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. |
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.