{
  "abstract": "Objective To evaluate Definition Of Remission In SLE (DORIS) and Lupus Low Disease Activity State (LLDAS) attainment with belimumab versus placebo in a dataset of pooled phase III clinical trials in systemic lupus erythematosus (SLE) using modified definitions that excluded the glucocorticoid (GC) component (‘non-GC-DORIS’ and ‘non-GC-LLDAS’) as the trials lacked mandated GC tapering protocols.Methods In this post hoc analysis, data of adults with SLE receiving belimumab (10 mg/kg/month intravenously or 200 mg/week subcutaneously) or placebo plus standard therapy were pooled from five clinical trials (BLISS-76 ( NCT00410384), BLISS-52 (NCT00424476), North East Asia (NCT01345253), BLISS-SC (NCT01484496) and EMBRACE (NCT01632241)). Non-GC-DORIS and non-GC-LLDAS attainment rates (calculated based on SLE Disease Activity Index 2000 and Physician’s Global Assessment only) with belimumab versus placebo were compared up to week 52 in the overall population and in patient subgroups of interest.Results Non-GC-DORIS and non-GC-LLDAS attainment at week 52 were significantly higher with belimumab (n=1869) versus placebo (n=1217; non-GC-DORIS: 18% vs 13%, risk ratio, RR (95% CI): 1.44 (1.20 to 1.71); p<0.001; non-GC-LLDAS: 32% vs 21%, RR (95% CI): 1.50 (1.32 to 1.71); p<0.001). Similar results were observed across most analysed patient subgroups; at week 52, differences were generally greater in the high versus low disease activity subgroups and Asian and White subgroups exhibited significantly higher attainment with belimumab versus placebo.Conclusion Belimumab was associated with higher attainment of DORIS remission and LLDAS excluding the GC component versus placebo; attainment rates were approximately twofold higher than those previously reported using the full definitions.",
  "authors": [
    {
      "affiliations": [
        "Department of Medicine Solna, Division of Rheumatology, Karolinska Institutet, Karolinska University Hospital, and Center for Molecular Medicine (CMM), Stockholm, Sweden",
        "Faculty of Medicine and Health, Department of Rheumatology, Örebro University, Örebro, Sweden"
      ],
      "name": "Ioannis Parodis"
    },
    {
      "affiliations": [
        "Department of Medicine Solna, Division of Rheumatology, Karolinska Institutet, Karolinska University Hospital, and Center for Molecular Medicine (CMM), Stockholm, Sweden"
      ],
      "name": "Julius Lindblom"
    },
    {
      "affiliations": [
        "GSK, Global Medical Affairs, Collegeville, Pennsylvania, USA"
      ],
      "name": "Roger A Levy"
    },
    {
      "affiliations": [
        "Department of Medicine Solna, Division of Rheumatology, Karolinska Institutet, Karolinska University Hospital, and Center for Molecular Medicine (CMM), Stockholm, Sweden"
      ],
      "name": "Alexander Tsoi"
    },
    {
      "affiliations": [
        "Department of Medicine, Division of Rheumatology, University of Padua, Padua, Italy"
      ],
      "name": "Margherita Zen"
    },
    {
      "affiliations": [
        "Department of Medicine Solna, Division of Rheumatology, Karolinska Institutet, Karolinska University Hospital, and Center for Molecular Medicine (CMM), Stockholm, Sweden"
      ],
      "name": "Dionysis Nikolopoulos"
    },
    {
      "affiliations": [
        "GSK, Medical Affairs, Dubai, UAE"
      ],
      "name": "Munther Khamashta"
    },
    {
      "affiliations": [
        "GSK, Research & Development, Collegeville, Pennsylvania, USA"
      ],
      "name": "Ryan Tomlinson"
    },
    {
      "affiliations": [
        "Division of Rheumatology, Columbia University Irving Medical Center, New York, New York, USA"
      ],
      "name": "Anca Askanase"
    },
    {
      "affiliations": [
        "Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Amsterdam, The Netherlands"
      ],
      "name": "Ronald van Vollenhoven"
    },
    {
      "affiliations": [
        "University of Sydney School of Public Health and Department of Rheumatology, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia"
      ],
      "name": "Mandana Nikpour"
    }
  ],
  "title": "Belimumab outperforms placebo for attainment of modified DORIS remission and LLDAS without the glucocorticoid component: a post hoc analysis of five phase III SLE trials",
  "uid": "1387f4c1-0706-58e3-afd5-44e9a8cbb215"
}