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Objectives The objective of this post hoc analysis of the phase 2 SLEek study ( NCT03978520) was to evaluate the achievement of LLDAS and DORIS with upadacitinib (UPA) monotherapy (30 mg) vs placebo (PBO).Methods LLDAS and DORIS were defined as outlined in table 1. Data were reported based on nonresponder imputation incorporating multiple imputation for missing data due to COVID-19. Between-group differences were adjusted using the Cochran-Mantel-Haenszel test and Cox proportional hazard model; adjustments were made for SLEDAI-2K score at screening (< 10 or >/= 10), baseline GC dose (< 10 mg or >/= 10 mg), baseline immunosuppressant use (yes or no), and baseline IFN score (high, low, or not applicable). No multiplicity adjustments were applied; all P values are nominal.Results Data were included from 137 patients (UPA 30 mg, n = 62; PBO, n = 75; female: 96.4%, White: 56.2%). Rates of achievement of LLDAS and DORIS, respectively, with UPA vs PBO at week 48 were 50.0% vs 24.0% (P < 0.001) and 19.4% vs 9.3% (P = 0.063). Median time to first achievement of LLDAS was shorter with UPA vs PBO (20.4 vs 39.9 weeks; HR [95% CI]: 2.0 [1.2, 3.2]; P = 0.005); median time to DORIS could not be estimated due to < 50% of patients achieving DORIS at any time point ( figure 1). Cumulative% of time spent in LLDAS and DORIS was greater with UPA vs PBO; LLDAS: LS mean [95% CI]: 28.9% [19.8, 38.1] vs 12.5% [4.6, 20.5]; P = 0.001; DORIS: 9.1% [3.4, 14.7] vs 3.0% [<->1.9, 8.0]; P = 0.051. Higher proportions of patients were in LLDAS or DORIS for various cumulative proportions of time with UPA vs PBO, and the proportions of patients who sustained LLDAS or DORIS for >/= 3, >/= 5, and >/=6 consecutive monthly visits were higher with UPA vs PBO (P < 0.05 for all; figure 1).Abstract PT4:01 Table 1Treat-to-target response measuresAbstract PT4:01 Figure 1Time to first reaching LLDAS or DORIS, and cumulative time in (B) LLDAS and C) DORIS and sustained consecutive monthly visits in (D) LLDAS and (E) DORISConclusions Patients receiving UPA versus PBO achieved higher rates of LLDAS and DORIS, shorter time to first LLDAS, and spent more cumulative time/more consecutive visits in LLDAS and DORIS. These data support the potential benefit of UPA in achieving stringent SLE treat-to-target measures.