Phase IV interim data on H.P. Acthar Gel shows reduced disease activity in rheumatoid arthritis.- Mallinckrodt.

Mallinckrodt is reporting interim data at the midway point of enrollment in the ongoing Phase IV, multicenter study assessing the efficacy and safety of H.P. Acthar Gel in patients with persistently active rheumatoid arthritis (RA) despite receiving disease-modifying anti-rheumatic drugs (DMARDs) and corticosteroids.

Preliminary data on 116 enrolled patients, of whom 100 have completed the open-label period (as of May 10, 2018), found that the interim analysis demonstrated there was a decrease in the mean Disease Activity Score 28-joint count Erythrocyte Sedimentation Rate (DAS28-ESR) scores from baseline through Week 12, with 61% of patients who completed the open-label period achieving low disease activity (LDA less or equal to 3.2) at Week 12. Similarly, the percentage of patients who achieved ACR 20, 50, and 70 criteria increased over time from Week 4 through Week 12, with 85%, 66% and 34% of patients who completed the open-label period having achieved ACR 20, 50, and 70 responses, respectively at 12 weeks. Improvement in patient-reported outcomes (PRO) scores from baseline through Week 12 was observed.

Adverse events observed were consistent with those in previous trials of H.P. Acthar Gel, and no new safety signals were reported. Fourteen subjects withdrew from the study. The data will be reported in a poster presentation on Tuesday, Oct. 23 at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting.