Robak Tadeusz
Medical University of Lodz and Copernicus Memorial Hospital, Department of Hematology, 93-510 Lodz, Ciołkowskiego 2, Poland.
Curr Opin Mol Ther. 2008 Jun;10(3):294-309.
Genmab A/S and licensee GlaxoSmithKline plc are developing ofatumumab, an anti-CD20 human mAb, for the potential intravenous treatment of non-Hodgkin's lymphoma and autoimmune diseases, such as rheumatoid arthritis (RA) and multiple sclerosis (MS). Phase I and II clinical trials have been completed in patients with chronic lymphocytic leukemia (CLL), rituximab-refractory follicular lymphoma (FL) and RA. At the time of publication ofatumumab was undergoing a phase II clinical trial in patients with diffuse large B-cell lymphoma and phase III clinical trials in patients with B-cell CLL (B-CLL) in which fludarabine and alemtuzumab treatments have failed and in patients with rituximab-refractory FL. Ofatumumab was also undergoing phase II clinical trials as a combination therapy for previously untreated patients with FL in combination with cyclophosphamide, adriamycin, vincristine, and prednisone and in combination with fludarabine and cyclophosphamide for the treatment of B-CLL. In addition, two phase III clinical trials to assess patients who have an inadequate response to methotrexate and TNFalpha therapy were ongoing for patients with RA, and a phase II clinical trial to investigate the effects of repeated doses of ofatumumab was recruiting patients with RA from a previous trial on ofatumumab. A phase I/II clinical trial of ofatumumab in relapsing-remitting MS was expected to commence in 2008.
丹麦基因免疫公司（Genmab A/S）及其被许可方葛兰素史克公司（GlaxoSmithKline plc）正在研发奥法木单抗（ofatumumab），这是一种抗CD20人源单克隆抗体，用于非霍奇金淋巴瘤以及类风湿性关节炎（RA）和多发性硬化症（MS）等自身免疫性疾病的潜在静脉治疗。针对慢性淋巴细胞白血病（CLL）、利妥昔单抗难治性滤泡性淋巴瘤（FL）和RA患者的I期和II期临床试验已经完成。在本文发表时，奥法木单抗正在进行弥漫性大B细胞淋巴瘤患者的II期临床试验，以及B细胞慢性淋巴细胞白血病（B-CLL）患者的III期临床试验，这些患者的氟达拉滨和阿仑单抗治疗均告失败，还有利妥昔单抗难治性FL患者的III期临床试验。奥法木单抗还在进行II期临床试验，作为联合疗法用于初治FL患者，联合环磷酰胺、阿霉素、长春新碱和泼尼松，以及联合氟达拉滨和环磷酰胺用于治疗B-CLL。此外，两项评估甲氨蝶呤和TNFα治疗反应不足的RA患者的III期临床试验正在进行，一项研究重复剂量奥法木单抗效果的II期临床试验正在从之前一项奥法木单抗试验中招募RA患者。奥法木单抗在复发缓解型MS中的I/II期临床试验预计于2008年开始。
