ADVANCE-CIDP 1
Trial question
What is the role of hyaluronidase-facilitated subcutaneous immunoglobulin for maintenance therapy in chronic inflammatory demyelinating polyneuropathy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 132
132 patients (58 female, 74 male).
Inclusion criteria: adult patients with definite or probable chronic inflammatory demyelinating polyneuropathy treated with IVIG for ≥ 12 weeks.
Key exclusion criteria: focal atypical or pure sensory atypical chronic inflammatory demyelinating polyneuropathy; current or past use of corticosteroids within 8 weeks of screening; use of other immunomodulatory or immunosuppressive treatments within 6 months of screening.
Interventions
N=62 subcutaneous immunoglobulin (human IgG 10% with recombinant human hyaluronidase at the same dose and interval as the patient's pre-randomization monthly equivalent IVIG).
N=70 placebo (albumin 0.25% solution together with recombinant human hyaluronidase).
Primary outcome
Relapse rate
9.7%
31.4%
31.4 %
23.5 %
15.7 %
7.8 %
0.0 %
Subcutaneous
immunoglobulin
Placebo
Significant
decrease ▼
NNT = 4
Significant decrease in relapse rate (9.7% vs. 31.4%; ARD -21.8, 95% CI -34.5 to -7.9).
Secondary outcomes
No significant difference in patients with functional worsening (37.5% vs. 54.4%; ARD -16.9, 95% CI -33.02 to 0.69).
Significantly lower reduction in least-square mean Rasch-built Overall Disability Scale centile score (0.9 vs. 6.1; AD -5.2 , 95% CI -9.9 to -0.5).
Safety outcomes
Significant differences in treatment-related adverse events (79.0% vs. 57.1%), injection/infusion site reactions (38.7% vs. 11.4%), nausea (11.3% vs. 2.9%), pyrexia (11.3% vs. 3.4%), and dizziness (6.5% vs. 1.4%).
Conclusion
In adult patients with definite or probable chronic inflammatory demyelinating polyneuropathy treated with IVIG for ≥ 12 weeks, subcutaneous immunoglobulin was superior to placebo with respect to relapse rate.
Reference
Vera Bril, Robert D M Hadden, Thomas H Brannagan rd et al. Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial. J Peripher Nerv Syst. 2023 Sep;28(3):436-449.
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