WARNING: Based on the results from a post-marketing safety study of another JAK inhibitor, RINVOQ should only be used if no suitable treatment alternatives are available in patients: Refer to Product Information. |
AE: adverse events; CPK: creatine phosphokinase; TEAE: treatmen-emergent adverse event; QD: once-daily; UC: ulcerative colitis; URTI: upper respiratory tract infection.
Results cannot be compared between studies. Studies were not powered for comparison of safety outcomes. Descriptive results only.
*Includes non-treatment emergent deaths.
AESI: adverse event of special interest; CPK: creatine phosphokinase; GI: gastrointestinal; MACE: major adverse cardiac event; NMSC: non-melanoma skin cancer; QD: once-daily; VTE: venous thromboembolism.
*Search criteria were based on Company MedDRA Query. †These events were determined on the basis of external adjudication. ‡MACE is defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. §VTE is defined as deep vein thrombosis and pulmonary embolism (fatal and non-fatal).
There were no AESIs of active tuberculosis or lymphoma in the study.
Results cannot be compared between studies. Studies were not powered for comparison of safety outcomes. Descriptive results only.
ALT: alanine aminotransferase; AST: aspartate aminotransferase; CTC: common toxicity criteria; QD: once-daily; ULN: upper limit of the normal.
*Indicates the number of patients with non-missing baseline and at least one post-baseline for the respective parameter.
Results cannot be compared between studies. Studies were not powered for comparison of safety outcomes. Descriptive results only.
AE: adverse events; CPK: creatine phosphokinase; TEAE: treatmen-emergent adverse event; QD: once-daily; UC: ulcerative colitis; URTI: upper respiratory tract infection.
Study not powered for comparison of safety outcomes. Descriptive results only.
*Includes non-treatment emergent deaths.
AESI: adverse event of special interest; CPK: creatine phosphokinase; GI: gastrointestinal; MACE: major adverse cardiac event; NMSC: non-melanoma skin cancer; QD: once-daily; VTE: venous thromboembolism.
*Search criteria were based on Company MedDRA Query. †These events were determined on the basis of external adjudication. ‡MACE is defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. §VTE is defined as deep vein thrombosis and pulmonary embolism (fatal and non-fatal).
There were no AESIs of active tuberculosis or lymphoma in the study.
Study not powered for comparison of safety outcomes. Descriptive results only.
ALT: alanine aminotransferase; AST: aspartate aminotransferase; CTC: common toxicity criteria; QD: once-daily; ULN: upper limit of the normal.
*Indicates the number of patients with non-missing baseline and at least one post-baseline for the respective parameter.
Study not powered for comparison of safety outcomes. Descriptive results only.
SAFETY PROFILE TO WEEK 48 OF THE LTE3
AE summary
With RINVOQ 15 mg and 30 mg given throughout
the maintenance and extension studies
The safety profile through Week 48 of the LTE study was consistent with previous analyses.2,3
Study not powered for comparison of safety outcomes. Descriptive results only.
aPYs after the first instance were not counted for that patient.
bThe events of malignancy excluding NMSC at 108 weeks were one event of papillary thyroid carcinoma (EAIR: 0.5) in the
RINVOQ 15 mg QD group and one event of squamous cell carcinoma of the uterine cervix (EAIR: 0.4) in the RINVOQ 30 mg QD group.
cDefined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.
dDefined as deep vein thrombosis and pulmonary embolism (fatal and non-fatal).
AE: adverse event; AESI: adverse event of special interest; rase; ALT: alanine aminotransferase; AST: aspartate aminotransferase; CI, confidence interval; CPK: creatine phosphokinase; CTC: common toxicity criteria; EAER, Exposure-adjusted event rate; EAIR, Exposure-adjusted incidence rate; GI: gastrointestinal; MACE: major adverse cardiac event; NMSC: non-melanoma skin cancer; PY: patient-years; QD: once-daily; TEAE: treatment-emergent adverse event; UC: ulcerative colitis; URTI: upper respiratory tract infection; VTE: venous thromboembolism.
REFERENCES
- RINVOQ Product Information.
- Danese S et al. Lancet 2022;399(10341):2113–28.
- Panaccione R et al. UEG Journal 2023;11(8):141–2.
WARNING: Based on the results from a post-marketing safety study of another JAK inhibitor, RINVOQ should only be used if no suitable treatment alternatives are available in patients: Refer to Product Information. |
PBS Information
RINVOQ: Authority required. Refer to PBS Schedule for full authority information.
Please review the full Product Information (PI) before prescribing, available below.
AU-ABBV-240088. May 2024