title: A randomized, double-blind study to assess the efficacy and safety of valtropin, a biosimilar growth hormone, in children with growth hormone deficiency.
abstract: 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.
authors.affiliation: Endocrinological Scientific Centre, Russian Academy of Science, Moscow, Russia.
authors.forename: Valentina
authors.initials: V
authors.lastname: Peterkova
authors.forename: Ilknur
authors.initials: I
authors.lastname: Arslanoglu
authors.forename: Elena
authors.initials: E
authors.lastname: Bolshova-Zubkovskaya
authors.forename: Tomasz
authors.initials: T
authors.lastname: Romer
authors.forename: Dragan
authors.initials: D
authors.lastname: Zdravkovic
authors.forename: Jürgen
authors.initials: J
authors.lastname: Kratzsch
authors.forename: Hyi-Jeong
authors.initials: HJ
authors.lastname: Ji
authors.forename: Conrad
authors.initials: C
authors.lastname: Savoy
authors.forename: Paul
authors.initials: P
authors.lastname: Saenger
mesh_terms: D001709:Biotechnology / Q000379:methods; D001827:Body Height / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006130:Growth Disorders / Q000188:drug therapy*; D013006:Growth Hormone / Q000008:administration & dosage* / Q000009:adverse effects; D019382:Human Growth Hormone / Q000008:administration & dosage* / Q000009:adverse effects / Q000172:deficiency*; D006801:Humans; D008297:Male; D012441:Saccharomyces cerevisiae; D016896:Treatment Outcome
chemical_list: D019382:Human Growth Hormone; D013006:Growth Hormone