Cyclosporine versus adalimumab added to corticosteroids for Vogt-Koyanagi-Harada disease
Purpose
To compare effectiveness of cyclosporine versus adalimumab added to corticosteroids for the treatment of Vogt-Koyanagi-Harada disease.
Methods
We randomly assigned 110 patients (27 early-phase and 83 late-phase VKH disease) to receive cyclosporine plus corticosteroids or adalimumab plus corticosteroids in a 1:1 ratio with disease phase as a stratification factor. The primary outcome was the change from baseline in best corrected visual acuity (BCVA) measured as Early Treatment Diabetic Retinopathy Study (ETDRS) score at week 26. The minimal clinically important difference for changes in ETDRS score is -7 letters, which constituted the margin of non-inferiority for cyclosporine plus corticosteroids. We analyzed the data from early and late-phase VKH patients as two separate studies.
Results
In early-phase VKH disease, the primary outcome was 12.1 letters (95% CI, 8.5 to 15.7) in the cyclosporine-corticosteroids group and 13.0 letters (95% CI, 9.1 to 16.9) in the adalimumab-corticosteroids group (difference, -0.8; 95% CI, -6.1 to 4.5). In late-phase VKH disease, the primary outcome was 7.2 letters (95% CI, 3.4 to 11.0) in the cyclosporine-corticosteroids group and 1.5 letters (95% CI, -2.3 to 5.3) in the adalimumab-corticosteroids (difference, 5.7; 95% CI, 0.2 to 11.2).
Conclusion
Cyclosporine plus corticosteroids was non-inferior to adalimumab plus corticosteroids on the basis of primary results of visual acuity at 26 weeks, regardless of early or late phase.
Conflict of interest
No
Authors 1
Last name
ZHONG
Initials of first name(s)
Z
Department
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Authors 2
Last name
Dai
Initials of first name(s)
L
Department
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Authors 3
Last name
Wu
Initials of first name(s)
Q
Department
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Authors 4
Last name
Gao
Initials of first name(s)
Y
Department
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Authors 5
Last name
Pu
Initials of first name(s)
Y
Department
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Authors 6
Last name
Su
Initials of first name(s)
G
Department
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Authors 7
Last name
Lu
Initials of first name(s)
X
Department
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Authors 8
Last name
Zhang
Initials of first name(s)
F
Department
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Authors 9
Last name
Tang
Initials of first name(s)
C
Department
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Authors 10
Last name
Yang
Initials of first name(s)
P
Department
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
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