British Society For Rheumatology Biologics Register Research Articles

P144 Socioeconomic deprivation is associated with reduced response and lower treatment persistence with anti-TNF therapies in people with rheumatoid arthritis

Abstract Background/Aims Recent global health crises have highlighted the importance of socioeconomic (SE) inequalities and its influence on health provision and outcomes. The impact of SE deprivation on treatment of rheumatoid arthritis (RA) is understudied in contemporary biologic-treated populations. The aim of this study was to investigate the association between SE deprivation and outcomes of TNF inhibitor (TNFi) treatment. Methods Individuals commencing their first TNFi in the BSR Biologics Register for RA from 2001 to 2020 were included. SE deprivation was proxied using the Index of Multiple Deprivation (IMD), which measures relative deprivation of geographic areas. Using the participants' residential postcode, each individual was assigned a relative rank score and categorised into the 20% most deprived, middle 40%, and 40% least deprived; thresholds were chosen because IMD gives greater distinction within the most deprived areas. DAS28, low disease activity (LDA) and EULAR response at 6 months were compared using linear, logistic and ordinal logistic regression models with the 40% least deprived as referent. Risk of drug discontinuation was compared using Cox models. Models were first unadjusted, then adjusted for potential confounders and/or mediators, namely age, gender, baseline DAS28, BMI, HAQ, number of comorbidities, age at diagnosis, ever smoking status and rheumatoid factor status. Multiple imputation was used for missing data. Results 17,117 individuals were included (mean±SD age 56±12 years, 76% female), of whom 3002 (18%) were in the 20% most, 6999 (41%) in the middle 40%, and 7116 (41%) in the 40% least deprived groups (Table 1). The 20% most deprived group had higher DAS28 at 6 months (beta=0.30, 95%CI 0.22-0.37) and were less likely to achieve LDA (OR 0.76; 0.68-0.84) and EULAR response (OR 0.73; 0.67-0.80) in unadjusted models. They were also more likely to discontinue treatment (HR 1.19; 1.13-1.25). Adjusted estimates were broadly similar (Table 1). Conclusion SE deprivation is associated with reduced response to TNFi and increased risk of treatment discontinuation. Estimates were largely unchanged despite adjusting for potential mediators. SE inequality embodies a multitude of factors that can be intervened upon, including behaviours and biases of clinicians or institutes, which should be a focus of future research. Disclosure S. Zhao: None. L. Kearsley-Fleet: None. K. Rogers: None. K. Watson: None. A. Bosworth: None. J. Galloway: None. S.M. Verstappen: None. J.H. Humphreys: None. A. Barton: None. K.L. Hyrich: None.

Long-term persistence of TNF-inhibitor treatment in patients with psoriatic arthritis. Data from the British Society for Rheumatology Biologics Register

BackgroundLong-term effectiveness of tumour necrosis factor alpha inhibitors (TNFi) has mainly been explored in patients with rheumatoid arthritis (RA) and the data available on patients with psoriatic arthritis (PsA) includes...

Discordant inflammation and pain in early and established rheumatoid arthritis: Latent Class Analysis of Early Rheumatoid Arthritis Network and British Society for Rheumatology Biologics Register data.

BackgroundRheumatoid arthritis (RA) disease activity is often measured using the 28-joint Disease Activity Score (DAS28). We aimed to identify and independently verify subgroups of people with RA that may be discordant with respect to self-reported and objective disease state, with potentially different clinical needs.MethodsData were derived from three cohorts: (1) the Early Rheumatoid Arthritis Network (ERAN) and the British Society for Rheumatology Biologics Register (BSRBR), (2) those commencing tumour necrosis factor (TNF)-α inhibitors and (3) those using non-biologic drugs. In latent class analysis, we used variables related to pain, central pain mechanisms or inflammation (pain, vitality, mental health, erythrocyte sedimentation rate, swollen joint count, tender joint count, visual analogue scale of general health). Clinically relevant outcomes were examined.ResultsFive, four and four latent classes were found in the ERAN, BSRBR TNF inhibitor and non-biologic cohorts, respectively. The proportions of people assigned with >80% probability into latent classes were 76%, 58% and 72% in the ERAN, TNF inhibitor and non-biologic cohorts, respectively. The latent classes displayed either concordance between measures indicative of mild, moderate or severe disease activity; discordantly worse patient-reported measures despite less markedly elevated inflammation; or discordantly less severe patient-reported measures despite elevated inflammation. Latent classes with discordantly worse patient-reported measures represented 12%, 40% and 21% of the ERAN, TNF inhibitor and non-biologic cohorts, respectively; contained more females; and showed worse function. In those latent classes with worse scores at baseline, DAS28 and function improved over 1 year (p < 0.001 for all comparisons), and scores differed less at follow-up than at baseline.ConclusionsDiscordant latent classes can be identified in people with RA, and these findings are robust across three cohorts with varying disease duration and activity. These findings could be used to identify a sizeable subgroup of people with RA who might gain added benefit from pain management strategies.Electronic supplementary materialThe online version of this article (doi:10.1186/s13075-016-1186-8) contains supplementary material, which is available to authorized users.

SAT0038 Factors Predicting Pain and Early Discontinuation of Tumour Necrosis Factor-Alpha-Inhibitors in People with Rheumatoid Arthritis: Results from the British Society for Rheumatology BIOLOGICS Register

BackgroundPain is a major problem in RA, but is not fully explained by inflammation.ObjectivesWe investigated factors predicting bodily pain 1 year after initiation of anti-TNF or conventional DMARD therapy change...

SAT0230 The Influence of Anti-TNF or Rituximab on Cancer Incidence in Patients with Rheumatoid Arthritis Who Have HAD A Prior Malignancy

BackgroundThe exact relationship between biologics and cancer remains unclear. Despite no evidence to date of an overall increased risk of cancer on biological therapies, concerns remain about starting therapy in...

SAT0148 Does depression affect response to anti-tumour necrosis factor-α therapy in patients with rheumatoid arthritis (RA)? Results from the british society for rheumatology biologics register (BSRBR)

BackgroundDepression is widely reported in RA, with prevalence estimates at 14-46%. Several studies have suggested that RA patients with persistent depression have poorer response to anti-TNF therapy.ObjectivesTo investigate the effects...

FRI0146 The risk of gastrointestinal perforations in patients with rheumatoid arthritis treated with anti-TNF therapy - results from the british society for rheumatology biologics register (BSRBR)

ObjectivesTo evaluate the risk of gastrointestinal perforation (GIP) in subjects with RA treated with anti-TNF therapy compared to non-biological disease-modifying antirheumatic drugs (nbDMARDs).MethodsThe analysis was conducted in the British Society...

SAT0123 Reactivation of latent tuberculosis infection and new infection of tuberculosis in patients with anti-tumor necrosis factor therapy for tuberculosis-endemic area

BackgroundProphylaxis of tuberculosis in patients treated with anti-tumor necrosis factor (Anti-TNF) prevents the latent tuberculosis infections (LTBI). But incidence rate of tuberculosis with anti-TNF therapy in tuberculosis-endemic area is higher...

THU0438 Peptidylarginine Deiminase Polymorphisms Associated with Susceptibility to Tuberculosis

BackgroundAnti–cyclic citrullinated peptide antibodies (as a serologic marker of RA) bind to citrulline residue which is now considered to play a pivotal role in various human diseases such as multiple...

SAT0154 Screening Latent Tuberculosis Infection with Tuberculin Skin Test and Quantiferon-Tb Gold Test in Patients with BehÇEt’S Disease and Takayasu’S Arteritis

BackgroundTumor Necrosis Factor-α (TNF-α) inhibitors have increased risk of reactivation of latent tuberculosis infection (LTBI). Screening for LTBI before initiating anti-TNF therapy is recommended.(1) Tuberculin skin test (TST) and in...

AB0494 Clinical characteristics of a moderate rheumatoid arthritis patient population: Data from a national british observational cohort

BackgroundWhile rheumatoid arthritis (RA) patients are often identified at an early stage, limited data are available on their clinical status while in the moderate stage. Prior work [1] underlines the...

The Risk of Lymphoma in Patients Receiving Anti-TNF Therapy for RA: Results from the BSR Biologics Register

This article presents data from the British Society for Rheumatology Biologics Register, a large cohort study showing no evidence that antibody to tumor necrosis factor therapy increases the risk of lymphoma over the background risk associated with rheumatoid arthritis.

Effectiveness of Rituximab in Patients with Rheumatoid Arthritis: Observational Study from the British Society for Rheumatology Biologics Register

To assess the effectiveness of rituximab (RTX) in patients with rheumatoid arthritis (RA) in routine clinical practice, and to identify predictors of 6-month response to RTX in patients for whom at least 1 anti-tumor necrosis factor-α (anti-TNF) therapy has failed. The analysis involved 646 patients with RA registered with the British Society for Rheumatology Biologics Register (BSRBR) who were starting RTX and were followed for at least 6 months. Change in the 28-joint Disease Activity Score (DAS28), European League Against Rheumatism (EULAR) response, and proportions of patients achieving disease remission were used to assess the clinical response 6 months after starting RTX. Regression analyses were used to identify factors associated with the response in the patients for whom anti-TNF therapy had not worked. The models included baseline demographics, disease characteristics, baseline Health Assessment Questionnaire (HAQ), and drug history including biologic history. The mean DAS28 at baseline was 6.2 (95% CI 6.1, 6.3), which decreased significantly to 4.8 (95% CI 4.7, 4.9) at the 6-month followup. Seventeen percent of the patients were EULAR good responders and 43% were moderate responders. Eight percent of the patients achieved disease remission. Subjects with higher baseline DAS28 score and those with positive rheumatoid factor (RF) status were significantly associated with a decrease in their DAS28 score (improvement), while women and patients with higher baseline HAQ score were less likely to improve. RTX has proven to be effective in routine clinical practice. When anti-TNF therapy fails, response to RTX was influenced by baseline DAS28 score, RF status, baseline HAQ score, and sex.

Concurrent Oral 1 - Therapy of rheumatic disease: OP4. Effectiveness of Rituximab in Rheumatoid Arthritis: Results from the British Society for Rheumatology Biologics Register (BSRBR)

Concurrent Oral 1 - Therapy of rheumatic disease: OP4. Effectiveness of Rituximab in Rheumatoid Arthritis: Results from the British Society for Rheumatology Biologics Register (BSRBR)

Anti-TNF therapies and pregnancy: outcome of 130 pregnancies in the British Society for Rheumatology Biologics Register

ObjectiveThe British Society for Rheumatology Biologics Register (BSRBR) has collected data on adverse events including pregnancies in patients with rheumatoid arthritis treated with anti-tumour necrosis factor (anti-TNF) therapy. The purpose...

Efficacy and safety of anti-TNF therapies in psoriatic arthritis: an observational study from the British Society for Rheumatology Biologics Register

Objectives. To evaluate the risk–benefit profile of anti-TNF therapies in PsA and to study the predictors of treatment response and disease remission [disease activity score (DAS)-28 < 2.6].Methods. The study included PsA patients (n = 596) registered with the British Society for Rheumatology Biologics Register (BSRBR). Response was assessed using the European League against Rheumatism (EULAR) improvement criteria. Univariate and multivariate logistic regression models were developed to examine factors associated with EULAR response and disease remission using a range of covariates. Poisson regression was used to calculate incidence rate ratios (IRRs) for serious adverse events (SAEs) vs seronegative RA controls receiving DMARDs, adjusting for age, sex and baseline co-morbidity.Results. At baseline, the mean (s.d.) DAS-28 was 6.4 (5.6). Of the patients, 70.3% were EULAR responders at 12 months. At 6 months, older patients [adjusted odds ratio (OR) 0.97 per year; 95% CI 0.95, 0.99], females (adjusted OR 0.51; 95% CI 0.34, 0.78) and patients on corticosteroids (adjusted OR 0.45; 95% CI 0.28, 0.72) were less likely to achieve a EULAR response. Over 1776.2 person-years of follow-up (median 3.07 per person), the IRR of SAEs compared with controls was not increased (0.9; 95% CI 0.8, 1.3).Conclusions. Anti-TNF therapies have a good response rate in PsA, and have an adverse event profile similar to that seen in a control cohort of patients with seronegative arthritis receiving DMARD therapy.

A case study: consequences of ANTI‐TNFα therapy and foot ulcerations. A patient with Ankylosing Spondylitis (AS) treated with Infliximab

The BSR Biologics Register demonstrates increased risk of serious soft tissue infections in anti-TNFα managed patients. Mobility levels may increase with successful symptom management. However patients’ feet present with a combination of foot deformity and compromised tissue viability, with associated risk of ulceration and concomitant infection.

Predictors of response to anti-TNF therapy in ankylosing spondylitis: results from the British Society for Rheumatology Biologics Register

Objective. Few data exist on the use of anti-TNF drugs for AS during routine clinical use in the UK. This report describes an improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI) after 6 months of therapy in 261 patients enrolled in a national prospective observational register.Methods. The British Society for Rheumatology Biologics Register (BSRBR) recruited patients starting anti-TNF therapy for AS between 2002 and 2006. Multivariable linear regression models were used to estimate the predictors of absolute improvement in BASDAI and BASFI at 6 months. Covariates included age, gender, disease duration, baseline BASDAI and BASFI, presence of raised inflammatory markers (defined as twice the upper limit of normal) and DMARD therapy.Results. The cohort was young (median age 43 years) and 82% were males. Median baseline BASDAI was 7.6 and BASFI 7.9. At 6 months, the mean improvements in BASDAI and BASFI were 3.6 and 2.6 U, respectively; 52% reached a BASDAI50. Patients with raised inflammatory markers at the start of therapy had a 0.9-U (95% CI 0.2, 1.5) better improvement in BASDAI compared with those without. Lesser responses were seen in those with higher baseline BASFI scores. Women had a 1.1-U (95% CI 0.3, 2.0) greater improvement in BASFI at 6 months, as did those who were receiving concurrent DMARD therapy [0.9 U (95% CI 0.2, 1.7)].Conclusions. The majority of patients receiving anti-TNF therapy for AS during routine care demonstrated an improvement in disease activity. Raised inflammatory markers at the start of therapy predicted a greater improvement in BASDAI, identifying a group of patients who may be more responsive to anti-TNF therapies, although the results were not confined to this group.

Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register (BSRBR)

BackgroundThe risk of tuberculosis (TB) in patients with rheumatoid arthritis (RA) is thought to be increased following anti-tumour necrosis factor (anti-TNF) therapy, with a proposed differential risk between the anti-TNF...

Dermatological complications and safety of anti-TNF treatments

It has been reported that tumour necrosis factor (TNF) inhibitors have adverse side-effects including infections, malignancies, demyelinating disease, and induction of autoimmune conditions. Dermatological complications of anti-TNF therapy include injection...