After patients in the placebo group switched to IVIG treatment in the open-label extension period, these patients achieved a response rate at week 40 similar to the week 16 response of patients who had originally received IVIG treatment.
TIS was compared between patients who received IVIG (group 1) and those who received placebo, and then were crossed over to IVIG at week 16 (group 2). At three specific time points, the mean TIS scores were:
- At week 16, 48.4% for group 1 compared with 21.6% for group 2;
- At week 28, 54% for group 1 compared with 44.4% for group 2; and
- At week 40, 55.44% for group 1 compared with 51.07% for group 2.
The safety and tolerability profile of IVIG was consistent with previously reported safety outcomes with IVIG administration. No new safety signals were identified.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- News release: FDA approves Octopharma’s Octagam 10% for adult dermatomyositis. Octapharma AG. 2021 Jul 20.
- Supplemental approval letter BL 125062/674: Immunoglobulin intravenous (human). U.S. Food & Drug Administration. 2021 Jul 15.
- Approval letter BL 125062/234: Octagam. U.S. Food & Drug Administration. 2014 Jul 11.
- Aggarwal R, Charles-Schoeman C, Schessl J, et al. A randomized, double-blind, placebo-controlled phase 3 trial of IVIG 10% in patients with dermatomyositis, the ProDERM study: Results on efficacy and safety [abstract OP0008]. Ann Rheum Dis. 2021;80:4–5.
- Octapharma AG. Study evaluating efficacy and safety of Octagam 10% in patients with dermatomyositis (idiopathic inflammatory myopathy [IIM]). ClinicalTrials.gov. 2021 Apr 21.
