. 2018 Aug 21;5(1):e000279. doi: 10.1136/lupus-2018-000279

Table 4.

Summary of measure responsiveness from RCTs

Reference	Citation	n	HRQoL Instrument	Clinical disease activity indicator	Time of endpoint assessment (from baseline)	Between-arm clinical improvement	Between-arm HRQoL improvement	Between-arm differences in HRQoL ≥MID	Within-arm HRQoL change from baseline (active arm or pooled) ≥MID	Notes
Galbraith et al, 2014²³	21	19	SF36	Renal or major non-renal SLE relapse	13 weeks	Yes	Unclear	Yes	Unclear
Uppal et al2009²⁴	22	27	SF36	SLEDAI	6 months	Yes	Yes	Partially	Yes
Nordmark et al, 2005²⁵	23	37	SF36	mSLEDAI	6 months	Yes, but not SS	Yes	Partially	Yes
Dussán et al, 2008²⁶	24	47	SF36	SRI	6 months	Not reported	Unclear	Partially	Yes
Arriens et al, 2015²⁷	25	50	SF36	SLEDAI	6 months	Yes, but not SS	Yes	Yes	Yes
Danowski et al, 2006²⁸	26	50	SF36	Patient-reported SLE activity	4 weeks	Yes, but not SS	Yes	No	Not reported
Hartkamp e t al, 2010²⁹	27	60	SF36	SLEDAI	5 months	Yes, but not SS	Yes	Not reported	Not reported
Furie et al, 2008³⁰	28	70	SF36	SLEDAI	Day 20	Yes, but not SS	Unclear	No	Not reported
Gordon et al, 2008³¹	29	71	SF36	SLEDAI	12 weeks	Yes, but not SS	Yes	Partially	Partially
Grootscholten et al, 2007³²	30	87	SF36	SLEDAI	1 year	No	No	No	Yes
Griffiths et al, 2010³³	31	90	SF36	BILAG	12 months	No	Yes	Partially^	Unclear”	^In MCS but not PCS; "analyses are adjusted at 12 months.
Strand 2014	32	90	SF36	BILAG	12 weeks	Yes	Yes	Yes	Yes
Wallace et al, 2016³⁵	33	113	SF36	SLEDAI-2K	108 weeks	Yes	Yes	Not reported*	Yes	This is an analysis of continuation phase of the active arm.*
Merrill 2010	34	118	SF36	BILAG	12 months	Yes	Yes	Partially*	Yes	In PCS but not MCS.*
Kiani et al, 2013³⁷	35	200	SF36	SLEDAI	24 months	Not reported	Unclear	No	No
Strand et al, 2003³⁸	36	230	SF36	Time to renal flare	16 weeks	Yes	Yes	Partially	Partially
Merrill 2010	37	257	SF36	BILAG	52 weeks	Yes, but not SS	Yes	Yes	Yes
Strand et al, 2005⁴¹	39	298	SF36	Clinical responder vs non-responder analysis	6 months	Yes	Yes	Partially	Partially
Cardiel et al, 2008⁴²	40	317	SF36	SLEDAI	48 weeks	Yes	No	No	No
Wallace et al, 2009⁴³	41	449	SF36	SLEDAI	52 weeks	Yes, but not SS	Yes	No	Yes
Furie et al, 2011⁴⁴	42	819	SF36	SLEDAI	52 weeks	Yes	Yes	No	No
Strand 2014	38	865	SF36	SRI	52 weeks	Yes	Yes	Partially	Yes
Furie et al, 2014⁴⁵	43	1684	SF36	SLEDAI	52 weeks	Yes, but not SS	Yes	Yes	Yes*	Among SRI responders vs non-responders.*
Wallace et al, 2017⁴⁶	44	183	SF36	SRI	24 weeks	Yes, but not SS	Yes	Partially	Yes
van Vollenhoven et al, 2012⁴⁷	45	1684	SF36	SRI	52 weeks	Yes	Yes	No	Yes
Wallace et al, 2017⁴⁶	44	183	EQ5D	SRI	25 weeks	Yes, but not SS	Yes	No	Yes
Furie et al, 2014⁴⁵	43	1684	FACIT-Fatigue	SRI	52 weeks	Yes, but not SS	Yes	Yes	Yes
Wallace et al, 2017⁴⁶	44	183	FACIT-Fatigue	SRI	26 weeks	Yes, but not SS	Yes	No	No
Petri et al, 2017⁴⁸	46	547	FACIT-Fatigue	SRI	52 weeks	Yes, but not SS	Yes	No	Yes*	Among SRI responders vs non-responders.*

BILAG, British Isles Lupus Assessment Group Disease Activity Index; EQ5D, EuroQol-5D; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; MCS, mental component summary; MID, minimally important differences; mSLEDAI, modified Systemic Lupus Erythematosus Disease Activity Index; PCS, physical component summary; RCT, randomised controlled trial; SF36, Medical Outcomes Study Short-Form 36; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index; SRI, Systemic Lupus Erythematosus Responder Index; SS, statistically significant; partially implies in some domains; HRQoL, health-related quality of life.