scholarly journals Comparison of Retention Rates Between Tumor Necrosis Factor-α Inhibitors in Patients With Ankylosing Spondylitis: Data From the Korean College of Rheumatology Biologics Registry

2021 ◽  
Vol 8 ◽  
Author(s):  
Hyoun-Ah Kim ◽  
Sun-Kyung Lee ◽  
Sohee Oh ◽  
Eun Hye Park ◽  
Yong-Beom Park ◽  
...  

This study aimed to investigate drug retention rates for various TNF inhibitors (TNFis) commonly prescribed to Korean patients with ankylosing spondylitis (AS) in the Korean College of Rheumatology Biologics registry (KOBIO; December 2012–June 2016). Discontinuation was defined as switching or stopping the biologic agent. Kaplan–Meier curves and Cox's proportional hazard models were used for further analysis. The reasons for discontinuation of TNFis were also assessed. Univariate and multivariate analyses were used to identify possible predictors of discontinuation. Data from 1,005 patients with AS were analyzed with a median follow-up period of 14 months. Seventy-six percent of patients were first-line biologic users. Discontinuation of TNFis occurred in 24.2% (switching in 9.6%) of patients during follow-up. An estimate of the drug failure showed that the adjusted hazard ratio (HR) for golimumab compared to etanercept was 0.441 (95% confidence interval: 0.277–0.703, p < 0.001). Reasons for discontinuation included lack of efficacy (32.6%), adverse events (23.6%), clinical improvement (11.2%), and others (32.6%). Predictors of discontinuation using a multivariate analysis were a shorter disease duration (HR: 0.973, p = 0.044) and being negative for HLA-B27 (HR: 1.623, p = 0.0093). In conclusion, few Korean patients with AS switched to other TNFis during their treatment. The drug retention rate for golimumab was higher than for other agents.

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1260.1-1260
Author(s):  
H. K. Min ◽  
K. Y. Kang

Background:The choice of second-line biologics for ankylosing spondylitis (AS) patients previously treated with a tumour necrosis factor inhibitor (TNFi) remains unclearObjectives:Here, we compared drug retention and clinical efficacy between AS patients who switched biologics to secukinumab and those who switched to a different TNFi.Methods:AS patients enrolled in the Korean College of Rheumatology BIOlogics registry were included. Patients with previous TNFi exposure were divided into the secukinumab group and the TNFi switching group. Drug retention and clinical efficacy (BASDAI50, ASAS20, ASAS40, ASDAS <2.1, ASDAS clinically important improvement, and ASDAS major improvement) were assessed at the 1 year follow-up. Propensity score (PS)-matched and covariate-adjusted logistic regression analyses were performed.Results:246 had available 1 year follow-up data. Secukinumab as third- or later-line biologics was more frequent than alternative TNFi (54% vs. 14%). PS-matched and multiple covariate-adjusted analyses showed that the odds ratio (OR) for drug discontinuation was comparable between the secukinumab and TNFi switching groups (OR=1.136; 95% CI, 0.843–1.531 and OR=1.000; 95% CI, 0.433–2.308, respectively). The proportion of patients who achieved BASDAI50 was also comparable between the two groups (OR=0.833; 95% CI, 0.481–1.441 in PS-matched analysis). Other clinical efficacy parameters were also comparable. In the subgroup analysis of AS patients with previous TNFi discontinuation due to ineffectiveness, all clinical efficacy parameters were comparable between the two groups.Conclusion:In AS patients with previous exposure to a TNFi, switching biologics to secukinumab and switching to an alternative TNFi resulted in comparable drug retention and clinical efficacy.References:[1]Micheroli R, Tellenbach C, Scherer A, et al. Effectiveness of secukinumab versus an alternative TNF inhibitor in patients with axial spondyloarthritis previously exposed to TNF inhibitors in the Swiss Clinical Quality Management cohort. Ann Rheum Dis 2020;79:1203-9.Disclosure of Interests:None declared.


2017 ◽  
Vol 26 (3) ◽  
pp. 122-128
Author(s):  
Marius Trandafir ◽  
◽  
Claudiu C. Popescu ◽  
Monica Gabriela Dimancescu ◽  
Florian Berghea ◽  
...  

Objective. The study aimed at observing drug survival and determining potential predictors of anti-TNFα switch among ankylosing spondylitis (AS) patients. Methods. The study retrospectively recorded clinical data of patients fulfilling modified New York criteria in a single university clinic. The data were analyzed using appropriate statistical test, which were considered significant if p < 0.05. Results. A total of 120 patients met the inclusion criteria. Switchers had a median BASFI score of 2.7, a median ASDASCRP of 1.59 and a 41.7% prevalence of uveitis, compared to non-switchers which had a median BASFI score of 2.0, a median ASDASCRP of 1.20 and a uveitis prevalence of 22.9% respectively (p = 0.009; p = 0.025; p = 0.043). After a median of 7.0 years of observation, 96 patients (80.0%) were still being treated with their first anti-TNFα agent, with a Kaplan-Meier survival time estimate of 11.5 (10.1-12.9) years. The Kaplan-Meier study of the time of treatment until switch of the first biologic agent according to ASDASCRP categories revealed 9.3 (8.8-9.8) years for inactive disease, 10.6 (8.8-12.5) years for moderately active disease and 7.1 (5.7-8.5) years for highly active disease. The switch hazard ratio for CRP was 1.019 (1.007-1.031; p = 0.002), for BASDAI 1.226 (1.017-1.477; p = 0.032), for BASFI 1.264 (1.057-1.513; p = 0.010) and for ASDASCRP 1.592 (1.173-2.159; p = 0.003). Conclusion. Romanian AS patients on anti-TNFα agents exhibit high retention rate and drug survival of anti-TNFα agents. Switchers have significantly higher baseline disease activity indices which, along baseline acute phase reactants, can significantly predict switching of the first anti-TNFα agent. Patients with AS treated with anti-TNFα agents had a higher prevalence of uveitis than those who did not therapeutic switch.


2021 ◽  
Vol 8 ◽  
Author(s):  
Sara Alonso ◽  
Ignacio Villa ◽  
Sabela Fernández ◽  
José L. Martín ◽  
Lilyan Charca ◽  
...  

Objectives: We aimed to evaluate the drug retention rate and safety of secukinumab (SEC) in patients with axial spondyloarthritis (AxSpA) and psoriatic arthritis (PsA) in a real clinical setting.Methods: This multicenter retrospective observational study included all AxSpA and PsA patients who received at least one dose of SEC. Adverse events (AE) and the drug retention rate were the main study outcomes. Drug survival was analyzed by Kaplan-Meier curves while predictive factors of discontinuation were evaluated using a Cox regression analysis. The weight of these associations was estimated by hazard ratio (HR) values.Results: We included 154 patients (59 PsA and 95 AxSpA). Mean disease duration was 6.5 years (IQR 2-8). Sixty-one percent of patients were treated with two or more biologics prior to SEC. The 1 and 2-year retention rates for SEC were 66 and 43%, respectively. The main causes of discontinuation were inefficacy (59%) and AE (36%). The factors associated with lower risk of discontinuation were male gender (HR 0.54, 95% CI 0.38-0.78 p = 0.001), obesity (HR 0.53, 95% CI 0.30-0.93 p = 0.027), hypertension (HR 0.55, 95% CI 0.30-0.93 p = 0.008), and diabetes (HR 0.42 95% CI 0.18-0.99 p = 0.047) while number of previous biologics and depression were predictors of discontinuation (HR 1.18, 95% CI 1.04-1.34 p = 0.011 and HR 2.53, 95% CI 1.61-3.96 p &lt; 0.001).Conclusions: SEC showed a good retention rate in a population previously exposed to several biological therapies. As a novelty, cardiometabolic comorbidities were associated with better drug survival.


2019 ◽  
Vol 78 (11) ◽  
pp. 1536-1544 ◽  
Author(s):  
Lykke Midtbøll Ørnbjerg ◽  
Cecilie Heegaard Brahe ◽  
Johan Askling ◽  
Adrian Ciurea ◽  
Herman Mann ◽  
...  

ObjectiveTo study drug retention and response rates in patients with axial spondyloarthritis (axSpA) initiating a first tumour necrosis factor inhibitor (TNFi).MethodsData from 12 European registries, prospectively collected in routine care, were pooled. TNFi retention rates (Kaplan-Meier statistics), Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive disease (<1.3), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <40 mm and Assessment of SpondyloArthritis International Society responses (ASAS 20/40) were assessed at 6, 12 and 24 months.ResultsA first TNFi was initiated in 24 195 axSpA patients. Heterogeneity of baseline characteristics between registries was observed. Twelve-month retention was 80% (95% CI 79% to 80%), ranging from 71% to 94% across registries. At 6 months, ASDAS Inactive disease/BASDAI<40 rates were 33%/72% (LUNDEX-adjusted: 27%/59%), ASAS 20/40 response rates 64%/49% (LUNDEX-adjusted 52%/40%). In patients initiating first TNFi after 2009, 6097 patients was registered to fulfil ASAS criteria for axSpA, 2935 was registered to fulfil modified New York Criteria for Ankylosing Spondylitis and 1178 patients was registered as having non-radiographic axSpA. In nr-axSpA patients, we observed lower 12-month retention rates (73% (70%–76%)) and lower 6-month LUNDEX adjusted response rates (ASDAS Inactive disease/BASDAI40 20%/50%, ASAS 20/40 45%/33%). For patients initiating first TNFi after 2014, 12-month retention rate, but not 6-month response rate, was numerically higher compared with patients initiating TNFi in 2009–2014.ConclusionA large European database of patients with axSpA initiating a first TNFi treatment in routine care, demonstrated that 27% of patients achieved ASDAS inactive disease after 6 months, while 59% achieved BASDAI <40. Four of five patients continued treatment after 1 year.


2021 ◽  
Author(s):  
Se Hee Kim ◽  
Hae-Rim Kim ◽  
Sang-Heon Lee ◽  
Kichul Shin ◽  
Hyoun-Ah Kim ◽  
...  

Abstract Background: The clinical data on the biologic disease-modifying antirheumatic drug (bDMARD) use in late-onset ankylosing spondylitis (LOAS) is limited. Thus, this study aimed to evaluate the drug efficacy and retention rate of bDMARDs in LOAS and compare it to young-onset ankylosing spondylitis (YOAS).Methods: Data of patients with AS receiving bDMARDs were extracted from the Korean College of Rheumatology Biologics and Targeted Therapy registry. Patients whose age of onset was > 50 years and < 50 years were classified as having LOAS and YOAS, respectively. Their baseline characteristics and disease-associated parameters were evaluated. Drug efficacy (Ankylosing Spondylitis Disease Activity Score [ASDAS]-clinically important improvement [CII], ASDAS-major improvement [MI], Assessment of SpondyloArthritis International Society [ASAS] 20, and ASAS 40) at 1-year follow-up and drug retention rates were assessed. Results: A total of 1708 patients (comprising 1472 patients with YOAS and 236 patients with LOAS) were included in this analysis. The LOAS group had a lower prevalence among males, lower HLA-B27 positivity and a higher prevalence of peripheral arthritis. Patients with LOAS were more likely to have higher disease-associated parameters (inflammatory reactants, patient global assessment, ASDAS-erythrocyte sedimentation rate, and ASDAS-C-reactive protein). LOAS was negatively associated with achieving ASDAS-CII, ASAS 20, and ASAS 40. The drug retention rate was lower in LOAS; however, the propensity score-matched and covariate-adjusted hazard ratios for bDMARD discontinuation were comparable to YOAS. There were no differences in the drug retention rates based on the type of bDMARD used in LOAS. Conclusion: Inferior clinical efficacy and drug retention rates were found in patients with LOAS receiving bDMARDs using real-world nationwide data. There were no differences among each bDMARD type.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Se Hee Kim ◽  
Hae-Rim Kim ◽  
Sang-Heon Lee ◽  
Kichul Shin ◽  
Hyoun-Ah Kim ◽  
...  

AbstractThe clinical data on the biologic disease-modifying antirheumatic drug (bDMARD) use in late-onset ankylosing spondylitis (LOAS) is limited. Thus, this study aimed to evaluate the drug efficacy and retention rate of bDMARDs in LOAS and compare it to young-onset ankylosing spondylitis (YOAS). Data of patients with AS receiving bDMARDs were extracted from the Korean College of Rheumatology Biologics and Targeted Therapy registry. Patients whose age of onset was > 50 years and ≤ 50 years were classified as having LOAS and YOAS, respectively. Their baseline characteristics and disease-associated parameters were evaluated. Drug efficacy [Ankylosing Spondylitis Disease Activity Score (ASDAS)-clinically important improvement (CII), ASDAS-major improvement (MI), Assessment of SpondyloArthritis International Society (ASAS) 20, and ASAS 40] at 1-year follow-up and drug retention rates were assessed. A total of 1708 patients (comprising 1472 patients with YOAS and 236 patients with LOAS) were included in this analysis. The LOAS group had a lower prevalence among males, lower HLA-B27 positivity and a higher prevalence of peripheral arthritis. Patients with LOAS were more likely to have higher disease-associated parameters (inflammatory reactants, patient global assessment, ASDAS-erythrocyte sedimentation rate, and ASDAS-C-reactive protein). LOAS was negatively associated with achieving ASDAS-CII, ASAS 20, and ASAS 40. The drug retention rate was lower in LOAS; however, the propensity score-matched and covariate-adjusted hazard ratios for bDMARD discontinuation were comparable to YOAS. There were no differences in the drug retention rates based on the type of bDMARD used in LOAS. Inferior clinical efficacy and shorter drug retention time were found in patients with LOAS receiving bDMARDs using real-world nationwide data. There were no differences among each bDMARD type.


2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Alice Bitossi ◽  
Alessandra Bettiol ◽  
Elena Silvestri ◽  
Gerardo Di Scala ◽  
Daniela Bacherini ◽  
...  

Objective. This study was aimed at assessing the long-term ocular control of adalimumab (ADA) in a large real-world population with noninfectious primary or secondary uveitis, focusing on the steroid-sparing effect and on disease-modifying antirheumatic drug (DMARD) cotreatment. Methods. In this retrospective, multicenter study, the efficacy of ADA was evaluated in terms of ocular control, changes in best-corrected visual acuity (BCVA), corticosteroid-sparing effect, and drug retention rate, overall and stratified according to DMARD cotreatment. Results. 106 patients were included. 88.7% had an associated systemic disease. After 6 and 12 months, proportions of patients with effective ocular control were 83.7% and 83.3%, respectively. At last the follow-up, 94.6% of patients had satisfactory ocular control. No difference in terms of ocular control at all time points emerged among patients starting ADA for ocular vs. systemic involvements. Patients with poor baseline BCVA remained stable or improved, while those with good BCVA hardly worsened. At 6 and 12 months, the median dose of prednisone significantly reduced to 5 mg/day (0-5) and 2.5 mg/day (0-5) (p<0.001). Over a median follow-up of 36 months, 38 subjects discontinued ADA treatment. Mild to moderate side effects were reported in 7 patients (6.6%). ADA ocular control, corticosteroid-sparing effect, and drug retention rate were not influenced by the concomitant use of DMARDs. Conclusion. The long-term ocular control of ADA in noninfectious primary or secondary uveitis is confirmed, also for BCVA preservation. Concomitant use of DMARDs does not provide additional benefits to ADA alone in terms of ocular control, steroid spare, and drug retention rate.


Rheumatology ◽  
2018 ◽  
Vol 58 (4) ◽  
pp. 650-655 ◽  
Author(s):  
Alexander Oldroyd ◽  
Jamie C Sergeant ◽  
Paul New ◽  
Neil J McHugh ◽  
Zoe Betteridge ◽  
...  

Abstract Objectives To characterize the 10 year relationship between anti-transcriptional intermediary factor 1 antibody (anti-TIF1-Ab) positivity and cancer onset in a large UK-based adult DM cohort. Methods Data from anti-TIF1-Ab-positive/-negative adults with verified diagnoses of DM from the UK Myositis Network register were analysed. Each patient was followed up until they developed cancer. Kaplan–Meier methods and Cox proportional hazard modelling were employed to estimate the cumulative cancer incidence. Results Data from 263 DM cases were analysed, with a total of 3252 person-years and a median 11 years of follow-up; 55 (21%) DM cases were anti-TIF1-Ab positive. After 10 years of follow-up, a higher proportion of anti-TIF1-Ab-positive cases developed cancer compared with anti-TIF1-Ab-negative cases: 38% vs 15% [hazard ratio 3.4 (95% CI 2.2, 5.4)]. All the detected malignancy cases in the anti-TIF1-Ab-positive cohort occurred between 3 years prior to and 2.5 years after DM onset. No cancer cases were detected within the following 7.5 years in this group, whereas cancers were detected during this period in the anti-TIF1-Ab-negative cases. Ovarian cancer was more common in the anti-TIF1-Ab-positive vs -negative cohort: 19% vs 2%, respectively (P < 0.05). No anti-TIF1-Ab-positive case <39 years of age developed cancer, compared with 21 (53%) of those ≥39 years of age. Conclusion Anti-TIF1-Ab-positive-associated malignancy occurs exclusively within the 3 year period on either side of DM onset, the risk being highest in those ≥39 years of age. Cancer types differ according to anti-TIF1-Ab status, and this may warrant specific cancer screening approaches.


1995 ◽  
Vol 10 (4) ◽  
pp. 183-188 ◽  
Author(s):  
M Gutiérrez ◽  
J Ballesteros ◽  
R González-Oliveros ◽  
J Ruíz de Apodaka

SummaryThe main finding of a former Spanish multicenter study (SMS) on the effectiveness of naltrexone maintenance in heroin addicts, was the high retention rate achieved at 24 weeks of follow-up since naltrexone induction (40%). The authors claimed this rate was one of the highest ever reported in the literature for a non-selected sample of opiate addicts and discussed the possible relevance of a set of variables — like motivations and expectations due to a new treatment — on the findings. To assess the possible effects of these variables, we have compared the retention rates in two similar naltrexone programmes. The first programme (hospital sample) included 56 individuals who were also included in the SMS where they accounted for 37% of the total sample. That programme was developed formerly to the naltrexone marketing. The second sample (ambulatory sample) included 67 individuals who were recruited at least a year apart since naltrexone marketing was approved by the Spanish Health Boards. The time-lag between the beginnig of both studies was in the range of 15 to 25 months.The subjects in both programmes had similar distributions regarding age (p = 0.27), sex (p = 0.79), weeks on treatment after naltrexone induction (p = 0.20), and program compliance (p = 0.78). The retention rates evaluated over a period of 24 weeks were also similar (p = 0.45). The only difference appeared at 12 weeks of follow-up, showing in higher retention the hospital sample than the ambulatory sample (+23%; p < 0.05). The results are discussed according to other studies and it is concluded that findings reported in the former SMS and in this study are not unusual but compatible with recent research. Also underlined is the potential importance of naltrexone as a concomitant treatment for extinguishing high risk behaviours and the conditional stimuli associated with treatment relapse in heroin addicts.


2021 ◽  
Vol 8 ◽  
Author(s):  
Dana Bielopolski ◽  
Ruth Rahamimov ◽  
Boris Zingerman ◽  
Avry Chagnac ◽  
Limor Azulay-Gitter ◽  
...  

Background: Microalbuminuria is a well-characterized marker of kidney malfunction, both in diabetic and non-diabetic populations, and is used as a prognostic marker for cardiovascular morbidity and mortality. A few studies implied that it has the same value in kidney transplanted patients, but the information relies on spot or dipstick urine protein evaluations, rather than the gold standard of timed urine collection.Methods: We revisited a cohort of 286 kidney transplanted patients, several years after completing a meticulously timed urine collection and assessed the prevalence of major cardiovascular adverse events (MACE) in relation to albuminuria.Results: During a median follow up of 8.3 years (IQR 6.4–9.1) 144 outcome events occurred in 101 patients. By Kaplan-Meier analysis microalbuminuria was associated with increased rate of CV outcome or death (p = 0.03), and this was still significant after stratification according to propensity score quartiles (p = 0.048). Time dependent Cox proportional hazard analysis showed independent association between microalbuminuria and CV outcomes 2 years following microalbuminuria detection (HR 1.83, 95% CI 1.07–2.96).Conclusions: Two years after documenting microalbuminuria in kidney transplanted patients, their CVD risk was increased. There is need for primary prevention strategies in this population and future studies should address the topic.


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