BACKGROUND: Nabiximols (Sativex®), in a cannabinoid-based oromucosal spray, is an add-on therapy option for patients with moderate to severe multiple sclerosis spasticity (MSS) resistant to other medications. The study objective was to provide long-term data on clinical outcomes, tolerability, quality of life and treatment satisfaction for MSS patients receiving nabiximols in routine care.
METHODS: This was the 12-month prolongation of the MOVE 2 study, an observational, prospective, multi-centre 3-month non-interventional study conducted in a routine care setting across Germany. Structured documentation forms, questionnaires and validated instruments were used for data collection.
RESULTS: In total, 52 patients were included in the effectiveness analysis after 12 months. The mean spasticity numerical rating scale (NRS, 0-10) score decreased significantly from 6.0 ± 1.8 points at MOVE 2 baseline to 4.8 ± 1.9 points after 1 month and remained on this level after 12 months (4.5 ± 2.0 points); in patients classified as 'initial responders' (≥20% NRS improvement after 1 month) similar results were found (baseline: 6.3 ± 1.4 points; after 1 month: 4.0 ± 1.0 points; after 12 months: 4.3 ± 1.9 points). The majority of patients (84%) did not report adverse events.
CONCLUSION: Real-life data confirm the long-term effectiveness and tolerability of nabiximols for the treatment of resistant MSS in everyday clinical practice.
ANTECEDENTES: Sativex (Sativex®), un aerosol por vía bucal a base de cannabinoides, es un complemento de la terapia para los pacientes con moderada a severa espasticidad de la esclerosis múltiple (MSS) resistencia a otros medicamentos. El objetivo principal era proporcionar la vida real los datos de observación de la experiencia clínica de Sativex en contraste con los ensayos clínicos formales de eficacia.
MÉTODOS: Se realizó un estudio prospectivo, multicéntrico, observacional, no intervencionista con un período de seguimiento de 3-4 meses, llevada a cabo en el establecimiento de atención de rutina en Alemania. Los pacientes con moderada a severa MSS se incluyeron en la iniciación Sativex '. formularios de documentación estructuradas, cuestionarios e instrumentos validados fueron utilizados para la recopilación de datos a la inclusión, 1 y 3 meses después de la inclusión.
RESULTADOS: En general, se evaluaron 335 pacientes de los cuales 276 cumplieron los criterios y fueron incluidos en el análisis de efectividad. Después de 1 mes, Sativex proporcionado alivio de MSS resistentes en el 74,6% de los pacientes de acuerdo a la evaluación del especialista; significa la espasticidad 0-10 escala de calificación numérica (NRS) puntuación se redujo de 6,1 ± 1,8 a 5,2 ± 2,0 puntos; en pacientes con una mejoría ≥20% NRS NRS media de la puntuación disminuyó en un 40%. Después de 3 meses, el 55,3% de los pacientes habían dejado de usar Sativex y la puntuación media NRS había disminuido en un 25% respecto al valor basal. 17% de los pacientes reportaron eventos adversos.
Conclusión: en la vida real los datos confirman Sativex como una opción de tratamiento eficaz y bien tolerado para MSS resistentes en la práctica clínica.
Este artículo no está incluido en ninguna revisión sistemática
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Sativex® (GW Pharmaceuticals PLC, Porton Down, UK; Laboratorios Almirall, SA, Barcelona, Spain), a cannabinoid oromucosal spray containing a 1:1 ratio of 9-δ-tetrahydrocannabinol and cannabidiol, has been licensed in Germany since July 2011 as add-on therapy for moderate-to-severe multiple sclerosis (MS) treatment-resistant spasticity symptoms. The 'MOVE 2' study evaluated clinical outcomes, treatment satisfaction, quality of life (QoL) and provision of care in MS patients with spasticity receiving Sativex in everyday clinical practice. Data from 300 patients were collected from 42 specialized MS centers across Germany and were available for this analysis. Assessments, including the MS spasticity 0-10 numerical rating scale, modified Ashworth scale, patients' and physicians' clinical impressions, and QoL scales were rated at baseline and at 1 and 3 months after starting treatment with Sativex. Sativex provided relief of MS-related spasticity in the majority of patients who were previously resistant to treatment. In addition, clear improvements were noted in MS spasticity-associated symptoms (e.g., sleep quality, bladder function and mobility), activities of daily living and QoL. Sativex was generally well tolerated. The majority of patients (84%) reported no adverse events, and there was only a limited risk of serious adverse reactions. Furthermore, based on data from Sativex clinical trials, a Markov model-based analysis has shown that Sativex is a cost-effective treatment option for patients with MS spasticity in Germany.
