A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

SRI-4 response:\>=4-point reduction in SLEDAI-2K total score, no British Isles Lupus Assessment Group (BILAG) A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (\<10 % increase)from baseline in Physician's Global Assessment(PGA).SLEDAI measures disease activity in 9 organ systems,higher scores=more severe disease activity.Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).

Time frame: Week 52

Population: The projected full analysis set (FAS) was defined as those participants (participants who received at least 1 dose \[partial or complete,intravenous \[IV\] or subcutaneous \[SC\] of study agent) who should have had a given visit based upon their latest scheduled study visit. Participants were set to non-responders if they met treatment failure (TF) or had data missing.

Reduction of glucocorticoid dose was defined as a reduction in average daily oral glucocorticoid dose by at least 50% (relative to the baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to the baseline dose) so that the average daily dose was reduced to less than or equal to (\<=) 7.5 milligram (mg) (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who, at baseline, were receiving oral glucocorticoids.

Time frame: Up to Week 52

Population: Analysis population is projected analysis set which included participants who received glucocorticoids at baseline. Here, 'N' (number of participants analyzed) refers to participants evaluable including participants who had or should have had a Week 52 visit based upon their last scheduled visit and the date of trial termination. Participants were set to non-responders if they met TF or had data missing.

Percentage of participants with reduction in glucocorticoid dose by Week 40, its sustenance through Week 52, and SRI 4 composite response at Week 52 were reported. Reduction of glucocorticoid dose was defined as reduction in average daily oral glucocorticoid dose by at least 50% (relative to baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to baseline dose) so that average daily dose is reduced to \<=7.5 mg (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who,at baseline,were receiving oral glucocorticoids. SRI-4 was defined as composite of at least 4-point improvement in SLEDAI-2K score of 0=no symptoms to 105=presence of all defined symptoms with higher scores representing increased disease activity),no worsening in BILAG and no worsening in PGA.

Time frame: Up to Week 52

Population: Analysis population is projected analysis set which included participants who received glucocorticoids at baseline. Here, 'N' (number of participants analyzed) refers to participants evaluable included participants who had or should have had a Week 52 visit based upon their last scheduled visit and the date of trial termination. Participants were set to non-responders if they met TF or had data missing.

The percentage of participants who achieved at least 50% improvement from baseline in number of joints with pain and signs of inflammation at Week 52 for participants with at least 4 joints with pain and signs of inflammation at baseline were reported.

Time frame: Week 52

Population: Analysis population is projected analysis set which included participants who had at least 4 joints with pain and signs of inflammation at baseline. Here, 'N' (number of participants analyzed) refers to participants evaluable included participants who had or should have had a Week 52 visit based upon their last scheduled visit and the date of trial termination.

SRI-4 response:\>=4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no BILAG A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (\<10 % increase)from baseline in PGA.SLEDAI measures disease activity in 9 organ systems, higher scores=more severe disease activity. Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).

Time frame: Week 24

Population: Population analyzed included projected analysis set among participants who had or should have had a Week 24 visit based upon their last scheduled visit.

Percentage of participants achieving at least 50% improvement in CLASI activity score at Week 52 reported in participants with a CLASI activity score of 4 or greater at baseline. The CLASI is an instrument to assess the disease activity and damage caused to the skin for cutaneous lupus erythematosus participants with or without systemic involvement. The CLASI activity score ranges from 0-70 with lower score being improved. Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia.

Time frame: Week 52

Population: Analysis population is projected FAS. Here, 'N' (number of participants analyzed) refers to participants who had or should have had a Week 52 visit based upon their last scheduled visit and the date of trial termination and with a CLASI activity score of 4 or greater at baseline. Participants were set to non-responders if they met TF or had data missing.

Time to flare is defined as the time (in days) post baseline when the first flare occurs. It was calculated with flare defined as either 1 or more BILAG A (severe disease activity) or 2 or more new BILAG B (moderate disease activity) domain scores relative to baseline. BILAG was defined as a measure of alterations or intensification to therapy consisting of 97 questions in 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. BILAG A flare was defined as at least 1 new BILAG A scores. BILAG B flare was defined as at least 2 new BILAG B scores.

Time frame: Up to Week 52

Population: Analysis population is projected FAS. Participants were set to have flare if they met TF criteria (exceeded baseline dose of permitted SLE medications, initiated a new permitted SLE medication, initiated new protocol-prohibited medication or discontinued study agent for any reason prior to Week 52).