Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)

Number of Participants Achieving SRI-4 Response at Week 52

The SRI was a composite index used to assess clinical improvement in participants with SLE. The SRI-4 response evaluated global improvement, any significant worsening in unaffected organ systems, and improvements in disease activity, without compromise to the participant's overall condition. SRI-4 response was binary and either achieved or not achieved by the participant, thus there was no associated score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.

Time frame: Week 52

Number of Participants Achieving BICLA Response at Week 52

The BICLA response was a composite global measure of SLE disease activity. It distinguished between partial and complete improvement in all body systems. BICLA response was binary and either achieved or not achieved by the participant, thus there was no associated score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.

Time frame: Week 52

Number of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28

The CLASI-A score was used to evaluate lupus skin manifestations, with higher scores indicating increased disease severity and lower scores indicating less disease severity. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represented disease severity of mild, moderate, and severe, respectively. CLASI-50 was 50% improvement from baseline in the CLASI-A score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.

Time frame: Week 28

Number of Participants With a CLASI-50 Response at Week 52

The CLASI-A score was used to evaluate lupus skin manifestations, with higher scores indicating increased disease severity and lower scores indicating less disease severity. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represented disease severity of mild, moderate, and severe, respectively. CLASI-50 was 50% improvement from baseline in the CLASI-A score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.

Time frame: Week 52

Change From Baseline in Swollen Joint Count at Week 28

The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of swelling. The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations was reported.

Time frame: Baseline and Week 28

Change From Baseline in Swollen Joint Count at Week 52

The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of swelling. The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations was reported.

Time frame: Baseline and Week 52

Change From Baseline in Tender Joint Count at Week 28

The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of tenderness. The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations was reported.

Time frame: Baseline and Week 28

Change From Baseline in Tender Joint Count at Week 52

The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of tenderness. The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations was reported.

Time frame: Baseline and Week 52

Change From Baseline in Swollen and Tender Joint Count at Week 28

The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of swelling and presence or absence of tenderness. The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations was reported.

Time frame: Baseline and Week 28

Change From Baseline in Swollen and Tender Joint Count at Week 52

The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of swelling and presence or absence of tenderness. The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations was reported.

Time frame: Baseline and Week 52

Change From Baseline in Oral Corticosteroid Dose at Week 28

Participants were assessed for corticosteroid dose change. Oral corticosteroid dose was based on prednisone or prednisone-equivalent dose. The oral corticosteroid dose at Week 28 was determined by the visit window of Week 28 (±7 days). Missing Week 28 dose was imputed with 0 if the participant completed Week 28 efficacy assessments. Oral corticosteroid doses as the weighted average of all doses taken at Week 28, weighted by the number of days each oral corticosteroid dose was administered was reported. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations were reported.

Time frame: Baseline and Week 28

Change From Baseline in Oral Corticosteroid Dose at Week 52

Participants were assessed for corticosteroid dose change. Oral corticosteroid dose was based on prednisone or prednisone-equivalent dose. The oral corticosteroid dose at Week 52 was determined by the visit window of Week 52 (±7 days). Missing Week 52 dose was imputed with 0 if the participant completed Week 52 efficacy assessments. Oral corticosteroid doses as the weighted average of all doses taken at Week 52, weighted by the number of days each oral corticosteroid dose was administered was reported. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations were reported.

Time frame: Baseline and Week 52

Cumulative Oral Corticosteroid Use Between Week 0 and Week 28

Participants were assessed for cumulative oral corticosteroid dose. Oral corticosteroid dose was based on prednisone or prednisone-equivalent dose. The cumulative oral corticosteroid dose at Week 28, calculated from Week 0 (Day 1) to Week 28 was reported. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations were reported.

Time frame: Up to approximately 28 weeks

Cumulative Oral Corticosteroid Use Between Week 0 and Week 52

Participants were assessed for cumulative oral corticosteroid dose. Oral corticosteroid dose was based on prednisone or prednisone-equivalent dose. The cumulative oral corticosteroid dose at Week 52, calculated from Week 0 (Day 1) to Week 52 was reported. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations were reported.

Time frame: Up to approximately 52 weeks

Number of Participants Who Achieved Low Level of Disease Activity (LLDAS) at Week 28

LLDAS was a low disease activity state associated with significant protection against flares and organ damage accrual. It included both the measurement of disease activity and maintenance of immunosuppressive medications. LLDAS response was defined as hybrid SLEDAI ≤4 (with no activity in major organ systems), no new features of SLE activity compared with previous assessment, physician's global assessment (PGA) ≤1.0, current prednisone (or equivalent) dose ≤7.5 mg daily, and well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs. LLDAS response was binary and was either achieved or not achieved by the participant, thus there was no associated score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.

Time frame: Week 28

Number of Participants Who Achieved LLDAS at Week 52

LLDAS was a low disease activity state associated with significant protection against flares and organ damage accrual. It included both the measurement of disease activity and maintenance of immunosuppressive medications. LLDAS response was defined as hybrid SLEDAI ≤4 (with no activity in major organ systems), no new features of SLE activity compared with previous assessment, physician's global assessment (PGA) ≤1.0, current prednisone (or equivalent) dose ≤7.5 mg daily, and well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs. LLDAS response was binary and was either achieved or not achieved by the participant, thus there was no associated score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.

Time frame: Week 52