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. Issue 10 (30th September 2022)

• Record Type: Journal Article
• Authors: Krause, Dietmar; Mai, Anna; Klaassen‐Mielke, Renate; Timmesfeld, Nina; Trampisch, Ulrike; Rudolf, Henrik; Baraliakos, Xenofon; Schmitz, Elmar; Fendler, Claas; Klink, Claudia; Boeddeker, Stephanie; Saracbasi‐Zender, Ertan; Christoph, Hans‐Joachim; Igelmann, Manfred; Menne, Hans‐Juergen; Schmid, Albert; Rau, Rolf; Wassenberg, Siegfried; Sonuc, Nilüfer; Ose, Claudia; Schade‐Brittinger, Carmen; Trampisch, Hans J.; Braun, Juergen
• Is Part Of: Arthritis & rheumatology. Volume 74:Issue 10(2022)
• Page Start: 1628
• Page End: 1637
• Publication Date: 2022-09-30
• Subjects: Arthritis -- Periodicals; Rheumatism -- Periodicals; 616.72
• DOI: 10.1002/art.42245
• Languages: English
• ISSNs: 2326-5191

Abstract

Abstract : 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.