Adrenocorticotropic hormone methylprednisolone added to interferon β in patients with multiple sclerosis experiencing breakthrough disease: a randomized, rater-blinded trial
| العنوان: | Adrenocorticotropic hormone methylprednisolone added to interferon β in patients with multiple sclerosis experiencing breakthrough disease: a randomized, rater-blinded trial |
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| المؤلفون: | Rohit Bakshi, Mohit Neema, Shahamat Tauhid, Steven Cen, Robert C. Axtell, Lilyana Amezcua, Regina Berkovich, Lawrence Steinman |
| المصدر: | Therapeutic Advances in Neurological Disorders, Vol 10 (2017) |
| بيانات النشر: | SAGE Publishing, 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | 0301 basic medicine, medicine.medical_specialty, Disease, Adrenocorticotropic hormone, lcsh:RC346-429, Lesion, 03 medical and health sciences, 0302 clinical medicine, Interferon β, Internal medicine, medicine, lcsh:Neurology. Diseases of the nervous system, Pharmacology, Bone mineral, Expanded Disability Status Scale, business.industry, Multiple sclerosis, medicine.disease, Surgery, 030104 developmental biology, Neurology, Methylprednisolone, Neurology (clinical), medicine.symptom, business, 030217 neurology & neurosurgery, medicine.drug |
| الوصف: | 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. |
| اللغة: | English |
| تدمد: | 1756-2864 1756-2856 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::29d1ffce1291cd858cf2fae618eca52d https://doaj.org/article/669da6c82be84a56bc0897534748db53 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....29d1ffce1291cd858cf2fae618eca52d |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 17562864 17562856 |
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