Proven Safety and Tolerability in Adult Dermatomyositis

Treatment of Adult Dermatomyositis With octagam 10% Was Generally Well Tolerated1-3

  • 62 of 95 patients (65.3%) experienced 282 treatment emergent adverse events
  • Most common related adverse events were headache, pyrexia, and nausea
  • Majority of adverse events were mild in intensity
Drug-Related Adverse Reactions Experienced by >5% of Subjects in Overall Period (N=95)
ReactionsNo. of Subjects (%)
Headache40 (42%)
Pyrexia18 (19%)
Nausea15 (16%)
Vomiting8 (8%)
Chills7 (7%)
Musculoskeletal pain7 (7%)
Blood pressure increased6 (6%)
Adverse Reactions in >5% of Subjects During and Within 72 Hours After End of Infusion Cycle, Irrespective of Causality (N=95)
ReactionsNo. of Subjects (%)
Headache44 (46%)
Pyrexia19 (20%)
Nausea16 (17%)
Vomiting8 (8%)
Blood pressure increased8 (8%)
Musculoskeletal pain5 (5%)
Heart rate increased5 (5%)
Dyspnea5 (5%)
Infusion site reactions5 (5%)

 

Incidence of Serious Adverse Events Was Similar for octagam 10% and Placebo During the Double-blind Comparison (First Period)

  • 3 patients (5.8%) in the octagam 10% group had 5 serious adverse events and 2 patients (4.2%) in the placebo group had 4 serious treatment-emergent adverse events
  • Serious adverse reactions observed in patients: muscle spasms and dyspnea (n=1); loss of consciousness (n=1), and thromboembolic events (n=5)

No subject met the criteria for a hemolytic transfusion reaction during the study. No deaths were reported during the study.

Thromboembolic Events (TEE) in DM patients:
Implications for ProDERM study

  • Some retrospective reports and studies have shown an increased risk of TEEs in patients with DM4,5
  • No known cause for increased risk, but acute inflammation seems to contribute to risk via components of the innate immune system

In the ProDERM Study:

  • Independent Data Monitoring Committee assessed all possible TEEs
  • Infusion rate titration with adjustments for adverse reactions was included in protocol
    • Maximum infusion rate was reduced from 0.12 to 0.04 ml/kg/min due to TEE overall rate of 1.54 per 100 patient months
    • After reduction of infusion rate was implemented, TEE overall rate decreased to 0.54 per 100

Review octagam 10% dosage and
administration
in adult patients with DM.

References:
  1. Octagam 10% Full Prescribing Information. Paramus, NJ: Octapharma USA Inc; rev June 2021.
  2. Octapharma. Data on file.
  3. Aggarwal R, et al. (ProDERM study). Submitted for publication. August 2021.
  4. Gaitonde SD, Ballou SP. J Rheumat. 2008; 35:11.
  5. Li Y et al. Ther Clin Risk Manag. 2018; 14:157–165.