OP0131 ANIFROLUMAB EFFECTS ON RASH AND ARTHRITIS IN PATIENTS WITH SLE AND IMPACT OF INTERFERON SIGNAL IN POOLED DATA FROM PHASE 3 TRIALS

Background: Treatment with the type I interferon (IFN) receptor antibody anifrolumab was associated clinical improvements in mucocutaneous and musculoskeletal disease activity patients systemic lupus erythematosus (SLE) phase 2 MUSE trial ( NCT01438489 ) 3 TULIP trials. 1–4 Because rash arthritis are most common manifestations of SLE, effect on these symptoms can be examined biomarker-defined subsets, as previously reported for trial. Objectives: To evaluate impact IFN gene signature (IFNGS) treatment response, using measures different stringency pooled data from Methods: TULIP-1 NCT02446912 TULIP-2 NCT02446899 were placebo-controlled, 52-week trials intravenous administered every 4 weeks moderate to severe SLE. 3,4 In this post hoc analysis, outcomes evaluated domains SLE Disease Activity Index 2000 (SLEDAI-2K) British Isles Lupus Assessment Group (BILAG) index. addition, modified Cutaneous Erythematosus Area Severity (mCLASI) score used rash, tender swollen joint counts assess arthritis. Results: 360 received 300 mg (IFNGS test–high, n=298; IFNGS test–low, n=62) 366 given placebo n=302; n=64). Change baseline Week 52 compared measured by outcomes, ordered their stringency. More anifrolumab-treated achieved improvement SLEDAI-2K (complete resolution: difference 13.5%, nominal P <0.001), BILAG (at least 1 severity grade lowering: 15.5%, mCLASI (?50% improvement, if >0: 15.6%, <0.001). Results comparable test–high subset (SLEDAI-2K: 17.0%, <0.001, BILAG: 16.1%, <0.001; mCLASI: 18.1%, There a trend toward anifrolumab-associated test–low (Figure). receiving had SLEDAI-2K–defined resolution (difference 8.2%, =0.029), lessening 11.8%, =0.002), ?50% decrease tender/swollen counts, when ?6 at 12.6%, =0.016). 11.7%, =0.005; 12.9%, =0.003; counts: 11.3%, =0.054). patients, there BILAG, number swollen/tender similar group, although sample size analysis very small Conclusion: trials, The findings largely driven who test–high. However, that more sensitive change, despite sizes, may also have benefit. References: [1]Furie R, et al. Arthritis Rheumatol . 2017;69:376–86. [2]Merrill JT, Sci Med. 2018;5:e000284. [3]Furie RA, Lancet 2019;1:e208–19. [4]Morand EF, N Engl J 2020;382:211–21. Acknowledgements: Writing assistance Victoria Alikhan, PhD, JK Associates Inc., part Fishawack Health. This study sponsored AstraZeneca. Disclosure Interests: Joan T Merrill Consultant of: AstraZeneca, AbbVie, Amgen, Aurinia, BMS, EMD Serono, GSK, Remegen, Janssen, Provention, UCB, Grant/research support from: BMS Werth Speakers bureau: University Pennsylvania, own copyright CLASI SDASI, Argenx, Biogen, Celgene, Chrysalis, CSL Behring, Cugene, Eli Lilly, Genentech, Incyte, Idera, Kirin, Medimmune, Medscape, Nektar, Octapharma, Pfizer, Principa, Regeneron, Resolve, Viela Bio, Corbus Pharmaceuticals, Gilead, Syntimmune, Richard Furie Eric F. Morand Michelle Kahlenberg Admirex Aurinia Boehringer Ingelheim, Ventus Therapeutics, BMS/Celgene Q32 Gabriel Abreu Employee Raj Tummala AstraZeneca