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Vedolizumab exposure across pregnancy

Compare intravenous vedolizumab exposure in the released pregnancy reference cases. A two-compartment model uses fixed baseline covariates and tracks cumulative exposure.

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MODEL IN MOTION 18 sec

How do the declared pregnancy and albumin effects change vedolizumab exposure?

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Q8w no pregnancy effects

Conditional maternal exposure with fixed baseline covariates and a declared periodic pre-pregnancy history.

0–280 day

Q8w no pregnancy effects

Conditional maternal exposure with fixed baseline covariates and a declared periodic pre-pregnancy history.

Readouts

Central concentration · mg/L
Conditional model quantity; exposure and elimination integrals are added nonfeedback accounting readouts.
Albumin g · g/L
Albumin g over the selected simulation window.
Linear elimination clearance · L/day
Conditional model quantity; exposure and elimination integrals are added nonfeedback accounting readouts.
Central volume · L
Conditional model quantity; exposure and elimination integrals are added nonfeedback accounting readouts.
Exposure (AUC) · mg*day/L
Conditional model quantity; exposure and elimination integrals are added nonfeedback accounting readouts.

Study purpose

  • How do the model's key biological readouts change under q8w no pregnancy effects?

Assumptions

  • Conditional maternal exposure model with explicit baseline covariates; no fetal/neonatal compartment, postpartum recovery or clinical-response prediction.
  • Time is physical days from GA0; gestational weeks equal days/7 and fertilization age equals GA−2. Albumin is held at its baseline until FA0.02 weeks (GA2.02/day14.14).
  • Albumin effects use fractional change from the predicted baseline C. Baseline C is 40.7 g/L, not a substituted observed albumin measurement.
  • The uncentered third-trimester factor applies at GA≥28; equality uses the declared right-hand convention.
  • All baseline controls are fixed within each context because changing them requires recalculating the pre-pregnancy periodic state.
  • The published schedule polynomial is a rounded exposure-maintenance illustration, not an individual threshold-triggered optimization or dosing recommendation.
  • No population draws, sequential fitting, residual likelihood, original patient histories or source concentration bands are reconstructed.

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Simulation time
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Biology

Explore conditional systemic antibody exposure and covariate effects.

Explore conditional systemic antibody exposure and covariate effects.

Model details

44 parameters · 4 states · 4 equations · 18 derived outputs

Classification & API access
Therapeutic
Vedolizumab
Modality
Monoclonal antibody
Target
Integrin α4β7
Disease / scope
Pregnant patients with inflammatory bowel disease
ParameterDefaultUnitDescription
Ada presentada_present0—Anti-drug antibody indicator.
Ada ratioada_ratio1.12—Table 2 ADACL; fixed.
Age on clearanceage_on_cl-0.0346—Table 2 AGECL; fixed.
Ageage_year30yearBaseline maternal age.
Albumin aalbumin_a0.0059g/L/week²Table 2 A; estimated.
Albumin balbumin_b-0.511g/L/weekTable 2 B; estimated.
Albumin calbumin_c40.7g/LTable 2 C; estimated.
Albumin change on clearancealbumin_change_on_cl-1.44—Table 2 DALBCL; estimated.
Albumin change on central distribution volumealbumin_change_on_vc-1.96—Table 2 DALBVC; estimated.
Albumin trend enabledalbumin_trend_enabled1—Declared scenario decomposition switch, not an estimated coefficient.
Amino presentamino_present0—Concomitant aminosalicylate.
Amino ratioamino_ratio1.02—Table 2 AMINOCL; fixed.
Aza presentaza_present0—Concomitant azathioprine.
Aza ratioaza_ratio0.998—Table 2 AZACL; fixed.
Baseline albumin on clearancebaseline_albumin_on_cl-1.18—Table 2 ALBCL; fixed.
Cd central distribution volume ratiocd_vc_ratio1.01—Table 2 CDVC; fixed.
Cdaicdai100—Declared approximate Crohn disease activity.
Cdai on clearancecdai_on_cl-0.0515—Table 2 CDAICL; fixed.
Clearance cdcl_cd0.155L/dayTable 2 CL_CD; fixed.
Clearance uccl_uc0.159L/dayTable 2 CL_UC; fixed.
Fcalfcal_mg_kg200mg/kgBaseline fecal calprotectin.
Fcal on clearancefcal_on_cl0.031—Table 2 FCALCL; fixed.
Is cdis_cd1—Diagnosis: Crohn1, UC0.
Kmkm_mg_l0.964mg/LTable 2 Km; fixed.
Mayomayo1—Declared approximate partial Mayo score.
Mayo on clearancemayo_on_cl0.0408—Table 2 MAYCL; fixed.
Mp presentmp_present0—Concomitant mercaptopurine.
Mp ratiomp_ratio1.04—Table 2 MPCL; fixed.
Mtx presentmtx_present0—Concomitant methotrexate.
Mtx ratiomtx_ratio0.983—Table 2 MTXCL; fixed.
Prior tnfprior_tnf1—Prior TNF therapy indicator.
Prior tnf ratioprior_tnf_ratio1.04—Table 2 TNFCL; fixed.
Q referenceq_reference_l_day0.12L/dayTable 2 Q; fixed.
Third trimester coefficientthird_trimester_coefficient0.151—Table 2 T3GACL; estimated.
Third trimester enabledthird_trimester_enabled1—Declared scenario decomposition switch, not an estimated coefficient.
Central distribution volume referencevc_reference_l4.33LTable 2 Vc; estimated.
Maximum elimination rate referencevmax_reference_mg_day0.265mg/dayTable 2 Vmax; fixed.
Peripheral distribution volume referencevp_reference_l1.65LTable 2 Vp; fixed.
Weightweight_kg70kgBaseline body weight.
Weight on clearanceweight_on_cl0.362—Table 2 WTCL; fixed.
Weight on qweight_on_q0.75—Table 2 WTQ; fixed.
Weight on central distribution volumeweight_on_vc0.467—Table 2 WTVC; fixed.
Weight on maximum elimination rateweight_on_vmax0.75—Table 2 WTVMAX; fixed.
Weight on peripheral distribution volumeweight_on_vp1—Table 2 WTVP; fixed.

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