Peterkova Valentina, Arslanoglu Ilknur, Bolshova-Zubkovskaya Elena, Romer Tomasz, Zdravkovic Dragan, Kratzsch Jürgen, Ji Hyi-Jeong, Savoy Conrad, Saenger Paul
Endocrinological Scientific Centre, Russian Academy of Science, Moscow, Russia.
Horm Res. 2007;68(6):288-93. doi: 10.1159/000105494. Epub 2007 Jul 11.
Valtropin is a recombinant human GH (rhGH) manufactured using a novel yeast expression system, classed as a 'biosimilar'. Valtropin was compared with Humatrope in children with GH deficiency (GHD). Treatment-naive, prepubertal children with GHD were randomized to Valtropin (n = 98) or Humatrope (n = 49) for 1 year. Standing height was measured 3-monthly and height velocity (HV) calculated. Serum IGF-I, IGFBP-3 and GH antibodies were determined centrally. HV at 1 year was 11.3 +/- 3.0 cm/year with Valtropin and 10.5 +/- 2.8 cm/year with Humatrope. Treatment difference was 0.09 cm/year with 95% confidence limits of -0.71, 0.90, within the preset non-inferiority limit of -2.0 cm/year. Height standard deviation (SD) scores were increased in both treatment arms with no acceleration of bone maturation. IGF-I and IGFBP-3 were increased comparably for both treatments. Adverse events showed no clinically relevant differences between treatment groups. Anti-GH antibodies were detected in 3 (3.1%) Valtropin and 1 (2.0%) Humatrope patients and the growth pattern was indistinguishable from the rest of the cohort. The 1-year efficacy and safety profile of Valtropin, a new biosimilar rhGH, are equivalent to the comparator rhGH, Humatrope. Valtropin can be used for the treatment of children with GHD and longer term data will fully establish its efficacy and safety profile.
Valtropin是一种使用新型酵母表达系统制造的重组人生长激素（rhGH），归类为“生物类似药”。对生长激素缺乏症（GHD）儿童的Valtropin与优猛茁进行了比较。未接受过治疗的青春期前GHD儿童被随机分为接受Valtropin治疗组（n = 98）或优猛茁治疗组（n = 49），治疗1年。每3个月测量一次站立身高并计算身高增长速度（HV）。血清胰岛素样生长因子-I（IGF-I）、胰岛素样生长因子结合蛋白-3（IGFBP-3）和生长激素抗体由中心实验室测定。使用Valtropin治疗1年时的HV为11.3±3.0厘米/年，使用优猛茁治疗时为10.5±2.8厘米/年。治疗差异为0.09厘米/年，95%置信区间为-0.71、0.90，在预设的非劣效性界限-2.0厘米/年之内。两个治疗组的身高标准差（SD）评分均有所增加，且骨成熟没有加速。两种治疗方法使IGF-I和IGFBP-3的增加程度相当。不良事件在治疗组之间未显示出临床相关差异。在3例（3.1%）使用Valtropin治疗的患者和1例（2.0%）使用优猛茁治疗的患者中检测到抗生长激素抗体，其生长模式与队列中的其他患者无明显差异。新型生物类似药rhGH Valtropin的1年疗效和安全性概况与对照rhGH优猛茁相当。Valtropin可用于治疗GHD儿童，长期数据将全面确立其疗效和安全性概况。
