Polypharmacy is associated with treatment response and serious adverse events: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis

Rheumatology ◽  
2019 ◽  
Vol 58 (10) ◽  
pp. 1767-1776 ◽  
Author(s):  
Katie Bechman ◽  
Benjamin D Clarke ◽  
Andrew I Rutherford ◽  
Mark Yates ◽  
Elena Nikiphorou ◽  
...  
Keyword(s):  
Adverse Events ◽  
Rheumatic Disease ◽  
Treatment Response ◽  
Biologic Therapy ◽  
British Society ◽  
Receiver Operator Characteristic ◽  
Serious Adverse Events ◽  
Comorbidity Index ◽  
Adjusted Model ◽  
Biologics Register

Abstract Objective To evaluate whether polypharmacy is associated with treatment response and serious adverse events (SAEs) in patients with RA using data from the British Society for Rheumatology Biologics Register (BSRBR-RA). Methods The BSRBR-RA is a prospective observational cohort study of biologic therapy starters and a DMARD comparator arm. A logistic regression model was used to calculate the odds of a EULAR ‘good response’ after 12 months of biologic therapy by medication count. Cox proportional hazards models were used to identify risk of SAEs. The utility of the models were compared with the Rheumatic Disease Comorbidity Index using Receiver Operator Characteristic and Harrell’s C statistic. Results The analysis included 22 005 patients, of which 83% were initiated on biologics. Each additional medication reduced the odds of a EULAR good response by 8% [odds ratios 0.92 (95% CI 0.91, 0.93) P < 0.001] and 3% in the adjusted model [adjusted odds ratios 0.97 (95% CI 0.95, 0.98) P < 0.001]. The Receiver Operator Characteristic demonstrated significantly greater areas under the curve with the polypharmacy model than the Rheumatic Disease Comorbidity Index. There were 12 547 SAEs reported in 7286 patients. Each additional medication equated to a 13% increased risk of an SAE [hazard ratio 1.13 (95% CI 1.12, 1.13) P < 0.001] and 6% in the adjusted model [adjusted hazard ratio 1.06 (95% CI 1.05, 1.07) P < 0.001]. Predictive values for SAEs were comparable between the polypharmacy and Rheumatic Disease Comorbidity Index model. Conclusion Polypharmacy is a simple but valuable predictor of clinical outcomes in patients with RA. This study supports medication count as a valid measure for use in epidemiologic analyses.

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

Rheumatology ◽  
2011 ◽  
Vol 50 (Supplement 3) ◽  
pp. iii31-iii34 ◽  
Author(s):  
M. M. Soliman ◽  
D. M. Ashcroft ◽  
K. D. Watson ◽  
M. Lunt ◽  
D. Symmons ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Rheumatic Disease ◽  
British Society ◽  
Biologics Register

scholarly journals P059 Wellbeing and shielding of patients with rheumatic disease on biologic therapy during the early COVID-19 pandemic: a single centre experience

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Lucy M Carter ◽  
Hannah Irvine ◽  
Adnan D’Cunha Kamath ◽  
Ankita Sahni ◽  
Patrick Hanna ◽  
...  
Keyword(s):  
Rheumatic Disease ◽  
Biologic Therapy ◽  
Initial Period ◽  
Medical Officer ◽  
Mental Wellbeing ◽  
British Society ◽  
Risk Category ◽  
Autoimmune Rheumatic Disease ◽  
The Uk ◽  
The Impact

Abstract Background/Aims  Individuals on immunosuppressive therapies were among those identified by the UK Department of Health and Chief Medical Officer as clinically extremely vulnerable to COVID-19. Advice on shielding from infection was disseminated by NHS England, primary care and NHS hospital trusts to those identified at highest risk. The British Society for Rheumatology (BSR) developed further risk stratification guidance specifically focused on autoimmune rheumatic disease. As the UK entered a period of nationwide lockdown on 23rd March 2020, the clinically highly vulnerable group were asked to shield from infection by staying at home and avoiding any face-to-face contact for an initial period of 12 weeks. The implications of social isolation, disruption to planned medical care and economic consequences became increasingly recognised. This work aimed to understand the experience and wellbeing of this patient group during week 5 -6 of UK Lockdown, as a guide to how we might best adapt services and address the needs of this group. Methods  Short semi-structured telephone interviews were conducted with 141 patients during week five and six of UK lockdown, between 20th April and 1st May 2020. Participants were sampled systematically from the departmental biologic therapy database at Wexham Park Hospital, a general hospital providing services to a diverse population of approximately 450,000 people in Berkshire and South Buckinghamshire. Results  Telephone interview was conducted with 141 patients prescribed biologic therapy. Written advice on risk and shielding was received by over 90%. Sixty four percent of respondents were female with a median age of 56 years. Thirty-nine percent of those interviewed fell within highest BSR risk category for whom full shielding was highly recommended, yet at the time of interview 51.1% of respondents reported they had committed to full shielding. Four percent of respondents self-identified as key workers and had continued their usual commitments. Amongst those interviewed, 35% reported significant adverse impact on their emotional and mental wellbeing within the first six weeks of UK lockdown. Isolation, uncertainty, limited physical exercise and cancellations to planned appointments were common themes. Twenty-eight percent of respondents felt their disease control had significantly deteriorated during the ongoing pandemic. Due to prevailing anxiety about the impact of immunosuppression on COVID-19 risk, 5% of patients had adjusted their prescribed therapies without the direct supervision or clinical advice. Conclusion  This study gives initial insights into the behaviours and concerns of patients with autoimmune and inflammatory disease on biologic therapy during the first wave of COVID-19 in the UK. Wellbeing and disease management have considerably suffered for many individuals. Further understanding patient experience may help guide restructuring of rheumatology services in next phase of the UK pandemic. Disclosure  L.M. Carter: None. H. Irvine: None. A. D’Cunha Kamath: None. A. Sahni: None. P. Hanna: None. N. Rahimi: None. K. Bhamra: None.

scholarly journals P246 Predicting non-response to biologic therapy amongst patients with axSpA: results from the British Society for Rheumatology Biologics Register

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Linda E Dean ◽  
Ejaz Pathan ◽  
Gareth T Jones ◽  
Gary J Macfarlane
Keyword(s):  
New York ◽  
Biologic Therapy ◽  
Treatment Strategies ◽  
British Society ◽  
Patient Reported ◽  
Parsimonious Models ◽  
Specific Factors ◽  
And Gender ◽  
Biologics Register

Abstract Background Biologic therapies have transformed treatment for axial spondyloarthritis (axSpA). However, although studies report overall benefits, these are average effects. There remains a subset of patients in whom response is not achieved. Here, we aimed to identify characteristics of patients who may need additional therapeutic approaches to optimise outcome. Methods The British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS) is a prospective cohort of axSpA patients recruited from 83 centres across Great Britain. All patients were biologic-naïve at recruitment, however those in the “biologic” cohort commenced a biologic therapy shortly thereafter, or during follow-up. Clinical data was collected from medical records, and socio-economic/patient reported outcomes via questionnaires. Response was assessed at first follow-up, between 10 weeks and 9 months from therapy commencement, and defined in four ways: ASAS20 and ASAS40 criteria, ≥1.1 reduction in ASDAS, and achieving moderate/inactive ASDAS (&lt;2.1). Factors associated with non-response were assessed by logistic regression and parsimonious models identified using stepwise methods. The ability to predict non-response was assessed by positive predictive value (PPV). Results 335 biologic participants provided information at a median follow-up of 14 weeks (inter-quartile range (IQR) 12-17). Median age was 47 years (IQR 36-56), 69% were male and 61% met AS modified New York criteria. The proportion meeting response varied by criteria: ASAS20 52%, ASAS40 33%, ASDAS reduction 47% and ASDAS &lt;2.1 35%. Socio-economic circumstances predicted non-response, specifically (in all models) work status and (in some models) fewer years of education (Table 1). Poorer mental health and high number of co-morbidities was associated with non-response across multiple (but not all) outcomes, while body mass index, enthesitis and gender were included in models for a single outcome. Disease-specific factors were largely not associated with non-response. All models demonstrated a good level of fit and were effective at predicting non-response (PPV 65%-77%). Conclusion We have identified factors which predict non-response to biologic therapy, some of which may be modifiable and others which identify patients who are unlikely to benefit from biologic therapy alone. In such patients additional/alternative treatment strategies should be considered to maximise the benefits which others gain from biologic therapy. Disclosures L.E. Dean None. E. Pathan Other; E.P. has recieved salary funding from Jansen (2019) and Merck (2018). G.T. Jones None. G.J. Macfarlane None.

Incisional Hernia in the United States: Trends in Hospital Encounters and Corresponding Healthcare Charges

2018 ◽  
Vol 84 (1) ◽  
pp. 118-125 ◽  
Author(s):  
Valeriy Shubinets ◽  
Justin P. Fox ◽  
Michael A. Lanni ◽  
Michael G. Tecce ◽  
Eric M. Pauli ◽  
...  
Keyword(s):  
United States ◽  
Adverse Events ◽  
Incisional Hernia ◽  
Private Insurance ◽  
The United States ◽  
Hospital Charges ◽  
Hospital Discharges ◽  
Serious Adverse Events ◽  
Comorbidity Index ◽  
Primary Payer

Incisional hernia (IH) is a challenging, potentially morbid condition. This study evaluates recent trends in hospital encounters associated with IH care in the United States. Using Nationwide Inpatient Sample databases from 2007 to 2011, annual estimates of IH-related hospital discharges, charges, and serious adverse events were identified. Significance in observed trends was tested using regression modeling. From 2007 to 2011, there were 583,054 hospital discharges associated with a diagnosis of IH. 81.1 per cent had a concurrent procedure for IH repair. The average discharge included a female patient (63.2%), 59.8 years of age, with either Medicare (45.3%) or Private insurance (38.3%) as the anticipated primary payer. Comparing 2007 to 2011, significant increases in IH discharges (12%; 2007 = 109,702 vs 2011 = 123,034, P = 0.009) and IH repairs (10%; 2007 = 90,588 vs 2011 = 99,622, P < 0.001) were observed. This was accompanied by a 37 per cent increase in hospital charges (2007 = $44,587 vs 2011 = $60,968, P < 0.001), resulting in a total healthcare bill of $7.3 billion in 2011. Significant trends toward greater patient age (2007 = 59.7 years vs 2011 = 60.2 years, P < 0.001), higher comorbidity index (2007 = 3.0 vs 2011 = 3.5, P < 0.001), and increased frequency of serious adverse events (2007 = 13.5% vs 2011 = 17.7%, P < 0.001) were noted. Further work is needed to identify interventions to mitigate the risk of IH development.

scholarly journals Biologic treatment response among adults with juvenile idiopathic arthritis: results from the British Society for Rheumatology Biologics Register

Rheumatology ◽  
2013 ◽  
Vol 52 (10) ◽  
pp. 1905-1913 ◽  
Author(s):  
Flora McErlane ◽  
Helen E. Foster ◽  
Rebecca Davies ◽  
Mark Lunt ◽  
Kath D. Watson ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Treatment Response ◽  
British Society ◽  
Biologic Treatment ◽  
Biologics Register

scholarly journals Is background methotrexate advantageous in extending TNF inhibitor drug survival in elderly patients with rheumatoid arthritis? An analysis of the British Society for Rheumatology Biologics Register

Rheumatology ◽  
2020 ◽  
Vol 59 (9) ◽  
pp. 2563-2571 ◽  
Author(s):  
Katie Bechman ◽  
Anuoluwapo Oke ◽  
Mark Yates ◽  
Sam Norton ◽  
Elaine Dennison ◽  
...  
Keyword(s):  
Older Adults ◽  
Adverse Events ◽  
Hazard Rate ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
British Society ◽  
Tnf Inhibitor ◽  
Drug Survival ◽  
Comorbidity Burden ◽  
Biologics Register

Abstract Objective To evaluate drug survival with monotherapy compared with combination therapy with MTX in RA older adults. Methods Patients from the British Society for Rheumatology Biologics Register, a prospective observational cohort, who were biologic naïve and commencing their first TNF inhibitors (TNFi) were included. The cohort was stratified according to age: &lt;75 and ≥75. Cox-proportional hazards models compared the risk of TNFi discontinuation from (i) any-cause, (ii) inefficacy and (iii) adverse events, between patients prescribed TNFi-monotherapy compared with TNFi MTX combination. Results The analysis included 15 700 patients. Ninety-five percent were &lt;75 years old. Comorbidity burden and disease activity were higher in the ≥75 cohort. Fifty-two percent of patients discontinued TNFi therapy during the follow-up period. Persistence with therapy was higher in the &lt;75 cohort. Patients receiving TNFi monotherapy were more likely to discontinue compared with patients receiving concomitant MTX [hazard rate 1.12 (1.06–1.18) P &lt;0.001]. This finding only held true in patients &lt;75 [hazard rate (HR) 1.11 (1.05–1.17) vs ≥75 [HR 1.13 (0.90–1.41)]. Examining TNFi discontinuation by cause revealed patients ≥75 receiving TNFi monotherapy were less likely to discontinue TNFi due to inefficacy [HR 0.66 (0.43–0.99) P=0.04] and more likely to discontinue therapy from adverse events [HR 1.41(1.02–1.96) P =0.04]. These results were supported by the multivariate adjustment in complete case and imputed analyses. Conclusion TNFi monotherapy is associated with increased treatment failure. In older adults, the disadvantage of TNFi monotherapy on drug survival is no longer seen. Patients ≥75 have fewer discontinuations due to inefficacy than adverse events compared with younger patients. This likely reflects greater disposition to toxicity but perhaps also a decline in immunogenicity associated with immunosenescence.

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