scholarly journals Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study

2020 ◽  
Vol 7 (1) ◽  
pp. e000412
Author(s):  
Murray B Urowitz ◽  
Robert L Ohsfeldt ◽  
Ronald C Wielage ◽  
John J Dever ◽  
Mehdi Zakerifar ◽  
...  
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Standard Therapy ◽  
Organ Damage ◽  
Systemic Lupus ◽  
Damage Progression ◽  
Damage Accrual ◽  
Post Hoc

ObjectiveLong-term extension (LTE) studies of belimumab in SLE do not include a comparator arm, preventing comparisons between belimumab plus standard therapy and standard therapy alone for organ damage accrual. Propensity score matching can be used to match belimumab-treated patients from LTE studies with standard therapy–treated patients from observational cohort studies. This analysis was designed to compare organ damage progression between treatment groups (belimumab plus standard therapy vs standard therapy alone) in patients with SLE with ≥5 years of follow-up, reproducing our previous study with more generalisable data.MethodsThis exploratory post hoc analysis used a heterogeneous population of US and non-US patients receiving monthly intravenous belimumab from pooled BLISS LTE trials (BEL112234/NCT00712933) and standard therapy–treated patients from the Toronto Lupus Cohort. Sixteen clinical variables were selected to calculate the propensity score.ResultsThe 592 LTE and 381 Toronto Lupus Cohort patients were highly dissimilar across the 16 variables; an adequately balanced sample of 181 LTE and 181 matched Toronto Lupus Cohort patients (mean bias=3.7%) was created using propensity score matching. Belimumab treatment was associated with a smaller increase in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) over 5 years than standard therapy alone (mean treatment difference=–0.453 (95% CI –0.646 to –0.260); p<0.001). Patients treated with belimumab were 60% less likely to progress to a higher SDI score over any given year of follow-up, compared with standard therapy alone (HR (95% CI) 0.397 (0.275 to 0.572); p<0.001).ConclusionUsing propensity score matching, this highly heterogeneous sample was sufficiently matched to the Toronto Lupus Cohort, suggesting that patients treated with intravenous belimumab may have reduced organ damage progression versus standard therapy alone. This analysis of a large and diverse pooled SLE population was consistent with our previously published US-focused study.

scholarly journals Organ damage in patients treated with belimumab versus standard of care: a propensity score-matched comparative analysis

2019 ◽  
Vol 78 (3) ◽  
pp. 372-379 ◽  
Author(s):  
Murray B Urowitz ◽  
Robert L Ohsfeldt ◽  
Ronald C Wielage ◽  
Kari A Kelton ◽  
Yumi Asukai ◽  
...  
Keyword(s):  
Propensity Score ◽  
Lupus Erythematosus ◽  
Damage Index ◽  
Standard Of Care ◽  
Organ Damage ◽  
Systemic Lupus ◽  
American College Of Rheumatology ◽  
Damage Progression

ObjectivesThe study (206347) compared organ damage progression in patients with systemic lupus erythematosus (SLE) who received belimumab in the BLISS long-term extension (LTE) study with propensity score (PS)-matched patients treated with standard of care (SoC) from the Toronto Lupus Cohort (TLC).MethodsA systematic literature review identified 17 known predictors of organ damage to calculate a PS for each patient. Patients from the BLISS LTE and the TLC were PS matched posthoc 1:1 based on their PS (±calliper). The primary endpoint was difference in change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score from baseline to 5 years.ResultsFor the 5- year analysis, of 567 (BLISS LTE n=195; TLC n=372) patients, 99 from each cohort were 1:1 PS matched. Change in SDI score at Year 5 was significantly lower for patients treated with belimumab compared with SoC (−0.434; 95% CI –0.667 to –0.201; p<0.001). For the time to organ damage progression analysis (≥1 year follow-up), the sample included 965 (BLISS LTE n=259; TLC n=706) patients, of whom 179 from each cohort were PS-matched. Patients receiving belimumab were 61% less likely to progress to a higher SDI score over any given year compared with patients treated with SoC (HR 0.391; 95% CI 0.253 to 0.605; p<0.001). Among the SDI score increases, the proportion of increases ≥2 was greater in the SoC group compared with the belimumab group.ConclusionsPS-matched patients receiving belimumab had significantly less organ damage progression compared with patients receiving SoC.

scholarly journals The impact of mild renal dysfunction on isolated cardiopulmonary coronary artery bypass grafting: a retrospective propensity score matching analysis

2019 ◽  
Vol 14 (1) ◽  
Author(s):  
Xian Wang ◽  
Yifan Zhu ◽  
Wen Chen ◽  
Liangpeng Li ◽  
Xin Chen ◽  
...  
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Artery Bypass ◽  
Term Survival ◽  
Group A ◽  
Group B ◽  
The Impact ◽  
New Onset

Abstract Background Mild preoperative renal dysfunction (RD) is not rare in patients receiving isolated cardiopulmonary coronary artery bypass grafting (CCABG). However, there are not too many studies about the impact of mild preoperative RD on in-hospital and follow-up outcomes after isolated CCABG. This single-centre, retrospective propensity score matching study designed to study the impact of mild preoperative RD on in-hospital and long-term outcomes after first isolated CCABG. Methods After propensity score matching, 1144 patients with preoperative estimated glomerular filtration rate (eGFR) of more than 60 ml/min/1.73 m2 receiving first isolated CCABG surgery from January 2012 to December 2015 entered the study, who were divided into 2 groups: A group (eGFR ≥90 ml/min/1.73 m2, n = 572) and B group (eGFR of 60–89 ml/min/1.73 m2, n = 572). The in-hospital and long-term outcomes were recorded and analyzed. The mean follow-up time was 54.4 ± 10.7 months. Acute kidney injury (AKI) was defined and classified according to the Acute Kidney Injury Network (AKIN) criteria. Results The 2 propensity score-matched groups had similar baseline and procedure except the baseline eGFR. There were 8 patients died in A group (mortality is 1.4%) and 14 died in B group (mortality is 2.5%) during the in hospital and 30-day postoperatively(χ2 = 1.159, p = 0.282). There were totally 38 patients lost to follow-up, 18 in group A and 20 in group B. 21 patients died in group A and 37 died in group B during the follow-up, and long-term survival in group A was higher than in group B (96.2% vs 93.1%, χ2 = 4.336, p = 0.037). Comparing with group A, group B was associated with an increased rates and severity of AKI postoperatively (total AKI: 62 vs 144. AKIN stageI: 54 vs 113; AKIN stageII: 6 vs 22; AKIN stageIII: 2 vs 9, p<0.0001). During follow-up, group B also had a higher rate of new onset of dialysis (0 vs 6, χ2 = 4.432, p = 0.039). Multivariable logistic regression showed that comparing with A group, the HR for long-term mortality and new onset of dialysis in B group was 1.67 and 1.52 respectively (95%CI 1.09–2.90, p = 0.035; 95%CI 1.14–2.49, p = 0.027). Conclusions Comparing with normal preoperative renal function, patients with mild preoperative RD had a similar in-hosptial mortality, but with an increased in-hosptial rates and severity of AKI, and with a decreased long-term survival and increased long-term new onset of dialysis.

scholarly journals Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension

Rheumatology ◽  
2019 ◽  
Vol 59 (2) ◽  
pp. 281-291 ◽  
Author(s):  
Ronald F van Vollenhoven ◽  
Sandra V Navarra ◽  
Roger A Levy ◽  
Mathew Thomas ◽  
Amy Heath ◽  
...  
Keyword(s):  
Lupus Erythematosus ◽  
Damage Index ◽  
Organ Damage ◽  
Index Score ◽  
Phase Iii ◽  
Extension Study ◽  
Laboratory Parameters ◽  
Damage Accrual

AbstractObjectiveThis extension study of the Phase III, randomized, placebo-controlled Belimumab International SLE Study (BLISS)-52 and BLISS-76 studies allowed non-US patients with SLE to continue belimumab treatment, in order to evaluate its long-term safety and tolerability including organ damage accrual.MethodsIn this multicentre, long-term extension study (GlaxoSmithKline Study BEL112234) patients received i.v. belimumab every 4 weeks plus standard therapy. Adverse events (AEs) were assessed monthly and safety-associated laboratory parameters were assessed at regular intervals. Organ damage (SLICC/ACR Damage Index) was assessed every 48 weeks. The study continued until belimumab was commercially available, with a subsequent 8-week follow-up period.ResultsA total of 738 patients entered the extension study and 735/738 (99.6%) received one or more doses of belimumab. Annual incidence of AEs, including serious and severe AEs, remained stable or declined over time. Sixty-nine (9.4%) patients experienced an AE resulting in discontinuation of belimumab or withdrawal from the study. Eleven deaths occurred (and two during post-treatment follow-up), including one (cardiogenic shock) considered possibly related to belimumab. Laboratory parameters generally remained stable. The mean (s.d.) SLICC/ACR Damage Index score was 0.6 (1.02) at baseline (prior to the first dose of belimumab) and remained stable. At study year 8, 57/65 (87.7%) patients had no change in SLICC/ACR Damage Index score from baseline, indicating low organ damage accrual.ConclusionBelimumab displayed a stable safety profile with no new safety signals. There was minimal organ damage progression over 8 years.Trial registrationClinicalTrials.gov, https://clinicaltrials.gov, NCT00424476 (BLISS-52), NCT00410384 (BLISS-76), NCT00732940 (BEL112232), NCT00712933 (BEL112234).

scholarly journals Assessing the Long-Term Role of Vaccination against HPV after Loop Electrosurgical Excision Procedure (LEEP): A Propensity-Score Matched Comparison

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 717
Author(s):  
Giorgio Bogani ◽  
Francesco Raspagliesi ◽  
Francesco Sopracordevole ◽  
Andrea Ciavattini ◽  
Alessandro Ghelardi ◽  
...  
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Cervical Dysplasia ◽  
The Cost ◽  
Matched Comparison ◽  
Term Data ◽  
Loop Electrosurgical Excision

Background: Primary prevention through vaccination is a prophylactic approach aiming to reduce the risk of developing human papillomavirus (HPV)-related lesions. No mature and long-term data supported the adoption of vaccination in women undergoing conization. Methods: This is a retrospective multi-institutional study. Charts of consecutive patients undergoing conization between 2010 and 2014 were collected. All patients included had at least 5 years of follow-up. We compared outcomes of patients undergoing conization plus vaccination and conization alone. A propensity-score matching algorithm was applied in order to reduce allocation biases. The risk of developing recurrence was estimated using Kaplan-Meir and Cox hazard models. Results: Overall, charts of 1914 women were analyzed. The study group included 116 (6.1%) and 1798 (93.9%) women undergoing conization plus vaccination and conization alone, respectively. Five-year recurrence rate was 1.7% (n = 2) and 5.7% (n = 102) after conization plus vaccination and conization alone, respectively (p = 0.068). After the application of a propensity-score matching, we selected 100 patients undergoing conization plus vaccination and 200 patients undergoing conization alone. The crude number of recurrences was 2 (2%) and 11 (5.5%) for patients undergoing conization plus vaccination and conization alone, respectively (p = 0.231). Vaccination had no impact on persistent lesions (no negative examination between conization and new cervical dysplasia; p = 0.603), but reduced the risk of recurrent disease (patients who had at least one negative examination between conization and the diagnosis of recurrent cervical dysplasia; p = 0.031). Conclusions: Patients having vaccination experience a slightly lower risk of recurrence than women who had not, although not statistically significantly different. Further evidence is needed to assess the cost effectiveness of adopting vaccination in this setting.

scholarly journals Digoxin treatment and long-term mortality depending on left ventricular ejection fraction and atrial fibrillation: a propensity score matched analysis

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M.R Grubler ◽  
N.D Verheyen ◽  
A Meinitzer ◽  
L Fiedler ◽  
M Tscharre ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Coronary Angiography ◽  
Propensity Score ◽  
Ejection Fraction ◽  
Propensity Score Matching ◽  
Increased Risk ◽  
All Cause Mortality

Abstract Background/Introduction Atrial fibrillation (AF) is a common heart rhythm disturbance, associated with an increased risk of stroke, hospital admissions and mortality, especially in patients with reduced ejection fraction. Among the oldest medications used for heart-rate control is digitalis, but largely due to observational studies showing an increased risk of death it has fallen out of favour. Recently newer clinical trials reported that the treatment with digitalis in permanent AF might be superior to beta blocker therapy in regard to functional status and symptom burden. Given this diverging results we attempt to analysis a large cohort of patients facilitating a propensity score matching algorithm. Purpose To assess the associations of digitalis treatment with mortality in patients with increased cardiovascular risk. Methods Patients were derived from a large cohort study including participants from a tertiary care centre who were referred to coronary angiography. The propensity score matching is based on a predefined list of variables, with digitalis as treatment. Matching strategy is nearest neighbour matching and to prove consistency, radius matching (radius = 0.1). For survival analysis we used a Cox proportional hazard regression comparing patients with and without digitalis for all-cause mortality. The analysis is conducted using STATA 13 MP. All patients provided written informed consent and the study was approved by the ethics committee. Results A total of 2457 patients (median age: 63.5 [IQR = 56.3–70.6] years, 30.1% women) referred to coronary angiography, with a median follow up of 9.9 (IQR = 8.5–10.7) years were included. The matching process and the resulting propensity score fulfilled all statistical assumptions and resulted in a balanced cohort. The risk for all-cause mortality was higher among propensity score matched participants not treated with digitalis compared to patients on treatment (n=514) HR 3.03 (95% CI 2.5 to 3.7). Total mortality in patients with AF on digitalis after a median follow-up of 9.9 years was 27.6%. At baseline, only 42.4% of patients with AF were on oral anticoagulation. Conclusions In the present cohort treatment with digitalis was associated with a lower risk of all-cause mortality after long-term follow-up. The patient population has a clinically significant 10-year mortality risk. The results may not apply to other cohorts but may help inform future clinical trials. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals Hypocomplementemia as a Risk Factor for Organ Damage Accrual in Patients with Systemic Lupus Erythematosus

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Warren Raymond ◽  
Gro Eilertsen ◽  
Johannes Nossent
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Predictive Value ◽  
Regression Models ◽  
Organ Damage ◽  
Underlying Disease ◽  
Systemic Lupus ◽  
Damage Accrual

While it is a common practice to monitor complement levels in patients with systemic lupus erythematosus to aid in flare prediction and detection, it is unclear if this strategy is helpful in preventing subsequent organ damage. We studied longitudinal complement levels in 102 SLE patients during a median follow-up of 13.8 years (IQR 7.0, 23.1). Low complement was defined as C3 < 0.84 g/L and/or C4 < 0.08 g/L, disease activity by clinical SLEDAI-2K, and organ damage by SLICC-DI. We calculated a time averaged clinical SLEDAI score (cWAS) and performed multivariate regression models to assess the independent predictive value of low complement for organ damage at last visit. Hypocomplementemia (HC) was observed in 67% of all patients and was more often due to low C3 (97%) than low C4 (54%). Compared to patients not developing HC (33%), HC patients were more frequently positive for anti-dsDNA Ab (72% vs 36%, p<0.01) and aPL (74% vs 40%, p<0.01) but HC was concurrently present with anti-dsDNA Ab in only half the cases. The time-adjusted cWAS scores (1.9 vs 1.2, p=0.9), frequency (SDI > 0, n=60), and type of organ damage accrual were similar for patients with and without HC (OR 1.08, p>0.20). Intermittent or sustained HC has no predictive value for damage accrual in SLE or the underlying disease activity over time. This together with significant discrepancies in the concurrence of low C3, C4, and anti-dsDNA Ab indicates frequent activation of the complement pathway by other factors than immune complexes in SLE.

scholarly journals Damage accrual and mortality over long-term follow-up in 300 patients with systemic lupus erythematosus in a multi-ethnic British cohort

Rheumatology ◽  
2019 ◽  
Author(s):  
Beatriz Tejera Segura ◽  
Brett Sydney Bernstein ◽  
Thomas McDonnell ◽  
Chris Wincup ◽  
Vera M Ripoll ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
High Dose ◽  
Concomitant Disease ◽  
Systemic Lupus ◽  
Increased Risk ◽  
Damage Accrual ◽  
Long Term Follow Up

Abstract Objective Damage in patients with systemic lupus erythematosus is irreversible change in organs due to disease activity, concomitant disease or medication side-effects. It is measured using the Systemic Lupus International Collaborative Clinics Damage Index (SDI) and is associated with increased mortality. Previous reports have suggested associations between damage accrual and various ethnic, disease and treatment factors, but there is a dearth of long-term follow-up data from large multi-ethnic cohorts. We describe a study of damage and mortality in 300 patients from London, UK followed for up to 40 years. Methods We carried out retrospective analysis of medical records and SDI scores of 300 patients followed for up to 40 years (median 13.3 years). Characteristics of the groups who did and did not develop damage and those who died or survived to the end of follow-up were compared using univariable and multivariable analysis. Kaplan-Meier analysis was used to analyse factors affecting mortality and accrual of damage. Results Damage developed in 231/300 (77%) of patients. There was a linear accrual of damage over 40 years follow-up. Factors associated with damage were African/Caribbean ethnicity, renal and cerebral involvement, early use of high-dose corticosteroids or immunosuppressants, anti-RNP and antiphospholipid antibodies. Damage was strongly associated with mortality. Of 87 patients who died, 93% had damage compared with 70% of survivors (P < 0.001). Conclusion Development of damage is strongly associated with increased mortality. We identified groups at increased risk of developing damage, including those treated with high-dose steroids and immunosuppressants within the first two years.

scholarly journals Damage accrual and mortality over long-term follow-up in 300 patients with systemic lupus erythematosus in a multi-ethnic British cohort

Rheumatology ◽  
2019 ◽  
Author(s):  
Beatriz Tejera Segura ◽  
Brett Sydney Bernstein ◽  
Thomas McDonnell ◽  
Chris Wincup ◽  
Vera M. Ripoll ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Systemic Lupus ◽  
Damage Accrual ◽  
Long Term Follow Up

scholarly journals Analysis of data collected in the European Society for Blood and Marrow Transplantation (EBMT) Registry on a cohort of lymphoma patients receiving plerixafor

2019 ◽  
Vol 55 (3) ◽  
pp. 613-622 ◽  
Author(s):  
Anna Sureda ◽  
Christian Chabannon ◽  
Tamás Masszi ◽  
David Pohlreich ◽  
Christof Scheid ◽  
...  
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Progression Free Survival ◽  
Hematopoietic Stem ◽  
Free Survival ◽  
Blood And Marrow Transplantation ◽  
Comparison Groups ◽  
Long Term Follow Up

Abstract Plerixafor + granulocyte-colony stimulating factor (G-CSF) is administered to patients with lymphoma who are poor mobilizers of hematopoietic stem cells (HSCs) in Europe. This international, multicenter, non-interventional registry study (NCT01362972) evaluated long-term follow-up of patients with lymphoma who received plerixafor for HSC mobilization versus other mobilization methods. Propensity score matching was conducted to balance baseline characteristics between comparison groups. The following mobilization regimens were compared: G-CSF + plerixafor (G + P) versus G-CSF alone; G + P versus G-CSF + chemotherapy (G + C); and G-CSF + plerixafor + chemotherapy (G + P + C) versus G + C. The primary outcomes were progression-free survival (PFS), overall survival (OS), and cumulative incidence of relapse (CIR). Overall, 313/3749 (8.3%) eligible patients were mobilized with plerixafor-containing regimens. After propensity score matching, 70 versus 36 patients were matched in the G + P versus G-CSF alone cohort, 124 versus 124 in the G + P versus G + C cohort, and 130 versus 130 in the G + P + C versus G + C cohort. For both PFS and OS, the upper bound of confidence interval for the hazard ratio was >1.3 for all comparisons, implying that non-inferiority was not demonstrated. No major differences in PFS, OS, and CIR were observed between the plerixafor and comparison groups.

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