Prescribing patterns of biologic and immunomodulatory therapies in pediatric inflammatory diseases: a cohort study at a national referral center in Paraguay, 2022
Keywords:
biologic therapies, immunomodulators, pediatrics, inflammatory diseases, autoimmune diseases, real-world evidence, ParaguayAbstract
Introduction: Pediatric chronic inflammatory diseases represent a growing therapeutic challenge. Refractoriness to conventional treatments has driven the development of biological therapies; however, real-world evidence regarding their use in middle-income countries —such as Paraguay— remains limited. Objective: To describe the prescription patterns of biotherapies and immunomodulators in patients aged 0 to 18 years treated at the Central Hospital of the Instituto de Previsión Social (IPS) during 2022; to identify the subspecialties with the highest prescribing frequency; and to characterize the diagnostic profile of the study population. Methods: An observational, descriptive, cross-sectional study was conducted based on secondary data sources, including the Hospital Information System (SIH), GESLAB, the Pharmacy Service, and the Telemedicine Service. Variables analyzed included sex, prescribing subspecialty, therapy type, and dispensing volume. Diagnoses were coded according to ICD-10. Results: A total of 4,786 therapeutic records from 937 patients were analyzed (48.9% female; 51.1% male). General Pediatrics accounted for 62.6% of all prescriptions, with parenteral methylprednisolone being the predominant agent. Pediatric Rheumatology (22.6%) exhibited the greatest pharmacological diversity —up to nine distinct agents— followed by Neurology (7.6%). A total of 125,845 dispensing units were recorded. Methotrexate represented 56.3% of total dispensed volume, followed by azathioprine (14.8%), tacrolimus (9.4%), and mycophenolate mofetil (7.0%). Biologic therapies —adalimumab, rituximab, tocilizumab, and infliximab— collectively accounted for only 0.55% of dispensed units, reserved for refractory or high-complexity cases. The most frequent diagnoses were bronchial asthma (30.8%), unspecified pneumonia (10.9%), and juvenile idiopathic arthritis (7.7%). Conclusion: The IPS applies a stepwise therapeutic model consistent with current international guidelines, prioritizing conventional immunomodulators as first-line therapy and reserving biologic agents for cases of greater complexity or treatment refractoriness. These findings underscore the need for institution-specific clinical protocols, strengthened pharmacovigilance systems, and longitudinal evidence on the effectiveness and safety of these therapies in pediatric cohorts within the Paraguayan healthcare setting.
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