DUPIXENT® – A proven safety profile

Demonstrated safety profile across all three clinical trials

The most common adverse reactions (incidence ≥1%) observed at week 16 were injection-site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, eosinophilia, and dry eye.1

Adapted from the Product Monograph.1

Q2W: every 2 weeks
† Safety data from the SOLO 1, SOLO 2 trials and a phase II dose-ranging study.
‡ Safety data from the CHRONOS trial in which patients were on background TCS therapy.
§ DUPIXENT® 600 mg at week 0 then 300 mg every other week.
¶ Conjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.
†† In clinical trials, herpes simplex cases were mucocutaneous, generally mild to moderate in severity, and did not include eczema herpeticum. Eczema herpeticum cases were reported separately and incidence was lower in patients treated with DUPIXENT® compared to placebo.1
‡‡ Keratitis cluster includes keratitis, ulcerative keratitis, allergic keratitis, atopic keratoconjunctivitis, and ophthalmic herpes simplex.

Long-term safety profile in adults1

The safety profile of DUPIXENT® + TCS through week 52 is consistent with the safety profile observed at week 16.

Discontinuation rates in adults due to adverse events with DUPIXENT® with or without TCS were comparable to those with placebo1

• 1.9% of patients treated with DUPIXENT® discontinued treatment at week 16 vs. 1.9% with placebo at week 16 (SOLO 1 and 2)1
• 1.8% of patients treated with DUPIXENT® Q2W + TCS discontinued treatment at week 52 vs. 7.6% with placebo + TCS (CHRONOS)1


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MAT-CA-2300298
Last updated: 06/2023

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