By Cole Petrochko, Staff Writer, MedPage Today
Published: March 10, 2013
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco
SAN DIEGO — Hormone pulse therapy may be effective at treating breakthrough multiple sclerosis (MS), with a more favorable profile for relapse and psychiatric side effects, researchers reported here.
In a pilot study, patients treated with adrenocorticotropic hormone (ACTH) with beta-interferon for breakthrough MS had a more than nine-fold lower risk of relapse versus treatment with methylprednisolone and beta-interferon (risk ratio 9.56, 95% CI 1.23 to 74.6, P=0.03), according to Regina Berkovich, MD, PhD, of the University of Southern California Keck Medical Center in Los Angeles, and colleagues.
Those treated with ACTH had no psychiatric episodes compared with those treated with methylprednisolone (P<0.0001), the authors reported in an abstract to be presented at the American Academy of Neurology’s annual meeting, which begins here on March 16.
Although ACTH gel is approved to treat MS relapses, its use as pulse therapy is unclear, the authors stated.
The single-center study evaluated the safety and efficacy of combination ACTH and beta-interferon, compared with methylprednisolone and beta-interferon, for breakthrough MS in 23 patients receiving ongoing beta-interferon treatment.
Participants were eligible if they had Expanded Disability Status Scale scores of 3.0 to 6.5 and more than one relapse or new T2- or gadolinium-enhanced lesion on MRI within the previous year.
Patients were randomly assigned to open-label ACTH (80 units intramuscular injection once daily for 3 consecutive days) or methylprednisolone (1 g intravenously at one dose) every month for 12 months.
Participants were assessed every 3 months over 15 months for relapse rate, disability, MS functional composite, and quality of life.
Over 15 months, those receiving ACTH had a cumulative 0.08 relapses per patient versus 0.8 per patient among those receiving methylprednisolone.
There were no psychiatric episodes among those in the ACTH arm, while in the methylprednisolone arm had a combined 0.55 psychiatric episodes per patient.
While mixed effect modeling showed no difference between groups in trajectory slopes of EDSS over time, there was a significantly stronger (P=0.03) improvement in Mental Health Inventory for ACTH (slope: 0.95/month, P=0.02) compared with methylprednisolone (slope: 0.29/month, P=0.32).
The ACTH group also had a lower cumulative rate of urinary tract infections (0.16 infections per patient versus 0.65 for placebo), although the difference was not significant.
Limitations of the study were the small sample size due to the single-center demographic and lack of blinding.
The authors noted that future research should include randomized, controlled trials to validate their findings.
The study was funded by Questcor Pharmaceuticals, which manufactures adrenocorticotropic hormone (ACTH).
The authors declared no conflicts of interest.
Primary source: American Academy of Neurology
Source reference:
Berkovich R, et al. “Pilot study of monthly pulse adrenocorticotropic hormone (ACTH) or methylprednisolone as an add-on therapy to beta-interferons for long-term treatment of multiple sclerosis” AAN 2013; Abstract P04.269.
Source reference:
Berkovich R, et al. “Pilot study of monthly pulse adrenocorticotropic hormone (ACTH) or methylprednisolone as an add-on therapy to beta-interferons for long-term treatment of multiple sclerosis” AAN 2013; Abstract P04.269.
Article source found here
..
USE OUR SHARE LINKS at the top of this page – to provide this article to others
If you would like, you can comment to our blog posts
LIKE this Blog by clicking the LIKE button – top left
REMAIN up to date with MS News and Education
Visit our MS Learning Channel on YouTube: http://www.youtube.com/msviewsandnews
