Phase 3 DETERMINE Study in Dermatomyositis
Topline results from the study are on track to be reported in the second quarter of 2021.
- Primary Endpoint: American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) 2016 Total Improvement Score (TIS) in Adult Dermatomyositis & Polymyositis at Week 28, lenabasum taken twice daily vs. placebo (n = 176)
- Key Secondary Endpoints: Definition of Improvement, Investigator Global Assessment scale of skin activity, and Cutaneous Dermatomyositis Activity and Severity Index activity score
- For complete study details, please view the study listing on clinicaltrials.gov: ClinicalTrials.gov Identifier: NCT03813160
Dermatomyositis, a form of myositis, is a chronic, rare, inflammatory, clinically heterogenous, life-threatening autoimmune disease affecting approximately 80,000 people in North America, EU and Japan.1 The signs and symptoms of dermatomyositis reflect multi-organ involvement, which includes distinctive skin rashes usually accompanied by proximal muscle weakness, and can also include pulmonary, cardiac, gastrointestinal, and joint involvement.2 Patients with dermatomyositis can have recurrent disease flares or chronic progressive disease activity, with increased mortality.3,4 The current mainstay of treatments include FDA-approved systemic glucocorticoids, adrenocorticotropic hormone analogue and off-label use of glucocorticoid-sparing immunosuppressive agents.5,6 There is significant unmet need for new treatments to achieve disease control in dermatomyositis because of limited efficacy or toxicity of immunosuppressive agents or refractory disease.7,8
Medical professionals may email us at DMphysicians@corbuspharma.com for more information about this study.
Patients, caregivers or patient advocates looking for additional information may email us at DMpatients@corbuspharma.com.
1. Health Advances, LLC Analysis
2. “Dermatomyositis Information Page.” National Institute of Neurological Disorders and Stroke, U.S. Department of Health and Human Services, 20 May 2021, www.ninds.nih.gov/Disorders/All-Disorders/Dermatomyositis-Information-Page
3. Marie, Isabelle. “Morbidity and Mortality in Adult Polymyositis and Dermatomyositis.” Current Rheumatology Reports, vol. 14, no. 3, 2012, pp. 275–285., doi:10.1007/s11926-012-0249-3
4. Schiopu, Elena, et al. “Predictors of Survival in a Cohort of Patients with Polymyositis and Dermatomyositis: Effect of Corticosteroids, Methotrexate and Azathioprine.” Arthritis Research & Therapy, vol. 14, no. 1, 2012, doi:10.1186/ar3704
5. FDA label Orapred ODT, availableat https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021959s004lbl.pdf; accessed 20 May 2021
6. FDA label H.P. Acthar gel, available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008372s057lbl.pdf; accessed 20 May 2021
7. Dalakas, Marinos C. “Immunotherapy of Myositis: Issues, Concerns and Future Prospects.” Nature Reviews Rheumatology, vol. 6, no. 3, Mar. 2010, pp. 129–137., doi:10.1038/nrrheum.2010.2
8. DeWane, Madeline, et al. Dermatomyositis: Clinical features and pathogenesis. J Am Acad Dermatol.