Janssen Provides Update on Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA® (abiraterone acetate) Plus Prednisone Combination
RARITAN, N.J., April 19, 2021 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today that regulatory submissions based on the Phase 3 ACIS study, which evaluated the combination of ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) plus prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), will not be pursued. As presented at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium in February 2021, the ACIS study met its primary endpoint of radiographic progression-free survival (rPFS); however, combination treatment did not show significant benefit over the active control ZYTIGA® plus prednisone in key secondary endpoints, including overall survival (OS). “Safety results from ACIS were consistent with prior studies of ERLEADA and ZYTIGA plus prednisone, with no new safety signals observed. The study also generated valuable scientific outcomes and insights in subgroups of patients with luminal type in PAM50 test and tumors with average or high androgen receptor activity (molecular signatures of hormone sensitivity), which warrant further investigation,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research &Development, LLC. “These data will be important in informing future programs in our pipeline, as we look to build upon our leadership and commitment in bringing transformation...
ConclusionsThe prevalence of OCI observed in our study is consistent with previous literature, and we confirm that it is more frequently retrieved in women. Longitudinal research is warranted to elucidate the evolution, while knowledge about the disorder is needed to raise the awareness of rheumatologists and radiologists and to properly identify and report the condition.Key Points• OCI may mimic sacroiliitis and is a major differential diagnosis of radiographic axial spondyloarthritis.• Prevalence of OCI in our sample is 1.0%, in line with previous literature.• OCI predominantly affects women, and our study...
AbstractLong-term sequel of acute COVID-19, commonly referred to as long COVID, has affected millions of patients worldwide. Long COVID patients display persistent or relapsing and remitting symptoms that include fatigue, breathlessness, cough, myalgia, arthralgia, sleep disturbance, cognitive impairment and skin rashes. Due to the shared clinical features, laboratory and imaging findings, long COVID could mimic rheumatic disease posing a diagnostic challenge. Our comprehensive literature review will help rheumatologist to be aware of long COVID manifestations and differentiating features from rheumatic diseases to ensure ...
ConclusionsImprovement was seen in most patients. One year after the start of treatment, more than half of the patients were untreated and around one-third in remission. Residual symptoms and deficits were common regardless of treatment.
Extra vaccine doses were expected to lower infection rates. But the shots also seem to be preventing severe illness caused by the new variant, the C.D.C. reported.
Data suggest that Black people are equally or more willing than White people to get a vaccine, which may mean access is the bigger problem, researchers say.Medscape Medical News
ConclusionsIn this updated systematic review and meta-analysis, uterine exteriorization was associated with an increased risk of IONV but no significant change in perioperative hemoglobin decrease compared within situ repair.Study registrationPROSPERO (CRD42020190074); registered 5 July 2020.
ConclusionsGiven the perceived benefits of regional over general anesthesia, approximately half of the members of three regional anesthesia societies seem to have expanded their use of regional anesthesia techniques during the initial surge of the COVID-19 pandemic.
ConclusionPlastic bronchitis can present in adult patients and be life-threatening when associated with acute respiratory failure. We report an unusual case of an adult patient treated with veno-venous ECMO for plastic bronchitis following cardiac surgery. Use of ECMO support while providing airway cleaning can be lifesaving in patients with respiratory failure secondary to plastic bronchitis.
ConclusionsIntra-abdominal hypertension is very common during cardiac surgery but its clinical implications are uncertain.
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