Dupilumab: Drug information

Dupilumab: Clinical Profile & Dosing Stratification

High bioavailability and indication-specific dosing intensity define the IL-4/IL-13 antagonist profile

Design Clinical Pharmacology Review Population Adults & Pediatrics (Asthma, AD, EoE, CRSwNP, PN) N Aggregated Clinical Trials Duration Variable (Maintenance Therapy) Comparator Placebo / Standard of Care (in trials referenced) Year 2024

Key Performance Indicators

PRIMARY
Bioavailability
64%
Range: 61%–64%
High subcutaneous absorption
Max Clearance Time
13 weeks
For 300 mg weekly dosing
Prolonged washout period
Max Injection Site Reaction
38%
Range: 6%–38%
Most common adverse event
Cost Per Dose
$2,282
AWP for both 200mg & 300mg
Flat pricing structure
01

Eosinophilic Esophagitis requires the highest maintenance intensity

Monthly maintenance dosage varies significantly by indication, with EoE requiring 4x the load of moderate asthma.

02

Injection site reactions and immunogenicity show wide variability

Adverse event rates reported in labeling show significant ranges, particularly for local reactions and antibody development.

03

Higher dosing frequency extends washout period significantly

The time to non-detectable concentration increases by 44% when dosing frequency is doubled from bi-weekly to weekly.

04

Flat pricing strategy: 200mg and 300mg doses carry identical acquisition costs

While the concentration differs, the total cost per pen is effectively identical, incentivizing higher-dose regimens where indicated.

05

Pediatric dosing escalates non-linearly with weight thresholds

Dosing for Atopic Dermatitis in children shows distinct step-changes at 15kg, 30kg, and 60kg thresholds.

Editorial Conclusion

“Dupilumab demonstrates a highly specific efficacy profile driven by IL-4/IL-13 blockade, with dosing intensity serving as the primary lever for managing different inflammatory phenotypes (EoE vs Asthma).”
Safety profile is dominated by injection site reactions (up to 38%) and ocular surface disease (up to 10%).
Pharmacokinetics support a long dosing interval (Q2W or QW), with a substantial washout period of up to 13 weeks.
Pricing structure is volume-agnostic, with both 200mg and 300mg presentations costing ~$2,282 per dose.
Clinical Implication
Clinicians must carefully select dosing based on specific indication and weight, while monitoring for ocular and injection-site adverse events.

Reference Data & Sources

Complete Data Table

viz_idchart_typelabelgroupvaluevalue_textlowhighsdpsigunitcategoryxytargetrank
viz1horizontal_barEosinophilic EsophagitisMaintenance Load12001200 mg/momg/month
viz1horizontal_barAtopic Dermatitis / PNMaintenance Load600600 mg/momg/month
viz1horizontal_barSevere AsthmaMaintenance Load600600 mg/momg/month
viz1horizontal_barCRSwNPMaintenance Load600600 mg/momg/month
viz1horizontal_barModerate AsthmaMaintenance Load400400 mg/momg/month
viz2range_plotInjection-site reactionLocal226-38%638%
viz2range_plotAntibody developmentImmunologic8.51-16%116%
viz2range_plotConjunctivitisOphthalmic50-10%10%
viz2range_plotUpper Resp. InfectionRespiratory1818%1818%
viz2range_plotNasopharyngitisRespiratory55%55%
viz3lollipop300 mg WeeklyClearance Time1313 weeksweeks
viz3lollipop300 mg Q2WClearance Time10.510-11 weeksweeks
viz3lollipop200 mg Q2WClearance Time99 weeksweeks
viz4paired_bar200 mg PenPrice per mL ($)2001.68USD
viz4paired_bar200 mg PenTotal Price per Dose ($)2281.91USD
viz4paired_bar300 mg PenPrice per mL ($)1140.96USD
viz4paired_bar300 mg PenTotal Price per Dose ($)2281.92USD
viz5line_chart5 to <15 kgMonthly Dose (mg)5200
viz5line_chart5 to <15 kgMonthly Dose (mg)14.9200
viz5line_chart15 to <30 kgMonthly Dose (mg)15300
viz5line_chart15 to <30 kgMonthly Dose (mg)29.9300
viz5line_chart30 to <60 kgMonthly Dose (mg)30400
viz5line_chart30 to <60 kgMonthly Dose (mg)59.9400
viz5line_chart≥60 kgMonthly Dose (mg)60600

Abbreviations

AbbrevMeaning
EoEEosinophilic Esophagitis
ADAtopic Dermatitis
CRSwNPChronic Rhinosinusitis with Nasal Polyposis
PNPrurigo Nodularis
Q2WEvery 2 Weeks
QWWeekly

Source

UpToDate

Limitations

  • Adverse reaction rates are aggregated from labeling and may vary by specific trial population.
  • Pricing data represents Average Wholesale Price (AWP) and may not reflect actual acquisition cost.
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