By Ed Susman
TORONTO -- April 16, 2010 -- Patients with multiple sclerosis (MS) and asthma comorbidities appear to avoid pulmonary issues when their MS is treated with the investigative oral disease-modifying therapy fingolimod, according to research presented here at the 62nd Annual Meeting of the American Academy of Neurology (AAN).
Researchers recruited 36 patients with comorbid MS and asthma and assigned them to 1 of 3 doses of fingolimod or placebo; they then compared lung-function tests. The team found no statistically significant differences in the change in forced expiratory volume in the first second (FEV1) or the forced expiratory flow, mid-expiratory phase (FEF25%-75%), explained William Collins, MD, Novartis, Basel, Switzerland, speaking here at his poster presentation on April 13.
Slight reductions were found in the higher doses -- 1.25 and 2.5 mg -- but the only significant difference was at day 10 in the FEV1 test, stated Dr. Collins. "These doses are higher than the therapeutic doses identified in clinical trials," he said. He also noted, however, that the company is only seeking approval for the 0.5 mg dose that exhibited the fewest pulmonary problems.
The peak expiratory flow rate was similar across all 4 arms of the study.
Adverse events also occurred more often in the 2 higher doses of fingolimod compared with the 0.5 mg dose and placebo. Liver-function abnormalities were reported only in the patients receiving high-dose fingolimod.
"This study investigated effects on pulmonary function during the first 10 days after starting therapy," Dr. Collins reported. "Data from previous long-term studies have suggested that effects on pulmonary function develop during the first weeks of treatment and remain stable afterward. The period investigated in this study is thus the key clinical window during which effects on pulmonary function are likely to emerge."
"Individuals with multiple sclerosis and stable, moderate asthma can start therapy with fingolimod at the therapeutic dose of 0.5 mg with minimal risk of effects on pulmonary function, exacerbation of asthma symptoms or increased use of short-acting beta2-agonists," Dr. Collins concluded.
The studies in volunteers without MS found that the treatment caused no lung-safety issues among otherwise healthy patients with asthma.
Funding for this study was provided by Novartis.
[Presentation title: Effects of Oral Fingolimod (FTY720) on Pulmonary Function Tests in Patients With Moderate Asthma. Abstract P01.175]
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