Oldfield Vicki, Plosker Greg L
Wolters Kluwer Health | Adis, North Shore, Auckland, New Zealand.
BioDrugs. 2009;23(2):125-35. doi: 10.2165/00063030-200923020-00005.
Golimumab is a human anti-tumor necrosis factor (TNF) monoclonal antibody that acts principally by targeting and neutralizing TNF to prevent inflammation and destruction of cartilage and bone. Large, randomized, double-blind trials in patients with rheumatoid arthritis who were methotrexate-naïve (GO-BEFORE) or -experienced (GO-FORWARD) have shown that golimumab 50 or 100 mg every 4 weeks, in combination with methotrexate, was more effective than methotrexate alone for improving signs and symptoms of arthritis at weeks 14 and/or 24, according to American College of Rheumatology (ACR) criteria. In patients with active rheumatoid arthritis despite previous treatment with anti-TNF agents (GO-AFTER), golimumab 50 or 100 mg every 4 weeks was more effective than placebo for improving ACR responses at weeks 14 and 24; most patients in the study received concomitant methotrexate. In patients with psoriatic arthritis in the GO-REVEAL study, significantly more golimumab than placebo recipients achieved a >or=20% improvement in ACR criteria at week 14. Golimumab was also superior to placebo for improving the signs and symptoms of ankylosing spondylitis in the GO-RAISE study; significantly more golimumab than placebo recipients achieved a >or=20% improvement in the Assessment in Ankylosing Spondylitis (ASAS) criteria at week 14. In the five phase III trials in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, there was no clear evidence of improved ACR or ASAS responses with the 100 mg dosage compared with the 50 mg dosage of golimumab. The tolerability profile of golimumab was generally consistent with that of other anti-TNF agents.
戈利木单抗是一种人抗肿瘤坏死因子(TNF)单克隆抗体,其主要作用机制是靶向并中和TNF,以防止软骨和骨的炎症和破坏。针对未使用过甲氨蝶呤(GO-BEFORE)或已使用过甲氨蝶呤(GO-FORWARD)的类风湿关节炎患者进行的大型随机双盲试验表明,根据美国风湿病学会(ACR)标准,每4周注射50或100mg戈利木单抗联合甲氨蝶呤,在第14周和/或24周时比单用甲氨蝶呤更有效地改善关节炎的体征和症状。在既往接受过抗TNF药物治疗但仍患有活动性类风湿关节炎的患者(GO-AFTER)中,每4周注射50或100mg戈利木单抗在第14周和24周时比安慰剂更有效地改善ACR反应;该研究中的大多数患者同时接受了甲氨蝶呤治疗。在GO-REVEAL研究的银屑病关节炎患者中,在第14周时,达到ACR标准改善≥20%的接受戈利木单抗治疗的患者显著多于接受安慰剂治疗的患者。在GO-RAISE研究中,戈利木单抗在改善强直性脊柱炎的体征和症状方面也优于安慰剂;在第14周时,达到强直性脊柱炎评估(ASAS)标准改善≥20%的接受戈利木单抗治疗的患者显著多于接受安慰剂治疗的患者。在针对类风湿关节炎、银屑病关节炎或强直性脊柱炎患者的五项III期试验中,没有明确证据表明与50mg剂量的戈利木单抗相比,100mg剂量能改善ACR或ASAS反应。戈利木单抗的耐受性总体上与其他抗TNF药物一致。