BAERe
Biological Agents Egyptian Registry
Project Managers
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Prof. Adel Mahmoud
Ain Shams University
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Prof. Hesham Hamoud
Al Azhar University
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Prof. Alaa Labib
Menofia University
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Dr. Medhat
Health Insurance
Objectives
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General Objective
Concerning the initial treatment of biological agents in daily practice, this project proposes to describe the Egyptian daily clinical practice reality, use/abuse of ACR/EULAR management recommendations, and the unmet needs with biological usage.
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Secondary objectives
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• Early diagnosis and start of biologic DMARDs.
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• To estimate the incidence and prevalence of biological agents among Egyptian populations.
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• To estimate the average time between the onset of symptoms and the first diagnosis.
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• To estimate the average time between diagnosis and the first dosage of treatment.
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• To estimate the average time between visits.
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• To estimate the frequency of therapies with biologic DMARDs.
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• To estimate the frequency of patients who start the drug and failed to achieve remission.
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• To estimate the frequency of prescription of different biological drugs after the failure of Conventional DMARDs
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• To estimate the frequency of patients who do not start the biological drug despite the clinical, laboratory indications.
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• To identify the limitations to use biological therapy despite the physician/patient consensus.
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• To evaluate the frequency of adverse events to biological DMARDs
Study design
Mixed cohort study. Prospective Study & Retrospective Study
Recruitment centers
All rheumatology departments among the Egyptian universities, in addition to some of the potential rheumatology private clinics will have a unique username and password to login and add his last recruitment patients: Consecutive patients. Recruitment 18 months. Minimum 12 month follow-up (First patient assessed: 30 months) study.
Factors of interest (exposure variables)
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Demographic variable
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Serological subset
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Clinical settings (outpatient / hospital / center analysis)
Analysis plan
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Analysis of the primary outcome
Primary outcomes will be estimated as a mean therapeutic delay and as a probability (risk) of achievement of the target / or adherence to recommendations and 95% confidence intervals
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Analysis of secondary outcomes
Secondary outcomes will be estimated in a similar way to primary ones
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Explorative analysis
The influence of demographic, clinical (serological), therapeutic factors (association with glucocorticoids), organizational (setting), pathway (time to referral, to diagnosis ,to treatment) on the variables of longitudinal outcome (target achievement, treatment survival, adverse events, biological switch) will be explored using regression models appropriate to type of outcome variable.