Table 3.
Baricitinib-treated patients with HBsAg−; HBcAb+ at baseline and quantifiable post-baseline HBV DNA
| Patient | Region | Baricitinib dose at event* | Baseline HBV DNA | Relevant history | Serial HBV DNA testing† | Reported TEAE | Antiviral treatment | ALT elevation | Study drug permanently discontinued | Study drug temporarily interrupted | Available post-baseline serology |
| Baricitinib-treated patients with baseline HBsAg−; HBcAb+/HBsAb+ and quantifiable (≥29 IU/mL) post-baseline HBV DNA | |||||||||||
| 1 | Asia (excluding Japan) |
4 mg | Not detected | – | <29,<29, ND, ND, ND,<29,<29,<29,<29,<29, ND,<29,<29,<29,<29, ND,<29,<29,<29,<29, ND,<29,<29, 256,<29,<29, | – | – | No | Yes | No | – |
| 2 | Japan | 4 mg | Not detected | – | 31, ND, ND, ND | Hepatitis B DNA assay positive | Entecavir | No | Yes | No | HBsAg−, HBsAb+, HbcAb+ |
| 3 | Asia (excluding Japan) |
4 mg | Not detected | Chronic hepatitis, parenchymal liver disease, liver nodule benign, fatty liver | ND,<29, 257,<29, ND | HBV DNA polymerase increase | Telbivudine | No | Yes | No | |
| 4 | Central and South America and Mexico | 4 mg | Not done | – | <29,<29,<29,<29,<29,<29, ND,<29, ND,<29,<29,<29,<29,<29,<29, 76 | – | – | No | No | No | HBsAg−, HBsAb+, HbcAb+ HepA IgM−, HepA Ab+, HepC Ab−, HepE IgM−, HepE, IgG−, HepE PCR− |
| 5 | Asia (excluding Japan) |
4 mg | Not detected | – | ND, ND, ND, 60, ND, ND, ND, ND, ND | HBV DNA polymerase increase | – | No | No | Yes | – |
| 6 | Asia (excluding Japan) |
2 mg | Not done | – | ND, ND, ND, 869, ND, ND, ND, ND, ND, ND | – | – | No | No | Yes | HBsAg−, HBsAb+, HbcAb+ |
| 7 | Japan | 2 mg | Not detected | – | ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, 1547, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND, ND | – | – | No | No | No | HBsAg−, HBsAb+, HbcAb+ HepA IgM−, HepA Ab−, HepC Ab−, HepE IgM−, HepE, IgG+, HepE PCR+ |
| Baricitinib-treated patients with baseline HBsAg−; HBcAb+/HBsAb− and quantifiable (≥29 IU/mL) post-baseline HBV DNA | |||||||||||
| 8 | Rest of world | 4 mg | Not detected | – | 36, ND, ND, ND,<29, ND, ND | – | Tenofovir | No | Yes | No | HBsAg−, HBsAb−, HbcAb+ |
Results include all scheduled visits, retests and hepatic monitoring. All patients were receiving concomitant methotrexate.
*Event defined as ≥29 IU/mL HBV DNA test result.
†All available post-baseline detectable (<29 IU/mL) and quantifiable (≥29 IU/mL) results; all patients reported a single quantifiable HBV DNA result (shown in red).
ALT, alanine transaminase; HBcAb, hepatitis B virus core antibody; HBsAb, hepatitis B virus surface antibody; HBsAg, hepatitis B virus surface antigen; HBV, hepatitis B virus; Hep, hepatitis; Ig, immunoglobulin; ND, not detected; TEAE, treatment-emergent adverse event.