Algahtani Hussein, Shirah Bader, Abobaker Hind, Alghanaim Nebras, Kamel Fatemah
King Saud bin Abdulaziz University for Health Sciences.
Pharmacology Department, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
Clin Neuropharmacol. 2018 Nov/Dec;41(6):199-201. doi: 10.1097/WNF.0000000000000305.
Natalizumab is the first targeted humanized monoclonal antibody to be approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). Natalizumab appears to be more effective than current first-line disease-modifying therapies. In our study, we aimed to evaluate the outcome of Saudi patients with active RRMS treated with natalizumab and compare the results with other outcomes in the Gulf and international trials.
We conducted a retrospective single-center observational study involving 32 patients with RRMS at King Abdulaziz Medical City in Jeddah, Saudi Arabia. The inclusion criteria included all patients diagnosed with RRMS according to the revised McDonald criteria who are currently receiving or received natalizumab treatment in the past for a minimum of 6 months.
The mean baseline Expanded Disability Status Scale score was 4.50 ± 1.80 (range, 1.5-6; median, 5), whereas the mean Expanded Disability Status Scale at the follow-up was 4.02 ± 2.08 (range, 1-6; median, 4.25) (P = 0.3274). The mean annualized relapse rate was significantly reduced from 2.41 ± 2.48 at baseline to 0.16 ± 0.37 at the last follow-up (P < 0.0001). Twenty-seven patients (84.4%) had no relapses since the treatment with natalizumab was started, whereas 5 patients (15.6%) had only 1 relapse. In addition to clinically measurable improvement, radiological improvement was observed through magnetic resonance imaging. Magnetic resonance imaging activity was significantly improved at follow-up magnetic resonance imaging studies when compared with baseline.
Our single-center study in Saudi Arabia provides further support for the efficacy of natalizumab in the clinical practice setting. The sharp decrease in relapse rate and progression of disability following the initiation of natalizumab treatment was similar to other observational studies conducted in different countries across the globe. Natalizumab was a satisfactory therapy for the management of our MS population, both from the patients' and the physicians' perspectives.
那他珠单抗是首个被批准用于治疗复发缓解型多发性硬化症（RRMS）的靶向人源化单克隆抗体。那他珠单抗似乎比目前的一线疾病修饰疗法更有效。在我们的研究中，我们旨在评估接受那他珠单抗治疗的沙特活动性RRMS患者的治疗结果，并将结果与海湾地区和国际试验中的其他结果进行比较。
我们在沙特阿拉伯吉达的阿卜杜勒阿齐兹国王医疗城进行了一项回顾性单中心观察性研究，纳入了32例RRMS患者。纳入标准包括所有根据修订的麦克唐纳标准诊断为RRMS且目前正在接受或过去接受过那他珠单抗治疗至少6个月的患者。
基线时扩展残疾状态量表（Expanded Disability Status Scale，EDSS）评分的平均值为4.50±1.80（范围为1.5 - 6；中位数为5），而随访时EDSS的平均值为4.02±2.08（范围为1 - 6；中位数为4.25）（P = 0.3274）。年化复发率平均值从基线时的2.41±2.48显著降至最后一次随访时的0.16±0.37（P < 0.0001）。自开始使用那他珠单抗治疗以来，27例患者（84.4%）未复发，而5例患者（15.6%）仅复发1次。除了临床上可测量的改善外，通过磁共振成像还观察到了影像学改善。与基线相比，随访磁共振成像研究时磁共振成像活动有显著改善。
我们在沙特阿拉伯进行的单中心研究为那他珠单抗在临床实践中的疗效提供了进一步支持。开始使用那他珠单抗治疗后复发率和残疾进展的急剧下降与全球不同国家进行的其他观察性研究相似。从患者和医生的角度来看，那他珠单抗是管理我们的MS患者群体的一种令人满意的疗法。
