The study involved 23 people with MS who were taking beta-interferon treatment and had at least one relapse or brain scan showing new disease activity within the previous year. They were considered to have "breakthrough" MS, which means that their treatment that had been working previously stopped being effective, leading to worsening disability and more frequent relapses, as well as increased evidence of disease activity on brain scans.
The study participants were given either ACTH or methylprednisolone as pulse therapy monthly in addition to their regular treatment for one year. The people with MS knew which treatment they were receiving, but the researchers examining them did not.
The participants were tested every three months for 15 months. Over that time, those receiving ACTH had fewer relapses, or 0.08 cumulative relapses per patient compared to 0.8 relapses per patient for those receiving methylprednisolone. Those taking ACTH also had no cases of psychiatric side effects, while those taking methylprednisolone had a cumulative number of 0.55 psychiatric episodes per patient.
"These results are of interest because few treatments are available for people with breakthrough MS," said study author Regina Berkovich, MD, PhD, of Keck Medical Center of USC in Los Angeles. "Further studies, including randomized controlled trials, are needed to validate these preliminary findings, but the results suggest a potential benefit of ACTH pulse therapy in breakthrough MS."
While ACTH has been approved for use in MS relapses for many years, its cost has limited its use to only those patients who are in need of a relapse treatment alternative to corticosteroids. This is believed to be the first study to have been done on its use as a chronic treatment for MS. ACTH is not FDA-approved for use as chronic treatment for MS.