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Saygin D, Oddis CV, Marder G, Moghadam-Kia S, Nandkumar P, Neiman N, Dzanko S, Koontz D, Aggarwal R—Rheumatology (Oxford), 2020
Disclosure statement: This was an investigator-initiated clinical trial funded by Mallinckrodt.
To evaluate the efficacy and safety of Acthar Gel in a 6-month long-term follow-up study
After the open-label, prospective trial, 8 of 10 patients* were followed in a 6-month long-term follow-up study1
PATIENT CHARACTERISTICS IN THE LONG-TERM FOLLOW-UP STUDY
*Two patients were lost to follow-up after the prospective trial ended, both of whom did not meet the primary endpoint.
Half of the patients maintained improvement during the long-term follow-up1
The 4 patients who remained stable continued to satisfy criteria for the definition of improvement (DOI) through the 6-month follow-up.
Changes in median core set measurements (CSMs) were minor, given that there were no medication adjustments, and patients remained clinically stable.
HAQ-DI=Health Assessment Questionnaire Disability Index; MD Global=Physician Global Assessment of Change; MMT=Manual Muscle Testing.
Most patients in the long-term follow-up maintained a reduced prednisone dose1
PREDNISONE DOSES THROUGH THE LONG-TERM FOLLOW-UP PERIOD
Safety of Acthar Gel in the long-term follow-up
Start the referral process for your appropriate patients
Acthar® Gel is indicated for:
Contraindications
Acthar is contraindicated:
Warnings and Precautions
Adverse Reactions
Pregnancy
Please see full Prescribing Information for additional Important Safety Information.
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