Table 2

Fragility evaluation of non-statistically significant randomised clinical trials involving patients with active SLE and lupus nephritis (LN)

Study drug, trialFirst author, yearConditionPrimary endpointsSample sizeEvents in interventionEvents in placeboRFI scoreFQ score
Abatacept
NCT0043067732Furie, 2014LNTime to complete response
Complete response at week 52		Abatacept 30/10
(n=99)		9890.045
Abatacept 10/10
(n=99)
Placebo (n=100)		1170.035
Anifrolumab
TULIP-1,
NCT024469124		Furie, 2019Adults with active SLESRI-4 response rate at week 52Anifrolumab 300 mg (n=180)
Placebo (n=184)		6574270.074
Atacicept
APRIL-SLE,
NCT0062433833		Isenberg, 2015Active SLEProportion of patients experiencing flare BILAG A or B at week 52Atacicept 75 mg
(n=159)		9285130.041
Atacicept 150 mg
(n=145)
Placebo (n=157)		54 (discontinued)
Baricitinib
SLE-BRAVE-I,
NCT0361691219		Petri, 2023Adults with active SLESRI-4 response at week 52Baricitinib 2 mg
(n=255)		126116150.030
Baricitinib 4 mg
(n=252)
Placebo (n=253)		1424*0.008
SLE-BRAVE-II,
NCT0361696420		Petri, 2023Adults with active SLESRI-4 response at week 52Baricitinib 2 mg
(n=261)		120116220.043
Baricitinib 4 mg
(n=258)
Placebo (n=256)		121190.037
Blisibimod
CHABLIS-SC1,
NCT0139574534		Merrill, 2018Adults with active SLESRI-6 response at week 52Blisibimod (n=245)
Placebo (n=197)		11583130.029
Epratuzumab
EMBODY1,
NCT0126236535		Clowse, 2017Active SLEBICLA response rate at week 48Epratuzumab 600 mg every week (n=248)9385140.028
Epratuzumab 1200 mg every 2 weeks (n=244)
Placebo (n=249)		9790.018
EMBODY2,
NCT0126179335		Clowse, 2017Active SLEBICLA response rate at week 48Epratuzumab 600 mg every week (n=264)9388180.034
Epratuzumab 1200 mg every 2 weeks (n=261)
Placebo (n=263)		89210.040
Rituximab
EXPLORER,
NCT0013796936		Merrill, 2010Active SLEMajor clinical response at week 52Rituximab (n=169)
Placebo (n=88)		5025200.078
LUNAR,
NCT0028234737		Rovin, 2012Active LNRenal response rate at week 52Rituximab (n=72)
Placebo (n=72)		1922160.111
Tabalumab
ILLUMINATE-1,
NCT0119609117		Isenberg, 2016Active SLESRI-5 response at week 52Tabalumab 120 mg every 2 weeks (n=381)121111170.022
Tabalumab 120 mg every 4 weeks (n=378)
Placebo (n=379)		13340.005
Ustekinumab
LOTUS†,
NCT0351772238		van Vollenhoven, 2022Active SLESRI-4 response at week 52Ustekinumab (n=173)
Placebo (n=116)		7651220.076

  • *Arm with significant results; results represent FI score.

  • †Study terminated early due to futility.

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