[Effectiveness on adherence to biological drugs and experience of a pharmaceutical intervention based on CMO model in patients with rheumatic disease (AdhER-2 study)].

BACKGROUND: We aimed to assess the effectiveness on adherence to treatment with biologic disease modifying anti-rheumatic drugs (b-DMARD) and experience with providers of healthcare of a CMO pharmaceutical intervention care model in subjects with rheu-matoid arthritis, psoriatic arthritis, and ankylosing spondylitis stratified according to their needs. METHOD: Prospective, single-centre randomized controlled study. The study period was eleven months. Non-compliant patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondy-litis treated with b-DMARD were included. Patients were randomized to a control (CG) or intervention group (IG) who received regular or the CMO pharmaceutical intervention model treatment, respec-tively. Baseline and final adherence were determined using medication possession ratio, the Compliance Questionnaire on Rheu-matology, and Morisky Medication Adherence Scale. To assess baseline and final patient experience with providers of healthcare we applied the Chronic Patient Experience Assessment Instrument (IEXPAC). RESULTS: For the IG, one patient (5.6%) was categorized as priority 1, nine (50.0%) as priority 2, and eight (44.4%) as priority 3. Ninety pharmaceutical interventions were carried out (5.1±1.8 interventions / patient). At the end of the study, the IG showed higher fre-quency of patients who adhered to the pharmaceutical intervention (77.8 vs 18.8%; p=0.002) and higher mean IEXPAC score (7.6±1.3 vs 5.8±1.1; p <0.001) in comparison to the CG. Conclusion The CMO pharmaceutical intervention model significantly improves patient adherence to b-DMARD and their experience with the providers of healthcare.

Eficacia de una intervención farmacéutica basada en el modelo CMO sobre la adherencia a fármacos biológicos y la experiencia del pacientecon enfermedad reumática (Estudio ADhER-2) / Effectiveness on adherence to biological drugs and experience of a pharmaceutical intervention based on CMO model in patients with rheumatic disease (AdhER-2 study)

Fundamento: Analizar la eficacia de una intervención farmacéutica basada en el modelo CMO sobre la adherencia a fármacos biológicos modificadores de la enfermedad (FAME-b) y sobre la experiencia con los profesionales y servicios sanitarios de pacientescon artritis reumatoide, artritis psoriásica y espondilitis anquilosante estratificados según sus necesidades de atención. Material y métodos: Estudio experimental prospectivo, unicéntrico y controlado de once meses de duración. Se incluyeron pacientes con artritis reumatoide, artritis psoriásica y espondilitis anquilosante no adherentes a FAME-b. Se aleatorizaron en grupo control (GC) e intervención (GI), que recibieron atención farmacéutica habitual o basada en CMO, respectivamente. La adherencia basaly final se calculó mediante la ratio media de posesión de medicamentos y las puntuaciones obtenidas en Compliance Questionnaire on Rheumatology y en Morisky Medication Adherence Scale. Para valorar la experiencia basal y final de los pacientes con los profesionales y servicios sanitarios se utilizó el instrumento de Evaluaciónde la Experiencia del Paciente Crónico (IEXPAC). Resultados: En el GI (n=18), solo un paciente fue estratificado como prioridad 1 (5,6%), nueve se estratificaron como prioridad2 (50,0%) y ocho como prioridad 3 (44,4%). Se realizaron 90 intervenciones farmacéuticas (5,1±1,8 intervenciones por paciente). Al finalizar el estudio, el GI mostró respecto del GC más pacientes adherentes (77,8 vs 18,8%; p=0,002) y mayor puntuación IEXPAC (7,6±1,3 vs 5,8±1,1; p <0,001). Conclusiones: La intervención farmacéutica basada en el modelo CMO mejoró significativamente la adherencia a FAME-b y la experiencia de los pacientes con los profesionales y el sistema sanitario.(AU)

Background: We aimed to assess the effectiveness on adherence to treatment with biologic disease modifying antirheumatic drugs (b-DMARD) and experience with providers of healthcare of a CMO pharmaceutical intervention care model in subjects with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis stratified according to their needs. Method: Prospective, single centre randomized controlled study. The study period was eleven months. Non compliant patients withrheumatoid arthritis, psoriatic arthritis, and ankylosing spondy litis treated with b-DMARD were included. Patients were randomized to a control (CG) or intervention group (IG) who receivedregular or the CMO pharmaceutical intervention model treatment, respectively. Baseline and final adherence were determined using medication possession ratio, the Compliance Questionnaire onRheumatology, and Morisky Medication Adherence Scale. To assess baseline and final patient experience with providers of healthcare we applied the Chronic Patient Experience Assessment Instrument (IEXPAC). Results: For the IG, one patient (5.6%) was categorized as priority1, nine (50.0%) as priority 2, and eight (44.4%) as priority 3. Ninety pharmaceutical interventions were carried out (5.1±1.8 interventions / patient). At the end of the study, the IG showed higherfrequency of patients who adhered to the pharmaceutical intervention (77.8 vs 18.8%; p=0.002) and higher mean IEXPAC score (7.6±1.3 vs 5.8±1.1; p <0.001) in comparison to the CG. Conclusion: The CMO pharmaceutical intervention model significantly improves patient adherence to b-DMARD and their experience with the providers of healthcare.(AU)

Experiencia clínica con erenumab durante el primer año de tratamiento / Clinical experience with erenumab during the first year of treatment

Introducción: El erenumab, un antagonista del péptido relacionado con el gen de la calcitonina, ha sido autorizado para la profilaxis de la migraña. Se presenta como una alternativa para pacientes con múltiples fracasos terapéuticos, los cuales presentan baja calidad de vida y alta discapacidad asociada.Objetivo: Analizar la efectividad y la seguridad del erenumab durante el primer año de tratamiento y evaluar su impacto en la calidad de vida y la discapacidad. Pacientes y métodos: Estudio observacional prospectivo longitudinal realizado durante 15 meses. Se incluyó a los pacientes que cumplían los criterios de financiación del erenumab. Se recogieron años de enfermedad, días de migraña/mes, intensidad del dolor, tratamientos previos, dosis y efectos adversos. Además, se evaluaron la calidad de vida y la discapacidad mediante los cuestionarios Migraine-Specific Quality Of Life Questionnaire 2.1 y Migraine Disability Assessment Scale, que se repitieron a los tres y a los 12 meses. Resultados:Se incluyó a 43 pacientes, el 79,1% mujeres, el 95,3% con migraña crónica y con una edad media de 48,2 años. Previamente al erenumab presentaban 20 días de migraña/mes, intensidad de dolor 8,2, un 30,6% de calidad de vida y el 72,5% tenía discapacidad muy grave. Quince pacientes suspendieron el erenumab por ineficacia y uno por intolerancia. Trece recibieron erenumab durante un año y 14 continuaban en tratamiento. Las cuatro variables de efectividad mejoraron significativamente con el erenumab al tercer mes. Quince pacientes (34,9%) presentaron efectos adversos, en su mayoría leves. El estreñimiento fue el más frecuente. Conclusiones: El erenumab mostró efectividad en la mayoría de los pacientes para profilaxis de migraña en los tres primeros meses, reduciendo significativamente los días de migraña/mes, la intensidad del dolor y la discapacidad asociada. Además, mejoró significativamente la calidad de vida. Es un fármaco seguro.(AU)

Introduction: Erenumab, a calcitonin gene-related peptide antagonist, has been approved for migraine prophylaxis. It represents an alternative for patients with multiple treatment failures, who have a low quality of life and high associated disability. Aim: To analyse the effectiveness and safety of erenumab during the first year of treatment and to assess its impact on quality of life and disability. Patients and methods. It is a longitudinal prospective observational study conducted over 15 months. Patients who met the funding criteria for erenumab were included. Data concerning years of illness, migraine days/month, pain intensity, previous treatments, doses and adverse effects were collected. In addition, quality of life and disability were assessed using the Migraine-Specific Quality Of Life Questionnaire 2.1 and Migraine Disability Assessment Scale, repeated at three and 12 months. Results: Forty-three patients were included, 79.1% female, 95.3% with chronic migraine and with a mean age of 48.2 years. Prior to erenumab they had 20 migraine days/month, a pain intensity of 8.2 and a 30.6% quality of life, and 72.5% had very severe disability. Fifteen patients stopped taking erenumab due to inefficacy and one due to intolerance. Thirteen received erenumab for one year and 14 continued with the treatment. All four effectiveness variables were significantly improved with erenumab by the third month. Fifteen patients (34.9%) had adverse effects, most of which were mild. Constipation was the most frequent. Conclusions: Erenumab proved effective in most patients for migraine prophylaxis in the first three months, significantly reducing the number of migraine days/month, pain intensity and associated disability. Moreover, it significantly improved their quality of life . It is a safe drug.(AU)

[Clinical experience with erenumab during the first year of treatment]. / Experiencia clínica con erenumab durante el primer año de tratamiento.

INTRODUCTION: Erenumab, a calcitonin gene-related peptide antagonist, has been approved for migraine prophylaxis. It represents an alternative for patients with multiple treatment failures, who have a low quality of life and high associated disability. AIM: To analyse the effectiveness and safety of erenumab during the first year of treatment and to assess its impact on quality of life and disability. PATIENTS AND METHODS: It is a longitudinal prospective observational study conducted over 15 months. Patients who met the funding criteria for erenumab were included. Data concerning years of illness, migraine days/month, pain intensity, previous treatments, doses and adverse effects were collected. In addition, quality of life and disability were assessed using the Migraine-Specific Quality Of Life Questionnaire 2.1 and Migraine Disability Assessment Scale, repeated at three and 12 months. RESULTS: Forty-three patients were included, 79.1% female, 95.3% with chronic migraine and with a mean age of 48.2 years. Prior to erenumab they had 20 migraine days/month, a pain intensity of 8.2 and a 30.6% quality of life, and 72.5% had very severe disability. Fifteen patients stopped taking erenumab due to inefficacy and one due to intolerance. Thirteen received erenumab for one year and 14 continued with the treatment. All four effectiveness variables were significantly improved with erenumab by the third month. Fifteen patients (34.9%) had adverse effects, most of which were mild. Constipation was the most frequent. CONCLUSIONS: Erenumab proved effective in most patients for migraine prophylaxis in the first three months, significantly reducing the number of migraine days/month, pain intensity and associated disability. Moreover, it significantly improved their quality of life . It is a safe drug.

TITLE: Experiencia clínica con erenumab durante el primer año de tratamiento.Introducción. El erenumab, un antagonista del péptido relacionado con el gen de la calcitonina, ha sido autorizado para la profilaxis de la migraña. Se presenta como una alternativa para pacientes con múltiples fracasos terapéuticos, los cuales presentan baja calidad de vida y alta discapacidad asociada. Objetivo. Analizar la efectividad y la seguridad del erenumab durante el primer año de tratamiento y evaluar su impacto en la calidad de vida y la discapacidad. Pacientes y métodos. Estudio observacional prospectivo longitudinal realizado durante 15 meses. Se incluyó a los pacientes que cumplían los criterios de financiación del erenumab. Se recogieron años de enfermedad, días de migraña/mes, intensidad del dolor, tratamientos previos, dosis y efectos adversos. Además, se evaluaron la calidad de vida y la discapacidad mediante los cuestionarios Migraine-Specific Quality Of Life Questionnaire 2.1 y Migraine Disability Assessment Scale, que se repitieron a los tres y a los 12 meses. Resultados. Se incluyó a 43 pacientes, el 79,1% mujeres, el 95,3% con migraña crónica y con una edad media de 48,2 años. Previamente al erenumab presentaban 20 días de migraña/mes, intensidad de dolor 8,2, un 30,6% de calidad de vida y el 72,5% tenía discapacidad muy grave. Quince pacientes suspendieron el erenumab por ineficacia y uno por intolerancia. Trece recibieron erenumab durante un año y 14 continuaban en tratamiento. Las cuatro variables de efectividad mejoraron significativamente con el erenumab al tercer mes. Quince pacientes (34,9%) presentaron efectos adversos, en su mayoría leves. El estreñimiento fue el más frecuente. Conclusiones. El erenumab mostró efectividad en la mayoría de los pacientes para profilaxis de migraña en los tres primeros meses, reduciendo significativamente los días de migraña/mes, la intensidad del dolor y la discapacidad asociada. Además, mejoró significativamente la calidad de vida. Es un fármaco seguro.