ProDERM: High-dose IV immunoglobulin boosts treatment response in dermatomyositis
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Intravenous immunoglobulin 10% in doses of 2 g/kg demonstrated significantly higher treatment response rates, compared with placebo, in patients with dermatomyositis, according to a speaker at the EULAR 2021 Congress.
The data come from the ProDERM study, which, according to presenter Rohit Aggarwal, MD, MS, of the University of Pittsburgh, is the first large, international, phase-3 randomized controlled trial to demonstrate the safety and efficacy of IVIG in dermatomyositis.
“The study was called the Progress in Dermatomyositis, or ProDERM study, with the aim to investigate the efficacy, safety and tolerability of 10% IVIG in dermatomyositis patients in a pivotal phase-3, randomized, double-blinded, placebo-controlled trial,” Aggarwal told attendees during the virtual meeting.
In the trial’s 16-week double-blind first period, investigators randomly assigned 95 adults with dermatomyositis 1:1 to either 2 g/kg of IVIG 10% (Octagam, Octapharma) every 4 weeks or placebo. At the end of 16 weeks, participants receiving IVIG without clinical worsening, and all those in the placebo group, entered the 24-week open-label extension period. During this period, participants received 2 g/kg infusions of IVIG every 4 weeks. Those who demonstrated clinical worsening — defined based on 2013 data from Oddis et al published in Arthritis & Rheumatology, with a slight adaptation, according to Aggarwal — at two consecutive visits between weeks 8 and 16 were switched to the alternative treatment group.
The primary endpoint was the proportion of responders in the IVIG group, compared with those receiving placebo, at week 16. Response was defined based on the 2016 American College of Rheumatology/EULAR Myositis response criteria of at least minimal improvement in the Total Improvement Score (TIS) — least 20 points — and without clinical worsening at two consecutive visits up to week 16.
According to the researchers, the study met the primary endpoint at week 16, with 78.7% of participants in the IVIG group responding to treatment, compared with 43.8% in the placebo arm (P = .0008). In the analysis of the responders-per-improvement category at week 16, the researchers reported a 45.2% (P < .0001) higher response rate for at least moderate improvement — or at least 40 points on the TIS — as well as a 23.6% (P < .0062) higher response rate for at least major improvement — at least 60 points — in the IVIG group, compared to the placebo arm.
Further, the mean TIS at week 16 was significantly higher in the IVIG group, at 48.4 (standard deviation = 24.4), compared with participants who received a placebo, 21.6 (SD = 20.2). After switching to IVIG in the extension period, participants in the placebo arm demonstrated a similar response rate at week 40 that the IVIG group did at week 16 — or approximately 70% for minimal improvement.
Secondary endpoints, including all the sub-components of TIS except muscle enzyme, as well as Cutaneous Dermatomyositis Disease Area and Severity Index, similarly demonstrated statistically significant improvement with IVIG compared with placebo.
According to Aggarwal, the safety and tolerability IVIG was consistent with previously reported safety outcomes for the drug.
“Based on the results of this study, in Europe, Octogam 10% is approved for the treatment of dermatomyositis in adults in a decentralized procedure, whereas in the United States, the FDA review is pending,” Aggarwal said. “This was the first large placebo-controlled, randomized clinical trial on IVIG treatment in patients with dermatomyositis, which clearly confirmed the efficacy, safety and tolerability of IVIG in patients with dermatomyositis.”
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