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Abstract Number: 1458

Sustained Efficacy and Safety of Iberdomide to Week 52 in Patients with Active Systemic Lupus Erythematosus (SLE) in a Phase 2, Randomized, Placebo-Controlled Study

Joan Merrill1, Victoria Werth2, Richard Furie3, Ronald van Vollenhoven4, Maria Majdan5, Michael Weiswasser6, Shimon Korish6, Zhaohui Liu6, Peter Schafer6 and Nikolay Delev6, 1Oklahoma Medical Research Foundation, Oklahoma City, OK, 2Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, 3Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, 4Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, 5Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Lublin, Poland, 6Bristol Myers Squibb, Princeton, NJ

Meeting: ACR Convergence 2021

Keywords: Outcome measures, randomized, Systemic lupus erythematosus (SLE)

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Session Information

Date: Monday, November 8, 2021

Session Title: Abstracts: SLE – Treatment: New Agents, Old Agents (1458–1463)

Session Type: Abstract Session

Session Time: 3:30PM-3:45PM

Background/Purpose: We previously reported 24-wk results of a phase 2b trial of iberdomide, a high-affinity cereblon ligand that promotes proteasomal degradation of Ikaros (IKZF1) and Aiolos (IKZF3), 2 key transcription factors linked to SLE. The study (NCT03161483) met its primary endpoint at wk 24.1 Results through wk 52 are reported here.

Methods: Adults (N=288) with autoantibody-positive SLE and SLEDAI 2K scores ≥6 were randomized (2:2:1:2) to oral iberdomide (0.45, 0.3, 0.15 mg) or placebo (PBO) daily, added to background lupus therapy. At wk 24, patients (pts) on PBO were re-randomized to iberdomide 0.3 or 0.45 mg, while pts on iberdomide continued their original regimens. Efficacy analyses were based on the intent-to-treat population, including all pts who were randomized at wk 0 and received ≥1 dose of study drug.

Results: 214 (87.0%) pts completed 52 wks. As previously reported, the primary endpoint, SRI-4 response at wk 24, was achieved by 54.3% of pts on iberdomide 0.45 mg vs. 34.9% on PBO (stratified difference, 19.4%; P=0.011). At wk 52, the proportions of SRI-4 responders were sustained or improved in all groups originally randomized to iberdomide: 0.45 mg (wk 24: 54.3% vs. wk 52: 51.9%), 0.3 mg (40.2% vs. 52.4%), and 0.15 mg (47.6% vs. 50.0%) (Figure). Of wk 24 SRI-4 responders, response was maintained at ≥70% of the visits through wk 52 by 75.0%, 81.8%, and 70.0% in the 0.45-mg, 0.3-mg, and 0.15-mg groups. Increased proportions of pts attained SRI-4 response after switching from PBO to 0.3 mg (41.7% vs. 61.1%) or from PBO to 0.45 mg (38.9% vs. 58.3%) (Figure). In the iberdomide 0.3-mg group and the 2 PBO switching groups, improvements in the proportions meeting SRI-6 and ≥4-point decrease in SLEDAI-2K at wk 52 were observed (Table 1). In pts originally randomized to iberdomide, there were trends of increased BICLA responses and improved swollen/tender joint counts at wk 52 (Table 1). In the 0.3-mg and 0.45-mg groups, the enhanced SRI-4 responses at wk 24 in the prespecified subsets of pts with Type 1 IFN high signatures at baseline were similar or improved at wk 52 and also achieved by pts switching from PBO to iberdomide (Figure and Table 1). In Aiolos-high pts at baseline, enhanced responses were observed at wk 52 in the 0.15-mg and 0.3-mg groups and PBO switching groups, but response rates were not sustained in the 0.45-mg group. There were no increases in exposure-adjusted incidence of treatment-emergent adverse events (TEAEs), TEAEs leading to drug interruption or withdrawal, or serious AEs (SAEs) (Table 2). Most TEAEs were mild to moderate in severity, the most common being urinary tract infection (14.9%), upper respiratory tract infection (11.2%), and neutropenia (9.8%). Neutropenia was reversible and rarely led to discontinuation (1.4%). One pt on iberdomide (0.3 mg) had an SAE of varicella zoster pneumonia with full recovery.

Conclusion: Iberdomide treatment of pts with SLE was associated with sustained clinical benefits in multiple measures of disease activity up to wk 52. Enhanced clinical responses in pts with IFN-high and Aiolos-high signatures were also observed at 52 wks. Iberdomide was well tolerated with safety data consistent with that reported at wk 24.

Reference:
1. Merrill J, et al. Arthritis Rheumatol. 2020;72 (suppl 10).


Disclosures: J. Merrill, GlaxoSmithKline, 2, 5, UCB, 2, AbbVie, 2, EMD Serono, 2, Remegen, 2, Celgene/Bristol Myers Squibb, 2, AstraZeneca, 2, 5, Daiichi Sankyo, 2, Servier, 2, Immupharma, 2, Amgen, 2, Janssen, 2, Lilly, 2, Genentech, 2, Resolve, 2, Alpine, 2, Aurinia, 2, Astellas, 2, Alexion, 2, Provention, 2; V. Werth, Celgene, 5, Resolve, 2, Janssen, 2, 5, Eli Lilly, 2, Biogen, 2, 5, Bristol Myers Squibb, 2, Gilead, 2, 5, Amgen, 2, EMD Serono, 2, Viela Bio, 2, 5, Kyowa Kirin, 2, AstraZeneca, 2, AbbVie, 2, GlaxoSmithKline, 2; R. Furie, GlaxoSmithKline, 2, 5; R. van Vollenhoven, Bristol Myers Squibb, 2, 5, Eli Lilly, 5, UCB, 2, 5, 6, Pfizer, 2, 6, 12, Support for educational programs; institutional grants, Roche, 12, Support for educational programs; institutional grants, Janssen, 2, 6, AbbVie, 2, 6, AstraZeneca, 2, Biotest, 2, GlaxoSmithKline, 2, 6, Biogen, 2, Galapagos, 2, 6, Gilead, 2, Sanofi, 2, Servier, 2, Vielabio, 2; M. Majdan, Novartis, 6, Lilly, 6, Amgen, 6, UCB, 6, Medac, 6; M. Weiswasser, Bristol Myers Squibb, 3, 11; S. Korish, Bristol Myers Squibb, 3, 11; Z. Liu, Bristol Myers Squibb, 3, 11; P. Schafer, Bristol Myers Squibb, 3, 11; N. Delev, Bristol Myers Squibb, 3, 11.

To cite this abstract in AMA style:

Merrill J, Werth V, Furie R, van Vollenhoven R, Majdan M, Weiswasser M, Korish S, Liu Z, Schafer P, Delev N. Sustained Efficacy and Safety of Iberdomide to Week 52 in Patients with Active Systemic Lupus Erythematosus (SLE) in a Phase 2, Randomized, Placebo-Controlled Study [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/sustained-efficacy-and-safety-of-iberdomide-to-week-52-in-patients-with-active-systemic-lupus-erythematosus-sle-in-a-phase-2-randomized-placebo-controlled-study/. Accessed January 31, 2023.
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