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Table 2 Outcomes after 8, 24 and 52 weeks of treatment with Secukinumab

From: Effectiveness and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a 52-week real-life study in an Italian cohort

 

All patients

AS patients

PsA patients

Effectiveness

   

Week 8

   

ASDAS-CRP or DAS28-CRP value, mean ± SD (median ± IQR)

-

2.5 ± 0.8 (2.1 ± 1.5)

4.2 ± 0.85 (4 ± 0.6)

(at least) Low disease activity, N. (%)

15 (18)

11 (38)

4 (7)**

Inactive disease or Remission, N. (%)

0 (0)

0 (0)

0 (0)

Change in ASDAS-CRP or DAS28-CRP, mean ± SD (median ± IQR)

-

-1.1 ± 0.75 (-1.5 ± 1.6)

-1.6 ± 0.9 (-1.6 ± 0.95)

(at least) CII or Moderate response, N. (%)

67 (79)

19 (65.5)

48 (86)*

Major improvement or Good response, N. (%)

4 (5)

0 (0)

4 (7)

Week 24

   

ASDAS-CRP or DAS28-CRP value, mean ± SD (median ± IQR)

-

1.7 ± 0.8 (1.2 ± 0.6)

2.7 ± 0.8 (2.5 ± 0.85)

(at least) Low disease activity, N. (%)

58 (68)

19 (65.5)

39 (70)

Inactive disease or Remission, N. (%)

39 (46)

13 (45)

26 (46)

Change in ASDAS-CRP or DAS28-CRP, mean ± SD (median ± IQR)

-

-2 ± 0.8 (-2.3 ± 0.65)

-3.1 ± 1.1 (-3.1 ± 1.3)

(at least) CII or Moderate response, N. (%)

70 (82)

21 (72)

49 (87.5)

Major improvement or Good response, N. (%)

55 (65)

16 (55)

39 (70)

Week 52

   

ASDAS-CRP or DAS28-CRP value, mean ± SD (median ± IQR)

-

1.3 ± 0.5 (1.2 ± 0)

2.2 ± 0.7 (2.2 ± 0.45)

(at least) Low disease activity, N. (%)

64 (75)

20 (69)

44 (79)

Inactive disease or Remission, N. (%)

57 (67)

19 (65.5)

38 (68)

Change in ASDAS-CRP or DAS28-CRP, mean ± SD (median ± IQR)

-

-2.3 ± 0.6 (-2.4 ± 0.3)

-3.6 ± 0.9 (-3.6 ± 1.2)

(at least) CII or Moderate response, N. (%)

67 (79)

20 (69)

47 (84)

Major improvement or Good response, N. (%)

63 (74)

19 (65.5)

44 (79)

Retention rate (Drug survival after 52 weeks), N. (%)

64 (75)

20 (69)

44 (79)

Safety

   

Serious adverse events, N.

0

0

0

Injection-site reactions, N.

4

1

3

  1. ASDAS- and DAS28-based disease activity states:
  2. - Low disease activity: ASDAS < 2.1; DAS28 ≤ 3.2.
  3. - Inactive disease: ASDAS < 1.3. Remission: DAS28 < 2.6.
  4. ASDAS-based (ASAS-EULAR) response criteria (for AS patients) [Ref. 21]:
  5. - Clinically important improvement (CII): ASDAS change compared to baseline ≥-1.1
  6. - Major improvement: ASDAS change ≥-2
  7. - No improvement: ASDAS change <-1.1
  8. DAS28-based (EULAR) response criteria (for PsA patients) [Ref. 22]:
  9. - Moderate response: DAS28 change compared to baseline >-1.2 with current DAS28 value > 3.2 or DAS28 change >-0.6 to ≤-1.2 with current DAS28 ≤ 5.1.
  10. - Good response: DAS28 change >-1.2 with current DAS28 ≤ 3.2.
  11. - No response: DAS28 change ≤-0.6 or DAS28 change >-0.6 to ≤-1.2 with current DAS28 value > 5.1
  12. (AS vs. PsA) * P < 0.05 (= 0.0484); ** P < 0.001 (= 0.0008)