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A Single-Site, Investigator Initiated Open-Label Trial of Ac | 91996

Revista de artritis

ISSN - 2167-7921

Abstracto

A Single-Site, Investigator Initiated Open-Label Trial of Acthar Gel (Repository Corticotropin Injection) a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides, in Subjects with Severely active Ankylosing Spondylitis (AS)

Joshua P. June

Ankylosing spondylitis (AS), is a chronic inflammatory arthritis of the spine which affects approximately 19 million people worldwide. It is defined by axial skeleton radiographic sacroiliitis, excess spinal bone formation, and a strong association with HLA–B27. It is also associated with burdensome chronic ailments such as psoriasis, peripheral arthritis, uveitis, inflammatory bowel disease, excessive fatigue and vertebral fractures. The goals of treatment are to reduce pain, improve function, maintain activities of daily living, stop skeletal / synovial damage, and delay loss of function. This is commonly approached with nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs, anti-tumor necrosis factor, and anti-interleukin-17 agents. These agents have established side effects thus decreasing their use would be ideal. The addition of Acthar Gel, to the regimen seems to help lessen the need for standard ankylosing spondylitis treatments. Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. The Acthar Gel manufacturing process convert the initial porcine pituitary extract with low ACTH content into a mixture having modified porcine ACTH and other related peptide analogs solubilized in gelatin. A major component in the formula complex mixture is N-25 deamidated porcine ACTH. They were administered with Acthar Gel subcutaneously twice weekly for six months. The subjects were assessed initially and every four weeks on ankylosing spondylitis scales (Ankylosing Spondylitis Quality of Life, Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Disease Activity Index, Patient Global Assessment, Tender Joint Count, Swollen Joint Count). They quickly showed marked improvement which was typically far greater than 50% in each of the subjects. Perhaps nearly as important the safety data endpoints resulted in normal physiologic results for systolic blood pressure, diastolic blood pressure, pulse rate, temperature, glycated hemoglobin (HgA1c,) and cortisol levels at baseline, compared to end of study measures. Our results strongly suggest that Acthar Gel added to standard of care therapies will demonstrate improvement of back pain and stiffness in patients with ankylosing spondylitis with a robust safety profile.