using multivariable ordinal logistic regression. Sensitivity analyses were performed using a 4-point ordinal scale: (1) no hospitalisation, (2) hospitalisation with no oxygen (and no death), (3) hospitalisation with oxygen/ventilation (and no death) and 4) death.Results Of 348 patients, 48% were not hospitalised, 39% were hospitalised (and did not die) and 13% died. Older age (OR=1.59/decade, 95% CI 1.31 to 1.91), high disease activity (OR=3.50, 95% CI 1.25 to 9.83; vs remission), ≥2 comorbidities (OR=2.63, 95% CI 1.39 to 4.98; vs none), prednisolone-equivalent dose >7.5 mg/day (OR=2.40, 95% CI 1.09 to 5.28; vs no intake) and exposure to rituximab (OR=2.71, 95% CI 1.28 to 5.72; vs conventional synthetic disease-modifying antirheumatic drugs only) were independently associated with severe COVID-19. In addition to these variables, in the sensitivity analyses, male sex (OR range: 1.65–1.83; vs female) was also significantly associated with severe outcomes, while COVID-19 diagnosis after 1 October 2020 (OR range: 0.51–0.59; vs on/before 15 June 2020) was significantly associated with less severe outcomes, but these associations were not significant in the main model (OR=1.57, 95% CI 0.95 to 2.59; and OR=0.61, 95% CI 0.37 to 1.00; respectively).Conclusions This is the first large registry data on outcomes of COVID-19 in people with IIM. Older age, male sex, higher comorbidity burden, high disease activity, prednisolone-equivalent dose >7.5 mg/day and rituximab exposure were associated with severe COVID-19. These findings will enable risk stratification and ...
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2022-11-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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