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

Table 2 Detailed summary of reasons for interruptions of baricitinib in the phase 3 studies, with data from all patients receiving baricitinib at any time, including any subsequent rescue

	RA-BEGIN (weeks 0–52)	RA-BEAM (weeks 0–52)	RA-BUILD (weeks 0–24)	RA-BEACON (weeks 0–24)
	All baricitinib exposures (N = 400)	All baricitinib exposures (N = 972)	All baricitinib exposures (N = 511)	All baricitinib exposures (N = 407)
Total number of interruptions^a	79	172	69	91
Reason for dose interruption^b
Adverse event	69	159	55	78
Infections (% total AEs)	39 (56.5)	93 (58.5)	36 (65.5)	55 (70.5)
Respiratory infections, n (% of infections)	26 (66.7)	60 (64.5)	18 (50.0)	38 (69.1)
Investigations (% of total AEs)^c	6 (8.7)	3 (1.9)	1 (1.8)	1 (1.3)
Abnormal laboratory result^d	9	8	12	8
Hepatic	5	1	3	1
eGFR/renal	1	1	2	2
Hemoglobin/hematocrit	3	2	0	0
Lymphocytes	0	2	1	2
Neutrophils	0	2	3	0
Creatine phosphokinase	0	0	2	2
Enrollment issue	0	0	1	1
Eosinophils	1	0	0	0
Myelocytes	0	0	1	0
Platelets	1	0	0	0

Patients who received any baricitinib dose includes patients who switched from placebo, adalimumab, or methotrexate to baricitinib, in addition to patients randomized to any baricitinib dose. Thus, these groups will be larger than the individual baricitinib treatment groups from each study added together
^aTemporary interruption is defined as a temporary withholding of study drug that is followed by resumption of study drug during the study; total count includes interruptions occurring while assigned to any dose of baricitinib, either by initial randomization or after rescue from other treatments
^bReasons for interruption were examined for baricitinib-treated patients only, including patients randomized to placebo or active-control who were rescued or switched to baricitinib; Interruptions are based on daily tablet baricitinib study drug
^cInvestigations included clinical laboratory tests (including biopsies), radiologic tests, physical examination parameters, or physiologic tests (e.g., pulmonary function test); these included only investigation procedures and qualitative results and not conditions
^dReasons for an individual interruption could be associated with multiple abnormal laboratory results
AE, adverse event; eGFR, estimated glomerular filtration rate

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