bluuebunny/crossref_metadata_2025_split huggingface dataset:
OA08 JAK inhibitors and the risk of malignancy: a meta-analysis across licenced disease indications
Authors: Stovin Christopher , Russell Mark D , Alveyn Edward , Adeyemi Olukemi , Patel Vishit , Adas Maryam A , Atzeni Fabiola , Ng Kenrick K H , Rutherford Andrew I , Norton Sam , Cope Andrew P , Galloway James B 
Published: April 2023

Abstract

Background/Aims
Concerns have been raised about the risk of malignancy with Janus kinase inhibitors (JAKi) following the ORAL Surveillance study, which reported an increased incidence of malignancy with tofacitinib compared with Tumor Necrosis Factor-α inhibitors (TNFi) in people with rheumatoid arthritis (RA) aged over 50 years who had additional cardiovascular risk factors. Our objective was to estimate the risk of malignancy for all licenced JAKi across disease indications, compared with TNFi, methotrexate (MTX), and placebo.

Methods
A systematic search of electronic databases (Medline, EMBASE, Cochrane) was performed to identify Phase 2/3/4 RCTs and long-term extension (LTE) studies of JAKi (tofacitinib, baricitinib, upadacitinib, filgotinib, peficitinib) in adults with RA, psoriatic arthritis, psoriasis, axial spondyloarthritis, inflammatory bowel disease, or atopic dermatitis. Comparators were placebo, MTX, and TNFi. Random-effects meta-analysis was performed to compare malignancy incidence rates between JAKi and comparators. Our primary outcome measure was the incidence of all malignancies including non-melanomatous skin cancers (NMSC). Secondary outcomes were malignancies excluding NMSC, and NMSC only.

Results
In 62 eligible RCTs and 14 LTE studies, there were 71,767 person-years of exposure to JAKi; 2,680 to placebo; 7,827 to TNFi; and 1,074 to MTX. Comparing JAKi with placebo arms of RCTs, the incidence rate ratio (RR) for all malignancies including NMSC was not significantly different (RR 0.81; 95% CI 0.52 to 1.26; p = 0.36). Similarly, when comparing JAKi with MTX, no significant differences were observed in the incidence of malignancy (RR 0.73; 95% CI 0.33 to 1.61; p = 0.43). Compared with TNFi, however, administration of JAKi was associated with an increased incidence of malignancy (RR 1.54; 95% CI 1.19 to 2.01; p = 0.001). For all analyses, findings were consistent when excluding NMSC, when analysing NMSC only, and when including LTE data.

Conclusion
In trial settings, JAKi do not associate with an increased risk of malignancy compared with placebo or MTX, but are associated with an increased risk of malignancy relative to TNFi.
Disclosure
C. Stovin: None. M.D. Russell: Honoraria; Lilly, Galapagos, Biogen, Menarini. Other; Lilly, Pfizer, Janssen, UCB. E. Alveyn: None. O. Adeyemi: None. V. Patel: None. M.A. Adas: None. F. Atzeni: None. K.K.H. Ng: None. A.I. Rutherford: None. S. Norton: None. A.P. Cope: Consultancies; BMS, Abbvie, GSK/Galvini. Grants/research support; BMS. J.B. Galloway: Honoraria; Abbvie, Biovitrum, BMS, Celgene, Chugai, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, Sobi, UCB.
OA17 Patient values and what matters to patients with axial spondyloarthritis in clinic
Authors: Chan Antoni , Suarez Annabel , Rigler Kathryn , Hamilton Jill 
Published: April 2023

Abstract

Background/Aims
Physician-patient discrepancy in the goals of treatment remains an issue in axial spondyloarthritis (AxSpA). The National Axial Spondyloarthritis Society (NASS) has recently launched a national survey on patient values. Bridging the gap and improving alignment of physician-patient goals may lead to better outcomes. The objectives of this study were to investigate what patients wanted to discuss prior to their clinic attendance and to explore if these topics were discussed by the physician. The discrepancies between patient and physician goals were reviewed and steps put in place to bridge this gap.

Methods
Patients fulfilled the ASAS criteria for AxSpA. At baseline 130 consecutive patients attending the AxSpA clinic between April to December 2021 were sent a pre-clinic questionnaire. Patients were asked 2 questions and these were: 1) What do you wish to discuss at your appointment? 2) What goals do wish to achieve following treatment? Questionnaires were collected prior to the clinic. The medical notes and clinic letters were then reviewed post-clinic to check if questions 1 and 2 were discussed. The patient demographics and disease activity scores BASMI, BASFI and BASDAI were also collected.

Results
At baseline, 100/130 (77%) patients returned the questionnaire prior to clinic. The mean age was 41 years (range 23-67). 74 patients (74%) were male and 80 patients (80%) were in work. Patients were seen by a doctor (38%), specialist nurse (32%) and physiotherapist (30%). In terms of treatment, patients were currently on biologics (64%), NSAIDs (46%) and DMARDs (30%). The mean BASMI was 1.6 (range 0.2-5.4), BASFI 2.7 (0-9.2), BASDAI 3.5 (0.2-8.6) and CRP 3 (0-20). For pre-clinic question 1, the top three topics were medication, pain management and progression of disease. For question 2, the top three topics were to be pain-free, maintain flexibility and being mobile and active. There were also other topics that were raised including fatigue, sleep, infections and family planning. Post clinic, the topics in question 1 were discussed directly by the physician in 73% and question 2 in 59% of cases. The topics that were most discussed in clinic were medication, exercise and pain. Pooling the topics, the top five themes were pain, medication, flexibility, exercise and disease progression. A limitation is that the post clinic analysis was based on written clinic notes and letters.

Conclusion
This study confirms a degree of discordance in patient and physician goals. To bridge this gap, we are now focused on the top topics that patients wish to discuss in clinic and what they hope to achieve from their treatment. We have updated our AxSpA pathway to include these topics. Understanding patient goals will help us develop the content for the interventions and educational programmes to improve alignment and clinical outcomes.
Disclosure
A. Chan: None. A. Suarez: None. K. Rigler: None. J. Hamilton: None.
OA32 Jaw claudication - does the textbook description need updating?
Authors: Lim Joyce , Dures Emma , Bailey Lawrence , Almeida Celia , Ruediger Carlee , Hill Catherine , Robson Joanna , Mackie Sarah L 
Published: April 2023

Abstract

Background/Aims
Recognition of jaw claudication is crucial to expedite diagnosis and treatment of giant cell arteritis (GCA). The ACR 1990 criteria defined claudication of the jaw, tongue or deglutition as “development or worsening of fatigue or discomfort in muscles of mastication, tongue, or swallowing muscles while eating”. We sought to describe the diverse ways in which patients may describe this key GCA symptom and its impact on health-related quality of life.

Methods
Secondary analysis of a qualitative dataset originally created for the development of a patient-reported outcome measure for GCA. Participants (n = 36) with GCA confirmed by biopsy/imaging were recruited using purposive sampling from two rheumatology clinics and one ophthalmology clinic in the UK (n = 25) and Australia (n = 11). Interviews transcripts from the original study were organised within QSR NVivo 12 software and analysed using template analysis. Themes were refined through discussion among researchers including a patient partner.

Results
20 of 36 participants (56%) reported jaw symptoms. Of these 20, the median age was 76.5 years; 60% were female. Five main themes were identified in the data: physical sensations; impact on function; impact on diet; symptom response to steroids; attribution to other causes (see Table 1). Whilst a large proportion of patients described jaw pain, jaw cramp, jaw stiffness and lockjaw had also been described. Symptom resolution following commencement of steroids varied among participants. Jaw symptom was misjudged as due to dental cavity, ear infection and teeth grinding by healthcare professionals in some cases. Some patients did not seek immediate help from healthcare professionals regarding their jaw symptoms as they were thought to be related to arthritis, age or viral illnesses.

Conclusion
Patients with GCA described their jaw symptoms in various ways, not exclusive to chewing. When Horton originally described jaw claudication, he also observed that some patients reported ‘lockjaw’. For early recognition and prompt diagnosis of GCA, we suggest that textbooks and teaching should be updated to reflect this. Patient education on the potential significance of jaw symptoms is also crucial to avoid delay in seeking help.
Disclosure
J. Lim: None. E. Dures: None. L. Bailey: None. C. Almeida: None. C. Ruediger: None. C. Hill: None. J. Robson: None. S.L. Mackie: Consultancies; Roche/Chugai, Sanofi, AbbVie, AstraZeneca. Other; SLM has given talks on behalf of her institution for Pfizer, Vifor and UCB. In all cases fees were paid to her institution and no personal fees were received, SLM was supported by Roche to attend EULAR2019 and by Pfizer to attend ACR2021 virtually, SLM has been an investigator on clinical trials for Sanofi and GSK, As a research grant co-applicant, SLM has received research funding (partial salary support) from Vifor, paid to her institution.
P009 Navigating giant cell arteritis (GCA) service during and post COVID-19 pandemic: an audit of GCA care at North Bristol NHS Trust against the BSR quality standards
Authors: Lim Kian Wah , Shahriar Imran , Villar Sarah J , Sin Fang En 
Published: April 2023

Abstract

Background/Aims
GCA is a systemic vasculitis predominantly affecting the large vessels that requires prompt diagnosis and management. This clinical audit aims to study the impacts of COVID-19 pandemic on our GCA service and to identify areas for improvement to ensure good and safe practice amid healthcare crisis.

Methods
We audited referrals for suspected GCA from February 2021 until September 2022 and measured our patient care against the BSR quality standards. We performed retrospective data collection from digital care record systems and analysed our data using the IBM SPSS Statistics version 29.

Results
106 patients with suspected GCA were included, 73% were female and the mean age was 70 years. 75% of the referrals were from primary care. Main presenting symptoms were headaches (95.7%), scalp tenderness (69.6%), tongue/jaw claudication (52.2%), visual symptoms (47.8%), constitutional symptoms (43.5%) and polymyalgic symptoms (21.7%). 33% of patients were diagnosed and treated as GCA. Mean CRP was 23.9mg/L and mean plasma viscosity was 1.89mPA. The mean referral-to-specialist review time has reduced to 1.6 days, compared with 2.7 days pre-pandemic. All patients had vascular ultrasound but only 7.5% had a temporal artery biopsy (TAB), compared with 41% pre-pandemic. Table 1 compares expected and achieved BSR quality standards.

Conclusion
Changes in work pattern during the pandemic meant that the time from referral to specialist review was significantly reduced, by implementing twice weekly registrar-led ‘Hot’ clinics and reserving ad hoc slot(s) in on-call consultant’s clinics for GCA referrals. We have ramped up our vascular imaging capacity for vascular ultrasound during the pandemic in response to reduced surgical operating capacity for TAB. Strategies to address areas for improvement identified in this audit include: (1) clear and timely communication with referrer about steroid initiation and dosage, at the time of referral; (2) improving communication with primary care, emphasising need for urgent Ophthalmology input in patients with suspected GCA-related visual symptoms, through updating our regional GCA guideline for primary care; (3) standardising and implementing a GCA review proforma or checklist in our department to ensure that the BSR GCA care bundle is being implemented and addressed at the earliest opportunity.
Disclosure
K. Lim: None. I. Shahriar: None. S.J. Villar: None. F. Sin: None.
P010 Real world experience of switching to an adalimumab biosimilar; different outcomes for axial spondylitis, psoriatic and rheumatoid arthritis
Authors: Holden Francesca A A , Hill Diane , Kiely Patrick 
Published: April 2023

Abstract

Background/Aims
Adalimumab is licenced to treat a variety of autoimmune conditions including inflammatory arthropathies. Switching stable patients from the bio-originator Humira to biosimilars has been strongly promoted on economic grounds and presumed equitable interchangeability regarding efficacy and tolerance across all disease indications. Our aims were to assess adalimumab biosimilar retention rates up to 1 year in patients with axial spondylitis (AS), psoriatic (PsA) and rheumatoid arthritis (RA) in a routine care setting and to determine by disease subtype reasons for switching back to Humira.

Methods
Retrospective observational study, utilising data from the St. George’s Hospital Rheumatology Biologics Database. Demographic details, retention duration and reasons for discontinuation for all patients switched from Humira to an adalimumab biosimilar were recorded up to 1 year.

Results
238 patients (female 54.5%) were switched from Humira to an adalimumab biosimilar: AS n = 95, PsA n = 82, RA n = 61. Overall, 53% patients switched back to Humira over a 1-year period, female 57%. By disease subtype, the biosimilar retention rate at 1 year was AS 36%, PsA 61%, RA 46%. Overall, the reason for switching back to Humira was an adverse effect or device specific problem (AE) in 59% and loss of efficacy (IR) in 41%. AEs in 98% were pain and other injection site reactions. By disease subtype, the reason for switching back was: AS 59% IR, 41% AE, PsA 22% IR, 78% AE, RA 27% IR, 73% AE.

Conclusion
Projected cost savings from the adalimumab biosimilar switch programme were not achieved, with 53% returning to Humira up to 1 year later. By disease indication patients with AS had the lowest retention on the biosimilar, in whom loss of efficacy was more likely than an AE to trigger the switch, and over twice as prevalent than in patients with RA and PsA. AEs were the most prevalent reason for PsA and RA patients to switch back, and citrate in the biosimilar buffer solution was the likely reason for this. The loss of efficacy, particularly prevalent in AS patients, implies that equitable interchangeability between Humira and biosimilar products cannot be assumed, and projected cost saving advantages may be overestimated.
Disclosure
F.A.A. Holden: None. D. Hill: None. P. Kiely: None.
P012 Using the BSR Lupus audit as a springboard to improve management of SLE in the outpatient clinic
Authors: Benson Rosalind M , Cotton Caroline , Soares Ines , Mewar Devesh , Mclaren Zoe 
Published: April 2023

Abstract

Background/Aims
In 2018, following BSR Lupus guidelines publication, we took part in the national multicentre Lupus audit. Audit standards developed by expert consensus to assess baseline care in the outpatient management of SLE were used. We present a series of audit cycles spanning the development of a connective tissue disease (CTD) service and a trust merger capturing quality improvement work that has been informed by audit results.

Methods
In 2018, participating in the BSR audit, 15 patients attending a non-specialist rheumatology clinic over a 4-week period were enrolled. In 2019, Liverpool University Hospitals NHS Foundation trust was formed following the merger of two large teaching hospitals. A trust-wide CTD service was established in 2020. The audit was repeated in 2020 including all 119 patients seen over a 12-month period with SLE. Conclusions informed two QI workstreams: urine sample collection and the development of an SLE review form for the electronic notes and electronic SLEDAI score. A further audit cycle was performed including 40 patients following the implementation of these changes selecting patients across both hospital sites seen both in general and specialist clinic settings.

Results
In 2018, 5/11 audit standards were met, 3/11 in 2020. In 2022 across all clinics 4/11 standards were attained, however this improved to 9/11 in the specialist clinic (see table).
In 2020, only 22% of patients had their urine tested; following a QI project (including nurse education and inclusion on clinic observation form) this improved to 90%.
Following introduction of the electronic SLE review form, when used, audit standards were met in all areas (9/11) apart from lipid testing and discussion of pregnancy (79% of patients vs standard of 80%).

Conclusion
Using the BSR audit as a tool to spearhead QI projects in our newly merged trust and CTD service, clear improvements have been made. The development of an SLE review form which can be used in all non-specialist rheumatology clinics prompts clinicians to target key audit standards, in turn improving patient care. Further departmental implementation will help drive further improvement with particular focus on SLEDAI assessment and lipid monitoring.
Disclosure
R.M. Benson: None. C. Cotton: None. I. Soares: None. D. Mewar: None. Z. Mclaren: None.
P018 Non-alcoholic fatty liver disease in spondyloarthritis: identifying patients on therapy at high risk of serious liver disease
Authors: Harrison Stephanie R , Nandasoma Udvitha , Parker Richard , Chimakurthi Chenchu , Laws Philip , Barr Andrew , Vandevelde Claire , Marzo-Ortega Helena , Freeston Jane 
Published: April 2023

Abstract

Background/Aims
People with Spondyloarthritis (SpA), especially those with psoriatic disease (PsD) [psoriasis (PsO) and psoriatic arthritis (PsA)], are at higher risk of non-alcoholic fatty liver disease (NAFLD) due to increased prevalence of metabolic syndrome, obesity, hypertension, dyslipidaemia and disease-specific factors such as duration/ severity of psoriasis. There is significant concern that both synthetic and biological DMARDs (including methotrexate) may worsen liver function in PsD patients with NAFLD. The Leeds Teaching Hospitals Trust (LTHT) NAFLD pathway uses three screening tools (ELF, FIB-4 and fibroscanning) to identify those needing further investigation/ treatment by hepatology. However, the pathway is not validated in PsD. Our aim was to survey the prevalence of liver disease in our PsD population and explore the performance of our hepatology referral pathway.

Methods
We audited consecutive patients referred from the Leeds Specialist SpA service at LTHT with persistently abnormal ALT, whom the consultant Rheumatologist felt required Hepatology referral for suspected NAFLD. Data collected were: age, sex, BMI, history of diabetes, ALT, AST, platelets, albumin, hepatitis B and C, ELF score, FIB-4 score, fibroscan score, abdominal ultrasound, liver biopsy result and final hepatology diagnosis (NAFLD, fibrosis/cirrhosis or other).

Results
72 patients were included; 84.2% had PsD (61/72), and 15.8% (11/62) had ‘Other’ forms of SpA (including axial spondyloarthritis, enteropathic arthritis, etc). Baseline characteristics, drug treatment and liver biochemistry/virology were similar between PsD and Other arthritis groups (Table 1) except for age which was lower in the Other. The average ELF scores were similar between PsD and Other, however FIB-4 scores were higher in PsD, and was associated with higher rates of fibrosis/cirrhosis (Table 1). FIB-4 &gt;1.3, but not ELF&gt;9.5, was statistically significantly associated with a high fibroscan score (p = 0.038 and p = 0.443 respectively).

Conclusion
PsD patients had higher rates of significant fibrosis/cirrhosis compared with patients with Other SpAs. FIB-4 was better than ELF for identifying which PsD patients required fibroscan and further investigation to exclude significant fibrosis/ cirrhosis. These findings will now be validated in a larger prospective study.
Disclosure
S.R. Harrison: None. U. Nandasoma: None. R. Parker: None. C. Chimakurthi: None. P. Laws: None. A. Barr: None. C. Vandevelde: None. H. Marzo-Ortega: None. J. Freeston: None.
P043 Income-Related Health Inequality and Osteoarthritis Intervention Outcomes: a Cohort Study
Authors: Battista Simone , Kiadaliri Ali , Englund Martin , Jönsson Thérése , Gustafsson Kristin , Testa Marco , Dell'Isola Andrea 
Published: April 2023

Abstract

Background/Aims
Osteoarthritis (OA) management programmes have been lately developed to tackle the osteoarthritis burden. Though beneficial, OA management programmes can be less effective on people in lower socioeconomic positions and widen the possible pre-existing inequalities gap (‘intervention-generated inequalities’). In Sweden, an OA management programme was implemented in the national healthcare system, including exercise and education. Its results are recorded in the ‘Better Management of People with Osteoarthritis’ (BOA) register, one of the most extensive OA datasets worldwide. Hence, this study investigated the influence of this Swedish osteoarthritis management programme on income-related inequality.

Methods
A register-based study with data from the BOA register. We calculated Erreygers’ and Wagstaff’s concentration indices and how they changed throughout time. We considered the variables ‘Pain intensity’, ‘Self-efficacy‘, ‘Use of NSAIDs’ and ‘Desire for surgery’ at three-time points (baseline, after three and twelve months from the beginning of the programme). Concentration indices’ values range from -1 to + 1. Zero indicates no income inequality. A positive (or negative) sign indicates an unequal concentration of the variables of interest among those with higher (or lower) income. We used bootstrapping (1000 replications) to compute 95% confidence intervals for changes in the concentration indices from baseline.

Results
A total of 115,403 people with knee and hip OA were identified. ‘Pain intensity’ and ‘Desire for surgery’ were disproportionately concentrated among those with lower income at the baseline, while the opposite happened for ‘Use of NSAIDs’ and ‘Self-efficacy’ (Table 1). Income inequalities for ‘Pain intensity’, ‘Self-efficacy’ and ‘Desire for surgery’ widened following the programme, though their magnitude was small. Conversely, income-related inequality in the ‘Use of NSAIDs’ narrowed after attending the programme.

Conclusion
Considering the concentration indices’ values, people with lower income were already experiencing higher levels of pain and desire for surgery and lower levels of self-efficacy than their higher counterparts. This trend got even worse after attending the abovementioned programme. Instead, people with higher income were keener on using NSAIDs but attending this programme narrowed this gap. These results highlighted ‘intervention-generated inequalities’ in the BOA data. OA management programmes should be structured to reduce inequalities among people with different incomes.
Disclosure
S. Battista: None. A. Kiadaliri: None. M. Englund: None. T. Jönsson: None. K. Gustafsson: None. M. Testa: None. A. Dell'Isola: None.