Longterm Retention Rate and Risk Factor for Discontinuation Due to Insufficient Efficacy and Adverse Events in Japanese Patients with Rheumatoid Arthritis Receiving Etanercept Therapy

2014 ◽  
Vol 41 (8) ◽  
pp. 1583-1589 ◽  
Author(s):  
Hiroyuki Matsubara ◽  
Toshihisa Kojima ◽  
Atsushi Kaneko ◽  
Yuji Hirano ◽  
Hisato Ishikawa ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Risk Factor ◽  
Adverse Events ◽  
Retention Rate ◽  
Drug Evaluation ◽  
Japanese Patients ◽  
Retention Rates ◽  
Rank Test ◽  
Drug Discontinuation ◽  
Discontinuation Rate

Objective.Assessing retention rate and risk factor for drug discontinuation is important for drug evaluation. We examined a 3-year retention rate and the risk factor for discontinuation due to insufficient efficacy (IE) and adverse events (AE) in Japanese patients with rheumatoid arthritis (RA) who are receiving etanercept (ETN).Methods.Data were collected from 588 patients treated with ETN as a first biologic from the Tsurumai Biologics Communication Registry. Baseline characteristics for the incidence of both IE and AE were analyzed using the Cox proportional-hazards regression model. Patients were divided into groups based on age and concomitant methotrexate (MTX). Drug retention rates were calculated using the Kaplan-Meier method and compared among groups using the log-rank test.Results.ETN monotherapy without concomitant MTX [MTX(–)] was significantly related to a higher incidence of discontinuation due to IE [hazard ratio (HR) = 2.226, 95% CI 1.363–3.634]. Older age and MTX(–) were significantly related to a higher incidence of discontinuation due to AE [HR = 1.040, 1.746, 95% CI 1.020–1.060, 1.103–2.763, respectively]. The MTX(–)/≥ 65 years group had the lowest retention rate (p < 0.001). The discontinuation rate due to IE was lower in the MTX(+)/< 65 years group compared to < 65 years/MTX(–), ≥ 65 years/MTX(–) group (p = 0.006, p < 0.001, respectively). The discontinuation rate due to AE was highest in the MTX(–)/≥ 65 years group (p < 0.001).Conclusion.Our findings suggest that the risk of discontinuation due to IE was high in the patients who did not use concomitant MTX and that the risk of discontinuation due to AE was high in elderly patients who did not use concomitant MTX.

scholarly journals POS0642 THE IMPACT OF AGE ON DISCONTINUATION OF BIOLOGIC DMARDs IN PATIENTS WITH RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 559.2-560
Author(s):  
V. Rivera Teran ◽  
S. Sicsik ◽  
D. Vega-Morales ◽  
F. Irazoque-Palazuelos ◽  
D. Miranda ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Effects ◽  
Adverse Events ◽  
Cox Regression ◽  
Retention Rate ◽  
Drug Discontinuation ◽  
Discontinuation Rate ◽  
Biologic Dmards ◽  
Conventional Dmards ◽  
The Impact

Background:Rheumatoid arthritis (RA) is the most common autoimmune disease. Older patients treated with biologic DMARDs (bDMARDs) are at a significantly greater risk of adverse effects (AEs) [1]. However, the rate of drug discontinuation because of adverse effects caused by bDMARDs has not differed in elderly compared to younger patients in different registries.Objectives:Determine if drug discontinuation of bDMARDs differs by age in patients with rheumatoid arthritis in the Mexican Adverse Events Registry (BIOBADAMEX).Methods:BIOBADAMEX is a Mexican ongoing cohort of patients using bDMARDs since 2016. In this analysis we included all patients with diagnosis of RA with at least two assessments. Survival on bDMARDs was estimated using Kaplan-Meier analysis. Predictors of discontinuation, including age older than median age in the sample were investigated by Cox regression analyses.Results:Among 743 patients in the registry, 497 had RA diagnosis, from which, 214 had at least two assessments. At baseline, patients had a median (IQR) age of 53.4 (45-61) years old, median disease duration of 10.7 (6-17) months and median DAS28 of 4.7 (3-6). Conventional DMARDS were used by 185 (87%) patients and 94 (44%) patients used corticosteroids. Comorbidities were present in 194 (91%). The most common bDMARDs received at baseline were abatacept 59 (27%), tocilizumab 45(21%), adalimumab 31 (15%) and certolizumab 30 (14%). At the time of analysis, the median bDMARDs treatment duration was 21.0(13-34) months, 128 (59%) had discontinued treatment, 66 for inefficacy, 32 for adverse events and 30 for others. Fig 1 shows discontinuation rate curves in patients younger and older than median age. Cox proportional-hazards demonstrated no significant differences regarding age older than median age (HR 1.1, 95% CI 0.8-1.4, p=0.7), female sex (HR 1.2, 95% CI 0.7-1.9, p=0.44), use of corticosteroids (HR 1.2, 95% CI 0.9-1.6, p=0.20), comorbidities (HR 0.9, 95% 0.6-1.5, p=0.78), DAS28 (HR 0.9, 95% 0.9-1.1, p=0.93) or other factors.Figure 1.Discontinuation rate curves in patients younger and older than median age (< 53.4 and >=53.4 years old)Conclusion:This analysis did not show a role of age on discontinuation of bDMARDs in Mexican RA patients. Further longitudinal analyses will be performed including more patients to assess retention rate of bDMARDs and identify predictive variables of discontinuation in Mexican population.References:[1]Akter R, et al. Can Geriatr J. 2020 May 1;23(2):184-189.[2]Ikari Y, et al. Medicine (Baltimore). 2020 Dec 24;99(52):e23861.Disclosure of Interests:None declared

scholarly journals The Effectiveness and Retention Rate of Iguratimod in Japanese Rheumatoid Arthritis Patients with/without Methotrexate in Daily Medical Care

Life ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. 261
Author(s):  
Asuka Inoue ◽  
Yuji Nozaki ◽  
Yasuaki Hirooka ◽  
Koji Kinoshita ◽  
Yasutaka Chiba ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Clinical Response ◽  
Disease Activity Score ◽  
Retention Rate ◽  
Retention Rates ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Secondary Endpoints

(1) Background: We evaluated the clinical response of iguratimod (IGU) in patients with rheumatoid arthritis (RA) being treated with or without methotrexate (MTX) over 54 weeks. (2) Methods: 106 patients with RA undergoing IGU were retrospectively observed. RA patients were divided into those treated with MTX+IGU (n = 35) and those treated with IGU (n = 71). The primary endpoint was the clinical response of the Disease Activity Score assessing 28 joints with C-reactive protein (DAS28-CRP) differences in the changes from baseline to 54 weeks between MTX+IGU and IGU groups. Secondary endpoints, such as the clinical response, retention rate, and safety, were evaluated. (3) Results: The DAS28-CRP difference in the changes between the two groups were −0.2. DAS28-CRP were significantly reduced from the baseline in the MTX+IGU and IGU groups (−1.43 and −1.20 from baseline, respectively). The retention rates were 71.4% in the MTX+IGU groups and 59.2% in the IGU groups (p = 0.16). Adverse events were observed in a total of 6 (17.1%) MTX+IGU patients and 20 (28.2%) IGU patients (p = 0.21). (4) Conclusions: IGU therapy may be a useful treatment option for patients who cannot be treated with MTX.

Longterm Retention Rate and Risk Factors for Adalimumab Discontinuation Due To Efficacy and Safety in Japanese Patients with Rheumatoid Arthritis: An Observational Cohort Study

2016 ◽  
Vol 43 (8) ◽  
pp. 1475-1479 ◽  
Author(s):  
Yosuke Hattori ◽  
Toshihisa Kojima ◽  
Atsushi Kaneko ◽  
Daihei Kida ◽  
Yuji Hirano ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Risk Factors ◽  
Risk Factor ◽  
Cohort Study ◽  
Retention Rate ◽  
Significant Risk ◽  
Japanese Patients ◽  
Observational Cohort Study ◽  
Efficacy And Safety ◽  
Observational Cohort

Objective.To evaluate the rates of retention and discontinuation of adalimumab (ADA) due to efficacy and safety in Japanese patients with rheumatoid arthritis (RA).Methods.All patients with RA (n = 476) who were treated with ADA in the Tsurumai Biologics Communication Registry were enrolled.Results.The retention rate of ADA was 46% at 5 years. When focusing on insufficient efficacy, previous biologics use and high baseline disease activity were significant risk factors for up to 1 year. Methotrexate (MTX) use was a significantly low risk factor after 1 year of treatment.Conclusion.Concomitant MTX contributes to the longterm efficacy of ADA therapy.

scholarly journals Drug retention rates and relevant risk factors for drug discontinuation due to adverse events in rheumatoid arthritis patients receiving anticytokine therapy with different target molecules

2012 ◽  
Vol 71 (11) ◽  
pp. 1820-1826 ◽  
Author(s):  
Ryoko Sakai ◽  
Michi Tanaka ◽  
Toshihiro Nanki ◽  
Kaori Watanabe ◽  
Hayato Yamazaki ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Clinical Status ◽  
Good Control ◽  
Biological Agents ◽  
Retention Rates ◽  
Drug Discontinuation ◽  
Drug Retention ◽  
Kaplan Meier ◽  
Frequent Reason

ObjectiveTo compare reasons for discontinuation and drug retention rates per reason among anticytokine therapies, infliximab, etanercept and tocilizumab, and the risk of discontinuation of biological agents due to adverse events (AE) in patients with rheumatoid arthritis (RA).MethodThis prospective cohort study included Japanese RA patients who started infliximab (n=412, 636.0 patient-years (PY)), etanercept (n=442, 765.3 PY), or tocilizumab (n=168, 206.5 PY) as the first biological therapy after their enrolment in the Registry of Japanese Rheumatoid Arthritis Patients for Long-term Safety (REAL) database. Drug retention rates were calculated using the Kaplan–Meier method. To compare risks of drug discontinuation due to AE for patients treated with these biological agents, the Cox proportional hazard model was applied.ResultsThe authors found significant differences among the three therapeutic groups in demography, clinical status, comorbidities and usage of concomitant drugs. Development of AE was the most frequent reason for discontinuation of biological agents in the etanercept and tocilizumab groups, and the second most frequent reason in the infliximab group. Discontinuation due to good control was observed most frequently in the infliximab group. Compared with etanercept, the use of infliximab (HR 1.69; 95% CI 1.14 to 2.51) and tocilizumab (HR 1.98; 95% CI 1.04 to 3.76) was significantly associated with a higher risk of discontinuation of biological agents due to AE.ConclusionsReasons for discontinuation are significantly different among biological agents. The use of infliximab and tocilizumab was significantly associated with treatment discontinuation due to AE compared with etanercept.

scholarly journals Drug retention of 7 biologics and tofacitinib in biologics-naïve and biologics-switched patients with rheumatoid arthritis -The ANSWER cohort study-

2020 ◽  
Author(s):  
Kosuke Ebina ◽  
Toru Hirano ◽  
Yuichi Maeda ◽  
Wataru Yamamoto ◽  
Motomu Hashimoto ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Disease Duration ◽  
Kinase Inhibitors ◽  
Certolizumab Pegol ◽  
Janus Kinase ◽  
Retention Rates ◽  
Drug Discontinuation ◽  
Naive Group ◽  
Drug Retention

Abstract Background: This multi-center, retrospective study aimed to clarify retention rates and reasons for discontinuation of 7 biological disease-modifying antirheumatic drugs (bDMARDs) and tofacitinib (TOF), one of the janus kinase inhibitors, in bDMARDs-naïve and bDMARDs-switched patients with rheumatoid arthritis (RA). Methods: This study assessed 3,897 patients and 4,415 treatment courses with bDMARDs and TOF from 2001 to 2019 (2,737 bDMARDs-naïve patients and 1,678 bDMARDs-switched patients [59.5% switched to their second agent], female 82.3%, baseline age 57.4 years, disease duration 8.5 years; rheumatoid factor positivity 78.4%; Disease Activity Score in 28 joints using erythrocyte sedimentation rate 4.3; concomitant prednisolone [PSL] dose 6.1 mg/day [42.4%], and methotrexate [MTX] dose 8.5 mg/week [60.9%]). Treatment courses included abatacept (ABT; n=663), adalimumab (ADA; n=536), certolizumab pegol (CZP; n=226), etanercept (ETN; n=856), golimumab (GLM; n=458), infliximab (IFX; n=724), tocilizumab (TCZ; n=851), and TOF (n=101/only bDMARDs-switched cases). Drug discontinuation reasons (categorized into lack of effectiveness, toxic adverse events, non-toxic reasons, or remission) and rates were estimated at 36 months using the Gray’s test, and statistically evaluated after adjusted by potential clinical confounders (age, sex, disease duration, concomitant PSL and MTX usage, starting date, and number of switched bDMARDs) using the Fine-Gray model. Results: Cumulative incidence of drug discontinuation for each reason was as follows: lack of effectiveness in the bDMARDs-naïve group (from 13.7% [ABT] to 26.9% [CZP]; P<0.001 between agents) and the bDMARDs-switched group (from 18.9% [TCZ] to 46.1% [CZP]; P<0.001 between agents). Toxic adverse events in the bDMARDs-naïve group (from 4.6% [ABT] to 11.2% [ETN]; P<0.001 between agents) and the bDMARDs-switched group (from 5.0% [ETN] to 15.7% [TOF]; P=0.004 between agents). Remission in the bDMARDs-naïve group (from 2.9% [ETN] to 10.0% [IFX]; P<0.001 between agents) and the bDMARDs-switched group (from 1.1% [CZP] to 3.3% [GLM]; P=0.9 between agents). Conclusions: Remarkable differences were observed in drug retention of 7 bDMARDs and TOF between bDMARDs-naïve and bDMARDs-switched cases.

scholarly journals POS0675 THE COMPARATIVE 3-YEAR RETENTION RATE OF TARGETED-SYNTHETIC AND BIOLOGIC DRUGS FOR RHEUMATOID ARTHRITIS: REAL-LIFE DATA FROM THE ITALIAN GISEA REGISTRY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 582.1-582
Author(s):  
E. G. Favalli ◽  
F. Iannone ◽  
E. Gremese ◽  
R. Gorla ◽  
R. Foti ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Retention Rate ◽  
Large Population ◽  
Real Life ◽  
Mechanisms Of Action ◽  
Biologic Drugs ◽  
Real Life Setting ◽  
Study Population ◽  
Targeted Drug

Background:Long-term observational data on the real-life use of JAK inhibitors (JAKis) for rheumatoid arthritis (RA) and their comparison with biological drugs are still very limited. Large population-based registries have been increasingly used to investigate the performance of targeted drugs in a real-life setting.Objectives:The aim of this study is to evaluate and compare the 3-year retention rate of JAKis, TNF inhibitors (TNFis) and biologic drugs with other mechanisms of action (OMAs) in the large cohort of RA patients included in the Italian national GISEA registry.Methods:Data of all RA patients treated with targeted synthetic or biologic drugs were prospectively collected in the Italian multicentric GISEA registry. The analysis was limited to patients who started a first- or second-line targeted drug in the period after the first JAKi was marketed in Italy (1st December 2017). The 3-year retention rate was calculated by the Kaplan-Meier method and compared between different drug classes by a log-rank test. A descriptive analysis of reasons for discontinuation was performed.Results:The study population included 1027 RA patients (79.8% females, mean age [±SD] 56.9 [±13.5] years, mean disease duration 9.8 [±9] years, mean baseline SDAI 17.5 [±11.9], ACPA positive 67.4%, RF positive 62.7%) who received JAKis (baricitinib or tofacitinib, n=297), TNFis (n=365), or OMAs (n=365) as first or second targeted drug. Main baseline characteristics of study population were overall well balanced between treatment groups. Retention rate was numerically but not statistically higher (p=0.18) in patients treated with JAKis compared with TNFis or OMAs (80.6, 78.9 and 76.4% at 1 year and 73, 56.8 and 63.8% at 3 years, respectively) (Figure 1). Drug survival was significantly higher in patients receiving concomitant methotrexate (MTX) compared with monotherapy only in TNFis (66.8 vs 47.1%, p=0.04) but not in JAKis (76.1 vs 70.1%, p=0.54) and OMAs (66.1 vs 61.9%, p=0.41) group. Therapy was discontinued in a total of 211 patients because of ineffectiveness (n=107), adverse events (n=88), or compliance/other reasons (n=16). The most frequent reason for treatment withdrawal was ineffectiveness in both JAKis (n=30 out of 56) and TNFis (n=45 out of 74) groups, whereas OMAs were discontinued more frequently because of adverse events (n=41 out of 81).Conclusion:Our data confirmed in a real-life setting a favorable 3-year retention rate of all available targeted mechanisms of action for RA therapy. As expected, concomitant MTX significantly impacted persistence on therapy of TNFis only. Discontinuations of JAKis for adverse events were infrequent overall, confirming the safety profile observed in randomized clinical trials.Figure 1.Three-year retention rate by treatment groupDisclosure of Interests:None declared

scholarly journals P258 Real-world secukinumab retention, response rates and adverse events in the treatment of PsA and axSpA

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Alistair Tindell ◽  
Saira Batool ◽  
Andrew McGucken ◽  
Stefan Siebert
Keyword(s):  
Adverse Events ◽  
Disease Activity ◽  
Real World ◽  
Retention Rate ◽  
Retention Rates ◽  
Hospital Death ◽  
Published Data ◽  
Cerebellar Haemorrhage ◽  
One Year ◽  
Randomised Controlled

Abstract Background Secukinumab, an IL-17A inhibitor, has been licensed for use in the United Kingdom for both axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) for several years. Despite this there is minimal published data on its use out with randomised controlled trials. We present here the collated real-world rheumatology experience of secukinumab use in Glasgow. Methods Patients who have ever received secukinumab for any rheumatology indication were identified using available medical records (from 14/05/2012 to 18/09/2019). Diagnosis, baseline demographics, disease activity at baseline and at 6 months, and whether patients are still currently on secukinumab was recorded. Primary inefficacy was defined as stopping treatment due to inefficacy ≤6 months. Reasons for discontinuation were also recorded. As disease activity scores were variably recorded, the primary outcome was retention rate as a surrogate for efficacy and lack of adverse event. Patients only included in disease scores if scores available both at baseline and 6 months. Results 352 patients (with 530 patient-years of exposure) identified. 251 (71.3%) patients currently remain on secukinumab. 301 of 336 (89.6%) patients remained on drug at six-month review (16 await review). Characteristics and response of two main diagnostic groups listed in Table 1 (Note: 3 patients had SAPHO, 5 had Juvenile Idiopathic Arthritis, 1 had reactive arthritis). Common adverse events were infections (11 patients), rash and/or pruritis (6 patients), mood change and/or fatigue (4 patients). Three patients developed inflammatory bowel disease (IBD) subsequent to starting secukinumab. Five patients had pre-existing IBD, none of which flared on secukinumab. Two patients required hospitalisation for abscesses whilst on secukinumab. One patient had a stroke and one patient had a myocardial infarction whilst on secukinumab - both patients had multiple risk factors for cardiovascular disease. No malignancies identified. Three patients died, with none felt related to secukinumab (cerebellar haemorrhage in warfarinised patient with high INR; pneumonia six months after switching from secukinumab to tocilizumab; one out of hospital death over one year after stopping secukinumab). Conclusion In this real world cohort of patients with axSpA and PsA, secukinumab retention rates at 6 months are high with no new safety signals identified. Disclosures A. Tindell None. S. Batool None. A. McGucken None. S. Siebert Consultancies; S.S. has received speaker or consultation fees or honoraria from AbbVie, UCB, Janssen, Boehringer Ingelheim, Novartis, Celgene. Honoraria: S.S. has received speaker or consultation fees or honoraria from AbbVie, UCB, Janssen, Boehringer Ingelheim, Novartis, Celgene. Grants/research support; S.S has received funding for research/ grants from Pfizer, Janssen, BMS, Celgene, UCB, Boehringer Ingelheim, Novartis, GSK.

scholarly journals Differential long-term retention of biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis by age group: an observational study

2020 ◽  
Author(s):  
Akio Kawabe ◽  
Kazuhisa Nakano ◽  
Satoshi Kubo ◽  
Takeshi Asakawa ◽  
Yoshiya Tanaka
Keyword(s):  
Rheumatoid Arthritis ◽  
Propensity Scores ◽  
Retention Rate ◽  
Age Groups ◽  
Therapeutic Strategies ◽  
Retention Rates ◽  
Age Group ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Disease Modifying

Abstract Background. The effectiveness and safety of biological disease-modifying antirheumatic drugs (bDMARDs) by age group (<65, 65–74, and ≥75 years) are uncertain. We examined retention rates reflecting the effectiveness and safety of bDMARDs in actual clinical practice for clarifying optimal therapeutic strategies for rheumatoid arthritis (RA) by age groups.Methods. Data of patients who were treated with tumor necrosis factor inhibitors (TNFi), abatacept (ABA), and tocilizumab (TCZ) between February 2011 and April 2017 were retrospectively collected from an observational registry of RA patients. A total of 1,362 patients were enrolled, of which 695 were aged <65 years, 402 were aged 65–74 years, and 265 were aged ≥75. Primary outcome was the drug retention rate in adjusted data using inverse probability of treatment weighting based on generalized propensity scores.Results. In patients aged <65 years, three-year retention rates of TNFi, ABA, and TCZ were 43%, 47%, and 69%, respectively (ABA versus TCZ, p = 0.017; TNFi versus TCZ, p = 0.002). In patients aged 65–74 years, three-year retention rates of TNFi, ABA, and TCZ were 44%, 53%, and 60%, respectively (TCZ versus TNFi, p = 0.034). In patients aged ≥75 years, three-year retention rates for TNFi, ABA, and TCZ were 38%, 63%, and 58%, respectively (ABA versus TNFi, p = 0.017).Conclusions. We found that the effectiveness and safety of TCZ were maximized in patients aged <75 years and that patients aged ≥65 years were the most suited candidates for ABA therapy. The use of therapeutic strategies appropriate to each age group might improve the outcomes of bDMARD therapy for RA.

Sign in / Sign up

Export Citation Format

Share Document