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INTRODUCTION: This retrospective cohort study (GSK213737) aimed to characterize treatment patterns, healthcare resource utilization (HCRU), and costs in patients with lupus nephritis (LN) initiating immunosuppressant therapy in clinical practice in Germany, to better understand the full picture of the real-world burden of LN. METHODS: Adult patients with LN who initiated mycophenolate mofetil (MMF), intravenous cyclophosphamide (CYC), azathioprine (AZA), tacrolimus, cyclosporin A, or rituximab therapy in 2011-2017 (index therapy) were identified from the Betriebskrankenkassen German Sickness Fund database. Treatment patterns, including immunosuppressant discontinuations, and therapy switches, were assessed (maximum follow-up 4 years). Corticosteroid use, HCRU, and total economic costs were also evaluated. HCRU and costs were compared with matched controls (individuals without systemic lupus erythematosus [SLE]/LN matched by age, sex, and baseline Charlson Comorbidity Index). RESULTS: Among 334 patients with LN, the median (interquartile range) duration of index immunosuppressant therapy use was 380.5 (126, 1064) days. Of those patients with 4 years complete enrollment, 70.8% had ≥ 1 discontinuation and 28.8% switched therapy. While most patients (71.2%) received only one immunosuppressant, gaps in treatment were common. After 1 year of follow-up, 41.6% of patients had a prednisone-equivalent corticosteroid dose of ≥ 7.5 mg/day. Patients with LN had greater HCRU use for most categories assessed and increased mean total costs per person-year versus controls (15,115.99 versus 4,081.88 in the first year of follow-up). CONCLUSIONS: This real-world analysis demonstrated the considerable burden of immunosuppressant-treated LN in Germany, with a high rate of discontinuations, frequent use of high-dose corticosteroids, and substantial HCRU/costs.
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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.
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OBJECTIVE: To characterise disease control and remission in patients with SLE receiving belimumab for up to 12 months in the real world. METHODS: This 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. RESULTS: US 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. CONCLUSION: Improved 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.
