Dermatomyositis Study Results: Improvement in TIS and Disease Severity

PRIMARY ENDPOINT – TIS Responder Rate1-3

Significantly more patients treated with octagam 10% achieved a TIS response* at Week 16 vs placebo

The efficacy of octagam 10% in patients with DM was confirmed, with the primary endpoint met. There was a higher proportion of responders at 16 weeks in the octagam 10% group than in the placebo group (78.7% vs 43.8%) and the difference in response rates was statistically significant: 34.97% (95% CI: 16.70, 53.24; p=0.0008).

Time to TIS response was shorter with octagam 10% vs placebo1-3

SECONDARY ENDPOINT – Responders With at Least Moderate or Major Improvement1-3

68% of patients treated with octagam 10% had an increase in TIS of ≥40-points (MODERATE IMPROVEMENT) and 32% had an increase of ≥60 points (MAJOR IMPROVEMENT)

SECONDARY ENDPOINT – Mean TIS From Weeks 4 to 401-3

At Week 16, mean TIS with octagam 10% was more than double that of placebo—and was maintained at 40 weeks

  • TIS rapidly improved in the placebo arm after patients were switched to octagam 10% at Week 16

SECONDARY ENDPOINT – Mean CDASI Total Activity Score1-3

Octagam 10% decreased CDASI score at Week 16*

* Mean total activity score: erythema, scale and erosion/ulceration. A 4- to 5-point decrease is considered clinical improvement.

SECONDARY ENDPOINT – TIS Responders at Week 401-3

Efficacy was maintained after 40 weeks in 71% of TIS responders

n=number of responders out of total number of patients at week 40.

Forty-five patients in the octagam 10% group and 46 patients in the placebo group completed the first period and entered the 24-week extension period where both groups received octagam 10%.

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.