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MONITORING BIOLOGICALS
Biological drugs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],+  Immunogenicity  -
Immunogenicity and bioavailability ,[object Object],[object Object],*“Guidelines on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins of 31 July 2007” **Clinical validation with 1400 samples of 70 RA patients “ All therapeutic proteins are potentially immunogenic”* Time after  beginning treatment (weeks) Free Infliximab (ug/ml) 10xanti-Infliximab  (UA/ml) DAS28
References… “ Several studies have shown that immunogenicity is associated with  allergic reactions and loss of response  in a significant number of patients treated with chimeric or human therapeutic antibodies. Monitoring of drug levels as well as of antibodies against therapeutic antibodies may lead to more rational treatment strategies.”   Wolbink et al. Curr Op Rheum 2009. “ Secondary response failure is associated with low trough levels of anti-TNF-alpha biologicals and development of antibodies against these drugs. Indeed, trough level assessments of anti-TNF-alpha drugs and measurements of antibodies against these biologicals are among the  parameters that best predict the response  of individual RA patients”  Radstake et al. Ann.Rheum.Dis 2009 “ Assesments of bioavailability and immunogenicity of infliximab may be used to  optimize dose regimens and prevent prolonged use of inadequate therapy .”  Svenson et al. Rheum 2007. “ We show that determining the immunogenic status of a non responding patient may be important for further decision making and could assist in developing an optimised treatment for the individual patient.”  Bartelds et al. Ann.Rheum.Dis 2009
Nowadays… ,[object Object],[object Object],[object Object],[object Object],[object Object],Monitoring biological drugs is a  regulatory requirement , to increase uniformity and consistency of measurement methods of patient´s response
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],PROMONITOR “ Early prediction of treatment failure”
Results of the clinical validation >1.5   g/ml <15 UA/ml ,[object Object]
PROMONITOR ,[object Object],* Clinical validation with 1400 samples of 70 RA patients Analysis  of infliximab and antibodies against infliximab  IFX > 1.5 ug/ml and Antibodies negative IFX < 1.5 ug/ml and Antibodies positive Good clinical response Bad responders Adequate treatment Treatment maybe is not efficient. Surveillance and monitoring required.
Results of the clinical validation ,[object Object],< 0.8 ug/ml < 8 AU/ml
PROMONITOR ,[object Object],* Clinical validation with 180 samples of  RA patients Analisys  of adalimumab and antibodies against adalimumab ADA > 0.8 ug/ml and Antibodies negative ADA < 0.8 ug/ml and Antibodies positive Good clinical response Bad responder Adequate treatment Treatment maybe is not efficient. Surveillance and monitoring required.
PROMONITOR PROMONITOR Optimizes each patient´s therapy  Adequate drug level+ no antibody response Decreased drug level + antibody response Low drug level+ significant antibody production Treatment OK Consider increasing dosage or  frequency of dosage Consider switching to another drug
PROMONITOR ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
PROMONITOR ELISA KIT ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],PROMONITOR KIT Cat. No. Promonitor IFX PG-PIFX-10200 Promonitor ADA PG-PADA-10700
MARKET ,[object Object],[object Object],[object Object],[object Object],Pathology Prevalence Europe Rheumatoid Arthritis 0.5-1 % 6.200.000 ¹ Inflammatory Bowel Disease 0.3 % 2.200.000 ²  TOTAL 8.400.000 20%TOTAL 1.680.000
 

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  • 4. References… “ Several studies have shown that immunogenicity is associated with allergic reactions and loss of response in a significant number of patients treated with chimeric or human therapeutic antibodies. Monitoring of drug levels as well as of antibodies against therapeutic antibodies may lead to more rational treatment strategies.” Wolbink et al. Curr Op Rheum 2009. “ Secondary response failure is associated with low trough levels of anti-TNF-alpha biologicals and development of antibodies against these drugs. Indeed, trough level assessments of anti-TNF-alpha drugs and measurements of antibodies against these biologicals are among the parameters that best predict the response of individual RA patients” Radstake et al. Ann.Rheum.Dis 2009 “ Assesments of bioavailability and immunogenicity of infliximab may be used to optimize dose regimens and prevent prolonged use of inadequate therapy .” Svenson et al. Rheum 2007. “ We show that determining the immunogenic status of a non responding patient may be important for further decision making and could assist in developing an optimised treatment for the individual patient.” Bartelds et al. Ann.Rheum.Dis 2009
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  • 11. PROMONITOR PROMONITOR Optimizes each patient´s therapy Adequate drug level+ no antibody response Decreased drug level + antibody response Low drug level+ significant antibody production Treatment OK Consider increasing dosage or frequency of dosage Consider switching to another drug
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Notas do Editor

  1. Resultados solo aplicables a pacientes de reumatología
  2. Resultados solo aplicables a pacientes de reumatología