Tolerance, survival and adherence to treatment with methotrexate in patients with rheumatoid arthritis

2019 ◽  
pp. 13-17
Author(s):  
J.M. Sevillano Gutierrez ◽  
D. Capelusnik ◽  
E.E. Schneeberger ◽  
G. Citera
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Descriptive Statistics ◽  
P Value ◽  
Multiple Logistic Regression ◽  
Adherence To Treatment ◽  
Exact Test ◽  
Cumulative Survival ◽  
Kaplan Meier ◽  
Chi2 Test

Background: Methotrexate (MTX) is the most frequently used medication in patients with Rheumatoid Arthritis (RA). However, several authors have questioned its success due to the presence of adverse events and the lack of adherence. Objectives: to determine cumulative survival of MTX, frequency and type of adverse events and causes of discontinuation in patients with RA. Methods: consecutive patients 18 years and older with a diagnosis of RA (ACR/EULAR 2010 criteria), who had begun treatment with MTX during their disease were included. Sociodemographic, clinical and therapeutic data were collected. Date of initiation and suspension of MTX, route of administration, concomitant treatments, consumption of coffee and tobacco, presence of adverse events (AE) were all consigned. Adherence was evaluated using the Compliance Questionnaire Rheumatology questionnaire 5-item summary version (CQR5). Statistical analysis: descriptive statistics. Chi2 test or Fisher’s exact test; Survival of treatment by Kaplan-Meier and log Rank. Multiple logistic regression. A p value <0.05 was considered significant.

scholarly journals AB0337 TOFACITINIB MONOTHERAPY OR COMBINED WITH METHOTREXATE IN PATIENTS WITH RHEUMATOID ARTHRITIS SHOW SIMILAR RETENTION OVER FOUR YEARS. REPORT FROM RHUMADATA ®

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1467.1-1467
Author(s):  
D. Choquette ◽  
L. Bessette ◽  
L. Choquette Sauvageau ◽  
I. Ferdinand ◽  
B. Haraoui ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Real World ◽  
Treatment Initiation ◽  
Retention Rate ◽  
Janus Kinase ◽  
P Value ◽  
Research Support ◽  
Medication Discontinuation ◽  
Kaplan Meier

Background:Since the introduction of biologic agents around the turn of the century, the scientific evidence shows that the majority of agents, independent of the therapeutic target, have a better outcome when used in combination with methotrexate (MTX). In 2014, tofacitinib (TOFA), an agent targeting Janus kinase 1 and 3, has reached the Canadian market with data showing that the combination with MTX may not be necessary [1,2].Objectives:To evaluate the efficacy and retention rate of TOFA in real-world patients with rheumatoid arthritis (RA).Methods:Two cohorts of patients prescribed TOFA was created. The first cohort was formed of patients who were receiving MTX concomitantly with TOFA (COMBO) and the other of patients using TOFA in monotherapy (MONO). MONO patients either never use MTX or were prescribed MTX post-TOFA initiation for at most 20% of the time they were on TOFA. COMBO patients received MTX at the time of TOFA initiation or were prescribed MTX post-TOFA initiation for at least 80% of the time. For all those patients, baseline demographic data definitions. Disease activity score and HAQ-DI were compared from the initiation of TOFA to the last visit. Time to medication discontinuation was extracted, and survival was estimated using Kaplan-Meier calculation for MONO and COMBO cohorts.Results:Overall, 194 patients were selected. Most were women (83%) on average younger than the men (men: 62.6 ± 11.0 years vs. women: 56.9 ± 12.1 years, p-value=0.0130). The patient’s assessments of global disease activity, pain and fatigue were respectively 5.0 ± 2.7, 5.2 ± 2.9, 5.1 ± 3.1 in the COMBO group and 6.2 ± 2.5, 6.5 ± 2.6, 6.3 ± 2.8 in the MONO group all differences being significant across groups. HAQ-DI at treatment initiation was 1.3 ± 0.7 and 1.5 ± 0.7 in the COMBO and MONO groups, respectively, p-value=0.0858. Similarly, the SDAI score at treatment initiation was 23.9 ± 9.4 and 25.2 ± 11.5, p-value=0.5546. Average changes in SDAI were -13.4 ± 15.5 (COMBO) and -8.9 ± 13.5 (MONO), p-value=0.1515, and changes in HAQ -0.21 ± 0.63 and -0.26 ± 0.74, p-value 0.6112. At treatment initiation, DAS28(4)ESR were 4.4 ± 1.4 (COMBO) and 4.6 ± 1.3 (MONO), p-value 0.5815, with respective average changes of -1.06 ± 2.07 and -0.70 ± 1.96, p-value=0.2852. The Kaplan-Meier analysis demonstrated that the COMBO and MONO retention curves were not statistically different (log-rank p-value=0.9318).Conclusion:Sustainability of TOFA in MONO or COMBO are not statistically different as are the changes in DAS28(4)ESR and SDAI. Despite this result, some patients may still benefit from combination with MTX.References:[1]Product Monograph - XELJANZ ® (tofacitinib) tablets for oral administration Initial U.S. Approval: 2012.[2] Reed GW, Gerber RA, Shan Y, et al. Real-World Comparative Effectiveness of Tofacitinib and Tumor Necrosis Factor Inhibitors as Monotherapy and Combination Therapy for Treatment of Rheumatoid Arthritis [published online ahead of print, 2019 Nov 9].Rheumatol Ther. 2019;6(4):573–586. doi:10.1007/s40744-019-00177-4.Disclosure of Interests:Denis Choquette Grant/research support from: Rhumadata is supported by grants from Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Consultant of: Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Speakers bureau: Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, Loïc Choquette Sauvageau: None declared, Isabelle Ferdinand Consultant of: Pfizer, Abbvie, Amgen, Novartis, Speakers bureau: Pfizer, Amgen, Boulos Haraoui Grant/research support from: Abbvie, Amgen, Pfizer, UCB, Grant/research support from: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, and UCB, Consultant of: Abbvie, Amgen, Lilly, Pfizer, Sandoz, UCB, Consultant of: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Merck, Pfizer, Roche, and UCB, Speakers bureau: Pfizer, Speakers bureau: Amgen, BMS, Janssen, Pfizer, and UCB, Frédéric Massicotte Consultant of: Abbvie, Janssen, Lilly, Pfizer, Speakers bureau: Janssen, Jean-Pierre Pelletier Shareholder of: ArthroLab Inc., Grant/research support from: TRB Chemedica, Speakers bureau: TRB Chemedica and Mylan, Jean-Pierre Raynauld Consultant of: ArthroLab Inc., Marie-Anaïs Rémillard Consultant of: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Paid instructor for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Diane Sauvageau: None declared, Édith Villeneuve Consultant of: Abbvie, Amgen, BMS, Celgene, Pfizer, Roche, Sanofi-Genzyme,UCB, Paid instructor for: Abbvie, Speakers bureau: AbbVie, BMS, Pfizer, Roche, Louis Coupal: None declared

Association of baseline body mass index (BMI) with response and survival in patients (Pts) with advanced melanoma (MEL) receiving PD-1 inhibitors.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9579-9579 ◽  
Author(s):  
Amit Hemadri ◽  
Huang Lin ◽  
Yan Lin ◽  
Amy Rose ◽  
Cindy Sander ◽  
...  
Keyword(s):  
Demographic Data ◽  
Stage Iv ◽  
Breslow Thickness ◽  
P Value ◽  
Baseline Body Mass Index ◽  
Fisher Exact Test ◽  
Exact Test ◽  
University Of Pittsburgh ◽  
Kaplan Meier ◽  
Prognostic Utility

9579 Background: Obesity promotes PD-1–mediated T cell dysfunction but also improves tumor response to PD-1 blockade. Obesity has been linked with positive outcomes in pts treated with PD-1 blockade. To evaluate the prognostic utility of BMI, we performed a retrospective evaluation of BMI and other covariates in 172 pts with stage IV cutaneous MEL. Methods: Pts with stage IV cutaneous MEL who received anti PD-1 therapy at the University of Pittsburgh between 2014-2018 were included in this analysis. PD-1 blockade was continued until progression or intolerable toxicity. Tumor assessment was performed at baseline and every 12 weeks and response classified per RECIST v1.1. Clinical and demographic data were obtained. BMI was defined based on values at the first treatment date and dichotomized into two groups: ≥30 vs. < 30. Fisher exact test was used to evaluate the correlation between BMI group and ORR. Kaplan Meier method and Cox proportional hazard models were performed to analyzed the time-to-event outcomes (OS and PFS). Results: 172 pts with advanced MEL were evaluated. Greater BMI was associated with greater ORR, PFS and OS across various BMI cutoffs (BMI≥28, BMI≥30 and BMI≥35) although this effect was most obvious at BMI≥30. Pts with BMI≥30 achieved higher ORR than those with BMI < 30 (74% vs. 58%, p-value = 0.04). Concordantly, pts with BMI≥30 had improved PFS and OS: median PFS (BMI≥30 21.1 mos vs. BMI < 30 10.7 mos) and median OS (BMI≥30 35.4 mos vs. BMI < 30 22.8 mos). Higher BMI was independently associated with improved OS (p = 0.018) and PFS (p = 0.047) adjusting for age, Breslow thickness and sex. No significant interaction was observed between the effects of BMI and that of age, sex, or Breslow thickness. Conclusions: Increased BMI was associated with greater ORR in addition to previously reported associations with PFS/OS in a large retrospective series of advanced MEL pts treated with PD-1 blockade. This data was independent of other prognostic factors and underscore the “inflammaging” effects of obesity and age in relation to anti PD-1 therapy in advanced cancer.

Association of immune related adverse events with superior outcomes in patients with hepatocellular carcinoma (HCC) treated with nivolumab.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16630-e16630
Author(s):  
Lorena Ostios-Garcia ◽  
David Ramiro-Cortijo ◽  
Mary Linton Bounetheau Peters ◽  
Andrea J. Bullock
Keyword(s):  
Adverse Events ◽  
Cox Regression ◽  
Statistical Significance ◽  
Onset Time ◽  
Progression Free Survival ◽  
Categorical Variables ◽  
Rank Test ◽  
Cancer Outcomes ◽  
Exact Test ◽  
Kaplan Meier

e16630 Background: Nivolumab, an anti-PD1 antibody, is FDA approved in patients (pts) with HCC. Anti-PD-1 promotes hyperstimulation of host immunity and is associated with a spectrum of toxicities known as immune-related adverse events (irAEs). In other malignancies, higher rates of irAEs are associated with improved cancer outcomes. This study shows correlation between irAEs and efficacy in pts with HCC treated with nivolumab. Methods: Demographic and toxicity data were collected retrospectively on all pts with HCC treated with nivolumab at a single institution from Jan 2012 – Sept 2019. Response was evaluated using RECISTv1.1. Adverse events were assessed according to CTCAEv5.0. Categorical variables were assessed by Fisher's exact test. Survival was estimated with the Kaplan-Meier method and compared using the log-rank test. Univariate and multivariate analyses were performed by the Cox-regression model. Results: 30 pts were treated; irAEs were detected in 16 (53%). There was no difference in baseline characteristics among those who did and did not experience irAEs (Table). The most frequent irAEs were elevated AST/ALT (n = 7; 44%), rash (n = 4; 25%), and hypothyroid (n = 4; 25%). 3 G3 (rash and transaminitis) and 1 G4 AE (pured red cell apalasia) were observed. Among all pts, overall response rate (RR) and disease control rate (DCR) were 13 and 50%, respectively. Median progression free survival (PFS) and overall survival (OS) were 27 and 56 weeks (w), respectively. The RR and DCR were higher among irAEs vs non-irAEs, although this did not reach statistical significance (RR 25 vs 0%; p = 0.05; DCR 62 vs 35%; p = 0.19). Median PFS and OS were longer in those with irAEs vs non-irAE; PFS 33 vs 16 w (HR: 0.26; CI 95%: 0.076-0.89; p = 0.028); (OS 69 vs 21 w HR: 0.18; CI 95%: 0.05-0.58; p = 0.002). On multivariate analysis, viral etiology was associated with prolonged PFS (p = 0.002) and MELD was associated with reduced OS (p = 0.004). Conclusions: Development of irAEs was associated with prolonged PFS and OS in pts with HCC treated with nivolumab. Further study is needed to determine whether type of irAE, onset time, or duration affect cancer outcomes. [Table: see text]

scholarly journals Analisis Pendampingan Lansia yang Mengalami Penyakit Rheumatoid Arthritis pada Lembaga Kesejahteraan Sosial di Aceh

2021 ◽  
Vol 8 (03) ◽  
pp. 182-186
Author(s):  
Iskandar Iskandar ◽  
Riyan Mulfianda
Keyword(s):  
Rheumatoid Arthritis ◽  
Descriptive Statistics ◽  
P Value ◽  
Purposive Sampling

Pendampingan lansia di Lembaga Kesejahteraan Sosial saat ini umumnya dilakukan oleh pekerja sosial bukan bidang kesehatan. Hal ini berpotensi terjadi kelemahan dalam perawatan lansia yang mengakibatkan menurunnya kondisi kesehatan lansia terutama yang mengalami penyakit kronik rematik. Penelitian ini bertujuan melakukan analisis pendampingan lansia yang mengalami penyakit rheumatodi arthritis pada lansia yang tinggal di panti jompo Darussa’adah Lhokseumawe provinsi Aceh. Desain penelitian ini menggunakan kuantitatif deskriptif dengan analisis descriptive statistics. Populasi dalam penelitian ini adalah seluruh lansia yang mengalami rematik dan jumlah sampel berjumlah 36 responden dengan teknik purposive sampling. Hasil analisis univariat menunjukkan pendampingan yang dilakukan oleh pendamping lansia  paling banyak berkategori kurang, yaitu sebanyak 19 responden (52.8%), monitoring negatif sebanyak 19 responden (52.8%), edukasi negatif sebanyak 21 responden (58.3%) dan motivasi kurang sebanyak 18 responden (50%). Hasil analisis bivariat menunjukkan ada hubungan pendampingan lansia dengan ketergantungan perawatan lansia yang mengalami masalah kesehatan kronis rematik (p value, 0.001). Pengelola Lembaga Kesejahteraan Sosial sebaiknya dapat berkoordinasi dengan Dinas Kesehatan setempat untuk meminta pendampingan dan perawatan lansia oleh perawat bagi lansia yang mengalami penyakit kronis rematik.

scholarly journals AB0196 SURVIVAL ANALYSIS OF TIME TO FIRST ADVERSE DRUG REACTION AND DRUG SURVIVAL IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH ADALIMUMAB AND ETANERCEPT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1122.1-1122
Author(s):  
M. Nguyen ◽  
K. Velthuis ◽  
J. Scholl ◽  
J. Jansen ◽  
L. Kosse ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Drug Treatment ◽  
Median Survival ◽  
Exact Test ◽  
Drug Survival ◽  
Time Treatment ◽  
Kaplan Meier ◽  
Ada 95 ◽  
Continuous Use ◽  
First Time

Background:Treatment of rheumatoid arthritis (RA) with biologic disease-modifying antirheumatic drugs (bDMARDs) has been common practice in the last two decades. However, differences in patients experiencing adverse drug reactions (ADRs) between individual bDMARDs, such as adalimumab (ADA) and etanercept (ETN), during first time treatment has not been studied yet in real-world settings.Objectives:To compare proportions of RA patients experiencing ADRs as well as survival to first ADR and drug survival during treatment with ADA and ETN.Methods:Retrospective single centre cohort study including adult patients with RA, treated with either ADA or ETN between 1 January 2003 and 30 April 2020. The proportions of patients experiencing an ADR were compared by assessing the percentage of patients, treated with either ADA or ETN, experiencing at least one ADR during their first time treatment. Survival to first ADR and drug survival were assessed by calculating time between start of treatment and first ADR and start of treatment and discontinuation of treatment respectively. Stop and restart of treatment within 90 days was considered as continuous use. Differences in proportions were statistically tested using Fisher’s Exact Test. Differences in drug survival between ADA and ETN were tested by Kaplan-Meier analysis and Log Rank tests.Results:A total of 422 patients were included in this study (ADA 259, ETN 163). For 93 patients (21.2%) an ADR was registered during first time treatment. The proportion of patients experiencing at least one ADR during their first time treatment was 22.7% for ADA and 20.2% for ETN (p=0.628). Survival time to first ADR did not differ significantly between ADA and ETN (median survival ADA 10.34 years (95% CI [7.62-13.06], median survival ETN not reached, p=0.109, figure 1A). Median drug survival was 1.75 years for ADA (95 CI [1.38-2.11]) and 2.68 years for ETN (95% CI [1.73-3.64]). Drug survival differed significantly (p<0.001, figure 1B).Figure 1.Kaplan-Meier survival curves for adalimumab and etanercept with (a) survival to first ADR and (b) drug survival.Conclusion:Neither the proportion of patients experiencing ADRs nor survival to first ADR during first time treatment with ADA and ETN differed significantly. Drug survival of first time drug treatment of ADA was significantly lower compared to drug survival of first time drug treatment of ETN.Disclosure of Interests:My Nguyen: None declared, Kimberly Velthuis: None declared, Joep Scholl: None declared, Jurriaan Jansen: None declared, Leanne Kosse: None declared, Peter ten Klooster: None declared, Naomi Jessurun: None declared, Harald Vonkeman Consultant of: BMS, Celgene, Celltrion, Galapagos, Gilead, Janssen-Cilag, Lilly, Novartis, Pfizer, Sanofi-Genzyme, Grant/research support from: Abbvie

scholarly journals POS0648 SURVIVAL ANALYSIS OF TIME TO FIRST ADVERSE DRUG REACTION AND DRUG SURVIVAL IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH METHOTREXATE AND HYDROXYCHLOROQUINE MONOTHERAPIES OR COMBINATION THERAPY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 562-563
Author(s):  
K. Velthuis ◽  
M. Nguyen ◽  
J. Scholl ◽  
J. Jansen ◽  
J. Van Lint ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Survival Analysis ◽  
Drug Use ◽  
Combination Therapy ◽  
Drug Discontinuation ◽  
Exact Test ◽  
Drug Survival ◽  
Kaplan Meier ◽  
First Time ◽  
Start Dates

Background:Methotrexate (MTX) and hydroxychloroquine (HCQ) are first line treatments of rheumatoid arthritis (RA). Adverse drug reactions (ADRs) during treatment with these drugs are common. Survival analysis on time to first ADR and on first time drug use duration have not yet been performed for these drugs in real-world settings.Objectives:To compare proportions of patients with ADRs during first time use of either MTX monotherapy, HCQ monotherapy or MTX+HCQ combination therapy and to compare survival to first ADR and drug survival between these drugs.Methods:Retrospective single centre cohort study including adult RA patients treated with either MTX monotherapy, HCQ monotherapy or MTX+HCQ combination therapy. First time users between 1 January 2003 and 30 April 2020 were followed until discontinuation of their first time drug use. The proportion of patients with ADRs was defined as the percentage of patients experiencing an ADR during their first time drug use. Survival to first ADR and drug survival of first time drug use were also assessed. MTX+HCQ use was considered combination therapy when the start dates of these drugs differed less than 14 days. For both monotherapies, end of first time drug use was defined as drug discontinuation for more than 90 days. For MTX+HCQ combination therapy, end of first time drug use was defined as discontinuation of either MTX, HCQ or both for more than 90 days. Differences in the proportion of patients experiencing an ADR during first time drug use of MTX, HCQ or a combination of both was statistically tested using Fisher’s Exact Test. Survival to first ADR and drug survival were studied by Kaplan-Meier analysis and statistically tested by performing Log Rank tests.Results:In total, 794 patients were included (MTX 363, HCQ 77, MTX+HCQ 354). For 156 patients (19.6%) at least one ADR was registered during first time drug use (MTX 59 [16.3%], HCQ 9 [11.7%], MTX+HCQ 88 [24.9%]). Proportions of ADRs differed significantly between MTX monotherapy and MTX+HCQ combination therapy (p=0.005) and between HCQ monotherapy and MTX+HCQ combination therapy (p=0.011). Survival to first ADR also differed significantly for both monotherapies compared to MTX+HCQ combination therapy (medians not reached, p<0.001 and p<0.008, respectively (figure 1A)). Drug survival differed significantly between MTX and HCQ monotherapy and between MTX monotherapy and MTX+HCQ combination therapy (median survival MTX 3.32 years (95% CI [2.81-3.83]; HCQ 1.39 years (95% CI [1.03-1.75]); MTX+HCQ 1.23 years (95% CI [1.11-1.34]), both p<0.001 (figure 1B)).Figure 1.Kaplan-Meier curves of MTX and HCQ monotherapies and MTX+HCQ combination therapy, with (a) survival to first ADR and (b) drug survival.Conclusion:Patients using MTX+HCQ combination therapy are more likely to experience an ADR during the first time drug use compared to MTX and HCQ monotherapies. MTX+HCQ combination therapy also leads to experiencing an ADR sooner compared to both monotherapies. Drug survival of patients treated with HCQ monotherapy as well as MTX+HCQ combination therapy is shorter compared to MTX monotherapy.Disclosure of Interests:Kimberly Velthuis: None declared, My Nguyen: None declared, Joep Scholl: None declared, Jurriaan Jansen: None declared, Jette van Lint: None declared, Peter ten Klooster: None declared, Harald Vonkeman Consultant of: BMS, Celgene, Celltrion, Galapagos, Gilead, Janssen-Cilag, Lilly, Novartis, Pfizer, Sanofi-Genzyme, Grant/research support from: Abbvie, Naomi Jessurun: None declared

scholarly journals AB0317 BIOLOGIC THERAPY OPTIMIZATION IN RHEUMATOID ARTHRITIS PATIENTS IN COLOMBIA

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1457.2-1458
Author(s):  
W. G. Rojas Zuleta ◽  
O. J. Felipe Díaz ◽  
A. E. Pantoja Marquez ◽  
R. Giraldo ◽  
J. G. López Velandia ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Drug Exposure ◽  
Biologic Therapy ◽  
Standard Dose ◽  
Rank Test ◽  
P Value ◽  
Sustained Remission ◽  
Disease Evolution ◽  
Kaplan Meier

Background:The optimization of biological agents (bDMARD), is a strategy that has proven to be cost effective and its use can reduce the risk related to drug exposure (1–3). It is included in the EULAR management guidelines and in the consensus of the Colombian Rheumatology Association.Objectives:To analyze optimization success of bDMARD therapies in patients with RA.Methods:Cohort study of RA patients in a specialized multicenter institution in Colombia, followed from January 2015 to December 2019. Patients in remission or low activity for at least 6 months with bDMARD, and with at least two consecutive medical visits, were included. Optimization types were dose decrease, application interval increments, or both. Patients who had disease reactivation (DAS28- CPR >3.2) and returned to standard dose, were considered a failure. By Kaplan-Meier analysis, the optimization failure was estimated according to bDMARD typeResults:92 patients were included, 78.26% were women, with a median age of 57 years (IQR 50-64), a disease evolution time of 15 years (IQR 10-21), a treatment of 5.6 years (IQR 2.7-8.0), and optimization of 7.75 months (IQR 3.25-15.75). The most commonly used bDMARD therapies were etanercept 36.96%, tocilizumab 30.43% and adalimumab 16.30%. 69.39% (34) were naive for biological treatment. The 53.26% (49) of patients had a follow-up time greater than 6 months.95.92% remained under optimization scheme without disease activity changes, and 4.08% of patients underwent definitive discontinuation of bDMARD, for sustained therapeutic objective. 8.16% (4) had relapses in the first 6 months after onset, of which 2 patients returned to standard doses. In survival analysis it was observed that patients who were optimized for antiTNF failed faster than the non-antiTNF, although this difference was not statistically significant (Log Rank test 0.003 p value = 0.959). Of the total patients, 28 have been optimized for 12 months or more, of these, 96.43% (27) continue in sustained remission, and 55.56% (15) received combined therapy with s synthetic DMARD (sDMARD).Figure 1.Kaplan MeierConclusion:During follow-up, most patients remain in optimization strategy. In those who continued in sustained remission, more than half received sDMARD, this suggests that their use may be a determining factor in preventing disease relapses. More studies are required to evaluate this hypothesis.References:[1]Niccoli L, Nannini C, Blandizzi C. Personalization of biologic therapy in patients with rheumatoid arthritis: Less frequently accounted choice-driving variables. Ther Clin Risk Manag. 2018;14:2097–111.[2]ASOREUMA. Asociación Colombiana de Reumatología. Consenso sobre recomendaciones para disminución y descontinuación de la terapia biológica en pacientes con artritis reumatoide, espondilitis anquilosante y artritis psoriásica. Rev Colomb Reumatol. 2019 Jan;26(1):11–23.[3]Cantini F, Niccoli L, Nannini C. Second-line biologic therapy optimization in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Semin Arthritis Rheum. 2017;47(2):183–92.Disclosure of Interests:None declared

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 Safety and efficacy of repeat Y90 radioembolization to the same hepatic arterial territory

2021 ◽  
pp. 20200752
Author(s):  
Wali Badar ◽  
Thuong Van Ha ◽  
Steven Zangan ◽  
Rakesh Navuluri ◽  
Anjana Pillai ◽  
...  
Keyword(s):  
Adverse Events ◽  
Meld Score ◽  
P Value ◽  
Glass Microspheres ◽  
Safety And Efficacy ◽  
Repeat Treatment ◽  
Kaplan Meier ◽  
Cumulative Activity ◽  
Y90 Radioembolization ◽  
Modified Recist

Objective: To study the efficacy and safety of repeat transarterial radioembolization (TARE) to similar hepatic arterial territories. Methods: Between 3/2011 and 4/2019, 26 patients (25 males and 1 Female, Mean Age: 65 yo, SD: 11.7 yo, Range: 18–83.0 yo) received TARE with Y90 glass microspheres to treat recurrent or residual primary disease in similar hepatic arterial lobe or segments. Tumor response was evaluated by imaging using the modified-RECIST criteria. Incidence of RILD and adverse events were categorized by a standardized scale using the Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Results: Mean cumulative activity after the first treatment was 2.50 GBq (SD:1.04 GBq, Range:0.61–4.93 GBq) and second treatment was 2.27 GBq (SD:1.01 GBq, Range:0.92–5.46 GBq). Mean interval time between initial and repeat treatments was 9.6 months (Range: 1–53 months). Tumor responses were complete, partial, or progression in 73% (n = 19/26), 23% (n = 6/26), and 4% (n = 1/26) in repeat treatment patients, respectively. The incidence of RILD was 0%. Toxicity after first and second treatment was seen in 19% (n = 5/26) & 23% (n = 6/26) patients, respectively, and were all of CTCAE Grade 2. No significant predictors of treatment toxicity for repeat treatment were identified except increased MELD score (p = 0.04). Kaplan-Meier survival analysis in patients with repeat treatment showed a median survival of 15.0 months (95% CI 8.8–21.1 months) and 19.0 months (95% CI 8.1–29.9 months) in patients who only received one treatment with a p value of 0.485. Conclusion: Repeat TARE with glass microspheres was an effective and safe treatment strategy for disease management in patients with residual or recurrent disease to the similar hepatic arterial territories without any major treatment related toxicity. Advances in knowledge: Although safety and efficacy of repeat radioembolism has been studied, no study has focused on repeat treatment to similar hepatic arterial territories. The current study shows that repeat treatment to the same hepatic arterial territory is as safe as single treatment to the same territory.

scholarly journals RELATIONSHIP OF AGE, MENOPAUSE STATUS, AND BMI WITH THE EVENT OF BACTERIAL VAGINOSIS IN NEW PATIENTS OF PELVIC ORGAN PROLAPSE

2021 ◽  
Vol 4 (2) ◽  
pp. 109
Author(s):  
Atmi Marmiati ◽  
Pungky Mulawardhana ◽  
Zakiyatul Faizah
Keyword(s):  
Logistic Regression ◽  
Pelvic Organ Prolapse ◽  
Maternal Age ◽  
Menopausal Status ◽  
Pelvic Organ ◽  
P Value ◽  
Multiple Logistic Regression ◽  
Chi Square ◽  
Exact Test ◽  
Relationship Of

AbstractBackground and Purpose : The prevalence of Bacterial Vaginosis (BV) among Asian women in India and Indonesia is 32% while in the case of BV in 2018 the obstetric clinic of Dr. Soetomo Regional Hospital is 181 BV sufferers. The impact of BV on Pelvic Organ Prolapse (POP) patients, namely the delay in POP treatment such as BV pessaries can be influenced by age, menopausal status, and BMI. This study aims to analyze the relationship of age, menopausal status, and BMI with the incidence of BV in POP patients. Methods: This study used observational analytics with a retrospective and cross sectional approach. The number of samples used was 86 patients. Samoel taking technique with total sampling. The independent variable is the incidence of BV, while the dependent variable is age, menopause status, BMI. Bivariate data analysis using chi square, fisher's exact test and multivariate test using multiple logistic regression tests. Results: The results showed a positive BV prevalence of 76.7% with the majority of patients aged over 60 years at 44.2%, having menopause at 81.4%, and having a BMI of 18.5-24.5 at 47.7%. Fisher's exact test analysis test showed p value of maternal age = 0.003 (RR = 6.398) and p value of BMI = 0.767 (p> 0.005). Chi square analysis test showed p value of menopause status = 0.009 (RR = 4.833). The multiple logistic regression analysis test showed that maternal age was the most dominant factor with a value of p = 0.006 (OR = 6.398 (1,711-23,929)). Conclusion: There is a relationship between age and menopausal status with the incidence of BV. Age is the most dominant independent factor in the incidence of BV.

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