IMPACT Study - Certolizumab Efficacy in APS Pregnancies

A pilot trial assessed the safety and value of tumour necrosis factor α inhibitor treatment with certolizumab in patients with high-risk pregnancies with antiphospholipid syndrome (APS). Certolizumab (CZP) was shown to reduced the risk of adverse pregnancy outcomes (APOs) in high-risk patients with APS.
 
Antiphospholipid syndrome can be associated with APOs, including fetal death and preterm birth due to pre-eclampsia with severe features or placental insufficiency and with arterial and venous thromboses. Pregnant patients with a lupus anticoagulant (LA) are also at higher risk poor outcomes.  
 
The IMPACT study was a multicenter trial single-arm open-label, phase 2 trial of CZP , a TNF inhibitor known to not cross the placenta. Patients were enrolled if they were pregnant with APS and lupus anticoagulant (LAC). CZP was given weeks 8 through 28, in addition to standard treatment with low molecular weight heparin (LMWH) plus low dose aspirin (ASA). The primary endpoints were a composite of fetal death ≥10 weeks’ gestation or pre-eclampsia with severe features or placental insufficiency requiring delivery <34 weeks’ gestation.  The number of observed APOs were compared to historic controls.
 
A total of 51 APS patients were enrolled and treated with CZP/LMWH/ASA.  Six patients were excluded for a pregnancy loss <10 weeks’ gestation and fetal loss due to genetic abnormalities. Results showed: 
  • Primary APO in 9 of 45 patients (20%)
    • This was significantly lower than APOs in historic controls (a priori estimated to be 40-44%)
  • Median gestational age at delivery in CZP patients was 36.5 weeks (30 weeks in APO pre-eclampsia patients) 
  • Neonatal survival to hospital discharge was 93%. 
  • No serious infections and no new cases or severe flares of lupus.
Certolizumab added to a regimen of LMWH and LDA appeared effective in preventing fetal death or delivery <34 weeks’ gestation due to pre-eclampsia with severe features or placental insufficiency in APS/LAC patients.
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Certolizumab pegol to prevent adverse pregnancy outcomes in patients with antiphospholipid syndrome and lupus anticoagulant (IMPACT): results of a prospective, single-arm, open-label, phase 2 trial

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The author has no conflicts of interest to disclose related to this subject
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