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 ForAge RangeDate Approved
Polyarticular Juvenile Idiopathic ArthritisChildren 2 Years & OlderJune 2024
Moderately to Severely Active Crohn’s Disease in AdultsAdultsMay 2023
Adults with Active Non-Radiographic Axial SpondyloarthritisAdultsOctober 2022
Active Ankylosing SpondylitisAdultsApril 2022
Moderately to Severely Active Ulcerative ColitisAdultsMarch 2022
Refractory, Moderate to Severe Atopic DermatitisAdults and Children 12 Years & OlderJanuary 2022
Active Psoriatic ArthritisAdults md Children 2 Years to less than 18 Years of Age Weighing at least 10kgDecember 2021
Moderate to Severe Rheumatoid ArthritisAdultsAugust 2019


Upadacitinib Indication/AgeInitial & Subsequent Dosage
Polyarticular Juvenile Idiopathic Arthritis
Pediatric Patients 2 Years of Age and Olderdosage is based on body weight
Crohn’s Disease
Adults – induction15 mg once daily for 12 weeks
Adults – maintenance15 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
Adults15 mg once daily
Ankylosing Spondylitis
Adults15 mg once daily
Ulcerative Colitis
Adults – induction15 mg once daily for 12 weeks
Adults – maintenance15 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 Age15 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 Older15 mg once daily
Psoriatic Arthritis
Adults15 mg once daily
Pediatric Patients 2 Years to less than 18 Years of Age weighing at least 10kgdosage is based on body weight
Rheumatoid Arthritis
Adults15 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

TopicSocietyTitlePub DateIncluded?
Polyarticular Juvenile Idiopathic ArthritisACRTreatment of Juvenile Idiopathic Arthritis (JIA): Therapeutic Approaches for Oligoarthritis, Temporomandibular Joint (TMJ) Arthritis and Systemic JIAMarch 2022No
Polyarticular Juvenile Idiopathic ArthritisACRTreatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non‐Systemic Polyarthritis, Sacroiliitis, and EnthesitisApril 2019No
Crohn’s DiseaseAGAMedical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s DiseaseMay 2021No
Crohn’s DiseaseACGManagement of Crohn’s Disease in AdultsMarch 2018No
Ankylosing Spondylitis & Active Non-Radiographic Axial SpondyloarthritisACRTreatment of Ankylosing Spondylitis and Nonradiographic Axial SpondyloarthritisAugust 2019No
Ulcerative ColitisAGAManagement of Moderate to Severe Ulcerative ColitisJanuary 2020No
Ulcerative ColitisACGUlcerative Colitis in AdultsFebruary 2019No
Atopic DermatitisAADManagement Of Atopic Dermatitis in Adults With Phototherapy And Systemic TherapiesNovember 2023Yes
Atopic DermatitisACAAI/AAAAIAtopic Dermatitis (Eczema)December 2023Yes
Psoriatic ArthritisACR/NPFTreatment of Psoriatic ArthritisNovember 2018No
Psoriatic ArthritisGRAPPAPsoriatic Arthritis Assessment and TreatmentJune 2022Yes
Rheumatoid ArthritisACRTreatment of Rheumatoid ArthritisJune 2021Yes

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.

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