Effectiveness of intravenous methylprednisolone pulse in patients with severe microscopic polyangiitis and granulomatosis with polyangiitis

• Published in: Rheumatology (Oxford, England) Vol. 63; no. 9; pp. 2484 - 2493
• Main Authors: Omura, Satoshi, Kida, Takashi, Noma, Hisashi, Inoue, Hironori, Sofue, Hideaki, Sakashita, Aki, Kadoya, Masatoshi, Nakagomi, Daiki, Abe, Yoshiyuki, Takizawa, Naoho, Nomura, Atsushi, Kukida, Yuji, Kondo, Naoya, Yamano, Yasuhiko, Yanagida, Takuya, Endo, Koji, Hirata, Shintaro, Matsui, Kiyoshi, Takeuchi, Tohru, Ichinose, Kunihiro, Kato, Masaru, Yanai, Ryo, Matsuo, Yusuke, Shimojima, Yasuhiro, Nishioka, Ryo, Okazaki, Ryota, Takata, Tomoaki, Ito, Takafumi, Moriyama, Mayuko, Takatani, Ayuko, Miyawaki, Yoshia, Ito-Ihara, Toshiko, Yajima, Nobuyuki, Kawaguchi, Takashi, Hirano, Aiko, Fujioka, Kazuki, Fujii, Wataru, Seno, Takahiro, Wada, Makoto, Kohno, Masataka, Kawahito, Yutaka
• Format: Journal Article
• Language: English
• Published: England 01.09.2024
• Subjects: Intravenous methylprednisolone pulse; Granulomatosis with polyangiitis; Microscopic polyangiitis; Observational study; Target trial emulation
• ISSN: 1462-0324; 1462-0332; 1462-0332
• DOI: 10.1093/rheumatology/keae219

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). 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-randomised 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 death, and the secondary outcomes were composite all-cause death 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. In this emulated target trial, of 201 eligible patients (MPA, 175; GPA, 26), 6 (2.8%) died, 4 (2.0%) had kidney failure, 11 (5.3%) had severe relapse, and 40 (19.8%) 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 death = 0.46 (95% confidence interval [95%CI]: 0.07-2.81) and 0.07 (95%CI: 0.01-0.41); all-cause death/kidney failure = 1.18 (95%CI: 0.26-5.31) and 0.59 (95%CI: 0.08-4.52); subdistribution HRs for severe relapse = 1.26 (95%CI: 0.12-13.70) and 3.36 (95%CI: 0.49-23.29); and serious infection = 1.88 (95%CI: 0.76-4.65) and 0.94 (95%CI: 0.28-3.13). IVMP 1.0 g/day pulse may improve 48-week mortality in patients with severe MPA/GPA.