Safety profile
DUPIXENT is a fully human monoclonal antibody with a generally tolerable safety profilea,1
| Adverse reactions reported from DUPIXENT clinical trials including CRSwNP, asthma, and atopic dermatitis patients, and post marketing experience | ||
| System class | Frequencyb | Adverse reaction |
| Blood and lymphatic system disorders | Common | Eosinophilia |
| Immune system disorders |
Uncommon
|
Angioedemac
|
| Rare |
Anaphylactic reaction Serum sickness reaction Serum sickness-like reaction | |
| Skin and subcutaneous tissue disorders | Uncommon | Facial rashc |
| Musculoskeletal and connective tissue disorders | Common | Arthralgiac |
| General disorders and administration site conditions | Common | Injection site reactions (includes erythema, oedema, pruritus, pain, swelling, and bruising) |
| Adverse events occurring predominantly in atopic dermatitis clinical trials | ||
| Infections and infestations | Common |
Conjunctivitis Oral herpes |
| Eye disorders | Common | Conjunctivitis allergic |
| Uncommon |
Keratitisc,d Blepharitisd Eye pruritusd Dry eyed | |
| Rare | Ulcerative keratitisc,d | |
DUPIXENT is NOT an immunosuppressant.
The safety profile through Week 52 was consistent with that observed at Week 241,2
In the safety pool (SINUS‑24 and SINUS‑52), the proportion of patients who discontinued treatment due to treatment-emergent adverse events (TEAE) at week 24 was:
- 3% (n=440) of the DUPIXENT group
- 5% (n=282) of the placebo group
aThe DUPIXENT safety data presented were predominantly derived from 12 randomised, placebo-controlled trials, including patients with atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP). These studies involved 4206 patients receiving DUPIXENT and 2326 patients receiving placebo during the controlled period.
bCommon (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000).
cFrom post marketing reporting.
dThe frequencies for eye pruritus, blepharitis, and dry eye were common and ulcerative keratitis was uncommon in atopic dermatitis studies.
ABBREVIATIONS
CRSwNP, chronic rhinosinusitis with nasal polyps; INCS, intranasal corticosteroids; MedRA, Medical Dictionary for Regulatory Activities; TEAE, treatment‑emergent adverse events
REFERENCES
- DUPIXENT (dupilumab) Summary of Product Characteristics (UK).
- Bachert C, et al. Lancet. 2019;394(10209):1638‑50.