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Aggarwal R, Marder G, Koontz DC, Nandkumar P, Qi Z, Oddis CV—Annals of the Rheumatic Diseases, 2018
Disclosure statement: Funding to support this study was provided by Mallinckrodt Pharmaceuticals.
To evaluate the efficacy, safety, tolerability, and glucocorticoid-sparing effect of Acthar Gel in an open-label, 24-week, proof-of-concept study of 11 adults with refractory and active DM/PM*
*Ten of the 11 enrolled patients completed the study. One patient dropped out due to heart block unrelated to the study drug and was not included in the efficacy analysis, as she did not complete the minimum 8 weeks of the study drug required for outcome assessment per study protocol.
Primary endpoint
Secondary endpoints
ACR=American College of Rheumatology; AE=adverse event; DOI=definition of improvement; EULAR=European League Against Rheumatism; IMACS=International Myositis Assessment and Clinical Studies Group; SAE=serious adverse event.
DM/PM patients had chronic and persistent disease activity and were previously treated with other regimens1
†Concomitant immunosuppressive agents or glucocorticoids were allowed as long as patients were on these therapies for ≥8 weeks (≥4 weeks for glucocorticoids) and on a stable dose for ≥4 weeks and ≥2 weeks, respectively, prior to the start of the trial. Not every patient was on the same concomitant treatments.
70% (n=7) of patients with refractory and active myositis treated with Acthar Gel demonstrated clinically significant responses after treatment with Acthar Gel
70% (n=7) of patients met the IMACS DOI after treatment with Acthar Gel
DOI=definition of improvement; IMACS=International Myositis Assessment and Clinical Studies Group.
Prednisone doses by Week 24 and discontinuation1
All patients decreased prednisone doses by Week 24, with 50% (n=5) of patients discontinuing prednisone completely by Week 24
AE=adverse event; SAE=serious adverse event.
†Total left hip arthroplasty.
‡Transvenous pacemaker insertion.
Acthar® Gel is indicated for:
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