Mallinckrodt has completed the open-label phase of the ongoing Phase 4, multicenter study assessing the efficacy and safety of H.P. Acthar Gel in patients with persistently active rheumatoid arthritis (RA) who were previously treated with disease-modifying anti-rheumatic drugs (DMARDs) and corticosteroids.
H.P. Acthar Gel is U.S. Food and Drug Administration (FDA)-approved as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in RA including juvenile RA (selected cases may require low-dose maintenance therapy).
Primary end point results observed from the 100% patient enrollment (n=259) point in the study's open-label phase are consistent with those observed at the 25% and 50% milestone assessments. As most recently reported relative to 50% patient enrollment data (n=116) – where primary end point results showed 61% of the 100 patients with persistently active RA who completed the open-label period achieved low disease activity (LDA) at 12 weeks – H.P. Acthar Gel continued to produce reduction in joint disease activity in patients whose disease was uncontrolled on prednisone and DMARDs. The company intends to present full open-label phase findings by mid-2019.
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"We are pleased with the insights gleaned thus far into the clinical utility of H.P. Acthar Gel in patients with persistently active rheumatoid arthritis who were previously treated with disease-modifying drugs and corticosteroids," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "Mallinckrodt remains committed to the ongoing study of H.P. Acthar Gel in rheumatology – building on the decades of clinical experience for the product – and continuing to meet the needs of the rheumatology community. We look forward to presenting the RA trial data at conferences later this year."
The controlled, double-blind phase of the study is ongoing with completion expected in the first quarter of 2019, and full results targeted for presentation at a research meeting later this year.
The study is a Phase 4, multicenter, two-part study assessing the efficacy and safety of H.P. Acthar Gel in adult subjects with rheumatoid arthritis with persistently active disease who were previously treated with DMARDs and corticosteroids. The primary endpoint of the study is the proportion of patients reaching LDA at 12 weeks.
Part 1 of the study was an open-label period. After 12 weeks of treatment with H.P. Acthar Gel, subjects were evaluated for treatment response using the DAS28-ESR2. At the interim analysis completed at the midway point of study enrollment (n=116), 14 patients had withdrawn and two patients were still active in Part 1. The most common adverse events (AEs) reported at the midway point – a secondary endpoint – were headache (10), urinary tract infection (4), hyperglycemia (3) and pharyngitis (3). Two patients reported serious AEs (chest pain and pneumonia).
The trial is now fully enrolled with 259 patients with persistently active RA who were previously treated with corticosteroids and conventional synthetic and/or biologic DMARDs.