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Relato de caso de paciente com rinossinusite crônica com polipose nasal em tratamento com dupilumabe. São descritos os aspectos clínicos e o impacto na qualidade da vida do paciente. Imagens tomográficas evidenciam a melhora do processo inflamatório e a regressão dos pólipos nasais.
We report the case of a patient with chronic rhinosinusitis with nasal polyps treated with dupilumab. The clinical features and impact on the patient's quality of life are described. Computed tomography shows improvement of the inflammatory process and regression of the nasal polyps.
Subject(s)
Humans , Male , Middle Aged , Antibodies, Monoclonal , Anti-Inflammatory Agents, Non-SteroidalABSTRACT
Abstract Background: Prurigo nodularis (PN) is a chronic inflammatory skin condition that has a significant unmet needs for effective treatment options. Objective: To assess the efficacy and safety of dupilumab in adult patients with PN refractory to traditional therapies. Methods: This ongoing, real-life study examined dupilumab treatment in 8 adult patients diagnosed with PN for at least 6 months. The included patients were prescribed 300 mg dupilumab biweekly for at least 16 weeks. Efficacy was the primary outcome by means of multiple standardized scale measurements while safety was also reported. Results: PN patients treated with dupilumab showed notable clinical improvement. After 16 weeks of dupilumab treatment, the mean Investigator Global Assessment (IGA) score reduced from 3.75 to 1.50. Patients mean Numerical Rating Scale Itch Intensity (NRSI), Dermatology Life Quality Index (DLQI), and Hospital Anxiety and Depression Scale (HADS) ratings reduced from 8.625, 15.13, and 14.50 to 1.563, 4.625, and 1.000 respectively. The majority of the patients (87.5%) reported dupilumab as effective while no adverse events have been reported. Study limitations: This study was limited to a small cohort of adult PN patients and a short-time observation period. Conclusions: Dupilumab is effective and tolerable in adult PN patients with significant improvement in skin lesions, itching, and quality of life.
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Objective:To investigate the clinical efficacy and safety of Dupilumab on the treatment of asthma combined with atopic dermatitis (AD) and other type 2 inflammatory co-morbidities in children.Methods:Clinical data of children with asthma combined with AD, allergic rhinitis (AR) type 2 inflammatory co-morbidities who received Dupilumab treatment for 16 weeks or longer in the Pediatric Asthma and Allergy Clinic of the Second Hospital of Tianjin Medical University from April 1, 2021 to September 1, 2022 were retrospectively analyzed.The efficacy and safety of Dupilumab on the treatment of asthma combined with AD and AR in children were assessed by comparing clinical symptoms before and after 16 weeks of treatment, changes in the dosage of inhaled corticosteroids (ICS), lung function, fractional exhaled nitric oxide (FeNO), and peripheral blood eosinophil (EOS) count, and the incidence of adverse events, respectively.The correlation between the efficacy on AD, AR and asthma was assessed.Quantitative indicators that were normally distributed were compared by the paired samples t-test; otherwise, they were compared by rank- sum test.The correlation between different indicators was compared by Spearman rank correlation test. Results:(1) Ten children with asthma combined with AD, AR were recruited, including 8 males and 2 females, with the mean age of 9 (4-14) years.Three children were previously treated with subcutaneous immunotherapy (SCIT) prior to Dupilumab treatment, and 1 child was transferred to Dupilumab treatment because of a poor responsiveness to Omalizumab.(2) Improvement of asthma: after 16 weeks of treatment, asthma symptoms were well controlled in the 10 children, and none of them had acute asthma attacks.The childhood asthma control test for children and asthma control questionnaire findings were significantly improved from baseline (all P<0.05). Forced expiratory volume in the first second to the predicted value was significantly improved from baseline ( P<0.05). The dosage of ICS [all converted to Beclomethasone Dipropionate, 0 (0, 125.00) μg/d vs.400.00 (200.00, 400.00) μg/d] and FeNO level [11.00(9.00, 19.25)×10 -9vs.38.00(18.25, 56.75)×10 -9] significantly decreased from baseline (all P<0.05). Serum T-IgE testing before and after treatment were performed in 3 children, which were significantly reduced at 16 weeks of treatment compared with baseline (case 1: 2 759 kU/L vs.>5 000 kU/L; case 2: 1 432 kU/L vs.3 546 kU/L; case 3: 655 kU/L vs.1 000 kU/L, all P<0.05). (3) Improvement of asthma co-morbidities: The scoring atopic dermatitis scores, and patient-oriented eczema measure scores at each time point of follow-up decreased significantly compared with baseline (all P<0.001). The overall peripheral blood EOS count increased during the treatment period compared with baseline[1.18(0.62, 1.51)×10 9/L vs.1.01(0.54, 1.90)×10 9/L, P=0.444], although no significant difference was detected.Visual analog scale and total rhinitis medication scores decreased significantly compared with baseline (all P<0.05). (4) There was a positive correlation between baseline AD severity and the therapeutic efficacy on asthma ( r=0.697, P=0.025). (5) Safety: during the treatment, one case developed bilateral conjunctivitis and one developed bilateral bulbar conjunctival hemosiderosis, both of whom were improved after symptomatic treatment. Conclusions:Dupilumab treatment significantly improves clinical symptoms of asthma, AD and AR in children with asthma combined with AD, AR type 2 inflammatory co-morbidities, which also reduces ICS dosage, FeNO level, rhinitis medication and serum T-IgE level, and improve pulmonary function, with a good safety profile.It is a promising treatment to children with type 2 inflammatory disease who have a poor Omalizumab efficacy, and its combination with SCIT is a favorable etiologic treatment.
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Food-dependent, exercise-induced anaphylaxis (FDEIA) is a potentially life-threatening disorder that often occurs with exercise, and patients typically have eaten a specific food within hours before disease onset. This disease is exceedingly rare, with a prevalence of 0.02%. No well-recognized prevention or treatment strategy has been available for FDEIA except avoiding triggers strictly. Here we report an 11-year-old boy with a history of recurrent anaphylaxis of unknown etiology more than 10 times within two years. As the anaphylactic symptoms had not been controlled after traditional treatments, the patient was given subcutaneous injection of dupilumab seven times within 33 weeks. During dupilumab treatments, the patient was exposed to culprit mushrooms plus exercises at least twice a month but without notable anaphylaxis. Thus, Dupilumab may improve the allergic reactions in FDEIA patients.
Subject(s)
Male , Humans , Child , Anaphylaxis/etiology , Food Hypersensitivity/diagnosis , Exercise-Induced Allergies , Antibodies, Monoclonal, Humanized/therapeutic useABSTRACT
OBJECTIVE To analyze the clinical manifestation and characteristics of ocular adverse drug reaction （ADR） related to dupilumab， so as to provide reference for clinically safe drug use. METHODS Retrieved from CNKI， Wanfang data， VIP and PubMed databases， the case reports about ocular ADR caused by dupilumab were collected， and then analyzed statistically in terms of gender， age， primary disease， drug use， occurrence time of ADR， main clinical manifestations， treatment or outcome， etc. RESULTS A total of 20 pieces of literature were selected， involving 46 patients， among which there were 29 males and 17 females. Mainly patients were under 60 years old. The results of the association evaluation was given as follows： 13 were “very likely” and 33 were “likely”. All patients were treated with dupilumab for atopic dermatitis （AD） without off-label medication. The occurrence time of ADR was 2 weeks to 2 years after administration， mainly within 6 months after medication. All patients received dupilumab monotherapy except that 3 patients with hypertension and 1 patient with chronic obstructive pulmonary disease and human immunodeficiency virus received other drugs simultaneously. Twenty-eight patients had a history of allergic disease， and 11 patients had a history of eye disease. Ocular ADRs were mainly conjunctivitis and uveitis， and the clinical manifestations mainly included conjunctival congestion， swelling， eye secretions， etc. Ten patients developed severe ADR， including uveitis， severe conjunctivitis， and tear point stenosis； 45 patients were improved after symptomatic treatment. AD， serious initial symptoms of AD， allergic disease and underlying ocular diseases might be the high-risk factors of ocular ADR caused by dupilumab. CONCLUSIONS Whether the patient has the history of allergic diseases and basic eye diseases should be asked in detail before clinical use of dupilumab. When using the drug， attention should be paid to monitoring whether the patient has intraocular inflammation， be alert to the occurrence of new or serious ADR， and give timely symptomatic treatment to ensure the safety of drug use.
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Monogenic inherited skin diseases are a group of clinically rare diseases that include nearly 1000 phenotypically distinct disorders. Through the concerted efforts of researchers in dermatological sciences and related disciplines worldwide, many advances have been made in the etiology and pathogenesis of these diseases in the last 30 years. However, it is important to note that the treatment of the majority of monogenic inherited skin diseases remains a challenge for clinicians. Dupilumab is a fully human monoclonal IgG4 antibody that specifically binds to the α subunit of the IL-4 receptor, thereby inhibiting the IL-4 and IL-13 signaling pathway. It was first approved for the treatment of moderate-to-severe atopic dermatitis (AD) and has been used worldwide. In recent years, the drug has been successfully used to treat some monogenic inherited skin diseases with AD-like clinical manifestations, such as hyper-IgE syndrome and Netherton syndrome, with good efficacy. The drug was later tried for the treatment of other monogenic inherited skin diseases, such as Hailey-Hailey syndrome and epidermolysis bullosa pruriginosa, where it was also proven to be effective. In this paper, we review literature reports related to dupilumab for the treatment of monogenic inherited skin diseases in recent years, focusing on its efficacy, safety and possible therapeutic mechanisms. We aim to provide a possible scientific basis for the future application of this drug in the field of rare monogenic inherited skin diseases.
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Objective:To evaluate clinical efficacy and safety of dupilumab in the treatment of moderate and severe atopic dermatitis (AD) in the elderly.Methods:An observational study was conducted, and a total of 42 elderly patients with moderate to severe AD were collected from Department of Dermatology, the First Affiliated Hospital of Soochow University from September 2021 to June 2022. These patients all received subcutaneous injection of dupilumab at an initial dose of 600 mg, followed by every-2-week injections at a dose of 300 mg, and the total course of treatment was 16 weeks. Clinical indicators, including eczema area and severity index (EASI) , numerical rating scale (NRS) , dermatology life quality index (DLQI) and investigator′s global assessment (IGA) , were recorded at weeks 0, 4, 8, 12 and 16, and the proportion of patients achieving more than 50% (EASI-50) and 75% (EASI-75) improvement in EASI scores were calculated; related laboratory indicators, including total serum immunoglobulin E (IgE) levels and eosinophil counts, were recorded at weeks 0, 4 and 16. During the treatment, adverse events were recorded. Statistical analysis was carried out by using chi-square test, one-way analysis of variance and t test with SPSS27 and GraphPad Prism 9.0 software. Results:Among the 42 patients, there were 25 males (59.5%) and 17 females (40.5%) , and their age was 71.82 ± 16.81 years. Among them, 17 patients (40.5%) presented with generalized eczema phenotype, 15 (35.7%) with flexor eczema phenotype, and 10 (23.8%) with prurigo nodularis phenotype. At weeks 4 and 16 after start of the treatment, the mean EASI score significantly decreased by 38.4% and 73.3% respectively, the mean NRS score significantly decreased by 53.0% and 77.4% respectively, and the mean DLQI score significantly decreased by 58.2% and 93.8% respectively compared with the corresponding scores before the treatment ( P < 0.05 or 0.001) . At weeks 4 and 16, the proportions of patients achieving an IGA score of 0 or 1 were 11.9% and 61.9% respectively, the proportions of patients achieving EASI-50 were 11.9% and 76.2% respectively, and the proportions of patients achieving EASI-75 were 2.4% and 57.1% respectively. Compared with the baseline levels, the mean total serum IgE level decreased by 23.1% and 38.2% at weeks 4 and 16 respectively ( P = 0.274, 0.395, respectively) , and the mean eosinophil count decreased by 24.4% and 37.5% at weeks 4 and 16 respectively ( P = 0.059, 0.735, respectively) . During the treatment, mild adverse events occurred in 6 (14.3%) patients, including conjunctivitis (3 cases) , fungal infection of the head and face (2 cases) , and psoriasiform dermatitis (1 case) , which subsided after symptomatic treatment. Conclusion:Dupilumab exhibited a rapid onset and marked efficacy in the treatment of moderate and severe AD in the elderly, with few and mild adverse events; however, some patients had not achieved EASI-50 or EASI-75 after 16-week treatment, and maintenance treatment was required.
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Objective: To compare the costs of dupilumab and omalizumab for treating severe allergic asthma patients from the perspective of the Brazilian private healthcare system. Methods: Using clinical and demographic inputs from the literature, we simulated a cohort of 5,000 severe allergic asthma patients and estimated the treatment cost with omalizumab. Results: In the simulated cohort, 81.3% were female, the mean body weight was 75.1 kg (SD 13.1), and the mean serum IgE was 532 IU/mL (SD 688). All patients were eligible for treatment with dupilumab, but 830 (16.6%) were ineligible for treatment with omalizumab due to serum IgE level and/or body weight combinations, according to the product label. Over four weeks, the mean dose of omalizumab was 537 mg (SD 285). The annual mean per-patient cost for treatment with omalizumab was BRL 110,783.89 (SD 58,385.81), ranging from BRL 31,797.49 to BRL 246,643.15. The treatment cost with dupilumab is BRL 111,724.21 for the first year and BRL 107,599.91 for subsequent years. Conclusions: We observed slightly lower mean treatment costs with dupilumab than with omalizumab. However, while the treatment cost with dupilumab is fixed and predictable, the treatment cost with omalizumab is highly variable, depending on patients' characteristics. Health managers should consider these findings for reimbursement and clinical protocol development decisions.
Objetivo: Comparar os custos de dupilumabe e omalizumabe para o tratamento de pacientes com asma alérgica grave na perspectiva do sistema de saúde privado brasileiro. Métodos: Utilizando parâmetros clínicos e demográficos a partir de dados da literatura, simulamos uma coorte com 5.000 pacientes com asma alérgica grave e estimamos o custo de tratamento com o omalizumabe. Resultados: Na coorte simulada, 81,3% eram do sexo feminino, com peso médio de 75,1 kg (DP 13,1) e IgE sérica de 532 IU/mL (DP 688). Todos os pacientes eram elegíveis para o tratamento com dupilumabe, porém 830 (16,6%) não eram elegíveis para o tratamento com omalizumabe devido a combinações específicas de IgE sérica e/ou peso corporal, de acordo com a bula do produto. Para o período de 4 semanas, a dose média de omalizumabe foi de 537 mg (DP 285). O custo médio anual por paciente do tratamento com omalizumabe foi de R$ 110.783,89 (DP 58.385,81), variando de R$ 31.797,49 a R$ 246.643,15. O custo do tratamento com dupilumabe é de R$ 111.724,21 no primeiro ano e R$ 107.599,91 nos anos seguintes. Conclusões: Foi observado que o custo médio do tratamento com dupilumabe é ligeiramente menor que o custo com omalizumabe. Todavia, enquanto o custo do tratamento com dupilumabe é fixo e previsível, o custo do tratamento com omalizumabe é altamente variável, dependendo de características dos pacientes. Esses achados devem ser considerados pelos gestores de saúde para decisões sobre reembolso e desenvolvimento de protocolos clínicos.
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Asthma , Costs and Cost Analysis , OmalizumabABSTRACT
A dermatite atópica (DA) é uma doença cutânea inflamatória, crônica, comum, complexa e de etiologia multifatorial, que se manifesta clinicamente com prurido muitas vezes incapacitante, lesões recorrentes do tipo eczema, xerose e que pode evoluir para liquenificação. Embora o conhecimento sobre a sua fisiopatologia venham crescendo nos últimos anos, ainda as formas graves são frequentes e representam um desafio para o clínico. Para o presente guia realizou-se revisão não sistemática da literatura relacionada à DA grave refratária aos tratamentos habituais com o objetivo de elaborar um documento prático e que auxilie na compreensão dos mecanismos envolvidos na DA, assim como dos possíveis fatores de risco associados à sua apresentação. A integridade da barreira cutânea é um dos pontos fundamentais para a manutenção da homeostase da pele. Além dos cuidados gerais: evitação dos agentes desencadeantes e/ou irritantes, o uso de hidratantes, suporte emocional, entre outros, o uso de agentes anti-inflamatórios/imunossupressores de uso tópico e/ou sistêmico também foi revisado. A aquisição de novos agentes, os imunobiológicos e as pequenas moléculas, melhorou a terapêutica para os pacientes com formas graves de DA, sobretudo as refratárias aos tratamentos convencionais.
Atopic dermatitis is a chronic, common, and complex inflammatory skin disease with a multifactorial etiology. It manifests clinically with often disabling pruritus, recurrent eczema-like lesions, and xerosis, and can progress to lichenification. Although understanding of the disease's pathophysiology has been growing in recent years, severe forms are still frequent and represent a challenge for clinicians. A non-systematic review of the literature on severe atopic dermatitis refractory to conventional treatment was conducted to develop the present guide, whose purpose is to help clarify the mechanisms involved in the disease and possible risk factors. The integrity of the skin barrier is fundamental for maintaining skin homeostasis. In addition to general care, patients should avoid triggering and/or irritating agents and moisturizers and seek emotional support, etc.; the use of topical and/or systemic anti-inflammatory/immunosuppressive agents was also reviewed. New agents, immunobiologicals, and small molecules have led to a broader range of therapies for patients with severe forms of the disease, especially cases refractory to conventional treatment.
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Humans , Societies, Medical , Immunoglobulin E , Cyclosporine , Adrenal Cortex Hormones , Calcineurin Inhibitors , Antibodies, MonoclonalABSTRACT
This clinical data of 3 cases of severe atopic dermatitis (AD) who had no remission after taking to-pical glucocorticoids and antihistamines were collected retrospectively.The patients were treated with Dupilumab in the Department of Pediatrics, the Second Hospital of Tianjin Medical University from April to October 2021.All 3 cases developed eczema-like rashes with strong itching and sleep disturbance within the first year after their birth.The children′ quality of life was seriously impaired.All the cases were combined with allergic rhinitis, 2 cases of whom were simultaneously complicated with bronchial asthma.After 14-18 weeks of treatment, the rash, pruritic symptoms and quality of life were significantly improved.Meanwhile, rhinitis symptoms were reduced, asthma control scores and lung function were improved to varying degrees.No serious adverse reactions occurred during the injection period.
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This clinical data of 3 cases of severe atopic dermatitis (AD) who had no remission after taking to-pical glucocorticoids and antihistamines were collected retrospectively.The patients were treated with Dupilumab in the Department of Pediatrics, the Second Hospital of Tianjin Medical University from April to October 2021.All 3 cases developed eczema-like rashes with strong itching and sleep disturbance within the first year after their birth.The children′ quality of life was seriously impaired.All the cases were combined with allergic rhinitis, 2 cases of whom were simultaneously complicated with bronchial asthma.After 14-18 weeks of treatment, the rash, pruritic symptoms and quality of life were significantly improved.Meanwhile, rhinitis symptoms were reduced, asthma control scores and lung function were improved to varying degrees.No serious adverse reactions occurred during the injection period.
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Objective:To investigate clinical efficacy and safety of dupilumab in the treatment of atopic dermatitis (AD) .Methods:An ambispective study was conducted on 123 AD patients treated with dupilumab in Department of Dermatology, the Second Xiangya Hospital of Central South University from July 2020 to March 2022, clinical data were collected, and efficacy and safety of dupilumab were evaluated. Primary outcomes included scores of eczema area and severity index (EASI) , patient-oriented eczema measure (POEM) , peak pruritus numerical rating scale (NRS) and dermatology life quality index (DLQI) before and after 4-, 8-, 12- and 16-week treatment, and adverse reactions and events were recorded. Comparison of scores before and after treatment was performed using paired t test or repeated measures analysis of variance, Mann-Whitney U test was used for the comparison of efficacy among patients with different types of skin lesions or different IgE levels, and multiple regression model based on robust standard errors was used to analyze factors influencing the efficacy. Results:Among the 123 AD patients, 107 were enolled into the efficacy analysis, and 85 (79.44%) completed at least 4 weeks of treatment, including 6 (7.06%) achieving EASI75 and 23 (27.06%) achieving EASI50, and the EASI, NRS, POEM, DLQI scores (10.41 ± 6.72, 4.12 ± 1.74, 8.60 ± 4.29, 7.81 ± 4.38, respectively) significantly decreased compared with those before treatment (18.08 ± 10.69, 7.21 ± 2.01, 16.88 ± 5.74, 12.95 ± 5.95, respectively; all P < 0.001) in the 85 patients. Among the 107 patients, 47 (43.93%) completed at least 16 weeks of treatment. Among the 47 patients, 23 (82.14%) of 28 adults and 17 (89.47%) of 19 adolescents and children achieved 75% or greater improvement in EASI score; the EASI, NRS, POEM and DLQI scores before the treatment all significantly differred from those 4, 8, 12, 16 weeks after the treatment (all P < 0.001) , and all the scores were significantly lower at weeks 4, 8, 12 and 16 than at the previous adjacent time points (all P < 0.05) . At week 4 during the treatment, the EASI improvement rate was significantly lower in the AD patients with prurigo nodularis than in those without ( U = 151.00, P = 0.006) , while there was no significant difference in the EASI improvement rate between the AD patients with xeroderma and those without ( P > 0.05) ; at week 16 during the treatment, there was no significant difference in the EASI improvement rate between patients with prurigo nodularis or xeroderma and those without (both P > 0.05) . Multiple regression analysis based on robust standard errors at week 16 showed that the improvement degree in the EASI score was not correlated with the type of skin lesions ( β = 3.20, P = 0.075) , but correlated with age ( β = -0.22, P = 0.030) , whether patients were in adulthood ( β = 9.54, P = 0.049) , immediate family history ( β = 7.46, P = 0.017) ; the improvement degree in the NRS score was correlated with the type of skin lesions ( β = 0.55, P = 0.032) , age ( β = -0.04, P = 0.033) , weight ( β = -0.05, P = 0.020) , whether patients were in adulthood ( β = 2.06, P = 0.003) and whether patients received combined treatment with antihistamines ( β = -1.91, P = 0.001) . Adverse reactions: among the 123 patients, 6 (4.88%) developed conjunctivitis, and 2 (1.63%) developed facial erythema. Adverse events: vitiligo-like changes occurred on the right forehead of 1 patient, and 3 patients discontinued the treatment with dupilumab due to Henoch-Sch?nlein purpura, distal axonal damage in peripheral nerves in both upper limbs, and epilepsy, respectively. The causal relationship between these adverse events and dupilumab was unclear. Conclusion:Dupilumab is effective in the treatment of AD with high overall safety, and can serve as a new treatment option for AD patients with an unsatisfactory response to traditional treatment.
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Objective:To retrospectively analyze the efficacy and safety of dupilumab in the treatment of bullous pemphigoid (BP) .Methods:Clinical data were collected from BP patients who received injections of dupilumab at an initial dose of 600 mg followed by an every-2-week regimen at a dose of 300 mg (the frequency of injections could be increased if necessary) in Department of Dermatology, Peking University First Hospital from October 2020 to October 2021, and their clinical manifestations and changes in laboratory indices were analyzed.Results:A total of 21 BP patients treated with dupilumab were included in this study. Nineteen (90.5%) patients achieved complete or marked disease control after 2-week treatment with dupilumab; 12 patients were followed up for 16 weeks, and all maintained complete disease control at 16 weeks. All patients had a bullous pemphigoid disease area index (BPDAI) score of 122.5 ± 51.1 points at baseline, which decreased to 30.6 ± 27.4 points after 2-week treatment with dupilumab ( t = 8.53, P < 0.001) , and continued to decrease to 12.7 ± 9.1 points after 4-week treatment ( t = 9.73, P < 0.001) . Pruritus was markedly relieved in all the 21 patients within 4-week treatment with dupilumab. Among 10 patients with elevated eosinophil counts at baseline, the eosinophil counts markedly decreased in 9 after treatment. The serum IgE level was elevated in 7 patients at baseline, which markedly decreased in 6 after treatment. Viral conjunctivitis occurred in 1 (4.8%) patient, and no adverse reactions were observed in other patients. Conclusion:Dupilumab is effective in the control of BP and relief of pruritus, with a favorable safety profile.
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To report a case of generalized lichen amyloidosis successfully treated with dupilumab in China. A 70-year-old male patient presented with extensive itchy papules on the trunk and extremities for 23 years. Skin examination revealed diffuse millet-to mung bean-sized hemispherical brown plaques on the trunk, right anterior shank, and extensor aspect of both upper arms, with a hard texture on palpation. No abnormalities were observed in the blood eosinophil count or serum IgE level. Histopathological examination of the skin lesion on the lower limb showed epidermal hyperkeratosis and homogeneous red-stained lumpy materials in the papillary dermis. Immunohistochemical study showed positive staining with Congo red. The pruritus numerical rating scale score was 10 points. The diagnosis of generalized lichen amyloidosis was confirmed. The patient received subcutaneous injection of dupilumab at an initial dose of 600 mg, followed by an every-2-week regimen at a dose of 300 mg. At week 2 after the start of treatment, pruritus was markedly relieved; at week 14, the skin lesions began to subside markedly; at week 18, the skin lesions on the chest and abdomen nearly completely subsided, and lesions on the lower back and limbs markedly regressed. No obvious adverse reactions were observed.
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Objective:To investigate short-term efficacy and safety of subcutaneous injection of dupilumab in the treatment of moderate-to-severe childhood atopic dermatitis (AD) .Methods:A retrospective study was conducted on clinical data from children who were diagnosed with moderate-to-severe AD and subcutaneously injected with dupilumab in Department of Dermatology, Beijing Children′s Hospital, Capital Medical University from March 2021 to August 2021. Changes in the Eczema Area and Severity Index (EASI), itch Numeric Rating Scale (NRS) score, SCORing Atopic Dermatitis (SCORAD) index, and Dermatology Family quality of life Index (DFI) were analyzed before and 4 weeks after the first subcutaneous injection of dupilumab. Adverse events were collected during the first injection to the first follow-up visit at week 4 after the start of treatment. Normally distributed measurement indices were compared by using paired t test, non-normally distributed measurement indices were compared by using signed rank test, and logistic regression analysis was used to evaluate the effects of disease duration, eosinophil counts, IgE levels, personal and family history of allergic diseases on EASI50 (≥ 50% decrease in the EASI score) after dupilumab treatment. Results:A total of 39 children were enrolled in this study, including 21 males and 18 females. Twenty-one patients were aged 2 to < 6 years, 18 were aged 6 to < 18 years, and their median age ( Q1, Q3) was 65.0 (53.0, 111.0) months. Four weeks after the single-dose subcutaneous injection of dupilumab, 18 patients (84.85%) achieved ≥ 50% decrease in EASI score, 13 (60.61%) ≥ 75% decrease in EASI score; 18 (75.76%) experienced a decrease of ≥ 4 points in peak NRS, and 20 (81.82%) ≥ 3 points in peak NRS; the SCORAD score decreased by ≥ 50% in 15 (68.75%) patients, and by ≥ 75% in 7 (18.75%). Neither common adverse events such as conjunctivitis, skin infections, injection site reactions, nor serious adverse events were observed in any of the children from the first injection to the first follow-up visit at week 4. Logistic regression analysis showed no significant effect of the disease duration, eosinophil counts, IgE levels, personal or family history of allergic diseases on EASI50 (all P > 0.05) . Conclusion:A single-dose subcutaneous injection of dupilumab can markedly improve pruritus and severity of skin lesions in children with moderate-to-severe AD, and enhance the family quality of life, with favorable short-term safety.
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Objective:To evaluate efficacy and safety of dupilumab in the treatment of atopic dermatitis (AD) .Methods:A retrospective study was conducted among patients with AD who showed poor response to topical agents and then received standardized injections of dupilumab for 16 weeks in Department of Dermatology, Peking University First Hospital from June 1, 2020 to September 1, 2021. Basic information on the patients was collected, so were the Investigator′s Global Assessment (IGA), Eczema Area and Severity Index (EASI), Itch Numeric Rating Scale (NRS), Dermatology Life Quality Index (DLQI), and Patient-Oriented Eczema Measure (POEM) scores recorded before and at weeks 2, 4, 8, 12, and 16 during treatment. Adverse reactions were recorded during treatment. Wilcoxon rank sum test was used to compare the scores of all patients at the end of follow-up with those before treatment.Results:A total of 57 patients were enrolled in the study, and all completed 16-week injections and follow-up. At week 16, the patients′ IGA, EASI, NRS, DLQI, and POEM scores significantly decreased from 4.0 (4.0, 5.0), 30.0 (17.2, 36.0), 9.0 (7.0, 10.0), 15.0 (11.5, 20.5), and 19.0 (15.5, 23.0) points respectively at baseline to 1.0 (1.0, 1.0), 4.0 (1.6, 7.3), 1.0 (0.0, 1.0), 3.0 (1.0, 4.0), and 4.0 (2.0, 4.0) points respectively ( Z = 6.65, 6.57, 6.59, 6.57, and 6.57 respectively, all P < 0.001). All the 5 scale scores showed a continuous downward trend within 16 weeks after the start of dupilumab treatment. During the follow-up period, no serious adverse reaction was observed, and only two patients developed conjunctivitis. Conclusion:Dupilumab shows marked efficacy in the treatment of AD, with favorable safety.
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Objective:To analyze the therapeutic effect of adding interleukin (IL)-4Rα monoclonal antibody (duplizumab) to patients with multiple types of inflammatory diseases.Methods:Six patients with multiple types of inflammatory diseases who started to use duplizumab from August 2020 were enrolled. The changes of airway inflammation, lung function, sinuses computed tomography (CT), Asthma Control Questionnaire-5 (ACQ-5), Sino-Nasal Outcome Test-22 (SNOT-22), Pennsylvania Smell Identification Test (UPSIT) and Numerical Rating Scale (NRS) score before and after duplizumab treatment were retrospectively analyzed. All patients were treated with doprilumab for more than 5 months.Results:4 of the 6 patients had both severe asthma and chronic sinusitis, and 2 patients had both severe asthma, chronic sinusitis and atopic dermatitis. After treatment, the pulmonary function of 6 patients was improved, the levels of sputum eosinophils, exhaled nitric oxide and total IgE were decreased (all P<0.05), and the scores of paranasal sinus CT, ACQ-5, SNOT-22 and UPSIT were significantly improved (all P<0.05). However, 3 patients had increased peripheral blood eosinophils during the treatment. Conclusions:Duplizumab is effective for a variety of type 2 inflammatory diseases without obvious adverse reactions, and the peripheral eosinophils may increase during the treatment.
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Atopic dermatitis (AD) is a chronic, relapsing, pruritic inflammatory skin disease.Dupilumab is a monoclonal antibody that inhibits interleukin (IL)-4 and IL-13 signaling pathways through its binding to IL-4α receptor, which has been demonstrated effective in treatment of moderate-to-severe AD.There is an increased incidence of the associated ocular adverse event in the treatment of AD, the probable mechanisms of which are likely related to abnormal mucosal immune regulation, dysfunction of the ocular barrier, and Demodex colonization.In this article, the epidemiology, clinical features, and management of dupilumab for AD were reviewed, and the shortcomings of the current researches about dupilumab-associated adverse events were analyzed, as well as further study directions in exploring etiology, mechanism, and matters needing attention in diagnosis and treatment were discussed.
ABSTRACT
Objective:To evaluate the efficacy and safety of dupilumab in the treatment of adult prurigo nodularis.Methods:A prospective study was conducted on patients with prurigo nodularis who received the treatment with dupilumab in Peking University People′s Hospital from January 2021 to November 2021. Efficacy was assessed using the Investigator′s Global Assessment (IGA) , Numerical Rating Scale (NRS) and Dermatology Life Quality Index (DLQI) at weeks 0, 4 and 16. Wilcoxon signed-rank test and paired t test were used to analyze changes in the above parameters before and after treatment. Results:A total of 17 patients were enrolled in this study, including 12 females and 5 males, aged 48.47 ± 16.26 years. After 16-week treatment with dupilumab, the pruritus NRS score decreased from 8.00 ± 1.50 at baseline to 1.29 ± 0.85 ( t = 6.98, P < 0.001) , the sleeplessness NRS score decreased from 5.18 ± 2.98 at baseline to 0.12 ± 0.49 ( t = 12.55, P < 0.001) , and the DLQI score declined from 13.29 ± 4.03 at baseline to 0.88 ± 0.70 ( t = 16.39, P < 0.001) ; at week 16, the IGA grade of all the 17 patients decreased from 3 - 4 at baseline to 0 - 2, 16 achieved IGA grades 0 - 1, and 12 achieved IGA grade 0. During the treatment, mild conjunctivitis occurred in 2 cases, local injection reaction occurred in 1, and both conditions were improved after short-term symptomatic treatment. Conclusion:Dupilumab is markedly effective and safe in the treatment of adult prurigo nodularis.
ABSTRACT
A urticária é uma lesão cutânea eritematosa, edematosa e pruriginosa, mais prevalente em mulheres entre 30 a 50 anos de idade, sendo classificada em aguda ou crônica. O quadro clínico da urticária crônica espontânea é desencadeado independentemente de estímulos exógenos, podendo ser acompanhado de angioedema em 40% dos casos. O diagnóstico é clínico e a doença pode ser monitorada com escores. O tratamento da urticária crônica espontânea é baseado em anti-histamínicos H1 de segunda geração como primeira linha. A segunda linha se baseia no aumento da dose de anti-histamínicos H1 em até quatro vezes a dose habitual, a terceira linha consiste na associação de imunobiológicos como o omalizumabe, e a quarta linha no uso de ciclosporina. Este relato de caso teve como objetivo analisar a eficácia e segurança do tratamento com dupilumabe na urticária crônica espontânea refratária ao omalizumabe, utilizando os escores de atividade da urticária e o questionário de qualidade de vida em dermatologia. A partir dos resultados obtidos, verificou-se sucesso terapêutico com dupilumabe, que se manteve mesmo após suspensão do medicamento. O uso off label do dupilumabe justificou-se pelo seu mecanismo de ação na fisiopatologia da doença. Este é o primeiro relato de caso brasileiro do uso de dupilumabe para urticária crônica espontânea refratária ao omalizumabe.
Urticaria is an erythematous, edematous, and pruritic skin lesion, most prevalent in women between 30 and 50 years of age, and classified as acute or chronic. The clinical features of spontaneous chronic urticaria are triggered regardless of exogenous stimuli and may be accompanied by angioedema in 40% of cases. The diagnosis is clinical and the disease can be monitored with scores. The first-line treatment of spontaneous chronic urticaria is based on second-generation H1 antihistamines. The second-line treatment is based on increasing the dose of H1 antihistamines by up to four times the standard dose, the third line consists of the association with biologics such as omalizumab, and the fourth line consists of the use of cyclosporine. The present case report aimed to analyze the efficacy and safety of dupilumab treatment for chronic spontaneous urticaria refractory to omalizumab, quantifying clinical improvement and quality of life using urticaria activity scores and a dermatology quality of life questionnaire, respectively. The results obtained showed therapeutic success with dupilumab, which was maintained even after drug suspension. Offlabel use of dupilumab was justified by its mechanism of action in the pathophysiology of the disease. This is the first Brazilian case report of the use of dupilumab for chronic spontaneous urticaria refractory to omalizumab.