Biweekly therapy inferior to weekly, daily therapy in GHD
PEGylated human growth hormone (PEG-rhGH) therapy in children with growth hormone deficiency (GHD) is inferior to either weekly PEG-rhGH or daily rhGH, according to a study.
In this multicenter, phase IV trial, 585 Tanner stage I children with GHD were randomly assigned to receive 0.20 mg/kg once-weekly or biweekly PEG-rhGH, or 0.25 mg/kg.w rhGH once daily for 26 weeks.
The study’s primary outcome was height SD scores for chronological age (HtSDSCA) at week 26 and safety measurements.
The median HtSDSCA at week 26 changed from -2.75 to -2.78 with weekly PEG-rhGH; from -2.82 to -2.31 with biweekly PEG-rhGH, and from -2.78 to -2.28 with daily rhGH. The difference in HtSDSCA was 0.17 ± 0.28 between weekly and biweekly PEG-rhGH, and 0.17 ± 0.27 between daily rhGH and biweekly PEG-rhGH, which failed to meet the non-inferiority threshold.
The height velocity of children receiving biweekly PEG-rhGH reached 76.42%-90.34% that of children receiving weekly PEG-rhGH and 76.08%-90.60% that of children receiving daily rhGH.
Adverse events were comparable amongst the groups.
Sun C, Lu B, Liu Y, et al. Reduced Effectiveness and Comparable Safety in Biweekly vs. Weekly PEGylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency: A Phase IV Non-Inferiority Threshold Targeted Trial. Front Endocrinol (Lausanne). 2021;12:779365. doi: 10.3389/fendo.2021.779365. PMID: 34899612; PMCID: PMC8655095.