Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus
SPRING HOUSE, PENNSYLVANIA, June 26, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today its decision to discontinue the Phase 3 LOTUS study of STELARA® (ustekinumab) in Systemic Lupus Erythematosus (SLE) due to lack of efficacy in SLE.The decision is based on data from a pre-planned interim efficacy analysis. Interim safety findings were consistent with the known safety profile of STELARA, and no new safety signals were identified. Investigators, study participants and health authorities have been informed of the decision. The company intends to thoroughly analyze the totality of the study data and publish findings.“Lupus patients are waiting for better treatments, which makes this outcome disappointing,” said Alyssa Johnsen, M.D., Ph.D., Vice President, Rheumatology Disease Area Leader, Janssen Research &Development, LLC. “Our hope is that by ultimately sharing these data with the scientific community we can help inform lupus research and therefore still have a positive impact on the lives of patients living with SLE. Janssen continues to be strongly committed to research and development of novel therapies for lupus.”The decision to discontinue the LOTUS study does not impact any other ongoing studies with ustekinumab or current indications.About the LOTUS ProgramLOTUS is a global, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study of ustekinumab in individuals with active Systemic...
Publication date: 15 February 2021Source: Journal of Hazardous Materials, Volume 404, Part BAuthor(s): Yanhua Liu, Yang Li, Shanshan Dong, Lu Han, Ruixin Guo, Yourong Fu, Shenghu Zhang, Jianqiu Chen
Publication date: 15 February 2021Source: Journal of Hazardous Materials, Volume 404, Part AAuthor(s): Zhongyi Zhang, Wen-Xiong Wang, Nengjian Zheng, Yansheng Cao, Hongwei Xiao, Renguo Zhu, Hui Guan, Huayun Xiao
Publication date: 15 February 2021Source: Journal of Hazardous Materials, Volume 404, Part BAuthor(s): Jinsoo Lee, Seong-Jin Choi, Ji-Seong Jeong, Sang Yun Kim, Sang-Hyub Lee, Mi Jin Yang, Seung-Jin Lee, Young-Jun Shin, Kyuhong Lee, Eun Ju Jeong, Sang-Yoon Nam, Wook-Joon Yu
We describe the most highly recommended generic and disease-specific PRO tools in SCD and discuss the challenges of incorporating them in clinical practice. EXPERT OPINION: PRO measures are essential to incorporate into SCD clinical trials either as primary or secondary outcomes. The use of PRO measures in SCD facilitates a patient-centered approach, which is likely to lead to improved outcomes. Significant challenges remain in adapting PRO tools to routine clinical use and in developing countries. PMID: 33034214 [PubMed - as supplied by publisher]
Authors: Musio F Abstract INTRODUCTION: Anemia has and will continue to be a central theme in medicine particularly as clinicians are treating a burgeoning population of complex multi-organ system processes. As a result of multiple randomized controlled trials (RCTs), meta-analyses, and societal recommendations overly restrictive paradigms and under-administration of erythropoiesis stimulating agents (ESAs) have likely been followed by clinicians among all specialties. AREAS COVERED: A review of anemia in the context of chronic kidney disease, hematologic malignancies and cancer is presented with focus on the e...
Authors: Bergland OU, Søraas CL, Larstorp ACK, Halvorsen LV, Hjørnholm U, Hoffman P, Høieggen A, Fadl Elmula FEM Abstract PURPOSE: The blood pressure (BP) lowering effect of renal sympathetic denervation (RDN) in treatment-resistant hypertension shows variation amongst the existing randomised studies. The long-term efficacy and safety of RDN require further investigation. For the first time, we report BP changes and safety up to 7 years after RDN, compared to drug adjustment in the randomised Oslo RDN study. MATERIALS AND METHODS: Patients with treatment-resistant hypertension, defined...
Authors: Zhang W, Xu JZ, Lu XH, Li H, Wang D, Wang JG Abstract PURPOSE: We hypothesise that dietary sodium intake interacts with serum uric acid to influence blood pressure (BP) in children and adolescents. In the present study, we investigated ambulatory BP in relation to hyperuricaemia, dietary sodium intake and their interaction in children and adolescents with hypertension. MATERIALS AND METHODS: A total of 616 study participants were 10-24 years old and had primary hypertension diagnosed after admission in a specialised inpatient ward. Ambulatory BP monitoring was performed during hospitalisat...
Publication date: Available online 10 October 2020Source: Meta GeneAuthor(s): Mansour Zamanpoor, Hamid Ghaedi, Mir Davood Omrani
Publication date: January 2021Source: Urology Case Reports, Volume 34Author(s): Nina Al-Saadi, Safa Al-Musawi, Yousuf Khan, Daben Dawam
CONCLUSIONS: Xyloglucan/gelose plus ORS was effective and safe in treating acute diarrhea in children. PMID: 33028102 [PubMed - as supplied by publisher]
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