scholarly journals FRI0245 Abatacept retention rates and prognostic factors of retention in patients with rheumatoid arthritis: 2-year results from the real-world action study

Author(s):  
R Alten ◽  
H-M Lorenz ◽  
X Mariette ◽  
H Nüßlein ◽  
M Galeazzi ◽  
...  
2021 ◽  
Author(s):  
Katsuhiko Takabayashi ◽  
Fumihiko Ando ◽  
Kei Ikeda ◽  
Shinsuke Fujita ◽  
Hiroshi Nakajima ◽  
...  

Abstract Objectives To describe the real-world prescription and treatment retention of molecular-targeted drugs for rheumatoid arthritis (RA) in Japan. Materials and Methods 204,416 patients with RA prescribed at least one of the eight molecular-targeted drugs in 7 years from the National Database of Health Insurance Claims and Specific Health Checkups of Japan covering 98.3% of the Japanese population. The retention rate of each drug as well as head-to head comparisons were estimated by Kaplan–Meier method. Results 121,131 RA patients were prescribed any molecular-targeted drug for the first time, while 36,633 uses of molecular-targeted drug switched from another (switch use). The overall retention rates of molecular-targeted drugs at 12, 36, and 60 months were 0.64, 0.42, and 0.32 for the naïve use and 0.59, 0.40, and 0.31 for the switch use, respectively. Non-tumor necrosis factor (TNF)-inhibitor molecular-targeted drugs, particularly tocilizumab and tofacitinib, had higher retention rates than TNF inhibitors for both naïve and switch uses regardless of the previous drug, and showed higher retention rates in head-to-head comparisons between eight molecular-targeted drugs. Conclusions Our data reveal that the real-world drug retention is overall lower than previously reported and higher with non-TNF inhibitors than with TNF inhibitors.


2022 ◽  
pp. annrheumdis-2021-221915
Author(s):  
Farzin Khosrow-Khavar ◽  
Seoyoung C Kim ◽  
Hemin Lee ◽  
Su Been Lee ◽  
Rishi J Desai

ObjectivesRecent results from ‘ORAL Surveillance’ trial have raised concerns regarding the cardiovascular safety of tofacitinib in patients with rheumatoid arthritis (RA). We further examined this safety concern in the real-world setting.MethodsWe created two cohorts of patients with RA initiating treatment with tofacitinib or tumour necrosis factor inhibitors (TNFI) using deidentified data from Optum Clinformatics (2012–2020), IBM MarketScan (2012–2018) and Medicare (parts A, B and D, 2012–2017) claims databases: (1) A ‘real-world evidence (RWE) cohort’ consisting of routine care patients and (2) A ‘randomised controlled trial (RCT)-duplicate cohort’ mimicking inclusion and exclusion criteria of the ORAL surveillance trial to calibrate results against the trial findings. Cox proportional hazards models with propensity score fine stratification weighting were used to estimate HR and 95% CIs for composite outcome of myocardial infarction and stroke and accounting for 76 potential confounders. Database-specific effect estimates were pooled using fixed effects models with inverse-variance weighting.ResultsIn the RWE cohort, 102 263 patients were identified of whom 12 852 (12.6%) initiated tofacitinib. The pooled weighted HR (95% CI) comparing tofacitinib with TNFI was 1.01 (0.83 to 1.23) in RWE cohort and 1.24 (0.90 to 1.69) in RCT-duplicate cohort which aligned closely with ORAL-surveillance results (HR: 1.33, 95% CI 0.91 to 1.94).ConclusionsWe did not find evidence for an increased risk of cardiovascular outcomes with tofacitinib in patients with RA treated in the real-world setting; however, tofacitinib was associated with an increased risk of cardiovascular outcomes, although statistically non-significant, in patients with RA with cardiovascular risk factors.Trial registration numberNCT04772248.


2019 ◽  
Vol 38 (5) ◽  
pp. 1535-1535
Author(s):  
Rieke Alten ◽  
Xavier Mariette ◽  
Hanns-Martin Lorenz ◽  
Hubert Nüßlein ◽  
Mauro Galeazzi ◽  
...  

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 24-24
Author(s):  
Meinolf Karthaus ◽  
B Hoell ◽  
G Zaun ◽  
M Guyot ◽  
Martin H. Schuler ◽  
...  

24 Background: Trifluridine/Tipiracil (FTD/TPI) is effective in pts with refractory mCRC. Enrollment into in the RECOURSE trial was allowed only for pts with ECOG < 1 pts, while real world pts may have a lower ECOG. In addition, predictive markers for the efficacy of FTD/TPI at late stage are open. This exploratory analysis assessed outcome of mCRC pts (including ECOG PS ≥ 2) upon FTD/TPI treatment by prognostic factors in the real world setting. Methods: This cohort included mCRC pts who were treated with FTD/TPI from 01/2016 until 08/2019 at two large volume CRC centers in Germany. Pts were classified with good prognosis characteristics (GPC) according to Tabernero et al. (abstract 677, ASCO-GI 2019) defined by 1 or 2 metastatic sites and time since diagnosis of first metastases ≥ 18 mo. Pts of this group without liver metastases had the best prognostic characteristics. Pts with poor prognostic characteristics (PPC) were characterized by ≥ 3 metastases sites and time since diagnosis of first metastases ≤ 18 mo. Results: A total of 44 mCRC pts were included in this analysis (mean age 62.5 yrs; 22 males and 22 females). Within the GPC population (n=28; median age 67 yrs; KRAS wt n= 21; KRAS mt n= 7; ECOG 0-1 n= 23; ECOG ≥ 2n=7) 6 pts were alive up to 08/2019 and 4 were lost to FU. Four pts of the GPC were without liver metastases. Within the PPC group (n=16; median age 59 yrs; KRAS wt n= 6; KRAS mt n= 10; ECOG 0-1 n= 15; ECOG ≥ 2 n=1) 2 pts were alive and 2 were lost to FU. The mPFS and mOS of the GPC group (n=18) were 2,15 mo (range 0,62-10,13) and 4,63 mo (range 0,95-14,39), respectively. The mPFS and mOS of the PPC group (n=12) were 1,31 mo (range 0,76-9,72) and 4,72 mo (range 0,76-16,61), respectively. Pts with an ECOG ≥ 2 had a mOS of 2,76 mo (range 0,95-6,92), and a mPFS 1,67 mo (range 0,53-1,77). Conclusions: GPC and PPC group pts treated with FTD/TPI differed with respect to mPFS, but these pts had a comparable mOS in the real world setting. PFS and OS were lower when compared to the Tabernero analysis of the RECOURSE trial, which may reflect the real world setting. Inclusion of pts with an ECOG of ≥ 2 was feasible but showed poor survival data in the third line. Nevertheless, all pts with mCRC benefited from FTD/TPI treatment.


2013 ◽  
Vol 72 (Suppl 3) ◽  
pp. A1023.1-A1023
Author(s):  
M. DiBonaventura ◽  
E. L. Nasonov ◽  
R. Vasilescu ◽  
B. Tang

2016 ◽  
Vol 35 (11) ◽  
pp. 2649-2656 ◽  
Author(s):  
Florenzo Iannone ◽  
Lugi Sinigaglia ◽  
Ennio Giulio Favalli ◽  
Piercarlo Sarzi-Puttini ◽  
Fabiola Atzeni ◽  
...  

2021 ◽  
Vol 8 (1) ◽  
pp. 71-78
Author(s):  
Xue Han ◽  
Francis Lobo ◽  
Michael Broder ◽  
Eunice Chang ◽  
Sarah N. Gibbs ◽  
...  

Background: Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling and destruction that leads to severe disability. There are no clear guidelines regarding the order of therapies. Gathering data on treatment patterns outside of a clinical trial setting can provide useful context for clinicians. Objectives: To assess real-world treatment persistence in early-line abatacept versus tumor necrosis factor-inhibitors (TNFi) treated patients with RA complicated by poor prognostic factors (including anti-cyclic citrullinated peptide antibodies [ACPA] and rheumatoid factor [RF] seropositivity). Methods: We performed a multi-center retrospective medical record review. Adult patients with RA complicated by poor prognostic factors were treated with either abatacept or TNFis as the first biologic treatment at the clinic. Poor prognostic factors included ACPA+, RF+, increased C-reactive protein levels, elevated erythrocyte sedimentation rate levels, or presence of joint erosions. We report 12-month treatment persistence, time to discontinuation, reasons for discontinuation, and risk of discontinuation between patients on abatacept versus TNFi. Select results among the subgroup of ACPA+ and/or RF+ patients are presented. Results: Data on 265 patients (100 abatacept, 165 TNFis) were collected. At 12 months, 83% of abatacept patients were persistent versus 66.1% of TNFi patients (P=0.003). Median time to discontinuation was 1423 days for abatacept versus 690 days for TNFis (P=0.014). In adjusted analyses, abatacept patients had a lower risk of discontinuing index treatment due to disease progression (0.3 [95% confidence interval (CI): 0.1-0.6], P=0.001). Among the subgroup of ACPA+ and/or RF+ patients (55 abatacept, 108 TNFis), unadjusted 12-month treatment persistence was greater (83.6% versus 64.8%, P=0.012) and median time to discontinuation was longer (961 days versus 581 days, P=0.048) in abatacept versus TNFi patients. Discussion: Patients with RA complicated by poor prognostic factors taking abatacept, including the subgroup of patients with ACPA and RF seropositivity, had statistically significantly higher 12-month treatment persistence and a longer time to discontinuation than patients on TNFis. Conclusions: In a real-world setting, RA patients treated with abatacept were more likely to stay on treatment longer and had a lower risk of discontinuation than patients treated with TNFis.


Sign in / Sign up

Export Citation Format

Share Document