Background/Purpose: Systemic lupus erythematosus (SLE) is a complex, chronic autoimmune disease characterized by frequent episodes of disease activity (flares) of varying severity.¹ SLE flares are often managed with corticosteroids, the frequent and extended use of which can cause severe side effects.² Anifrolumab clinical trials have shown reductions in flare rates along with corticosteroid dose tapering – two major treatment goals for SLE.^3,4 This study examined real-world changes in disease flares and oral corticosteroid (OCS) use before and after initiation of anifrolumab therapy in adults with SLE in the United States.

Methods: This retrospective observational study included claims data of adults with SLE in the MORE² Registry® (Commercial, Medicare Advantage, and Managed Medicaid), plus 100% Medicare Fee-for-Service data (8/1/2020-9/30/2023). Eligible patients: 1) had an SLE diagnosis: ≥1 inpatient or ≥2 non-diagnostic outpatient claims with SLE diagnosis code (ICD-10-CM M32.xx) separated by 30-365 days; 2) had initiated anifrolumab: ≥1 claim for anifrolumab on/after August 1, 2021 (earliest claim = index date); 3) were adherent to anifrolumab (≥3 claims in a 6-month period); 4) and ≥18 years old at index, 5) with ≥6 months of continuous enrollment with insurance benefits before and after index. Outcomes were assessed in 6-month windows pre-index (baseline) and post-index (follow-up). Outcomes of interest included: i) SLE disease flares (proportion of patients experiencing flares by frequency [≥1 to ≥4] and severity [moderate, severe]), as determined with an adaptation of the validated algorithm from Garris et al,⁵ and ii) prednisone-equivalent OCS use (number of claims, mean daily OCS dose, cumulative OCS dose). Group estimates were reported.

Results: Of the 522 eligible participants, 40.6% were white, 92.5% female, 36.6% commercially insured, with a mean (SD) age of 48.2 (15.1) years (Table 1). At baseline, 516/522 (98.9%) patients experienced ≥1 flare, 467 (89.5%) ≥2 flares, 320 (61.3%) ≥3 flares, and 144 (27.6%) ≥4 flares (Table 2). During follow-up, 463/522 (88.7%) patients experienced ≥1 flare, 342 (65.5%) ≥2 flares, 151 (28.9%) ≥3 flares, and 49 (9.4%) ≥4 flares. The proportion of patients with moderate and severe flares decreased from 94.4% and 6.1% at baseline to 86.6% and 4.4% during follow-up, respectively. The mean (SD) cumulative OCS dose declined by 24% from 684 (1137) mg pre-index to 516 (924) mg post-index (Table 2).

Conclusion: This real-world study showed reductions in the frequency of SLE disease flares and OCS use in the 6 months following anifrolumab treatment initiation. These early changes in disease flare rates and cumulative OCS dose among SLE patients suggest the potential for steroid-sparing with anifrolumab therapy. Further analyses to determine long-term outcomes with anifrolumab are underway.

References:

1. Hammond E, et al. Lupus Sci Med. 2021;8(1):e000504

2. Frodlund M, et al. Rheumatology. 2024;63(4):1104-1112

3. Furie R, et al. Lupus. 2021;30(8):1254-1263

4. Kalunian K, et al. Arthritis Rheumatol. 2023;75(2):253-265

5. Garris C, et al. J Med Econ. 2013;16(5):667-77

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/real-world-reduction-in-disease-flares-and-oral-corticosteroid-use-with-anifrolumab-therapy-in-systemic-lupus-erythematosus-a-claims-based-study/