Dermatomyositis
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Dermatomyositis

Dermatomyositis (DM)

What is Dermatomyositis?

Dermatomyositis is an immune-mediated idiopathic inflammatory myopathy (IIM) characterised by chronic inflammation of the skin and muscles, leading to cutaneous rashes and progressive, mainly proximal, muscle weakness.1

Patients with IIMs (including DM) often experience an increased morbidity, malignancy and mortality compared to the healthy population.2,3

A rare inflammatory disease with female preponderance and a higher prevalence among older age group.3

IM's are associated with increased morbidity rate with up to 80% of treated patients reporting long-term disability.2

Recent studies indicate increased risk of cancer.2

Evidence supporting therapies used for IlMs were until recently limited to observational data rather than large randomized controlled studies.2

learn more on manage dermatomyositis.com

octagam 10% is the first and only IVIg approved for dermatomyositis*4

*based on the results of a prospective, phase 3, double-blind, randomized, placebo-controlled trial.5,6

Total Improvement Score (TIS) responders6

TIS responders with least moderate improvement6

Safety and tolerability profile consistent with previously reported safety outcomes for IVIg administration5,6

Demonstrated Efficacy in Dermatomyositis

The ProDERM (Progress in DERMatomyositis) study was a prospective, double-blind, randomised, parallel-group, placebo-controlled, multicentre, phase 3 study of octagam® (intravenous human normal immunoglobulin) in adults with active dermatomyositis.6

Dermatomyositis Study Design

STUDY DESIGN AND DEFINITIONS

Dermatomyositis Study Results: Improvement in TotaI Improvement Score (TIS) and Disease Severity

Primary Endpoint – TIS Responder Rate6:

Significantly more patients treated with octagam 10% achieved a TIS response at Week 16 vs placebo6.

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).6

octagam 10% Placebo = percent change N = total number of patients n = number of responders * Improvement of ≥20 points on TIS (based on 6 Core Set Measures). = 34.97% | =0.0008 octagam® 10% N=48 Placebo N=47 78.7% n=37 43.8% n=21 100% 80% 60% 40% 20% 0% Proportion of responders Primary endpoint*
octagam 10% Placebo = percent change N = total number of patients n = number of responders * Improvement of ≥20 points on TIS (based on 6 Core Set Measures). = 34.97% | =0.0008 octagam® 10% N=48 78.7% n=37 Placebo N=47 43.8% n=21 100% 80% 60% 40% 20% 0% Proportion of responders Primary endpoint*

Secondary Endpoint – Responders With at Least Moderate or Major Improvement6:

68% of patients treated with octagam 10% had an increase in TIS of ≥40 points (at least moderate improvement) and 32% had an increase of ≥60 points (major improvement).

Proportion of patients 0% 20% 40% 60% 80% 100% 68.1% n=32 22.9% n=11 = 45.17% 
[95% CI: 27.3%, 63.0%] 8.3% n=4 31.9% n=15 = 23.58% 
[95% CI: 8.1%, 39.0%] At Least Moderate 
TIS Improvement Major 
TIS Improvement octagam 10% Placebo = percent change n = number of responders CI=Confidence interval. octagam® 10% octagam® 10% Placebo Placebo Secondary endpoints: proportion of responderswith at least moderate or major improvement
Proportion of patients 0% 20% 40% 60% 80% 100% = 45.17% 
[95% CI: 27.3%, 63.0%] = 23.58% 
[95% CI: 8.1%, 39.0%] At Least Moderate TIS 
Improvement Major TIS 
Improvement 68.1% n=32 22.9% n=11 octagam® 10% Placebo 31.9% n=15 8.3% n=4 octagam® 10% Placebo CI=Confidence interval. octagam 10% Placebo = percent change n = number of responders Secondary endpoints: proportion of responders with at least moderate or major improvement

Secondary Endpoint – Mean TIS From Weeks 4 to 406:

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.

octagam 10%
(post-placebo) Placebo octagam 10% Mean TIS 10.7 15.8 18.5 44.4 51.1 21.6 24.4 36.4 43.4 54.0 55.4 48.4 0% Weeks 20% 40% 60% 80% 100% 0 4 8 12 16 20 24 28 32 36 40 Double-Blind Open-label Mean TIS from week 4 to 40
Mean TIS 10.7 15.8 18.5 44.4 51.1 21.6 24.4 36.4 43.4 54.0 55.4 48.4 0 4 8 12 16 20 24 28 32 36 40 0% Weeks 20% 40% 60% Double-Blind Open-label Mean TIS from week 4 to 40 octagam 10% Placebo octagam 10% (post-placebo)

Secondary Endpoint – Mean CDASI Total Activity Score6:

Octagam 10% decreased CDASI score at Week 16.

*Mean total activity score: erythema, scale and erosion/ulceration. A 4- to 5-point decrease is consideredclinical improvement. 18.8 9.5 17.0 Switch to octagam 10% 19.0 7.9 10.3 mean: -9.4 mean: -1.2 0 5 10 15 20 25 30 Week 0 Week 16
(4 months) Week 40
(10 months) Placebo-controlled period Open-label extension period octagam 10%
(post-placebo) percent change Placebo octagam 10% octagam 10% achieved a mean decrease of 9.4 points vs 1.2 points with placebo CDASI total activity score in placebo-controlled and open-label extension periods
18.8 9.5 17.0 Switch to octagam 10% 19.0 7.9 10.3 mean: -9.4 mean: -1.2 0 5 10 15 20 25 Week 0 Week 16
(4 months) Week 40
(10 months) Placebo-controlled period Open-label 
extension period 
 achieved a of points vs points with placebo octagam 10%mean decrease9.41.2 CDASI total activity score* *Mean total activity score: erythema, scale and erosion/ulceration. A 4- to 5-point decrease is consideredclinical improvement. CDASI total activity score in placebo-controlled and open-label extension periods octagam 10%
(post-placebo) percent change Placebo octagam 10%

Secondary Endpoint – TIS Responders at Week 406:

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

71.1% 69.6% Response maintained in all TIS responders After switch from placebo to octagam 10%, similar TIS response achieved octagam 10% Placebo then octagam 10% 
weeks 16-40 TIS responders at week 40
Placebo then octagam 10% 
weeks 16-4069.6%After switch from placebo to octagam 10%, similar TIS response achievedoctagam 10%71.1%Response maintained in all TIS responders. TIS responders at 40 weeks
EFFICACY AND SAFETY ASSESSMENTS

Safety and Tolerability in patients with Dermatomyositis

octagam® was generally well tolerated throughout the study. The majority of adverse events (AEs) were mild in intensity. The most commonly reported related AEs were headache (42%), nausea (16%) and pyrexia (19%).5,6

The incidence of serious AEs was low and similar in the two treatment groups. No deaths occurred during the study.5,6

Patients with dermatomyositis are at an increased risk of thromboembolic events (TEEs)7,8. A total of 8 TEEs in 6 patients were reported, of which 6 events in 5 patients were assessed as being related to the treatment. The maximum allowable infusion rate was reduced to 0.04 ml/kg/min after 6 TEEs had occurred, leading to a decrease in the exposure-adjusted incidence rate for TEEs.5,6

References

  1. Goyal, N. A. 2019; Continuum 25, 1564–1585.

  2. D’Silva, K. M. et al. 2021; Rheumatology 60, 2653–26602.

  3. Malik, A et al. 2016; Front Neurol, 20;7:64

  4. Octagam®10%. Summary of Product Characteristics. July 2024.

  5. Aggarwal, R et al. 2024; Arthritis Res Ther 26, 27

  6. Aggarwal R et al. 2022; N Engl J Med 387(14):1264-1278

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