Table 1

Fragility evaluation of phase III, randomised, placebo-controlled trials with statistically significant results involving patients with active SLE and lupus nephritis (LN)

Study drug, trialFirst author, yearConditionPrimary endpointsSample sizeEvents in interventionEvents in placeboFI scoreFQ score
Anifrolumab
TULIP-2,
NCT024468995		Morand, 2020Adults with active SLEBICLA response at week 52Anifrolumab 300 mg (n=180)
Placebo (n=182)		8657110.030
Baricitinib
SLE-BRAVE-I,
NCT0361691219		Petri, 2023Adults with active SLESRI-4 response at week 52Baricitinib 2 mg
(n=255)		12611615*0.030
Baricitinib 4 mg
(n=252)
Placebo (n=253)		14240.008
Belimumab
BLISS-52,
NCT0042447628		Navarra, 2011Adults with active SLESRI-4 response at week 52Belimumab 10 mg/kg (n=290)
Placebo (n=287)		167125170.029
BLISS-76,
NCT0041038429		Furie, 2011Adults with active SLESRI-4 response at week 52Belimumab 10 mg/kg (n=273)
Placebo (n=275)		1189240.007
BLISS-SC,
NCT0148449630		Stohl, 2017Adults with active SLESRI-4 response rate at week 52Belimumab 200 mg subcutaneous (n=556)
Placebo (n=280)		341136160.019
BEL113750,
NCT0134525331		Zhang, 2018Adults with active SLESRI-4 response rate at week 52Belimumab 10 mg/kg (n=451)
Placebo (n=226)		24087150.022
BLISS-LN,
NCT0163933916		Furie, 2020Adults with active LNPrimary efficacy renal response at week 104Belimumab 10 mg/kg (n=223)
Placebo (n=223)		967230.007
Tabalumab
ILLUMINATE-2,
NCT0120543818		Merrill, 2016Active SLESRI-5 response at week 52Tabalumab 120 mg every 2 weeks (n=372)143104150.020
Tabalumab 120 mg every 4 weeks (n=376)
Placebo (n=376)		13120.002
Voclosporin
AURORA-1,
NCT030214997		Rovin, 2021Adults with active LNComplete renal response at week 52Voclosporin (n=179)
Placebo (n=178)		7340150.042

  • *Arm with non-significant results; results represent reverse FI score.

  • BICLA, BILAG (British Isles Lupus Assessment Group)-based composite lupus assessment; FI, fragility index; FQ, fragility quotient; SRI, SLE responder index.