1. Phase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year results
- Author
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Comi, G, O'Connor, P, Montalban, X, Antel, J, Radue, Ew, Karlsson, G, Pohlmann, H, Aradhye, S, Kappos, L, Easton, Jd, Kesselring, J, Weinshenker, Bg, Laupacis, A, Zarbin, M, Calandra, T, Temkin, N, Dimarco, J, Hudson, Ld, Durcan, L, Bar Or, A, Duquette, P, Bernier, G, Freedman, M, Maclean, H, Costello, F, Gray, Ta, Hohol, M, Devonshire, V, Oger, J, Hashimoto, S, Sørensen, Ps, Datta, P, Faber Rod JC, Frederiksen, J, Knudsen, S, Petrenaite, V, Färkkila, M, Harno, H, Halavaara, J, Elovaara, I, Kuusisto, H, Palmio, J, Airas, L, Kaasinen, V, Laaksonen, M, Vermersch, P, Pelletier, J, Feuillet, L, Suchet, L, Mauch, E, Gunser, C, Oberbeck, K, Rieckmann, P, Buttmann, M, Klein, M, Ghezzi, A, Zaffaroni, M, Baldini, S, Mancardi, G, Cioli, F, Capello, E, Rodegher, M, Radaelli, M, Pozzilli, C, Onesti, Emanuela, Romano, Silvia, Czlonkowska, A, Litwin, T, Darda Ledzion, L, Kwiecinski, H, Golebiowski, M, Podlecka, A, Cunha, L, Sousa, L, Matias, F, Pedrosa, R, Almeida, M, Pena, Je, de Sá, J, Ferreira, J, Rosa, M, Arbizu, T, Carmona, O, Casado, V, Tintore, M, Pelayo, R, Arroyo, R, Bartolome, M, De las Heras, V, Casanova, B, Bosca, I, Fernandez, O, Leon, A, Romero, F, Izquierdo, G, Gamero, M, Garcia, Jm, Kuhle, J, Mehling, M, Achtnichts, L, Goebels, N, Skulina, C, Waskoenig, J, Bates, D, Nichols, P, Bendfeldt, K, de Vera, A, Gruenbauer, W., Ben Dahan, David, Centre de résonance magnétique biologique et médicale (CRMBM), Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), and Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS)
- Subjects
Oral ,Adult ,Male ,medicine.medical_specialty ,Multiple Sclerosis ,Time Factors ,Adolescent ,Phases of clinical research ,Administration, Oral ,Kaplan-Meier Estimate ,Relapsing-Remitting ,administration /&/ dosage/adverse effects ,Placebo ,law.invention ,Pulmonary function testing ,03 medical and health sciences ,Disability Evaluation ,Young Adult ,0302 clinical medicine ,Multiple Sclerosis, Relapsing-Remitting ,Randomized controlled trial ,law ,Sphingosine ,Internal medicine ,Fingolimod Hydrochloride ,administration /&/ dosage/adverse effects/analogs /&/ derivatives ,medicine ,Humans ,Adverse effect ,business.industry ,Fingolimod ,Magnetic Resonance Imaging ,diagnosis/drug therapy/pathology ,Administration ,Oral, Adolescent, Adult, Disability Evaluation, Female, Humans, Immunosuppressive Agents ,administration /&/ dosage/adverse effects, Kaplan-Meier Estimate, Magnetic Resonance Imaging, Male, Multiple Sclerosis ,diagnosis/drug therapy/pathology, Propylene Glycols ,administration /&/ dosage/adverse effects, Sphingosine ,administration /&/ dosage/adverse effects/analogs /&/ derivatives, Time Factors, Treatment Outcome, Young Adult ,3. Good health ,Surgery ,Clinical trial ,Treatment Outcome ,Neurology ,Propylene Glycols ,030220 oncology & carcinogenesis ,Female ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Immunosuppressive Agents ,medicine.drug - Abstract
In a 6-month, placebo-controlled trial, oral fingolimod (FTY720) 1.25 or 5.0 mg, once daily, significantly reduced MRI inflammatory activity and annualized relapse rate compared with placebo in patients with relapsing multiple sclerosis (MS). The objectives were to monitor the 36-month, interim efficacy and safety results of the ongoing extension of this study. In the extension (months 7—36), placebo-treated patients were re-randomized to either dose of fingolimod; fingolimod-treated patients continued at the same dose. During months 15—24, all patients receiving fingolimod 5.0 mg switched to 1.25 mg. Of the 250 patients who entered the extension study, 173 (69%) continued to month 36. Most patients were free from gadolinium-enhanced lesions (88—89%) or new T2 lesions (70—78%) at month 36. Patients receiving continuous fingolimod treatment had sustained low annualized relapse rates of 0.20—0.21, and 68—73% remained relapse-free at month 36. Over 36 months, nasopharyngitis (34%), headache (30%), fatigue (19%) and influenza (18%) were the most commonly reported adverse events. Pulmonary function remained stable and blood pressure was stable after an initial increase (3—5 mmHg) during the first 6 months of fingolimod treatment; serious adverse events included infections and skin cancer. The low MRI and clinical disease activity at 6 months were maintained at 36 months with fingolimod, which was generally well tolerated by most patients. The efficacy and safety of oral fingolimod are being further evaluated in a large phase III MS study programme.
- Published
- 2010