Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.

BACKGROUND: Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. OBJECTIVE: To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. METHODS: The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort. RESULTS: Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5). LIMITATIONS: Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered. CONCLUSION: Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.

Evaluación de percepción de competencias de trabajadores respecto del Modelo Integral de Atención en Salud / Perception of competencies of health workers related to the integrated health care model

Resumen Introducción: Santander es pionero en atención primaria y lidera la implementación del nuevo Modelo Integral de Atención en Salud (MIAS) en Colombia. Este proceso requiere fortalecer las competencias del recurso humano encargado de atender los usuarios del sistema de salud. Objetivo: Identificar la percepción de los trabajadores de salud del primer nivel, y sus supervisores, respecto a sus competencias para desempeñarse dentro del MIAS. Metodología: Estudio transversal. Se construyó y validó un cuestionario de competencias en el saber Ser, Conocer y Hacer, basado en lineamientos del MIAS e instrumentos de competencias de profesionales de medicina y enfermería; se aplicó en línea a profesionales de siete profesiones de salud y auxiliares de enfermería. Se realizó un análisis por grupo de trabajadores y se compararon las percepciones de éstos y sus supervisores. Resultados: Participaron 359 trabajadores y 102 supervisores. En el Ser hubo menores puntajes dados por los supervisores en competencias de liderazgo profesional, trabajo en equipo y autonomía profesional. En el Conocer observamos menor percepción en competencia sobre Rutas Integrales de Atención en Salud (RIAS), priorización de grupos de riesgo, niveles y redes de prestadores, planes de beneficios, actores del sistema, y actividades a realizar en los entornos definidos por el MIAS. En el Hacer las competencias con menores puntajes fueron actividades de investigación en salud pública y ejecución de programas intersectoriales. Conclusiones: Múltiples competencias se deben fortalecer en los trabajadores de salud del primer nivel de atención, para implementar el MIAS.

ABSTRACT Introduction: Santander is pioneer in primary health care and is leading the implementation of the new comprehensive health care model (CHCM) in Colombia. This process requires to strength the competences of the health system's workers. Objective: To identify the primary health care workers' perception, and their supervisor's perception, regarding their competences for working in the framework of the new CHCM. Methods: We conducted a cross-sectional online survey in health professionals and technicians, and their supervisors, working in primary health care centers. We built and validated a questionnaire for the assessment of the three competences dimensions (attitude, knowledge, skills) based on the CHCM conceptual documents and questionnaires of competences for physicians and nurses. We stratified results by health profession and then, the worker and supervisors' perceptions were compared. Results: Participants were 359 health workers and 102 supervisors. In the attitude dimension, scores of leadership, teamwork, and professional autonomy were lower in supervisors than workers. In the knowledge dimension, the items with lower perception were those related to the new healthcare delivery's routes, risk prioritization's mechanisms, health services' network, plans of benefits and health system's structure. In the skills dimension, the competences with lower scores were the ones related to public health research and interdisciplinary work. Conclusions: We identify specific competencies that should be strengthened in primary healthcare workers, in order to achieve the expected performance in the new healthcare model in Colombia.

Development of clinical prediction models for good or bad response to classic systemic drugs, anti-TNFs, and ustekinumab in psoriasis, based on the BIOBADADERM cohort.

BACKGROUND: Identifying patients likely to have very good or bad results from systemic psoriasis therapy could improve efficiency of therapy. OBJECTIVE: To develop prognostic models for good or bad response to classic systemic drugs, anti-TNFs, and ustekinumab in psoriasis. METHODS: Multivariable logistic regression of a prospective multicenter cohort of psoriatic patients in clinical practice (6449 person-years of follow-up). We used as possible predictors demographic characteristics, comorbidities, characteristics of the psoriasis (type, PASI, arthritis), history of past therapy at entry in the cohort, and history of response to previous cycles while in the cohort. We defined good response to a treatment cycle as either cycle end due to disease remission or a cycle longer than 2 years that does not end later due to inefficacy in the follow-up period. Bad response to a treatment cycle was defined as a cycle that is finished due to inefficacy, based on the physician judgment, after more than 3 months of treatment. RESULTS: Patients with fewer previous therapies, lower body mass index, older at start of therapy, and with previous history of good responses to therapy are more likely to have positive results of therapy. However, the predictive characteristics of models are poor. CONCLUSION: Predictive models of clinical response to systemic drugs in psoriasis with the studied variables do not seem to outperform drug selection by a dermatologist.

Use of off-label doses is frequent in biologic therapy for moderate to severe psoriasis: A cross-sectional study in clinical practice.

INTRODUCTION: Biologic medications increase dramatically the burden of a chronic and high prevalent disease like psoriasis. The objective of the study was to quantify the use of dose reduction or dose escalation strategies, not reflected in the drug summary of product characteristics, in clinical practice. METHODS: An observational, cross-sectional study of a subset of patients from the Spanish Registry for Systemic Treatments in Psoriasis (BIOBADADERM) treated for over six consecutive months with the same biologic agent. RESULTS: The study included 637 patients. At the cut-off date, the initial dose had been reduced in 223 patients (35%; 95% CI: 31.3-38.9%) and escalated in 46 (7.2%; 95% CI: 5.3-9.5%). When compared with the patients treated with standard doses, the patients on reduced doses had a lower PASI score at the cut-off date (a mean 2.6 versus 1; -1.6 points) and exhibited greater improvement in PASI since the start of biologic therapy (mean reduction over baseline 75% versus 87%). By contrast, the patients receiving an escalated dose had higher PASI scores (2.6 versus 8.0) and showed less improvement in PASI (75% versus 46.8%). CONCLUSION: Off-label doses of biologic agents for psoriasis are frequent in clinical practice. This information is especially relevant for pharmacoeconomic models.

Risk of serious adverse events associated with biologic and nonbiologic psoriasis systemic therapy: patients ineligible vs eligible for randomized controlled trials.

OBJECTIVE: To describe the use of systemic therapy for psoriasis (biologic and nonbiologic [classic] drugs) in patients not adequately represented in randomized controlled trials (RCTs) and the risk of serious adverse events (SAEs) in these patients. DESIGN: A registry inception cohort was used. SETTING: Thirteen dermatology departments in Spain participated. PATIENTS: A consecutive sample of patients treated with biologics and a systematic sample of patients treated with classic systemic therapy were evaluated. A total of 1042 patients (2179 person-years) were included. EXPOSURE: Inadequate representation in trials was defined as the presence of any of the following factors: elderly age (>70 years); type of psoriasis other than chronic plaque psoriasis; history of infection caused by hepatitis B, hepatitis C, or human immunodeficiency virus; history of cancer (excluding nonmelanoma skin cancer); and chronic renal or hepatic disease. MAIN OUTCOME MEASURES: Serious adverse events as defined by the International Conference on Harmonization were evaluated. RESULTS: In all, 29.8% of patients receiving systemic therapy for psoriasis would not have been eligible for RCTs. These individuals had an increased risk of SAEs (incidence rate ratio, 2.7; 95% CI, 1.5-4.7). Patients exposed to biologics had an adjusted increased risk of SAEs (incidence rate ratio, 2.3; 95% CI, 1.1-4.8) that was similar in patients eligible and ineligible for RCTs. CONCLUSIONS: Patients ineligible for RCTs are an important proportion (30%) of those receiving systemic therapy for psoriasis. These patients have a higher risk of SAEs and should be closely monitored. Patients exposed to biologics (whether these patients are eligible for RCTs or ineligible) are susceptible to the same increase in risk of SAEs, but biologics add to a higher baseline risk in patients who are ineligible for RCTs. The risk-benefit ratio in ineligible patients receiving biologics might be different from the ratio in eligible patients.