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. |
RINVOQ has been studied in:1
 | 3 |
PHASE 3 RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL STUDIES
 | 833 PATIENTS |
| 1203 | PATIENT-YEARS OF EXPOSURE |
SAFETY PROFILE THROUGH 12 WEEKS1,2
OVERVIEW OF MOST COMMON AEs
With RINVOQ 45 mg
Results cannot be compared between studies. Studies were not powered for comparison of safety outcomes. Descriptive results only.
*In U-EXCEED, there was one non-treatment emergent death due to infectious shock in a patient who received RINVOQ 45 mg QD for 5 days; the death occurred 159 days after premature discontinuation from the study.
SAFETY PROFILE THROUGH 12 WEEKS2
AEs OF SPECIAL INTEREST
With RINVOQ 45 mg
Results cannot be compared between studies. Studies were not powered for comparison of safety outcomes. Descriptive results only.
*In U-EXCEL, one event of adjudicated gastrointestinal perforation was reported in a patient who was a clinical non-responder to placebo and was on RINVOQ 45 mg QD in the extended induction period. †In U-EXCEED, two additional events of adjudicated gastrointestinal perforation were reported in patients who were non-responders to placebo and were on RINVOQ 45 mg QD in the extended induction period.
SAFETY PROFILE THROUGH 12 WEEKS1,2
LAB ABNORMALITIES
With RINVOQ 45 mg
Potentially clinically important laboratory parameters (≥Grade 3, according to CTC toxicity grade)
SAFETY PROFILE THROUGH 52 WEEKS1,2
OVERVIEW OF MOST COMMON AEs
With RINVOQ 15 mg and RINVOQ 30 mg
Study not powered for comparison of safety outcomes. Descriptive results only.
SAFETY PROFILE THROUGH 52 WEEKS2
AEs OF SPECIAL INTEREST
With RINVOQ 15 mg and RINVOQ 30 mg
Study not powered for comparison of safety outcomes. Descriptive results only.
*Hepatic vein thrombosis concurrent with an event of exacerbation of CD. †Metastatic ovarian cancer in a patient in the RINVOQ 15 mg group and colon cancer and invasive lobular breast cancer in one patient each in the RINVOQ 30 mg QD group.
SAFETY PROFILE THROUGH 52 WEEKS1,2
LAB ABNORMALITIES
With RINVOQ 15 mg and RINVOQ 30 mg
Potentially clinically important laboratory parameters (≥Grade 3, according to CTC toxicity grade)
SAFETY PROFILE TO WEEK 204 OF THE LTE3
OVERVIEW OF MOST COMMON AEs
With RINVOQ 15 mg and 30 mg given throughout
the maintenance and extension studies
Includes all responders to 12 weeks of RINVOQ 45 mg induction therapy who were re-randomised to placebo, RINVOQ 15 mg or RINVOQ 30 mg in the maintenance study.
Abstract data; from the U-ENDURE long-term extension study.
Study not powered for comparison of safety outcomes. Descriptive results only.
*An event of suicide with no reasonable possibility to be related to the study drug as assessed by investigator.
SAFETY PROFILE TO WEEK 204 OF THE LTE3
AEs OF SPECIAL INTEREST
With RINVOQ 15 mg and 30 mg given throughout
the maintenance and extension studies
Abstract data; from the U-ENDURE long-term extension study. Study not powered for comparison of safety outcomes. Descriptive results only.
*Oesophageal candidiasis (n=1) and Pneumocystis jirovecii pneumonia (n=1) in the RINVOQ 15 mg group, and oesophageal candidiasis (n=1) in the RINVOQ 30 mg group. The event of Pneumocystis jirovecii pneumonia was serious and led to the discontinuation of study drug.
†Ovarian cancer metastatic (n=1) and malignant melanoma (n=1) in the RINVOQ 15 mg group; adenocarcinoma of colon (n=1), invasive lobular breast carcinoma (n=1), and malignant fibrous histiocytoma (n=1) in the RINVOQ 30 mg group.
AE: adverse events; AESI: adverse events of special interest; ALT: alanine aminotransferase; AST: aspartate aminotransferase; CD: Crohn’s disease; E, event; HZ, herpes zoster; LTE, long-term extension; MACE, major adverse cardiovascular events; NMSC, non-melanoma skin cancer; PY, patient years; QD: once-daily; TB, tuberculosis; URTI: upper respiratory tract infection; VTE, venous thromboembolism.
REFERENCES
- RINVOQ Product Information.
- Loftus EV, et al. N Engl J Med. 2023;388:1966–80 (incl. supplementary appendix).
- D’Haens G, et al. Presented at the 19th Congress of ECCO, 21–24 Feb 2024, Stockholm, Sweden: OP10.
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-220271. March 2024