{
  "abstract": "Objectives Post hoc analyses of clinical data demonstrated higher Definition Of Remission in SLE (DORIS) remission rates in patients with SLE receiving belimumab versus placebo, plus standard therapy. Real-world SLE remission data for patients in the USA initiating belimumab are scarce and there is a lack of clarity on characteristics of patients achieving remission; this retrospective, observational cohort study (GSK Study 222161) explored predictors of remission in this patient population.Methods Study period: 1 Jan 2013 to 31 May 2024. Data derived from OM1 PremiOM SLE dataset. Eligible patients had >=1 belimumab pharmacy/medical encounter during the identification period (1 Jan 2014 to 31 Oct 2023). Real-world SLE remission was defined per DORIS proxy (SLEDAI/estimated SLEDAI=0; Physician’s Global Assessment [PGA] <2; prednisone-equivalent dose <=5 mg/day) and assessed to 52 weeks post-belimumab initiation. Probability of achieving remission was assessed using Kaplan–Meier estimates. Two censoring approaches assessed estimate robustness: 1) last available score – earlier of latest available SLEDAI/PGA score in follow-up period and end of follow-up; 2) end of follow-up – earlier of 52 weeks post-index (first belimumab receipt)/last activity date/date of data cutoff. Characteristics associated with remission were identified (prespecified exploratory analysis) using logistic regression.Results Of 398 patients, 71% were White, with a mean (standard deviation) age of 51 (14) years at index. Unadjusted estimates showed patients aged >=50 years, non-White patients and those with SLEDAI <=5 had a slightly higher probability of achieving remission than their counterparts; estimates differed by censoring approach and confidence bounds overlapped ( figure 1). The adjusted model showed that older and non-White patients were significantly more likely to achieve remission by 52 weeks than younger (odds ratio: 1.03 [95% confidence interval: 1.00,1.06], p=0.0248) and White (2.57 [1.27,5.19], p=0.0092) patients (figure 2). Patients with baseline SLEDAI >5 were significantly less likely to achieve remission than those with SLEDAI <=5 (0.46 [0.21,0.96], p=0.0378).Abstract PO:11:295 Figure 1Unadjusted probability estimates of achieving real-world SLE remission (per DORIS proxy) stratified by (A) age, (B) race, and (C) baseline SLEDAI disease activity, as assessed by two censoring approachesAbstract PO:11:295 Figure 2Logistic regression model with real-world SLE remission (per DORIS proxy) by 52 weeks as the event, and baseline patient demographics and clinical characteristics as covariatesConclusions Predictors of real-world SLE remission with belimumab include non-White race, increasing age and SLEDAI <=5. The observation that remission was observed even in patients with lower levels of disease activity supports benefits of initiating belimumab treatment earlier in the disease course. Funding: GSK, Original presentation: ACR 2025",
  "authors": [
    {
      "affiliations": [
        "US Medical Affairs, GSK, Durham, USA"
      ],
      "name": "Aarat M Patel"
    },
    {
      "affiliations": [
        "Real-World Evidence, Cencora, Conshohocken, USA"
      ],
      "name": "Renee L Gennarelli"
    },
    {
      "affiliations": [
        "Real-World Evidence, Cencora, Conshohocken, USA"
      ],
      "name": "Temitope Bello"
    },
    {
      "affiliations": [
        "Real-World Evidence, Cencora, Conshohocken, USA"
      ],
      "name": "Ali Bonakdar"
    },
    {
      "affiliations": [
        "Medical Department, GSK, Madrid, Spain"
      ],
      "name": "Mariola Gordo-Lopez"
    },
    {
      "affiliations": [
        "Global Real-World Evidence and Health Outcomes Research, GSK, Collegeville, USA"
      ],
      "name": "Karen Worley"
    }
  ],
  "title": "PO:11:295 Predictors of real-world remission in patients with SLE initiating belimumab in the USA",
  "uid": "bc05482b-55c5-5b2c-8474-a05dac5e0744"
}