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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
AE=adverse event; IMACS=International Myositis Assessment and Clinical Studies Group; SAE=serious adverse event.
†Concomitant immunosuppressive agents or glucocorticoids were allowed as long as patients were on these therapies for ≥8 weeks (and ≥4 weeks for glucocorticoids) and on a stable dose for ≥4 weeks and ≥2 weeks, respectively, prior to the start of the trial.
DM/PM patients had chronic and persistent disease activity and were previously treated with other regimens1
70% of patients (n=7) met the primary endpoint after treatment with Acthar Gel1
Primary endpoint: definition of improvement
DOI=definition of improvement; IMACS=International Myositis Assessment and Clinical Studies Group.
All patients (n=10)* decreased or discontinued prednisone doses by Week 241
50% (n=5) of patients discontinued prednisone completely by Week 24
Patients showed improvements in several CSMs
Results are based on 10 patients who completed the study. This study may not be fully representative of outcomes in the overall patient population. All patients were on multiple therapies; therefore, the clinical outcomes may not be solely attributable to Acthar Gel. Acthar Gel has not been formally studied in combination with other treatments.
*Ten of the 11 enrolled patients completed the study.
†Criteria for improvement were based on the 2016 ACR/EULAR myositis response criteria.
‡Metric derived from the 2016 ACR/EULAR myositis response criteria, which corresponds to magnitude of improvement.
Many of the observed AEs were similar to those seen with glucocorticoids. Other factors typically associated with high-dose steroids given for an extended period, such as significant weight gain, diabetes, or Cushingoid features, were not observed.
SUMMARY OF ADVERSE EVENTS
Results are based on 10 patients who completed the study. This study may not be fully representative of outcomes in the overall patient population. All patients were on multiple therapies; therefore, the clinical outcomes may not be solely attributable to Acthar Gel. Acthar Gel has not been formally studied in combination with other treatments.
AE=adverse event; N/A=not available; SAE=serious adverse event.
†Total left hip arthroplasty.
‡Transvenous pacemaker insertion.
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Please see full Prescribing Information for additional Important Safety Information.
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