Table 2

Overview of opportunistic infections excluding tuberculosis

n (IR)	Placebo controlled (to week 24)*			2–4 mg-extended†		All-bari-RA
n (IR)	Placebo N=1070	Bari 2 mg‡ N=479	Bari 4 mg N=997	Bari 2 mg N=479	Bari 4 mg N=479	All-bari-RA N=3492§
Multidermatomal HZ¶	1 (0.3)	0	1 (0.3)	0	1 (0.2)	22 (0.3)
Cytomegalovirus**	0	0	0	0	0	5 (0.1)
Aspergillus	0	0	0	0	0	1 (0.0)
Candida††	1 (0.3)	0	2 (0.5)	0	0	10 (0.1)
Cryptococcal	0	0	0	1 (0.2)	0	1 (0.0)
Histoplasmosis	0	0	0	1 (0.2)	0	1 (0.0)
Paracoccidioides	0	0	0	0	1 (0.2)	1 (0.0)
Pneumocystis‡‡	0	0	0	0	0	4 (0.1)

*Data from treatment period up to week 24, with data up to rescue.
†All analysis based on as-treated method, with data censored at rescue or dose change.
‡Baricitinib 2 mg data in the placebo-controlled analysis set is derived from four studies in which both baricitinib 2 mg and 4 mg were options during randomisation.
§All-bari-RA (patients who received any baricitinib dose) includes patients who switched from placebo, adalimumab or methotrexate to baricitinib, in addition to patients randomised to any baricitinib dose. Thus, it is a larger group than the 2 mg and 4 mg groups added together.
¶Multidermatomal HZ, as defined by HZ infection distributed beyond primary and adjacent dermatomes.
**Includes preferred terms cytomegalovirus infection (n=2), septic shock and cytomegalovirus infection (n=1), pneumonia cytomegaloviral (n=1) and pneumonia (with infecting organisms cytomegalovirus and Pneumocystis carinii; n=1).
††Includes oesophageal candidiasis (n=7 total; 2/7 events on baricitinib 4 mg in placebo-controlled period), lung infection (Candida albicans; n=1), sinusitis (Candida glabrata; n=1) and muscle abscess ((C. albicans and C. tropicalis; on placebo) and soft-tissue infection (C. tropicalis; on baricitinib); n=1).
‡‡Includes preferred terms Pneumocystis jirovecii pneumonia (n=3) and pneumonia (with infecting organisms reported as cytomegalovirus and Pneumocystis carinii; n=1). The infecting organism Pneumocystis jirovecii was previously classified as Pneumocystis carinii.
Bari, baricitinib; HZ, herpes zoster; IR, incidence rate; n, number of patients in the specified category; N, number of patients in the analysis set; RA, rheumatoid arthritis.