相关临床试验
2
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1934
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Unknown
2
100.0%
暂无批准数据
- CMS proposed a new rule requiring payers to respond to urgent drug prior authorization requests within 24 hours, expedited within 72 hours, and standard within 7 days, with compliance by October 2027. - An industry pledge led by AHIP reportedly reduced prior authorizations by 11%, but only 33% of physicians surveyed by the AMA believe it will make a meaningful difference. - The American College of Rheumatology supports the CMS rule but urges further detail on denial reasons, specialty-level reporting, and extension to Medicare Part D and state-based exchanges. - A 2025 Commonwealth Fund analysis found 21% of working-age adults with private insurance were denied physician-recommended care, with 41% experiencing delayed care as a result.
- Many patients with rheumatoid arthritis and other immune-mediated inflammatory diseases fail to meet treatment goals despite biologic therapy, giving rise to a "difficult-to-treat" population that requires holistic care. - Psychosocial distress, comorbidities, chronic pain syndromes, and system-related barriers — not just pharmacotherapeutic failure — drive poor outcomes in difficult-to-treat patients, according to viewpoint articles in Nature Reviews Rheumatology and Lancet Rheumatology. - Experts emphasize that rheumatologists must look beyond disease activity scores, incorporating multidisciplinary care, lifestyle medicine, and patient-centered communication to address the full complexity of these cases. - Leading rheumatologists call on organizations like the ACR and EULAR to expand clinical guidelines, fund research into non-pharmacologic therapies, and codify whole-person care models for this underserved population.
- Sonoma Biotherapeutics announced positive interim results from its Phase 1 REGULATE-RA trial of SBT-77-7101, showing a favorable safety profile with no dose-limiting toxicities or cytokine release syndrome in refractory rheumatoid arthritis patients. - By week 4, 67% of participants achieved a 50% or greater reduction in swollen and tender joint counts, with 83% showing improvements in DAS28-CRP and CDAI disease activity scores. - The engineered CAR-Treg therapy demonstrated both systemic and local activity, with CAR+ Tregs detected in synovial tissue and blood, and participants in higher-dose cohorts experiencing deeper and more durable responses through week 24.
- R-Pharm presented new clinical data on olokizumab at ACR Convergence 2025, demonstrating sustained patient improvement over 106 weeks of treatment with reduced pain, stiffness, and daily task difficulties. - Real-world evidence showed olokizumab's effectiveness in rheumatoid arthritis patients remained largely unaffected by the number or severity of co-existing conditions, with additional benefits including reduced depression symptoms. - Phase II pediatric trial results revealed higher efficacy of olokizumab in adolescents with polyarticular juvenile idiopathic arthritis who had elevated blood IL-6 levels. - The drug's unique direct IL-6 targeting mechanism distinguishes it from other treatments in the same class, with international rheumatologists expressing interest in accessing the therapy.
- The AURORA 2 follow-up study by Rovin et al found no evidence of increased nephrotoxicity with voclosporin treatment over 18 months in lupus nephritis patients. - Renal biopsies from 16 voclosporin-treated patients and 10 controls showed no significant differences in histological endpoints or progression of kidney damage. - This represents the first double-blind investigation to directly address the long-term histopathologic impact of voclosporin in lupus nephritis treatment. - The findings provide reassurance for clinicians using voclosporin, though longer-term follow-up and larger studies are needed for broader applicability.
- Gout affects approximately 4% of US adults, with prevalence more than doubling since the 1960s and projected to continue rising in coming decades. - The 2020 American College of Rheumatology guidelines provide 42 recommendations for gout management, including specific guidance for patients with comorbidities like chronic kidney disease. - The guidelines address the long-standing debate between allopurinol and febuxostat use in chronic kidney disease patients, emphasizing the importance of personalized treatment approaches.
- The American College of Rheumatology (ACR) is initiating programs to address the under-representation of African American and Hispanic patients in lupus clinical trials. - TIMELY, a $500,000 grant-funded program, will combine existing models to address barriers to clinical trial participation among providers and patients. - New Continuing Medical Education (CME) content will be developed for dermatologists and nephrologists to improve lupus diagnosis and treatment. - The ACR aims to create a patient-centered approach in lupus clinical trials, aligning it with aspirations for everyday patient care.
