Overview of treatment-emergent infections, serious infection, TB, HZ, opportunistic infection and infection leading to death
| Placebo-controlled (to Week 24)* | 2–4 mg-extended† | All-bari-RA | ||||
| Placebo N=1070 PYE=393.8‡ | Bari 2 mg§ N=479 PYE=185.8‡ | Bari 4 mg N=997 PYE=409.4‡ | Bari 2 mg N=479 PYE=604.9‡ | Bari 4 mg N=479 PYE=645.9‡ | All-bari-RA N=3492¶ PYE=7860.3‡ | |
| TE infections, n (EAIR) | 299 (75.9) | 156 (84.0) | 362 (88.4)*** | 230 (38.0) | 266 (41.2) | 2114 (26.9) |
| Led to temporary interruption of study drug | 52 (13.4) | 34 (18.3) | 67 (16.6) | 63 (10.4) | 73 (11.3) | 623 (8.0) |
| Led to permanent discontinuation from study drug | 8 (2.0) | 7 (3.8) | 22 (5.2)** | 11 (1.8) | 22 (3.3) | 139 (1.7) |
| Serious infection, n (IR) | 17 (4.2) | 8 (4.2) | 16 (3.8) | 20 (3.3) | 31 (4.8) | 231 (3.0) |
| Tuberculosis, n (IR) | 0 | 0 | 1 (0.2) | 0 | 6 (0.5) | 11 (0.1) |
| HZ, n (IR) | 4 (1.0) | 6 (3.1) | 18 (4.3)** | 17 (2.8) | 25 (3.9) | 258 (3.3) |
| Opportunistic infection excluding TB, n (IR) | ||||||
| Including MD HZ†† | 2 (0.5) | 0 | 3 (0.8) | 2 (0.3) | 2 (0.3) | 43 (0.5)‡‡ |
| Excluding MD HZ†† | 1 (0.3) | 0 | 2 (0.5) | 2 (0.3) | 1 (0.2) | 21 (0.3)‡‡ |
| Infection leading to death, n (EAIR) | 2 (0.5) | 0 | 1 (0.2) | 0 | 1 (0.2) | 7 (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.
‡Including postdrug follow-up period where applicable.
§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.
**p≤0.01, ***p≤0.001 for baricitinib 4 mg compared with placebo.
††Multidermatomal HZ, as defined by HZ infection distributed beyond primary and adjacent dermatomes.
‡‡Two patients reported two OIs; one patient with pneumonia (with infecting organisms of cytomegalovirus and Pneumocystis) and one patient with concurrent cytomegalovirus infection and oesophageal candidiasis. Overall, 43 patients reported 45 total OIs including MD HZ; 21 patients reported 23 OIs not including MD HZ.
Bari, baricitinib; EAIR, exposure-adjusted incidence rate; HZ, herpes zoster; IR, incidence rate; MD, multidermatomal; n, number of patients in the specified category; N, number of patients in the analysis set; OI, opportunistic infection; PYE, patient-years of exposure; RA, rheumatoid arthritis; TB, tuberculosis; TE, treatment-emergent.