ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: L18

A Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), Telitacicept (RC18), in Systemic Lupus Erythematosus (SLE): Results of a Phase 2b Study

Di Wu1, Jing Li 2, Dong Xu 2, Wenxiang Wang 3, Lin Li 4, Jianmin Fang 3 and Fengchun Zhang 5, 1Peking Union Medical College Hospital, Beijing, Beijing, China (People's Republic), 2Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Beijing, China (People's Republic), 3RemeGen, Ltd., Yantai, China (People's Republic), 4RemeGen, Ltd., Beijing, China (People's Republic), 5Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (People's Republic)

Meeting: 2019 ACR/ARP Annual Meeting

Date of first publication: October 23, 2019

Keywords: APRIL, BLyS, clinical trials, Late-Breaking 2019, Systemic lupus erythematosus (SLE)

  • Tweet
  • Email
  • Print
Session Information

Date: Tuesday, November 12, 2019

Title: 5T132: Late-Breaking Abstracts

Session Type: Late-Breaking Abstract Session

Session Time: 4:00PM-6:00PM

Background/Purpose: Telitacicept, also named RC18, is a novel recombinant fusion protein constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophylin ligand interactor (TACI) receptor and the Fc domain of human immunoglobulin (Ig) G1 targeting and neutralizing B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). This phase 2b study evaluated the efficacy and safety of Telitacicept versus placebo in combination with standard therapy in SLE patients.

Methods: SLE patients aged 18 to 65 years with positive ANA and/or anti-dsDNA and with a SELENA-SLEDAI score ≥8 were randomized 1:1:1:1 to receive subcutaneous Telitacicept at 80 mg, 160 mg, 240 mg or placebo once a week in combination with standard therapy for 48 weeks. The primary endpoint was response rate of SLE Responder Index 4 (SRI4) at Week 48. The SRI4 response was defined as: ≥4 points reduction from baseline in SELENA-SLEDAI score, and no new BILAG A organ domain score or 1 new BILAG B organ domain score compared with baseline, and no worsening (increase of < 0.30 points from baseline) in Physician’s Global Assessment (PGA). This trial is registered with ClinicalTrials.gov, number NCT02885610.

Results: 249 patients were randomized to receiving Telitacicept 80 mg (n=62), 160 mg (n=63), 240 mg (n=62) or placebo (n=62). Results from full analysis set (FAS) showed significantly higher response rates of SRI4 with Telitacicept 80mg (71.0%, p< 0.0001), 160 mg (68.3%, p=0.0001) and 240 mg (75.8%, p< 0.0001) than with placebo (33.9%) at Week 48; more patients had a reduction of ≥ 4 points in SELENA-SLEDAI score at Week 48 with Telitacicept 80mg (75.8%, p=0.003), 160 mg (77.8%, p=0.001) and 240 mg (79.0%, p< 0.001) than with placebo (50.0%); no worsening in PGA score was noted in more patients with Telitacicept 80mg (96.8%, p< 0.001), 160 mg (92.1%, p=0.013) and 240 mg (96.8%, p< 0.001) than with placebo (75.8%) at Week 48. Results from Per protocol set (PPS) were consistent with that from FAS. The incidences of AEs was 93.5%、92.1%、90.3%、82.3% in the Telitacicept 240mg, 160mg, 80mg and placebo group. There were 13 SAEs in 8 subjects treated with 240mg Telitacicept, 16 SAEs in 10 subjects treated with 160mg Telitacicept, 12 SAEs in 8 subjects treated with 80mg Telitacicept, 12 SAEs in 10 subjects treated with placebo, the incidences of SAEs were 12.9%, 15.9%,12.9%, 16.1% in the Telitacicept 240mg, 160mg, 80mg and placebo groups, respectively. The incidence of AEs and SAEs was similar across groups (p >0.05). There was 1 death in Telitacicept 240mg group which was considered not related to the study drug. The most common AEs were upper respiratory tract infection and injection site reactions. 11 pregnancies occurred during the study in subjects received Telitacicept (4 on 240mg, 3 on 160 mg and 4 on 80 mg) while no pregnancy occurred in the placebo group. 1 pregnancy resulted in live birth and 10 in elective termination.

Conclusion: This phase 2b trial in patients with active SLE treated with Telitacicept in combination with standard therapy met the SRI4 primary endpoint. Telitacicept was well tolerated in SLE patients.

Figure 1. SRI4 Response by Visit

Table 1. SRI4 Response at Week 48


Disclosure: D. Wu, None; J. Li, None; D. Xu, None; W. Wang, RemeGen, Ltd., 1, 2; L. Li, RemeGen, Ltd., 1, 2; J. Fang, RemeGen, Ltd., 1, 2; F. Zhang, GlaxoSmithKline, 9.

To cite this abstract in AMA style:

Wu D, Li J, Xu D, Wang W, Li L, Fang J, Zhang F. A Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), Telitacicept (RC18), in Systemic Lupus Erythematosus (SLE): Results of a Phase 2b Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/a-human-recombinant-fusion-protein-targeting-b-lymphocyte-stimulator-blys-and-a-proliferation-inducing-ligand-april-telitacicept-rc18-in-systemic-lupus-erythematosus-sle-results-of-a-phase/. Accessed .
  • Tweet
  • Email
  • Print

« Back to 2019 ACR/ARP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-human-recombinant-fusion-protein-targeting-b-lymphocyte-stimulator-blys-and-a-proliferation-inducing-ligand-april-telitacicept-rc18-in-systemic-lupus-erythematosus-sle-results-of-a-phase/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology