Belimumab Linked to Long-Term Corticosteroid Reduction in Patients with Lupus

Karen Worley, PhD, MS

Credit: LinkedIn

Belimumab was associated with significantly reduced corticosteroid dosage and overall use among treated patients with systemic lupus erythematosus (SLE), according to findings from a new trial.

In new data from a retrospective cohort analysis, a team of US investigators reported that the BLyS inhibitor monoclonal antibody belimumab may provide a significant rate of steroid-sparing efficacy in patients being treated for SLE. The findings support a long-term treatment strategy among relevant patients treating the rheumatic disease with a significant rate of corticosteroids.

Led by Karen Worley, PhD, MS, director of US Value Evidence & Outcomes at GlaxoSmithKline (GSK), the industry-supported team of investigators sought to compare oral corticosteroid use among US patients with SLE both prior to and following belimumab initiation. Originally approved by the US Food and Drug Administration (FDA) for SLE in 2010, belimumab has been previously indicated a promising long-term therapy for the indication; one such study published in 2022 suggested disease control and consistent safety outcomes were applicable over ≥6 years among treated patients.

Worley and colleagues noted analyses of large, pooled data from BLISS-52 and BLISS-76, as wel as the retrospective OBSErve studies, demonstrated significantly reduced rates of corticosteroid use among patients receiving belimumab for either SLE or lupus nephritis.

“While previous research has evaluated data from randomized trials, retrospective claims and prospective chart reviews, the present study is unique in that it brings the perspective of community rheumatologists by leveraging real-world data from a large US rheumatology network,” investigators wrote. “It seeks to evaluate patterns of oral corticosteroid use before and during treatment with belimumab.”

The team conducted their retrospective cohort analysis using data from the Patient-Important Outcomes Data Repository (PIONEER-Rheumatology) database, that which includes >300,000 patients treated by >300 providers across 22 US states. Their data was extracted from the observation period of July 2011 – June 2022, with data indexed by the date of first belimumab initiation. The 3 analysis periods included the baseline 180 days pre-index, the first 6 months post-index, and the second 6 months post-index.

Eligible patients were ≥18 years old diagnosed with SLE treated by belimumab. Eligible patients were stratified by those who were receiving oral corticosteroids during period 1 pre-belimumab, and those who continued, increased or decreased their corticosteroids during periods 2 and 3 of treatment. Investigators’ primary outcome was change in oral corticosteroid use from period 1 to periods 2 and 3 per the following outcomes:

• Proportion of patients receiving any oral corticosteroid.
• Mean total prednisone-equivalent dose per patient.
• Mean total number of oral corticosteroid days supplied per patient.
• Mean daily oral corticosteroid dose for days supplied per patient among those with a prescription.
• Proportion of patients with oral corticosteroid doses of ≤5 mg/day and ≤7.5 mg/day for days supplied.

The final analysis included 608 patients who received belimumab for 180 days, and 492 who received it for 360 days. A majority of patients were female (92.8%) and reported moderate cases of SLE (70.4%).

In period 1, investigators observed that a slight majority of both full-analysis patients (56.3%) and patients who persisted with belimumab for 360 days (54.5%) received oral corticosteroids. Among such patients receiving the corticosteroids, significantly fewer received a regimen in period 2 (78.4%) and period 3 (64.9%).

The team additionally observed significant reductions in mean total oral corticosteroid dose per patient from period 1 to periods 2 and 3. Additionally, mean daily corticosteroid dose for days supplied, as well as proportions of patients with a ≤5 or ≤7.5 mg daily dose, significantly reduced among belimumab-treated patients into periods 2 and 3.

“Our results are consistent with those observed in randomized clinical trials as well as previous real-world observational studies, demonstrating that belimumab-treated patients either reduced or eliminated OCS use,” the team noted. “For example, a previous claims-based study in a large sample of US patients with SLE demonstrated that OCS use was significantly lower in the 6 months post-belimumab initiation than in the 6 months pre-belimumab initiation.”

Worley and colleagues noted that their results indicate a lowered proportion of patients reliant on oral corticosteroids for the management of SLE after initiation of belimumab. “This study suggests that long-term use of belimumab in a community rheumatology practice may allow for a reduction in overall oral corticosteroid use and its associated deleterious effects in patients with SLE,” they concluded.

References

1. ^{Worley K, Milligan S, Rubin B. Steroid-sparing effect of belimumab: results from a retrospective observational study of real-world data. Lupus Sci Med. 2023;10(2):e001024. Published 2023 Dec 22. doi:10.1136/lupus-2023-001024}
2. ^{Pine L. Belimumab Shows Favorable Long-Term Disease Control in Patients With SLE. HCPLive. Published April 20, 2022. https://www.hcplive.com/view/belimumab-shows-favorable-long-term-disease-control-in-patients-with-sle}