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. 2024 Jun 30;35(Suppl 2):392–401. doi: 10.31138/mjr.160524.tns

Secondary Outcomes1

[1] - Patient’s demographic and clinical characteristics, overall and by disease activity state.
[2] - LupusPRO overall score, total HRQoL and N-HRQoL constructs’ scores, and individual domain and item scores at the study visit.
- EQ-5D-5L utility index score and EQ-Visual Analogue Scale (VAS) score at the study visit.
- Proportion of patients with reported problems for each level on each dimension of the EQ-5D and proportion of patients with ‘no problems’ (i.e., level 1) and ‘with problems’ (i.e., level 2 to 5).
[3] - WPAI:RS domain scores referring to absenteeism, presenteeism, and work productivity loss, among the study population who are employed at the study visit.
- WPAI:RS domain score referring to activity impairment among all patients.
[4] - FSS total and item scores.
- Proportion of patients with an FSS total score ≥36 indicating the presence of clinically significant fatigue.
[5] - Total SDI score.
- Proportions of patients with and without organ damage (i.e., with SDI score ≥1 and 0, respectively), and frequencies of the different SDI states (SDI score: 0, 1, 2, 3, 4 and ≥5).
- Frequency of damage in the different organ systems/domains and items of the SDI.
[6] - Number of swollen (SJC) and of tender joints (TJC) based on 28-joint counts, and total number of affected joints (swollen and/or tender).
- Moderate to severe joint disease activity (active joint count of ≥8 tender and/or swollen joints).
- Swollen to tender joint ratio (STR [SJC/TJC]) and frequencies of low (STR <0.5), moderate (0.5 ≤ STR ≤ 1.0), and high (STR >1.0) joint disease activity.
- Percentage of body surface area (BSA) affected by SLE.
- Moderate to severe skin disease as reflected by a BSA affected by SLE ≥10%.
[7] - Frequencies of current pharmacologic treatments by type/pharmacological category [monotherapy, combination regimen; AMs, GCs, IS, biological agents, NSAIDs, other], drug class, treatment duration, and number of dose intensifications since the start of current treatment including reason for intensification.
- Types and frequencies of past (before the start of current treatment) pharmacologic treatment modalities by pharmacological category and drug class.
[8] - Correlation coefficient and association (through linear regression analysis) of the SLEDAI-2K score, SLEDAI-2KG score, and PhGA score (as continuous variables), each with the following: SDI score; LupusPRO HRQoL total and individual domain scores; LupusPRO N-HRQoL total and individual domain scores; WPAI overall work productivity loss; WPAI activity impairment score; FSS score.
[9] - Association of patient, disease and treatment characteristics with the presence of at least moderate disease activity determined using the cSLEDAI-2K.
- Association of patient, disease and treatment characteristics with the presence of at least moderate disease activity determined using the cSLEDAI-2KG.
1

The numbering of the outcomes follows the numbering of the corresponding objectives. All outcomes will be assessed in the overall study population and in the subpopulations 1A / 1B & 2A / 2B, except for #8 and #9.