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The Efficacy of Short‐Term Bridging Strategies With High‐ and Low‐Dose Prednisolone on Radiographic and Clinical Outcomes in Active Early Rheumatoid Arthritis: A Double‐Blind , Randomized, Placebo‐Controlled Trial
Author(s) -
Krause Dietmar,
Mai Anna,
KlaassenMielke Renate,
Timmesfeld Nina,
Trampisch Ulrike,
Rudolf Henrik,
Baraliakos Xenofon,
Schmitz Elmar,
Fendler Claas,
Klink Claudia,
Boeddeker Stephanie,
SaracbasiZender Ertan,
Christoph HansJoachim,
Igelmann Manfred,
Menne HansJuergen,
Schmid Albert,
Rau Rolf,
Wassenberg Siegfried,
Sonuc Nilüfer,
Ose Claudia,
SchadeBrittinger Carmen,
Trampisch Hans J.,
Braun Juergen
Publication year - 2022
Publication title -
arthritis and rheumatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.106
H-Index - 314
eISSN - 2326-5205
pISSN - 2326-5191
DOI - 10.1002/art.42245
Subject(s) - medicine , prednisolone , rheumatoid arthritis , erythrocyte sedimentation rate , placebo , rheumatology , confidence interval , randomized controlled trial , gastroenterology , surgery , pathology , alternative medicine
Objective In active early rheumatoid arthritis (RA), glucocorticoids are often used for bridging, due to the delayed action of methotrexate. This study was undertaken to compare the effect of 3 bridging strategies, including high‐dose and low‐dose prednisolone, on radiographic and clinical outcomes. Methods Adult RA patients from 1 rheumatology hospital and 23 rheumatology practices who presented with moderate/high disease activity were randomized (1:1:1) to receive 60 mg prednisolone (high‐dose prednisolone [HDP]) or 10 mg prednisolone (low‐dose prednisolone [LDP]) daily (tapered to 0 mg within 12 weeks) or placebo. The 12‐week intervention period was followed by 40 weeks of therapy at the physicians' discretion. The primary outcome measure was radiographic change at 1 year measured using the total modified Sharp/van der Heijde score (SHS). Disease activity was assessed with the Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28‐ESR). Results Of 395 randomized patients (HDP, n = 132; LDP, n = 131; placebo, n = 132), 375 (95%) remained in the modified intention‐to‐treat analysis. Mean ± SD changes in SHS scores in the 3 groups after 1 year were comparable: mean ± SD 1.0 ± 2.0 units in the HDP group, 1.1 ± 2.2 units in the LDP group, and 1.1 ± 1.5 units in the placebo group. The primary analysis showed no superiority of HDP compared to placebo (estimated difference of the mean change −0.04 [95% confidence interval (95% CI) −0.5, 0.4]). At week 12, the mean DAS28‐ESR differed: −0.6 (95% CI −1.0, −0.2) for HDP versus placebo; –0.8 (95% CI −1.2, −0.5) for LDP versus placebo. At week 52, there was no significant difference in DAS28‐ESR between the 3 groups (range 2.6–2.8). Serious adverse events occurred similarly often. Conclusion Short‐term glucocorticoid bridging therapy at a high dose showed no benefit with regard to progression of radiographic damage at 1 year.