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Effectiveness of intravenous methylprednisolone pulse in patients with severe microscopic polyangiitis and
Satoshi Omura1, Takashi Kida1, Hisashi Noma2
1Inflammation and Immunology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
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.
Insights
Higher doses of intravenous methylprednisolone (IVMP) may reduce mortality in severe microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA). This study suggests IVMP 1.0 g/day pulse therapy could improve outcomes for these rare autoimmune diseases.
Area of Science:
- Rheumatology
- Nephrology
- Clinical Pharmacology
Background:
- Microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA) are severe autoimmune diseases often requiring aggressive treatment.
- Intravenous methylprednisolone (IVMP) pulse therapy is a common treatment, but optimal dosing for severe cases remains debated.
Purpose of the Study:
- To compare the effectiveness and safety of two different IVMP pulse doses (0.5 g/day vs. 1.0 g/day) against no IVMP in patients with severe MPA or GPA.
- To evaluate the impact of IVMP dosing on mortality, kidney failure, relapse, and infection rates.
Main Methods:
- An emulated target trial was conducted using nationwide registry data from Japan.
- 201 patients with severe glomerulonephritis or diffuse alveolar hemorrhage were pseudo-randomized into non-IVMP, IVMP 0.5 g/day, and IVMP 1.0 g/day groups.
- Propensity score-based overlap weighting and Cox/Fine-Gray models were used to estimate treatment effects on mortality and other outcomes.
Main Results:
- The 1.0 g/day IVMP group showed a significantly lower hazard ratio for all-cause mortality (0.07; 95% CI: 0.01, 0.41) compared to the non-IVMP group.
- While not statistically significant, trends suggested potential benefits for the 1.0 g/day dose regarding mortality/kidney failure and serious infections.
- Higher doses did not appear to increase the risk of severe relapse compared to no IVMP.
Conclusions:
- Intravenous methylprednisolone 1.0 g/day pulse therapy may be more effective in reducing 48-week mortality for patients with severe MPA and GPA.
- Further research is warranted to confirm these findings and establish optimal IVMP dosing strategies for severe ANCA-associated vasculitis.
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