Achievement of real-world adapted DORIS remission targets among patients with systemic lupus erythematosus initiating belimumab in the USA: A retrospective, observational, cohort study.

Abstract

IntroductionRemission is a key treatment goal associated with improved patient outcomes in systemic lupus erythematosus (SLE), often measured by Definition of Remission In SLE (DORIS) criteria. In a post hoc analysis of clinical trial data, belimumab, a B-cell modulator targeting the central immunopathogenic pathway in SLE, plus standard therapy, improved DORIS remission rates versus placebo plus standard therapy; however, US real-world remission rates remain limited. Measuring DORIS criteria in real-world clinical practice is challenging because required variables, particularly the SLE Disease Activity Index (SLEDAI) component, are often unavailable or incompletely recorded. Therefore, we evaluated an adapted DORIS definition for real-world datasets and examined predictors of remission among US patients initiating belimumab.MethodsThis retrospective observational cohort study analysed data for patients with SLE initiating belimumab from the OM1 PremiOM™ SLE dataset, comprising electronic health records/healthcare claims data (2013-2024) for patients with SLE. The primary outcome was probability of achieving adapted DORIS remission at 28, 48, and 52 weeks post-treatment initiation, defined as clinician-recorded SLEDAI (crSLEDAI) or estimated SLEDAI (eSLEDAI) = 0, Physician Global Assessment (PGA) <2 on a 0-10 numerical rating scale, and prednisone-equivalent dose ≤5 mg/day. Kaplan-Meier estimates provided remission probabilities and logistic regression identified predictors of remission.ResultsMost patients (N = 398) were White, female, from the Southern region of the USA, and had commercial insurance. The probability of achieving adapted DORIS remission reached 28.3% (95% confidence interval: 19.8-35.9) by 52 weeks post-belimumab initiation. Older patients (≥50 years), non-White individuals, and patients with cr/eSLEDAI ≤5 demonstrated slightly higher remission probabilities than their counterparts; however, estimates differed by censoring approach, and confidence bounds overlapped. Adjusted multivariable analysis confirmed increasing age, non-White race, and cr/eSLEDAI ≤5 as significant predictors of remission.ConclusionThis study demonstrates the application of an adapted DORIS definition to large real-world observational datasets. The probability of adapted DORIS remission in US patients initiating belimumab was similar to rates reported in observational studies outside the USA, supporting the real-world effectiveness of belimumab. The increased likelihood of remission in patients with cr/eSLEDAI ≤5 supports the benefits of initiating belimumab treatment early in the disease course.