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Table 2 Incidence of TEAEs, SAEs, discontinuations due to AEs, and AESIs occurring up to month 24

From: Efficacy and safety of tofacitinib in patients with rheumatoid arthritis by previous treatment: post hoc analysis of phase II/III trials

 

Tofacitinib 5 mg BID

Tofacitinib 10 mg BID

Placebo

Non-MTX csDMARD-IRa (n = 208)

MTX-IRb (n = 1147)

bDMARD-IR (n = 270)

Non-MTX csDMARD-IRa (n = 247)

MTX-IRb (n = 1192)

bDMARD-IR (n = 289)

Non-MTX csDMARD-IRa (n = 82)

MTX-IRb (n = 774)

bDMARD-IR (n = 223)

TEAEs

 n (%)

146 (70.2)

825 (71.9)

201 (74.4)

174 (70.4)

860 (72.1)

210 (72.7)

35 (42.7)

414 (53.5)

131 (58.7)

 CIRc (95% CI)

118.4 (99.9–139.2)

190.4 (177.6–203.8)

311.0 (269.5–357.1)

136.3 (116.8–158.1)

193.5 (180.7–206.8)

371.9 (323.3–425.7)

264.1 (183.9–367.3)

294.9 (267.2–324.7)

429.5 (359.1–509.7)

SAEs

 n (%)

21 (10.1)

122 (10.6)

21 (7.8)

21 (8.5)

103 (8.6)

20 (6.9)

2 (2.4)

25 (3.2)

10 (4.5)

 CIRc (95% CI)

8.5 (5.2–12.9)

12.5 (10.4–14.9)

12.6 (7.8–19.3)

7.4 (4.6–11.3)

9.9 (8.1–12.0)

12.5 (7.6–19.3)

10.8 (1.3–39.1)

11.6 (7.5–17.1)

20.5 (9.8–37.7)

Discontinuation due to AEs

 n (%)

18 (8.7)

97 (8.5)

25 (9.3)

21 (8.5)

110 (9.2)

25 (8.7)

2 (2.4)

26 (3.4)

10 (4.5)

 CIRc (95% CI)

7.1 (4.2–11.2)

9.6 (7.8–11.7)

14.4 (9.3–21.2)

7.2 (4.5–11.0)

10.3 (8.5–12.4)

15.3 (9.9–22.6)

10.8 (1.3–39.1)

12.0 (7.8–17.5)

20.4 (9.8–37.6)

AESIs

 Serious infection event

  n (%)

7 (3.4)

35 (3.1)

3 (1.1)

4 (1.6)

39 (3.3)

5 (1.7)

1 (1.2)

3 (0.4)

2 (0.9)

  CIRc (95% CI)

2.8 (1.1–5.7)

3.4 (2.4–4.8)

1.7 (0.4–5.0)

1.4 (0.4–3.5)

3.6 (2.6–5.0)

3.0 (1.0–7.1)

5.4 (0.1–30.1)

1.4 (0.3–4.0)

4.1 (0.5–14.7)

Opportunistic infection, excluding tuberculosis

 n (%)

1 (0.5)

1 (0.1)

0 (0.0)

0 (0.0)

6 (0.5)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

 CIRc (95% CI)

0.4 (0.0–2.2)

0.1 (0.0–0.6)

0.0 (0.0–2.1)

0.0 (0.0–1.3)

0.6 (0.2–1.2)

0.0 (0.0–2.3)

0.0 (0.0–19.9)

0.0 (0.0–1.7)

0.0 (0.0–7.5)

Tuberculosis

 n (%)

0 (0.0)

0 (0.0)

0 (0.0)

1 (0.4)

7 (0.6)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

 CIRc (95% CI)

0.0 (0.0–1.4)

0.0 (0.0–0.4)

0.0 (0.0–2.1)

0.3 (0.0–1.9)

0.7 (0.3–1.4)

0.0 (0.0–2.3)

0.0 (0.0–19.9)

0.0 (0.0–1.7)

0.0 (0.0–7.5)

Herpes zoster (non-serious and serious)

 n (%)

3 (1.4)

37 (3.2)

9 (3.3)

10 (4.0)

51 (4.3)

10 (3.5)

0 (0.0)

6 (0.8)

0 (0.0)

 CIRc (95% CI)

1.2 (0.2–3.5)

3.7 (2.6–5.1)

5.3 (2.4–10.0)

3.5 (1.7–6.4)

4.9 (3.6–6.4)

6.3 (3.0–11.6)

0.0 (0.0–19.9)

2.8 (1.0–6.0)

0.0 (0.0–7.5)

Major adverse cardiovascular eventsd

 n (%)

2 (1.1)

3 (0.3)

2 (0.8)

2 (1.0)

5 (0.5)

1 (0.4)

0 (0.0)

1 (0.2)

0 (0.0)

 CIRc (95% CI)

0.8 (0.1–2.9)

0.3 (0.1–0.9)

1.2 (0.1–4.2)

0.7 (0.1–2.6)

0.5 (0.2–1.2)

0.7 (0.0–3.6)

0.0 (0–41.1)

0.7 (0.0–3.7)

0.0 (0.0–8.7)

Malignancies (excluding non-melanoma skin cancer)

 n (%)

1 (0.5)

8 (0.7)

2 (0.7)

1 (0.4)

8 (0.7)

3 (1.0)

0 (0.0)

0 (0.0)

0 (0.0)

 CIRc (95% CI)

0.4 (0.0–2.2)

0.8 (0.3–1.5)

1.1 (0.1–4.1)

0.3 (0.0–1.9)

0.8 (0.3–1.5)

1.8 (0.4–5.4)

0.0 (0.0–19.9)

0.0 (0.0–1.7)

0.0 (0.0–7.5)

Deep vein thrombosis

 n (%)

4 (1.9)

6 (0.5)

2 (0.7)

1 (0.4)

9 (0.8)

2 (0.7)

0 (0.0)

0 (0.0)

1 (0.4)

 CIRc (95% CI)

1.6 (0.4–4.0)

0.6 (0.2–1.3)

1.1 (0.1–4.1)

0.3 (0.0–1.9)

0.8 (0.4–1.6)

1.2 (0.2–4.4)

0.0 (0.0–19.9)

0.0 (0.0–1.7)

2.0 (0.1–11.3)

Pulmonary embolism

 n (%)

0 (0.0)

7 (0.6)

1 (0.4)

0 (0.0)

7 (0.6)

3 (1.0)

0 (0.0)

1 (0.1)

2 (0.9)

 CIRc (95% CI)

0.0 (0.00–1.4)

0.7 (0.3–1.4)

0.6 (0.0–3.2)

0.0 (0.0–1.3)

0.7 (0.3–1.3)

1.8 (0.4–5.4)

0.0 (0.0–19.9)

0.5 (0.0–2.6)

4.1 (0.5–14.7)

Deep vein thrombosis or pulmonary embolism

 n (%)

4 (1.9)

12 (1.0)

2 (0.7)

1 (0.4)

15 (1.3)

5 (1.7)

0 (0.0)

1 (0.1)

2 (0.9)

 CIRc (95% CI)

1.6 (0.4–4.0)

1.2 (0.6–2.1)

1.1 (0.1–4.1)

0.3 (0.0–1.9)

1.4 (0.8–2.3)

3.1 (1.0–7.1)

0.0 (0.0–19.9)

0.5 (0.0–2.6)

4.1 (0.5–14.7)

Deep vein thrombosis and pulmonary embolism

 n (%)

0 (0.0)

1 (0.1)

1 (0.4)

0 (0.0)

1 (0.1)

0 (0.0)

0 (0.0)

0 (0.0)

1 (0.4)

 CIRc (95% CI)

0.0 (0.0–1.4)

0.1 (0.0–0.6)

0.6 (0.0–3.2)

0.0 (0.0–1.3)

0.1 (0.0–0.5)

0.0 (0.0–2.3)

0.0 (0.0–19.9)

0.0 (0.0–1.7)

2.0 (0.1–11.3)

Death

 n (%)

1 (0.5)

9 (0.8)

2 (0.7)

1 (0.4)

3 (0.3)

0 (0.0)

0 (0.0)

1 (0.1)

0 (0.0)

 CIRc (95% CI)

0.4 (0.0–2.2)

0.9 (0.4–1.7)

1.1 (0.1–4.1)

0.3 (0.0–1.9)

0.3 (0.1–0.8)

0.0 (0.0–2.3)

0.0 (0.0–19.9)

0.5 (0.0–2.6)

0.0 (0.0–7.5)

  1. Data presented for the FAS; non-responder imputation
  2. Abbreviations: AE adverse event, AESI adverse event of special interest, bDMARD biologic disease-modifying antirheumatic drug, BID twice daily, CI confidence interval, CIR crude incidence rate (unique patients with events/100 PY), csDMARD conventional synthetic disease-modifying antirheumatic drug, FAS full analysis set; IR inadequate response or intolerance, MTX methotrexate, PY patient-years, SAE serious adverse event, TEAE treatment-emergent adverse event
  3. aNon-MTX csDMARD-IR but not bDMARD-IR
  4. bMTX-IR but not bDMARD-IR
  5. cPer 100 PY
  6. dN for tofacitinib 5 mg BID: 185 (non-MTX csDMARD-IR), 933 (MTX-IR), and 247 (bDMARD-IR); N for tofacitinib 10 mg BID: 204 (non-MTX csDMARD-IR), 942 (MTX-IR), and 241 (bDMARD-IR); N for placebo: 32 (non-MTX csDMARD-IR), 468 (MTX-IR), and 181 (bDMARD-IR)
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Arthritis Research & Therapy

ISSN: 1478-6362

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