Real-world experience of dupilumab in the treatment of moderate-to-severe atopic dermatitis.

Dear Editor,

Atopic dermatitis (AD) is a chronic inflammatory skin condition marked by intense, persistent pruritus and epidermal barrier dysfunction. , Dupilumab is a monoclonal antibody that inhibits IL (interleukin)‐4 and IL‐13, resulting in the downregulation of epidermal proliferation and inflammatory mediators, consequently promoting normalization of the skin. Clinical trials have demonstrated the efficacy of dupilumab treatment in AD and supported an acceptable side effect profile. , There is currently limited evidence for its use in real‐world clinical practice. , , , , Therefore, the aim of this study is to analyze the safety and efficacy of dupilumab in a real‐world Canadian dermatology practice.

A retrospective chart review was conducted at a dermatology clinic in Ontario, Canada, from September 2018 to June 2019. Patients were included if they had moderate‐to‐severe AD and received at least one dose of dupilumab. At the prescriber’s discretion, some patients received concomitant topical or systemic treatment in addition to dupilumab for the optimal control of symptoms. All patients were administered a 600 mg loading dose of dupilumab given by subcutaneous injection, followed by 300 mg every 2 weeks. Safety was assessed by recording adverse events (AEs). An evaluation of overall response to treatment was done with a description of patient satisfaction and clinical response recorded in the patient's clinical chart at each visit.

Baseline characteristics of 34 patients in this study cohort are outlined in Table 1. Of the 34 patients analyzed, 20 (58.9%) reported an AE (Table 2). There was an average of 1.5 ± 1.6 AEs reported per patient on dupilumab. The most frequently reported AEs included nasopharyngitis (n = 4, 11.8%) and conjunctivitis (n = 4, 11.8%). Dupilumab was discontinued in two patients: one due to persistence of the disease and the other due to an AE of the development of swollen glands, otalgia, and myalgias.

Table 1

Characteristics of the study cohort of patients treated with dupilumab (n = 34)

Variable	Value (%)
Sex, N (%)
Female	20 (58.8)
Age, mean ± SD, years
Mean age	50.1 ± 13.4
Dose administered
Biweekly 300 mg subcutaneous injections	34 (100)
Duration on dupilumab administration
Mean duration ± SD, years	1.8 ± 1.4
Shortest duration, years	0.1
Longest duration, years a	4.5
No of previously failed therapies, mean ± SD	4.8 ± 2.0
Topical therapies failed prior to dupilumab first dose, N (%)
Topical corticosteroids	34 (100)
Tacrolimus	18 (53)
Calcipotriol	4 (12)
Pimecrolimus	3 (9)
Crisaborole	3 (9)
Conventional systemic therapies prior to dupilumab first dose, N (%)
Methotrexate	19 (56)
Prednisone	17 (50)
Phototherapy	17 (50)
Cyclosporine	15 (44)
Antihistamine	9 (26)
Triamcinolone acetonide (intramuscular)	7 (21)
Alitretinoin	6 (18)
Azathioprine	3 (9)
Apremilast	2 (6)
No of concomitant therapies with dupilumab, mean ± SD	1.7 ± 0.9
Concomitant topical therapies with dupilumab N (%)
Topical corticosteroids	26 (76)
Tacrolimus	10 (29)
Calcipotriol	1 (3)
Crisaborole	3 (9)
Concomitant systemic therapies with dupilumab N (%)
Methotrexate	6 (18)
Antihistamine	6 (18)
Prednisone	1 (3)
Cyclosporine	1 (3)
Phototherapy	1 (3)
Alitretinoin	1 (3)

SD, standard deviation.

Includes patients who completed a dupilumab clinical trial.

Table 2

Safety outcomes of patients treated with dupilumab (n = 34)

Variable	Value (%)
Reported AEs per patient, N (%)
0	14 (41.2)
1	5 (14.7)
2	4 (11.8)
3	7 (20.6)
4	3 (8.8)
5	1 (2.9)
Mean ± SD	1.5 ± 1.6
AEs reported >1, N (%)
Nasopharyngitis	4 (11.8)
Conjunctivitis	4 (11.8)
Hypertension exacerbation	3 (8.8)
Chest pain	2 (5.9)
Injection site reaction	2 (5.9)

AE, adverse events; SD, standard deviation.

Of our cohort, 33/34 showed some clinical improvement upon initiating dupilumab. Although most patients demonstrated a positive response, formal objective assessments were not completed for all patients. Clinical response to dupilumab was generally performed with the use of a global assessment scale to describe the overall appearance of the skin lesions (described as clear, almost clear, mild, moderate, or severe). There were variations in the degree to which the AD was controlled which may have been related to patient variability in the use of concomitant therapies.

Our results confirm that dupilumab provides promising clinical improvement in patients suffering from moderate‐to‐severe AD in real‐world practice. In regards to safety, in this cohort, 11.8% of patients reported nasopharyngitis and 11.8% reported conjunctivitis compared to 15.7% and 8.0%, respectively, in clinical trials. Moreover, 5.9% of patients reported injection site reactions compared to 13.2% of patients in clinical trials.

Our main study limitation is that of small numbers, and because our study was conducted in a busy community practice, it was not practical to measure objective indices of efficacy such as eczema area and severity index (EASI) and Scoring AD (SCORAD) for each patient at every visit. There are also inherent limitations of chart reviews which can be a threat to both internal bias (confounding bias) and external validity.

In conclusion, in real‐world practice, our evaluation of dupilumab indicates that its use has both a lack of serious adverse effects and provides clinical improvement in a majority of patients with moderate‐to‐severe AD. Furthermore, in the context of the coronavirus disease 2019 (COVID‐19) pandemic, the European Task Force on Atopic Dermatitis (ETFAD) has expressed that the use of dupilumab should be preferred over conventional systemic immune‐suppressive treatments for the management of AD. We support the clinical value of dupilumab as a promising therapy for the treatment of AD in our current landscape.