Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)

Summary

Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")

Timeline

Start

2017-02-27

Primary completion

2019-11-05

Completion

2019-11-05

Outcome

Met primary endpoint

paper had a TIS of at least 20 (difference, 35 percentage points; 95% confidence interval, 17 to 53; P<0.001). PMID 36198179 ↗

release “in patients with dermatomyositis. The primary endpoint of the study was met” octapharma.com ↗

Publications

• Aggarwal R, Schessl J, Bata-Csorgo Z, Dimachkie MM, Griger Z, Moiseev S, Oddis CV, Schiopu E, Vencovsky J, Clodi E, Levine T, Charles-Schoeman C; ProDERM investigators. Efficacy of Intravenous Immunoglobulin for Systemic Manifestations of Dermatomyositis Beyond Muscular and Cutaneous: Sub-analysis of the ProDERM Study. Rheumatol Ther. 2025 Oct;12(5):855-871. doi: 10.1007/s40744-025-00775-5. Epub 2025 Jul 5.
• Charles-Schoeman C, Schessl J, Bata-Csorgo Z, Dimachkie MM, Griger Z, Moiseev S, Oddis CV, Schiopu E, Vencovsky J, Clodi E, Levine T, Aggarwal R. Predictors of response to intravenous immunoglobulin in patients with dermatomyositis: the ProDERM study. Rheumatology (Oxford). 2025 Jun 1;64(6):3767-3776. doi: 10.1093/rheumatology/keaf070.
• Aggarwal R, Schessl J, Charles-Schoeman C, Bata-Csorgo Z, Dimachkie MM, Griger Z, Moiseev S, Oddis CV, Schiopu E, Vencovsky J, Beckmann I, Clodi E, Levine T; ProDERM investigators. Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis: results from the randomised, placebo-controlled ProDERM study. Arthritis Res Ther. 2024 Jan 17;26(1):27. doi: 10.1186/s13075-023-03232-2.
• Werth VP, Aggarwal R, Charles-Schoeman C, Schessl J, Levine T, Kopasz N, Worm M, Bata-Csorgo Z. Efficacy of intravenous immunoglobulins (IVIg) in improving skin symptoms in patients with dermatomyositis: a post-hoc analysis of the ProDERM study. EClinicalMedicine. 2023 Oct 2;64:102234. doi: 10.1016/j.eclinm.2023.102234. eCollection 2023 Oct.
• Aggarwal R, Charles-Schoeman C, Schessl J, Bata-Csorgo Z, Dimachkie MM, Griger Z, Moiseev S, Oddis C, Schiopu E, Vencovsky J, Beckmann I, Clodi E, Bugrova O, Danko K, Ernste F, Goyal NA, Heuer M, Hudson M, Hussain YM, Karam C, Magnolo N, Nelson R, Pozur N, Prystupa L, Sardy M, Valenzuela G, van der Kooi AJ, Vu T, Worm M, Levine T; ProDERM Trial Group. Trial of Intravenous Immune Globulin in Dermatomyositis. N Engl J Med. 2022 Oct 6;387(14):1264-1278. doi: 10.1056/NEJMoa2117912.
• Aggarwal R, Charles-Schoeman C, Schessl J, Dimachkie MM, Beckmann I, Levine T. Prospective, double-blind, randomized, placebo-controlled phase III study evaluating efficacy and safety of octagam 10% in patients with dermatomyositis ("ProDERM Study"). Medicine (Baltimore). 2021 Jan 8;100(1):e23677. doi: 10.1097/MD.0000000000023677.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	intravenous immune globulin	Protein / enzyme biologic	1 g/kg	Intravenous
Subject	intravenous immune globulin	Protein / enzyme biologic	2 g/kg	Intravenous

Indications