Background: Corticosteroid (CS) treatment effectively reduces swelling and pain caused by inflammation in patients with systemic lupus erythematosus (SLE). However, prolonged CS treatment is associated with adverse events including weight gain, infections, bone loss, and premature atherosclerosis. CS treatment should be minimised to ≤7.5 mg/day prednisone or equivalents for chronic use and withdrawn when possible. Available data on the impact of CS discontinuation on patients with SLE are limited.

Objectives: To understand CS treatment patterns and impact of CS discontinuation on flares using a real-world cohort of patients with SLE from the United States.

Methods: This retrospective cohort study used the IBM MarketScan Commercial/Medicare supplemental claims database. Patients with SLE receiving CS who subsequently discontinued treatment during 2015 through 2019 were included. The index date was the completion date of the last CS prescription prior to discontinuation. The duration of CS exposure, daily oral CS dose, and CS medication types prescribed, converted into a prednisone-equivalent dose (PEQ), were evaluated during a 12-month pre-index (baseline) period. Outcomes were evaluated during the follow-up period, which started on the date of CS discontinuation and continued until health plan disenrollment or last day of data. Outcomes included flares, CS treatment restarts, and CS-free period prior to resuming therapy. A published algorithm, which draws on SLE-related healthcare resources and medication use, was used to identify and classify flares as mild, moderate, or severe. ¹ Multivariable Cox regression models evaluated the association between oral CS dose and occurrence of flare.

Results: Overall, 17,759 patients were included in the study ( Table 1 ). The most frequently prescribed oral CS treatments were prednisone (62.7%) and methylprednisolone (23.8%). The mean (SD) duration of CS use prior to discontinuation was 104 (130) days. Most patients (86.6%) received ≥6 mg/day oral daily CS PEQ prior to discontinuation. During a mean follow-up of 27.7 months, nearly all patients (90%) had at least one flare and 73.2% resumed CS treatment following discontinuation. Three-quarters of patients (76%) had no CS treatment for a continuous period of ≥6 months after discontinuation. The mean (SD) number of flares during follow-up was 6.9 (6.4) and approximately 50% experienced a severe flare. In Cox proportional hazards models with adjustment for baseline characteristics, the high baseline cumulative oral CS dose tertile was associated with the greatest risk of flare (hazard ratio 1.2 vs. low dose, p<0.001) followed by the middle dose tertile (hazard ratio 1.1 vs. low dose, p<0.001).

Conclusion: Flares were common in patients with SLE who discontinued CS and most patients restarted CS treatment over an average follow-up of 28 months. Patients in the highest cumulative oral CS dose tertile were most at risk of disease flares following CS withdrawal.

REFERENCES:

[1]Garris C, et al. Healthcare utilization and cost of systemic lupus erythematosus in a US managed care health plan. J Med Econ. 2013;16(5):667-677

Disclosure of Interests: Andrea Phillips-Beyer Consultant of: Idorsia Pharmaceuticals, Qian Li Consultant of: Idorsia Pharmaceuticals, Michael E. Stokes Consultant of: Idorsia Pharmaceuticals, Marilia Pozzobon da Silva Employee of: Idorsia Pharmaceuticals