Table 2.

Distribution according to the original 2016 ACR/EULAR response criteria for improvement and their modified version

Original 2016 ACR/EULAR response criteria for adult myositis of minimal (≥20 points), moderate (≥40 points), and major (≥60 points) improvement according to the Total Improvement Score (range 0–100) based on six core set measures: physician’s global activity (range 0–20), patient’s global activity (range 0–10), extramuscular disease activity (range 0–20), MMT (range 0–32.5), HAQ (range 0–10), and enzyme levels (range 0–7.5). However, the percentage distribution of patients in each category was calculated only from MMT-8, HAQ, and CK, thus amounting to a maximum Total Improvement Score of 50
Interval (weeks)	Category of improvement (points)	Intervention group (% of patients)	Control group (% of patients)	p-value for each category	p-value for overall distribution
0–12	Least improvement (0–19) or worsening	48	100	<0.001	<0.001
	Minimal improvement (20–39)	52	0	<0.001
	Moderate improvement (40–59)	0	0	NA
	Major improvement (≥60)	0	0	NA
0–24	Least improvement (0–19) or worsening	11	100	<0.001	<0.001
	Minimal improvement (20–39)	78	0	<0.001
	Moderate improvement (40–59)	11	0	<0.001
	Major improvement (≥60)	0	0	NA
0–48	Least improvement (0–19) or worsening	44	91	<0.001	<0.001
	Minimal improvement (20–39)	52	9	<0.001
	Moderate improvement (40–59)	4	0	0.046
	Major improvement (≥60)	0	0	NA
Modification of the original 2016 ACR/EULAR response criteria for adult myositis with minimal (≥10 points), moderate (≥20 points), and major (≥30 points) improvement due to the maximum Total Improvement Score of 50, as a sum of only three core set measures: MMT-8, HAQ, and CK, which better characterizes the overall improvement based on these three outcome measures
Interval (weeks)	Category of improvement (points)	Intervention group (% of patients)	Control group (% of patients)	p-value for each category	p-value for overall distribution
0–12	Least improvement (0–9) or worsening	4	100	<0.001	<0.001
	Minimal improvement (10–19)	44	0	<0.001
	Moderate improvement (20–29)	44	0	<0.001
	Major improvement (≥30)	8	0	0.004
0–24	Least improvement (0–9) or worsening	0	83	<0.001	<0.001
	Minimal improvement (10–19)	15	17	0.689
	Moderate improvement (20–29)	44	0	<0.001
	Major improvement (≥30)	41	0	<0.001
0–48	Least improvement (0–9) or worsening	11	78	<0.001	<0.001
	Minimal improvement (10–19)	33	13	0.001
	Moderate improvement (20–29)	41	9	<0.001
	Major improvement (≥30)	15	0	<0.001

Acronyms: Statistically significant differences (p < 0.05) are marked in bold

ACR American College of Rheumatology, EULAR European League Against Rheumatism, MMT Manual Muscle Testing, HAQ Health Assessment Questionnaire, MMT-8 MMT assessing eight muscle groups, CK creatine kinase NA not applicable