Patient Survival and Safety With Biologic Therapy. Results of the Mexican National Registry Biobadamex 1.0

Ventura‐Ríos, Lucio; Bañuelos-Ramírez, David; Hernández-Quiroz, María del Carmen; Román, Manuel Robles-San; Irazoque-Palazuelos, Fedra; Goycochea-Robles, María Victoria

doi:10.1016/j.reumae.2012.06.017

Cited by 12 publications

(4 citation statements)

References 24 publications

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“…Treatment of these diseases is complex and often requires an early multidisciplinary management. 5 The first-line treatment includes physiotherapy and physical exercise, and pharmacological therapy is based on disease-modifying antirheumatic drugs and symptomatic treatment with nonsteroidal anti-inflammatory drugs and corticosteroids. Patients who do not respond to the conventional treatment at maximum recommended doses are candidates for biological therapy with anti–tumor necrosis factor α agents (anti-TNFα): infliximab, etanercept, adalimumab, golimumab, and certolizumab, with the last one only authorized in RA.…”

Section: Introductionmentioning

confidence: 99%

Reasons for Discontinuation and Adverse Effects of TNFα Inhibitors in a Cohort of Patients With Rheumatoid Arthritis and Ankylosing Spondylitis

et al. 2016

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Section: Introductionmentioning

confidence: 99%

Reasons for Discontinuation and Adverse Effects of TNFα Inhibitors in a Cohort of Patients With Rheumatoid Arthritis and Ankylosing Spondylitis

et al. 2016

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“…The reasons beyond the research that might have given origin to the record include medical care, periodic medical examination, etc. 11 In contrast, the cross-sectional study is when the patient is assessed in a stationary form, with the baseline state and the maneuver, as well the outcome being measured at a single time. At this point, it should be mentioned that even when everything is measured in a single moment and there is no documented evidence of the actual time the facts occurred, artificially reconstructing the real temporality of each section should be tried; for example: in a patient with a five-year history of diabetes in whom studying the damage to a target organ as a result of metabolic control is wanted, his/her baseline state can be rebuilt by asking about his/ her situation five years back, taking into account both the criteria that at the time would have been applied, and his/her baseline characteristics and the metabolic control he/she has experienced since then and until the moment the study is carried out.…”

Section: Research Design Characteristics (Table 1)mentioning

confidence: 99%

Back to the clinic. Methods I. Research designs. Higher quality of information, more certainty to the answer

Talavera¹,

Roy-García²,

Palacios‐Cruz³

et al. 2023

GMM

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Research designs refer to the way information is obtained and are limited by ethical, economic and temporal viability. Research designs are standardized strategies to reduce biases, which in the architectural model of research are identified in the baseline state, the maneuver and the outcome; hence, there are no specific designs for each question. The design with the lowest probability of bias is the clinical trial, followed by cohort and case-control studies and, finally, by cross-sectional surveys. Among the main characteristics that give merit to research designs are the following: population inquiry, which refers to the situation of the population in relation to the clinical course/natural history of the disease; the maneuver, or action that is expected to modify the baseline state, which can be observational or experimental; follow-up, or documented monitoring that is given to each subject, which can be longitudinal or cross-sectional; and directionality, which can prolective or retrolective and refers to the timing of data collection for research purposes. It will always be better having a valuable question, even when answered with a design with higher risk of bias, than a question that is irrelevant or has no applicability.

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“…Each registry is owned by a national rheumatology society or association and has its own staff and governance . Registries established in Brazil (BiobadaBrasil), Argentina (BIOBADASAR), and Mexico (BIOBADAMEX) have provided useful information on biologic use in clinical practice . However, substantial funding is required to implement and maintain these registries, resulting in inconsistent participation among countries …”

Section: Pharmacovigilance Of Biosimilars In Latin Americamentioning

confidence: 99%

Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey

Castañeda‐Hernández

Sandoval

Coindreau

et al. 2019

Pharmacoepidemiology and Drug

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Purpose This review summarises the current status of regulatory guidelines for the approval of biosimilars in Latin America and highlights the main barriers to effective pharmacovigilance in this region. We also report results from a survey of Latin American rheumatologists assessing their understanding of prescribing biosimilars and the pharmacovigilance of these drugs. Methods We reviewed the current guidelines for the regulatory approval of biosimilars and barriers to effective pharmacovigilance in Latin American countries. Rheumatologists attending the II Pan‐American League of Rheumatology Associations PANLAR Review Course (Biosimilars update) in Lima, Peru were asked to complete a short survey to determine their knowledge of biosimilars. Results Many Latin American countries continue to lag behind Europe and the United States in establishing regulatory guidance and effective pharmacovigilance systems for biosimilars. Results from our survey also highlight a lack of awareness regarding the availability of biosimilars, their nomenclature, automatic substitution, and reporting adverse drug reactions because of these drugs. Conclusions The main barriers to effective pharmacovigilance in Latin America are the lack of consensus on the interchangeability of reference biologics and biosimilars, and the need for more suitably trained personnel to carry out effective postmarketing pharmacovigilance of biosimilars. Inconsistencies in biosimilar nomenclature make it difficult to adequately trace drugs and record adverse drug reactions associated with their use, creating a barrier to the global pharmacovigilance of biologics.

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Patient Survival and Safety With Biologic Therapy. Results of the Mexican National Registry Biobadamex 1.0

Cited by 12 publications

References 24 publications

Reasons for Discontinuation and Adverse Effects of TNFα Inhibitors in a Cohort of Patients With Rheumatoid Arthritis and Ankylosing Spondylitis

Reasons for Discontinuation and Adverse Effects of TNFα Inhibitors in a Cohort of Patients With Rheumatoid Arthritis and Ankylosing Spondylitis

Back to the clinic. Methods I. Research designs. Higher quality of information, more certainty to the answer

Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey

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