The ProDERM Study

The ProDERM study is the first prospective phase III randomized, placebo-controlled trial demonstrating efficacy, safety and tolerability of IVIg (octagam®10%) in dermatomyositis.7

Patient population

  • Diagnosis of definite or probable DM with confirmed active disease*

    –    Manual Muscle Testing-8 (MMT-8) score: <142
    –    ≥2 other abnormal core set measures

  • Age range 22-79 years; 25% male, 75% female

  • Patient disease severity, based on the physicians’ GDA assessment was:
    –    27% mild disease
    –    59% moderate disease
    –    14% severe disease

Concomitant medication use

  • 98.9% of patients continued on their stable prior DM medications

  • A similar proportion of patients used concomitant DM medications in both treatment arms.
    The most common were:
    –    88% systemic corticosteroids
    –    57% immunosuppressants
    –    21% anti-inflammatory and anti-rheumatic products

* According to the Bohan and Peter criteria for the diagnosis and classification of DM based on: symmetric proximal muscle weakness,muscle biopsy evidence of myositis, elevation of serum skeletal muscle enzymes, electromyographic finding consistent with myositis, and typical dermatomyositis skin rash.

† VAS of patient global activity ≥2 cm, physician’s GDA ≥2 cm, extra-muscular activity ≥2 cm, at least one muscle enzyme >1.5 times ULT, or HAQ ≥0.25.

GDA=global disease activity; HAQ=health assessment questionnaire; ULT=upper limit of normal; VAS=visual analog scale

Octagam®10% efficacy was evaluated using the Total Improvement Score (TIS)7

TIS is a validated assessment tool to quantify DM improvement, developed by ACR/EULAR*. It is a composite score of 6 core set measures that assesses improvement on a scale of 0-100.6

Primary and secondary efficacy end points using TIS in the ProDERM study7

Primary endpoint

  • Proportion of TIS responders* in the octagam®10% and placebo arms at 16 weeks (end of the placebo-controlled period) compared to baseline

 Secondary endpoints

  • Proportion of TIS responders by improvement category (minimal, moderate, major) at 16 weeks and 40 weeks

  • Mean TIS at end of placebo controlled period (16 weeks) and at end of open-label extension period (40 weeks)

  • Median time to response (minimal improvement in TIS) in the octagam®10% treatment arm

  • Mean change at 16 weeks and 40 weeks in the modified CDASI activity score

* A responder was defined as a patient with a TIS improvement of at least ≥20 points (minimal improvement), who had not met criteria for confirmed deterioration at 2 consecutive visits up to and including week 16.

octagam®10% achieved the primary and secondary efficacy endpoints in the ProDERM Study4,5,7

octagam®10% demonstrated a higher responder rate* vs placebo in all 3 categories of TIS improvement at 16 weeks4,5,7

A significantly higher proportion of patients receiving octagam®10% achieved at least minimal improvement on the TIS score compared to placebo. (78.72% vs 43.75%; P=0.0008) (primary endpoint).

* Improvement categories: ≥20 points (minimal improvement), ≥40 points (moderate improvement), ≥60 points (major improvement) without deterioration after 2 consecutive visits up to and including week 16.

The mean TIS was significantly higher in the octagam®10% arm than in the placebo arm at week 164,5,7

At 40 weeks, at the end of the open label extension period, patients who had been switched from placebo to octagam®10% achieved a similar mean TIS versus patients who had received octagam®10% throughout the entire study.4,5,7

Secondary Endpoints:

At week 16, greater improvements in mean mCDASI* activity scores were observed in the octagam®10% arm vs placebo arm.4,5,7

  • A greater improvement in mCDASI total activity score was demonstrated with octagam10% vs placebo at 16 weeks4,5,7

  • After patients were switched from placebo to octagam®10% at 16 weeks, both treatment arms achieved similar mean mCDASI activity scores at 40 weeks4,5,7

  • CDASI scores of ≥15 indicate moderate to-severe skin disease6,8

  • In clinical studies, the target treatment difference between the study drug and placebo arms is a 5 to 10-point difference in change from baseline6,8

* Modified Cutaneous Dermatomyositis Disease Area Severity Index (mCDASI) (v2) is a validated clinician-scored single page outcome measure instrument for DM:
– separately measures activity and damage in the skin of DM patients over 15 body areas
– 3 activity measures (erythema, scale, and erosion/ulceration)
– 2 damage measures (poikiloderma and calcinosis)

In addition:
– Gottron papules on the hands (activity and damage)
– activity of periungual changes
– alopecia

Sub-components of TIS showed statistically significant improvement with octagam®10% treatment compared to placebo4,5,7


1. Goyal, N. A. (2019) Immune-Mediated Myopathies. Continuum 25, 1564–1585.

2. D’Silva, K. M. et al. (2021) Persistent premature mortality gap in dermatomyositis and polymyositis: A United Kingdom general population-based cohort study. Rheumatology 60, 2653–26602.

3. Glaubitz S. et al. (2020). Therapeutic advances in musculoskeletal disease 12, 1759720X19886494.

4. Octagam®10%. Summary of Product Characteristics. May 2021.

5. USA Product Information /Package Insert- OCTAGAM 10% ( Octapharma USA Inc. June 2021.

6. Aggarwal, R. et al. 2016 American College of Rheumatology/European League Against Rheumatism criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis. An International Myositis Assessment and Clinical Studies Group/ Paediatric Rheumatology International Trials Organisation Collaborative Initiative. Ann. Rheum. Dis. 76, 792–801

7. Aggarwal, R. et al. Prospective, double-blind, randomized, placebo-controlled phase III study evaluating efficacy and safety of octagam®10% in patients with dermatomyositis (“ProDERM Study”). Medicine (Baltimore) 100, e23677

8. Ahmed S, Chen KL, Werth VP. The validity and utility of the Cutaneous Disease Area and Severity Index (CDASI) as a clinical outcome instrument in dermatomyositis: a comprehensive review. Semin Arthritis Rheum. 2020;50(3):458-462.

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IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).

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