Table 2

Overview of opportunistic infections excluding tuberculosis

n (IR)Placebo controlled
(to week 24)*
2–4 mg-extended†All-bari-RA
Bari 2 mg‡
Bari 4 mg
Bari 2 mg
Bari 4 mg
Multidermatomal HZ¶1 (0.3)01 (0.3)01 (0.2)22 (0.3)
Cytomegalovirus**000005 (0.1)
Aspergillus000001 (0.0)
Candida††1 (0.3)02 (0.5)0010 (0.1)
Cryptococcal0001 (0.2)01 (0.0)
Histoplasmosis0001 (0.2)01 (0.0)
Paracoccidioides00001 (0.2)1 (0.0)
Pneumocystis‡‡000004 (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.