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Table 1 Summary of interruptions and temporary interruptions during baricitinib phase 3 studies in RA

From: Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis

 

RA-BEGIN (0–52 weeks)a

RA-BEAMa

RA-BUILD (0–24 weeks)a

RA-BEACON (0–24 weeks)a

0–24 weeks

0–52 weeksb

MTX (N = 210)

BARI

4 mg (N = 159)

MTX+ BARI

4 mg (N = 215)

PBO (N = 488)

BARI

4 mg (N = 487)

ADA (N = 330)

BARI

4 mg (N = 487)

ADA (N = 330)

PBO (N = 228)

BARI

2 mg (N = 229)

BARI

4 mg (N = 227)

PBO (N = 176)

BARI

2 mg (N = 174)

BARI

4 mg (N = 177)

Initiated interruptions (n)

46

21

66

80

69

36

119

58

38

33

48

25

54

52

Study drug ever restarted

42 (91.3)

18 (85.7)

60 (90.9)

67 (83.8)

62 (89.9)

30 (83.3)

106 (89.1)

47 (81.0)

33 (86.8)

25 (75.8)

41 (85.4)

21 (84.0)

47 (87.0)

48 (92.3)

Restarted during LTE

0

1

0

0

0

0

3

1

1

1

1

3

4

4

Total temporary interruptions (n) during studyc

42

17

60

67

62

30

103

46

32

24

40

18

43

44

Patients with ≥ 1 interruption, n (%)

31 (14.8)

15 (9.4)

48 (22.3)

54 (11.1)

50 (10.3)

28 (8.5)

75 (15.4)

40 (12.1)

29 (12.7)

21 (9.2)

34 (15.0)

15 (8.5)

31 (17.8)

32 (18.1)

Number of interruptions per interrupted patient, mean (SD)

1.4 (0.6)

1.1 (0.4)

1.3 (0.4)

1.2 (0.5)

1.2 (0.4)

1.1 (0.3)

1.4 (0.6)

1.2 (0.4)

1.1 (0.4)

1.1 (0.4)

1.2 (0.4)

1.2 (0.6)

1.4 (0.6)

1.4 (0.7)

Time from first dose to first interruption, mean (SD), days

120.7 (100.9)

134.4 (113.5)

146.6 (97.9)

68.9 (43.0)

70.6 (48.6)

73.2 (49.4)

126.9 (93.4)

112.3 (74.0)

53.1 (40.1)

41.0 (39.3)

53.6 (37.7)

64.4 (39.1)

63.1 (46.1)

59.2 (43.1)

Duration of individual interruptions, mean (SD), days

16.3 (16.7)

15.0 (14.9)

17.5 (16.3)

11.7 (13.2)

11.4 (9.4)

19.4 (24.6)

15.1 (15.7)

23.1 (29.1)

11.6 (10.2)

12.3 (12.6)

10.7 (9.8)

16.8 (10.0)

12.9 (19.2)

12.6 (9.5)

Reason for interruptions, n (%)

 Adverse event

36 (85.7)

14 (82.4)

53 (88.3)

53 (79.1)

57 (91.9)

28 (93.3)

95 (92.2)

43 (93.5)

26 (81.3)

19 (79.2)

32 (80.0)

15 (83.3)

36 (83.7)

38 (86.4)

 AE reported as an abnormal lab resultd

9 (25.0)

0

9 (17.0)

6 (11.3)

9 (15.8)

7 (25.0)

–

–

2 (7.7)

1 (5.3)

0

1 (6.7)

1 (2.8)

1 (2.6)

 Abnormal laboratory result

6 (14.3)

3 (17.6)

6 (10.0)

11 (16.4)

3 (4.8)

0

6 (5.8)

0

4 (12.5)

5 (20.8)

6 (15.0)

2 (11.1)

4 (9.3)

4 (9.1)

 Investigator decision

0

0

1 (1.7)

3 (4.5)

2 (3.2)

2 (6.7)

2 (1.9)

3 (6.5)

2 (6.3)

0

2 (5.0)

1 (5.6)

3 (7.0)

1 (2.3)

  1. Interruptions were based on daily tablet baricitinib study drug, including in non-baricitinib groups, which represent interruptions of the matching placebo for baricitinib. Temporary interruption is defined as a temporary withholding of study drug that is followed by resumption of study drug during the study
  2. aData up to rescue (all studies) or switch from PBO (RA-BEAM)
  3. bNo 0–52 week data for patients randomized to PBO because they were switched to baricitinib after week 24
  4. cInterruption did not lead to permanent discontinuation and was therefore, by definition, considered a temporary interruption
  5. dPercent is calculated with the number of adverse events as the denominator
  6. ADA adalimumab, AE adverse events, BARI baricitinib, LTE long-term extension, MTX methotrexate, PBO placebo, SD standard deviation
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Arthritis Research & Therapy

ISSN: 1478-6362

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