MITIGATE
Trial question
What is the role of inebilizumab, an anti-CD19 monoclonal antibody, in patients with IgG4-related disease?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 135
135 patients (47 female, 88 male).
Inclusion criteria: adult patients with active IgG4-related disease.
Key exclusion criteria: history of solid organ or cell-based transplantation or known immunodeficiency disorder; active malignancy; receipt of any biologic B-cell-depleting therapy or non-depleting B-cell-directed therapy in the past 6 months; eGFR < 30 mL/min/1.73 m².
Interventions
N=68 inebilizumab (intravenous infusion of 300 mg on days 1 and 15 and week 26 for a 52-week treatment period).
N=67 placebo (matching placebo on days 1 and 15 and week 26 for a 52-week treatment period).
Primary outcome
Disease flares
10%
60%
60.0 %
45.0 %
30.0 %
15.0 %
0.0 %
Inebilizumab
Placebo
Significant
decrease ▼
NNT = 2
Significant decrease in disease flares (10% vs. 60%; HR 0.13, 95% CI 0.06 to 0.28).
Secondary outcomes
Significant decrease in annualized flare rate (0.1 vs. 0.71; RR 0.14, 95% CI 0.06 to 0.31).
Significant increase in flare-free, treatment-free complete remission at week 52 (57.4% vs. 22.4%; OR 4.68, 95% CI 2.21 to 9.91).
Significant increase in flare-free, corticosteroid-free complete remission at week 52 (58.8% vs. 22.4%; OR 4.96, 96% CI 2.34 to 10.52).
Safety outcomes
No significant difference in at least one adverse event.
Conclusion
In adult patients with active IgG4-related disease, inebilizumab was superior to placebo with respect to disease flares.
Reference
John H Stone, Arezou Khosroshahi, Wen Zhang et al. Inebilizumab for Treatment of IgG4-Related Disease. N Engl J Med. 2025 Mar 27;392(12):1168-1177.
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