A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)

The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. A total improvement score (range 0 to 100; higher the score, better the condition), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were >= 20, >= 40, and >= 60 points, respectively on the TIS. Least squares (LS) means were estimated using a mixed model repeated measures (MMRM) including treatment, visit, the interaction between treatment and visit, region, and baseline MMT-8 (<=142 points vs >142 points) as fixed effects, participant as a random effect.

The MMT-8 was a set of 8 designated muscles which were tested bilaterally (potential score ranging from 0 to 150): 7 biaxial muscles with a potential score 0 to 140 and 1 axial (neck flexors) with a potential score of 0 to 10. Improvement is documented with an increase in score. LS means were estimated using a MMRM including treatment, visit, the interaction between treatment and visit, and region as fixed effects, baseline MMT-8 as a continuous covariate and participant as a random effect.

The CDASI in its modified version 2 (V2) is a validated tool of skin disease activity (3 items) and damage (3 items) assessment. Scores range from 0-100 for activity and from 0-32 for damage. Improvement is documented with a decrease in score. LS means were estimated using a MMRM including treatment, visit, the interaction between treatment and visit, region, and baseline MMT-8 (<=142 points vs >142 points) as fixed effects, baseline CDASI-A as a continuous covariate, and participants as a random effect.

Reduction in corticosteroid dose.

The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were >= 20, >= 40, and >= 60 points on the TIS.

The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were >= 20, >= 40, and >= 60 points on the TIS.

Participants were considered and reported in more than one category (TIS >= 20, >= 40 and >= 60 Points).

Participants were considered and reported in more than one category (TIS >= 20, >= 40 and >= 60 Points).

The observation was censored if no improvement was observed before the intake of rescue/increased doses of oral corticosteroids in SP1 or before the end of the period.

The observation was censored if no improvement was observed before the intake of rescue/increased doses of oral corticosteroids in SP1 or before the end of the period.

Individual CSMs included following: Myositis Disease Activity Assessment Tool (MDAAT) Physician global disease activity (PGDA), PGA assessment, MMT-8, health assessment questionnaire-disability index (HAQ-DI), and MDAAT-EGA. Higher values were associated with a better state of health for the MMT-8 (range 0 -150) assessment, while lower values were associated with a better state of health for: MDAAT-PGDA (range 0 -100), PGA (range 0-100), HAQ-DI (range 0-3), MDAAT-EGA (range 0 -100), and CDASI-A (range 0-100).

Individual CSMs included following: MDAAT-PGDA, PGA assessment, MMT-8, HAQ-DI, and MDAAT extramacular global assessment. Higher values were associated with a better state of health for the MMT-8 (range 0 -150) assessment, while lower values were associated with a better state of health for: MDAAT-PGDA (range 0 -100), PGA (range 0-100), HAQ-DI (range 0-3), MDAAT-EGA (range 0 -100), and CDASI-A (range 0-100).

The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment Visual Analog Scale (VAS) worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)

The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)

The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)

The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)

The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The observation was censored if no DOW was observed before the intake of rescue treatment or before the end of the period.

The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The Number of participants meeting DOW and who received rescue steroid treatment are reported here.

The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening >= 2 cm* and MMT-8 worsening >= absolute 10%, or EGA worsening >= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by >= absolute 20%. (*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The percentage of participants meeting DOW and who received rescue steroid treatment are reported here.

The observation was censored if no Rescue was observed before the last day of the last week with IMP intake or before the end of the period.

EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from "no problems" to "unable to" walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure.

EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from "no problems" to "unable to" walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure.

EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from "no problems" to "unable to" walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having no reduction, at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure.

EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from "no problems" to "unable to" walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having no reduction, at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure.