RESEARCH - HPA axis function in RA patients treated with nighttime-release prednisone

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Journal of Rheumatology

Oct 2010

Hypothalamus-Pituitary-Adrenal Axis Function in Patients with

Rheumatoid Arthritis Treated with Nighttime-Release Prednisone

RIEKE ALTEN, GISELA DÖRING, MAURIZIO CUTOLO, ERIKA GROMNICA-IHLE,

STEPHAN WITTE, RAINER STRAUB and FRANK BUTTGEREIT

+ Author Affiliations

From the Department of Internal Medicine, Rheumatology, Clinical

Immunology, Schlosspark-Klinik, Teaching Hospital, Charité University

Medicine, Berlin; Merck KGaA, Darmstadt; Immanuel Krankenhaus,

Berlin-Buch; Nitec Pharma GmbH, Mannheim; University Hospital

Regensburg, Regensburg, Germany; and Research Laboratory and Academic

Unit of Clinical Rheumatology, University of Genoa, Genoa, Italy.

R. Alten, MD, Department of Internal Medicine, Rheumatology, Clinical

Immunology, Schlosspark-Klinik, Teaching Hospital, Charité University

Medicine; G. Döring, MD, Merck KGaA; M. Cutolo, MD, Research

Laboratory and Academic Unit of Clinical Rheumatology, University of

Genoa; E. Gromnica-Ihle, MD, Immanuel Krankenhaus; S. Witte, PhD,

Nitec Pharma GmbH; R.H. Straub, MD, University Hospital Regensburg; F.

Buttgereit, MD, Department of Rheumatology and Clinical Immunology,

Charité University Medicine.

Address correspondence to Dr. R. Alten, Department of Internal

Medicine II, Rheumatology, Clinical Immunology, Schlosspark-Klinik,

Teaching Hospital, Charité University Medicine, Heubnerweg 2, 14059

Berlin, Germany.

Abstract

Objective. To investigate the effects of longterm low-dose

chronotherapy with modified-release (MR) prednisone for rheumatoid

arthritis (RA) on the hypothalamus-pituitary-adrenal (HPA) axis as

part of the Circadian Administration of Prednisone in Rheumatoid

Arthritis (CAPRA-1) study. This consisted of a 3-month

active-controlled phase and a 9-month open-label extension with MR

prednisone including patients previously treated with prednisone

(ClinicalTrials.gov number NCT00146640).

Methods. Corticotropin-releasing hormone (CRH) tests were performed on

28 patients at 3 timepoints: at baseline on prestudy immediate-release

(IR) prednisone, after the 3-month double-blind phase on either IR

prednisone or MR prednisone, and after the 9-month open-label

extension on MR prednisone. Changes of cortisol were assessed and

compared to individual patients’ efficacy and safety data.

Results. The increase (mean, SD) of cortisol plasma concentrations

after injection of corticorelin was 5.5 (4.37) μg/dl on IR prednisone

at baseline (n = 21) and 5.3 (4.07) μg/dl on MR prednisone at 12

months (n = 22). Numbers of normal/suppressed/no response reactions

did not differ among treatments. Switching from IR to MR prednisone

did not influence responses, nor did longterm treatment of up to 12

months with MR prednisone. No worsening of adrenal impairment was

observed on treatment with nighttime-release prednisone in patients

with low responsiveness to CRH testing before the treatment with MR

prednisone.

Conclusion. Treatment with nighttime-release prednisone did not change

adrenocortical function over 12 months. We presume that chronotherapy

with this nighttime-release prednisone may improve the efficacy of

longterm low-dose glucocorticoid treatment in patients with RA.

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Read the full article here:

http://jrheum.org/content/37/10/2025.full

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