Abiraterone acetate to lower androgens in women with classic 21-hydroxylase deficiency
Open accessAbstract
CONTEXT: Chronic supraphysiological glucocorticoid therapy controls the androgen excess of 21-hydroxylase deficiency (21OHD) but contributes to the high prevalence of obesity, glucose intolerance, and reduced bone mass in these patients. Abiraterone acetate (AA) is a prodrug for abiraterone, a potent CYP17A1 inhibitor used to suppress androgens in the treatment of prostate cancer. OBJECTIVE: The objective of the study was to test the hypothesis that AA added to physiological hydrocortisone and 9α-fludrocortisone acetate corrects androgen excess in women with 21OHD without causing hypertension or hypokalemia. DESIGN: This was a phase 1 dose-escalation study. SETTING: The study was conducted at university clinical research centers. PARTICIPANTS: We screened 14 women with classic 21OHD taking hydrocortisone 12.5-20 mg/d to enroll six participants with serum androstenedione greater than 345 ng/dL (>12 nmol/L). INTERVENTION: AA was administered for 6 days at 100 or 250 mg every morning with 20 mg/d hydrocortisone and 9α-fludrocortisone acetate. MAIN OUTCOME MEASURE: The primary endpoint was normalization of mean predose androstenedione on days 6 and 7 (< 230 ng/dL [<8 nmol/L)] in greater than 80% of participants. Secondary end points included serum 17-hydroxyprogesterone and testosterone (T), electrolytes, plasma renin activity, and urine androsterone and etiocholanolone glucuronides. RESULTS: With 100 mg/d AA, mean predose androstenedione fell from 764 to 254 ng/dL (26.7-8.9 nmol/L). At 250 mg/d AA, mean androstenedione normalized in five participants (83%) and decreased from 664 to 126 ng/dL (23.2-4.4 nmol/L), meeting the primary end point. Mean androstenedione declined further during day 6 to 66 and 38 ng/dL (2.3 and 1.3 nmol/L) at 100 and 250 mg/d, respectively. Serum T and urinary metabolites declined similarly. Abiraterone exposure was strongly negatively correlated with mean androstenedione. Hypertension and hypokalemia were not observed. CONCLUSION: AA 100-250 mg/d added to replacement hydrocortisone normalized several measures of androgen excess in women with classic 21OHD and elevated serum androstenedione.
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Androstenedione normalized in 5 of 6 women when abiraterone was added to physiologic doses of glucocorticoid and fludrocortisone.
“Androstenedione normalized in 5 of 6 women when abiraterone was added to physiologic doses of glucocorticoid and fludrocortisone, showing promising results.”
From Congenital adrenal hyperplasia (2017) · cites this paper as [145]
On the higher dose of abiraterone, five of six patients demonstrated normalization of androstenedione, which decreased from a mean serum concentration of 664 ng/dl to 126 ng/dl.
“On the higher dose of abiraterone, five of six patients demonstrated normalization of androstenedione, which decreased from a mean serum concentration of 664 ng/dl to a mean concentration of 126 ng/dl (23.2 nmol/l to 4.4 nmol/l).”
From Management challenges and therapeutic advances in congenital adrenal hyperplasia (2022) · cites this paper as [121]
Abiraterone also reduced serum levels of testosterone and 11-oxygenated androgens and urinary androgen metabolites.
“Abiraterone also reduced serum levels of testosterone and 11-oxygenated androgens and urinary androgen metabolites121,122.”
From Management challenges and therapeutic advances in congenital adrenal hyperplasia (2022) · cites this paper as [121]
Abiraterone adjunct therapy was safe and well tolerated over the short-term study duration.
“This adjunct therapy was safe and well tolerated over the short-term study duration121.”
From Management challenges and therapeutic advances in congenital adrenal hyperplasia (2022) · cites this paper as [121]
In that trial, a 250 mg daily dose brought predose androstenedione into the normal range by day 7 for every participant.
“At 250 mg/d, abiraterone acetate normalized the predose androstenedione on day 7 in all participants.”
From Congenital Adrenal Hyperplasia Due to Steroid 21-Hydroxylase Deficiency: An Endocrine Society* Clinical Practice Guideline (2018) · cites this paper as [319]
A phase 1 open-label multiple-dose study enrolled six adult women with classic CAH and high serum androstenedione concentrations.
“A phase 1, open-label, multiple-dose study of abiraterone acetate enrolled six adult women with classic CAH and high serum androstenedione concentrations (.345 ng/dL or .12nmol/L) (319).”
From Congenital Adrenal Hyperplasia Due to Steroid 21-Hydroxylase Deficiency: An Endocrine Society* Clinical Practice Guideline (2018) · cites this paper as [319]
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- Authors
- Auchus, R. J., Buschur, E. O., Chang, A. Y., Hammer, G. D., Ramm, C., Madrigal, D., Wang, G., Gonzalez, M., Xu, X. S., Smit, J. W., Jiao, J., & Yu, M. K.
- Affiliations
- University of Michigan (US)
- Mayo Clinic (US)
- Janssen Research & Development (United States) (US)
- Janssen (Belgium) (BE)
- ORCID
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2014-08-01
- Volume
- 99
- Issue
- 8
- Pages
- 2763-2770
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- PMC
- PMC4121028
- OpenAlex
- W2079872982
- Cited by
- 97
- References
- 42
- Citations by year
- 2026: 8 · 2025: 5 · 2024: 16 · 2023: 8 · 2022: 10 · 2021: 8 · 2020: 5 · 2019: 2 · 2018: 11 · 2017: 7 · 2016: 6 · 2015: 8 · 2014: 3
- FWCI
- 3.28
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (T32DK007245, P30DK020572, R01DK062027)
- National Center for Research Resources (UL1RR024986)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Sexual Differentiation and Disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Keywords
- abiraterone, 21-hydroxylase deficiency, congenital adrenal hyperplasia, hyperandrogenism, CYP17 inhibition, androstenedione, cortisol, fludrocortisone acetate, women, dose escalation, hypertension, hypokalemia, 17-hydroxyprogesterone, testosterone
- MeSH terms
- Abiraterone Acetate, Adrenal Hyperplasia, Congenital, Adult, Androgen Antagonists, Androgens, Androstadienes, Androstenedione, Androsterone, Desoxycorticosterone, Dose-Response Relationship, Drug, Female, Humans, Hydrocortisone, Treatment Outcome, 17-alpha-Hydroxyprogesterone
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