ACR Meeting Abstracts

ACR Meeting Abstracts

  • Home
  • Meetings Archive
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018 ACR/ARHP Annual Meeting
    • 2017-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • Meeting Resource Center

Abstract Number: 0695

Safety and Tolerability of IVIg (Octagam 10%) in Patients with Active Dermatomyositis. Results of a Randomized, Double-Blind, Placebo-Controlled Phase III Trial

Rohit Aggarwal1, Christina Charles-Schoeman2, Joachim Schessl3, Zsuzsanna Bata-Csorgo4, Mazen Dimachkie5, Zoltan Griger6, Sergey Moiseev7, Chester Oddis1, Elena Schiopu8, Jiri Vencovsky9, Irene Beckmann10, Elisabeth Clodi10, Todd Levine11 and and the ProDERM Investigators12, 1University of Pittsburgh, Pittsburgh, PA, 2Department of Medicine, University of California, Los Angeles, Los Angeles, CA, 3Friedrich-Baur-Institut/Medical University Munich, München, Germany, 4University of Szeged, Faculty of Medicine, Szeged, Hungary, 5University of Kansas Medical Center, Kansas City, KS, 6University of Debrecen, Debrecen, Hungary, 7First Moscow State Medical University, Moscow, Russia, 8University of Michigan, Ann Arbor, MI, 9Institute of Rheumatology, Prague, Czech Republic, 10Octapharma PPG, Vienna, Austria, 11Phoenix Neurological Associates, LTD, Phoenix, AZ, 12Different Institutions in several countries, Vienna, Austria

Meeting: ACR Convergence 2021

Keywords: autoimmune diseases, dermatomyositis, Randomized Trial

  • Tweet
  • Email
  • Print
Session Information

Date: Sunday, November 7, 2021

Session Title: Muscle Biology, Myositis & Myopathies Poster (0683–0722)

Session Type: Poster Session B

Session Time: 8:30AM-10:30AM

Background/Purpose: Dermatomyositis (DM) is a chronic systemic autoimmune disease with characteristic skin rash and muscle weakness. Intravenous immunoglobulin (IVIg) has long been used as adjuvant treatment for DM and its efficacy was recently shown in a double-blind, randomized, placebo-controlled, phase III clinical trial (ProDERM study). The aim of this sub-analysis of the ProDERM study was to present detailed safety and tolerability data of IVIg in DM subjects.

Methods: The trial enrolled adults with definite or probable DM (Bohan & Peter criteria) with active disease and muscle weakness (MMT < 142/150). In the double-blind, placebo-controlled First Period, subjects were randomized 1:1 to either high dose IVIg (2g/kg every 4 weeks) or placebo.
After week 16, all patients on placebo and patients without clinical worsening while on IVIg entered the open label Extension Period, receiving 2 g/kg IVIg infusions every 4 weeks for an additional 24 weeks period. IVIg was given in equally divided doses over 2-5 consecutive days (=1 infusion cycle) every 4 weeks.

Results: A total of 95 adult DM patients (mean age: 53 years; 75% females) were enrolled and received at least one dose of IVIg. Baseline clinical characteristics were balanced between the 2 arms. Overall 96% and 73% patients completed the first and extension period, with 3 (3%) and 9 (10%) subjects discontinuing due to adverse events (1 of 3 and 6 of 9 due to IVIg related events), respectively.

A total of 664 infusions cycles were administered and 545 adverse events (AEs) were reported. Of these AEs, 282 in 62 (65%) subjects were assessed as being related to study drug. The majority of related AEs were mild (73.4%, 207), some were moderate (23.4%, 66) or severe (3.2%, 9). Most were infusion reactions (92%, 260). Headache (42% of subjects), pyrexia (19%) and nausea (16%) were the most common AEs (Table 1). Premedication for infusions was required by only 21.3% of patients before IVIg administration.

The incidence of serious AEs was similar in the two treatment groups during the First Period: 3 subjects (5.8%) experienced 5 serious AEs after IVIg and 2 subjects (4.2%) experienced 4 serious AEs after placebo.
Overall, serious AEs were reported in 16 patients (Table 2). In 7 patients these were assessed as related to IVIg including thromboembolic events (TEE) in 5 subjects. All subjects with TEE had 1 or more other risk factors for TEE in addition to DM. During the study the exposure-adjusted incidence rate for TEE was efficiently lowered from 1.54 events per 100 patient months to 0.54 by reducing the maximum allowed infusion rate from 0.12 mL/kg/min to 0.04 mL/kg/min.

Conclusion: The safety and tolerability profile for high dose IVIg administration in patients with active DM was as expected with headache, pyrexia and nausea being most commonly reported during or after the infusions. Patients should be monitored for TEE (especially those with additional risk factors) with risk mitigation by using a low maximum infusion rate. This is the first large international, randomized, placebo-controlled phase III trial demonstrating the safety and tolerability of IVIg as a treatment for patients with DM.

Table 1:
Related AEs reported > 2% of subjects (First and Extension Period)

Table 2:
All serious adverse events (First and Extension Period) with intensity and relationship to IVIg


Disclosures: R. Aggarwal, Mallinckrodt, 1, 5, Bristol Myers-Squibb, 2, 5, Pfizer, 2, Genentech, 5, Orphazyme, 1, 2, CSL Behring, 1, 2, AstraZeneca, 2, Kezar, 2, Q32, 2, 5, Alexion, 2, Argenx, 2, Boehringer Ingelheim, 2, Corbus, 2, EMD Serono, 2, 5, Janssen, 2, Kyverna, 2, Octapharma, 1, 2; C. Charles-Schoeman, AbbVie, 2, 5, Bristol-Myers Squibb, 5, Pfizer Inc, 2, 5, Gilead Sciences, 2, Sanofi-Regeneron, 2; J. Schessl, Octapharma, 1; Z. Bata-Csorgo, Novartis, 1, 6, Sanofi-Genzyme, 1, 6, Ewopharma, 1, 6, Abbvie, 1; M. Dimachkie, Octapharma, 2, 5, CSL-Behring, 2, 5, Orphazyme, 2, 5, Kezar, 1, 2, 5, UCB, 1, 2, 5, Shire Takeda, 2, 5, Bristol-Myers Squibb, 5, Corbus, 5, FDA/OOPD, 5, IMACS, 4; Z. Griger, Octapharma, 1, Abbvie, 6, Roche, 6, Lilly, 6, CSL-Behring, 6, Boehringer Ingelheim, 6, Janssen-Cilag, 6; S. Moiseev, Octapharma, 12, Travel grant; C. Oddis, Genentech, 5, Pfizer, 2, Corbus, 5, CSL Behring, 5, EMD Serono, 2, 5; E. Schiopu, Octapharma, 2, 5; J. Vencovsky, AbbVie, 1, 6, Boehringer Ingelheim, 2, Eli Lilly, 1, 6, Gilead, 1, Octapharma, 1, Biogen, 6, MSD, 6, Pfizer, 6, Roche, 6, Sanofi, 6, UCB, 6, Novartis, 6, Werfen, 6; I. Beckmann, Octapharma, 3; E. Clodi, Octapharma, 3; T. Levine, Octapharma, 1, NuFactor, 1; a. Investigators, None.

To cite this abstract in AMA style:

Aggarwal R, Charles-Schoeman C, Schessl J, Bata-Csorgo Z, Dimachkie M, Griger Z, Moiseev S, Oddis C, Schiopu E, Vencovsky J, Beckmann I, Clodi E, Levine T, Investigators a. Safety and Tolerability of IVIg (Octagam 10%) in Patients with Active Dermatomyositis. Results of a Randomized, Double-Blind, Placebo-Controlled Phase III Trial [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/safety-and-tolerability-of-ivig-octagam-10-in-patients-with-active-dermatomyositis-results-of-a-randomized-double-blind-placebo-controlled-phase-iii-trial/. Accessed January 27, 2023.
  • Tweet
  • Email
  • Print

« Back to ACR Convergence 2021

ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-tolerability-of-ivig-octagam-10-in-patients-with-active-dermatomyositis-results-of-a-randomized-double-blind-placebo-controlled-phase-iii-trial/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

ACR Pediatric Rheumatology Symposium 2020

© COPYRIGHT 2023 AMERICAN COLLEGE OF RHEUMATOLOGY

Wiley

  • Home
  • Meetings Archive
  • Advanced Search
  • Meeting Resource Center
  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences