Table 2 Secondary outcomes at week 26 in intention-to-treat population

From: A randomized non-inferiority trial of therapeutic strategy with immunosuppressants versus biologics for Vogt-Koyanagi-Harada disease

Outcome

Cyclosporine-Corticosteroids (N = 56)

Adalimumab-Corticosteroids (N = 54)

Difference (95% CI)a

Improvement in ETDRS score by 15 letters or greater

 No. of patients assessed

43

41

-

 Percentage of patients who achieved in either eye (95% CI)b

37.0 (24.6–55.8)

24.6 (14.0–43.3)

12.4 (−8.1–33.0)

 Percentage of patients who achieved in both eyes (95% CI)b

19.1 (9.9–36.8)

11.0 (4.4–27.6)

8.0 (−8.1–24.2)

Inactive uveitis in both eyes

 No. of patients assessed

43

41

-

 Percentage of patients who achieved (95% CI)b

92.3 (77.8–97.3)

81.7 (60.7–91.5)

10.6 (−3.2–24.4)

Visual field index

 No. of eyes assessed

80

78

-

 Change from baseline (95% CI), %c

10.0 (7.3–12.7)

10.3 (7.6–13.1)

−0.4 (−4.3–3.6)

Mean deviation

 No. of eyes assessed

80

78

-

 Change from baseline (95% CI), dBc

4.1 (3.1–5.1)

4.0 (3.0–5.1)

0.1 (−1.3–1.5)

Pattern standard deviation

 No. of eyes assessed

80

78

-

 Change from baseline (95% CI), dBc

−0.9 (−1.4 to −0.3)

−0.3 (−0.7–0.2)

−0.6 (−1.3–0.1)

Resolution of retinal detachment

 No. of eyes assessedd

26

13

-

 Percentage of eyes with resolution (95% CI)

92.3 (75.9–97.9)

100 (77.2–100)

−7.7 (−24.1–15.8)

Central macular thickness

 No. of eyes assessed

78

64

 

 Change from baseline (95% CI), μmc

−82.7 (−94.0 to −71.4)

−70.0 (−80.9 to −59.1)

−12.7 (−30.4–5.0)

EQ-5D score

 No. of patients assessed

43

41

-

 Change from baseline (95% CI)e

0.068 (0.027–0.110)

0.082 (0.038–0.126)

−0.013 (−0.079–0.052)

VFQ-25 composite score

 No. of patients assessed

43

41

-

 Change from baseline (95% CI)e

20.1 (15.3–24.9)

20.1 (14.8–25.4)

0.0 (−6.7–6.6)

Step-treatment before week 26

 No. of patients assessedf

56

-

-

 No. of patients who received (%)

4 (7.1)

-

-

  1. BCVA best-corrected visual acuity, ETDRS Early Treatment Diabetic Retinopathy Study, EQ-5D European Quality of Life-5 Dimensions, VFQ-25 Visual Functioning Questionnaire-25.
  2. aThe 95% confidence intervals were not adjusted for multiple comparisons.
  3. bThe percentages of patients and the differences between the two groups were adjusted for disease phase, with the use of the log-binomial regression.
  4. cThe least-squares mean changes and between-group differences were adjusted for baseline value, disease phase, and the correlation between eyes of the same patient, with the use of the generalized estimating equation.
  5. dThis end point was assessed in eyes with retinal detachment at baseline and with available data at 26 weeks.
  6. eThe least-squares mean changes and between-group differences were adjusted for baseline value and disease phase, with the use of the generalized estimating equation.
  7. fThis end point was assessed in patients initially assigned to the cyclosporine-corticosteroids group.
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