Intravenous immune globulin (IVIG) for the therapy of dermatomyositis has not been extensively evaluated.
We carried out a randomized, placebo-controlled trial involving sufferers with lively dermatomyositis. The sufferers have been assigned in a 1:1 ratio to obtain IVIG at a dose of two.0 g per kilogram of physique weight or placebo each 4 weeks for 16 weeks. The sufferers who acquired placebo and people with out confirmed scientific deterioration whereas receiving IVIG may enter an open-label extension part for one more 24 weeks. The first finish level was a response, outlined as a Complete Enchancment Rating (TIS) of not less than 20 (indicating not less than minimal enchancment) at week 16 and no confirmed deterioration as much as week 16. The TIS is a weighted composite rating reflecting the change in a core set of six measures of myositis exercise over time; scores vary from 0 to 100, with larger scores indicating better enchancment. Key secondary finish factors included not less than reasonable enchancment (TIS ≥40) and main enchancment (TIS ≥60), and alter in rating on the Cutaneous Dermatomyositis Illness Space and Severity Index.
A total of 95 patients underwent randomization: 47 patients were assigned to the IVIG group, and 48 to the placebo group. At 16 weeks, 79% of the patients in the IVIG group (37 of 47) and 44% of those in the placebo group (21 of 48) had a TIS of at least 20 (difference, 35 percentage points; 95% confidence interval, 17 to 53; P<0.001). The results with respect to the secondary end points, including at least moderate improvement and major improvement, were generally in the same direction as the results of the primary end-point analysis, except for the change in creatine kinase level (an individual core measure of the TIS), which did not differ meaningfully between the two groups. Over 40 weeks, 282 treatment-related adverse events occurred in the IVIG group, including headache (in 42% of patients), pyrexia (in 19%), and nausea (in 16%). A total of 9 serious adverse events that were considered to be related to IVIG occurred, including 6 thromboembolic events.
In this 16-week trial involving adults with dermatomyositis, the percentage of patients with a response of at least minimal improvement based on a composite score of disease activity was significantly greater among those who received IVIG than among those who received placebo. IVIG was associated with adverse events, including thromboembolism. (Funded by Octapharma Pharmazeutika; ProDERM ClinicalTrials.gov number, NCT02728752.)