Subcutaneous Leuprolide Acetate Safe in Suppressing Pubertal Maturation in Central Precocious Puberty

Six-month treatment with subcutaneous leuprolide acetate was found to effectively suppress clinical signs of pubertal maturation in children with central precocious puberty, according to the results of research presented at the 30th Annual Scientific and Clinical Congress of the American Association of Clinical Endocrinologists (ENVISION 2021).

Researchers presented a secondary analysis of data from a phase 3 trial (ClinicalTrials.gov Identifier: NCT02452931) evaluating 6-month subcutaneous leuprolide acetate 45 mg for central precocious puberty. Data analyzed included bone age advancement, weight, body mass index (BMI), pubertal maturation, and predicted adult height.

The study cohort included 62 children (60 girls) with central precocious puberty who were treatment naive. The participants received 2 doses of subcutaneous leuprolide acetate 45 mg at 24-week intervals. Assessment of mean bone age, weight, BMI, and predicted adult height was conducted prior to treatment and at weeks 24 and 48.

Bone age was determined through left hand and wrist radiographs using the Greulich and Pyle method; the rate of bone age advancement was determined through the ratio of bone age to chronological age. The investigators categorized pubertal maturation using the Tanner staging system.

At the beginning of treatment, mean patient age was 7.5±0.1 years. Throughout treatment, the bone age to chronological age ratio declined from 1.4±02 at baseline to 1.3±0.1 at 24 weeks to 1.3±0.1 at 48 weeks. BMI was stable throughout the study, although mean weight increased 8.7% from baseline to week 24 and 16.9% from baseline to week 48.

Among girls, Tanner breast stages 1 and 2 development increased from 9% at baseline to 37% at week 48. The proportion of girls with advanced Tanner development — stages 4 and 5 — decreased from 18% to 5% between baseline and week 48.

Predicted adult height among participants increased from 157±1.0 cm at baseline to 160±1.0 cm at week 48, while growth velocity decreased 39% and 32% at weeks 24 and 48, respectively.

The investigators noted the beneficial features of the treatment, including small injection volume and twice-yearly dosing, which may lead to improved adherence and subsequently improved clinical outcomes.

“Six-month 45 mg subcutaneous leuprolide acetate is a promising addition to existing treatment options for [central precocious puberty],” the researchers wrote, adding that treatment effectively suppressed [luteinizing hormone], suppressed clinical signs of pubertal maturation, and demonstrated a “good safety profile.”

Disclosure: This clinical trial was supported by Tolmar Pharmaceuticals, Inc. Please see the original reference for a full list of authors’ disclosures.

Reference

Benson M, Boldt-Houle D, Atkinson S, Klein K. 6-month subcutaneous leuprolide acetate effectively suppresses clinical signs of puberty in children with central precocious puberty. Presented at: 2021 AACE Virtual Annual Meeting, May 26-29, 2021.