Nicole P C Konijn1, Lilian H D van Tuyl2, Maarten Boers3, Peter M van de Ven4, Debby den Uyl2, Marieke M Ter Wee3, Pit Kerstens5, Alexandre E Voskuyl2, Dirkjan van Schaardenburg6, Willem F Lems7, Michael T Nurmohamed7. 1. Department of Rheumatology, Amsterdam Rheumatology and immunology Center n.konijn@vumc.nl. 2. Department of Rheumatology, Amsterdam Rheumatology and immunology Center. 3. Department of Rheumatology, Amsterdam Rheumatology and immunology Center Department of Epidemiology & Biostatistics, VU University Medical Center. 4. Department of Epidemiology & Biostatistics, VU University Medical Center. 5. Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam Department of Rheumatology, Westfriesgasthuis, Hoorn. 6. Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Academic Medical Center, Amsterdam, The Netherlands. 7. Department of Rheumatology, Amsterdam Rheumatology and immunology Center Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam.
Abstract
OBJECTIVE: To investigate the effect of two different high-dose, step-down prednisolone regimens on body composition in early RA patients after 26 weeks of treatment. METHODS:Prednisolone-naive patients with recent-onset RA (n = 108) were randomized to either COBRA (prednisolone 60 mg/day, tapered to 7.5 mg/day in 6 weeks; MTX and SSZ) or COBRA-light therapy (prednisolone 30 mg/day, tapered to 7.5 mg/day in 8 weeks and MTX). Body composition was assessed at baseline (before or soon after start of treatment) and after 26 weeks with DXA, and recorded as total body mass (TBM), total fat mass (FM), total lean mass (LM) and trunk/peripheral fat ratio. Log-ratio analyses assessed the proportional distribution of TBM (between LM, FM and bone mass) and FM (between trunk, extremities and head). The subgroup of patients with a DXA before start of treatment (n = 38) was analysed separately. RESULTS: In the subgroup of patients with a DXA before start of treatment, TBM increased by 1.6 kg (P < 0.001) and total FM by 1.3 kg (P < 0.001). The trunk/peripheral fat ratio and the proportional distribution of TBM and FM remained stable over time. There were no differences between the treatment groups. Similar results were obtained in the study population as a whole. CONCLUSION: Both high-dose, step-down prednisolone regimens caused increases in TBM, mainly caused by an increase in FM, but we found no fat redistribution from peripheral to central tissues. This absence in fat redistribution contradicts the widely held assumption of rapid adverse effects of prednisolone on body composition in RA. TRIAL REGISTRATION: ISRCTNregistry, http://www.isrctn.com, ISRCTN55552928.
RCT Entities:
OBJECTIVE: To investigate the effect of two different high-dose, step-down prednisolone regimens on body composition in early RApatients after 26 weeks of treatment. METHODS:Prednisolone-naive patients with recent-onset RA (n = 108) were randomized to either COBRA (prednisolone 60 mg/day, tapered to 7.5 mg/day in 6 weeks; MTX and SSZ) or COBRA-light therapy (prednisolone 30 mg/day, tapered to 7.5 mg/day in 8 weeks and MTX). Body composition was assessed at baseline (before or soon after start of treatment) and after 26 weeks with DXA, and recorded as total body mass (TBM), total fat mass (FM), total lean mass (LM) and trunk/peripheral fat ratio. Log-ratio analyses assessed the proportional distribution of TBM (between LM, FM and bone mass) and FM (between trunk, extremities and head). The subgroup of patients with a DXA before start of treatment (n = 38) was analysed separately. RESULTS: In the subgroup of patients with a DXA before start of treatment, TBM increased by 1.6 kg (P < 0.001) and total FM by 1.3 kg (P < 0.001). The trunk/peripheral fat ratio and the proportional distribution of TBM and FM remained stable over time. There were no differences between the treatment groups. Similar results were obtained in the study population as a whole. CONCLUSION: Both high-dose, step-down prednisolone regimens caused increases in TBM, mainly caused by an increase in FM, but we found no fat redistribution from peripheral to central tissues. This absence in fat redistribution contradicts the widely held assumption of rapid adverse effects of prednisolone on body composition in RA. TRIAL REGISTRATION: ISRCTNregistry, http://www.isrctn.com, ISRCTN55552928.
Authors: Samina A Turk; Dirkjan van Schaardenburg; Maarten Boers; Sylvia de Boer; Cindy Fokker; Willem F Lems; Michael T Nurmohamed Journal: PLoS One Date: 2018-03-22 Impact factor: 3.240
Authors: Alissa W Zhang; John T Wiernikowski; Carol Portwine; Lehana Thabane; M Constantine Samaan Journal: Sci Rep Date: 2022-01-26 Impact factor: 4.379