Bono, Stephanie de

Bruce, Ian N

Cardiel, Mario H

DeLozier, Amy M

Dörner, Thomas

Furie, Richard A

Gomez, Elisa

Hoffman, Robert W

Janes, Jonathan M

Kalunian, Kenneth C

Linnik, Matthew D

Mosca, Marta

Petri, Michelle

Silk, Maria E

Tanaka, Yoshiya

Wallace, Daniel J

Undetermined

Open Access Repository

199 BARICITINIB IN PATIENTS WITH SYSTEMIC LUPUSERYTHEMATOSUS: RESULTS FROM A PHASE 2,RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLEDSTUDY1Maria E Silk*, 2Daniel J Wallace, 3Richard A Furie, 4Yoshiya Tanaka, 5Kenneth C Kalunian,6Marta Mosca, 7Michelle Petri, 8Thomas Dörner, 9Mario H Cardiel, 10Ian N Bruce,1Elisa Gomez, 1Amy M DeLozier, 1Jonathan M Janes, 1Matthew D Linnik, 1Stephaniede Bono, 1Robert W Hoffman. 1Eli Lilly and Company; 2Cedars-Sinai Medical Center/DavidGeffen School of Medicine University of California Los Angeles; 3Zucker School of Medicineat Hofstra/Northwell; 4University of Occupational and Environmental Health, Japan;5University of California at San Diego School of Medicine; 6University of Pisa; 7JohnsHopkins University School of Medicine; 8Charite Universitätsmedizin Berlin and DeutschesRheuma-Forschungszentrum (DRFZ); 9Centro de Investigación Clínica de Morelia SC; 10TheUniversity of Manchester, Arthritis Research UK Centre for Epidemiology, Centre forMusculoskeletal Research, Faculty of Biology Medicine and Health10.1136/lupus-2019-lsm.199Background Baricitinib (Bari), an oral selective inhibitor ofJanus kinase (JAK)1 and JAK2, has been approved for thetreatment of rheumatoid arthritis (RA) in over 50 countriesincluding the United States, European countries, and Japan.The purpose of this study was to report results from a24 week global, Phase 2, double-blind, placebo (PBO)-con-trolled study of Bari in patients with systemic lupus erythema-tosus (SLE) receiving standard therapy.Methods Patients with SLE (positive antinuclear antibody[ANA] or anti-double stranded DNA [anti-dsDNA], clinicalSLE Disease Activity Index 2000 [SLEDAI-2K] 4, arthritis orrash required) receiving stable background SLE therapy wererandomized 1:1:1 to PBO or Bari (2- or 4 mg) once-daily.The primary endpoint was resolution of arthritis or rash asdefined by the SLEDAI-2K at Week 24.Results Of 314 patients randomized, 79%, 82%, and 83%completed 24 weeks of treatment in the PBO, Bari 2 mg, andBari 4 mg groups, respectively. At Week 24, a significantlygreater proportion of patients in the Bari 4 mg group com-pared to PBO achieved resolution of arthritis or rash (67% vs53%, p<0.05) and SLE Responder Index (SRI)4 response(64% vs 48%, p<0.05). At Week 24, the proportions ofpatients achieving flare reduction (Safety of Estrogens inLupus Erythematosus National Assessment [SELENA]-SLEDAIFlare Index [SFI]), Lupus Low Disease Activity State (LLDAS),Physicians Global Assessment, and tender joint count changefrom baseline were also significantly improved for Bari 4 mgcompared to PBO (Table). No statistically significant differen-ces were observed between Bari 2 mg and PBO in any of theabove endpoints. There were no significant changes in anti-dsDNA or complement in patients treated with Bari. Rates ofadverse events leading to treatment discontinuation and seriousadverse events (SAEs) were higher for both Bari dose groupscompared to PBO. There were no deaths, malignancies, majoradverse cardiovascular events, tuberculosis, or serious herpeszoster infections; 1 SAE of deep vein thrombosis was reportedin a patient with risk factors (Bari 4 mg group).Conclusions In patients with SLE receiving standard back-ground therapy, once-daily oral Bari 4 mg was associated withsignificant clinical improvements compared to PBO and anacceptable benefit/risk profile. These findings support furtherstudy of Bari as a potential therapy for patients with SLE.Funding Source(s): This study was funded by Eli Lilly andCompany.200 EFFICACY AND SAFETY OF BELIMUMAB IN PATIENTSOF BLACK RACE WITH SYSTEMIC LUPUSERYTHEMATOSUS: RESULTS FROM THE EMBRACESTUDY1David D’Cruz, 2Kathleen Maksimowicz-McKinnon, 3Jim Oates*, 4MittermayerBarreto Santiago, 5Damon Bass, 6Susan Burriss, 7Jennifer Gilbride, 8James Groark,6Michelle Miller, 9Beulah Ji. 1Louise Coote Lupus Unit, Guys Hospital, London, UK; 2HenryFord Hospital, Wayne State University, Detroit, MI, USA; 3Division of Rheumatology andImmunology, Medical University of South Carolina; 4Bahia School of Medicine and PublicHealth; 5GlaxoSmithKline, Immuno-inflammation and Future Pipeline, Collegeville, PA, USA;6GSK, Collegeville, PA, USA; 7GSK, Stevenage, Hertfordshire, UK; 8GlaxoSmithKline; 9GSK,Uxbridge, Middlesex, UK10.1136/lupus-2019-lsm.200Background Black patients have an increased prevalence andseverity of systemic lupus erythematosus (SLE), alongsidehigher mortality rates. The efficacy and safety of intravenous(IV) belimumab has been demonstrated in several Phase 2/3studies; however, the small number of black patients withinthese trials, and the conflicting results, have limited conclu-sions regarding efficacy in this population. The objective ofthis study was to specifically assess the efficacy and safety ofIV belimumab plus standard of care (SoC) in black patientswith active, auto antibody-positive SLE.Methods EMBRACE (NCT01632241) is a randomized, multi-center, double-blind, placebo-controlled trial in patients of selfidentified black race, aged 18 years, with active SLE atAbstract 199 Table 1 Efficacy and safety outcomes of patientswith systemic lupus erythematosus in a phase 2 study of baricitinibPBO(n=105)Bari 2 mg(n=105)Bari 4 mg(n=104)Efficacy measure Week 24Resolution of arthritis or rash (SLEDAI-2K) 56 (53.3) 61 (58.1) 70 (67.3)*SRI-4 50 (47.6) 54 (51.4) 67 (64.4)*Flare (SFI, any severity) 54 (51.4) 45 (42.9) 34 (32.7)*Flare (SFI, severe) 12 (11.4) 10 (9.5) 6 (5.8)LLDAS 27 (25.7) 35 (33.3) 40 (38.5)*D Tender joint count 5.59 6.50 6.86*D Swollen joint count 4.60 4.12 4.76D Physician’s Global Assessment 26.3 25.9 32.2*D Complement C3, g/L 0 0 0.02D Complement C4, g/L 0.01 0.01 0.01Safety measure Weeks 0–24‡TEAEs 68 (64.8) 75 (71.4) 76 (73.1)SAEs 5 (4.8) 11 (10.5) 10 (9.6)Serious infections 1 (1.0) 2 (1.9) 6 (5.8)Deep vein thrombosis 0 0 1 (1.0)D=least squares mean change from baseline; Bari=baricitinib; LLDAS=Lupus Low DiseaseActivity State; n=number of patients in the analysis population; n=number of patients inthe specified category; PBO=placebo; SAEs=serious adverse events; SFI=Safety of Estrogensin Lupus Erythematosus National Assessment [SELENA]-Systemic Lupus Erythematosus Dis-ease Activity Index [SLEDAI] Flare Index; SLEDAI-2K=Systemic Lupus Erythematosus DiseaseActivity Index 2000; SRI-4=Systemic Lupus Erythematosus Responder Index-4; TEAEs=treat-ment emergent adverse events.Data are n (%) patients, unless otherwise indicated.*p£0.05 vs placebo.‡Includes up to 30 days post-treatment.Wallace et al. Baricitinib in patients with systemic lupus erythematosus: results from aphase 2, randomized, double-blind, placebo-controlled study [abstract].Arthritis Rheumatol. 2018; 70 (suppl 10).Wallace et al. Baricitinib for systemic lupus erythematosus: a double-blind, randomised,placebo-controlled, phase 2 trial. Lancet. 2018; 392: 222–31.AbstractsLupus Science & Medicine 2019;6(Suppl 1):A1–A227 A149 on June 8, 2020 by guest. Protected by copyright.http://lupus.bmj.com/Lupus Sci Med: first published as 10.1136/lupus-2019-lsm.199 on 1 April 2019. Downloaded from 

199 Baricitinib in patients with systemic lupus erythematosus: results from a phase 2, randomized, double-blind, placebo-controlled study

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199 Baricitinib in patients with systemic lupus erythematosus: results from a phase 2, randomized, double-blind, placebo-controlled study

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