1. Effectiveness of intravenous methylprednisolone pulse in patients with severe microscopic polyangiitis and granulomatosis with polyangiitis.
- Author
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Omura S, Kida T, Noma H, Inoue H, Sofue H, Sakashita A, Kadoya M, Nakagomi D, Abe Y, Takizawa N, Nomura A, Kukida Y, Kondo N, Yamano Y, Yanagida T, Endo K, Hirata S, Matsui K, Takeuchi T, Ichinose K, Kato M, Yanai R, Matsuo Y, Shimojima Y, Nishioka R, Okazaki R, Takata T, Ito T, Moriyama M, Takatani A, Miyawaki Y, Ito-Ihara T, Yajima N, Kawaguchi T, Hirano A, Fujioka K, Fujii W, Seno T, Wada M, Kohno M, and Kawahito Y
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Treatment Outcome, Glucocorticoids administration & dosage, Glucocorticoids therapeutic use, Pulse Therapy, Drug, Administration, Intravenous, Japan, Severity of Illness Index, Proportional Hazards Models, Methylprednisolone administration & dosage, Methylprednisolone therapeutic use, Microscopic Polyangiitis drug therapy, Microscopic Polyangiitis complications, Granulomatosis with Polyangiitis drug therapy, Granulomatosis with Polyangiitis complications
- Abstract
Objectives: To evaluate the effectiveness and safety of two different intravenous methylprednisolone (IVMP) pulse doses in patients with severe microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA)., Methods: We emulated a target trial using observational data from the nationwide registry in Japan. Patients with severe glomerulonephritis or diffuse alveolar haemorrhage were selected and pseudo-randomized into three groups using propensity score-based overlap weighting as follows: non-IVMP, IVMP 0.5 g/day and IVMP 1.0 g/day. The primary outcome was all-cause mortality, and the secondary outcomes were composite all-cause mortality and kidney failure, severe relapse and serious infection from 2 to 48 weeks after treatment initiation. To estimate the treatment effects, the Cox proportional hazard model and Fine-Gray subdistribution hazard model were used., Results: In this emulated target trial, of 201 eligible patients (MPA, 175; GPA, 26), 6 (3%) died, 4 (2.0%) had kidney failure, 11 (5.5%) had severe relapse, and 40 (19.9%) had severe infections. Hazard ratios (HR) for IVMP 0.5 g/day and IVMP 1.0 g/day pulse groups compared with non-IVMP pulse were as follows: all-cause mortality 0.46 (95% CI: 0.07, 2.81) and 0.07 (95% CI: 0.01, 0.41), respectively; all-cause mortality/kidney failure 1.18 (95% CI: 0.26, 5.31) and 0.59 (95% CI: 0.08, 4.52), respectively; subdistribution HRs for severe relapse were 1.26 (95% CI: 0.12, 13.70) and 3.36 (95% CI: 0.49, 23.29), respectively; and for serious infection 1.88 (95% CI: 0.76, 4.65) and 0.94 (95% CI: 0.28, 3.13), respectively., Conclusion: IVMP 1.0 g/day pulse may improve 48-week mortality in patients with severe MPA/GPA., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2024
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