377. The impact of glucocorticoid dosing on health-related quality of life in ANCA-associated vasculitis
Creators: name: Joanna Tieu1, 2
Publisher: name: Zenodo
Year: 2022
Subjects: Vasculitis
ANCA
Abstracts
Giant Cell Arthritis
MPA
GPA
EGPA
Takayasu
IgA vasculitis

description: <strong>Background/Objectives</strong>: Glucocorticoids are a mainstay of the treatment of ANCA-associated vasculitis (AAV) but are associated with substantial toxicity. The RITAZAREM trial enrolled patients with a relapse of AAV to receive rituximab and one of two glucocorticoid regimens in the induction phase, followed by the maintenance phase, where patients were randomized to receive fixed interval, repeat dose rituximab or azathioprine maintenance therapy. The current study aimed to describe the health-related quality of life (HRQoL) in patients with a relapse of AAV treated with one of two different glucocorticoid regimens during the induction phase of the RITAZAREM trial. <strong>Methods: </strong>During the induction phase of RITAZAREM, all enrolled patients received rituximab and either lower- or higher-dose glucocorticoids. Glucocorticoid regimens were non-randomized and determined by the treating clinician. HRQoL was assessed using the short form-36 (SF-36), EuroQoL Group 5-Dimensions 5-Level, and Patient-Reported Outcome Measurement Information System (PROMIS) fatigue, pain interference, and physical function questionnaires. All scores were standardized to United States population data. A 10-point patient global assessment (PtGA) scale asked patients to rate their vasculitis disease activity over the previous 28 days. HRQoL outcome measures between glucocorticoid groups were compared using t-tests. A propensity-score weighted model was used to account for potential bias in selection of glucocorticoid regimen, after confirming the absence of endogeneity. Covariates for the treatment selection component were selected based on background knowledge with considerations of baseline imbalances. The treatment selection component included age, sex, relapse severity, baseline physician global assessment, baseline Combined Damage Assessment score, and neurological manifestations, which have previously been shown to impact HRQoL in patients with AAV. Sensitivity analyses for the outcome model incorporated study site geographic region. <strong>Results:</strong> Of the 188 patients included in the induction phase of RITAZAREM, 134 (71%) received the lower-dose glucocorticoid regimen and 54 (29%) the higher-dose regimen. Patients who received lower-dose glucocorticoid were more likely to be female (37% vs 54%, p = 0.030), have non-severe relapses (44% vs 19%, p = 0.001), and have previously received rituximab (40% vs 34%, p = 0.036). Lower-dose glucocorticoid was more commonly used in Europe and Australia compared with North America. Average SF-36 physical and mental component scores (PCS, MCS) and PROMIS fatigue, pain interference, and physical function scores were impaired at baseline compared with population norms. All HRQoL scores improved during the induction phase (p &lt;0.001 for all). At Month 4, patients who received lower-dose glucocorticoid, compared with higher-dose, had greater SF-36 physical component scores (mean difference (MD) 5.29 (95% confidence interval (CI) 1.10, 9.48) and less fatigue MD -3.50 (95% CI -6.93, -0.06) (Figure1) in the propensity-score weighted model. Sensitivity analyses did not alter interpretation of results. <strong>Conclusions:</strong> Among patients with a relapse of AAV who receive a combination rituximab and glucocorticoids for induction of remission, compared to a higher-dose glucocorticoid regimen, a lower-dose glucocorticoid regimen is associated with greater improvements in physical HRQoL and less fatigue. These results provide support for ongoing efforts to reduce the use of glucocorticoids in patients with AAV. <strong>Disclosures: </strong>JT- Research grant, Vifor Pharma. CH- Research grant, Vifor Pharma. RS – Research support GlaxoSmithKline, Roche, Union Therpaeutics. PM: Consulting and Research Support: AbbVie, AstraZeneca, Boeringher-Ingelheim, Bristol-Myers Squibb, ChemoCentryx, Forbius, Genentech/Roche, Genzyme/Sanofi, GlaxoSmithKline, InflaRx, Takeda.Consulting only: CSL Behring, Dynacure, EMDSerono, Jannsen, Kiniksa, Kyverna, Magenta, MiroBio, Neutrolis, Novartis, Pfizer, Sparrow, Talaris. Royalties: UpToDate.