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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