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: 0850

What Does It Mean to Be a BICLA (BILAG-Based Composite Lupus Assessment) Responder? Post Hoc Analysis of the Phase 3 TULIP-1 and TULIP-2 Trials

Richard Furie1, Eric Morand2, Ian Bruce3, David Isenberg4, Ronald van Vollenhoven5, Gabriel Abreu6, Lilia Pineda7 and Raj Tummala7, 1Zucker School of Medicine at Hofstra/Northwell, Great Neck, 2Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia, 3Centre for Epidemiology Versus Arthritis, The University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, 4Centre for Rheumatology, University College London and Department of Rheumatology, University College Hospital, London, United Kingdom, 5Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, 6BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, 7BioPharmaceuticals R&D, AstraZeneca, Gaithersburg

Meeting: ACR Convergence 2020

Keywords: Disease Activity, glucocorticoids, 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: Saturday, November 7, 2020

Title: SLE – Treatment Poster I

Session Type: Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: BICLA is a validated composite global measure of SLE disease activity that incorporates BILAG, an instrument that distinguishes between partial and complete improvement. BICLA was an endpoint in the phase 3 TULIP-1 and TULIP-2 trials of anifrolumab.1,2 This study investigated the relationships between BICLA response and SLE clinical and laboratory assessments in TULIP-1 and -2, irrespective of treatment assignment.

Methods: This was a post hoc analysis of pooled data from the 52-week (wk), double-blind TULIP-1 and -2 trials. Patients with moderately to severely active SLE, despite standard of care, were randomized to receive anifrolumab (150 or 300 mg IV Q4W) or placebo for 48 wks. BICLA responses were defined by the following: reduction of all baseline BILAG-2004 A and B domain scores to B/C/D and C/D, respectively, and no worsening in any organ system; no worsening of SLEDAI-2K score; and no worsening ≥0.3 points in Physician’s Global Assessment (range 0–3).3 Attempts to taper oral corticosteroids (OCS) to ≤7.5 mg/day between Wks 8 and 40 were required for patients receiving OCS ≥10 mg/day at baseline. Sustained OCS dosage reduction was defined as OCS dosage ≤7.5 mg/day achieved by Wk 40 and sustained through Wk 52.

Results: Baseline characteristics were generally similar between BICLA responders (n=318) and nonresponders (n=501). Overall, improved outcomes were observed in BICLA responders vs nonresponders, including numerically greater improvements in SLEDAI-2K (–7.4 [SD: 3.64] vs –4.2 [SD: 4.28]) from baseline to Wk 52 (Table 1). Greater mean daily OCS dosage reduction was observed in BICLA responders vs nonresponders (–5.41 [SD: 6.84] vs –1.67 [SD: 8.08] mg/day) from baseline to Wk 52, and sustained OCS dosage reduction was achieved by more BICLA responders vs nonresponders (79.2% vs 19.1%). A ≥50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score, for patients with baseline score ≥10, was achieved by more BICLA responders vs nonresponders (92.0% vs 23.2%) at Wk 52. Greater reductions of mean anti-dsDNA antibody levels were observed in BICLA responders vs nonresponders (–46.1 [SD: 335.69] vs 15.8 [SD: 450.92] U/mL) from baseline to Wk 52; numeric improvements were also observed for complement C3 (Table 2). More patients who were BICLA responders vs nonresponders reported improved patient-reported outcomes, with greater improvements in the Functional Assessment of Chronic Illness Therapy-Fatigue of >3 points (55.6% vs 15.7%) and the Short Form 36 Health Survey physical component summary of >3.4 (57.9% vs 12.8%) (Table 3).

Conclusion: BICLA response was associated with clinical benefit in multiple SLE measures, including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. These data uphold the value of BICLA as an endpoint in SLE trials and also expand its benefit to translating trial data to metrics that are clinically meaningful in everyday practice.

References 

  1. Morand EF. N Engl J Med. 2020;382:211–21.
  2. Furie RA. Lancet Rheumatol. 2019;1:e208–19.
  3. Wallace DJ. Ann Rheum Dis. 2014;73:183–90.

Writing assistance by Rosie Butler, PhD (JK Associates Inc., a Fishawack Health Company).

This study was sponsored by AstraZeneca.

Table 1. SLE Assessments in BICLA Responders vs Nonresponders in Pooled Data From the Phase 3 TULIP-1 and TULIP-2 Trials

Table 2. Change in Biomarker Levels From Baseline to Week 52 in BICLA Responders vs Nonresponders in Pooled Data From the TULIP Trials

Table 3. Improvement in Patient-Reported Outcome Assessments From Baseline to Week 52 in BICLA Responders vs Nonresponders in Pooled Data From the TULIP Trials


Disclosure: R. Furie, AstraZeneca/Medimmune, 2, 5; E. Morand, AstraZeneca, 2, 5, 8, Bristol-Myers Squibb, 2, 5, Eli Lilly, 2, 5, GlaxoSmithKline, 2, 5, Janssen, 2, 5, Merck Serono, 2, 5, Neovacs, 5, Sandoz, 5, Novartis, 8, AbbVie, 5, Amgen, 5, Biogen, 5; I. Bruce, Genzyme/Sanofi, 2, GlaxoSmithKline, 2, 5, 8, Roche, 2, UCB, 2, 5, 8, Eli Lilly, 5, Merck Serono, 5, ILTOO, 5, AstraZeneca, 8; D. Isenberg, AstraZeneca, 5, Celgene, 5, Merck Serono, 5, UCB, 5, Servier, 5; R. van Vollenhoven, BMS, 2, GSK, 2, Lilly, 2, UCB, 2, 5, 8, AbbVie, 5, 8, AstraZeneca, 5, 8, Biogen, 5, Biotest, 5, Celgene, 5, Gilead, 5, Pfizer, 5, 8, Servier, 5, Janssen, 5, 8, Galapagos, 5, 8; G. Abreu, AstraZeneca, 3; L. Pineda, AstraZeneca, 3; R. Tummala, AstraZeneca, 3.

To cite this abstract in AMA style:

Furie R, Morand E, Bruce I, Isenberg D, van Vollenhoven R, Abreu G, Pineda L, Tummala R. What Does It Mean to Be a BICLA (BILAG-Based Composite Lupus Assessment) Responder? Post Hoc Analysis of the Phase 3 TULIP-1 and TULIP-2 Trials [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/what-does-it-mean-to-be-a-bicla-bilag-based-composite-lupus-assessment-responder-post-hoc-analysis-of-the-phase-3-tulip-1-and-tulip-2-trials/. 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 2020

ACR Meeting Abstracts - https://acrabstracts.org/abstract/what-does-it-mean-to-be-a-bicla-bilag-based-composite-lupus-assessment-responder-post-hoc-analysis-of-the-phase-3-tulip-1-and-tulip-2-trials/

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