Study of the Impact of Restrictions on Access to Biological Drugs for the Management of Psoriasis on the Minimum Disease Activity Criteria: Subanalysis of AEDV EQUIDAD and AME Projects. / Estudio del impacto de las restricciones en el acceso a fármacos biológicos en psoriasis sobre la actividad mínima de la enfermedad: subanálisis de los proyectos EQUIDAD y AME de la AEDV.

Spanish Autonomous Communities (ACs) are entitled to decide on the prescription requirements of their own territories, which can create inequalities in access to new drugs in the management of psoriasis. The objective of this study was to assess whether the level of restrictions in the access to new drugs for the management psoriasis was associated with the probability of achieving disease control measured using the Minimum Disease Activity (MDA) criteria. Therefore, we combined the results of 2 previous independent, cross-sectional studies: one that described the MDA in psoriasis by AC, and another that evaluated the level of restrictions to drug access by AC. We found that the higher the number of restrictions the lower the chances of achieving the MDA criteria (P=.013). Our results suggest that, in Spain, geographical differences in the access to new drugs may be creating health inequalities across the country.

Autoadministración domiciliaria de biológicos. Una encuesta de satisfacción en una unidad de asma grave en tiempo de pandemia por COVID-19 / Home self-administration of biologics. A satisfaction survey in a severe asthma unit during a COVID-19 pandemic

Objetivo: Evaluar las preferencias y satisfacción de los pacientes con asma grave, relacionadas con el lugar de administración de fármacos biológicos subcutáneos: hospital, centro de salud y domicilio, durante la pandemia COVID-19. Métodos: Estudio observacional, descriptivo y transversal que analizó, mediante una encuesta telefónica realizada del 23 al 27 de noviembre de 2020, las preferencias y el grado de satisfacción con la administración de fármacos biológicos subcutáneos en pacientes asmáticos atendidos en la consulta de Alergología de un Hospital General. Resultados: Respondieron la encuesta 33 pacientes, edad media 51,5 años, 57,6% mujeres. Un 57,6% de los pacientes se administraron los fármacos (omalizumab, mepolizumab y benralizumab) en su domicilio, 21,2% en el Hospital de Día y en el Centro de Salud, respectivamente. Los motivos para la administración fuera del hospital fueron la comodidad y evitar el contagio por virus SARS-CoV-2 (30,7%).Tras la pandemia, los pacientes preferían continuar con la dispensación y autoadministración domiciliaria del biológico y tener consultas médicas presenciales. El grado de satisfacción fue 9,7 (escala 0 a 10). Conclusiones: Los pacientes prefieren autoadministrarse en su domicilio los fármacos biológicos para el AG con el apoyo de la dispensación domiciliaria de éstos, mostrando un alto grado de satisfacción por la comodidad que les aporta. Finalizada la pandemia, demandan que las visitas médicas sean presenciales pero desean continuar autoadministrándose el fármaco tras su dispensación domiciliaria por el Servicio de Farmacia. (AU)

Objective: To assess preferences and satisfaction of patients with severe asthma about the place of administration of subcutaneous biological drugs: hospital, health center and home, during the COVID-19 pandemic. Methods: Observational, descriptive and cross-sectional study that analyzed, from November 23 to 27, 2020, through a telephone survey, the preferences and degree of satisfaction with the administration of subcutaneous biological drugs in asthmatic patients treated in the Allergology consultation of a General Hospital. Results: A total of 33 patients responded to the survey, the mean age was 51.5 years, 57.6% were women. The patients that received subcutaneous biological drugs (omalizumab, mepolizumab and benralizumab) at home were 57,6%, at the Day Hospital and at the Health Center 21,2 %, in both cases. The reasons for the administration outside the hospital were comfort and to avoid the spread of the SAR-CoV-2 virus (30.7%). After the pandemic, patients prefer home deliveries, self-administration and face-to-face medical consultations. The degree of satisfaction with the treatment was very high. Conclusions: Patients prefer to self-administer biological drugs for GA at home with the support of their home dispensing, showing a high degree of satisfaction with the comfort it provides. Once the pandemic is over, they demand that medical visits be face-to-face but they want to continue self-administering the drug after it is dispensed at home by the Pharmacy Service. (AU)

Very Rapid Improvement in Extended Nitric Oxide Parameters Is Associated With Clinical and Functional Improvement in Patients With Chronic Rhinosinusitis With Nasal Polyps Treated With Dupilumab

Background: Dupilumab, an anti–IL-4 receptor a monoclonal antibody, was recently approved for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) and moderate-to-severe asthma. Onset of its clinical effects is rapid. CRSwNP is characterized by extended type 2 inflammatory involvement that can be assessed using extended nitric oxide analysis. Objectives: We investigated whether dupilumab was associated with a rapid improvement in extended nitric oxide parameters, lung function, and clinical outcomes in patients with CRSwNP. Methods: Consecutive patients with CRSwNP and an indication for dupilumab were evaluated for extended nitric oxide analysis (exhaled, FeNO; bronchial, JawNO; alveolar, CalvNO; nasal, nNO) and lung function 15 and 30 days after initiation of treatment and for clinical outcomes (nasal polyps score [NPS], quality of life questionnaires, visual analog scale [VAS] for the main symptoms, and the Asthma Control Test [ACT]) 30 days after initiation of treatment. Results: We enrolled 33 patients. All extended nitric oxide and lung function parameters improved significantly after 15 days of treatment, remaining stable at 30 days. Scores on the NPS, VAS for the main CRSwNP symptoms, quality of life questionnaires, and the ACT improved significantly 30 days after initiation of treatment. Conclusions: Dupilumab is associated with very rapid improvement in type 2 inflammation in all airway areas. This is associated with improved lung function and clinical parameters in patients with CRSwNP. (AU)

Antecedentes: El dupilumab, un anticuerpo monoclonal anti-IL-4 receptor alfa, ha sido aprobado recientemente para el tratamiento de la rinosinusitis crónica con pólipos nasales (CRSwNP) y asma de moderada a grave, demostrando un inicio rápido de los efectos clínicos. La CRSwNP se caracteriza por un infiltrado extenso inflamatorio de tipo 2 que puede evaluarse mediante el análisis de óxido nítrico exhalado extendido. Objetivos: En este estudio, investigamos si dupilumab se asocia con una mejora rápida en los parámetros de óxido nítrico extendido, la función pulmonar y los resultados clínicos en pacientes con CRSwNP. Métodos: Se incluyeron pacientes consecutivos con CRSwNP e indicación para ser tratados con dupilumab y fueron evaluados mediante el análisis de óxido nítrico extendido (exhalado, FENO; bronquial, JawNO y alveolar, componentes CalvNO; nasal, nNO) y función pulmonar, 15 y 30 días después del inicio del tratamiento; y en el caso de las variables clínicas (puntuación del tamaño de los pólipos nasales [NPS]; cuestionarios de calidad de vida; escalas analógicas visuales [EVA] para los principales síntomas principales, prueba de control del asma [ACT]) solo después de 30 días de iniciado el tratamiento. Resultados: Se incluyeron 33 pacientes. Todos los parámetros del análisis extendido del óxido nítrico y la función pulmonar mejoraron significativamente después de 15 días de tratamiento, permaneciendo estables a los 30 días de tratamiento. El NPS, las EVA para los principales síntomas de CRSwNP, el cuestionario de calidad de vida y el ACT mejoraron significativamente después de 30 días de inicio del tratamiento. Conclusiones: En pacientes con CRSwNP, el tratamiento con dupilumab se asocia con una mejoría muy rápida en la inflamación tipo 2 en todos los compartimentos de las vías respiratorias y esto se asocia con una mejor función pulmonar y los parámetros clínicos. (AU)

Seguridad de los fármacos antirreumáticosmodificadores de la enfermedad biológicos en la artritis reumatoide / Safety of biological disease-modifying antirheumatic drugs in rheumatoid arthritis

Objetivo: Analizar la seguridad del tratamiento con fármacos biológicosmodificadores de la enfermedad prescritos con mayor frecuencia enpacientes con artritis reumatoide en la práctica clínica habitual.Método: Estudio observacional retrospectivo, a partir de la historia clínicadigitalizada de pacientes con artritis reumatoide de un hospital detercer nivel, sobre la seguridad de los fármacos biológicos modificadoresde la enfermedad, entre los años 2001 y 2013. Además de analizar lasreacciones adversas que motivaron la retirada del tratamiento, se hizoun análisis de desproporcionalidad comparando los órganos y sistemasimplicados en las reacciones adversas asociadas a los diferentes fármacosbiológicos modificadores de la enfermedad calculando la odds ratiocon un intervalo de confianza del 95% [odds ratio (IC95%)], del periodode latencia entre el inicio del tratamiento y el diagnóstico de los efectosadversos, y de su conocimiento previo.Resultados: Se analizaron las historias clínicas de 210 pacientes (73%mujeres; mediana de edad: 47 años), que incluían 399 líneas de tratamientocon algún fármaco biológico modificado de la enfermedad y 1.545reacciones adversas potencialmente relacionadas con ellos. Se identificóun incremento significativo de reacciones adversas en los siguientes órganosy sistemas afectados: trastornos generales y del lugar de administración[2,3 (1,3-4,0)] para infliximab; infecciones [1,6 (1,3‑2,1)] y trastornos delsistema inmunológico [4,2 (1,2-14,6)] para etanercept; trastornos hepatobiliares[2,1 (1,2-3,6)] para adalimumab; trastornos oculares [1,9 (1,2-3,1)]y cardiacos [2,9 (1,0-8,4)] para rituximab; trastornos de la sangre y del sistema linfático [2,9 (1,8-4,7)] para tocilizumab y abatacept [3,0 (1,6-5,8)].La latencia media osciló entre 5 y 33 meses.

Objective: The aim of this study was to assess the safety of the mostfrequently used biologic disease-modifying antirheumatic drugs in rheumatoidarthritis patients in clinical practice.Method: A retrospective longitudinal observational study was performed.Clinical information was obtained from the electronic health recordsof patients diagnosed and treated for rheumatoid arthritis, who hadreceived at least one biologic disease-modifying antirheumatic drug dispensedbetween 2001 and 2013 from a third-level Hospital pharmacy.Adverse reactions during biologic disease-modifying antirheumatic drugstreatments were analysed, as well as the reasons for treatment discontinuation.A disproportionality analysis (odds ratio with 95% confidenceinterval) was performed to compare adverse drug reactions related todifferent system organ classes, the period between the drug start dateand the reaction start date (latency period), and previous knowledge ofthe adverse reactions.Results: In total, 210 patients were included in the analysis (73% women,median age 47 years), with 399 prescriptions for biologic diseasemodifyingantirheumatic drugs and 1,515 adverse reactions potentiallyrelated to them. The increased frequency of adverse reactions for eachsystem organ class related to each biologic disease-modifying antirheumaticdrug was as follows: general disorders and administration sitedisturbances with infliximab (2.3 [1.3-4.0]), infections (1.6 [1.3-2.1]) andimmune system reactions with etanercept (4.2 [1.2-14.6]), hepatobiliarydisorders with adalimumab (2.1 [1.2-3.6]), ophthalmic adverse reactions (1.9 [1.2-3.1]) and cardiac disorders (2.9 [1.0-8.4]) with rituximab, andblood and lymphatic system disorders with tocilizumab (2.9 [1.8-4.7])and abatacept (3.0 [1.6-5.8)]. The mean latency period was 5 to 33months.

Psoriasis induced by biological therapy.

OBJECTIVE: To describe a multicentre case series of new onset or worsening of psoriasis in patients treated with biological drugs. MATERIAL AND METHODS: Descriptive study. We reviewed the clinical history of patients with chronic inflammatory disease (CID) treated with biological drugs, who developed new onset or worsening of psoriasis during the follow-up period. RESULTS: Twenty-six cases of paradoxical psoriasis (PP) were recorded. Ninety-three percent of the patients were treated with anti-TNFα and adalimumab was responsible for 50% of the cases. Only 5 patients had a personal history of psoriasis. The biological drug was discontinued in 13 patients. Lesion recurrence was more frequent when another anti-TNFα was reintroduced. CONCLUSIONS: The PP is a reversible adverse effect that can be observed in patients exposed to biological drugs, mainly anti-TNFα.

Psoriasis inducida por terapia biológica / Psoriasis Induced by Biological Therapy

Objetivo: Describir una serie multicéntrica de casos de inducción o empeoramiento de psoriasis en pacientes tratados con fármacos biológicos. Material y métodos: Estudio descriptivo. Se revisó la historia clínica de pacientes con enfermedad inflamatoria crónica (EIC) en tratamiento con fármacos biológicos, y que presentaron durante el período de seguimiento, psoriasis de nueva aparición o empeoramiento de la misma. Resultados: Se registraron 26 casos de psoriasis paradójica (PP). El 93% de los pacientes estaban en tratamiento con un anti-TNFα, siendo el adalimumab el responsable del 50% de los casos. Solo 5 pacientes presentaban antecedentes personales de psoriasis. En 13 pacientes fue necesario retirar el fármaco biológico y la recidiva de las lesiones fue más frecuente en los pacientes en los que se reintrodujo otro anti-TNFα. Conclusiones: La PP es un efecto adverso reversible que se puede observar en pacientes expuestos a fármacos biológicos, principalmente a anti-TNFα.(AU)

Objective: To describe a multicentre case series of new onset or worsening of psoriasis in patients treated with biological drugs. Material and methods: Descriptive study. We reviewed the clinical history of patients with chronic inflammatory disease (CID) treated with biological drugs, who developed new onset or worsening of psoriasis during the follow-up period. Results: Twenty-six cases of paradoxical psoriasis (PP) were recorded. Ninety-three percent of the patients were treated with anti-TNFα and adalimumab was responsible for 50% of the cases. Only 5 patients had a personal history of psoriasis. The biological drug was discontinued in 13 patients. Lesion recurrence was more frequent when another anti-TNFα was reintroduced. Conclusions: The PP is a reversible adverse effect that can be observed in patients exposed to biological drugs, mainly anti-TNFα.(AU)

Persistencia de tratamiento con antagonistas del factor de necrosis tumoral frente a antagonistas de interleucinas en psoriasis moderada-grave / Persistence of treatment with tumor necrosis factor antagonists versus interleukin antagonists in moderate-severe psoriasis

Objetivo: Evaluar y comparar el tiempo de persistencia y analizar los motivos de suspensión con fármacos antagonistas del factor de necrosis tumoral (anti-TNF) frente a antagonistas de interleucinas (anti-IL) en primera línea de tratamiento biológico en pacientes con psoriasis.Material y métodos: Estudio retrospectivo observacional realizado entre 01/2010 y 05/2019. Se incluyeron pacientes adultos diagnosticados de psoriasis moderada-grave en tratamiento con anti-TNF o anti-IL en primera línea de tratamiento biológico. Se estudiaron variables demográficas y relacionadas con el tratamiento, calculándose el tiempo de persistencia con el fármaco de estudio, así como las suspensiones de tratamiento. Resultados: Se incluyeron 94 pacientes (39 mujeres) con una media de 49 años (desviación estándar 13,0), 46 (48,9%) pacientes tratados con anti-TNF (35/46 adalimumab y 11/46 etanercept) y 48 (51,1%) pacientes tratados con anti-IL (26/48 secukinumab, 15/48 ustekinumab y 7/48 ixekizumab). El tiempo de persistencia en primera línea de tratamiento biológico fue de 18,4 (rango intercuartílico (RIQ) 22,2) meses, siendo 9,3 (RIQ 21,7) meses superior en los pacientes tratados con anti-IL (24,7 vs. 15,4 meses; p=0,002). A la finalización del seguimiento el 38,3% (36/94) de la población había interrumpido el tratamiento, debido a: falta de efectividad (34,8% (16/46) anti-TNF vs. 14,6% (7/48) anti-IL; p=0,003), eventos adversos (2,2% (1/46) anti-TNF) y otros motivos (17,4% (8/46) anti-TNF vs. 8,3% (4/48) con anti-IL; p>0,05). Conclusiones: El tiempo de persistencia en primera línea de tratamiento biológico fue de 18,4 meses, siendo significativamente superior en los pacientes tratados con anti-IL. El principal motivo de suspensión fue la falta de efectividad en ambos grupos de tratamiento. (AU)

Objective: To evaluate and compare the time of persistence and to analyse the discontinuation reasons with tumor necrosis factor antagonists (anti-TNF) vs. interleukin antagonists (anti-IL) as first line with biological treatments in patients with psoriasis. Material and methods: Retrospective observational study carried out between 01/2010 and 05/2019. Adult patients diagnosed with moderate to severe psoriasis in treatment with anti-TNF or anti-IL as first line with biological treatments were included. Demographic and treatment-related variables were studied, calculating the time of persistence with the study drug, as well as treatment discontinuations. Results: We included 94 patients (39 women) with a mean of 49 years (standard deviation 13.0), 46 (48.9%) patients treated with anti-TNF (35/46 adalimumab and 11/46 etanercept) and 48 (51.1%) patients treated with anti-IL (26/48 secukinumab, 15/48 ustekinumab and 7/48 ixekizumab). Persistence time with biological treatment in first line was 18.4 (interquartile range (IQR) 22.2) months, being 9.3 (IQR 21.7) months higher in patients treated with anti-IL (24.7 vs. 15.4 months; p=0.002). At the end of the follow-up, 38.3% (36/94) of the population had discontinued their treatments. The reasons for discontinuation were: lack of effectiveness (34.8% (16/46) anti-TNF vs. 14.6% (7/48) anti-IL; p=0.003), side effects (2.2% (1/46) anti-TNF) and other reasons (17.4% (8/46) anti-TNF vs. 8.3% (4/48) anti-IL; p>0.05). Conclusion: The persistence time with biological treatment in first line was 18.4 months, being significantly higher in the anti-IL group. The main reason of discontinuation was lack of effectiveness in both groups of treatment. (AU)

Psoriasis Induced by Biological Therapy. / Psoriasis inducida por terapia biológica.

OBJECTIVE: To describe a multicentre case series of new onset or worsening of psoriasis in patients treated with biological drugs. MATERIAL AND METHODS: Descriptive study. We reviewed the clinical history of patients with chronic inflammatory disease (CID) treated with biological drugs, who developed new onset or worsening of psoriasis during the follow-up period. RESULTS: Twenty-six cases of paradoxical psoriasis (PP) were recorded. Ninety-three percent of the patients were treated with anti-TNFα and adalimumab was responsible for 50% of the cases. Only 5 patients had a personal history of psoriasis. The biological drug was discontinued in 13 patients. Lesion recurrence was more frequent when another anti-TNFα was reintroduced. CONCLUSIONS: The PP is a reversible adverse effect that can be observed in patients exposed to biological drugs, mainly anti-TNFα.

Satisfaction, fulfillment of expectations and adherence to subcutaneous biological drugs in patients with rheumatoid arthritis: ARCO study. / Satisfacción, cumplimento de expectativas y adherencia al fármaco biológico subcutáneo en pacientes con artritis reumatoide. Estudio ARCO.

OBJECTIVES: In the ARCO study, adherence to subcutaneous biological agents by patients with rheumatoid arthritis improved with monthly administration. We assess whether adherence can be related to fulfillment of expectations and satisfaction with treatment. PATIENTS AND METHODS: Adherence was assessed by calculating the Medication Possession Ratio, and satisfaction and fulfillment of expectations using the «EXPRESAR¼ group questionnaire. RESULTS: In 346 patients, those who were satisfied/very satisfied with efficacy and tolerability were ≥80% and 64.4%, with no differences between weekly, biweekly or monthly administration regimens. Regarding the fulfillment of expectations, 59.9% considered the effect of the treatment greater than expected and 52.6% reported lower/much lower than expected discomfort; the latter percentage was higher in patients with monthly administration (P=.049). The percentages for nonadherence were 15.6% (discomfort greater than expected), 18.5% (expected discomfort) and 11.1% (lower than expected or no discomfort) (P=.189). CONCLUSIONS: Satisfaction and fulfillment of expectations were high. Fulfillment of expectations of tolerability was better with monthly administration, which could contribute to better adherence.

Complicaciones asociadas a tratamiento biológico en pacientes con artritis reumatoide: consideraciones en relación a un caso clínico / Associated complications with biological treatment in patients with rheumatoid arthritis: considerations in relation to a clinical case

La artritis reumatoide (AR) es una enfermedad inflamatoria sistémica de origen autoinmune, caracterizada por una evolución variable, con remisiones y reacti-vaciones. Se considera que un diagnóstico y tratamiento precoz permiten evitar el daño articular, mejorar el pronóstico y la calidad de vida del paciente. El trata-miento actual está basado en el uso de fármacos antirreumáticos sintéticos mo-dificadores de la enfermedad (sDMARDS), asociado a glucocorticoides en dosis bajas. Frente al fracaso o intolerancia de este tratamiento o bien en casos de una enfermedad inicial muy severa, en especial con manifestaciones extraarticulares, se recomienda el uso de fármacos biológicos modificadores de la enfermedad (bDMARD). Estos fármacos, usados en las condiciones señaladas, han significado un avance importante en el control y pronóstico de la enfermedad. Sin embargo, no están exentos de la presencia de reacciones adversas, por lo que deben ser monitorizados permanentemente.

Rheumatoid arthritis (RA) is a systemic inflammatory disease of autoimmune ori-gin, characterized by a variable evolution, with remissions and reactivations. It is considered that a diagnosis and early treatment allow avoiding the joint damage, improving the prognosis and the quality of life of the patient. The current treat-ment is based on the use of synthetic antirheumatic drugs modifying the disease (sDMARDS), associated with low-dose glucocorticoids. Faced with the failure or intolerance of this treatment or in cases of a very severe initial disease, especially with extra-articular manifestations, the use of biological drugs that modify the disease (bDMARD) is recommended. These drugs, used in the indicated condi-tions, have meant an important advance in the control and prognosis of the dis-ease. However, they are not exempt from the presence of adverse reactions, so they should be monitored permanently.

Resources used in the treatment of perianal Crohn's disease and the results in a real-life cohort. / Recursos empleados en el tratamiento de la enfermedad de Crohn perianal y sus resultados en una serie de vida real.

OBJECTIVE: To study the multidisciplinary management of patients with Crohn's disease (CD) and perianal disease (perianal Crohn's disease, PCD), as well as to analyse a possible relationship between the recurrence of perianal symptoms, the type of fistula and the treatment used. PATIENTS AND METHODS: Descriptive, retrospective study of patients with PCD who were treated in the Inflammatory Bowel Disease Unit. Epidemiological, clinical, diagnostic and therapeutic variables were collected, as well as clinical outcome and response to treatment. RESULTS: Of the 300 patients who attended the outpatient clinic at a university hospital, 65 had PCD. Sixteen simple fistulas (24.6%) and 49 complex fistulas (75.4%) were diagnosed. The most commonly used diagnostic technique was the endoanal ultrasound (45%). Antibiotics were used in 77.4% of patients, and 70% needed anti-TNF therapy to manage the PCD. Surgery was performed on 75.4% of the patients overall. PCD recurred in 41.5% of cases, requiring a change of the biological drugs administered and/or surgery. Complex fistulas were more likely to require surgery (P=.012) and recurrence of PCD was also more common with complex fistulas (P=.036). CONCLUSION: Management of PCD must be multidisciplinary and combined. Most patients with complex PCD require treatment based on biological drugs. Despite therapy, remission of perianal symptoms is not achieved in a percentage of patients, supporting the need to develop new therapies for refractory cases.

Therapeutic approach to Crohn disease: possible parallels with hidradenitis suppurativa. / Abordaje terapéutico de la enfermedad de Crohn: posibles paralelismos con la hidradenitis supurativa.

The current controversy in the setting of dermatology surrounding the treatment of inflammatory diseases, and specifically hidradenitis suppurativa, bears strong similarities with the debate concerning inflammatory bowel disease (IBD) that took place several years ago. That debate led to new perspectives on this disease and, in particular, its treatment after the development of biological agents.

Etanercept combined with systemic drugs or phototherapy for treatment of psoriasis.

Biologic drugs have provided excellent results in the treatment of moderate to severe psoriasis. Nevertheless, in routine clinical practice, combinations of biologic drugs with phototherapy or systemic drugs can increase efficacy, diminish toxicity, and reduce the cost of treatment. Published experience with these combinations is scarce, although the results are often satisfactory. This review examines the most relevant published experience in the combination of the most studied drug in this field-etanercept-with methotrexate, acitretin, ciclosporin, and narrowband UV-B phototherapy. Findings reported in the literature can help when taking major decisions on the management of biologic and systemic drugs in moderate to severe psoriasis.

How to compare biologic drugs.

This consensus document reviews the evidence on the evaluation of biological drugs. The main conclusions of the group are: a) the current evidence on biological comparisons is based on indirect comparisons and is generally unreliable and with important methodological limitations. Therefore, b) it is considered necessary to amend the regulatory directives in the sense of strongly favoring randomized non-inferiority studies comparing face to face the new biological treatment with current standards, avoiding trials versus placebo, c) A key element in this process will be determined by consensus among regulatory agencies, scientific societies, the pharmaceutical industry and health authorities regarding the clinical differences that should be considered relevant in each of the conditions tested.

Indústria farmacêutica: uma abordagem crítica / Pharmaceutical industry: a critical approach

JUSTIFICATIVA E OBJETIVOS: É feita uma abordagem crítica da indústria farmacêutica, no sentido de apontar o seu lado perverso.O objetivo foi analisar os ensaios clínicos e também a relação da indústria farmacêutica com os médicos e os pesquisadores. CONTEÚDO: Na área de Pesquisa & Desenvolvimento (P&D) é ressaltado que os ensaios clínicos são balizados pelos executivos dos laboratórios farmacêuticos e não pelos médicos-pesquisadores. É salientado que os custos de um novo fármaco são superestimados para justificar os preços abusivos para os usuários. A questão do marketing é analisada, com ênfase no poder de manipulação da indústria farmacêutica sobre a corporação médica e a sociedade. Na área das patentes de novos fármacos é abordada a sua longa duração e ainda que os laboratórios usam de muitos artifícios para prorrogá-las. O uso do placebo, nos ensaios clínicos, é enfocado dentro da ótica da legislação brasileira. Outras questões são levantadas, como o ingresso dos genéricos no mercado farmacêutico e a frustração da terapia gênica. CONCLUSÃO: Alguns aspectos são equacionados e algumas recomendações são feitas com o objetivo de corrigir ou minimizar as distorções apontadas.

BACKGROUND AND OBJECTIVES: A critical approach of pharmaceutical Industry is made, to show its dark side. This study intended to evaluate the clinical essays and also the relationship of pharmaceutical companies with the medical class and researchers. CONTENTS: In the area of research and development is pointed out that the clinical trials are controlled by the staff of pharmaceutical companies, not by the medical-researchers. The cost of innovation (a new drug) is overestimate to justify the overcharge to consumers. The marketing affair is analyzed and the power of manipulation of the pharmaceutical industry concerning the medical corporation and society is emphasize. The patents of new drugs have a very long duration and the companies use several artifices to extend them. The approach of placebo use in the trials is made according to Brazilian law. Other questions are analyzed as the entrance of generics in the market and the frustration of gene therapy. CONCLUSION: Some features are considered and some recommendations are made to correct or to reduce the distortions to point out.