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: 2551

Remission and Low Disease Activity (LDA) in Patients with SLE Treated with Belimumab (BEL): Results from a Large Integrated Analysis

Ioannis Parodis1, Julius Lindblom1, Roger A. Levy2, Margherita Zen3, Nursen Cetrez1, Alvaro Gomez4, Shereen Oon5, Christine Henning6, Munther Khamashta7, Holly A. Quasny8, Deven Chauhan9, Anca Askanase10, Ronald van Vollenhoven11 and Mandana Nikpour12, 1Karolinska Institutet, Stockholm, Sweden, 2GlaxoSmithKline, Global Medical Affairs, Collegeville, PA, 3University of Padua, Division of Rheumatology, Department of Medicine, Padua, Italy, 4Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden, 5University of Melbourne at St Vincent’s Hospital, Departments of Rheumatology and Medicine, Fitzroy, Australia, 6GlaxoSmithKline, US Medical Affairs, Durham, NC, 7GSK Gulf, Medical Affairs Department, Dubai, United Arab Emirates, 8GlaxoSmithKline, Research & Development, Durham, NC, 9GlaxoSmithKline, Value Evidence and Outcomes, Brentford, United Kingdom, 10Columbia University Medical Center, New York, NY, 11Amsterdam Rheumatology and Immunology Center and Amsterdam University Medical Centers, Department of Rheumatology, Amsterdam, Netherlands, 12The University of Melbourne at St. Vincent’s Hospital Melbourne, Departments of Medicine and Rheumatology, Melbourne, Australia

Meeting: ACR Convergence 2023

Keywords: Biologicals, Disease Activity, Outcome measures, Response Criteria, Systemic lupus erythematosus (SLE)

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print
Session Information

Date: Tuesday, November 14, 2023

Title: Abstracts: SLE – Diagnosis, Manifestations, & Outcomes III: Disease Activity

Session Type: Abstract Session

Session Time: 4:00PM-5:30PM

Background/Purpose: A key treatment goal in SLE management is the attainment of remission or LDA,1 for which various definitions exist, including “Definitions of Remission in SLE” (DORIS),2 and “Lupus LDA State” (LLDAS).3Using DORIS and LLDAS criteria, we evaluated remission or LDA attainment in patients with SLE treated with BEL, an approved treatment for active SLE and LN, with standard therapy.

Methods: This is a post hoc analysis of pooled data for adults with SLE from five trials: BLISS-76, BLISS-52, NEA, BLISS-SC, and EMBRACE (GSK Studies BEL110751, BEL110752, BEL113750, BEL112341, and BEL115471). Included patients received BEL (10 mg/kg/month intravenously or 200 mg/week [wk] subcutaneously) or placebo (PBO), plus standard therapy. Attainment of LLDAS and DORIS was compared between BEL and PBO using logistic regression adjusted for trial variance, in the overall population and in the following baseline patient subgroups: SLEDAI 2000 (SLEDAI-2K)score ³10; anti-dsDNA positivity; anti-dsDNA positivity or low complement C3/C4 levels; glucocorticoid (GC) dose (prednisone-equivalent) >7.5 mg/day.

Results: Among 1869 BEL and 1217 PBO patients analyzed, 94.4% were female, mean (standard deviation, SD) age was 37 (12) years. In the overall population, significantly greater attainment of remission was observed for BEL vs PBO at Wk 20 (odds ratio, OR [95% confidence interval, CI]: 1.59 [1.01, 2.50]; p=0.047) and Wk 28 (1.83 [1.20, 2.79]; p=0.005), and BEL superiority was maintained from Wk 48 (1.45 [1.07, 1.95]; p=0.016) to Wk 52 (Figure). Statistically significantly greater attainment of LLDAS with BEL vs PBO was first observed at Wk 24 (1.35 [1.04, 1.74]; p=0.022) and was maintained through Wk 52 (Figure). Similar results were observed for the baseline patient subgroups, with greater remission/LLDAS attainment with longer treatment, except for the GC >7.5 mg/day dose subgroup, where no significant difference in remission attainment was seen with BEL vs PBO (Figure). The earliest superiority of BEL in attaining remission was seen for patients with baselineSLEDAI-2K ³10 at Wk 20 (2.34 [1.11, 4.96]; p=0.026), which was maintained to Wk 52 (Figure). Superiority of BEL in attaining LLDAS was first seen at Wk 16 for patients with baselineSLEDAI-2K ³10 (1.65 [1.01, 2.69]; p=0.045), baseline anti-dsDNA positivity (1.48 [1.01, 2.18]; p=0.043), and baseline anti-dsDNA positivity/low C3/C4 (1.49 [1.04, 2.12]; p=0.029), and was maintained from Wk 24 (1.78 [1.20, 2.65]; p=0.004, 1.46 [1.05, 2.02]; p=0.025, and 1.49 [1.09, 2.02]; p=0.011, respectively) to Wk 52 (Figure).

Conclusion: In this large analysis, statistically significant differences in attainment of remission and LLDAS in favor of BEL vs PBO were seen as early as 24 wks after treatment, with 8% (vs 6%) and 17% (vs 10%) of BEL-treated patients achieving remission and LLDAS, respectively, at Wk 52. BEL appeared particularly beneficial for patients with baselineSLEDAI-2K ³10 and baseline anti-dsDNA positivity/low C3/C4, in whom LLDAS was attained earlier than in the overall population.
Funding: GSK

References

1 Fanouriakis A et al. Ann Rheum Dis 2019;78:736–45
2 van Vollenhoven RF et al. Lupus Sci Med 2021;8:e000538
3 Franklyn K et al. Ann Rheum Dis 2016;75:1615–21

Supporting image 1

Figure. Remission* (A) and LLDAS† (B) rates in patients with SLE treated with BEL versus PBO, in the overall population, and in patient subgroups per baseline characteristics. Logistic regression (adjusted for the trials) was used for comparisons between BEL and PBO.

*The DORIS remission definition requires a clinical SLEDAI_2K score=0 and a PGA score <0.5 (scale 0–3), while it allows serological activity and use of low-dose GCs (prednisone-equivalent <=5 mg/day) and immunosuppressive or biological agents at standard doses; †the LLDAS definition requires a SLEDAI_2K score <=4, excluding major organ activity and fever or new activity since the previous assessment, and PGA score <=1 (scale 0–3), and it allows a prednisone-equivalent dose <=7.5 mg/day and immunosuppressive or approved biological agents at standard doses.
IV, intravenous; PGA, Physician Global Assessment; SC, subcutaneous; ST, standard therapy.


Disclosures: I. Parodis: Amgen, 5, 6, AstraZeneca, 5, 6, Aurinia Pharmaceuticals, 5, 6, Bristol-Myers Squibb(BMS), 5, 6, Elli Lilly and Company, 5, 6, F. Hoffmann-La Roche AG, 5, 6, Gilead Sciences, 5, 6, GSK, 5, 6, Janssen Pharmaceuticals, 5, 6, Novartis, 5, 6, Otsuka Pharmaceutical, 5, 6; J. Lindblom: None; R. Levy: GSK, 3, 11; M. Zen: Eli Lilly, 6, GSK, 6; N. Cetrez: None; A. Gomez: None; S. Oon: None; C. Henning: GSK, 3, 11; M. Khamashta: GSK, 3, 11; H. Quasny: GSK, 3, 11; D. Chauhan: GSK, 3, 11; A. Askanase: AbbVie, 2, Amgen, 2, AstraZeneca, 2, Aurinia, 2, Bristol-Myers Squibb, 2, Celgene, 2, Eli Lilly, 2, Genentech, 2, GSK, 2, Idorsia, 2, Janssen, 2, Mallinckrodt, 2, Pfizer, 2, UCB Pharma, 2; R. van Vollenhoven: AbbVie/Abbott, 2, 6, AstraZeneca, 2, Biogen, 2, Biotest, 2, Bristol-Myers Squibb(BMS), 2, Galapagos, 2, 6, Gilead, 2, GSK, 6, Janssen, 2, 6, Pfizer, 2, 5, 6, Roche, 5, 6, Sanofi, 2, Servier, 2, UCB, 2, 6, Vielabio, 2; M. Nikpour: AstraZeneca, 2, 6, Boehringer-Ingelheim, 2, 6, GSK, 2, 6, Janssen Pharmaceuticals, 2, 5, 6.

To cite this abstract in AMA style:

Parodis I, Lindblom J, Levy R, Zen M, Cetrez N, Gomez A, Oon S, Henning C, Khamashta M, Quasny H, Chauhan D, Askanase A, van Vollenhoven R, Nikpour M. Remission and Low Disease Activity (LDA) in Patients with SLE Treated with Belimumab (BEL): Results from a Large Integrated Analysis [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/remission-and-low-disease-activity-lda-in-patients-with-sle-treated-with-belimumab-bel-results-from-a-large-integrated-analysis/. Accessed .
  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to ACR Convergence 2023

ACR Meeting Abstracts - https://acrabstracts.org/abstract/remission-and-low-disease-activity-lda-in-patients-with-sle-treated-with-belimumab-bel-results-from-a-large-integrated-analysis/

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