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LO-021 Interim safety and efficacy of subcutaneous (s.c.) dose ianalumab (VAY736; anti-BAFF-R mAb) administered monthly over 28 weeks in patients with systemic lupus erythematosus (SLE)
  1. Shin-Seok Lee1,
  2. Stanislav Ignatenko2,
  3. Alexander Gordienko3,
  4. Josefina Hernandez4,
  5. Nancy Levin5,
  6. Pongthorn Narongroeknawin6,
  7. Katarzyna Romanowska-Prochnicka7,
  8. Nan Shen8,
  9. Hanna Ciferska9,
  10. Masanari Kodera10,
  11. Cheng-Chung Wei11,
  12. Piotr Leszczynski12,
  13. Joung Liang Lan13,
  14. Rafal Wojciechowski14,
  15. Tunde Tarr15,
  16. Elena Vishneva16,
  17. Yi Hsing Chen17,
  18. Yuko Kaneko18,
  19. Stephanie Finzel19,
  20. Alberta Hoi20,
  21. Masato Okada21,
  22. Ajchara Koolvisoot22,
  23. Lie Dai23,
  24. Hiroshi Kaneko24,
  25. Bernadette Rojkovich25,
  26. Lingyun Sun26,
  27. Eugeny Zotkin27,
  28. Berta Paula magallares28,
  29. Tirtha Sengupta29,
  30. Carole Sips30 and
  31. Stephan Oliver30
  1. 1Division of Rheumatology, Department of Internal Medicine, Chonnam National University Medical School and Hospital, Republic of Korea
  2. 2Department of Rheumatology, Charité Research Organisation GmbH, Berlin, Germany
  3. 3Department of Rheumatology, SM Kirov Military Medical Academy, St Petersburg, Russian Federation
  4. 4Lupus Unit, Rheumatology Department, Vall d’Hebron Hospitals, Barcelona, Spain
  5. 5Yabludowicz Center for Autoimmune Disease, Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel
  6. 6Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand
  7. 7Department of Systemic Connective Tissue Diseases, National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland
  8. 8Department of Rheumatology, Shanghai Institute of Rheumatology, Renji Hospital, Shanghai Jaiotong University School of Medicine, China
  9. 9Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic
  10. 10Department of Dermatology, Japan Community Healthcare Organization, Chukyo Hospital, Nagoya, Japan
  11. 11Department of Rheumatology, Chung Shan Medical University Hospital, Taichung, Taiwan
  12. 12Department of Internal Medicine, Poznan University of Medicine Sciences, Poznan, Poland
  13. 13Rheumatology and Immunology Center, China Medical University Hospital, Taichung, Taiwan
  14. 14Department of Rheumatology and Systemic Connective Tissue Diseases, University Hospital No. 2, Bydgoszcz, Poland
  15. 15Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary
  16. 16Department of Rheumatology, LLC Family Clinic, Yekaterinburg, Russian Federation
  17. 17Department of Rheumatology, Taichung Veterans General Hospital, Taichung, Taiwan
  18. 18Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
  19. 19Department of Rheumatology and Clinical Immunology, University Medical Center Freiburg, Freiburg, Germany
  20. 20Department of Rheumatology, Monash Health, Monash University, Melbourne, Australia
  21. 21Immuno-Rheumatology Center, St. Luke’s International Hospital, Tokyo, Japan
  22. 22Division of Rheumatology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
  23. 23Department of Rheumatology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China
  24. 24Division of Rheumatic Disease, National Center for Global Health and Medicine, Tokyo, Japan
  25. 25Department of Rheumatology and Physiotherapy, Polyclinic of the Hospitaller Brothers of St. John of God, Semmelweis University, Budapest, Hungary
  26. 26Department of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China
  27. 27Department of Rheumatology, VA Nasonova Research Institute of Rheumatology, Moscow, Russian Federation
  28. 28Department of Rheumatology, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain
  29. 29Immunology, Novartis Healthcare Pvt Ltd, Hyderabad, India, India
  30. 30Immunology, Novartis Pharm AG, Basel, Switzerland


Background Ianalumab (VAY736; defucosylated, human IgG1 anti-BAFF-receptor mAb), provides both antibody-dependent cellular cytotoxicity-mediated B cell depletion and BAFF-receptor signaling blockade. We report here ianalumab safety and efficacy in patients with active SLE.

Methods Placebo-controlled, randomized, parallel group, double-blind treatment cohort within a multi-center platform trial. Patients with ANA ≥1:80 and meeting ≥4/11 ACR 1997 SLE classification criteria, with SLEDAI-2K score ≥6 and BILAG-2004 ≥1A or ≥2B, including activity in either mucocutaneous and/or musculoskeletal domains were enrolled. We report interim analysis for the first 48 patients enrolled into the ianalumab-treatment cohort (active=22, placebo=26) completing the 28-week (w) blinded treatment period, comprised of ianalumab 300mg or placebo monthly s.c. injections. Outcomes were measured at baseline and every 4w till w28. Primary outcome was proportion patients meeting composite endpoint: achieving w28 SRI-4 and tapering predniso(lo)ne to ≤5 mg/d or ≤baseline dose, whichever was lower, by w16 and remaining so to w28. Secondary/exploratory outcomes included safety, incidence moderate/severe flare (BILAG-2004 ≥1A or ≥2B), LLDAS, SLEDAI-2K, BILAG-2004, and physician/patient global VAS.

Results Ianalumab was safe/well-tolerated with no drug-related SAE or dropouts and one pandemic-related discontinuation in placebo arm. Mean age=40y; 7 males (placebo=5, ianalumab=2). Baseline mean(range) for ianalumab and placebo was: SLEDAI-2K, 12.4(6–32) and 11.6(4–21), and predniso(lo)ne 11.3mg(3–30) and 11.4mg(3–28). Proportion ianalumab or placebo patients achieving w28 SRI-4 (figure 1) was 77.3% (n=17) vs. 26.9% (n=7), and also meeting composite endpoint: 54.5%(n=12) vs. 11.5%(n=3). Proportion with moderate or severe flare were 40.9% (ianalumab, n=9) vs. 65.4% (placebo, 17). Ianalumab also showed treatment benefit vs placebo in time-to-moderate or severe flare and achieving w28 LLDAS.

Conclusions Treatment of SLE with ianalumab was safe, well tolerated, and more patients achieved composite primary endpoint SRI-4 with sustained steroid reduction vs. placebo arm, with other evidence for clinical improvement, including reductions in moderate/severe flares and LLDAS.

Abstract LO-021 Figure 1

Proportion patients attaining SRI-4 and achieving w28 composite endpoint

  • B-cell depletion
  • Ianalumab
  • Systemic lupus erythematosus

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