RT Journal Article
SR Electronic
T1 Oral contraceptives combined with interferon β in multiple sclerosis
JF Neurology - Neuroimmunology Neuroinflammation
JO Neurol Neuroimmunol Neuroinflamm
FD Lippincott Williams & Wilkins
SP e120
DO 10.1212/NXI.0000000000000120
VO 2
IS 4
A1 Carlo Pozzilli
A1 Laura De Giglio
A1 Valeria T. Barletta
A1 Fabiana Marinelli
A1 Floriana De Angelis
A1 Valentina Gallo
A1 Veronica A. Pagano
A1 Stefano Marini
A1 Maria C. Piattella
A1 Valentina Tomassini
A1 Patrizia Pantano
YR 2015
UL http://nn.neurology.org/content/2/4/e120.abstract
AB Objective: To test the effect of oral contraceptives (OCs) in combination with interferon β (IFN-β) on disease activity in patients with relapsing-remitting multiple sclerosis (RRMS).Methods: One hundred fifty women with RRMS were randomized in a 1:1:1 ratio to receive IFN-β-1a subcutaneously (SC) only (group 1), IFN-β-1a SC plus ethinylstradiol 20 μg and desogestrel 150 μg (group 2), or IFN-β-1a SC plus ethinylestradiol 40 μg and desogestrel 125 μg (group 3). The primary endpoint was the cumulative number of combined unique active (CUA) lesions on brain MRI at week 96. Secondary endpoints included MRI and clinical and safety measures.Results: The estimated number of cumulative CUA lesions at week 96 was 0.98 (95% confidence interval [CI] 0.81–1.14) in group 1, 0.84 (95% CI 0.66–1.02) in group 2, and 0.72 (95% CI 0.53–0.91) in group 3, with a decrease of 14.1% (p = 0.24) and 26.5% (p = 0.04) when comparing group 1 with groups 2 and 3, respectively. The number of patients with no gadolinium-enhancing lesions was greater in group 3 than in group 1 (p = 0.03). No significant differences were detected in other secondary endpoints. IFN-β or OC discontinuations were equally distributed across groups.Conclusions: Our results translate the observations derived from experimental models to patients, supporting the anti-inflammatory effects of OCs with high-dose estrogens, and suggest possible directions for future research.Classification of evidence: This study provides Class II evidence that in women with RRMS, IFN-β plus ethinylstradiol and desogestrel decreases the cumulative number of active brain MRI lesions compared with IFN-β alone.AE=adverse event; ARR=annualized relapse rate; CI=confidence interval; CUA=combined unique active; EAE=experimental autoimmune encephalomyelitis; EDSS=Expanded Disability Status Scale; Gd=gadolinium; IFN=interferon; IL=interleukin; ITT=intention to treat; MS=multiple sclerosis; OC=oral contraceptive; RA=rheumatoid arthritis; RRMS=relapsing-remitting MS; SC=subcutaneous; tiw=3 times a week