Safety and efficacy of somapacitan in adults with growth hormone deficiency who were switched from daily growth hormone therapy: A systematic review and meta-analysis

Abstract

Background: The safety and efficacy of somapacitan, a novel long-acting growth hormone (GH) formulation, in adults with GH deficiency (GHD) remain insufficiently explored in systematic reviews and meta-analyses (SR/MA). We aimed to fill this knowledge gap. Methods: Databases were searched to identify RCTs and real-world studies involving adults with GHD who had previously been treated with daily GH and switched to once-weekly somapacitan. The primary outcome was the risk of adverse events (AEs); additional outcomes included treatment satisfaction, body composition measures, and insulin-like growth factor-1 standard deviation scores (IGF-1 SDS). Results: This SR/MA included five studies (N = 297); four RCTs (n = 286) with a daily GH comparator group were meta-analyzed. Compared to daily GH, somapacitan increased the risk of all AEs (RR 1.31, 95 % CI [1.07, 1.61], P = 0.01), but not the risk of serious AEs or other specific AEs. Glucose homeostasis was less affected by somapacitan, indicated by a lesser increment in HbA1c in the somapacitan group and larger increases in fasting insulin and HOMA-IR in the daily GH group. The convenience score increased more with somapacitan, while effectiveness and satisfaction scores changed similarly in both groups. No differences in body composition changes were observed, but somapacitan improved lumbar spine bone mineral content and density in one study. By the end, IGF-1 SDS values were comparable (MD -0.05 [−0.24, 0.15], P = 0.64). Conclusion: Somapacitan is as effective as daily GH in treating adults with GHD, with a reasonable safety profile and modest benefits for glucose homeostasis, as well as treatment convenience.