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Table 2 Summary of pooled safety data from secukinumab clinical trials

From: Long-term safety of secukinumab in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post-marketing surveillance data

 

PsO studies

PsA studies

AS studies

Any secukinumab

N = 5181

Any secukinumab

N = 1380

Any secukinumab

N = 794

Total exposure, pt-years

10,416.9

3866.9

1943.1

Min–max exposure (days)

1–1825

8–1827

1–1530

Death, n (%)

9 (0.2)

11 (0.8)

5 (0.6)

Discontinuations due to AEs, n (%)

331 (6.4)

104 (7.5)

58 (7.3)

AEs, EAIR per 100 pt-years (95% CI)

 Any AE

204.4 (198.4, 210.5)

147.0 (138.9, 155.5)

140.1 (129.8, 151.0)

 Any serious AE

6.9 (6.3, 7.4)

7.9 (7.0, 8.9)

6.3 (5.2, 7.6)

Most common AEs1

 Viral URTI2

21.0 (19.9, 22.0)

12.1 (10.9, 13.4)

9.8 (8.4, 11.5)

 Headache

6.2 (5.8, 6.8)

3.8 (3.2, 4.5)

5.3 (4.3, 6.5)

 Diarrhea

3.8 (3.4, 4.2)

3.7 (3.1, 4.4)

5.2 (4.2, 6.4)

 URTI

5.4 (4.9, 5.9)

9.1 (8.1, 10.2)

5.2 (4.2, 6.4)

  1. 1AEs in the secukinumab group that occurred with an IR > 5.0 during the entire safety period in any of the pooled groups
  2. 2Includes cases of common cold (LLT)
  3. AE adverse event, AS ankylosing spondylitis, CI confidence interval, EAIR exposure-adjusted incidence rate per 100 patient-years, IR incidence rate, LLT low-level term, N number of patients in the analysis, n number of patients with a response, PsA psoriatic arthritis, PsO psoriasis, pt patient, URTI upper respiratory tract infection
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Arthritis Research & Therapy

ISSN: 1478-6362

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