Methods

ANALYSIS OF ADVERSE DRUG REACTION PROFILE OF IMMUNOBIOLOGICAL

TNF-alpha INHIBITORS: A PHARMACOVIGILANCE OVERVIEW

João Victor C. Costa*,**, Adalton G. Ribeiro*, Sergio Mengardo* and Eunice K. Kano**

*Department of Pharmacovigilance, Health Surveillance Center; **College of Pharmaceutical Sciences, University of São Paulo

ADR

PeriWeb

DAP

Notification

Data collection

ADR grouping Analysis

May 2005/May 2011

Serious ADRs

July 1963/March 2011

All ADRs

Aknowledgement

This project was supported by the “Education through Work” Program (PET-VS) from Brazilian Ministry of Health

Introduction

Immunobiological drugs are one of the most effective choices for autoimmune diseases treatment. Within this terapeutic class are tumor necrosis factor-alpha (TNF-alpha) inhibitors (etanercept, infliximab and adalimumab), used to treat several diseases such as psoriatic and rheumatoid arthritis and Crohn’s disease.

Pharmacovigilance consists in a science and activities related to the detection, assessment, understanding and prevention of adverse drug-reactions (ADRs) or any other drug related problem (WHO, 2002). Considering that these drugs are responsible for unknown and/or serious ADRs, constituting a potential risk to public health, pharmacovigilance is fundamental to ensure drug safety for users and for the community.

The aim of this study was to evaluate ADR profile of immunobiological TNF-alpha inhibitors in Brazil (PeriWeb, Health Surveillance Center), comparing data with United Kingdom (DAP, Medicines and Healthcare Products Regulatory Agency), in way to propose points of intervention and sanitary actions.

Conclusions

These results raised different hypothesis:

• Differences between notification profiles in Brazil and United Kingdom could be due to:

local epidemiologic peculiarities;

variations in health and pharmacovigilance systems;

different notifier profile.

• Differences between ADR profiles of etanercept, infliximab and adalimumab could demonstrate different effectiveness/safety ratio among the three drugs.

Perspectives

Investigation of pharmaceutical industries Pharmacovigilance Sector and analysis of Periodic Safety Uptade Report.

Investigation and revision of healthcare protocols and improvement of health professional training quality.

Implementation of programs that aim to spread Pharmacovigilance concept, encouraging health professional and users to notify ADRs.

Then, these hypothesis can be tested and corrected by further actions, such as:

Results

Fig. 1 – ADR Notifications General Profile from PeriWeb. Only serious ADRs were considered. Unlikely notifications were excluded.

Fig. 2 – Notification Profile of Immunobiological TNF-alpha Inhibitors in Brazil and United Kingdom. Comparison of total and grouped notification number between Brazil and United Kingdom and among the drugs.

Fig. 3 – Grouped ADR profile from Immunobiological TNF-alpha Inhibitors in Brazil and United Kingdom. Comparison of ADR grouped by type of reaction and country of origin.

Fig. 4 – Tuberculosis Rate within Infections Notified. Ratio bewteen tuberculosis cases and infections notified from the three drugs in Brazil and United Kingdom.

Fig. 5 – ADR General Profile of Immunobiological TNF-alpha Inhibitors. Comparison of grouped ADR notification rate of each drug in Brazil and United Kingdom