SAFETY PROFILE IN PATIENTS WITH AD ≥12 YEARS OF AGE2
Key safety considerations for RINVOQ
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. |
Contraindications
The use of RINVOQ is contraindicated in patients who are hypersensitive to the active substance or to any of the excipients.
RINVOQ must not be used in combination with biologic disease-modifying anti-rheumatic drugs (bDMARDs). Combination use with other potent immunosuppressants (e.g., azathioprine, cyclosporine, tacrolimus, other JAK inhibitors) is not recommended.
Serious & opportunistic infections including TB
RINVOQ increases the risk of serious infections and opportunistic infections, including tuberculosis and herpes zoster; RINVOQ should not be used in patients with active TB or active serious infections, including localised infections.
Do not use live, attenuated vaccines during, or immediately prior to RINVOQ treatment.
Thrombosis – DVT and PE
Events of thrombosis (including DVT, PE, arterial thrombosis) have occurred. Avoid RINVOQ in patients with an increased risk of thrombosis and re-evaluate periodically for VTE risk. Promptly evaluate and discontinue RINVOQ in patients with suspected VTE.
Pregnancy and breastfeeding
RINVOQ should not be used during pregnancy (category D) or during breastfeeding.
Major adverse cardiovascular events
Events of MACE were observed in clinical studies of RINVOQ.
Monitor for lipid elevation and manage according to guidelines.
Malignancy and NMSC
Lymphoma, other malignancies and NMSCs have been reported in patients treated with RINVOQ. A higher rate of malignancies, driven by NMSC was observed with RINVOQ 30 mg compared to RINVOQ 15 mg.
Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Use in patients ≥65 years of age
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed with another JAK inhibitor, RINVOQ should only be used in these patients if no suitable treatment alternatives are available. The recommended dose for long-term use in patients ≥ 65 years of age is 15 mg once daily.
GI perforation
RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation.
Mortality
In a large, randomised, post-marketing safety study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years of age and older with at least one additional cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with tofacitinib compared to TNF inhibitors. Mortality was mainly due to cardiovascular events, infections and malignancies.
SAFETY DATA IN AD through 52 weeks1-3
The safety profile of RINVOQ at Week 52 was similar to the safety profile observed at Week 162
Study is not powered for comparison on safety outcomes between treatment arms, therefore no comparisons can be made. No statistical analysis done.
OVERVIEW & MOST COMMON AEs
AEs of SPECIAL INTEREST
LAB ABNORMALITIES
The PI recommends initiation of upadacitinib at 15 mg with the option for titration to 30 mg after 4 weeks in appropriate patients (refer to full PI).
These data include patients initiated on 30 mg; there are no studies which examine the outcomes for patients who are titrated from 15 to 30 mg.
AE: adverse events; CPK: Creatine phosphokinase; GI: gastrointestinal; MACE: major adverse cardiac events; NMSC: mon-melanoma skin cancer; QD: once daily; TEAE: Treatment Emergent Adverse Event; VTE: venous thromboembolic events.
2 TRIALS IN UC: Consisting of 3 Phase 3 studies: U‑ACHIEVE Induction U‑ACCOMPLISH (Induction); and U‑ACHIEVE Maintenance
8 TRIALS IN RA: SELECT‑EARLY, SELECT‑NEXT, SELECT‑COMPARE, SELECT‑MONOTHERAPY, SELECT‑BEYOND, SELECT‑CHOICE, SELECT‑SUNRISE, SELECT‑CHINA
2 TRIALS IN PsA: SELECT‑PsA 1, SELECT‑PsA 2
2 TRIALS IN AS: SELECT‑AXIS 2, SELECT AXIS 1
5 TRIALS IN AD: RISING‑UP, MEASURE‑UP 1, MEASURE‑UP 2, AD‑UP, HEADS‑UP
1 TRIAL IN NON-RADIOGRAPHIC AS: SELECT AXIS 2
FIND OUT MORE ABOUT RINVOQ
REFERENCES
- Guttman-Yassky E et al. Lancet 2021;397(10290):2151–2168.
- RINVOQ Approved Product Information.
- Simpson EL et al. Efficacy and Safety of Upadacitinib in Patients With Atopic Dermatitis: Results Through Week 52 From Replicate, Phase 3, Randomized, Double-Blind, Placebo-Controlled Studies: Measure Up 1 and Measure Up 2. Poster presented at the 2021 Dermatology Education Foundation (DEF) Essential Resource Meeting (DERM2021), August 5–8, 2021, Las Vegas NV, USA.
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. This product is not listed on the PBS for the treatment of Crohn’s disease.
Please review the full Product Information (PI) before prescribing, available below.
AU-ABBV-210078. August 2023