gms | German Medical Science

Introduction: Corticosteroids (CS) are a mainstay of systemic lupus erythematosus (SLE) treatment, but cumulative CS exposure leads to organ damage [1]. A key SLE treatment priority is to minimize CS exposure and organ damage risk while controlling disease activity [2], [3]. This analysis described CS use in a cohort of adults with SLE in Germany.

Methods: CHaracteristics and impact of flares on clinicAl and econoMic OutcoMes In patients with systemic Lupus Erythematosus: a German Claims Database Study (CHAMOMILE) was an observational, retrospective cohort study. Patients aged ≥18 years with SLE were identified from the Betriebskrankenkassen German Sickness Fund Database between July 1, 2010 and December 31, 2013, and followed for up to 8 years. Baseline period was the first year with SLE diagnosis. CS usage (any systemic CS) was analyzed by dose (<10, 10–40, >40 prednisone mg-equivalent [eq]), cumulative dose, route of administration (oral, parenteral, intra-articular [IA]), and baseline flare exposure (no, mild, moderate/severe) [4].

Results: Of 2,088 patients, mean (standard deviation) age was 51.4 (16.1) years; 1,767 (84.6%) were female. Patients with moderate/severe baseline flares had higher CS use (96%) than the mild flares (78%) or no flares (66%) subgroups. Compared to patients without flares using CS, parenteral, IA, and oral CS (OCS) use was 34%, 13%, and 3% greater, respectively, in patients with moderate/severe flares (Table 1 [Tab. 1]). OCS were most commonly administered and of this group, 22.4% received >40 prednisone mg-eq (Table 2 [Tab. 2]). Cumulative OCS doses were consistent across all study years for all flare exposure subgroups; mean cumulative dose of the moderate/severe flare subgroup was highest (1,700 mg-eq/year) (Figure 1 [Fig. 1]).

Conclusion: In Germany, adult patients with SLE, both with and without flares, are exposed to high cumulative CS doses, despite their association with organ damage. Cumulative dose may be underestimated in our study because OCS dose excludes alternative administration routes. These results highlight that there is an unmet need for innovative immunomodulators (ie, biologics) to reduce CS use and achieve remission beyond low disease activity. Further studies are needed to evaluate the impact of EULAR 2019 CS reduction guidelines on minimizing CS use (≤7.5 mg/day prednisone eq) in patients with SLE.

Disclosures: BDing, BV, BDesta, SG, and HS-F are employees of AstraZeneca. MP is an employee of ZEG Berlin GmbH and managed this research for AstraZeneca. EG-P is an employee of Team Gesundheit GmbH which executed this research for ZEG Berlin GmbH. AS and TM are consultants for AstraZeneca.