AbbVie Advances JAK1 Inhibitor Rinvoq to Phase III Trial in Systemic Lupus Erythematosus Following Positive Phase II Results

On March 23, AbbVie announced positive results from the Phase II SLEek study of Rinvoq (upadacitinib, 30mg), an oral JAK1 inhibitor, as a monotherapy or in combination with ABBV-599 (upadacitinib + BTK inhibitor elsubrutinib) for the treatment of moderate to severe active systemic lupus erythematosus (SLE). At week 24, the upadacitinib group met the primary endpoint of SRI-4. Based on these results, AbbVie plans to advance the clinical program of upadacitinib for the treatment of SLE into Phase III.

This Phase II study enrolled 341 subjects, who were subsequently divided into five treatment groups based on the treatment regimen (Upadacitinib + placebo; two different doses of Upadacitinib combined with Elsubrutinib; Elsubrutinib + placebo; placebo). The primary endpoint was the proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 24 while taking a daily steroid dose of less than or equal to 10mg of prednisone equivalent. SRI-4 is defined as a reduction of greater than or equal to 4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score, with no overall worsening or significant disease activity occurring in new organ systems.

The safety results of the 30mg upadacitinib group in this study were generally consistent with the known safety profile, with no new safety signals identified. The full results of the study will be presented at a future medical conference.

Rinvoq has been rapidly penetrating the market in the past two years, with 7 indications successively filed for approval or approved for marketing in multiple countries. Although the FDA required Rinvoq and other JAK drugs for treating chronic inflammation to include a black box warning in the package insert, this has not slowed down the speed at which Rinvoq captures the market.

IL-23 Monoclonal Antibody Skyrizi Has Established a Strong Position in the Psoriasis Market with Superior Efficacy and Expanded to Crohn's Disease (CD) and Ulcerative Colitis (UC). On the same day, the Phase III INSPIRE study of Skyrizi for treating adult patients with moderate to severe active UC also achieved positive key results. AbbVie anticipates that by 2027, the peak sales of these two products will surpass the peak revenue of Humira (adalimumab) at $21 billion.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message or send a notification to the WeChat Official Account backend, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

PharmaCube Reader Survey Questionnaire

Thank You for Your Company, Looking Forward to Your Feedback

Scan the QR code to provide valuable suggestions