Table 1.

Primary and secondary objectives of the NYMERIA observational study.

Primary Outcomes
[1]	-	Proportion of patients classified as having at least moderate clinical disease activity, defined by a cSLEDAI-2K score ≥6.
	-	Proportion of patients classified as having at least moderate clinical disease activity, defined by a cSLEDAI-2KG score ≥6.
	-	Proportion of patients classified as having at least moderate clinical disease activity, defined by a PhGA score >1.
[2]	-	Frequencies of different clinical disease activity states (i.e., no activity, mild, moderate, high, and very high activity) using the cSLEDAI-2K, the cSLEDAI-2KG, and the PhGA score, respectively.
	-	Reclassification rate and concordance (kappa coefficient) between the different indices (i.e., cSLEDAI-2K and cSLEDAI-2KG; cSLEDAI-2K and PhGA; and cSLEDAI-2KG and PhGA) in terms of patient distribution in the “inactive/mild” and the “at least moderate” disease activity state.
[3]	-	Proportion of patients in clinical remission (as per the 2021 DORIS definition) defined as cSLEDAI-2K=0 and PhGA<0.5; the patient may be on AMs, low dose GCs (prednisolone equivalent<5 mg/day), and/or stable IS including biologics.