RINVOQ is a once-daily JAK1-selective inhibitor for the treatment of atopic dermatitis in adults and adolescents aged 12 years and above who weigh at least 40 kg, who have moderate-to-severe atopic dermatitis that is inadequately controlled with active topical pharmacotherapies, and for whom systemic therapy is indicated.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. |
‡Rapid skin clearance with EASI 75 as early as Week 2 for RINVOQ 15 mg (38% [107/281] & 33% [91/276]) vs placebo (4% [10/281] & 4%) [10/278], multiplicity-controlled p<0.0011
†Superior itch reduction rates (patients with an improvement in Worst Pruritus NRS ≥4 from baseline) 2 days after treatment initiation (day 3) for RINVOQ 15 mg (16% [45/275] & 12% [31/269]) vs placebo (3% [9/270] & 3% [8/267]); multiplicity-controlled p<0.0011
§Skin clearance rates (EASI 90) for RINVOQ 15 mg at Week 16 (51% [273/532]) and at Week 52 (62% [287/463]) 2,3
¥Itch reduction rates (patients with an improvement in Worst Pruritus NRS ≥4 from baseline) for RINVOQ 15 mg at Week 16 (55% [265/478]) and at Week 52 (65% [293/452])2,3
AD: Atopic Dermatitis; EASI: Eczema Area and Severity Index; EASI 75/90: ≥75/90% reduction in EASI; JAK: Janus kinase; NRS: numerical rating scale; QD: once daily.
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate or other conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).2
Psoriatic arthritis
RINVOQ is indicated for the treatment of moderate to severe active psoriatic arthritis in adult patients who have responded inadequately to, or are intolerant to, one or more DMARDs. RINVOQ may be used as monotherapy or in combination with a non-biological DMARD.2
Ankylosing spondylitis
RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis.2
Atopic dermatitis
RINVOQ is indicated for use in adults and adolescents aged 12 years and above who weigh at least 40 kg, for the treatment of moderate to severe atopic dermatitis which is inadequately controlled with active topical pharmacotherapies and for whom systemic therapy is indicated.2
Ulcerative colitis
RINVOQ is indicated for the treatment of adult patients with moderate to severe active ulcerative colitis, who have had inadequate response, loss of response or intolerance to conventional or biological medicine.
Non-radiographic
Axial Spondyloarthritis
RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) change, who have responded inadequately to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
AD: atopic dermatitis; AS: ankylosing spondylitis; (cs)DMARD, (conventional synthetic) disease-modifying anti-rheumatic drug; PsA: psoriatic arthritis; RA: rheumatoid arthritis; nr-axSpA: Non-radiographic Axial Spondyloarthritis. UC: ulcerative colitis.
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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.
- Blauvelt A et al. JAMA Dermatol 2021; DOI: 10.1001/jamadermatol.2021.3023.
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-210075. August 2023