Not the same, but is it the same? Cycling of biologic agents in rheumatoid arthritis. Experience in the Instituto Mexicano del Seguro Social.

INTRODUCTION: Available data for biocomparable drugs are not enough to make clear decisions with respect to the potential consequences of a change for non-medical reasons in efficacy, security and inmunogenicity in patients. In the near future, options on biological treatments, biocomparable drugs, non biocomparable drugs and new chemical synthesis options will grow. Therefore, it is important to know how patients behave in persistence of treatment after a change for non- medical reasons, which already happens on a regular basis in social security institutions in Mexico. This information will help us to better understand the standard of treatment for patients with chronic immunomediated conditions. OBJECTIVE: The primary objective was to measure the impact of change for non-medical reasons in patients with rheumatoid arthritis (RA) treated with an innovative biological on persistence of treatment after changing to a biocomparable drug or a non-biocomparable drug, compared with those patients staying with the innovative biological. STUDY DESIGN: This is an observational study (non-interventionist) of paired cohorts, where an historic cohort obtained by review of clinical records of stable patients in which no modifications to treatment were made for at least six months is compared with two cohorts of patients whose treatments were switched to another treatment with the same therapeutic mechanism for-non-medical reasons (cycling). RESULTS: We included 264 RA patients (ACR/EULAR, 2010); 132 were switched for non-medical reasons, and 132 were not switched. Two-hundred and thirty (87.1%) were female. Average age was 53.9 years, ranging from 16 to 84 years. Two-hundred and sixty-three patients were Latino (99.6%); one was Caucasian. Persistence of treatment 12 months after the change was 84.8% (85.8% in Enbrel/Infinitam, 78.9% for Remicade/Remsima). No statistical difference was found with respect to RA clinical activity measured by DAS28 12 months after the switch (P > .05). In the 134 switched patients, 20 discontinued the new treatment due to lack of efficacy of the new drug and were changed to a different drug with a different biologic target. Although no differences were found in the cohorts of switched patients with respect to DAS 28 after 12 months of use, we did find differences in the frequency of adverse events. Forty-two patients had an adverse event in the drug switch cohorts: 33 in the Enbrel-Infinitam group and 9 in the Remicade-Remsima group. CONCLUSIONS: The persistence of treatment after switching from an innovative drug to a biocomparable or a non- biocomparable in RA patients did not show statistically significative differences in our cohorts, but we did find a higher number of adverse events when comparing those who were changed with those who continued on an innovative drug. Twenty patients in the switch groups had to receive a new drug with a different biological target due to lack of efficacy of the switched drug.

Not the same, but ¿is it the same? Cycling of biologic agents in rheumatoid arthritis. Experience in the Instituto Mexicano del Seguro Social. / No es el mismo pero ¿es igual? Cycling de agentes biológicos en artritis reumatoide. Experiencia en el Instituto Mexicano del Seguro Social.

INTRODUCTION: Available data for biocomparable drugs are not enough to make clear decisions with respect to the potential consequences of a change for non-medical reasons in efficacy, security and inmunogenicity in patients. In the near future, options on biological treatments, biocomparable drugs, non biocomparable drugs and new chemical synthesis options will grow. Therefore, it is important to know how patients behave in persistence of treatment after a change for non-medical reasons, which already happens on a regular basis in social security institutions in Mexico. This information will help us to better understand the standard of treatment for patients with chronic immunomediated conditions. OBJECTIVE: The primary objective was to measure the impact of change for non-medical reasons in patients with rheumatoid arthritis (RA) treated with an innovative biological on persistence of treatment after changing to a biocomparable drug or a non-biocomparable drug, compared with those patients staying with the innovative biological. STUDY DESIGN: This is an observational study (non-interventionist) of paired cohorts, where an historic cohort obtained by review of clinical records of stable patients in which no modifications to treatment were made for at least six months is compared with two cohorts of patients whose treatments were switched to another treatment with the same therapeutic mechanism for-non-medical reasons (cycling). RESULTS: We included 264 RA patients (ACR/EULAR, 2010); 132 were switched for non-medical reasons, and 132 were not switched. Two-hundred and thirty (87.1%) were female. Average age was 53.9years, ranging from 16 to 84years. Two-hundred and sixty-three patients were Latino (99.6%); one was Caucasian. Persistence of treatment 12months after the change was 84.8% (85.8% in Enbrel/Infinitam, 78.9% for Remicade/Remsima). No statistical difference was found with respect to RA clinical activity measured by DAS28 12months after the switch (P>.05). In the 134 switched patients, 20 discontinued the new treatment due to lack of efficacy of the new drug and were changed to a different drug with a different biologic target. Although no differences were found in the cohorts of switched patients with respect to DAS28 after 12months of use, we did find differences in the frequency of adverse events. Forty-two patients had an adverse event in the drug switch cohorts: 33 in the Enbrel-Infinitam group and 9 in the Remicade-Remsima group. CONCLUSIONS: The persistence of treatment after switching from an innovative drug to a biocomparable or a non-biocomparable in RA patients did not show statistically significative differences in our cohorts, but we did find a higher number of adverse events when comparing those who were changed with those who continued on an innovative drug. Twenty patients in the switch groups had to receive a new drug with a different biological target due to lack of efficacy of the switched drug.

Update of the Mexican College of Rheumatology Guidelines for the Pharmacological Treatment of Rheumatoid Arthritis, 2018. / Actualización de las guías del tratamiento farmacológico de la artritis reumatoide del Colegio Mexicano de Reumatología 2018.

Therapeutic advances in rheumatoid arthritis require periodic review of treatment guidelines. OBJECTIVE: To update the Mexican College of Rheumatology guidelines on the pharmacological treatment of rheumatoid arthritis. METHOD: Board certified rheumatologists from different health institutions and regions of the country participated. Work teams were formed that reviewed the previous guidelines, elaborated new questions, reviewed the literature, and scored the evidence that was presented and discussed in plenary session. The conclusions were presented to infectologists, gynaecologists and patients. Recommendations were based on levels of evidence according to GRADE methodology. RESULTS: Updated recommendations on the use of available medications for rheumatoid arthritis treatment in Mexico up to 2017 are presented. The importance of adequate and sustained control of the disease is emphasized and relevant safety aspects are described. Bioethical conflicts are included, and government action is invited to strengthen correct treatment of the disease. CONCLUSIONS: The updated recommendations of the Mexican College of Rheumatology on the pharmacological treatment of rheumatoid arthritis incorporate the best available information to be used in the Mexican health care system.

No es el mismo pero ¿es igual? Cycling de agentes biológicos en artritis reumatoide. Experiencia en el Instituto Mexicano del Seguro Social / Not the same, but is it the same? Cycling of biologic agents in rheumatoid arthritis. Experience in the Instituto Mexicano del Seguro Social

Introducción: Los datos disponibles para los biocomparables comercializados actualmente no son concluyentes con respecto al potencial impacto del cambio por razones no médicas sobre la eficacia, la seguridad y la inmunogenicidad en los pacientes. En el futuro se expandirán las opciones de tratamiento biológico, biocomparable, no bio-comparables y otros de síntesis química, por lo que es importante conocer cómo se comporta la persistencia al tratamiento tras un cambio por razón no médica, que ya ocurre como un hecho habitual en los servicios médicos de seguridad social en México, ya que esto nos ayudará a entender los mejores estándares de tratamiento para pacientes con enfermedades inmunomediadas crónicas. Objetivos: El objetivo primario fue evaluar el impacto del cambio por razón no médica en pacientes con artritis reumatoide (AR) estables tratados con biológico innovador sobre la persistencia en el tratamiento, después de cambiar a un biocomparable o a un no biocomparable, en relación con los pacientes que continúan con el biológico innovador. Diseño del estudio: Estudio observacional (no intervencionista) de cohortes emparejado donde se comparó una cohorte histórica obtenida por la revisión de historias médicas de pacientes estables que no fueron cambiados de tratamiento por al menos 6meses, con dos cohortes de pacientes que fueron cambiados de tratamiento por razones no médicas a otro fármaco con la misma diana terapéutica (cycling). Resultados: Se incluyeron 264 pacientes con diagnóstico de AR (ACR/EULAR, 2010): 132 pacientes que fueron cambiados de tratamiento por razones no médicas por un fármaco de mecanismo similar de acción y 132 pacientes que no fueron cambiados de tratamiento. De los 264 pacientes participantes en el estudio, 230 pacientes (87,1%) corresponden al sexo femenino. El promedio de edad fue de 53,9años, la edad mínima 16años y la máxima 84 años. (AU)

Introduction: Available data for biocomparable drugs are not enough to make clear decisions with respect to the potential consequences of a change for non-medical reasons in efficacy, security and inmunogenicity in patients. In the near future, options on biological treatments, biocomparable drugs, non biocomparable drugs and new chemical synthesis options will grow. Therefore, it is important to know how patients behave in persistence of treatment after a change for non-medical reasons, which already happens on a regular basis in social security institutions in Mexico. This information will help us to better understand the standard of treatment for patients with chronic immunomediated conditions. Objective: The primary objective was to measure the impact of change for non-medical reasons in patients with rheumatoid arthritis (RA) treated with an innovative biological on persistence of treatment after changing to a biocomparable drug or a non-biocomparable drug, compared with those patients staying with the innovative biological. Study design: This is an observational study (non-interventionist) of paired cohorts, where an historic cohort obtained by review of clinical records of stable patients in which no modifications to treatment were made for at least six months is compared with two cohorts of patients whose treatments were switched to another treatment with the same therapeutic mechanism for-non-medical reasons (cycling). Results: We included 264 RA patients (ACR/EULAR, 2010); 132 were switched for non-medical reasons, and 132 were not switched. Two-hundred and thirty (87.1%) were female. Average age was 53.9years, ranging from 16 to 84years. Two-hundred and sixty-three patients were Latino (99.6%); one was Caucasian.(AU)

[Treatment with rituximab for thrombocytopenia due to systemic lupus erythematosus]. / Tratamiento con rituximab para la trombocitopenia secundaria a lupus eritematoso sistémico.

UNLABELLED: Some patients with thrombocytopenia due SLE fail to respond to conventional therapies. Rituximab has been reported to be an alternative for patient treatment. OBJECTIVE: To evaluate the response of thrombocytopenia due to Systemic Lupus Erythematosus to the use of Rituximab and patient relapse time at our hospital. PATIENTS AND METHODS: We analyzed patients with SLE than received a 2 gram rituximab treatment for thrombocytopenia. We analyzed the rate of patients that achieved complete remission (CR), defined as a platelet count over 100mil/mm(3), partial remission (PR) described as platelets within 50-100mil/mm(3) and no response (NR) if platelets remained unchanged and the time the remission was sustained. RESULTS: 16 treatments were applied to 13 patients, aged 28±9 years of age and SLE mean duration time of 68±44 months with a mean platelet count of 38±29mil. In 14 treatments (87%) remission was achieved after 5±2 weeks where 2 patients (12.5%) were non respondent. One of them died due to a massive hemorrhage. The mean response time without relapse was 15.6±6 months. Follow up of three patients was not possible and 3 other died due to infections. CONCLUSIONS: Rituximab is an alternative for treatment of thrombocytopenia due to Systemic Lupus Erythematosus.

Tratamiento con rituximab para la trombocitopenia secundaria a lupus eritematoso sistémico / Treatment with rituximab for thrombocytopenia due to systemic lupus erythematosus

En algunos casos la trombocitopenia secundaria a lupus eritematoso sistémico (LES) no responde al tratamiento convencional. En los últimos años se ha reportado que el rituximab es una alternativa para estos pacientes. Objetivo Evaluar la respuesta de la trombocitopenia (T) secundaria a LES con el uso de rituximab y determinar el tiempo que se mantiene el efecto libre de recaída. Material y métodos Se revisaron los expedientes de los pacientes con diagnóstico de LES con T que recibieron tratamiento con rituximab (2g) para conocer la proporción de pacientes que lograron remisión completa (RC): definida como una cuenta plaquetaria >100.000/mm3; remisión parcial (RP): cuenta plaquetaria entre 50.000 y 100.000/mm3 y los no respondedores (NR); así como el tiempo que se mantiene el paciente sin recaída. Resultados Se aplicaron 16 tratamientos en 13 pacientes, en una paciente 3 y en otra 2 ciclos. Fueron 12 mujeres y 1 hombre con edad media de 28±9 años y tiempo medio de duración del LES de 68±44 meses, con una cuenta media plaquetaria de 38.000±29.000. En 14 tratamientos (87%) se logró RC después de 5±2 semanas y 2 pacientes (12.5%) fueron NR. Una de ellas murió por hemorragia masiva. El tiempo medio de respuesta sin recaída fue de 15,6±6 meses. Tres pacientes perdieron el seguimiento y 3 murieron de infecciones. Conclusiones El rituximab es una alternativa de tratamiento en pacientes con T secundaria a LES (AU)

Some patients with thrombocytopenia due SLE fail to respond to conventional therapies. Rituximab has been reported to be an alternative for patient treatment. Objective To evaluate the response of thrombocytopenia due to Systemic Lupus Erythematosus to the use of Rituximab and patient relapse time at our hospital. Patients and methods We analyzed patients with SLE than received a 2 gram rituximab treatment for thrombocytopenia. We analyzed the rate of patients that achieved complete remission (CR), defined as a platelet count over 100mil/mm3, partial remission (PR) described as platelets within 50–100mil/mm3 and no response (NR) if platelets remained unchanged and the time the remission was sustained.Results16 treatments were applied to 13 patients, aged 28±9 years of age and SLE mean duration time of 68±44 months with a mean platelet count of 38±29mil. In 14 treatments (87%) remission was achieved after 5±2 weeks where 2 patients (12.5%) were non respondent. One of them died due to a massive hemorrhage. The mean response time without relapse was 15.6±6 months. Follow up of three patients was not possible and 3 other died due to infections. Conclusions Rituximab is an alternative for treatment of thrombocytopenia due to Systemic Lupus Erythematosus (AU)