[Adverse Reactions Related to the Administration of TNF Inhibitors. Analysis of a Registry of Biologic Therapy]. / Reacciones adversas relacionadas con la administración de inhibidores del TNF. Análisis de un registro de terapias biológicas.

OBJECTIVE: To estimate the frequency of administration related reactions (ARR), the risk window from the starting date, and finally if there are any differences between infliximab, etanercept and adalimumab. PATIENTS AND METHOD: BIOBADASER is an adverse events registry established in 2001 for active long-term follow-up of safety of biological therapies in rheumatic patients. Data from patients, diagnosis, treatment, and adverse events are recorded. RESULTS: Four-hundred ninety six relevant ARR were registered, 19.6% (496/2531) of all the adverse events communicated and 6.3% (496/2531) of all the patients registered. The incidence rate per 1000 patients-year with infliximab is 28 cases (95% CI, 25-31), with etanercept 0.2 (95% CI, 0.1-0.4) and with adalimumab 0.2 (95% CI, 0.07-0.7). Treatment was interrupted in more than 50% of all the ARR and 5% of all patients were hospitalized. More than 20% ARR happened after 15 months of treatment; in addition 2 appeared after 5 years of treatment. In delayed reactions the symptoms that most frequently were recorded were rash, fever, malaise, and myalgia. CONCLUSIONS: ARR can appear in any moment of the treatment; they are among the most frequent causes of treatment interruption. Although with less frequency, ARR are also associated with etanercept and adalimumab with symptoms that cannot be identified as such.

Risk of tuberculosis in patients treated with tumor necrosis factor antagonists due to incomplete prevention of reactivation of latent infection.

OBJECTIVE: To evaluate the causes of new cases of active tuberculosis (ATB) in patients treated with tumor necrosis factor (TNF) antagonists included in the national registry BIOBADASER (Base de Datos de Productos Biológicos de la Sociedad Española de Reumatología) after the dissemination of recommendations to prevent reactivation of latent tuberculosis infection (LTBI). METHODS: Incidence rate of ATB per 100,000 patient-years and 95% confidence intervals (95% CIs) were calculated in patients entering BIOBADASER after March 2002 and were stratified by compliance with recommendations (complete or incomplete). ATB rates in BIOBADASER were compared with the background rate and the rate in the rheumatoid arthritis cohort EMECAR (Estudio de la Morbilidad y Expresión Clínica de la Artritis Reumatoide) not treated with TNF antagonists. In addition, rates of ATB among patients treated with adalimumab, etanercept, and infliximab were estimated and compared only for treatments started after September 2003, when all 3 drugs became fully available. RESULTS: Following March 2002, a total of 5,198 patients treated with a TNF antagonist were registered in BIOBADASER. Fifteen ATB cases were noted (rate 172 per 100,000 patient-years, 95% CI 103-285). Recommendations were fully followed in 2,655 treatments. The probability of developing ATB was 7 times higher when recommendations were not followed (incidence rate ratio 7.09, 95% CI 1.60-64.69). Two-step tuberculosis skin test for LTBI was the major failure in complying with recommendations. CONCLUSION: New cases of ATB still occur in patients treated with all available TNF antagonists due to lack of compliance with recommendations to prevent reactivation of LTBI. Continuous evaluation of recommendations is required to improve clinical practice.

Registro Español de Acontecimientos Adversos de Terapias Biológicas en Enfermedades Reumáticas (BIOBADASER): informe de la situación, 26 de enero de 2006 / Spanish Registry for Adverse Events of Biological Therapy in Rheumatic Diseases (BIOBADASER): state report, January 26 th, 2006

Objetivo: BIOBADASER es un registro de pacientes reumatológicos en tratamiento con agentes biológicos, para el seguimiento de la supervivencia y la seguridad a largo plazo. Pacientes y métodos: El 26 de enero de 2006, se ha registrado a 6.969 pacientes procedentes de 100 centros, que aportan información de 8.321 tratamientos con terapias biológicas. Resultados: El tratamiento se suspendió en 2.351 ocasiones (28%), principalmente como resultado de un acontecimiento adverso (960; 41%), seguido de ineficacia (942; 40%). Se comunicaron 2.503 acontecimientos adversos, de los cuales el más frecuente fue la infección (909; 36%), seguido de las reacciones infusionales (500; 20%), y los trastornos cutáneos (255; 10%) y cardiovasculares (165; 7%). Conclusiones: El análisis actual de BIOBADASER constata el aumento de las infecciones con el tratamiento, no así el de neoplasias o insuficiencia cardíaca. Las medidas específicas son útiles para la prevención de acontecimientos definidos (AU)

Objective: BIOBADASER is a prospective registry of rheumatic patients treated with biological therapies, which aim is the analysis of long-term survival and safety of these agents. Patients and methods: As of January 26th 2006, 6,969 patients from 100 centers were included in BIOBADASER. In total, 8,321 treatments with biological therapies have been registered. Results: Treatment was discontinued in 2,351 (28%) occasions, mostly as a result of an adverse event (960;41%) or inefficacy (942;40%). A total of 2,503 adverse events were notified. Of these, the most frequent ones were infections (909;36%), followed by postinfusion reactions (500;20%), skin lesions (255;10%) and cardiovascular events (165;7%). Conclusions: The analysis reassures us in the increased rate of infections with biological therapies. Neither the rates of neoplasm nor of cardiac failure are significantly increased with these therapies. Specific measures have proved useful in preventing the occurrence of defined events (AU)

[Spanish Registry for Adverse Events of Biological Therapy in Rheumatic Diseases (BIOBADASER): state report, January 26 th, 2006]. / Registro Español de Acontecimientos Adversos de Terapias Biológicas en Enfermedades Reumáticas (BIOBADASER): informe de la situación, 26 de enero de 2006.

OBJECTIVE: BIOBADASER is a prospective registry of rheumatic patients treated with biological therapies, which aim is the analysis of long-term survival and safety of these agents. PATIENTS AND METHODS: As of January 26(th) 2006, 6,969 patients from 100 centers were included in BIOBADASER. In total, 8,321 treatments with biological therapies have been registered. RESULTS: Treatment was discontinued in 2,351 (28%) occasions, mostly as a result of an adverse event (960;41%) or inefficacy (942;40%). A total of 2,503 adverse events were notified. Of these, the most frequent ones were infections (909;36%), followed by postinfusion reactions (500;20%), skin lesions (255;10%) and cardiovascular events (165;7%). CONCLUSIONS: The analysis reassures us in the increased rate of infections with biological therapies. Neither the rates of neoplasm nor of cardiac failure are significantly increased with these therapies. Specific measures have proved useful in preventing the occurrence of defined events.