Dupilumab: Trials, Approved Uses and Reported Side Effects

Dupilumab is a human monoclonal antibody given by injection under the skin. It was first approved in 2017 for atopic dermatitis, the common form of eczema (Baghdasarian 2026). The US label dated 22 April 2026 lists nine uses, from eczema and asthma to bullous pemphigoid, a rare autoimmune blistering skin disease. This page sets out how the drug works, what the main trials measured, what the label warns about, and what published reports say about its less expected effects. The abstracts of the atopic dermatitis, asthma, eosinophilic esophagitis and chronic obstructive pulmonary disease trials, and the nasal polyp report, state that the drug's manufacturers funded them.

Table of Contents

  1. How It Blocks the Interleukin-4 and Interleukin-13 Signal
  2. The Uses Listed on the US Label
  3. Pivotal Trials in Skin Disease
  4. Pivotal Trials in the Airways and Sinuses
  5. Pivotal Trials in Eosinophilic Esophagitis
  6. What the Label Warns About
  7. Eye-Surface Side Effects
  8. Joint Pain and Arthritis Reports
  9. Rashes, Psoriasis and Head-and-Neck Dermatitis
  10. Reports of Cutaneous T-Cell Lymphoma Being Unmasked
  11. Eosinophilia and Eosinophilic Conditions
  12. What Is Known and Unknown About Long-Term Use
  13. Key Research Papers
  14. Connections
  15. Featured Videos

How It Blocks the Interleukin-4 and Interleukin-13 Signal

Interleukin-4 and interleukin-13 are messenger proteins. They are two central drivers of what immunologists call type 2 inflammation, the pattern behind eczema, allergic asthma, nasal polyps and related diseases (McCann 2024). Each one works by docking onto a receptor on the surface of a cell.

The two signals share one receptor part, called interleukin-4 receptor alpha. Dupilumab binds that shared part. The label describes the result: interleukin-4 signaling is blocked through the Type I receptor, and both interleukin-4 and interleukin-13 signaling are blocked through the Type II receptor. One antibody therefore silences two messengers.

The label lists mast cells, basophils, eosinophils, macrophages, lymphocytes, epithelial cells and goblet cells among the cell types that carry this receptor part. It states that inflammation driven by these two messengers is an important part of all nine diseases on its list.

Laboratory markers show the block at work. In people with asthma, the label reports falls in exhaled nitric oxide, eotaxin-3, periostin and immunoglobulin E, the allergy antibody. Most markers were near their lowest point after 2 weeks. Immunoglobulin E fell more slowly, with a median drop of 52% at week 24 in one trial and 70% at week 52 in the QUEST trial.

The drug's target is this receptor part and not the eosinophil itself. That matters later on this page, because blood eosinophil counts can rise during treatment in some diseases.

The Uses Listed on the US Label

The label on DailyMed, dated 22 April 2026, lists these uses:

The label also states limits. The drug is not indicated for sudden bronchospasm or status asthmaticus, and it is not indicated for forms of urticaria other than the spontaneous form.

Pivotal Trials in Skin Disease

Atopic dermatitis: SOLO 1 and SOLO 2

These two identical trials enrolled 671 and 708 adults whose eczema was not controlled by skin treatments. The trial gave 300 mg weekly, 300 mg every other week, or placebo for 16 weeks. The main measure was skin rated clear or almost clear, with at least a 2-point improvement on a physician's scale.

Itch, anxiety and depression symptoms and quality of life also improved. Injection-site reactions and conjunctivitis were more frequent on the drug. The authors wrote that longer trials were needed to assess long-term effectiveness and safety (Simpson 2016). More on eczema itself is on the Eczema page.

Prurigo nodularis: PRIME and PRIME2

Prurigo nodularis causes intensely itchy skin nodules; the disease is also covered on the Itching page. These trials enrolled 151 and 160 adults with at least 20 nodules and severe itch. The trial gave 300 mg or placebo every 2 weeks for 24 weeks. An itch score drop of at least 4 points was reached by 60.0% against 18.4% at week 24 in PRIME, and by 37.2% against 22.0% at week 12 in PRIME2 (Yosipovitch 2023).

Chronic spontaneous urticaria: the CUPID studies

The results differed by the group studied. In Study A (138 people who had never had omalizumab), the urticaria activity score improved by 8.5 points more than placebo, and the itch score by 4.2 points more. In Study B (108 people who had not tolerated or not fully responded to omalizumab), the activity score improved by 5.8 points more than placebo and itch by 2.9 points more, which was not statistically significant. The authors state that the primary end point for Study B was not met and that the effects in this group were small (Maurer 2024).

A replicate trial, CUPID Study C, enrolled 151 people who had never had an anti-immunoglobulin E drug. Itch improved by 2.54 points more than placebo and the activity score by 4.65 points more. Side effects were reported by 53.5% on the drug and 55.9% on placebo in the pooled data from Studies A and C (Casale 2026). The disease is described on the Chronic Urticaria page.

Bullous pemphigoid: ADEPT

The label describes this 52-week trial of 106 adults with moderate-to-severe disease. All of them also received oral corticosteroids with a planned taper, and the mean age was 71.3 years. The numbers at week 36, drug against placebo:

The trial's design was published in advance (Murrell 2024). The searches for this page found that design paper and the label's results, but not a full journal report of the results. The wider picture of this disease and its other treatments is on the Bullous Pemphigoid page.

Pivotal Trials in the Airways and Sinuses

Asthma: QUEST and VENTURE

QUEST enrolled 1902 people aged 12 and over with uncontrolled asthma, for 52 weeks. The trial gave 200 mg or 300 mg every 2 weeks, or matching placebo. At the lower dose, severe attacks ran at 0.46 per year against 0.87 on placebo, a 47.7% lower rate, and results were similar at the higher dose. Air blown out in the first second rose by 0.32 liters at week 12, which was 0.14 liters more than placebo. In people with at least 300 blood eosinophils per cubic millimeter, the rates were 0.37 against 1.08, a 65.8% lower rate. Blood eosinophilia appeared in 4.1% on the drug and 0.6% on placebo (Castro 2018).

VENTURE enrolled 210 people with severe asthma who were taking oral corticosteroids, for 24 weeks. The steroid dose fell 70.1% on the drug against 41.9% on placebo, and 48% against 25% stopped oral steroids completely. Severe attacks ran 59% lower. Transient blood eosinophilia appeared in 14% against 1% (Rabe 2018). See also the Asthma page.

Chronic rhinosinusitis with nasal polyps: SINUS-24 and SINUS-52

These trials enrolled 276 and 448 adults with severe disease, who received the drug on top of standard care. The trial gave 300 mg every 2 weeks, and SINUS-52 also tested a schedule that dropped to every 4 weeks after week 24. At 24 weeks, compared with placebo:

The most common side effects, including worsening polyps and asthma, headache and nosebleed, were more frequent on placebo (Bachert 2019). The condition is described on the Nasal Polyps page.

Allergic fungal rhinosinusitis: AIMS

This 52-week trial is small, with 33 people on the drug and 29 on placebo. The sinus scan score was 7.36 points lower than placebo at week 52. The risk of needing systemic corticosteroids or sinus surgery was 92% lower (Luong 2026). The label gives the raw counts: 1 of 33 against 9 of 29 received systemic corticosteroids, and 0 of 33 against 2 of 29 had surgery.

Chronic obstructive pulmonary disease: BOREAS and NOTUS

Both trials enrolled people with a blood eosinophil count of at least 300 per microliter. The trial gave 300 mg or placebo every 2 weeks for 52 weeks.

The label's indication covers only the eosinophilic pattern of this disease. The disease is described on the Chronic Obstructive Pulmonary Disease page.

Pivotal Trials in Eosinophilic Esophagitis

In this disease, eosinophils pile up in the wall of the esophagus and make swallowing difficult. The trial in people aged 12 and over had three parts, and the main results came from Parts A and B at week 24. Remission on biopsy meant 6 or fewer eosinophils per high-power microscope field.

The swallowing score tells a different story from the biopsy. It improved with weekly dosing, by 12.32 points more than placebo in Part A and 9.92 points more in Part B. It did not improve with every-2-week dosing, where the difference was 0.51 points (Dellon 2022).

The EoE KIDS trial enrolled children aged 1 to 11 for 16 weeks, with dosing tiered by body weight. Remission occurred in 25 of 37 (68%) on the higher-exposure schedule, 18 of 31 (58%) on the lower-exposure schedule, and 1 of 34 (3%) on placebo. COVID-19, nausea, injection-site pain and headache were each at least 10 percentage points more common on the drug (Chehade 2024). A later analysis noted that the trial was not powered to detect a significant difference on its main symptom measure: the share of days with a sign of the disease fell 48.5% on the higher-exposure schedule against 19.65% on placebo (Chehade 2026). More on the disease is on the Eosinophilic Esophagitis page.

What the Label Warns About

The label states one contraindication: known hypersensitivity to dupilumab or any of its ingredients. Its Warnings and Precautions section covers the following.

In the pooled atopic dermatitis trials without skin steroids, through week 16, injection-site reactions occurred in 10% against 5% on placebo, conjunctivitis in 10% against 2%, and oral herpes in 4% against 2%. In those trials 1.9% of each group stopped treatment because of side effects.

On pregnancy, the label says case reports and case series have not identified a drug-associated risk of major birth defects, miscarriage or other adverse outcomes, and that a pregnancy registry exists. Antibodies of this class cross the placenta, most of all in the third trimester. There are no data on the drug in human milk.

Eye-Surface Side Effects

Conjunctivitis was the top safety signal in one analysis of US adverse event reports (Cabrera-Perez 2025), and its frequency depends strongly on which disease is being treated.

A review of the placebo-controlled trials found conjunctivitis more frequent with the drug in most atopic dermatitis trials, and linked it to more severe eczema and an earlier history of conjunctivitis. Most cases were mild to moderate and recovered during treatment. Two people permanently stopped the drug because of conjunctivitis or keratitis. The authors wrote that the cause and treatment need further study (Akinlade 2019). A meta-analysis of 23 randomized trials and 9153 patients put the risk ratio at 2.43 in atopic dermatitis, and at 0.71 in other diseases, where no increase was found (Lin 2023).

The label gives the same pattern by disease, drug against placebo:

Studies that examine the eyes directly report higher figures. A Dutch cohort examined 150 adults with atopic dermatitis before and during treatment. Ocular surface disease was already present in 94.0% at the start, though only 60.0% reported eye symptoms. During 28 weeks, 30.7% developed disease attributed to the drug, and the share using eye medication rose from 15.3% to 64.7%. The number of conjunctival goblet cells, which make the mucus layer of the tear film, stayed stable but low, while one of their mucin products, MUC5AC, fell (Veldhuis 2026). In a Dutch registry of 309 children, this was the most frequently reported side effect, at 36.6% (Vroman 2026).

Reports to the US Food and Drug Administration Adverse Event Reporting System produced 85 eye-surface signals, with dry eye the most reported at 3503 reports (Chen 2026). Such a database cannot give a true rate, since nobody knows how many people were exposed or how many events went unreported.

Severe outcomes are on the label from post-approval use, where it states that frequency cannot be reliably estimated: ectropion, scarring eyelid disease, narrowing of the tear drainage openings, symblepharon, and temporary or ongoing vision loss, including visual impairment and blindness associated with conjunctivitis, keratitis or blepharitis. The label says the drug is used with caution in people with significant dry eye, a history of significant eyelid abnormalities or surgery, or tear duct surgery. It also describes prompt eye examination and possibly stopping the drug when signs suggest keratitis, or when conjunctivitis or blepharitis does not resolve with standard treatment. Background on the condition is on the Conjunctivitis page.

Joint Pain and Arthritis Reports

The label's trial tables show arthralgia, meaning joint pain, slightly more often on the drug than on placebo:

The label adds that some people reported trouble walking or reduced mobility, and that some cases led to hospital admission. Onset ranged from days to months after the first dose. New-onset psoriatic arthritis needing systemic treatment has been reported. Some people's symptoms resolved while they stayed on the drug, and others recovered or were recovering after stopping it.

One center recorded 470 people with atopic dermatitis starting the drug. Of 36 referred for rheumatology assessment, 26 had a syndrome of inflammation at tendon attachments (enthesitis), arthritis or tendon-sheath inflammation, confirmed on ultrasound and magnetic resonance imaging. Symptoms were mild in 16, moderate in 6 and severe in 4. Anti-inflammatory drugs, a reduced dose or stopping the drug led to improvement, but moderate or severe symptoms persisted for many months. All 26 had a very good response of their eczema to the drug (Hughes 2023).

A literature review notes that the drug has been linked to diseases driven by T helper 17 cells, including seronegative arthritis and enthesitis, and says the problem is probably underestimated (Napolitano 2024).

In the US Food and Drug Administration's adverse event database, 5055 of 207,370 reports (2.4%) involved joint-related events. The share was highest in reports for nasal polyps (11.2%), then asthma (8.7%) and atopic dermatitis (4.7%), and adults aged 50 and over stood out. The authors note that the database cannot calculate an incidence (Annadata 2025).

Rashes, Psoriasis and Head-and-Neck Dermatitis

Redness of the face and neck

The label lists facial skin reactions from post-approval use: redness, rash, scaling, swelling, bumps, itch, burning and pain. A 2026 systematic review gathered 867 cases of face and neck redness. It was new in 54.9% and a worsening of earlier redness in 39.2%.

The reported causes included allergic contact dermatitis (21.2%), hypersensitivity to Malassezia, a yeast living on the skin (13.5%), and leftover eczema (2.8%). Reported complete resolution was 69.6% (16 of 23) with antifungal creams, 66.1% (82 of 124) with oral antifungals, and 100% (35 of 35) with upadacitinib. Of those who continued the drug with no added treatment, 27.7% (13 of 47) cleared. The authors warn of non-standard reporting, no controlled comparisons and possible publication bias (Jo 2026).

A multicentre prospective study linked the problem to raised Malassezia-specific immunoglobulin E before treatment (Kozera 2022).

Psoriasis

The label reports new-onset psoriasis, starting weeks to months after the first dose, with partial or complete resolution after the drug was stopped in postmarketing reports. Those who stayed on the drug received added psoriasis treatment.

A 2026 cohort study using two large health-record networks compared people with atopic dermatitis on this drug with those on other treatments. It found no increase over two years against topical corticosteroids (hazard ratio 0.91), other anti-type 2 biologics (1.03) or Janus kinase inhibitors (0.86). The authors say the data do not support a risk specific to this drug and may reflect diagnostic uncertainty or genetic susceptibility, and that prospective studies are needed (Block 2026).

Reports of Cutaneous T-Cell Lymphoma Being Unmasked

Cutaneous T-cell lymphoma is a cancer of T cells that lodges in the skin. One form, mycosis fungoides, can be mistaken for eczema, which is the root of this question (Xu 2026). The label text read for this page does not contain the words lymphoma or malignancy. What exists is a set of published reports and database studies, and they disagree on what the signal means.

The case reports

One published letter describes a 65-year-old man whose first skin biopsy looked like eczema. His eczema improved on the drug, but 6 months later a new rash appeared and biopsy showed mycosis fungoides, which progressed rapidly (Toker 2023). A 2026 review counts 178 reported cases of cutaneous T-cell lymphoma linked to the drug in atopic dermatitis between 2017 and 2023 (Xu 2026).

Three explanations in the literature

The numbers

Asthma is where the disagreement is sharpest. The 2026 review reasons that causation is unlikely partly because these lymphomas have appeared only in people treated for atopic dermatitis (Xu 2026). Yet a large US cohort of people with asthma found 54 lymphomas on the drug against 43 on inhaled combination treatment after matching, a hazard ratio of 1.79, with 19 against 10 or fewer T-cell and natural killer cell lymphomas. All-cause death in the same study was lower on the drug (328 against 793, hazard ratio 0.65) (Ma 2025). Other researchers published a letter arguing that this study has methodological flaws and is biologically implausible (Bacharier 2026).

The published work reports an association. Whether the drug causes these lymphomas, reveals them, or both remains unsettled. The sources read for this page include no randomized trial designed to answer it.

Eosinophilia and Eosinophilic Conditions

Eosinophils are white blood cells involved in allergy and in the response to parasites. A rise in their blood count during treatment is a well-documented effect that varies by disease.

The label reports an initial rise in atopic dermatitis, asthma, nasal polyps and chronic obstructive pulmonary disease. At early time points, mean increases were 100 cells per microliter in adults with atopic dermatitis, 130 in asthma, 150 in nasal polyps and 60 in chronic obstructive pulmonary disease, and 478 in children under 6 with atopic dermatitis. The medians were much smaller, from 0 to 90. No rise over placebo was seen in eosinophilic esophagitis or chronic spontaneous urticaria. In the chronic obstructive pulmonary disease trials, counts of at least 1000 occurred in 13.6% against 8.1% on placebo. In bullous pemphigoid, counts of at least 500 occurred in 21% against 11%.

A study from 14 Italian centers followed 564 people with nasal polyps. By its definition, 48.2% developed the rise, and the mean count peaked at 3 months and fell by 12 months. Most were early and temporary (30.7% of all patients), while 14.4% were early and persistent and 3.2% started late. It was more common in people with asthma and earlier oral steroid use. Counts above 1500 were linked to mild side effects. The authors call the phenomenon mostly transient and harmless (De Corso 2026).

Serious cases have also been reported. The label describes eosinophilic pneumonia and eosinophilic granulomatosis with polyangiitis, a blood vessel inflammation, in people treated for asthma and in those with both asthma and nasal polyps. The signs it lists are vasculitic rash, worsening lung symptoms, heart complications, kidney injury and neuropathy in someone with eosinophilia. Published case reports include:

What Is Known and Unknown About Long-Term Use

What the long studies show

What remains open

Key Research Papers

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  3. Yosipovitch G, Mollanazar N, Ständer S, Kwatra SG, Kim BS, Laws E, et al. Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials. Nat Med. 2023;29(5):1180-1190. PubMed PMID: 37142763
  4. Maurer M, Casale TB, Saini SS, Ben-Shoshan M, Giménez-Arnau AM, Bernstein JA, et al. Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): Two randomized, double-blind, placebo-controlled, phase 3 trials. J Allergy Clin Immunol. 2024;154(1):184-194. PubMed PMID: 38431226
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PubMed Topic Searches

  1. PubMed: dupilumab phase 3 trials
  2. PubMed: dupilumab and ocular surface disease
  3. PubMed: dupilumab, arthritis and enthesitis
  4. PubMed: dupilumab and cutaneous T-cell lymphoma
  5. PubMed: dupilumab and eosinophilia

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