Assessment of adrenal function after prednisolone treatment in patients with polymyalgia rheumatica and/or giant cell arteritis - Data from the double edge-replace study

Hansen Simon Boggild; Dreyer Anja Fenger; Nanna Thurmann Jorgensen; Hajir Al-Jorani; Bislev Lise Sofie; Victor Brun Boesen; Stina Willemoes Borresen; Louise Lehmann Christensen; Dorte Glintborg; Ellen Hamge; Merete Lund Hetland; Richard Christian Jensen; Soren Andreas Just; Kresten Keller; Marianne Klose; Kristina Lamgesen; Marie Louise Lund; Jelena Stankovic; Paul M Stewart; Henrik Toft Sorensen; Randi Tei; Anne Voss; Ulla Feldt-Rasmussen; Jens Otto Jorgensen; Marianne Andersen

doi:10.1530/endoabs.99.RC11.5

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Endocrine Abstracts (2024) 99 RC11.5 | DOI: 10.1530/endoabs.99.RC11.5

ECE2024 Rapid Communications Rapid Communications 11: Adrenal and Cardiovascular Endocrinology | Part II (7 abstracts)

Assessment of adrenal function after prednisolone treatment in patients with polymyalgia rheumatica and/or giant cell arteritis – Data from the double edge-replace study

Simon Bøggild Hansen ^1,2 , Anja Fenger Dreyer ^3,4 , Nanna Thurmann Jørgensen ^5,6 , Hajir Al-Jorani ^3,4 , Lise Sofie Bislev ^1,2 , Victor Brun Boesen ⁶ , Stina Willemoes Borresen ⁶ , Louise Lehmann Christensen ^3,4 , Dorte Glintborg ³ , Ellen Hamge ⁷ , Merete Lund Hetland ⁸ , Richard Christian Jensen ³ , Søren Andreas Just ⁹ , Kresten Keller ¹⁰ , Marianne Klose ⁶ , Kristina Lamgesen ^2,11 , Marie Louise Lund ^5,6 , Jelena Stankovic ^1,2 , Paul M Stewart ¹² , Henrik Toft Sørensen ^2,11 , Randi Tei ¹ , Anne Voss ¹³ , Ulla Feldt-Rasmussen ^5,6 , Jens Otto Jørgensen ^1,2 & Marianne Andersen ^3,4

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Author affiliations

¹Aarhus University Hospital, Department of Endocrinology and Internal Medicine, Aarhus N; ²Aarhus University, Department of Clinical Medicine, Aarhus N; ³Odense University Hospital, Department of Endocrinology, Odense C, Denmark; ⁴University of Southern Denmark, Research Unit OPEN, Department of Clinical Research, Odense, Denmark; ⁵University of Copenhagen, Department of Clinical Medicine, Faculty of Health and Clinical Sciences, København, Denmark; ⁶Copenhagen University Hospital, Rigshospitalet, Department of Endocrinology and Metabolism, København, Denmark; ⁷Aarhus University Hospital, Department of Rheumatology, 8200 Aarhus N, Denmark; ⁸Copenhagen University Hospital, Rigshospitalet, Center of Rheumatology and Joint Diseases, Denmark; ⁹Odense University Hospital, Svendborg Hospital, Department of Rheumatology, Denmark, ¹⁰Aarhus University Hospital, Department of Rheumatology, Denmark, ¹¹Aarhus University Hospital, Department of Clinical Epidemiology, Denmark, ¹²University of Leeds, Faculty of Medicine and Health, United Kingdom, ¹³Odense University Hospital, Department of Rheumatology, Denmark

Introduction: Pharmacological glucocorticoid (GC) treatment may cause iatrogenic adrenal insufficiency (GIA), although the prevalence and clinical implications are debated. With 3% of the Danish population redeeming prescriptions of systemic GC annually, the number of patients at risk is potentially extensive. Taken together, there is an unmet need for a prospective and unbiased assessment of the GIA prevalence.

Materials and Methods: The data for this report stem from an ongoing randomized clinical trial – REPLACE. The study systematically investigates adrenocortical function in patients with polymyalgia rheumatica (PMR)/giant cell arteritis (GCA), 2-12 weeks after patients have stopped long-term (>12 weeks) prednisolone treatment. We used the standard 250 µg ACTH test (SST) and analyzed plasma cortisol at 0 and 30 minutes with Liquid Chromatography Mass Spectrometry and/or Electrochemiluminescence immunoassay (Roche Elecsys Cortisol II) with GIA defined as 30-minute cortisol <420 nmol/l. The participants also completed a 30-item disease-specific (AddiQoL-30) quality of life questionnaire with scores from 30 (worst) to 120 (best).

Results: Among 238 patients who were tested, four (1.6%) patients exhibited an insufficient response to the SST. 64/192 (33%) of patients with completed AddiQoL-30 displayed marked symptoms, with an AddiQoL-30 score ≤85 (average for AI patients in literature). AddiQoL-30 score ≤85 was related to lower basal plasma cortisol levels taken at median time 11:30 (IQR 10:09-12:50) of 261 (95%CI: 239-283) nmol/l vs 307 (95%CI: 292-322) nmol/l, P<0.001. Linear regression adjusted for age, sex, BMI and sample time revealed a positive correlation between AddiQoL-30 score and basal cortisol of 1.5 (95%CI: 0.3-2.9) points/50 nmol/l (P=0.015). Risk factors associated with low Addiqol-30 score included upper quartile body fat percentage (OR: 7.3, 95%CI: 1.8-30.7) compared to lower quartile, lower quartile hand grip strength (OR: 6.2, 95%CI: 1.9-20.6) compared to upper quartile and female sex (OR: 1.9, 95%CI: 1.0-3.7) compared to male (all P<0.05). There was no association with age, type of or duration of PMR/GCA, cumulative 6-month prednisolone exposure or levels of C-reactive protein.

Conclusions: • The risk of GIA defined by the SST after finished prednisolone treatment in patients with PMR/GCA is much lower than previously reported, but the prevalence of GIA symptoms is high and accompanied by lower cortisol levels.

• It remains to be experimentally tested, if patients with symptoms attributable to adrenal insufficiency after planned cessation of prednisolone treatment benefit from hydrocortisone replacement therapy.

• Our data add important information about the so-called steroid withdrawal syndrome, which merits future research.EudraCT (2020-006121-65).

Funding: NNF20OC0063280