In this edition of our Guidelines+ Monographs Series, we will be taking a look at AbbVie’s medication Upadacitinib, brand name Rinvoq. Initially approved in 2019 Rinvoq is a Janus kinase (JAK) inhibitor used to treat a variety of conditions, including rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.
This Guidelines+ Monograph will take a deeper dive into Upadacitinib, as well as outline the current clinical practice guidelines featuring the medication. Please note that this Guidelines+ Monograph for Rinqoq is current as of June 2024. Make sure to review our medication look up tool and guideline summaries library to ensure you are always accessing the most current information.
Medication Overview:
- Brand name: Rinvoq
- Generic name: Upadacitinib
- Manufacturer(s): AbbVie
- Initial FDA Approval: August 2019
- Available Dosages: RINVOQ extended-release tablets: 15 mg, 30 mg, and 45 mg; RINVOQ LQ oral solution: 1 mg/mL
Indications and FDA Approval Details
| Indicated For | Age Range | Date Approved |
| Polyarticular Juvenile Idiopathic Arthritis | Children 2 Years & Older | June 2024 |
| Moderately to Severely Active Crohn’s Disease in Adults | Adults | May 2023 |
| Adults with Active Non-Radiographic Axial Spondyloarthritis | Adults | October 2022 |
| Active Ankylosing Spondylitis | Adults | April 2022 |
| Moderately to Severely Active Ulcerative Colitis | Adults | March 2022 |
| Refractory, Moderate to Severe Atopic Dermatitis | Adults and Children 12 Years & Older | January 2022 |
| Active Psoriatic Arthritis | Adults md Children 2 Years to less than 18 Years of Age Weighing at least 10kg | December 2021 |
| Moderate to Severe Rheumatoid Arthritis | Adults | August 2019 |
Dosing
| Upadacitinib Indication/Age | Initial & Subsequent Dosage |
| Polyarticular Juvenile Idiopathic Arthritis | |
| Pediatric Patients 2 Years of Age and Older | dosage is based on body weight |
| Crohn’s Disease | |
| Adults – induction | 15 mg once daily for 12 weeks |
| Adults – maintenance | 15 mg once daily; maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease (use lowest effective dosage needed to maintain response) |
| Active Non-Radiographic Axial Spondyloarthritis | |
| Adults | 15 mg once daily |
| Ankylosing Spondylitis | |
| Adults | 15 mg once daily |
| Ulcerative Colitis | |
| Adults – induction | 15 mg once daily for 12 weeks |
| Adults – maintenance | 15 mg once daily; maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease (use lowest effective dosage needed to maintain response) |
| Atopic Dermatitis | |
| Pediatric Patients 12 Years of Age and Older Weighing at Least 40 kg and Adults Less Than 65 Years of Age | 15 mg once daily; except those with severe renal impairment, if adequate response is not achieved, consider increasing the dosage to 30 mg orally once daily |
| Adults 65 Years of Age and Older | 15 mg once daily |
| Psoriatic Arthritis | |
| Adults | 15 mg once daily |
| Pediatric Patients 2 Years to less than 18 Years of Age weighing at least 10kg | dosage is based on body weight |
| Rheumatoid Arthritis | |
| Adults | 15 mg once daily |
Warnings and Precautions
- Serious Infections: Avoid use in patients with active, serious infection, including localized infections.
- Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. Discontinue if a serious hypersensitivity reaction occurs.
- Gastrointestinal (GI) Perforations: Monitor patients at risk for GI perforations and promptly evaluate patients with symptoms.
- Laboratory Abnormalities: Monitoring recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids.
- Embryo-Fetal Toxicity: May cause fetal harm based on animal studies. Advise female patients of reproductive potential of the potential risk to a fetus and to use effective contraception.
- Vaccinations: Avoid use with live vaccines.
- Medication Residue in Stool: Observed in stool or ostomy output in patients with shortened GI transit times. Monitor patients clinically and consider alternative treatment if inadequate therapeutic response.
- Drug Interactions with Strong CYP3A4 Inhibitors
Adverse Reactions
- Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis: Adverse reactions (≥ 1%) were: upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, and headache.
- Atopic dermatitis: Adverse reactions (≥ 1%) are: upper respiratory tract infections, acne, herpes simplex, headache, blood creatine phosphokinase increased, cough, hypersensitivity, folliculitis, nausea, abdominal pain, pyrexia, increased weight, herpes zoster, influenza, fatigue, neutropenia, myalgia, and influenza like illness.
- Ulcerative colitis: Adverse reactions (≥ 5%) reported during induction or maintenance are: upper respiratory tract infections, increased blood creatine phosphokinase, acne, neutropenia, elevated liver enzymes, and rash.
- Crohn’s disease: Adverse reactions (≥ 5%) reported during induction or maintenance are: upper respiratory tract infections, anemia, pyrexia, acne, herpes zoster, and headache.
Specific Inclusions of Upadacitinib in Clinical Guidelines
- Atopic Dermatitis (Eczema)
- Authoring Society: American College of Allergy, Asthma, and Immunology / American Academy of Allergy, Asthma & Immunology
- Publication Date: December 17, 2023
- Upadacitinib-Related Recommendation(s):
- In adults and adolescents with moderate-severe AD refractory, intolerant, or unable to use mid- to high-potency topical treatment and systemic treatment inclusive of a biologic recommended previously, the panel suggests replacing the systemic treatment with one of the following oral JAK inhibitors (alphabetical order: abrocitinib 100-200 mg [age 12 years or above], baricitinib 2-4 mg [age 18 years or above], upadacitinib 15-30 mg [age 12 years or above]) over not using one of these JAK inhibitors. (Conditional Recommendation, Low Quality of Evidence)
- Management Of Atopic Dermatitis in Adults with Phototherapy and Systemic Therapies
- Authoring Society: American Academy of Dermatology
- Publication Date: November 7, 2023
- Upadacitinib-Related Recommendation(s):
- For adults with moderate to severe AD, we recommend upadacitinib. (Strong Recommendation, Moderate Quality of Evidence). Remarks: Upadacitinib is approved by the FDA in patients with AD who have failed other systemic therapies (pills or injections, including biologics) or when use of those therapies is inadvisable.
- Psoriatic Arthritis Assessment and Treatment
- Authoring Society: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
- Publication Date: June 27, 2022
- Upadacitinib-Related Recommendation(s):
- Many recommendation that include JAKis – see guideline for full breakdown
- Treatment of Rheumatoid Arthritis
- Authoring Society: American College of Rheumatology
- Publication Date: June 8, 2021
- Upadacitinib-Related Recommendation(s):
- For patients taking maximally tolerated doses of methotrexate who are not at target, addition of a bDMARD or tsDMARD is conditionally recommended over triple therapy. (Very Low Evidence).
Summary Table Upadacitinib in Clinical Guidelines
As you can see, Rinvoq is not yet included in the majority of the key guidelines for which it has indications for. This will almost certainly change over the coming months and years as these guidelines update.
This concludes the June 2024 Edition of our Upadacitinib / Rinvoq Guidelines Monograph. Contact us if there is a specific medication you would like to see us cover in future monograph series installments.
Copyright © 2024 Guideline Central, All rights reserved.