ECE2022 Rapid Communications Rapid Communications 2: Adrenal and Cardiovascular Endocrinology 1 (8 abstracts)
Fertility in congenital adrenal hyperplasia (CAH) patients on modified release hydrocortisone capsules (MRHC, Efmody)
Lea Tschaidse 1 , Marcus Quinkler 2 , Wiebke Arlt 3 , Aude Brac De La Perriere 4 , Angelica Linden Hirschberg 5 , Anders Juul 6 , Ashwini Mallappa 7 , Deborah P Merke 8 , John DC Newell-Price 9 , Colin Graham Perry 10 , Alessandro Prete 3 , Aled Rees 11 , Monica Stikkelbroeck 12 , Philippe A Touraine 13 , Helen Coope 14 , John Porter 14 , Richard John M Ross 14 & Nicole Reisch 1
1Endokrinologie, Nephrologie und weitere Sektionen - Medizinische Klinik und Poliklinik IV - Campus Innenstadt, München, Germany; 2Endocrinology in Charlottenburg, Berlin, Germany; 3University of Birmingham, United Kingdom; 4Louis Pradel Hospital, Bron, France; 5Karolinska Institute, Sweden; 6Rigshospitalet, København, Denmark; 7AstraZeneca, Gaithersburg, United States; 8NIH Clinical Center, Bethesda, United States; 9The University of Sheffield, United Kingdom; 10Queen Elizabeth University Hospital, United Kingdom; 11Cardiff University, United Kingdom; 12Radboud University Medical Center, Nijmegen, Netherlands; 13University Hospitals Pitié Salpêtrière - Charles Foix, Paris, France; 14Diurnal, United Kingdom
Background: Fertility in CAH women is impaired: 0.25 live births vs 1.8 in the UK population and 45% have irregular menses vs 13.6% in healthy women1. Male fertility is also impaired in CAH with oligospermia reported in 48%2. Treatment of infertility usually involves increasing the glucocorticoid dose to normalise adrenal androgens and progesterone to facilitate ovulation and implantation, respectively. Modified-release hydrocortisone (MRHC) capsules, (Efmody, Diurnal Ltd, Cardiff, UK), replicate the physiological cortisol diurnal rhythm and improve CAH control compared to standard therapy. In the phase 3 randomised study of MRHC versus standard treatment3; 4 women had restoration of menses on MRHC versus 1 on standard treatment but seeking fertility was an exclusion criteria. We have examined fertility in the ongoing MHRC single arm extension study.
Methods: Review of fertility in the ongoing MHRC single arm extension study. Standard therapy dose is given as hydrocortisone dose equivalent (HDE=prednisolone dose 5 & dexamethasone 80).
Results: Twenty-seven of 49 premenopausal women were not using oral or intrauterine contraception. Of these women, 10/27 (37%) reported evidence of improved fertility: 5 reported menstrual regularisation and 5 women reported 6 pregnancies (3 healthy live births, 1 ongoing, 2 miscarriages). In these women the mean(SD) HDE on standard treatment before the study and pregnancy was 29(12) mg and then on MRHC at time of interim analysis or withdrawal due to positive pregnancy test the dose was 28(8) mg. In the 29 men (contraception data not collected), 4 pregnancies occurred in 3 female partners resulting in healthy live births; the baseline mean(SD) HDE dose was 28(3) mg before the study and at time of pregnancy 32(10) mg. Two men had a dose increase from baseline, the 3rd subject had a dose decrease at time of first partner pregnancy, and increase to baseline dose at 2nd same partner pregnancy. 1 man had spermatograms with severe oligospermia and scarce mobile sperm on standard treatment and moderate oligospermia and 45% mobile sperm on MRHC.
Conclusions: Fertility is impaired in women and men with CAH and treatment usually aims to increase glucocorticoid dose. In the MRHC single arm extension study patients reported improved fertility with no increase in glucocorticoid dose in women.
References: 1. Reisch N. Endocrinol Metab Clin North Am 2019 48 619-641.2. King TF. Clin Endocrinol (Oxf) 2016 84 830-836.3. Merke DP. JCEM 2021 106 e2063-e2077.
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