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
References
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% (fda.gov) 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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