2 research outputs found
Oral contraceptives combined with interferon β in multiple sclerosis
Objective: To test the effect of oral contraceptives (OCs) in combination with interferon b (IFN-b)
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 IFNb-1a
subcutaneously (SC) only (group 1), IFN-b-1a SC plus ethinylstradiol 20 mg and desogestrel
150 mg (group 2), or IFN-b-1a SC plus ethinylestradiol 40 mg and desogestrel 125 mg (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 5 0.24) and 26.5% (p 5 0.04) when comparing
group 1 with groups 2 and 3, respectively. The number of patients with no gadoliniumenhancing
lesions was greater in group 3 than in group 1 (p 5 0.03). No significant differences
were detected in other secondary endpoints. IFN-b 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