scholarly journals All-case Japanese post-marketing surveillance of the real-world safety and efficacy of rituximab treatment in patients with refractory nephrotic syndrome

2021 ◽  
Author(s):  
Mana Kobayashi ◽  
Yutaro Kageyama ◽  
Takashi Ando ◽  
Junko Sakamoto ◽  
Shohji Kimura
Keyword(s):  
Nephrotic Syndrome ◽  
Standard Deviation ◽  
Real World ◽  
Pediatric Patients ◽  
Safety And Efficacy ◽  
The Real ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Refractory Nephrotic Syndrome ◽  
Observation Period

Abstract Background Rituximab is conditionally approved in Japan for use in patients with refractory nephrotic syndrome. To meet the conditions of approval, an all-case post-marketing surveillance study was conducted to confirm the real-world safety and efficacy of rituximab in patients of all ages with refractory nephrotic syndrome. Methods All patients scheduled to receive rituximab treatment for refractory nephrotic syndrome were eligible to register (registration: August 29, 2014 through April 15, 2016); the planned observation period was 2 years from the initiation of rituximab treatment (intravenous infusion, 375 mg/m2 once weekly for four doses). The study was conducted at 227 hospitals throughout Japan. Adverse drug reactions (ADRs) were collected for safety outcomes. The efficacy outcomes were relapse-free period and the degree of growth in pediatric (< 15 years) patients. Results In total, 997 (447 pediatric) patients were registered; 981 (445) were included in the safety analysis set; 852 (402) completed the 2-year observation period; and 810 (429) were included in the efficacy analysis set. Refractory nephrotic syndrome had developed in childhood for 85.0% of patients, and 54.6% were aged ≥15 years. ADRs were observed in 527 (53.7%) patients, treatment-related infection/infestation in 235 (24.0%) patients, and infusion reactions in 313 (31.9%) patients. The relapse-free period was 580 days (95% confidence interval, 511–664). There was a significant change in height standard deviation score (pediatric patients; mean change, 0.093; standard deviation, 0.637; P = 0.009). Conclusion The safety and efficacy of rituximab treatment in patients with refractory nephrotic syndrome were confirmed in the real-world setting. Clinical trial registration UMIN000014997.

scholarly journals Real-world safety and efficacy of CT-P13, an infliximab biosimilar, in Japanese rheumatoid arthritis patients naïve to or switched from biologics

2021 ◽  
Author(s):  
Tsutomu Takeuchi ◽  
Kiyohiro Nishikawa ◽  
Fumika Yamada ◽  
Shiro Ohshima ◽  
Makoto Inoue ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Real World ◽  
Remission Rate ◽  
Cost Effective ◽  
Japanese Patients ◽  
Safety And Efficacy ◽  
Reactive Protein ◽  
First Line Therapy ◽  
Post Marketing Surveillance ◽  
Post Marketing

ABSTRACT Objectives The aim of this post-marketing surveillance (PMS) study is to evaluate the real-world safety and efficacy of CT-P13, the first biosimilar of infliximab (IFX). Methods Japanese patients with rheumatoid arthritis were prospectively registered from November 2014 and followed up for 1 year. Results Of 794 patients in the analysis set, 318 patients naïve to biological disease-modifying antirheumatic drugs (bDMARDs) showed an immediate decrease in Disease Activity Score in 28 joints with C-reactive protein (DAS28-CRP) and increased remission rate (DAS28-CRP &lt; 2.6). In patients who switched from IFX to CT-P13 for non-medical reasons (n = 374), the low DAS28-CRP due to previous IFX treatment decreased further with continued CT-P13 therapy. As in naïve patients, patients who switched from other bDMARDs, mainly for medical reasons (n = 102), responded similarly to CT-P13. CT-P13 in this PMS and IFX in a previous PMS had similar adverse reaction profiles, although the incidence rate in naïve patients in this current PMS was lower due to earlier initiation of CT-P13 therapy. Conclusions CT-P13 showed excellent effectiveness as first-line therapy, no clinical difficulties in switching from IFX, and clinical improvement in patients who failed other bDMARDs. CT-P13 could be a cost-effective alternative to IFX in the treatment of rheumatoid arthritis.

Abstract 83: 30-Day Mortality After Carotid Artery Stenting (CAS) in Trial Versus Real-World Settings

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Jessica J Jalbert ◽  
Louis L Nguyen ◽  
Marie D Gerhard-Herman ◽  
Michael R Jaff ◽  
John D Seeger ◽  
...  
Keyword(s):  
Mortality Risk ◽  
Real World ◽  
Surgical Risk ◽  
The Real ◽  
Mortality Risks ◽  
Asymptomatic Patients ◽  
Post Marketing Surveillance ◽  
Comorbidity Burden ◽  
High Surgical Risk ◽  
Post Marketing

Background and Purpose: Clinicians rely on randomized controlled trial (RCT) evidence to select treatments but the risk/benefit profile may differ in the real-world. We compared 30-day mortality after CAS among Medicare, contemporary US registry, and landmark RCT patients. Methods: We linked Medicare data (2000-2009) to CMS’s CAS Database (CAS-D; 2005-2009) and the Society for Vascular Surgery’s Vascular Registry (SVS-VR; 2005-2008) and estimated 30-day mortality among beneficiaries at least 66 years of age. We compared 30-day mortality risk among our Medicare-linked registry patients to those of landmark RCT and post-marketing commitment registries. Results: Average age was lower among RCT patients than among post-marketing registries or Medicare-linked registry patients while symptomatic patients were less common in post-marketing than in Medicare-linked registries or RCTs (Table). SAPPHIRE was the only RCT enrolling high-surgical risk patients but the majority of real-world patients were at high-surgical risk. RCT and post-marketing surveillance registries had minimum provider proficiency requirements while the CAS-D and SVS-VR did not. 30-day mortality risk among Medicare-linked CAS-D (n=22,516) and SVS-VR (n=1,999) was 1.7% (95% CI: 1.5-1.8%) and 1.8% (95% CI: 1.2-2.4%), respectively. 30-day mortality risks among symptomatic Medicare patients were 1.6 to 3.8 times that of RCT CAS patients and mortality risks among RCT patients were lower than among Medicare-linked asymptomatic patients. 30-day mortality risks among registries providing physician training was ~1%, between that of RCTs and Medicare-linked registry patients. Conclusion: Medicare CAS patients have much higher 30-day mortality risks than patients in RCTs or registries with provider training programs because of differences in age, comorbidity burden, and provider proficiency. These findings underscore the importance of evaluating CAS effectiveness in the real-world.

scholarly journals Safety and efficacy of cabazitaxel in 660 patients with metastatic castration-resistant prostate cancer in real-world settings: results of a Japanese post-marketing surveillance study

2019 ◽  
Vol 49 (12) ◽  
pp. 1157-1163 ◽  
Author(s):  
Kazuhiro Suzuki ◽  
Nobuaki Matsubara ◽  
Hirotaka Kazama ◽  
Takeshi Seto ◽  
Shoko Tsukube ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Real World ◽  
Japanese Patients ◽  
Surveillance Study ◽  
Castration Resistant Prostate Cancer ◽  
Safety And Efficacy ◽  
Castration Resistant ◽  
Post Marketing Surveillance ◽  
Post Marketing

This PMS demonstrated that cabazitaxel was generally tolerated and showed promising efficacy in Japanese patients with mCRPC treated in real-world settings. Results are consistent with those of pre-registration clinical trials.

scholarly journals Long-Term, Real-World Safety and Efficacy of Teneligliptin: A Post-Marketing Surveillance of More Than 10,000 Patients with Type 2 Diabetes in Japan

2019 ◽  
Vol 37 (3) ◽  
pp. 1065-1086 ◽  
Author(s):  
Takashi Kadowaki ◽  
Masakazu Haneda ◽  
Hiroshi Ito ◽  
Kazuyo Sasaki ◽  
Miyuki Matsukawa ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Real World ◽  
Safety And Efficacy ◽  
Post Marketing Surveillance ◽  
Post Marketing
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