A Randomized Controlled Double-Masked Trial of Albuterol Add-on Therapy in Patients With Multiple Sclerosis

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Abstract
Multiple sclerosis (MS) is a chronic inflammatory disease characterized by the presence of perivascular infiltrates composed of mononuclear cells that lead to demyelination of central nervous system white matter. T cells recognizing myelin antigens seem to be involved in the pathogenesis and perpetuation of the disease.1,2 It is hypothesized that MS is a helper T cell subtype 1 (TH1)–mediated autoimmune disease. Interleukin 12 (IL-12) is a heterodimeric cytokine produced by phagocytic cells and promotes TH1 generation. There are increased IL-12 messenger RNA transcripts in acute inflammatory lesions found in MS brains3 and increased anti-CD3–induced IL-12 secretion in patients with secondary progressive (SP) MS.4 Elevated serum levels of IL-12 have been reported in SP MS.5 It was previously reported that IL-12 production is elevated in monocytes from patients with MS and that monthly treatment with combined cyclophosphamide-methylprednisolone boosts normalized IL-12 production.6 Albuterol sulfate, a β2-adrenergic agonist commonly used in the treatment of bronchospasm, was reported to decrease IL-12 expression in monocytes of healthy individuals through increased intracellular cyclic adenosine monophosphate.7 It was earlier reported that oral albuterol treatment in patients with SP MS induced a significant decrease in IL-12 and interferon γ (IFN-γ).4 Glatiramer acetate is approved for the treatment of relapsing-remitting MS. Daily subcutaneous injections of glatiramer acetate invoked a loss of in vitro responsiveness to glatiramer acetate, with increased ratios of IL-5 and IL-13 to IFN-γ secretion in glatiramer acetate–reactive T cells, corresponding to immune deviation toward TH2-cytokine secretion.8 We investigated the clinical and immunologic effects of albuterol treatment as an add-on therapy in patients starting glatiramer acetate treatment.

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