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Table 3 TEAEs by Preferred Terma occurring in ≥ 5% of patients in any group in the Phase 3 and LTE studies

From: Efficacy and safety of tofacitinib in an open-label, long-term extension study in patients with psoriatic arthritis who received adalimumab or tofacitinib in a Phase 3 randomized controlled study: a post hoc analysis

 

Phase 3 study

LTE study

Interval

To month 3

To month 12

To month 3

To month 12

 

ADA→

tofacitinib

5 mg BID (N = 91)

Continuing tofacitinib

5 mg BID (N = 89)

ADA→

tofacitinib

5 mg BID (N = 91)

Continuing tofacitinib

5 mg BID (N = 89)

ADA→

tofacitinib

5 mg BID (N = 91)

Continuing tofacitinib

5 mg BID (N = 89)

ADA→

tofacitinib

5 mg BID (N = 91)

Continuing tofacitinib

5 mg BID (N = 89)

ALT increased

n (%)

4 (4.4)

1 (1.1)

7 (7.7)

3 (3.4)

1 (1.1)

0 (0.0)

1 (1.1)

0 (0.0)

IR

(95% CI)

19.7

(5.4–50.3)

4.9

(0.1–27.4)

9.1

(3.6–18.7)

3.7

(0.8–10.9)

5.2

(0.1–28.8)

0.0

(0.0–19.7)

1.7

(0.0–9.4)

0.0

(0.0–6.8)

AST increased

n (%)

3 (3.3)

0 (0.0)

7 (7.7)

0 (0.0)

1 (1.1)

0 (0.0)

1 (1.1)

0 (0.0)

IR

(95% CI)

14.7

(3.0–43.1)

0.0

(0.0–18.0)

9.0

(3.6–18.6)

0.0

(0.0–4.5)

5.2

(0.1–28.8)

0.0

(0.0–19.7)

1.7

(0.0–9.4)

0.0

(0.0–6.8)

Blood creatine phosphokinase increased

n (%)

2 (2.2)

1 (1.1)

3 (3.3)

5 (5.6)

1 (1.1)

1 (1.1)

1 (1.1)

3 (3.4)

IR

(95% CI)

9.8

(1.2–35.2)

4.9

(0.1–27.3)

3.8

(0.8–11.0)

6.3

(2.0–14.7)

5.2

(0.1–28.8)

5.4

(0.1–30.1)

1.7

(0.0–9.4)

5.7

(1.2–16.8)

Headache

n (%)

5 (5.5)

3 (3.4)

7 (7.7)

4 (4.5)

0 (0.0)

1 (1.1)

0 (0.0)

2 (2.3)

IR

(95% CI)

24.9

(8.1–58.0)

15.0

(3.1–43.9)

9.1

(3.7–18.7)

5.1

(1.4–13.0)

0.0

(0.0–18.9)

5.4

(0.1–30.0)

0.0

(0.0–6.2)

3.8

(0.5–13.6)

Hypertension

n (%)

1 (1.1)

0 (0.0)

4 (4.4)

1 (1.1)

2 (2.2)

0 (0.0)

6 (6.6)

2 (2.3)

IR

(95% CI)

4.9

(0.1–27.0)

0.0

(0.0–18.0)

5.0

(1.4–12.9)

1.2

(0.0–6.9)

10.5

(1.3–37.8)

0.0

(0.0–19.7)

10.7

(3.9–23.3)

3.8

(0.5–13.6)

Injection-site erythema

n (%)

5 (5.5)

0 (0.0)

5 (5.5)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

IR

(95% CI)

24.8

(8.0–57.8)

0.0

(0.0–18.0)

6.4

(2.1–15.0)

0.0

(0.0–4.5)

0.0

(0.0–18.9)

0.0

(0.0–19.7)

0.0

(0.0–6.2)

0.0

(0.0–6.8)

Nasopharyngitis

n (%)

5 (5.5)

3 (3.4)

9 (9.9)

6 (6.7)

2 (2.2)

0 (0.0)

8 (8.8)

2 (2.3)

IR

(95% CI)

24.6

(8.0–57.4)

14.9

(3.1–43.6)

11.8

(5.4–22.4)

7.6

(2.8–16.6)

10.4

(1.3–37.5)

0.0

(0.0–19.7)

14.1

(6.1–27.8)

3.8

(0.5–13.6)

Pharyngitis

n (%)

1 (1.1)

0 (0.0)

7 (7.7)

4 (4.5)

1 (1.1)

0 (0.0)

2 (2.2)

0 (0.0)

IR

(95% CI)

4.8

(0.1–26.8)

0.0

(0.0–18.0)

8.8

(3.6–18.2)

5.0

(1.4–12.7)

5.2

(0.1–28.9)

0.0

(0.0–19.7)

3.4

(0.4–12.4)

0.0

(0.0–6.8)

Psoriasis

n (%)

0 (0.0)

0 (0.0)

3 (3.3)

3 (3.4)

1 (1.1)

0 (0.0)

7 (7.7)

1 (1.1)

IR

(95% CI)

0.0

(0.0–17.7)

0.0

(0.0–18.0)

3.7

(0.8–10.9)

3.7

(0.8–10.9)

5.1

(0.1–28.6)

0.0

(0.0–19.7)

12.2

(4.9–25.1)

1.9

(0.1–10.4)

Upper respiratory tract infection

n (%)

2 (2.2)

2 (2.3)

7 (7.7)

10 (11.2)

2 (2.2)

1 (1.1)

4 (4.4)

5 (5.6)

IR

(95% CI)

9.8

(1.2–35.2)

9.9

(1.2–35.8)

8.9

(3.6–18.3)

13.0

(6.2–23.9)

10.4

(1.3–37.4)

5.4

(0.1–29.9)

6.9

(1.9–17.5)

9.7

(3.2–22.7)

  1. aMedDRA (v22.0) coding dictionary applied
  2. Total follow-up time calculated up to the first day of the first event, subject to a risk period of 28 days beyond the last dose or to the data cut-off date. Gaps in dosing between treatment switches or between the Phase 3 and LTE studies are included up to 28 days or to the data cut-off date
  3. ADA: adalimumab, ALT: alanine aminotransferase, AST: aspartate aminotransferase, BID: twice daily, CI: confidence interval, IR: incidence rate, LTE: long-term extension, MedDRA: Medical Dictionary for Regulatory Activities, N: number of evaluable patients, n: number of patients with events, TEAE: treatment-emergent adverse event
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Arthritis Research & Therapy

ISSN: 1478-6362

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