inThought Research, Wolters Kluwer Pharma Solutions, Yardley, PA, USA.
BioDrugs. 2011 Jun 1;25(3):203-5. doi: 10.2165/11591850-000000000-00000.
Speaking for the inThought Expert Discussion Series in February, Dr George Tsokos mirrored the opinion of many lupus thought leaders: Human Genome Sciences (HGS) and GlaxoSmithKline's (GSK) belimumab (Benlysta®) was likely to be approved by the US FDA and, despite modest efficacy, will be used by a large proportion of lupus patients. Dr Tsokos praised HGS and GSK's clinical trial program for belimumab, noting that huge trials and unique trial endpoints were needed to demonstrate the drug's efficacy, allowing it to succeed where so many other lupus drugs have failed. Still, belimumab's trial design may not become standard in future lupus trials - questions about identification of appropriate lupus patients with active disease, trial endpoints, and subgrouping lupus patients remain. Although Dr Tsokos does not expect other agents currently being tested in lupus trials to be significantly more efficacious than belimumab, his research suggests that significantly better results could be obtained using agents targeting interleukin-17, spleen tyrosine kinase (SYK), and calcium/calmodulin-dependent protein kinase type IV (CaMKIV). In line with Dr Tsokos' comments and consistent with inThought's outlook for belimumab, the US FDA granted approval for belimumab in March 2011, making it the first new lupus drug to be approved in more than 50 years. inThought projects US sales of $1.1 billion for belimumab by 2017. † Adapted and reproduced from Weintraub B. Benlysta Efficacy is "Mild" but Market Potential Still Great: Anticipating U.S. Approval of the First Lupus Drug Since 1957. inThought Research, 2011 Feb 24.
在 2 月的 inThought 专家讨论系列中发言时，George Tsokos 博士反映了许多狼疮领域思想领袖的观点：人类基因组科学公司（HGS）和葛兰素史克公司（GSK）的贝利木单抗（Benlysta®）很可能获得美国 FDA 的批准，尽管疗效有限，但将被很大一部分狼疮患者使用。Tsokos 博士称赞 HGS 和 GSK 的贝利木单抗临床试验计划，指出需要进行大规模试验和独特的试验终点来证明该药物的疗效，从而使其在许多其他狼疮药物失败的地方取得成功。尽管贝利木单抗的试验设计可能不会成为未来狼疮试验的标准——关于识别有活动疾病的合适狼疮患者、试验终点和对狼疮患者进行分组的问题仍然存在。虽然 Tsokos 博士预计目前正在狼疮试验中测试的其他药物不会比贝利木单抗更有效，但他的研究表明，使用靶向白细胞介素 17、脾酪氨酸激酶（SYK）和钙/钙调蛋白依赖性蛋白激酶 IV（CaMKIV）的药物可能会获得更好的结果。与 Tsokos 博士的评论一致，也与 inThought 对贝利木单抗的展望一致，美国 FDA 于 2011 年 3 月批准贝利木单抗，使其成为 50 多年来首个获得批准的新型狼疮药物。inThought 预测贝利木单抗到 2017 年的美国销售额为 11 亿美元。†改编自 Weintraub B. Benlysta Efficacy is "Mild" but Market Potential Still Great: Anticipating U.S. Approval of the First Lupus Drug Since 1957. inThought Research, 2011 Feb 24.
