Dupixent (dupilumab) is a biologic medication used to treat several inflammatory conditions, including moderate-to-severe atopic dermatitis (eczema), asthma, and chronic rhinosinusitis with nasal polyps [1.6.2]. It works by blocking two proteins, interleukin-4 (IL-4) and interleukin-13 (IL-13), which are key drivers of type 2 inflammation [1.11.1]. Since many of these conditions require ongoing management, understanding the long-term safety of Dupixent is crucial for patients and healthcare providers.
Long-Term Safety Studies
Extensive clinical data from open-label extension studies have evaluated the safety of Dupixent for up to five years. A study involving 2,677 adults with atopic dermatitis found that over a five-year period, the safety profile remained consistent with previous reports from shorter trials [1.7.1]. Exposure-adjusted rates of treatment-emergent adverse events (TEAEs) were generally stable or declined over the course of the study [1.7.1]. Similarly, a study on patients with moderate-to-severe asthma showed Dupixent was well-tolerated for up to an additional three years, with safety findings consistent with its known profile [1.2.2]. These studies support the use of dupilumab as a continuous, long-term treatment [1.2.3, 1.7.4].
Common Long-Term Side Effects
Even with a generally acceptable long-term safety profile, certain side effects are reported more frequently. The most common TEAEs (≥5% incidence) observed in long-term studies include [1.2.3, 1.7.1]:
- Nasopharyngitis (common cold symptoms)
- Upper respiratory tract infection
- Injection site reactions (redness, swelling, pain, itching)
- Conjunctivitis (pink eye)
- Headache
- Oral herpes (cold sores)
- Atopic Dermatitis (worsening of the condition itself)
Injection site reactions are among the most common side effects but typically resolve on their own [1.5.1, 1.9.2].
Ocular (Eye-Related) Side Effects
The most notable and frequently discussed long-term side effect of Dupixent involves the eyes. Ocular issues can include [1.5.3, 1.10.2]:
- Conjunctivitis: Inflammation of the lining of the eye, which can be allergic, bacterial, or viral [1.10.1]. In studies, this occurred in up to 21% of patients [1.5.3].
- Keratitis: Inflammation of the cornea, which can be serious and, in rare cases, lead to ulcerative keratitis if left untreated [1.5.3, 1.10.4].
- Blepharitis: Inflammation of the eyelids [1.10.1].
- Dry Eye and Itchy Eyes: These are also commonly reported symptoms [1.10.1].
The mechanism is thought to be related to Dupixent's blockage of IL-13, which also plays a role in maintaining mucus-producing goblet cells in the eye that are essential for tear stability [1.10.1]. Patients experiencing new or worsening eye pain, redness, itching, or changes in vision should consult their healthcare provider promptly [1.3.2, 1.10.4].
Serious but Less Common Side Effects
While less frequent, some serious side effects require immediate medical attention. These include:
- Severe Allergic Reactions (Hypersensitivity): Symptoms can include breathing problems, swelling of the face, lips, or throat, fever, hives, joint pain, and severe skin rash [1.3.2].
- Joint Pain (Arthralgia): Some patients experience new or worsening joint aches and pain, which in some cases have been severe enough to cause difficulty walking or require hospitalization [1.3.2, 1.9.4]. This side effect was reported in 2-3% of patients in certain trials [1.9.1].
- Eosinophilic Conditions: Rarely, patients (particularly those with asthma) may develop high levels of eosinophils (a type of white blood cell) that can lead to serious conditions like eosinophilic pneumonia or inflammation of blood vessels (vasculitis) [1.5.1, 1.4.5].
- New or Worsening Psoriasis: Some individuals have reported the development of psoriasis while on Dupixent [1.4.3].
| Side Effect Category | Common Examples | Serious (Rare) Examples |
|---|---|---|
| Most Common | Injection site reactions, nasopharyngitis, headache [1.2.3] | Severe allergic reactions (anaphylaxis) [1.5.3] |
| Ocular (Eye) | Conjunctivitis, dry eye, eye itching [1.10.1] | Keratitis, ulcerative keratitis [1.5.3] |
| Musculoskeletal | Arthralgia (joint pain), myalgia (muscle pain) [1.5.5, 1.9.4] | Severe arthralgia requiring hospitalization [1.3.2] |
| Immune System | Eosinophilia (high white blood cell count) [1.3.2] | Eosinophilic pneumonia, vasculitis [1.4.5, 1.5.2] |
Controversy and Emerging Concerns
Recently, some lawsuits have alleged a link between Dupixent and an increased risk of cutaneous T-cell lymphoma (CTCL), a rare skin cancer [1.4.4]. Plaintiffs claim that symptoms of early CTCL can mimic eczema, potentially leading to a delayed diagnosis [1.4.4]. One study noted a higher risk of CTCL in eczema patients using Dupixent compared to non-users, especially in the first year of therapy [1.4.4]. However, this link is still under investigation and not officially listed on the drug's warning label [1.5.5].
Conclusion
Based on clinical trial data extending up to five years, Dupixent has a well-established safety profile for long-term use, with benefits often outweighing the risks for patients with severe inflammatory conditions [1.2.3, 1.7.1]. The most common long-term side effects are generally mild to moderate and include injection site reactions, upper respiratory infections, and particularly eye-related issues like conjunctivitis [1.2.3]. Serious side effects like severe allergic reactions and significant joint pain are rare but possible [1.3.2]. Patients should maintain open communication with their healthcare providers to monitor for any new or worsening symptoms, especially concerning the eyes or joints, to ensure safe and effective long-term treatment.
For more detailed information, you can review the patient information provided by the manufacturer. https://www.regeneron.com/downloads/dupixent_ppi.pdf
