Video: Knock on Wood| Webinar: ACR/CHEST ILD Guidelines in Practice
fa-facebookfa-linkedinfa-youtube-playfa-rss

An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

  • Conditions
    • Axial Spondyloarthritis
    • Gout and Crystalline Arthritis
    • Myositis
    • Osteoarthritis and Bone Disorders
    • Pain Syndromes
    • Pediatric Conditions
    • Psoriatic Arthritis
    • Rheumatoid Arthritis
    • Sjögren’s Disease
    • Systemic Lupus Erythematosus
    • Systemic Sclerosis
    • Vasculitis
    • Other Rheumatic Conditions
  • FocusRheum
    • ANCA-Associated Vasculitis
    • Axial Spondyloarthritis
    • Gout
    • Lupus Nephritis
    • Psoriatic Arthritis
    • Rheumatoid Arthritis
    • Systemic Lupus Erythematosus
  • Guidance
    • Clinical Criteria/Guidelines
    • Ethics
    • Legal Updates
    • Legislation & Advocacy
    • Meeting Reports
      • ACR Convergence
      • Other ACR meetings
      • EULAR/Other
    • Research Rheum
  • Drug Updates
    • Analgesics
    • Biologics/DMARDs
  • Practice Support
    • Billing/Coding
    • EMRs
    • Facility
    • Insurance
    • QA/QI
    • Technology
    • Workforce
  • Opinion
    • Patient Perspective
    • Profiles
    • Rheuminations
      • Video
    • Speak Out Rheum
  • Career
    • ACR ExamRheum
    • Awards
    • Career Development
  • ACR
    • ACR Home
    • ACR Convergence
    • ACR Guidelines
    • Journals
      • ACR Open Rheumatology
      • Arthritis & Rheumatology
      • Arthritis Care & Research
    • From the College
    • Events/CME
    • President’s Perspective
  • Search

Trial Pits Upadacitinib vs. Adalimumab for Psoriatic Arthritis

Vanessa Caceres  |  Issue: October 2021  |  October 14, 2021

Dr. McInnes

Dr. McInnes

AbbVie designed and sponsored the trial and provided the medications. AbbVie is the manufacturer of upadacitinib.

Among the 1,704 patients, 429 received the 15 mg dose of upadacitinib, 423 received the 30 mg dose of upadacitinib, 423 received the placebo and 429 received adalimumab. Ninety-one percent of patients completed the trial through week 24. Demographic characteristics were similar among all patient groups.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

By week 12, an ACR20 response was observed in 70.6% of patients who received the 15 mg dose of upadacitinib, compared with 78.5% who received the 30 mg dose. An ACR20 response was observed by week 12 in 36.2% of those receiving placebo and in 65% of those in the adalimumab group.

The results showed that both the 15 mg and 30 mg doses were non-inferior to adali­mu­mab in achieving an ACR20 response at week 12, and the 30 mg upadacitinib dose, but not the 15 mg dose, was superior to adalimumab.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

Compared with placebo, the upadacitinib results were better for other aspects of PsA, including objective measures of psoriatic activity, physical function and fatigue. Because of the trial results, certain end points comparing 15 mg of upadacitinib and adalimumab could not be analyzed, the study researchers write.

McInnes et al. found some differences in the number of adverse and serious adverse events, with more frequent occurrences among those receiving the 30 mg upadacitinib dose. An upper respiratory tract infection was the most common adverse event. Serious infections occurred in 1.2% of patients taking the 15 mg upadacitinib dose, 2.6% taking the 30 mg dose, 0.9% taking placebo and 0.7% taking adalimumab.

Through week 24, other infections included a case of Candida urethritis with the 15 mg dose and one case of Pneumocystis jirovecii pneumonia and cytomegalovirus with the 30 mg dose. Herpes zoster occurred in four patients receiving the 15 mg dose of upadacitinib, five receiving the 30 mg dose, three receiving placebo, and none among those receiving adalimumab. One pulmonary embolism occurred with the 30 mg dose.

Cancer was diagnosed in one patient in the 15 mg upadacitinib group (i.e., neuroendocrine carcinoma), one in the placebo group (i.e., basal cell carcinoma) and three patients each in the 30 mg and adalimumab groups. In the 30 mg group, two patients were diagnosed with basal cell carcinoma and one with a malignant lung neoplasm. In the adalimumab group, one patient was diagnosed with colon cancer, one with ovarian cancer and one with uterine cancer.

The percentage of patients with adverse events involving hepatic disorders was 9.1% in the 15 mg upadacitinib group, 12.3% in the 30 mg group, 3.8% in the placebo group and 15.6% in the adalimumab group.

Anemia and lymphopenia occurred with similar incident rates with the 15 mg upadacitinib and placebo doses, but more frequently with the 30 mg dose. One patient had a grade 3 decrease in their hemoglobin level and another a grade 3 decrease in their platelet count after stopping the 30 mg dose of upadacitinib. The 30 mg group also had a higher frequency in grade 3 decreases in neutrophil and lymphocyte levels.

Going Forward

Longer and larger trials are needed to further analyze the effects and risks of upadacitinib and its effects compared with other drugs for PsA, McInnes et al. conclude.

The availability of more treatments for PsA is welcome considering that few new modalities existed until recently, says study author Iain B. McInnes, FRCP, PhD, professor of rheumatology and director of the Institute of Infection, Immunity and Inflammation at the University of Glasgow, Scotland, U.K. He points to several new pathways for PsA treatment, including JAKs, interleukin (IL) 17A, IL-12/23p40, IL-23p19, and phosphodiesterase 4, as well as TNF inhibitors.

“More [treatments] are on the way, which is very exciting,” Dr. McInnes says.

Vivian P. Bykerk, MD, FRCPC, professor of medicine and director of the Inflam­matory Arthritis Center at the Hospital for Special Surgery, New York, sees the results as encouraging but also notes the 30 mg dose of upadacitinib was associated with more safety concerns and severe adverse advents. If this dose is approved for use in patients with PsA, providers will need to use its with caution, she notes, adding that upadacitinib 15 mg daily is a very good option for treatment of PsA, with a safety profile consistent with JAK inhibitors in other trials. If physicians choose JAKs for PsA, they should continue to monitor lab results for changes, Dr. Bykerk adds.

“The next steps require that we understand the best order of therapeutic intervention and which patient groups will benefit from the variety of modes of action now available to us,” Dr. McInnes says.


Vanessa Caceres is a medical writer in Bradenton, Fla.

References

  1. McInnes IB, Anderson JK, Magrey M, et al. Trial of upadacitinib and adalimumab for psoriatic arthritis. N Engl J Med. 2021 Apr 1;384(13):1227–1239.
  2. Losavio K. FDA Requires new Boxed Warnings on JAK inhibitors, places restrictions on use. 2021 Sep 1. The-Rheumatologist.org.

Page: 1 2 3 | Single Page
Share: 

Filed under:ConditionsDrug UpdatesPsoriatic Arthritis Tagged with:adalimumabPsoriatic Arthritisupadacitinib

Related Articles

    Psoriatic Arthritis: Advances in Therapeutics, Imaging & More Presented at ACR Convergence 2022

    December 1, 2022

    PHILADELPHIA—Selecting my top 10 picks for abstracts in psoriatic arthritis (PsA) at the ACR Convergence 2022 meeting was not easy because there was a great deal to review and learn from the 139 abstracts submitted to the meeting. I focused first and foremost on advances in therapeutics that encompassed both new and approved therapeutics, novel…

    The Heterogeneity of Psoriatic Arthritis

    November 21, 2023

    SAN DIEGO—Differences between psoriatic arthritis and rheumatoid arthritis highlight the need for the development of imaging modalities, laboratory tests and other biomarkers that are explored and validated specifically for PsA to advance the goal of personalized or precision medicine. In this article, expert David S. Pisetsky, MD, PhD, explores the top research in psoriatic arthritis presented at ACR Convergence 2023.

    Upadacitnib for RA: Researchers Compared Upadacitinib with Placebo & Adalimumab in Patients with RA & an Inadequate Response to Methotrexate

    March 9, 2021

    In phase 3 clinical trial, upadacitnib proved superior to placebo and adalimumab in improving the signs and symptoms of RA in patients on stable background methotrexate.

    ajt/shutterstock.com

    FDA Approves Upadacitinib for Non-Radiographic Axial Spondyloarthritis

    October 27, 2022

    The FDA has approved upadacitinib for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) based on a short-term study that demonstrated improved pain, function and other symptoms of nr-axSpA in patients with active disease.

  • About Us
  • Meet the Editors
  • Issue Archives
  • Contribute
  • Advertise
  • Contact Us
fa-facebookfa-linkedinfa-youtube-playfa-rss
  • Copyright © 2025 by John Wiley & Sons, Inc. All rights reserved, including rights for text and data mining and training of artificial technologies or similar technologies. ISSN 1931-3268 (print). ISSN 1931-3209 (online).
  • DEI Statement
  • Privacy Policy
  • Terms of Use
  • Cookie Preferences