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Table 1 Summary of treatment-emergent adverse events incidence rate per 100 patient-years in patients who received upadacitinib over 84 weeks (safety analysis set)

From: Efficacy and safety of upadacitinib over 84 weeks in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE)

AE, incidence (n/100 PY)

Upadacitinib 7.5 mg QD (n = 65)

Upadacitinib 15 mg QD (n = 64)

Upadacitinib 30 mg QD (n = 66)

AEs

64 (316.8)

64 (369.9)

66 (458.3)

Serious AEs

13 (10.8)

17 (15.3)

20 (20.3)

AEs leading to discontinuation of study drug

6 (4.6)

8 (6.4)

20 (18.6)

Deaths

0

0

2 (1.8)

Infection

52 (117.1)

57 (140.0)

58 (167.1)

 Serious infection

6 (4.7)

8 (6.7)

13 (12.7)

 Opportunistic infection

1 (0.8)

4 (3.3)

8 (7.6)

 Herpes zoster

9 (7.3)

14 (12.3)

16 (16.5)

 Active/latent tuberculosis

0

0

1 (0.9)

Malignancy (incl. NMSC)

0

1 (0.8)

1 (0.9)

Hepatic disorder

7 (5.8)

7 (6.1)

8 (8.1)

Gastrointestinal perforation

0

1 (0.8)

1 (0.9)

MACE

1 (0.8)

0

1 (0.9)

Adjudicated VTE

0

0

1 (0.9)

Anemia

0

2 (1.6)

5 (4.9)

Neutropenia

1 (0.8)

2 (1.7)

7 (7.1)

Lymphopenia

5 (3.9)

7 (5.9)

8 (7.8)

CPK elevation

5 (4.0)

7 (6.1)

8 (8.2)

Renal dysfunction

0

0

1 (0.9)

  1. Two subjects treated with placebo in period 1 discontinued treatment and thus were not included in the safety analysis set
  2. AE adverse event, CPK creatine phosphokinase, MACE, major adverse cardiovascular event, NMSC nonmelanoma skin cancer, PY patient-years, QD once daily, VTE, venous thromboembolism
  3. Includes non-treatment-emergent deaths
  4. Defined as cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke