Effectiveness and Safety of Teriflunomide in Relapsing-Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study.

INTRODUCTION: Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing-remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. METHODS: This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. RESULTS: A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14-0.21) from the baseline of 0.42 (95% CI 0.38-0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12-24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. CONCLUSION: Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression.

Fingolimod: efectividad y seguridad en la práctica clínica habitual. Estudio observacional, retrospectivo y multicéntrico en Galicia / Fingolimod: effectiveness and safety in routine clinical practice. An observational, retrospective, multi-centre study in Galicia

INTRODUCCIÓN: La efectividad y seguridad del fingolimod en pacientes con esclerosis múltiple remitente recurrente (EMRR) se demostró en ensayos clínicos. Sin embargo, por las limitaciones de éstos, es importante saber cómo se comporta en condiciones de práctica clínica habitual. Así, el objetivo de este estudio es evaluar la efectividad y seguridad del fingolimod después de 12 meses de uso en la práctica clínica en Galicia. PACIENTES Y MÉTODOS: Estudio retrospectivo y multicéntrico (n = 8) de pacientes con EMRR y tratados con una o más dosis de fingolimod, 0,5 mg/día. Se evaluó la efectividad -tasa anualizada de brotes (TAB), cambio en la puntuación de la escala expandida del estado de discapacidad (EDSS), porcentaje de pacientes libres de brotes, libres de progresión de discapacidad y libres de actividad en resonancia- para el total de pacientes y según tratamiento previo. Se evaluó la seguridad a partir del porcentaje de pacientes que discontinuaron y que presentaron efectos adversos. RESULTADOS: Después de 12 meses de uso, el fingolimod redujo un 87% la TAB (de 1,7 a 0,23; p < 0,0001) y, en consecuencia, un 81% de pacientes estuvo libre de brotes. La puntuación de la EDSS disminuyó un 9%. Un 91% de pacientes estuvo libre de progresión de discapacidad y un 72%, libre de actividad en resonancia. En el 43% de los pacientes no se evidenciaron signos de la actividad de la enfermedad. La mayoría de los beneficios del fingolimod difirieron según el tratamiento previo. Alrededor de un tercio de los pacientes comunicaron efectos adversos, pero sólo el 2% discontinuó debido a ellos. CONCLUSIONES: La mayoría de los resultados de efectividad de los ensayos clínicos del fingolimod se observa durante los 12 primeros meses de tratamiento en la práctica clínica. Se observó un mejor perfil de seguridad al comunicado en los ensayos clínicos

INTRODUCTION: The effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) have been proven in clinical trials. Yet, due to their limitations, it is important to know how it behaves under everyday clinical practice conditions. Hence, the aim of this study is to evaluate the effectiveness and safety of fingolimod after 12 months' usage in clinical practice in Galicia. PATIENTS AND METHODS: We conducted a retrospective, multi-centre study (n = 8) of patients with RRMS who were treated with one or more doses of fingolimod, 0.5 mg/day. Effectiveness was assessed -annualised relapse rate (ARR), changes in the score on the Expanded Disability Status Scale (EDSS), percentage of patients free from relapses, free from progression of disability and free from activity in resonance- for the total number of patients and according to previous treatment. Safety was assessed based on the percentage of patients who withdrew and presented adverse side effects. RESULTS: After 12 months' use, fingolimod reduced the ARR by 87% (1.7 to 0.23; p < 0.0001) and, consequently, 81% of patients were free from relapses. The score was reduced by 9%. In all, 91% of patients were free from progression of disability and 72% were free from resonance activity. No signs of disease activity were found in 43% of the PATIENTS: Most of the benefits of fingolimod differed depending on previous treatment. About a third of the patients reported adverse side effects, but only 2% of them withdrew for this reason. CONCLUSIONS: In clinical practice, most of the results on the effectiveness of the clinical trials conducted with fingolimod were observed during the first 12 months of treatment. A better safety profile was observed than that reported in the clinical trials (AU)

Manejo de las complicaciones relacionadas con la infusión intraduodenal de levodopa/carbidopa en pacientes con enfermedad de Parkinson / Management of complications related to intraduodenal infusion of levodopa/carbidopa in patients with Parkinson’s disease

La infusión continua de levodopa/carbidopa intraduodenal es un tratamiento eficaz que mejora las complicaciones motoras y la calidad de vida de los pacientes con enfermedad de Parkinson avanzada. Sin embargo, no está exento de complicaciones. Éstas pueden presentarse en el postoperatorio de la cirugía (gastrostomía) o a largo plazo durante el seguimiento, y pueden estar relacionadas con la medicación (levodopa/carbidopa), el estoma, la gastrostomía o el dispositivo (bomba, sonda enteral, piezas del sistema FREKA). El objetivo de la presente revisión es describir el manejo de las complicaciones que pueden presentar los pacientes con enfermedad de Parkinson avanzada tratados con infusión continua de levodopa/carbidopa intraduodenal (AU)

Continuous infusion of intraduodenal levodopa/carbidopa is an effective treatment that improves the motor complications and the quality of life of patients in the advanced stages of Parkinson’s disease. However, it is not free of complications. These may present in the post-operative period following surgery (gastrostomy) or in the long-term during the follow-up period and can be related with the medication (levodopa/carbidopa), the stoma, the gastrostomy or the device (pump, enteral tube, parts of the FREKA system). The aim of this review is to report on the management of the complications that can be observed in patients with advanced Parkinson’s disease treated with continuous infusion of intraduodenal levodopa/carbidopa (AU)

[Management of complications related to intraduodenal infusion of levodopa/carbidopa in patients with Parkinson's disease]. / Manejo de las complicaciones relacionadas con la infusion intraduodenal de levodopa/carbidopa en pacientes con enfermedad de Parkinson.

Continuous infusion of intraduodenal levodopa/carbidopa is an effective treatment that improves the motor complications and the quality of life of patients in the advanced stages of Parkinson's disease. However, it is not free of complications. These may present in the post-operative period following surgery (gastrostomy) or in the long-term during the follow-up period and can be related with the medication (levodopa/carbidopa), the stoma, the gastrostomy or the device (pump, enteral tube, parts of the FREKA system). The aim of this review is to report on the management of the complications that can be observed in patients with advanced Parkinson's disease treated with continuous infusion of intraduodenal levodopa/carbidopa.

TITLE: Manejo de las complicaciones relacionadas con la infusion intraduodenal de levodopa/carbidopa en pacientes con enfermedad de Parkinson.La infusion continua de levodopa/carbidopa intraduodenal es un tratamiento eficaz que mejora las complicaciones motoras y la calidad de vida de los pacientes con enfermedad de Parkinson avanzada. Sin embargo, no esta exento de complicaciones. Estas pueden presentarse en el postoperatorio de la cirugia (gastrostomia) o a largo plazo durante el seguimiento, y pueden estar relacionadas con la medicacion (levodopa/carbidopa), el estoma, la gastrostomia o el dispositivo (bomba, sonda enteral, piezas del sistema FREKA). El objetivo de la presente revision es describir el manejo de las complicaciones que pueden presentar los pacientes con enfermedad de Parkinson avanzada tratados con infusion continua de levodopa/carbidopa intraduodenal.

Dolor en la enfermedad de Parkinson: prevalencia, características, factores asociados y relación con otros síntomas no motores, calidad de vida, autonomía y sobrecarga del cuidador / Pain in Parkinson’s disease: prevalence, characteristics, associated factors, and relation with other non motor symptoms, quality of life, autonomy, and caregiver burden

Introducción. El dolor es un síntoma no motor muy frecuente en la enfermedad de Parkinson (EP), aunque infravalorado. Analizamos la prevalencia del dolor, características, factores asociados y su repercusión sobre la calidad de vida y autonomía del paciente en una serie consecutiva de pacientes con EP. Pacientes y métodos. El diagnóstico de dolor se realizó de acuerdo con la International Association for the Study of Pain. Efectuamos una entrevista estructurada y utilizamos el Brief Pain Inventory y el Medical Outcome Study 36-Item Short Form. Resultados. De un total de 159 pacientes incluidos (edad media: 72,31 ± 8,83 años; 51,3% mujeres), 115 (72,3%) presentaban dolor. De éstos, el 51,3% presentaba dolor antes del diagnóstico de EP y un 27,8% más de un tipo de dolor, siendo los más frecuentes el musculoesquelético (74,8%) y el radicular-neuropático (24,3%). En el 53%, el dolor se clasificó como relacionado con la EP. Un 37,4% no recibía ningún tratamiento para el dolor. La presencia de sintomatología depresiva se mostró como un predictor independiente de dolor (odds ratio = 7,82; intervalo de confianza al 95%, IC 95% = 1,151- 53,183; p = 0,035). El dolor se mostró como un predictor independiente de peor calidad de vida (Parkinson’s Disease Questionnaire-39; coeficiente de regresión: 25,53; error estándar: 11,852; IC 95% = 1,48-49,57; p = 0,03) y menor autonomía(escala de actividades de la vida diaria de Schwab y England; coeficiente de regresión: –13,85; error estándar: 6,327; IC 95% = –26,58 a –1,2; p = 0,034). Conclusiones. El dolor es un síntoma no motor muy frecuente en la EP, que se asocia a la presencia de depresión, y que predice una peor calidad de vida y autonomía por parte del paciente (AU)

Introduction. Pain is one of the most common non motor symptoms in patients with Parkinson’s disease (PD). However, it is underrecognized. We examine the prevalence of pain, characteristics, associated factors, and relation with quality of life and autonomy in a consecutive series of PD patients. Patients and methods. Pain was identified according to International Association for the Study of Pain. Brief Pain Inventory and Medical Outcomes Study 36-Item Short Form were used. Results. Of the 159 patients (72.31 ± 8.83 years; 51.3% female), 115 (72.3%) presented pain. Of these, 51.3% reported pain onset before PD-diagnosis, 27.8% two or more pain types, and 53% PD-related pain. Musculoskeletal (74.8%) andradicular-neuropathic (24.3%) were the types of pain most frequent. The 37.4% of the patients with pain did not received analgesic treatment. Depression was an independent predictor of pain (OR = 7.82; 95% CI = 1.151-53.183; p = 0.035).Pain was an independent predictor of worst quality of life (PDQ-39; regression coefficient: 25.53; standard error: 11.852; 95% CI = 1.48-49.57; p = 0.03) and lower autonomy (Schwab & England; regression coefficient: –13.85; standard error: 6.327; 95% CI = –26.58 to –1.2; p = 0.034). Conclusions. Pain is very frequent in PD patients. It is associated with depression, and predicts a worst quality of life and lower autonomy for the patient (AU)

[Pain in Parkinson's disease: prevalence, characteristics, associated factors, and relation with other non motor symptoms, quality of life, autonomy, and caregiver burden]. / Dolor en la enfermedad de Parkinson: prevalencia, características, factores asociados y relación con otros síntomas no motores, calidad de vida, autonomía y sobrecarga del cuidador.

INTRODUCTION: Pain is one of the most common non motor symptoms in patients with Parkinson's disease (PD). However, it is underrecognized. We examine the prevalence of pain, characteristics, associated factors, and relation with quality of life and autonomy in a consecutive series of PD patients. PATIENTS AND METHODS: Pain was identified according to International Association for the Study of Pain. Brief Pain Inventory and Medical Outcomes Study 36-Item Short Form were used. RESULTS: Of the 159 patients (72.31 ± 8.83 years; 51.3% female), 115 (72.3%) presented pain. Of these, 51.3% reported pain onset before PD-diagnosis, 27.8% two or more pain types, and 53% PD-related pain. Musculoskeletal (74.8%) and radicular-neuropathic (24.3%) were the types of pain most frequent. The 37.4% of the patients with pain did not received analgesic treatment. Depression was an independent predictor of pain (OR = 7.82; 95% CI = 1.151-53.183; p = 0.035). Pain was an independent predictor of worst quality of life (PDQ-39; regression coefficient: 25.53; standard error: 11.852; 95% CI = 1.48-49.57; p = 0.03) and lower autonomy (Schwab and England; regression coefficient: -13.85; standard error: 6.327; 95% CI = -26.58 to -1.2; p = 0.034). CONCLUSIONS: Pain is very frequent in PD patients. It is associated with depression, and predicts a worst quality of life and lower autonomy for the patient.