Journal article
Adrenocorticotropic hormone versus methylprednisolone added to interferon β in patients with multiple sclerosis experiencing breakthrough disease: a randomized, rater-blinded trial
Therapeutic advances in neurological disorders, Vol.10(1), pp.3-17
01/01/2017
DOI: 10.1177/1756285616670060
PMCID: PMC5400152
PMID: 28450891
Abstract
Background:
The objective of this study was to evaluate monthly intramuscular adrenocorticotropic hormone (ACTH) gel versus intravenous methylprednisolone (IVMP) add-on therapy to interferon β for breakthrough disease in patients with relapsing forms of multiple sclerosis.
Methods:
This was a prospective, open-label, examiner-blinded, 15-month pilot study evaluating patients with Expanded Disability Status Scale (EDSS) score 3.0–6.5 and at least one clinical relapse or new T2 or gadolinium-enhanced lesion in the previous year. Twenty-three patients were randomized to ACTH (n = 12) or IVMP (n = 11) and completed the study. The primary outcome measure was the cumulative number of relapses. Secondary outcomes included EDSS, Mental Health Inventory (MHI), plasma cytokines, MS Functional Composite (MSFC), Quality-of-Life (MS-QOL) score, bone mineral density (BMD), and new or worsened psychiatric symptoms per month. Brain magnetic resonance imaging was analyzed post hoc. This was a preliminary and small-scale study.
Results:
Relapse rates differed significantly [ACTH 0.08, 95% confidence interval (CI) 0.01–0.54 versus IVMP 0.80, 95% CI 0.36–1.75; rate ratio, IVMP versus ACTH: 9.56, 95% CI 1.23–74.6; p = 0.03]. ACTH improved (p = 0.03) MHI (slope 0.95 ± 0.38 points/month; p = 0.02 versus slope −0.38 ± 0.43 points/month; p = 0.39). On-study decreases (all p < 0.05) in eight cytokine levels occurred only in the ACTH group. However, on-study EDSS, MSFC, MS-QOL, BMD, and MRI lesion changes were not significant between groups. Psychiatric symptoms per patient were greater with IVMP than ACTH (0.55, 95% CI 0.12–2.6 versus 0; p < 0.0001). Other common adverse events were insomnia and urinary tract infections (IVMP, seven events each) and fatigue or flu symptoms (ACTH, five events each).
Conclusions:
This study provided class II evidence that ACTH produced better examiner-assessed cumulative rates of relapses per patient than IVMP in the adjunctive treatment of breakthrough disease in multiple sclerosis.
Details
- Title: Subtitle
- Adrenocorticotropic hormone versus methylprednisolone added to interferon β in patients with multiple sclerosis experiencing breakthrough disease: a randomized, rater-blinded trial
- Creators
- Regina Berkovich - LAC+USC Medical CenterRohit Bakshi - Brigham and Women's HospitalLilyana Amezcua - University of Southern CaliforniaRobert C. Axtell - Oklahoma Medical Research FoundationSteven Y. Cen - University of Southern CaliforniaShahamat Tauhid - Brigham and Women's HospitalMohit Neema - Brigham and Women's HospitalLawrence Steinman - Stanford University
- Resource Type
- Journal article
- Publication Details
- Therapeutic advances in neurological disorders, Vol.10(1), pp.3-17
- Publisher
- SAGE Publications
- DOI
- 10.1177/1756285616670060
- PMID
- 28450891
- PMCID
- PMC5400152
- ISSN
- 1756-2864
- eISSN
- 1756-2864
- Language
- English
- Date published
- 01/01/2017
- Academic Unit
- Psychiatry
- Record Identifier
- 9984627247002771
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