Subcutaneous Leuprolide Acetate Shows Promise for Treatment of CPP

A 6-month, 45 mg dose of subcutaneous leuprolide acetate treatment has shown efficacy in treating central precocious puberty (CPP), according to research recently presented at the Endocrine Society’s ENDO 2021 conference, held virtually from March 20 to 23, 2021.

This study included an intent-to-treat population of 62 children (2 boys, 60 girls) with treatment-naive CPP (2 boys, 60 girls), all of whom were given 2 doses of 45 mg subcutaneous leuprolide acetate at 6-month intervals. Within this population, the mean age at initial treatment was 7.5 years plus or minus 0.9 years (range 4 years to -9 years).

Bone age was measured using radiography of the left hand and wrist, with a blinded central reader assessing the scans. A ratio of bone age to chronological age (BA/CA) was used to determine the rate of bone age advancement, while the Tanner staging system was used to assess pubertal maturation through external genitalia, pubic hair, and breast development. The safety profile of the treatment was also assessed.

Over the course of treatment, BA/CA declined from 1.4 plus or minus 0.2 at baseline to 1.3 plus or minus 0.1 at weeks 24 and 48. Body mass index remained stable throughout the course of the study, despite mean weight increases (week 0 to 24, 8.9%; week 0 to 48, 17.3%).

At the beginning of the study, 9% of girls had early breast development (Tanner stages 1 and 2); by week 48the end, this figure was 36%. Conversely, the proportion of girls with late breast development (Tanner stages 4 and 5) decreased from 19% to 7% over the course of the study.

The external genitalia of the 2 boys regressed from Tanner stagte 3 to stage 2 by weekover the 48 weeks of the study, while pubic hair development was stable for 80% of the study population and decreased for 7% by the end of the study. Of the 53 treatment-emergent adverse events, 52 were mild or moderate.

The study authors concluded that 6-month, 45 mg subcutaneous regimen of leuprolide acetate represents a promising treatment option for CPP. The treatment demonstrated a favorable safety profile and suppressed both luteinizing hormone and pubertal maturation. Furthermore, the study authors noted “subcutaneous administration, small injection volume, and twice-a-year dosing” as additional benefits.

This research may inform the suggested shift in CPP therapy toward subcutaneous injections and longer-acting formulations.

Reference

Eugster EA, Atkinson S, Boldt-Houle D, Miller BS. 6-month subcutaneous leuprolide acetate effectively suppresses clinical signs of puberty in children with central precocious puberty. Poster presented at: ENDO 2021 virtual conference; March 20-23, 2021. Session P34.