ObjectiveTo characterise disease control and remission in patients with SLE receiving belimumab for up to 12 months in the real world.MethodsThis post hoc analysis (GSK Study 213502) used data from the US evaluation Of use of Belimumab in clinical practice SEttings (OBSErve) study (GSK Study 117295), an observational cohort study of adults with SLE initiating and continuing belimumab for ≥6 months. Data were collected every 6 months by physician chart review; details of disease activity using the Safety of Estrogens in Lupus Erythematosus National Assessment–SLE Disease Activity Index (SELENA-SLEDAI) score were collected if routinely used by physicians. Disease control definitions evaluated were SELENA-SLEDAI score of ≤2 at 12 months, SELENA-SLEDAI score of ≤2 and glucocorticoid (prednisone equivalent) dose of ≤5 mg/day at 12 months, SELENA-SLEDAI score of ≤2 and glucocorticoid dose of ≤5 mg/day at both 6 and 12 months. Disease remission definition was SELENA-SLEDAI score=0 at 12 months. Glucocorticoid dose during follow-up was quantified.ResultsUS OBSErve enrolled 501 patients, 90 of whom had eligible SELENA-SLEDAI scores for inclusion in this analysis. Mean (SD) SELENA-SLEDAI scores were 13.1 (3.0) at baseline and 4.9 (3.4) at 12 months. Disease control at 12 months was achieved by 31.1% of patients when defined as a SELENA-SLEDAI score of ≤2 (95% CI 21.8 to 41.7); this decreased to 25.6% when requiring a SELENA-SLEDAI score of ≤2 and glucocorticoid dose of ≤5 mg/day (95% CI 16.9 to 35.8) and 17.8% when requiring a SELENA-SLEDAI score of ≤2 and glucocorticoid dose of ≤5 mg/day at both 6 and 12 months (95% CI 10.5 to 27.3). No patient achieved remission at 12 months. Glucocorticoids decreased from a baseline median of 20.0 mg/day (IQR 15.0–30.0) to 5.0 mg/day (IQR 0–10.0) at 12 months.ConclusionImproved disease control and reduced glucocorticoid use was achieved for a proportion of patients following up to 12 months of belimumab treatment in a US real-world setting.

Introduction Lupus nephritis (LN) treatment aims to control and prevent flares and irreversible kidney damage. Around 30% of patients are unresponsive to treatment; however, real-world LN treatment patterns have not been reported. Objectives of this retrospective cohort study (GSK 209758) were to quantify the time to switching/re-initiating induction therapy in patients with LN initiating immunosuppressant therapy and conversion from induction to maintenance immunosuppressant therapy, and to assess corticosteroid use. Methods Patients with LN initiating induction or maintenance immunosuppressant therapy were identified using claims data. Patients were followed up from the index date (immunosuppressant initiation date) until treatment discontinuation, death, disenrollment, administrative censoring, or the end of follow-up period. The cumulative incidence of switching/re-initiating induction therapy and conversion to maintenance therapy was estimated using outpatient pharmacy claims and procedure codes. Corticosteroid use was estimated using pharmacy claims; a mean daily dose of ≥ 7.5 mg/day was considered high. Results In total, 5000 patients with LN contributed 5516 treatment episodes (induction cohort, N = 372; maintenance cohort, N = 5144). In the induction cohort, the cumulative incidence (95% confidence interval) of switching between induction therapies was 24.6% (20.1–30.0) at 12 months, while 59.6% (52.4–66.1) of patients converted to maintenance therapy at 12 months. In the maintenance cohort, 21.2% (19.9–22.5) re-initiated induction therapy at 12 months. Oral corticosteroid use decreased during the follow-up in both cohorts, but 21.5% of patients remained on a high dose at 12 months in the induction cohort, while 15.8% in the maintenance cohort were taking a high dose at 24 months. Conclusions Around a quarter of patients with LN initiating immunosuppressant therapy switched within 12 months, while a fifth re-initiated induction therapy within 12 months. Use of high corticosteroid doses were observed during 24 months of follow-up. These data suggest that many patients do not respond to existing standard LN therapies. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-023-00577-7.

BACKGROUND AND AIMS Lupus nephritis (LN) is the most common severe manifestation of systemic lupus erythematosus (SLE) and can lead to end-stage renal disease and death. However, there are limited data to contextualize the burden of LN in Germany, with no published studies using national claims data. This cross-sectional study aimed to estimate the annual prevalence of SLE and LN from 2011–17 using claims data from the Betriebskrankenkassen (BKK) German Sickness Fund Database. METHOD For each study year (2011–17), three patient populations were identified using International Classification of Diseases, Tenth Revision, German Modification (ICD-10-GM) codes: (1) Patients with SLE (≥1 SLE inpatient claim or ≥1 outpatient claim with a confirmatory claim in a separate quarter within ± 3 years); (2) Patients with LN, sensitive definition (based on the presence of SLE [as above] with ≥ 1 nephritis claim within ± 1 year from the initial SLE claim) and (3) Patients with LN, specific definition (based on the presence of SLE [as above] with ≥ 2 nephritis claims in separate quarters within ± 1 year from the initial SLE claim). For each year, the annual prevalence of SLE and LN/100 000 was estimated by dividing the number of patients identified in each population by the number of individuals insured in the database in that year. The proportion of SLE patients with LN was also estimated. To estimate the total number of patients with SLE and LN in Germany by age and sex standardization, the German statutory health insurance (SHI) system (covering 87% of the German population) was used to extrapolate from the prevalence calculated in the BKK database. RESULTS Approximately 5 million patients were insured in the BKK database between 2011–17; the ratio of insured males to females was ∼1:1 throughout the study period. The annual prevalence of SLE and LN/100 000 increased from 2011 (SLE, 37.68; LN sensitive, 12.79; LN specific, 9.99) to 2017 (SLE, 54.74; LN sensitive, 19.06; LN specific, 15.16) (Fig. 1). In 2017, the ratio of males to females/100 000 patients was ∼1:5.5 for the SLE cohort, 1:4.5 for the LN-sensitive cohort and 1:4.4 for the LN-specific cohort. The proportion of SLE patients with LN remained consistent across the study period, ranging from 26.51% (specific definition) and 33.96% (sensitive definition) in 2011 to 27.69% and 34.82%, respectively, in 2017. When extrapolating the prevalence estimates to the wider German SHI system, the estimated number of SLE patients was >41 000 in 2017, with the total LN patient population ranging from 11 515 (specific definition) to 14 483 (sensitive definition) (Fig. 2). CONCLUSION The prevalence of LN increased between 2011 and 2017 among patients insured in the BKK database and is estimated to impact >11 000 patients in the wider German SHI system. Limitations include an absence of renal biopsy information and the inability to distinguish patients with active nephritis from those with historical or inactive LN based on clinical parameters. Nonetheless, these data highlight the prevalence of LN among patients with SLE and the need for effective screening and disease management to improve patient outcomes. Further work to understand the treatment and economic burden of LN among patients with SLE in Germany is ongoing.